A phase II study of weekly docetaxel plus capecitabine for patients with advanced nonsmall cell lung carcinoma

BACKGROUND. Docetaxel is an active agent in advanced nonsmall-cell lung carcinoma (NSCLC) and demonstrates preclinical and clinical synergism with capecitabine. We conducted the current Phase II study to evaluate the efficacy and safety of the docetaxel/capecitabine combination in chemotherapy-naive patients with advanced NSCLC. METHODS. Eligibility required Stage IIIB or W NSCLC, bidimensionally measurable disease, and an Eastern Cooperative Oncology Group performance score of 2 or lower. Treatment consisted of docetaxel 36 mg/m(2) intravenously on Days 1 and 8 plus capecitabine 1000 mg/m(2) orally twice per day on Days 1-14 of a 21-day cycle, for a maximum of 6 cycles. RESULTS. Of 39 patients enrolled, 39 and 36 patients were evaluated for toxicity and response, respectively. The overall response rate was 53% (95% confidence interval [Cl], 37-69%) with 19 partial responses (no complete response). The median duration of response was 6.2 months (range, 2.1-15.7 months). At a median follow-up of 14.2 months, 19 patients died. The median overall survival time was 17.8 months, with a 1-year survival rate of 56.4% (95% Cl, 40.9 -72.0%). There were two treatment-related deaths (one death due to pneumonia and one due to sepsis). Hematologic toxicity was mild to moderate. Thirteen percent of the patients had Grade 3 or 4 neutropenia. However, Grade 2 or 3 nonhematologic toxicities were frequent, which included asthenia (51%), stomatitis (33%), hand-foot syndrome (33%), and diarrhea (29%). CONCLUSIONS. The docetaxel/capecitabine combination showed promising antitumor activity for chemotherapy-naive patients with advanced NSCLC, However, it was frequently associated with moderate-to-severe nonhematologic toxicities, suggesting clinical synergism in both efficacy and toxicity. Further adjustment of the dose schedule is recommended to maximize the therapeutic index. (C) 2003 American Cancer Society.