Randomized, phase II trial comparing amrubicin with topotecan in patients (pts) with previously treated small cell lung cancer (SCLC)

Abstract

8042 Background: Amrubicin (A), a new anthracycline agent, and topotecan (T) are both active for previously treated SCLC. No comparative study with these two agents has been reported. This randomized phase II study was conducted to select A or T for future evaluation in a phase III setting. Methods: Previously treated SCLC pts were randomized to receive A (40 mg/m2, day1–3, every 3weeks) or T (1.0 mg/2, day1–5, every 3 weeks). The primary endpoint was overall response rate (ORR), and secondary endpoints were progression-free survival (PFS) and toxicity profile. Assuming that ORR of 40% in eligible pts would indicate potential usefulness while ORR of 20% would be the lower limit of interest, with alpha = 0.05 and beta = 0.10, the estimated accrual was 27 pts in each arm. Results: From February 2004 to July 2007, 60 pts were enrolled from 12 institutions. One patient in A arm did not receive any protocol treatment due to rapid disease progression and 59 pts were evaluable for efficacy and safety. Patient characteristics were: Male/Female 49/10; median age 67 (range 32–78); Performance status 0/1/2 31/19/9; Sensitive relapse (S) / Refractory relapse 36/23. The median numbers of treatment cycles were 3 (range 1–7) in A arm and 2 (range 1–4) in T arm. ORRs and disease control rates (DCRs) were 38% (95%CI: 20–56) and 79% (95%CI: 64–94) for A, and 13% (95%CI: 1–25) and 47% (95%CI: 29–65) for T, respectively. In subset analysis on type of relapse, ORRs and DCRs were 53% and 88% for A, and 21% and 63% for T in S pts, and 17% and 67% for A, and 0% and 18% for T in R pts. Median PFS on A arm was 105 days and on T arm was 60 days. Neutropenia was significantly severe in A arm. One treatment related death due to infection was observed in A arm. Conclusions: A is more active agent than T with acceptable toxicity for previously treated SCLC pts, especially for pts with R. Further evaluation of A as a single agent or in combination is warranted in SCLC. No significant financial relationships to disclose.