Abstract
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 IV 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 [CI], 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% CI, 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. Cancer 2003. © 2003 American Cancer Society.