A randomized phase III trial (389): Oral topotecan/cisplatin (TC) vs IV etoposide/cisplatin (PE) as treatment for chemotherapy-naïve patients (pts) with extensive disease small cell lung cancer (ED-SCLC): Interim tolerability results

7046 Background: IV topotecan is an established therapy in relapsed, “sensitive” SCLC. Oral and IV topotecan have similar activity and tolerability. Phase II data in combination with cisplatin as well as data from Noda et al provided the rationale for this study. Methods: Chemotherapy-naive patients with ED-SCLC and performance status ECOG 0, 1, or 2 stratified by gender, performance status, LDH, and country were randomized to receive either oral topotecan (days 1–5: 1.7 mg/m2)/cisplatin (day 5: 60 mg/m2) (TC) or IV etoposide (days 1–3: 100 mg/m2)/cisplatin (day 1: 80 mg/m2) (PE). The dose of oral topotecan was reduced from 2.0 mg/m2/day to 1.7 mg/m2/day because of neutropenia and diarrhoea. Primary endpoint was overall survival; secondary endpoints were response rate, response duration, time to progression, tolerability, and symptom improvement. Results: Between May 2001 and December 2002, 859 patients were recruited. Preliminary tolerability data are available for 732 pts (TC: 364/PE: 368). Baseline cha...