Phase II study of bendamustine in relapsed chemotherapy sensitive or resistant small-cell lung cancer.

Lammers PE, Shyr Y, Li CI, Hutchison AS, Sandler A, Carbone DP, Johnson DH, Keedy VL, Horn L
J Thorac Oncol. 2014 9 (4): 559-62

PMID: 24736081 · PMCID: PMC3990869 · DOI:10.1097/JTO.0000000000000079

INTRODUCTION - To determine the time to progression (TTP), response rate (RR), 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 chemotherapy-resistant disease treated with up to two prior lines of chemotherapy. Patients were treated with 120 mg/m of bendamustine on days 1 and 2 of a 21-day cycle for up to six cycles. Primary end point was TTP; secondary end points included toxicity, RR, and overall survival.

RESULTS - Fifty-nine patients were accrued, 50 patients met eligibility for enrollment. The median age of patients was 62, and 56% were men. Twenty-nine patients (58%) had chemotherapy-sensitive disease. Median TTP was 4.0 months (95% confidence interval [CI], 3.3-5.4), median overall survival was 4.8 months (95% CI, 3.8-6.3), and the RR was 26% (95% CI, 13.3%-39.5%). Patients with chemosensitive disease had a median TTP of 4.2 months (95% CI, 3.3-6.0) compared with 3.4 months (95% CI, 2.7-∞) for chemotherapy-resistant disease. The RR was 33% (95% CI, 14.2%-51.8%) in patients with chemosensitive disease and 17% (95% CI, 0%-34.4%) in those with chemoresistant disease. The most common grade 3/4 adverse events were fatigue (20%), dyspnea (12%), and anemia (12%).

CONCLUSION - Bendamustine has modest activity in relapsed SCLC similar to other agents evaluated in this patient population.

MeSH Terms (18)

Adult Aged Antineoplastic Agents, Alkylating Bendamustine Hydrochloride Drug Resistance, Neoplasm Female Follow-Up Studies Humans Lung Neoplasms Male Middle Aged Neoplasm Recurrence, Local Neoplasm Staging Nitrogen Mustard Compounds Prognosis Salvage Therapy Small Cell Lung Carcinoma Survival Rate

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