Randomized phase II study (EORTC 08062) of amrubicin as single agent or in combination with cisplatin versus etoposide-cisplatin as first-line treatment in patients (pts) with extensive disease small cell lung cancer (ED SCLC).

7052 Background: Outcome for pts with ED SCLC remains poor, despite standard treatment with platinum and etoposide (E). Amrubicin (A) is a synthetic anthracycline and a potent topoisomerase II inhibitor, with less cardiotoxicity than doxorubicin, approved in Japan for the treatment of NSCLC and SCLC. Methods: Eligible pts had previously untreated, histologically confirmed ED SCLC,WHO performance status (PS) 0-2and measurable disease according to RECIST. Pts were randomized to 3 weekly cycles of either (1) A alone 45 mg/m2 d1-3, (2) cisplatin (C) 60 mg/m2 d1 and A 40 mg/m2 d1-3 or (3) E 100 mg/ m2 d1, d2-3 i.v/po and C 75 mg/m2 d1. The primary endpoint was overall response rate (ORR) aiming at ORR = 80% and powered to rule out an ORR < 55% in any experimental arm. Patients were stratified by center, gender and PS. To declare success, 19 responses out of 27 eligible pts who started treatment (ORR of at least 70%) were needed in each arm using a Fleming design. Results: The number of randomized/eligible pts ...