Newsletter - SAKK – Swiss Group for Clinical Cancer Research

Transcrição

Newsletter
No 2 / 2015
July 1
EDITORIAL
10 years CEO means 101 trials activated
A
fter being elected by the SAKK Executive Committee, I started as Co-CEO in May 2005. In
this period SAKK still struggled with the consequences of the implementation of the Federal
Act on Medicinal Products and Medical Devices (HMG) in 2002, which led to the partial
shutdown of SAKK and a profound reorganization. The implementation of the HMG changed academic clinical research fundamentally and required higher (quality) standards.
Nevertheless, the conduct of clinical trials was less complex at that time than it is today. For example, the trial coordination
unit, responsible for trial development and conduct, consisted of 12 co-workers in 2005 and was a full service provider.
Today, the same unit – now Clinical Trial Management – has 38 co-workers with specializations in trial management, data
management and monitoring. Furthermore, several tasks have been outsourced to other units such as regulatory affairs,
contract management, safety office, quality assurance, education and fundraising. Specialization was and is the key word
for further development.
Some may question the necessity of this growth in size and competence of the SAKK Coordinating Center during the past
years. However, in my opinion, and also concluded in the evaluation by international experts (press release and publication
of the report coming soon), the size of the present SAKK CC is needed to be able to develop and to manage as many trials
as SAKK does.
Besides, the growth of SAKK also includes our members; we have 19 members today – which is twice as much as in 2005.
This development makes it challenging to act in the interest of all members as their specific requirements differ widely.
Taking the needs of the different stakeholders into account and integrating them into a strategy makes a CEOs life very
demanding.
So what is my motivation after ten years as CEO of SAKK? It is the will to offer attractive, scientifically sound clinical trials
to the centers. It is still exciting to take part in the progress in oncology and seeing the enhancements of SAKK. I am very
proud to look back on a period of 50 years of SAKK and seeing what progress clinical research has brought to patient care.
In spite of all difficulties and challenges it is satisfying to work with so many dedicated people for the greater good: bringing
progress to cancer care. And I hope serving SAKK and its goals
Contents
for another decade.
Thank you for your support and commitment!
Peter Brauchli
SAKK CEO
The Swiss Oncology Research Network
SAKK News
2-4
SAKK Anniversary
4-8
General Assembly, Semi-Annual Meeting
9-11
Trial News
12-18
Publications, Presentations
19-20
IBCSG21-23
ETOP23-24
Cancer League
24
Grants, Events, Education
25-27
Dates, Flag
28
2 July 1, 2015
SAKK Newsletter
SAKK NEWS
News from the SAKK board
HD21: coordinating investigator A. Moccia
At its board meeting and retreat on May 5 & 6, 2015,
in Oberhofen, the SAKK board discussed various strategic
issues and also held a regular session to discuss and approve trial proposals.
Treatment optimization trial in the first-line treatment of
advanced stage Hodgkin lymphoma.
Topics of the retreat included the discussion of the research strategy paper where several international advisors and project group presidents have given inputs.
Also, the next steps of the concept for the involvement
of patients and patient organizations were presented by
Claudia Weiss. The goal is to have a SAKK patient consortium appointed by the end of 2015 and the respective job
description in place.
Further topics were the lessons learnt from the evaluation
by the Swiss National Science Foundation and our phase I
activities. In the regular session, the following trials were
accepted in the final assessment:
PRODIGE 32 ESOSTRATE: coordinating
investigator T. Ruhstaller
Randomised phase II-III strategic trial in operable oesophageal cancer in case of clinical complete re-sponse
after chemoradiation: systematic surgery vs surveillance
with selective salvage surgery in case of operable recurrence.
This trial was initiated by French cooperative groups and
addresses complete clinical responders to CRT. In patients
with esophageal carcinoma treated with initial chemoradiation followed by surgery, neither the resolution of
symptoms, nor the normalization of radiographic studies,
nor endoscopy or endoscopic ultrasonography accurately
identified pathologic complete response.
Indeed, no current procedure is able to give a reliable
prediction of the degree of response. However, if clinical
complete responders to CRT are tightly followed-up and
proposed surgery in case of operable loco-regional recurrence, one can expect a survival not different from survival after systematic surgery. Thus choosing between both
strategies (with or without systematic surgery) might rely
on factors other than overall survival only: disease free
survival, quality of life, or life threatening adverse events.
The board members agreed to participate in this trial.
This trial was initiated by the German Hodgkin Study
Group and is the follow-up of HD18. The aim of the HD21
trial is to prove that the new chemotherapy regimen,
BrECADD, is non-inferior to BEACOPP as first-line treatment in advanced stage classical Hodgkin lymphoma patients aged ≤ 60. The combination of conventional chemotherapy with brentuximab vedotin is designed to reduce
the doses of certain conventional cytostatics in order to
reduce the rate of adverse effects while maintaining an
equally good response to treatment. The board members
agreed to participate in this trial.
SAKK 08/15 PROMET: coordinating investigator
A. Dal Pra
Multicenter, Randomized, Double Blind, Placebo Controlled Phase II Trial of Salvage Radiotherapy +/- Metformin HCL after Prostatectomy Failure.
PROMET is an international trial with SAKK in the lead.
This trial offers an opportunity for optimization of the
therapeutic window through an inexpensive and safe
drug in a scenario where therapy is controversial and outcomes are overall suboptimal. A prospective trial would
help consolidate the biological rationale, which has been
built in pre-clinical studies and hypothesized in several
retrospective cohorts. Through associated translational
studies (separate proposal) this trial could offer unique
potentials for the discovery of novel prospective and predictive biomarkers. It will be essential to identify those
patients for whom treatment de- or intensification is required. The board members agreed to conduct the trial
under the condition that 70 % of the costs are covered.
Subproject SAKK 06/14: coordinating
investigator C. Rentsch
Investigating phagocytosis of recombinant BCG
VPM1002BCG after intravesical instillation in patients
with recurrent non-muscle invasive bladder cancer.
The aim of the subproject is to compare descriptively the
internalization of the VPM1002 GMO strain versus a conventional BCG strain but also to localize important host
factors within the cells. The samples which are needed
for this project are collected within the trial treatment of
July 1, 2015 3
SAKK Newsletter
SAKK NEWS
SAKK 06/14 and no additional funding is required. The
board members agreed to initiate this subproject.
Approval of the new president of the project
group New Anticancer Drugs
Markus Joerger was elected in the project group unani-
mously. The board members approved of this election.
Joerger replaces Cristiana Sessa as she was elected as
board member in November 2014.
Farewell
Karin Marchesi has worked as assistant regulatory affairs.
She left the coordinating center end of May.
Claudia Weiss, responsible for politics & development in
the staff unit, and Severin Strasky, Head of Fundraising &
Communications and member of the executive committee, will both leave the coordinating center end of July.
Fatma Karabulut Memis, clinical research associate, and
Lukas Stalder, clinical project manager, will both leave the
Awards and promotions
coordinating center in late summer.
PD Dr. Martin Früh, leading physician at
the Cantonal Hospital in St.Gallen, was
nominated as associate professor at the
University of Bern. Früh is member of the
SAKK project group lung cancer.
Prof. Dr. Niklaus Schaefer, Assistant
We thank them for their commitment and dedication to
SAKK and we wish them all the best for their future.
For information about job vacancies at SAKK, please contact us and/or refer to http://sakk.ch/en/download/19
M. Früh
Professor for "Bildgestützte Molekulare
Therapie" at the University of Zurich and University Hospital of Zurich was promoted to Associate Professor for Theragnostics at the
Centre Hospitalier Universitaire Vaudois
(CHUV) and University of Lausanne. The
aim of Theragnostics is to combine diagnostic and therapeutic capabilities
in complex disease patterns as cancer
N. Schaefer
medicine.
SAKK CC Staff News
Peter Brauchli, SAKK CEO, celebrated his 10-year jubilee
at the coordinating center. He started in 2005 under the
presidency of Richard Herrmann. His year-long experience
and his profound knowledge of clinical cancer research is
an asset for our organization.
Cornelia Kruschel, Head of CDM, and Michael Beyeler,
clinical project manager, both celebrated their 5-year jubilee at the coordinating center.
We thank them for their great commitment over the past
years and wish them all the best for the coming ones.
Direct phone numbers of SAKK CC staff
All direct phone numbers of the SAKK CC staff are new
published on our website: http://sakk.ch/en/about-sakk/
organization/coordinating-center/
Swiss Post Asco Event
Under the lead of SAKK, on
June 11, 2015, at the Stade
de Suisse in Bern, nationwide recognized speakers
presented the scientific results of the annual meeting of the American Society of
Clinical Oncology (ASCO) at the Swiss PostASCO event
to a large audience of specialists and experts. The ASCO
annual meeting is a leading event in the field of oncology
with a strong focus on research and innovation.
