Integrierter Studienbericht

Nichtinterventionelle Studie ML 21725
Roche Pharma AG
Integrierter Abschlussbericht
Status: Final 1.0 (28.03.2013)
Integrierter Studienbericht
Studientitel
Lebensqualität unter oraler Chemotherapie mit Capecitabin
(Xeloda®) bei metastasiertem Brustkrebs
Studienmedikation
Xeloda® (Capecitabin)
Indikation
Therapie des metastasierten Mammakarzinoms bei HER2negativen oder –positiven Patientinnen
Sponsor
Roche Pharma AG Grenzach-Wyhlen
Studiennummer
ML 21725
Studienphase
NIS (nichtinterventionelle Studie)
Studiendaten
Einschluss der ersten Patientin:
Letzte Dokumentation:
Wissenschaftliche Leitung
Dr. med. M. Zaiss
Praxis für interdisziplinäre
Onkologie & Hämatologie
Breisacher Str. 117
79106 Freiburg
(federführend)
Medizinische Leitung Sponsor
Dr. Stefanie Henken
Medical Manager Herceptin BC
Roche Pharma AG
Grenzach-Wyhlen
CRO-Projektkoordination
Dr. Martin Indorf
Clinical Trial Leader
iOMEDICO AG
Freiburg
Autoren
Kirsten Hauswald
PD Dr. med. Jens Hasskarl
Dr. Martin Indorf
Melanie Franzem
iOMEDICO AG
Freiburg
Medical Writing
Dr. Rainer Gottwald
Otto-Baab-Str. 4
67297 Marnheim
19.08.2008
28.09.2012
Dr. med. S. Fuxius
Kurfürstenanlage 34
69115 Heidelberg
(nicht federführend)
Die in dem vorliegenden Dokument enthaltenen Informationen sind vertraulich und das Eigentum der
Roche Pharma AG. Sie dürfen nicht ohne vorherige schriftliche Zustimmung der Roche Pharma AG
genutzt oder offengelegt werden
Nichtinterventionelle Studie ML 21725
Roche Pharma AG
1
Integrierter Abschlussbericht
Status: Final 1.0 (28.03.2013)
Unterschriften
Die in diesem Bericht behandelte Studie wurde gemäß den Empfehlungen des Bundesinstituts
für Arzneimittel und Medizinprodukte und des Paul-Ehrlich-Instituts zur Planung,
Durchführung und Auswertung von Anwendungsbeobachtungen und des Verbands der
forschenden Arzneimittelhersteller (VfA) durchgeführt. Entsprechend der gesetzlichen
Vorgaben werden die Studiendaten 10 Jahre archiviert.
Datum des Berichtes: 28.03.2013
Ich habe den vorliegenden Studienbericht gelesen und bestätige mit meiner Unterschrift, dass
er die Studiendurchführung und die Darstellung der Studienergebnisse adäquat wiedergibt.
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Nichtinterventionelle Studie ML 21725
Roche Pharma AG
2
Integrierter Abschlussbericht
Status: Final 1.0 (28.03.2013)
Synopsis
AIMS No.:
ML 21725
Title:
Non-interventional post marketing surveillance study (NIS) on
Quality of Life of Capecitabine (Xeloda®) in patients with metastatic
breast cancer.
Version and Date:
Draft, 28.03.2013
Sponsor:
Roche Pharma AG, Grenzach Whylen
Objectives:
The objective of this NIS according to §67 Abs 6 AMG was the
documentation of data concerning the quality of life (qol) of
metastatic breast cancer patients treated with Capecitabine
(Xeloda®) in mono- or combination chemotherapy of HER2negative or –positive metastatic breast cancer. In addition,
information on physician’s decision making efficacy of treatment
and qol-influencing factors like compliance, individual treatment
information level and treatment satisfaction was to be collected.
