Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 5006
© 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 Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Cure, H. Articles by Pujade-Lauraine, E. Search for Related Content PubMed Articles by Cure, H. Articles by Pujade-Lauraine, E.

Abstract

Phase III randomized trial of high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) support as consolidation in patients (pts) with advanced ovarian cancer (AOC): 5-year follow-up of a GINECO/FNCLCC/SFGM-TC study

Centre Jean Perrin, Clermont, Ferrand, France; GINECO, Paris-Naples, France

5006

Background: Phase II studies have suggested that HDC is most effective in chemosensitive AOC pts with low tumor burden. Methods: We compared the disease free-survival (DFS), overall survival (OS) and toxicity of women with AOC randomized after second-look surgery (SLS) to receive either HDC Carboplatin-Cyclophosphamide and PBSC support (Cb 400 mg/m²/d and Cy 1500 mg/m²/d x 4 days) or 3 cycles of conventional-dose maintenance (CDM) (q4w, Cb 300 mg/m², Cy 500 mg/m²). Eligibility criteria were: age <60 yrs, FIGO stage III-IV, disease responsive to 4 - 6 cycles of a platinum-based first-line chemotherapy, tumor size <2 cm at the end of the SLS or a pathological complete response (pCR) but high-risk factors. Results: Between 07/1995 to 10/2000, 110 pts were enrolled, 57 in the HDC and 53 in the CDM arm. Pts characteristics were well balanced between the 2 arms. Half of the pts received paclitaxel in first-line. Nine pts had Stage IV and 101 pts stage III with at SLS: pCR (39%), microscopic (20%) and macroscopic (41%) disease. In the HDC arm, 1 pt was ineligible and 11 (20%) did not receive the HDC because of poor PBSC mobilization (n= 7), pt refusal (n=3) or early relapse (n=1). Median time to neutrophil and platelet recovery was 11 days. Two pts died from toxic myocarditis and renal insufficiency respectively. Median follow-up is 60 months. At time of analysis, 94 pts have relapsed and 63 have died. DFS and OS were not significantly different between the 2 arms. Median DFS and OS from randomization were 12.2 (95% CI: 7.3–17.1) and 42.5 (95% CI: 28.8–56.6) months in the CDM arm, and were 17.5 (95% CI: 5.2–29.9) (p=.22) and 49.7 (95% CI: 29.9–69.4) (p=.43) months in the HDC arm, respectively. Conclusions: These data do not support high-dose consolidation chemotherapy in AOC.

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen

Abstract presentation from the 2004 ASCO Annual Meeting