Since not all Swiss experts in medical oncology are able
to attend the ASCO annual meeting, the PostASCO Academy and SAKK organize a Swiss PostASCO event in Switzerland every year after the official annual meeting. The
PostASCO event allows easy access to scientific news and
state of the art interpretation (www.swisspostasco.ch).
Welcome
Beatrice Kummer joined the SAKK team in March as as-
sistant regulatory affairs.
4 July 1, 2015
SAKK Newsletter
SAKK NEWS
Experts reach consensus at
prostate cancer conference in
St.Gallen
The first international Advanced Prostate Cancer Consensus Conference (APCCC) took place from 12 to 14 March
2015 in the Congress Center of Hotel Einstein in St.Gallen.
The aim of the international prostate cancer consensus
conference was to bring together existing expert knowledge on the field and formulate recommendations, so
that men affected by this disease can receive optimum
therapy and be offered the best possible individual treatment concepts.
This first conference was extremely successful. More than
400 people from a total of 47 countries took part. The first
two days were devoted to lectures and debates in which
current knowledge concerning the treatment of men with
prostate cancer was presented and discussed. On the
third day, around 90 questions prepared in the run-up to
the conference were then debated and agreed upon by
the 41 international experts.
Building on the questions and results, a publication will
now be produced following the conference with a set of
recommendations for the treatment of men with prostate
cancer that should be followed worldwide. The event was
also supported by SAKK.
SAKK ANNIVERSARY
SAKK studies effect of sport on
chemotherapy
SAKK 41/14/ACTIVE-2: Physical activity program in patients with metastatic colorectal
cancer who receive palliative
first-line chemotherapy. A multicentre open label randomized
phase III trial.
Researchers from our network lead by clinical investigator Viviane Hess want to establish whether patients with
cancer of the colon benefit more from treatment if they
are physically active. This is the first time that we study
cancer therapy that includes sport. With this trial, SAKK is
also continuing its efforts to improve the quality of life of
patients. The trial was launched with a press conference
and press release on May 20, 2015 together with our public anniversary event on Bundesplatz in Bern (see below
for details). Several newspapers, Radio Suisse Romande
and Tele Bärn have released reports on the trial.
It is known from large studies that people who exercise
are less likely to suffer from cancer of the colon. Physically active patients also suffer less often from relapses.
However, it is still not known to this day whether sport
during therapy for colon cancer leads to better treatment
results. The trial will be conducted under the lead of SAKK
in numerous hospitals in Switzerland, Austria and Germany with the collaboration of the Austrian Working Group
AGMT.
Active Against Cancer Event in
Bern on May 20th, 2015
SAKK celebrated its 50th anniversary on May 20th on
Bundesplatz in Bern. The village set up with a children’s
tent, an information tent and a marquee for guests, as
well as food stalls and a stage, was open from 3 pm to
10 pm. The varied program was hosted by former Miss
Switzerland and SAKK ambassador, Tanja Gutmann. Radio Bern 1 broadcasted live from Bundesplatz and interviewed SAKK CEO Peter Brauchli and the musicians Luca
Hänni and GUSTAV.
J. Hochstrasser, V. Hess, B. Thürlimann
July 1, 2015 5
SAKK Newsletter
SAKK ANNIVERSARY
tition was held in the evening, in which four teams competed in three contests. The teams were supported by the
SAKK ambassadors Stefan Kobel, Jaël Malli and Laszlo I.
Kish. Dumb bells were lifted, SAKK jumped and towers
built. The winning team was appointed 50th Ambassador.
Animation and fun for children
At the start of the jubilee celebrations, fairy story teller
Prisca Saxer mesmerized the kids in the children’s tent
with the Story of Little Muck. The well-known Swiss cartoonist and artist Ted Scapa inspired the many curious
budding young artists with amusing drawings and handed out his children’s books. And the band Leierchischte
XXL rounded off the children’s program with a concert.
"SAKK jumping" during the sports competition
Concerts of Swiss artists
But the golden jubilee of the SAKK was also celebrated
with music. Luca Hänni enthralled the audience with his
new single and a rain of confetti, before BAUM and GUSTAV rocked the stage of the Active Against Cancer event.
Voices of artists and staff of the
event
The two artists and SAKK ambassadors, BAUM and
GUSTAV, who performed at the event as well as staff
members of the SAKK CC comment on their impression
of the Active Against Cancer Event.
Drawing with T. Scapa
Information on clinical cancer research for the
public
For passers-by who wanted more detailed information on
the subject of clinical cancer research, SAKK employees
were on hand in the information tent to explain the cancer chart, answer questions and supply visitors with flyers
and brochures.
Sports competition with the participation of
ambassadors
True to the motto Active Against Cancer a sports compeBAUM in concert
6 July 1, 2015
SAKK Newsletter
SAKK ANNIVERSARY
Who is who
A. Fuhrer: I really liked the event mainly because of the
BAUM started his official career as a solo support act with
great spirit of all staff members and the lovely people that
came to visit us on Bundesplatz. It truly was a village of
joy and fun.
great musicians such as Van Morrison, The John Butler
Trio and Gawn DeGraw. After being nominated "artist of
the month" by Peter Gabriel’s portal We7, BAUM pursued
his own musical growth on solo tours and appearances at
Swiss festivals. The moment had come for BAUM to tackle
his first studio album "Music for my Landlord", which he
recorded at the Cutting Room Studios in New York.
GUSTAV is acting in various music formations on Swiss
stages since 20 years. His life shows are highly popular
and brought the bilingual musician and songwriter to almost every corner in the country.
S. Hayoz: it was very interesting to meet the artists and
to see what is going on backstage of an event. The whole
event was very well organized, everything went smoothly
which is impressive for an event of this size.
Why did you decide to be involved in the Active
Against Cancer Event?
GUSTAV: I think everyone has distant relatives or maybe
even somebody close – family members, friends who died
of cancer. Only research can find a cure for the disease.
We have to repeat this fact over and over again to the
people. As a musician I can support organizations such as
SAKK to get visibility in the public – and help in the fight
against cancer.
BAUM: we first got the offer to play at the festival as a
band, then I was even asked to promote SAKK's goals as
one of their ambassadors which both was and is a huge
honor to me! Right from the start it was absolutely clear
that we would all give our very best to support SAKK's
philosophy and commitment.
B. Tschanz: I feel proud of being a small wheel in the canGUSTAV on stage
cer research of SAKK. Thus, I also wanted to contribute to
"our" event and was very curious about what we would
encounter on Bundesplatz.
Andrea Fuhrer, Catherine Berset and Estelle Cassoly are
working as clinical project managers at the SAKK CC.
Britta Tschanz works as clinical research associate and
Martin Bigler and Stefanie Hayoz are both statisticians.
C. Berset: I was convinced that it was a good thing; a
good way to reach the goals of increasing awareness,
informing the public, and celebrating the achievements
How did you experience the Active Against
Cancer Event?
BAUM: usually festivals are busy for everyone involved the schedule is tight, there's not enough space behind the
stage, everyone and everything feels like being squeezedin. But playing at the Active Against Cancer Event was
absolutely different! Everyone was nice and friendly, the
atmosphere was relaxed and warmhearted, you could tell
that everyone felt that we're part of something bigger
and more important than just a regular festival.
GUSTAV: Despite the bad weather many people came to
visit the concerts and we had a great evening. Everything
was well organized and brought good visibilty for SAKK:
The SAKK village on Bundesplatz
July 1, 2015 7
SAKK Newsletter
SAKK ANNIVERSARY
of the last 50 years. Sonja Bill and her team transmitted
their enthusiasm. The event was well thought and well
planned.
A. Fuhrer: I think it is very important that the public is
introduced to the background and also the goals of a
clinical trial. As a clinical project manager mainly works
behind the scenes, the event offered the possibility to be
an active part in making SAKK and its contribution to the
fight against cancer known to the public.
I was so touched by the positive spirit, the smiling faces
and the kindness of everyone involved. So in my opinion,
the festival should take place every year, as it combines
the important campaign for cancer awareness with everyone having a good time!
B. Tschanz: it was very touching to meet visitors and
patients in the information tent. We closely experienced
their interest in what SAKK stands for and their joy in participating at the contest (Note for readers: visitors could
win various prizes by answering a quizz, see below)
What did you like the most about the Active
Against Cancer Event?
GUSTAV: the ambiance was great for everyone: the organizors, the bands and the visitors. What else is needed?
M. Bigler: it was nice to see how people came and en-
joyed the Active Against Cancer Event. They were informed about what SAKK does and how important it’s
tasks are, so that SAKK is better known to more people.
E. Cassoly: The general ambiance. How everyone
contributed to the event, either by helping or attending.
