Purpose: This study was conducted to evaluate the efficacy and safety of sunitinib in patients with relapsed or refractory small cell lung cancer (SCLC).
Patients and methods: Eligibility included histologic or cytologic diagnosis of SCLC, ECOG PS of 0-2, cancer progression following one or two prior chemotherapy or chemo-radiotherapy (CRT) and adequate organ functions. Treatment regimen consisted of a 6-week cycle of sunitinib given as 50mg p.o. daily for 4 weeks followed by 2 weeks off. The primary end point was objective response rate (ORR).
Results: From March 2008 to October 2010, 25 patients were enrolled and 24 received treatment. The median age was 64.5 years; 22 patients (92%) were male. Eight patients (33%) displayed sensitive relapse. Seven patients (29%) received CRT and fifteen patients (63%) had received one prior chemotherapy. A median of 1 cycle (range 1-4) of sunitinib was administered, and 23 patients were evaluable for response. Two patients displayed partial response, and seven patients presented stable disease with a ORR of 9% (95% CI, 1-28%). The median progression-free (PFS) and overall survivals were 1.4 months (95% CI, 1.1-1.7) and 5.6 months (95% CI, 3.5-7.7), respectively. The common grade 3 or 4 toxicities included thrombocytopenia (63%), asthenia (29%) and neutropenia (25%).
Conclusions: Although tumor response was noted in 2 patients, the median PFS was short and most patients were unable to tolerate the treatment. At the current dose schedule, sunitinib does not appear to warrant further evaluation.
Trial registration: ClinicalTrials.gov NCT00620347.
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