Final result of phase II study of amrubicin (AMR) combined with carboplatin (CBDCA) for elderly patients with small cell lung cancer (SCLC)

Le résumé fourni par la source

8054 Background: AMR, a new anthracycline agent, is active for SCLC. We had previously reported a phase I study of AMR combined with CBDCA for elderly patients with SCLC (J Thorac Oncol 1:551, 2006). The objective of this study is to evaluate the efficacy and the safety of this combination for elderly patients with SCLC. Methods: Chemotherapy naïve elderly patients (70 years or older) with SCLC received AMR (35 mg/m2, day1–3) and CBDCA (AUC 4.0, day1) every 3 weeks. The primary endpoint was overall response rate (ORR), and secondary endpoints were progression-free survival (PFS), overall survival and toxicity profile. Assuming that ORR of 60% in eligible pts would indicate potential usefulness while ORR of 40% would be the lower limit of interest, with alpha = 0.10 and beta = 0.20, the estimated accrual was 30 patients. Results: From January 2005 to November 2007, 36 pts were enrolled from 11 institutions. Patient characteristics were: Male/Female 27/9; median age 76 (range 70–83); Performance status 0/1 17/19. The median numbers of treatment cycles were 4 (range 2–7). The objective responses were CR 1, PR 31, SD 2, PD 2, and the ORR was 89%. Median PFS was 5.8 months and median survival time was 18.6 months. Grade 3–4 neutropenia was observed in all the patients and 5 patients (14%) suffered from grade 3–4 febrile neutropenia. Other toxicities were moderate and no treatment related death was observed. Conclusions: AMR combined with CBDCA is quite effective for SCLC with acceptable toxicities even for the elderly population. Further evaluation of this regimen is warranted. No significant financial relationships to disclose.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.