Introduction
To determine the time to progression (TTP), response rate, and toxicity for North American patients with relapsed small cell lung cancer (SCLC) treated with bendamustine in the second or third line setting.
Methods
Patients with relapsed, histologically confirmed SCLC were eligible for enrollment on study. The study population included patients with both chemotherapy sensitive and resistant disease treated with up to two prior lines of chemotherapy. Patients were treated with bendamustine 120 mg/m2 on days 1 and 2 of a 21-day cycle for up to 6 cycles. Primary endpoint was TTP; secondary endpoints included toxicity, response rate (RR), and overall survival (OS).
Results
Fifty-nine patients were accrued, 50 patients met eligibility for enrollment. The median age of patients was 62, and 56% were male. Twenty-nine patients (58%) had chemotherapy sensitive disease. Median TTP was 4.0 months (95% C.I. 3.3–5.4), median OS was 4.8 months (95% C.I. 3.8–6.3), and the RR was 26% (95% C.I. 13.3%–39.5%). Patients with chemosensitive disease had a median TTP of 4.2 months (95% C.I. 3.3–6.0) compared to 3.4 months (95% C.I. 2.7–∞) for chemotherapy resistant disease. The response rate was 33% (95% C.I. 14.2%–51.8%) in patients with chemosensitive disease and 17% (95% C.I. 0%–34.4%) in those with chemoresistant disease. The most common grade 3/4 adverse events were fatigue (20%), dyspnea (12%), and anemia (12%).
Conclusions
Bendamustine has modest activity in relapsed SCLC similar to other agents evaluated in this patient population.