Activity of intravenous Topotecan in patients with advanced non-small cell lung cancer pre-treatred with platinum and taxanes: Results of the first analysis: P2-318

Topotecan, a semi-synthetic camptothecin analogue with topoisomerase I interaction has shown to be an active agent in the treatment of advanced refractory lung cancer and ovarian cancer. In this report, experience with this drug is described when used as a single agent in patients with advanced NSCLC refractory to chemotherapy regimens containing at least platinum and taxanes. twenty-four patients (pts) with NSCLC refractory to previous chemotherapy and KI ≥60% were included in the study showing the following features: median age of 52 years (range 43-69) and karnofsky PS of 70 (50-80), 21 were male and 3 female. Fifteen (62 %) pts had adenocarcinoma, six (25%) squamous cell and three (13%) undifferentiated carcinoma. The median number of disease sites and prior regimens received were two in both cases. Topotecan was given at a dose of 1.25 mg/m2 I.V. daily for five days, repeated every 21 days until progression disease, maximal response or intolerable toxicity occurred. After 52 cycles administered, pts received a median of 2 cycles of treatment (1-6). All patients except one were considered evaluable for toxicity, with the recording of five episodes of (22%) nausea/vomiting grade 1-2 and one (4%) of asthenia grade 1. Four (17%) patients developed anaemia grade 2-3 and neutropenia grade1. Two additional patients (9%) had neutropenia grade 2 and one (4%) grade V. Among twenty evaluable pts for activity, one (4%) showed partial response, seven (29%) stable disease and twelve (50%) progression disease. Median time to progression and overall survival are 54 (12-210) and 60 (12-485) days respectively. At this time of evaluation, intravenous Topotecan with this schedule and dose shows promising activity. The accrual still continues until the planned sample size following the Simon Two-stage design.