Phase II study of amrubicin and carboplatin in patients with the refractory or relapsed small cell lung cancer (SCLC).

Abstract

7057 Background: Amrubicin achieved the high response rate of 78.8% and median survival of 11.3 months in patients with previously untreated extensive disease SCLC. The combination of amrubicin with platinum derivative showed additive effect against a human small cell lung cancer cell line. In the phase I study of amrubicin plus carboplatin for untreated SCLC patients with 70 year or older, the recommended dose was determined to be 35 mg/m2 of amrubicin on days 1-3 and AUC of 4 mg min/mL of carboplatin on day 1. We examined the safety and efficacy of the combination of amrubicin plus carboplatin for refractory or relapsed SCLC. Methods: Patients with previously treated SCLC were eligible if they had a performance status of 0 to 2, were 75 years or younger, and had adequate organ function. Patients received the combination of carboplatin with AUC of 4 mg min/ml using the Calvert formula on day 1 plus amrubicin 30 mg/m2 on days 1-3 every 3 weeks. The trial was designed as a phase II study, with response rate as the primary endpoint. A planned sample size was 27. Results: From June 2005 through April 2009, 28 patients (22 men and 6 women; median age, 65 years; range, 55 to 74 years) were enrolled. At the time of recurrence, 3 patients had limited disease and 25 patients had extensive disease. The overall response rate was 35.7% (95% CI, 18.6% to 55.9%). In patients with sensitive disease, the response rate was 63.6% (95% CI, 30.8% to 89.1%). The median survival time was 184 days (range 24 to 1,290 days). Hematologic toxicities included grade 3 to 4 neutropenia in 86% of patients, grade 3 to 4 thrombocytopenia in 46%, and grade 3 to 4 anemia in 61%. Grade 3 infection developed in only 7% of patients. No patients had grade 3 to 4 diarrhea, nausea, or vomiting. There was no treatment death. Conclusions: This regimen is effective and well tolerated in patients with relapsed or refractory SCLC. No significant financial relationships to disclose.