BAUM: we all know that cancer is not only a "topic", it's
a sad reality and it affects our lives every day. Therefore,
Luca Hänni in Concert
Winners of the quizz challenge of
the Active Against Cancer Event on
May 20, 2015
First prize: Microsoft Surface Pro 3 i5 Tablet
Stefan von Burg, Biel
2nd to 4th prize: 12 admissions to the savo
fitness studio
Elisabeth Wittwer, Langnau
Stefan Gertsch, Bern
Blerim Tupan, Schmitten
5th to 7th prize: Activity Tracker fitbit flex
Xenia Kipouros, Windisch
Rahel Koller, Appenzell
Sophie Jenzer, Vinelz
CEO Peter Brauchli handing over the first prize to
Stefan von Burg
The prizes were kindly offered by alphaTrust.ch ag and
savo.ch.
8 July 1, 2015
SAKK Newsletter
SAKK ANNIVERSARY
SAKK in the media and anniversary
booklet
Besides this public event, our anniversary was taken up in
the media as well. The NZZ published an article on SAKKs
history and achievements of the last 50 years on March
11 with the title: "Für jeden Patienten die bestmögliche
Therapie".
New SAKK information brochures
Within the framework of the anniversary year and our
corporate identity, SAKK published new information brochures. Every member center has received a stock of these
newly designed hand-out material.
The information flyer summarizes
the most important aspects of our
organization, clinical studies and
participation in studies.
Furthermore, an anniversary booklet was published by
SAKK in June and distributed together with the Swiss
Cancer Bulletin. Among others, Federal Councilor Johann
Schneider-Ammann wrote congratulations to SAKK and
stated: “SAKK has gained national and international significance in cancer research, not least because it manages to build bridges between fundamental research
and clinical research. As a result, it brings added scientific value to biomedical disciplines and complements
the research activities at universities and the ETH departments.” Other topics include success stories of the
SAKK project groups, patients’ voice and reports of SAKK
members.
Copies can be ordered at the SAKK CC (mail to claudia.
[email protected]) and an online version is published on
our website http://sakk.ch/en/about-sakk/publications/.
The SAKK brochure for patients
provides comprehensive information on clinical studies. It explains
what a clinical study is, why and
how it is carried out, what rights
and responsibilities patients have
and what the opportunities and
risks of a study are.
The flyer summarizes what we
want, what we do and contains the map of clinical cancer
research
All three publications are available in German, French and
Italian and can be ordered by
e-mail to [email protected].
Online versions are
on our website http://
sakk.ch/en/sakk-provides/for-patients/brochures/
In addition, the banner "Aktiv gegen Krebs - 50 Jahre
SAKK" can be borrowed for your regional anniversary
events (see picture on page 7). For details and measurements contact [email protected]
July 1, 2015 9
SAKK Newsletter
SAKK GENERAL ASSEMBLY & SEMI-ANNUAL MEETING
General Assembly
During the General Assembly, which took place on
June 24 in the Marriott Hotel in Zurich, the participants
reelected Stefan Aebi from the Cantonal Hospital Lucerne
as board member. Achim Weber from
the University Hospital Zurich resigned
from his board membership and
Ellen C. Obermann, leading physician at the University Hospital Basel,
was elected as
new representative of pathology in the board.
The members
A. Weber
thanked Weber
for his great contribution over the
past years and wished him success
for his future projects.
E. Obermann
In addition to the elections, the General Assembly approved the annual report and accounts 2014 and granted
discharge to the SAKK board. Furthermore, an excerpt of
the discussed topics can be given as follows:
• The board suggested a revision of the SAKK bylaws.
The changes were presented by legal councilor Dr.
Claude Thomann. The member representatives discussed the proposal and added some changes. The
new bylaws will be implemented soon and be available on our website www.sakk.ch
• The law in Human Research (HFG) requires new contracts between the SAKK and its member centers. VAT
has not to be added to the work of the sites; this applies in any case, unless a third party (e.g. company)
has exclusive rights. The contracts should be finalized
by the end of July 2015.
welcoming speech SAKK President Beat Thürlimann congratulated the co-founders of SAKK and appreciated their
braveness, courage and spirit for this important step in
clinical cancer research. He summarized the anniversary
events organized by the Coordinating Center (see also
page 4) and the regional activities at the centres (upcoming events see page 28)
In his very eloquent and humorous talk, Franco Cavalli
gave a short overview of the trends during the past fifty
years in cancer research. Impressively, the overall cure
rate of cancer is above 70 % but there are still tumors in
which there is little hope to overcome the disease. SAKK
with its broad network and bold approaches contributed
significantly to this progress in the last 50 years; however, due to political reasons, Switzerland is loosing the
pioneering role which we had in clinical research in the
sixties and seventies. But for Cavalli the question remains:
Do we win the war over cancer? Especially in underdeveloped countries cancer becomes an increasing health
issue due to very limited possibilities for treatment. In
over 30 countries there is no access to radiotherapy and
drugs are rarely available. To win the war, Cavalli stretch-
Semi-Annual Meeting
On June 25 and 26, SAKK held its summer semi-annual
meeting in Zurich, which was attended by more than 250
specialists.
SAKK 50 years Symposium
The 50 years symposium was dedicated to SAKKs anniversary. In three short presentations both the past and the
future of clinical cancer research were illuminated. In his
F. Cavalli
10 July 1, 2015
SAKK Newsletter
SEMI-ANNUAL MEETING
es the need to search for new and innovative approaches
at the scientific, political and economical level.
lytic viruses. SAKK has contributed impressively to new
treatment possibilities with its combined chemotherapy
approach in SAKK 44/00.
Markus Wartenberg turned over a new leave in cancer
research – patient involvement will be increasingly important especially but not only for rare cancers. May it
be at the level of patient friendly communication and information, as advocates for clinical trials and definitely
in helping to identify neglected topics. He demonstrated
impressively the current leading role of the German patient advocacy group Lebenshaus being involved in the
development of study designs for cancer trials up to the
discussion with regulatory authorities and politicians.
He mentioned possible approaches for SAKK and gave
unique insights of "expert patients" along the whole research and development life cycle.
Beat Thürlimann closed the Symposium with the outlook
that SAKK contributes with its trials, broad network and
expertise to the improvement of cancer therapy and the
quality of life for cancer patients. Furthermore, SAKK will
launch its own patient advocacy group with the aim to
integrate the patients voice at SAKK on several levels.
Satellite Symposium
M. Wartenberg
In the last presentation with the title "Back to the future", Michael Montemurro reported on achievements
and challenges of the rare, however very aggressive and
often too late diagnosed, pancreatic cancer. Innovative
treatment strategies and targets give new hope for the
future. Currently in evaluation are vaccines, checkpoint
inhibitors, agents targeting the tumor stroma and onco-
A highlight of the semi-annual meeting was the satellite
symposium on “The next level in melanoma therapy”,
chaired by SAKK Vice-President Roger von Moos and
held with participation of the renowned experts Olivier
Michielin, Lausanne, Reinhard Dummer, Zurich, and
Andreas Wicki, Basel, which approached the different aspects of the resistance to targeted therapy in melanoma
treatment and possible solutions.
The speeches were followed by a panel discussion. The
satellite symposium was kindly sponsored by Roche
Pharma (Schweiz) AG.
M. Montemurro
SAKK Newsletter
July 1, 2015 11
SEMI-ANNUAL MEETING
SAKK/Dr. Paul Janssen Fellowship for
Simone M. Goldinger
underdosing in cancer patients with normal renal function using estimated GFR: lessons learnt from a stage I
seminoma cohort". The winning proposal was chosen out
of 12 initial applications by a jury consisting of 3 experts.
Fehr and Cathomas published the data on the use of
A. Sauerborn (Janssen), M. Goldinger,
B. Thürlimann
Simone M. Goldinger from the University Hospital Zurich
obtained the SAKK/Dr. Paul Janssen Fellowship, which is
jointly awarded by SAKK and Janssen-Cilag. The educational grant is endowed with CHF 30'000 and is aimed
at offering young doctors the opportunity to spend four
months at a renowned research center abroad to gain experience and acquire the necessary know-how and tools
to develop and conduct top-quality clinical trials.
Goldinger will spend her fellowship in the two centres of
excellence for immunotherapy and targeted therapy for
melanoma at the UCLA in Los Angeles and at the Henri
and Belinda Termeer Center in Boston.
carboplatin as an adjuvant therapy for 426 patients with
early-stage seminoma who were at moderate risk of recurrence in the Annals of Oncology in March 2014. The
carboplatin dose was determined by the Calvert formula:
(GFR + 25) × AUC, with a target area under the curve
(AUC) of 7 mg ml/min. All patients underwent measurement of glomerular filtration rate (GFR) with radioisotopebased methods (51Cr-EDTA or 99mTc-DTPA). Measured GFR
was compared with estimated GFR (eGFR) using various
formulas, none of which carried out very well: if the carboplatin dose had been calculated using eGFR instead
of actual GFR, a significant proportion of patients would
have been under- or overdosed.
