Sequential combination of paclitaxel-carboplatin and paclitaxel-liposomal doxorubicin as 1st line treatment in patients with ovarian cancer: A multicenter phase II clinical trial

Abstract

5108 Background: To evaluate the efficacy and toxicity of the sequential administration of paclitaxel-carboplatin (T/C) and paclitaxel-liposomal doxorubicin (T/D) as 1st line treatment in pts with ovarian cancer. Methods: From 2/2001 to 6/2002, 52 pts with histologically proven, FIGO stage III/IV ovarian cancer were enrolled. No prior chemotherapy, radiotherapy or endocrine therapy was allowed. Other eligibility criteria included age<75 years, PS 0–2, life expectance > 6 months, adequate hepatic, renal, cardiac and bone marrow function. Median age was 60 years (range 40 to 74). In 36 pts cytoreductive surgery was performed. Patients received 4 cy of Paclitaxel 175mg/m2, 3-h infusion and Carboplatin 6 AUC both on day 1 every 3 weeks, followed by 4 additional cy of liposomal doxorubicin 40mg/m2 and Carboplatin 6 AUC both on day 1 every 3 weeks. Results: At the time of the present analysis, 41 patients were evaluable for toxicity and 39 for response. A total of 284 cy were delivered (median cy: 8/pt). Grade 3–4 neutropenia occurred in 24.7% of cy, thrombocytopenia in 6.4%. There were no episodes of febrile neutropenia. G-CSF was required in 49.6% of the cy and non-hematological toxicity was mild except alopecia. Chemotherapy was delayed in 20.4% of the cycles (median delay: 7 days, range 4–44) but due to hematological toxicity in only 9.1% of the cy. The median follow-up was 11.5 months (range 1–29 mo). 20 (51.2%) and 12 (30.8%) pts achieved CR and PR with the T/C regimen, respectively and 7 (18%) had SD. The administration of T/D regimen resulted in 3 (15.8%) additional CRs. The overall response rate was 66% (CR 44%, PR 22%), with a median duration of response of 10.2 months (range 1–25.8 mo); the time to progression was 12.1 months (range 1–28.9 mo) and the median survival has not yet been reached. Conclusions: The results of the analysis indicate that the sequential administration of paclitaxel-carboplatin followed by paclitaxel-liposomal doxorubicin is an active regimen with acceptable toxicity as a 1st line treatment in patients with ovarian cancer. No significant financial relationships to disclose.