A Pilot Phase Ii Study Of Capecitabine With Carboplatin In Patients With Advanced Nonsmall Cell Lung Cancer

Carboplatin forms the backbone of many regimens for nonsmall cell lung cancer (NSCLC). 5-fluorouracil (5-FU) is modestly active in NSCLC and is synergistic with platinum analogs. This trial evaluated the activity and toxicity of capecitabine, an oral 5FU prodrug, with carboplatin in patients with unresectable NSCLC. Eligibility criteria included untreated measurable stage IIIB/IV NSCLC, ECOG performance status < 2, and adequate organ function. Carboplatin, AUC=5, was administered on day one, with capecitabine, 4000 mg days 1-14, every 28 days. Tumor assessments were obtained every other cycle. Fifteen patients (median age = 64; median performance status = 0) were enrolled and received 46 cycles of protocol therapy; 13 were evaluable for response, with 5 partial responses (38.5%). Five withdrew due to toxicity; four possibly related to study therapy. Median survival was 8 months. Capecitabine and carboplatin are active in NSCLC. Further investigation is not warranted, as this current regimen is too toxic.