breast cancer, early stage

Annals of Oncology 25 (Supplement 4): iv85–iv109, 2014
doi:10.1093/annonc/mdu327.12
breast cancer, early stage
264PD
GAIN2: ADJUVANT PHASE III TRIAL COMPARING AN
INTENSIFIED DOSE-DENSE ADJUVANT THERAPY WITH
ENPC COMPARED WITH A DOSE-DENSE, DOSE-ADAPTED
THERAPY WITH DTEC DTDOCETAXEL IN PATIENTS WITH
PRIMARY BREAST CANCER AND A HIGH RISK OF
RECURRENCE
Aim: Combined chemotherapy requires compromises in terms of dosage and
treatment interval due to toxicities. The sequential administration of monotherapies
allows high doses of single substances and dose-dense intervals. So far, such regimens
have proved to be very effective in early breast cancer with high risk of recurrence.
Nab-paclitaxel (nP) leads to a more favorable toxicity profile and greater efficacy
compared with solvent-based taxanes.
Methods: The GAIN2 study compares toxicity and efficacy of a pre-defined dose-dense
high-dose regimen (EnPC) with a dose-dense regimen, where single doses are adjusted
depending on individual haematological and non-haematological toxicities
(dtEC-dtD). Primary endpoint is the invasive disease-free survival in patients with
primary node-positive or high-risk node-negative breast cancer.
Two safety interim analyses after 200 and 900 patients who have completed
chemotherapy are planned. The results of the first safety analysis will be presented. In
addition to the standard analyses for haematological and non-haematological
toxicities, any affections of the cranial nerves as well as the rate of macular degeneration
and anaphylactic reactions are of special interest.
Results: In terms of hematological adverse events, the rate of febrile neutropenia grade
3-4 (14% vs. 5%) and thrombocytopenia grade 3-4 (14% vs. 5%) was significantly
increased in the EnPC arm. As for the non-haematological side effects, there were
significantly more patients developing anorexia (grade 1-4) in the EnPC arm. There
were no differences between the treatment arms for the toxicities of special interest. In
the EnPC arm, 28% required dose-reductions due to hematological toxicities compared
with only 11% in the dtEC dtD arm ( p = 0.002). The dose could be escalated to the
maximum in half of the patients receiving dtEC dtD. In 7% of women a reduction was
required in the 4th cycle of docetaxel.
Conclusions: Due to similar toxicity profiles, the study will be continued without
changes.
Disclosure: A. Schneeweiss: Honoraria, Research Funding and Advisory Role: Celgene
and Roche; G. von Minckwitz: Honoraria and Research Funding: Amgen, Celgene and
Roche; V. Möbus: Honoraria and Research Funding: Amgen, GSK, Sanofi-Aventis,
Pfizer, Roche. All other authors have declared no conflicts of interest.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
All rights reserved. For permissions, please email: [email protected].
abstracts
S. Noeding1, H. Forstbauer2, G. Wachsmann3, A. Ober4, A. Schneeweiss5,
B. Christensen6, E. von Abel7, E. Grischke8, H. Höffkes9, P. Klare10, Y. Ko11,
S. Schmatloch12, N. Burchardi13, S. Loibl13, G. von Minckwitz13, V. Möbus14
1
Gynäkologisch-onkologische, Schwerpunktpraxis, Hannover, GERMANY
2
Brustzentrum, GOSPL - Gesellschaft für onkologische Studien, Rheinsieg,
GERMANY
3
Frauenklinik, Klinikum Sindelfingen-Böblingen, Böblingen, GERMANY
4
Brustzentrum, St. Vincenz Krankenhaus, Limburg, GERMANY
5
University Hospital, National Center for Tumor Diseases, Heidelberg, GERMANY
6
Brustzentrum, Ruppiner Kliniken, Neuruppin, GERMANY
7
Frauenklinik, Klinikum Schwäbisch-Gmünd, Schwäbisch-Gmünd, GERMANY
8
Frauenklinik, Uniklinik Tübingen, Tübingen, GERMANY
9
Frauenklinik, Klinikum Fulda, Fulda, GERMANY
10
Oncologie, Praxis Berlin, Berlin, GERMANY
11
Frauenklinik, Evangelische Kliniken Bonn, Bonn, GERMANY
12
Frauenklinik, Elisabeth Krankenhaus, Kassel, GERMANY
13
Medicine and Research, German Breast Group (GBG) Forschungs GmbH,
Neu-Isenburg, GERMANY
14
Klinik für Gynäkologie und Geburtshilfe, Klinikum Frankfurt Höchst GmbH,
Frankfurt, GERMANY