The purpose of this investigation was to document the quality of life
under Capecitabine (Xeloda®) treatment as a part of the daily routine
treatment in Germany. The implementation of this NIS did not
influence the physician’s decision regarding diagnostics, therapy of
frequency of medical examination during and after the treatment.
Selected patient
population:
HER2-negative or –positive patients with metastatic breast cancer
Number of patients:
Planned: 750 Patients
Actual: 756 patients registered of whom 754 started documentation
and 735 received at least one dose of Capecitabine (Xeloda®)
Selected physician
population:
Oncologists and gynecologists in clinics, outpatient clinics and
office-based physicians specialized in oncology. Internet access at
site was obligatory. The sites were selected by the gynecooncology
sales force of Roche Pharma AG
Number of centers:
Planned: 200
Actual: 161 who included patients
Selection criteria:
Inclusion criteria:
x
$JH•\HDUV
x
Written and signed informed consent prior to onset of
documentation
x
Pre- or postmenopausal female patients with first-line or
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Nichtinterventionelle Studie ML 21725
Roche Pharma AG
Integrierter Abschlussbericht
Status: Final 1.0 (28.03.2013)
further line locally advanced recurrent or metastatic breast
cancer which are eligible for a mono-/polychemotherapy
with Capecitabine (Xeloda®) by physician’s decision.
Exclusion criteria:
x
Main parameters of
interest:
Study medication:
Contraindications for Capecitabine (Xeloda®) according to
SmPC
The following questions were of particular importance:
x
The overall and domain-related quality of life
x
Compliance with Capecitabine (Xeloda®) treatment
x
Patient satisfaction with Capecitabine (Xeloda®) therapy
x
Physicians satisfaction with Capecitabine (Xeloda®) therapy
x
Knowledge and satisfaction of patients with their patientphysicians communication and care
x
Which criteria determine the therapy choice for Capecitabine
(Xeloda®)
x
Handling of hand-foot-syndrome (hfs) if this event occurs
x
Response and time-based efficacy parameters of mono- or
combination Capecitabine (Xeloda®) chemotherapy
x
Demographic characteristics and medical history of the
patient
Capecitabine (Xeloda®) was prescribed and provided from
commercial stock in each study centre.
Recommended dosing according to
(summary of product characteristics):
the
„Fachinformation“
Mono and combination therapy: 1250 mg/m² twice a day for a
duration of 14 days, followed by a therapy break of 7 days
Statistical
considerations:
Descriptive statistics or frequency counts for all variables as
appropriate.
Differences in QoL-scales between monotherapy and combination
therapy were analyzed using mean differences with respective
confidence intervals.
To analyze effects on progression free survival a cox proportional
regression model was used. Combination drug, therapy line and
occurance of hand-foot-syndrome where included covariates.
UAWs were summarized and displayed after MedDRA coding.
Three descriptive interim data analyses were performed in addition
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Nichtinterventionelle Studie ML 21725
Roche Pharma AG
Integrierter Abschlussbericht
Status: Final 1.0 (28.03.2013)
to the final statistical analysis.
Duration:
First patient in: Aug 2008
Last patient in: Oct 2011
Treatment duration per patient: up to 9 months
Follow-up period: none
Summary of
Effectiveness
Results:
QoL: Global score 53%. No correlation of QoL and hand-foot
syndrome.
Response: ORR 35,1%, DCR 64,4%.
Best Response: CR 4,2%, PR 30,9%, SD 29,3%, PD 23,0%,
Progression-free survival:
PFS (median) 6,81 months (95% CI 6,32-7,63);
PFS (with HFS): 8,4 months (95%-CI 7,5-9,2; p<0,0001)
Summary of Safety
Results:
Incidence of Serious Adverse Reactions: 6,8%
Incidence of hand-foot syndrome (all grades): 27,1%.
Safety and tolerability are assessed as acceptable
Conclusion:
No negative impact of hand-foot syndrome on global QoL.
Hand-foot syndrome predictive factor with regard to prolonged PFS.
Favourable risk-benefit relation.
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