The authors conclude that radioisotope methods are recommended when adjuvant carboplatin is prescribed for
stage I seminoma, where doses below AUC 7 may be associated with inferior outcomes. The publication had a
high international response within the scientific community and was quoted several times in medical journals –
for example in the British Medical Journal, the European
Journal of Cancer and the Journal of Clinical Oncology.
In Switzerland, the data lead to a change of practice in
various Swiss oncological departments and discussions in
journal clubs.
The scope of these visits is to have the opportunity to be
mentored by experts in the field and to transfer knowledge to the home country Switzerland. Indeed, the goal is
to increase the promotion and acquisition of clinical trials
for the local melanoma patient population in Switzerland,
improve the network and the exchange with other excellence centers.
SAKK/Pfizer Award for Richard Cathomas
and Martin Fehr
Sonja Nick, Medical Advisor Oncology at Pfizer, and Beat
Thürlimann, SAKK President, awarded the winners of the
SAKK Pfizer Award, Richard Cathomas, Cantonal Hospital Graubünden and Martin Fehr, Cantonal Hospital
B. Thürlimann, R. Cathomas, M. Fehr, S. Nick
St.Gallen, for the project "Relevant risk of carboplatin
12 July 1, 2015
SAKK Newsletter
TRIAL NEWS
Trials to be activated 2015/2016, effective June 2015
Trial
Trial Name
SAKK 06/14
A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation Q3 2015
of the recombinant BCG VPM1002 in patients with recurrent non-muscle invasive bladder (August)
cancer after standard BCG therapy
SAKK 25/14
Eribulin 1st line in elderly (≥ 70years) and old patients (> 80y) with metastatic breast cancer: Q3 2015
a phase II trial
SAKK 36/13
Combination of Ibrutinib and Bortezomib to treat mantle cell lymphomas patients – a mul- Q3 2015
ticenter phase I/II trial
Alliance/
Prospect trial
A phase II/III trial of neoadjuvant folfox, with selective use of combined modality chemora- Q3 2015*
diation vs. preoperative combined modality chemoradiation for locally advanced rectal cancer patients undergoing low anterior resection with total mesorectal excision
BIG 6-13
A randomised, double‐blind, parallel group, placebocontrolled multi‐centre Phase III study to Q3 2015*
assess the efficacy and safety of olaparib vs placebo as adjuvant treatment in patients with
high risk germline BRCA mutated HER2‐negative breast cancer who have completed definitive local and systemic neoadjuvant/adjuvant treatment
IELSG-42
An international phase II trial assessing tolerability and efficacy of sequential Methotrexate- Q3 2015*
Aracytin-based combination and R-ICE combination followed by high-dose chemotherapy
supported by autologous stem cell transplant in patients with systemic DLBCL with CNS
involvement at diagnosis or relapse (MARIETTA regimen)
IELSG-43
High-dose chemotherapy and autologous stem cell transplant consolidating conventional Q3 2015*
chemotherapy in primary CNS lymphoma -randomized phase III trial
SAKK 35/14
Extended Rituximab with or without Ibrutinib. A randomized blinded Phase II trial
SAKK 08/14
IMPROVE
Enzalutamide in combination with metformin vs. enzalutamide in patients with CRPC pro- Q3-4 2015
gressing on androgen deprivation therapy (ADT)
SAKK 41/13
Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double- Q4 2015
blinded, placebo-controlled, phase III trial.
SAKK 41/14
Active-2
Physical activity program in patients with metastatic colorectal cancer who receive palliative Q4 2015
first-line chemotherapy. A multicenter open label randomized controlled phase III trial
GRAALL-2014
Treatment of adult acute lymphoblastic leukemia (ALL), evaluating the addition of a second Q4 2015*
late intensification course in B-lineage PH-negative ALL, the addition of Nelara-bine in highrisk T-lineage ALL, and the reduction of chemotherapy intensity in Ph+ ALL
SAKK 16/14
Perioperative anti-PD-L1 antibody MEDI4736 in addition to standard neoadjuvant chemo- Q1 2016
therapy in non-small cell lung cancer (NSCLC) patients with mediastinal lymph node metastases (stage IIIA, N2)
SAKK 21/12
(Phase II part)
A Phase I and stratified, multicenter Phase II trial of transdermal CR1447 (4-OH-testosterone) Q1 2016
in endocrine responsive-HER2 negative and triple negative-androgen receptor positive metastatic or locally advanced breast cancer
HD21
Treatment optimization trial in the first-line treatment of advanced stage Hodgkin Lympho- Q1 2016*
ma: comparision of 6 cycles of escaleted BEACOPP with 6 cycles of BrECADD
*Dependent on the cooperative group, just an estimated opening for accrual
Opening of
the first site
Q3-4 2015
July 1, 2015 13
SAKK Newsletter
TRIAL NEWS
Trials to be activated 2015/2016, effective June 2015
HOVON 103 SEL
SAKK 30/10
A randomized phase II multicenter study with a safety run-in to assess the tolerability and Q1 2016*
efficacy of the addition of oral selinexor (KPT-330) to standard induction therapy in AML high
risk myelodysplasia (MDS) (IPSS-R risk score >4.5) in patients aged ≥ 66 years
PRODIGE 32
Randomised phase II-III strategic trial in operable oesophageal cancer in case of clinical Q1 2016*
complete response after chemoradiation: systematic surgery vs surveillance with selective
salvage surgery in case of operable recurrence
SAKK 08/15
ProMET
Multicenter, Randomized, Double Blind, Placebo Controlled Phase II Trial of Salvage Radio- Q1-2 2016§
therapy +/- Metformin HCL after Prostatectomy Failure
SAKK 09/15
Extended pelvic lymph node dissection vs. no pelvic lymph node dissection at radical pros- Q1-2 2016§
tatectomy for intermediate- and high-risk prostate cancer: A randomized multicenter international trial
SAKK 06/13
BOOST: A prospective placebo controlled randomized study comparing intradermal BCG im- on hold
munization before intravesical BCG to standard intravesical BCG therapy alone in patients
with non-muscle invasive bladder cancer
*Dependent on the cooperative group, just an estimated opening for accrual
§
If financing is secured
Trials Open for Accrual June 2015
Disease
Group
Trial Name
Trial Description
Accrual Current Estimated
Target Accrual* Closure for
Accrual
Trial Coordinator
Urogenital
Cancers
SAKK 01/10
Involved Node Radiotherapy and Car- 115
boplatin Chemotherapy in Stage IIA/B
Seminoma
43
15.06.2017
stavros.milatos@sakk.
ch
Urogenital
Cancers
SAKK 63/12
Prospective cohort study with collection 1930
of clinical data and serum of patients
with prostate disease
118
15.10.2016
[email protected]
Urogenital
Cancers
SAKK 96/12
Prevention of Symptomatic Skeletal 1380
Events with Denosumab Administered
every 4 Weeks versus every 12 Weeks – A
Non-Inferiority Phase III Trial
66
16.01.2019
[email protected]
Urogenital
Cancers
STAMPEDE
Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug
Efficacy A 5-stage multi-arm randomised
controlled trial
47
31.12.2016
estelle.cassoly
@sakk.ch
Lung
Cancers
SAKK 15/12
Early prophylactic cranial irradiation with 42
hippocampal avoidance in patients with
limited disease small-cell lung cancer. A
multicenter phase II trial
9
11.05.2016
[email protected]
Updated
*Current accrual as of end of May, 2015. Accrual for non-SAKK trials only includes patients enrolled at SAKK centers.
14 July 1, 2015
SAKK Newsletter
TRIAL NEWS
Disease
Group
Trial Name
Trial Description
Accrual
Lung
Cancers
SAKK 16/08
Preoperative chemotherapy and radio- 69
therapy with concomitant Cetuximab
in non-small cell lung cancer (NSCLC)
patients with IIIB disease. A multicenter
phase II trial
62
30.12.2015
heike.kenner
@sakk.ch
Lung
Cancers
SPLENDOUR
A randomised, open-label phase III trial 1000
evaluating the addition of denosumab to
standard first-line anticancer treatment in
advanced NSCLC
18
30.03.2018
SPLENDOUR@etop-eu.
org
Lung
Cancers
EORTC
LungArt
Phase III study comparing post-operative 700
conformal radiotherapy to no post-operative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 involvement
1
31.08.2018
oussama.karroum@
eortc.be
Breast
Cancers
SAKK 22/10
A randomized phase II trial of pertu- 208
zumab in combination with trastuzumab
with or without chemotherapy, both followed by T-DM1 in case of progression,
in patients with HER2-positive metastatic
breast cancer
151
30.11.2015
marie-aline.
