Abstract
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
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