Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 533
© 2004 American Society of Clinical Oncology

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Wallwiener, D. Articles by Untch, M. Search for Related Content PubMed Articles by Wallwiener, D. Articles by Untch, M.

Abstract

A phase III trial comparing adjuvant treatment with leuprorelin acetate 3M-Depot for 24 months with CMF chemotherapy in ER/PR + node + pre-perimenopausal breast cancer patients

University of Tuebingen, Tuebingen, Germany; Charité Humboldt University, Berlin, Germany; Institute for Oncology and Radiology, Kiew, Ukraine; Oncologic Clinic, Kriwoj Rog, Ukraine; Takeda Pharma, Aachen, Germany; University Munich, Dept of Ob/Gyn, Munich, Germany

533

Background: Recent studies proved that ovarian ablation with LHRH-analogues is not inferior to CMF-chemotherapy in pre-perimenopausal ER/PR+ breast cancer patients (bc pts). Methods: A randomized phase III trial in pre-perimenopausal bc pts (pT1–3, N+, M0, ER+ and/or PR+) tested the H0 hypothesis that a 2 y treatment with 8 injections of leuprorelin acetate 3M-depot (LAD 3M) was not inferior (> 10 % below CMF) to 6 double cycles of CMF (C 500-, M 40-, F 600 mg/sqm/d 1 and 8 q4w). Primary endpoint was 2y- progression free survival (PFS), secondary were 5y- PFS, overall survival (OS), state of health and safety. Other parameters were E2 serum levels and menstrual status. This was a planned 2 y final (589/599 pts) and 5 y interim analysis (359/599 pts). Results: Of 599 pts randomized 526 were eligible for per protocol analysis. 2y- PFS was 80.9 % (207/256, CMF) and 83.0 % (224/270, LAD 3M). The H0 hypothesis was rejected (p = 0.0002). In CMF 51 pts (49 ongoing /145) and in LAD 3M 58 pts (46 ongoing /154) showed 5y- PFS. Mean time to progression was 48.1 ± 1.1 (LAD 3M) vs. 47.3± 1.1 mths (CMF) (Kaplan-Meier, p = 0.866). OS was 98.7 % (152/154, LAD 3M) vs. 97.2 % (141/145, CMF, n.s.). SAEs were reported in 14/294 pts (4.8%, LAD 3M) vs. 27/295 pts (9.2%, CMF). CMF was more often associated with chemotherapy side effects like vomiting, weakness, alopecia compared to LAD 3M which was associated with typical menopausal symptoms like hot flushes, sweating. CMF led to a longer time off work compared to LAD 3M (155±135d vs. 98±120d, p<0.001). LAD 3M led to a more rapid and persistent E2- and menstrual suppression. After 3 years cessation of menstruation was present in 43.7% and 44.9% in the LAD 3M and CMF group respectively. Conclusions: In HR+, N+, pre-perimenopausal bc pts 8 injections of LAD 3M were not inferior to six double cycles of CMF (d 1and 8) with regard to PFS and OS. Side effects had a different profile with typical cytostatic associated adverse events and longer time off work in the CMF group. This study was sponsored by Takeda-Pharma, Germany.

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Takeda Pharma, Germany Takeda Pharma, Germany Takeda Pharma, Germany Takeda Pharma, Germany

Abstract presentation from the 2004 ASCO Annual Meeting