[email protected]
Breast
Cancers
SAKK 23/13
Randomized Controlled Trial to Evaluate 142
the Impact of a Surgical Sealing Patch on
Lymphatic Drainage after Axillary Lymph
Node Dissection for Breast Cancer
7
31.03.2017
estelle.cassoly@sakk.
ch
Breast
Cancers
SAKK 96/12
Prevention of Symptomatic Skeletal 1380
Events with Denosumab Administered
every 4 Weeks versus every 12 Weeks – A
Non-Inferiority Phase III Trial
58
16.01.2019
[email protected]
Breast
Cancers
EORTC 10085 EORTC 10085 prospective part, Clinical and bioPRO
logical characterization of Male Breast Cancer: an
international EORTC, BIG and NABCG intergroup
study
16
30.06.2016
estelle.cassoly@sakk.
ch
Breast
Cancers
IBCSG 42-12
SNAP
A randomized phase II study evaluating 258
different schedules of nab-Paclitaxel in
metastatic breast cancer
73
Q2 2015
ibcsg42_SNAP
@fstrf.org
Breast
Cancers
IBCSG 43-09
HOHO
Prospective observational study of young 300
women (£ 40 years at diagnosis) with
breast cancer. Data analyzed will include
serial patient surveys and medical record
information
71
Q4 2015
Monica.Ruggeri
@ibcsg.org
Updated
Trial Coordinator
July 1, 2015 15
SAKK Newsletter
TRIAL NEWS
Disease
Group
Trial Name
Trial Description
Accrual
Trial Coordinator
Breast
Cancers
IBCSG 48-14/ A study evaluating the pregnancy out- 500
BIG 8-13
comes and safety of interrupting endocrine therapy for young women with
endocrine responsive breast cancer who
desire pregnancy
2
Leukemias
SAKK 33/14
Effects of sympathicomimetic agonists on 39
the disease course and mutant allele burden in patients with JAK2-mutated myeloproliferative neoplasms A multicenter
phase II trial
2
30.09.2016
[email protected]
Leukemias
APL 2006
Randomized phase III trial assessing 800
the role of arsenic trioxide and/or ATRA
during consolidation course in newly diagnosed acute promyelocytic leukemia
(APL)
64
15.05.2016
fatma.karabulut
@sakk.ch
Leukemias
CML V
Treatment optimization of newly diag- 628
nosed Ph/BCR-ABL positive patients with
chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus
interferon alpha induction and nilotinib
or interferon alpha maintenance therapy
14
Q1 2016
anna.tomaszewska@
sakk.ch
Leukemias
EBMT HCT
vs CT
Compare conventinal chemotherapy to 231
low dose total body irradiation-based
conditioning and hematopoietic cell
transplantation as consolidation therapy
9
31.12.2015
fatma.karabulut
@sakk.ch
Leukemias
HOVON 103TOS
A randomized phase II multicenter study 200
with a safety run-in to assess the tolerability and efficacy of the addition of oral
tosedostat to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients
aged ≥ 66
6
15.10.2015
[email protected]
Leukemias
HOVON 132
Randomized study with a run-in dose- 860
selection phase to assess the added value
of lenalidomide in combination with standard remission-induction chemotherapy
and post-remission treatment in patients
aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high
risk myelodysplasia (MDS) (IPSS-R risk
score > 4.5)
1
30.06.2017
[email protected]
Monica.Ruggeri
@ibcsg.org
Updated
16 July 1, 2015
SAKK Newsletter
TRIAL NEWS
Disease
Group
Trial Name
Trial Description
Accrual
Lymphomas
SAKK 39/10
Nelfinavir and lenalidomide/dexametha- 35
sone in patients with progressive multiple
myeloma that have failed lenalidomidecontaining therapy. A single arm phase I/
II trial
17
31.03.2016
michael.beyeler
@sakk.ch
Lymphomas
SAKK 39/13
Nelfinavir and lenalidomide/dexametha- 34
sone in patients with progressive multiple
myeloma that have failed lenalidomidecontaining therapy. A single arm phase I/
II trial
8
31.08.2016
catherine.berset@
sakk.ch
Lymphomas
HD 16
HD16 for early stages: Treatment optimi- 1100
zation trial in the first-line treatment of
early stage Hodgkin lymphoma; treatment stratification by means of FDG-PET
60
30.09.2015
katrin.eckhardt
@sakk.ch
Lymphomas
HD 17
Therapieoptimierungsstudie in der Primär- 1100
therapie des intermediären Hodgkin Lymphoms: Therapiestratifizierung mittels
FDG-PET
50
01.12.2016
katrin.eckhardt
@sakk.ch
Lymphomas
IELSG-37
A randomized, open-label, multicentre, 540
two-arm phase III comparative study assessing the role of involved mediastinal
radiotherapy after Rituximab containing
chemotherapy regimens to patients with
newly diagnosed Primary Mediastinal
Large B-Cell Lymphoma (PMLBCL)
7
31.12.2016
simona.berardi
@sakk.ch
Lymphomas
T-cell project
Das T-Cell project ist eine Registrierstudie
mit Referenzpathologie um Daten zu
seltenen malignen Erkrankungen der TZell Linie zu gewinnen
32
31.12.2016
simona.berardi
@sakk.ch
New Drugs
SAKK 66/12
A Phase I, open-label, multi-center, dose
escalation study of oral CGM097, a p53/
HDM2-interaction inhibitor, in adult patients
with se-lected advanced solid tumors characterized by wild-type TP53
6
30.06.2016
simona.berardi
@sakk.ch
New Drugs
SAKK 66/13
INC280 Combination with BKM120 for 58
glioblastoma patients, Phase I/II trial
2
02.05.2016
simona.berardi
@sakk.ch
New Drugs
SAKK 69/13
Phase IB of oral BGJ398 (pan FGFR inhibitor)
and oral BYL719 (a specific PI3K inhibitor)
in adult patients with selected solid tumors
1
30.04.2016
simona.berardi
@sakk.ch
Updated
*Current accrual as of end of May 2015. Accrual for non-SAKK trials only includes patients enrolled at SAKK centers.
Trial Coordinator
July 1, 2015 17
SAKK Newsletter
TRIAL NEWS
Disease
Group
Trial Name
Trial Description
Accrual
Trial Coordinator
Gynaecological
Cancers
Mito/
Mango 16b
A multicenter phase III randomized study 400
with second line chemotherapy plus or minus bevacizumab in patients with platinum
sensitive epithelial ovarian cancer recurrence
after a bevacizumab/chemotherapy first line
5
31.12.2015
heidi.baumgartner@
sakk.ch
Gynaecological
Cancers
INOVATYON
Phase III international, randomized study of tra- 588
bectedin plus Pegylated Liposomal Doxorubicin
(PLD) versus Carboplatin plus PLD in patients
with ovarian cancer progressing within 6-12
months of last platinum
16
30.06.2017
anna.tomaszewska@
sakk.ch
Activated trials
SAKK 33/14
Effects of sympathicomimetic agonists on the disease course and mutant allele burden in patients with JAK2-mutated myeloproliferative neoplasms A multicenter phase II trial
Activated
Coordinating investigator
Clinical project manager
April 23, 2015
HOVON 132/SAKK 30/13
Randomized study with a run-in dose-selection phase to assess the added value of lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in pa-
tients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk mye-
lodysplasia (MDS) (IPSS-R risk score > 4.5)
Activated
EORTC Lung Art
Activated
Jakob Passweg, Basel
[email protected]
May 4, 2015
Thomas Pabst, Bern
[email protected]
Phase III study comparing post-operative conformal radiotherapy to no post-operative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 involvement
May 18, 2015
Oliver Riesterer, Zurich, and Francesca Caparrotti, Geneva
[email protected]
Authorized trials
Alliance/PROSPECT trial
Approval Swissmedic
Approval ethical committee
A phase II/III trial of neoadjuvant folfox, with selective use of combined modality chemoradiation vs. preoperative combined modality chemoradiation for locally advanced rectal cancer patients undergoing low anterior resection with total mesorectal excision
January 28, 2015
March 26, 2015
Michael Montemurro, Bellinzona
[email protected]
18 July 1, 2015
SAKK Newsletter
TRIAL NEWS
STAMPEDE
Approval Swissmedic
Approval ethical committee
Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
A 5-stage multi-arm randomised controlled trial. ARM ENZALUTAMIDE.
