A phase II study of weekly carboplatin and paclitaxel as first-line treatment of elderly patients with advanced ovarian cancer - A Multicentre Italian Trial in Ovarian cancer (MITO-5) study

Background: Carboplatin/paclitaxel every 3 weeks is the standard for patients with ovarian cancer, but elderly patients frequently receive modified schedules or single agent chemotherapy to avoid toxicity. A phase 11 study was conducted to describe tolerability of a weekly schedule of both drugs in elderly patients. Methods: Patients aged >= 70 years with stage IC-IV ovarian cancer, performance status <= 2, were eligible. Treatment was carboplatin (AUC 2) + paclitaxel (60 mg/m(2)) on days 1, 8, 15 every 4 weeks, up to six cycles. A two-stage design was applied with lack of unacceptable toxicity as primary endpoint; 26 patients were required at the final stage, with at least 23 of them without unacceptable toxicity to conclude for a positive result. Geriatric assessment was performed by activity daily living (ADL) and instrumental ADL (IADL) scales. Results: Twenty-six patients were analysed (median age 77 years, range 70-84). Performance status was 0 in 10 and I in 16 patients; 14 patients had two or more comorbidities; 8 and 18 patients had some dependency in ADL or IADL. Twenty-three patients (88.5%) were treated without suffering unacceptable toxicity. Unacceptable toxic events were grade 3 heart rhythm, grade 3 increase of liver transaminases and prolonged haematological toxicity. Grade I neuropathy was reported in four cases. Out of 13 patients evaluable by RECIST, 5 partial responses were observed (response rate 38.5%). Two complete responses were observed among six patients with non-target lesions. Eight patients eligible for CA-125 response assessment had a response after six cycles. Median estimated progression-free survival was 13.6 months, and median overall survival was 32.0 months. Conclusions: In a series of elderly ovarian cancer patients, characterized by a high incidence of comorbidities and functional impairment, weekly carboplatin and paclitaxel demonstrated a favourable toxicity profile. (C) 2008 Elsevier Ireland Ltd. All rights reserved.