A phase II trial of amrubicin (AMR) for recurrent or refractory small cell lung cancer (SCLC)

Abstract

17053 Background: AMR, a totally synthetic 9-amino-anthracycline, demonstrated excellent single-agent activity for previously untreated extensive stage SCLC (Yana et al., Proc. ASCO, 1998, abstr.No.1734). The aim of this trial was to evaluate clinical activity of AMR in the treatment of patients with recurrent or refractory SCLC. Methods: Eligibility criteria were patients having histologically or cytologically proven measurable SCLC, had relapsed after one or two previous systemic chemotherapies, an Eastern Cooperative Oncology Group performance status (PS) of 0–2 and adequate organ function. AMR (40 mg/m2) was administered on days 1–3 every 3 weeks. This study, with a planned sample size of 25, had 80% power to support the hypothesis that the true response rate was >30%, and 5% significance to deny the hypothesis is the true RR was <10%. Results: Between July 2003 and October 2005, 19 patients were enrolled with the following characteristics: male/female, 15/4; median age, 66 years (range 47–78); PS 0/1/2, 0/16/3; sensitive relapse/refractory case, 7/12. Median number of treatment cycles was 3. A total of 59 courses were assessable for safety. The principle toxicity was myelosuppression. Grade 3/4hematologic toxicities were leukopenia (53/32%), neutropenia (32/53%), thrombocytopenia (32/0%) and anemia (42/0%). Non-hematologic toxicities weremild with no grade 4 toxicities; grade 3neutropenic fever (16%), infection (11%), diarrhea (5%), constipation (5%), and AST/ALT (11%) were observed.Responses included 7PR (3 sensitive cases and 4 refractory cases) and 8SD; for an objective RR of 37% (95% CI 16–59%). Conclusions: AMR is well tolerated and promising for treatment of recurrent or refractory SCLC. This regimen warrants further evaluation in a phase III trial. No significant financial relationships to disclose.