March 27, 2015
April 17, 2015
George Thalmann, Bern
[email protected]
Approval pending
SAKK 06/14
A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of the recombinant BCG VPM1002 in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy
Submitted to EC
Submitted to Swissmedic
January 28, 2015
January 23, 2015
Cyrill Rentsch, Basel
[email protected]
SAKK 36/13
Combination of Ibrutinib and Bortezomib to treat mantle cell lymphomas patients – a multicenter phase I/II tria
Submitted to EC
SAKK 25/14
February 27, 2015
Urban Novak, Bern
[email protected]
Eribulin 1st line in elderly (≥ 70years) and old patients (> 80y) with metastatic breast cancer: a phase II trial
Submitted to EC & Swissmedic May 19, 2015
Ursula Hasler-Strub, St.Gallen
[email protected]
Trial closed for accrual
SAKK 65/12
Closed for accrual
Phase I study of LDE225 in combination with Paclitaxel in patients with advanced solid tumors
REMoDL-B
A randomised evaluation of Molecular guided therapy for Diffuse Large B-Cell Lymphoma with
Bortezomib (phase III)
Closed for accrual
Christoph Mamot, Aarau
[email protected]
June 30, 2015
Anastastios Stathis, Bellinzona
[email protected]
June 12, 2015
|www| All information on SAKK trials can also be found under www.sakk.ch in the members’ section
July 1, 2015 19
SAKK Newsletter
PUBLICATIONS Q2 2015
Urogenital Cancers
Chau C, Cathomas R, Wheater M, Klingbiel D, Fehr M,
Bennett J, Markham H, Lee C, Crabb SJ, Geldart T. Treatment outcome and patterns of relapse following
adjuvant carboplatin for stage I testicular seminomatous germ cell tumour: Results from a 17
year UK experience. Ann Oncol. 2015 Jun 2.
Lung Cancers
Franzini A, Baty F, Macovei II, Durr O, Droege C, Betticher D, Grigoriu BD, Klingbiel D, Zappa F, Brutsche M.
Gene expression signatures predictive of bevacizumab/erlotinib therapeutic benefit in advanced
non-squamous non-small cell lung cancer patients (SAKK 19/05 trial). Clin Cancer Res. 2015 Apr
28.
Varga Z, Cassoly E, Li Q, Oehlschlegel C, Tapia C, Lehr HA,
Klingbiel D, Thürlimann B, Ruhstaller T. Standardization
for Ki-67 Assessment in Moderately Differentiated Breast Cancer. A Retrospective Analysis of
the SAKK 28/12 Study. PLoS One. 2015 Apr 17.
Zaman K, Winterhalder R, Mamot C, Hasler-Strub U,
Rochlitz C, Mueller A, Berset C, Wiliders H, Perey L, Rudolf
CB, Hawle H, Rondeau S, Neven P. Fulvestrant with
or without selumetinib, a MEK 1/2 inhibitor, in
breast cancer progressing after aromatase inhibitor therapy: A multicentre randomised placebo-controlled double-blind phase II trial, SAKK
21/08. Eur J Cancer. 2015 Apr 16.
Leukemia
Gautschi O, Mach N, Rothschild SI, Li Q, Stahel RA, Zippelius A, Cathomas R, Früh M, Betticher DC, Peters S, Rauch
D, Feilchenfeldt J, Bubendorf L, Savic S, Jaggi R, Leibundgut EO, Largiadèr C, Brutsche M, Pilop C, Stalder L, Pless
M, Ochsenbein AF; Swiss Group for Clinical Cancer Research. Bevacizumab, Pemetrexed, and Cisplatin,
or Bevacizumab and Erlotinib for Patients With
Advanced Non-Small Cell Lung Cancer Stratified
by Epidermal Growth Factor Receptor Mutation:
Phase II Trial SAKK19/09. ClinLungCancer. 2015 Mar 5.
Chalandon Y, Thomas X, Hayette S, Cayuela JM, Abbal
C, Huguet F, Raffoux E, Leguay T, Rousselot P, Lepretre S,
Escoffre-Barbe M, Maury S, Berthon C, Tavernier E, Lambert JF13, Lafage-Pochitaloff M, Lhéritier V, Chevret S,
Ifrah N, Dombret H. Randomized study of reducedintensity chemotherapy combined with imatinib
in adults with Ph-positive acute lymphoblastic
leukemia. Blood. 2015 Apr 15.
Breast Cancers
Putora PM, Bedenne L, Budach W, Eisterer W, Van Der
Gaast A, Jäger R, Van Lanschot JJ, Mariette C, Schnider A,
Stahl M, Ruhstaller T. Oesophageal cancer: exploring controversies overview of experts' opinions
of Austria, Germany, France, Netherlands and
Switzerland. Radiat Oncol. 2015 May 21.
Leyland-Jones B, Gray KP, Abramovitz M, Bouzyk M, Young
B, Long B, Kammler R, Dell'Orto P, Biasi MO, Thürlimann
B, Lyng MB, Ditzel HJ, Harvey VJ, Neven P, Treilleux I, Rasmussen BB, Maibach R, Price KN, Coates AS, Goldhirsch A,
Pagani O, Viale G, Rae JM, Regan MM. CYP19A1 polymorphisms and clinical outcomes in postmenopausal women with hormone receptor-positive
breast cancer in the BIG 1-98 trial. Breast Cancer
Res Treat. 2015 May 3.
Gastrointestinal Cancers
Declercq J, Jacobs B, Biesmans B, Roth A, Klingbiel D,
Tejpar S, Creemers JW. Single Nucleotide Polymorphism (rs4932178) in the P1 Promoter of FURIN Is
Not Prognostic to Colon Cancer. BioMed Research
International. 2015.
|www| All information on SAKK publications can also be found under www.sakk.ch
20 July 1, 2015
SAKK Newsletter
PRESENTATIONS Q2 2015
13th International Conference on Malignant
Lymphoma in Lugano
Joint meeting of the International Biometric
Society (IBS) Austro-Swiss and Italian Regions in
Milano
Posters
Bigler M. et al. Comparison of design options for phase
IB clinical trials in oncology: simulation results.
Hayoz S. et al. Effect of one-patient clusters on power
in cluster-randomized trials.
2015 ASCO Annual Meeting in Chicago
Oral presentation
Oral presentations
Zucca E. et al. Independent review of CT responses in
the trial SAKK 35/10 comparing rituximab with or without
lenalidomide in untreated follicular lymphoma patients in
need of therapy.
Hitz F. et al. Rituximab, bendamustine and lenalidomide
in patients with relapsed/refractory aggressive B-cell lymphoma not eligible for salvage chemotherapy. Phase II
trial - SAKK 38/08
102. Jahreskongress der Schweizerischen Gesellschaft für Chirurgie in Bern
Oral presentations
Hamel C. et al. Factors influencing the surgeon`s decision to comply or not to comply with the assigned
randomization for rectal replacement in a prospective
randomized trial SAKK 40/04 comparing side-to-end
anastomosis, colon-J-pouch, and straight coloanal anastomosis in patients with rectal cancer.
Käser S. et al. Does the radicality and quality of colorectal cancer surgery depend on the patient’s age?
Käser S. et al. Do cancers located at the hepatic or
splenic flexure have a worse outcome compared to other
colon cancers?
Seddon B. et al. GeDDiS: A prospective randomised
controlled phase III trial of gemcitabine and docetaxel
compared with doxorubicin as first line treatment in previously untreated advanced unresectable or metastatic
soft tissue sarcomas (EudraCT 2009-014907-29)
Posters
Ghadjar P. et al. Acute toxicity and early quality of life
after dose intensified salvage radiotherapy for biochemically recurrent prostate cancer after prostatectomy. First
results of the randomized trial SAKK 09/10.
Kristeleit R. et al. A phase 1 first-in-human (FIH) doseescalation (DE) study of the oral dual PI3K/mTOR inhibitor PQR309 in patients (pts) with advanced solid tumors:
Final DE results.
19th Annual SASRO Meeting in Basel
Oral presentations
Herrmann E. et al. External Beam Radiotherapy For
Unresectable Hepatocellular Carcinoma. An International
Multicenter Phase I Trial, SAKK 77/07
AACR Annual Meeting 2015 in Philadelphia
Poster
Wicki A. et al. First-in-man (FIM) pharmacodynamic
(PD) and pharmacokinetic (PK) phase I trial of PQR309 in
advanced solid tumours
July 1, 2015 21
SAKK Newsletter
IBCSG
IBCSG 22-00 results presented
at ASCO
At this year’s ASCO Annual Meeting, Dr. Marco Colleoni
from the European Institute of Oncology in Milan, Italy,
presented the results of the trial, which has investigated
the impact of metronomic, low-dose maintenance chemotherapy for patients with hormone receptor negative
early breast cancer. The patients were randomized to a
maintenance regimen of 12 months of cyclophosphamide
and methotrexate (CM) or observation and then first
treated with one of a defined list of approved chemotherapy regimens, before continuing with the CM maintenance/observation part of the trial. Cyclophosphamide
was administered at a dose of 50 mg/day orally continu-
chemotherapy alone. The observed benefit was greater in
women with triple-negative disease; CM treatment following adjuvant chemotherapy reduced their relative risk
of recurrence by 20%, and reduced the absolute risk of recurrence by 4.1%. Patients with triple negative and node
positive disease experienced the largest benefit: a 7.9%
reduction in their absolute risk of recurrence. The results
are not statistically significant.
