Final Analysis Of Weekly Paclitaxel And Weekly Carboplatin (P) As First-Line Chemotherapy In 130 Patients With Advanced Ovarian Cancer (Aoc).

5057 Background: The combination of paclitaxel (Taxol) and platinum in a three weeks schedule has emerged as the current standard approach for the adjuvant setting of AOC. Exposition duration of the drug is important for cell death. In animal model additional anti-angionetic effects of low dose paclitaxel infusion was observed. Methods: Based on our phase I study with T and C (ASCO 2000) we conducted a multi-institutional phase II-trial. Following schedule was used after primary radical surgery: first treatment block (6 cycles, q 7d) - 14 d break - second block (6 cycles, q 7d) - 28 d break- third block (3 cycles, q 7d). T was given in a dose of 100mg/m2, C according AUC 2. No primary use of G-CSF was allowed. Eligibility criteria: AOC (FIGO IIb-IV), ECOG performance status 0–2, normal organ function. Results: Between 02/1999 and 02/2003, 130 patients from 12 institutions were enrolled. The median age was 60 years (23–89). FIGO-stages were: II: 6.2%, III: 72.3%, IV: 21.5%. 1676 cycles were analyzed and in median 15 courses were applied (range 3–18). The incidence of non-hematological toxicities was very low. Alopecia (grade 1–3) was the most common side effect (82%). 29.5% of all pts experienced neurotoxicity grade 2, only 2.3 pts grade 3. Nail changes ≥grade 2 occurred in 3.9%. There were no chemotherapy-related fatalities. Grade 3–4 hematological toxicity (% of all pts) included: thrombocytopenia (2.3%), anemia (12.3%), leucopenia (12.3%), neutropenic fever (0.6%). 78% of all pts with initially elevated CA-125 achieved normalization by the end of therapy. After a median follow-up interval of 24 months (range: 1–62) median progression free survival is 21 months and median overall survival 43 months. Conclusions: These mature results suggest that this weekly schedule represents an efficacious and well-tolerated regimen with a favorable therapeutic index for patients with AOC. (Supported by BristolMyers Squibb Germany and AMGEN) No significant financial relationships to disclose.