The treatment was generally well tolerated: only 13.5%
of patients receiving at least one dose of the CM regimen
reported a grade 3 or 4 treatment-related adverse event.
The most frequently reported side effects were abnormal
lab values including elevated SGPT levels and leukopenia.
Completing the entire year of CM was difficult for some
patients: one quarter of patients who started CM did not
complete the full year of treatment due to adverse events
or patient/medical decision.
At a cost of approximately 10 € per month, this CM regimen is very cost-efficient, particularly if compared to the
extremely expensive novel targeted therapies currently in
development. An oral CM regimen for hormone receptornegative patients, in particular for patients at higher risk
for recurrence, therefore may represent a serious treatment option.
Translational studies are ongoing (e.g. multigene assays
to further tailor recommendations). Trial 22-00 is one of
the largest trials ever conducted in patients with ER- and
PgR-negative disease and patients consented to prospective tissue collection.
M. Colleoni
ously, methotrexate at 2.5 mg twice per day orally days
1 and 2 of every week. The trial enrolled 1´086 women
with hormone receptor-negative early stage breast cancer
between January 2001 and December 2012; 176 patients
were recruited by SAKK sites. The trial was powered to
detect a DFS hazard ratio of 0.72 with a power of 70%.
The relatively low power is mainly due to the lower than
expected overall rate of recurrence and to the fact that
13% of patients randomized to CM never started the
maintenance treatment.
The maintenance treatment reduced the relative risk of
developing breast cancer recurrence by 16% in these
patients when compared to treatment with adjuvant
CLINICAL TRIALS
IBCSG 42-12 SNAP
The trial evaluates in a randomized phase II fashion three
different schedules of nab-Paclitaxel in patients with histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer who have not received
any prior chemotherapy. Based on recommendations
from the IBCSG Data and Safety Monitoring Committee
(DSMC), IBCSG issued an amendment to adapt the dose
of nab-Paclitaxel in the induction phase. It was decided
to decrease the dose in the induction phase to 125 mg/
m² while keeping the current doses in the maintenance
phase. The amendment has to be activated by end of the
year 2014.
22 July 1, 2015
SAKK Newsletter
IBCSG
IBCSG 48-14/BIG 8-13 POSITIVE
Based on a recommendation from the DSMC, IBCSG has
decided to increase the total sample size from 240 to
258. The corresponding protocol amendment has been
approved by several sites, and recruitment is continuing
and expected to reach the new goal in July.
The best available evidence suggests that pregnancy after breast cancer does not negatively impact disease outcome and is safe for the offspring but no definitive information is available to recommend a safe interval from BC
diagnosis to pregnancy. The POSITIVE trial will investigate
endocrine therapy (ET) interruption to enable conception
for young women between 18 and 42 years of age with
endocrine responsive early breast cancer who received
adjuvant ET for 18 to 30 months and wish to attempt
pregnancy. The main objectives are:
• To assess the risk of breast cancer relapse associated
with temporary interruption of endocrine therapy to
permit pregnancy
• To evaluate factors associated with pregnancy success after interruption of endocrine therapy.
The trial will also allow for the testing of biologic correlates of pregnancy and disease outcome.
IBCSG’s Program for Young Patients
IBCSG 43-09 HOHO
IBCSG 43-09 is the Young Women’s Breast Cancer Study,
and HOHO stands for “Helping Ourselves Helping Others”. It is a longitudinal cohort study of 300 young women
with breast cancer (early or advanced) in selected institutions in Europe. All eligible patients treated at each center
are invited to join the cohort. Patient surveys and medical
record review are utilized. Women are surveyed every 6
months for the first 3 years after diagnosis, then yearly
thereafter for an additional 7 years (for a total follow-up
of 10 years following diagnosis). The study has two main
objectives:
A psycho-oncological companion study evaluating psychological distress, fertility concerns and decisional conflict in young women who participate in POSITIVE has
been developed and will be activated in sites interested
and capable to conduct it. The participation of the USAmerican Alliance Group is currently being negotiated.
The other countries scheduled for activation are Belgium,
Italy, Greece, Spain, Denmark, Hungary and Australia, and
sites from several other countries have shown great interest in trial.
1. To identify in selected institutions in Europe a cohort
of young women (age 18-40) newly diagnosed with
breast cancer (early or advanced) to assess a broad
range of variables at baseline and over the course of
the ensuing 10 years.
2. To characterize this population at diagnosis and in
follow-up regarding disease and psychosocial outcomes (e.g., presentation and disease characteristics,
fertility and menopausal issues, and long term outcome).
A total of 500 patients are planned to be recruited into
the trial from centers worldwide in approximately 4 years.
The trial is currently being activated in Switzerland, 11 out
of 13 planned sites are open. The Institute of Oncology of
Southern Switzerland is the first site which has opened
the trial worldwide, and has accrued the first patient in
December; Brustkrebszentrum Zürich has recruited the
2nd patient.
At present 17 centers in Italy and 5 centers in Switzerland
are participating in the trial and have accrued 266 patients up to end of May 2015, 71 of them by Swiss sites.
Accrual of open clinical trials
(As of May 31, 2015)
Trials
Current accrual
Current accrual SAKK
Total target accrual
42-12 SNAP
247
73
258
43-09 HOHO
266
71
300
48-14 POSITIVE
4
2
500
SAKK Newsletter
July 1, 2015 23
IBCSG & ETOP
Latest IBCSG publication
Leyland-Jones B, Gray KP, Abramovitz M, Bouzyk M, Young B, Long B, Kammler R, Dell’Orto P, Biasi MO, Thürlimann B, Lyng
MB, Ditzel HJ, Harvey V, Neven P, Treilleux I, Rasmussen BB, Maibach R, Price KN, Coates AS, Goldhirsch A, Pagani O, Viale G,
Rae JM, Regan MM; on behalf of the BIG 1-98 Collaborative Group. CYP19A1 Polymorphisms and clinical outcomes
in postmenopausal women with hormone-receptor positive breast cancer in the BIG 1-98 trial. Breast Cancer Res Treat 151:373-84, 2015. (BIG 1-98)
The complete IBCSG publication list can be downloaded from http://www.ibcsg.org/Member/Publi/IBCSG_Publi/Pages/default.aspx
Rudolf Maibach
IBCSG Coordinating Center (www.ibcsg.org)
European Thoracic Oncology Platform (ETOP)
Clinical trials
ETOP 2-11 BELIEF
BELIEF, a phase II prospective trial sponsored by ETOP and coordinated together with the Spanish Lung Cancer Group (SLCG)
will determine the long-term outcome of patients with advanced non-squamous NSCLC with activating EGFR mutations
(L858R and exon 19 deletion) with or without T790M resistance mutation at diagnosis and treated with the combination of
erlotinib and bevacizumab. The accrual goal of 102 patients was reached in October 2014. Treatment and follow-up continue
as planned. A presentation of the results is planned for ECCO-ESMO 2015 in Vienna.
ETOP 3-12 EMPHASIS-lung
In the EMPHASIS-lung trial, the predictive value of Veristrat, a serum proteomic test, was assessed regarding the efficacy of
erlotinib in pretreated patients with advanced squamous cell lung carcinoma. Over 50 centers from several European countries were activated and by the end of January 2013, 81 patients were randomized. Recruitment was terminated prematurely
due to an accrual rate that was deemed insufficient and publication of controversial new data from another study. No safety
concerns led to the decision to close accrual. A pooled analysis with a similar trial conducted in all advanced NSCLC subtypes
was presented at ASCO 2015. Manuscript preparation, presenting the final results, is ongoing.
ETOP 4-12 STIMULI
The prognosis of small cell lung carcinoma (SCLC) patients with limited-stage disease under current forms of treatment is
still very poor, with a median survival of 16 to 24 months and only 15-25% long-term survivors. The standard treatment
approach in limited-stage SCLC is a combination of chemotherapy and thoracic radiotherapy. Several studies have showed
that the stimulation of immune cells via immune checkpoint-inhibitors have the potential to impede tumor growth.
STIMULI, a randomized multi-center open-label trial, will investigate the efficacy and tolerability of the standard treatment
alone or with subsequent consolidation with ipilimumab, a monoclonal antibody targeting the immune receptor protein
CTLA-4, in patients with limited-disease SCLC.
ETOP is conducting the trial in collaboration with the Intergroupe Francophone de Cancérologie Thoracique (IFCT). The trial
was activated in July 2014 and as of 9 June 2015 14 patient have been recruited into this trial. To increase the somewhat
unsatisfactory accrual rate, an amendment to the trial protocol is currently under development.
24 July 1, 2015
SAKK Newsletter
ETOP
ETOP 5-12 SPLENDOUR
Denosumab is a monoclonal antibody targeting and inhibiting RANKL, a protein that acts as the primary signal for bone resorption. The purpose of this study is to investigate the potential of the combination of standard treatment (chemotherapy)
with denosumab as compared to the standard treatment alone to increase survival of patients with advanced NSCLC with
or without bone metastasis as first line therapy. ETOP is the sponsor of this trial that is being conducted in collaboration
with EORTC as coordinating group, as well as CECOG. The 1000 patients will be enrolled within approximately 3 years. Nine
SAKK sites are participating in this trial. The first sites have been activated in December 2014 and the accrual as of 8 June
2015 is 89 patients, 18 from SAKK sites.
ETOP 7-14 NICHE
The erbB family of proteins comprises the receptor tyrosine kinase EGFR and the closely related HER2, HER3 and HER4. HER2
mutations are identified in about 2% of non-small-cell lung cancers (NSCLC) and appear to be critical for lung carcinogenesis. Clinically relevant HER2 mutations are clustered in exon 20 of the HER2 gene and commonly include small exon 20
insertions, single amino acid or clustered substitutions. Afatinib is a selective and irreversible small molecule inhibitor of the
erbB family of proteins. It has been shown to effectively inhibit EGFR, HER2 and HER4 phosphorylation resulting in subsequent suppression of tumor growth. The primary objective of this trial is to evaluate the ability of afatinib to control disease
in pretreated patients with advanced NSCLC harboring HER2 exon 20 mutations. The trial protocol has been distributed for
activation in December 2014 and site activation is ongoing. In Switzerland, the University Hospital Zürich and the CHUV in
Lausanne will participate in this trial.
Solange Peters
Heidi Roschitzki
Scientific Coordinator
www.etop-eu.org
ETOP Coordinating Office
SWISS CANCER LEAGUE
Cancer Registry Law under Parliamentary Deliberation
Cancer registries data are an indispensable basis for an effective policy on cancer. Oncosuisse, responsible for the coordination of political issues on fighting cancer in Switzerland, supports the establishment of a Swiss federal law and has stated
its position to the Committee for Social Security and Health of the National Council last week in Bern.
The new cancer registry law should regulate how cancer data in all Swiss cantons are to be recorded at the national level
and consolidated within national structures in accordance with uniform standards. In the eyes of Oncosuisse, the cantonal
cancer registries and the Swiss Childhood Cancer Registry take largely into account the law’s requirements for a modern
illness-monitoring system; and it is well suited for the intended purpose. As stated in the attached Oncosuisse statement
(available in German and French), the organizations who are active in the fight against cancer propose two points for an
amendment to this draft law.
The Committee for Social Security and Health of the National Council has heard the opinions of the Swiss Cancer League,
representatives from the National Institute for Cancer Epidemiology and Registration (NICER), the Swiss Childhood Cancer
Registry (SCCR), the Cancer Registry of the Canton Ticino, the Swiss Medical Association, the Patient Safety Organization
(PSO), as well as the Association of the Data Protection Commissioners. The Committee shall begin the detailed consultation
on the law at its next session.
Contact
Ori Schipper
Communications Manager
[email protected]
SAKK Newsletter
July 1, 2015 25
GRANTS
SAKK/Amgen Research Grant
For the sixth time, SAKK and AMGEN award a grant for outstanding and novel translational cancer research. The call for proposals for the SAKK/AMGEN Research Grant
2015 is open.
The deadline for submission is August 31, 2015
• The grant is endowed with CHF 50’000.- and will be given to a researcher or a research team from a Swiss hospital or institution conducting translational
cancer research (oncology/hematology).
• The grant should contribute to an independent research project, predominately be performed in Switzerland, and should cover a substantial scientific part of the project. The submitted research project should not be a small translational part of a large clinical trial.
• The criteria to determine the winning project are: novelty, clinical relevance and feasibility.
• The independent jury, chaired by Prof. Beat Thürlimann (President of SAKK), will evaluate the proposals.
• The grant will be awarded at the SAKK semi-annual meeting in November 2015 and will be published in the Schweizer Krebsbulletin.
The proposal should comprise the completed application form, the completed project
description form in English (max. 4 pages, anonymously), a CV of the applicant(s)
and the list of publications.
The submissions should be sent electronically to: [email protected]. The regulations for the grant, application and project description forms can be downloaded from http://www.amgen.ch/german/medpro/research_
grant.html.
For more information, please contact: Dr. Christian Merkle, Therapeutic Area Head Oncology, AMGEN Switzerland
AG, E-Mail: [email protected], Tel. Direct line: 041 369 01 85
26 July 1, 2015
SAKK Newsletter
EVENTS
Orphan Malignancies Seminar
Management des Schilddrüsen und Merkelzellkarzinoms
September 10, 2015, 15h00-19h30
The Central Plaza Hotel Central 1, 8001 Zurich
Information and registration: http://sakk.ch/en/calendar/
Planned in between meetings of project groups and working groups 2015
Group
Next meetings
Urogenital Tumors
September 18, 2015, 14h15-16h45
Breast Cancers
September 10, 2015, 11h45-15h45
Leukemia
September 10, 2015, 13h30-17h00
Lung Cancer
September 17, 2015, 14h15-16h45
Lymphoma
September 17, 2015, 12h15-16h30
New Anticancer Drugs
October 1, 2015, 11h30-14h30
Gynecological Cancer
September 17, 2015, tbd
Gastrointestinal Cancer
September 17, 2015, 13h15-16h15
Detailed information regarding time, place and agenda of the meetings can be found on the members'section on
our website www.sakk.ch
Verfassen naturwissenschaftlicher
Publikationen (Biowissenschaften, Medizin)
September 3 & 4, 2015, Kantonsspital Winterthur
Information and registration: http://sakk.ch/en/calendar/ or [email protected]
July 1, 2015 27
SAKK Newsletter
EDUCATION, EVENTS
SAKK Training course for
CRCs and CTNs
SAKK Investigators'education
October 22 & 29, 2015
August 27, 2015, Bern
SAKK, Bern
For members of the SAKK network and SPOG
the course is free of charge.
For members of the SAKK network and SPOG
the course is free of charge.
More information:
http://sakk.ch/en/calendar/education/
More information:
http://sakk.ch/en/calendar/education/
Supported by
Supported by
2nd Swiss Cancer Congress "Quality in oncology"
27th August 2015, University of Fribourg
We invite you to sign up for the 2nd Swiss Cancer Congress which will take place on 27th August 2015 at the
University of Fribourg.
The central topic of the congress is quality. Can quality be quantified? And if yes, how? What importance does quality
have in the overall social context, and, more specifically, in oncology? These questions will be addressed in a plenary
session and subsequent workshops focusing on specific aspects of quality.
The congress offers a unique platform for doctors, nurses and all professionals involved in the treatment and care of
cancer patients to engage in a multidisciplinary and inter-professional exchange.
For more information and online registration please refer to the congress website www.swisscancercongress.ch.
Congress organiser: Pro Medicus GmbH,
[email protected], phone 041 266 99 17
28 July 1, 2015
SAKK Newsletter
SAKK ANNIVERSARY EVENTS
•
•
•
•
•
•
•
July 2, EHA/post-ICML educational event, Zurich
August 26, Lecture, Thun
August 29, Public event City of St.Gallen
September 22, Public event @ Cantonal Hospital Graubünden, GKB Auditorium
October 9, Scientific Symposium @ DGHO, Basel
October 29, Symposium @ Cantonal Hospital St.Gallen
November 19, Symposium @ Semi-Annual Meeting, Zurich
SAKK DATES 2015
•
•
•
•
•
•
August 27, 2nd Swiss Cancer Congress Fribourg
September 1, 2015, Board Meeting
September 10, 2015, Orphan Malignancies Seminar Zurich
November 3, 2015, Board Meeting
November 25, 2015, General Assembly
November 26 & 27, 2015, Semi-Annual Meeting Zurich
Flag
Swiss Group for Clinical Cancer Research
Coordinating Center
Effingerstrasse 40
3008 Bern
Tel. +41 31 389 91 91
Fax +41 31 389 92 00
E-mail: [email protected]
www.sakk.ch
Claudia Herren
[email protected]
Peter Brauchli

Newsletter - SAKK – Swiss Group for Clinical Cancer Research

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