Paclitaxel and gemcitabine versus carboplatin and gemcitabine in patients with advanced non-small-cell lung cancer. A phase III study of the Hellenic Cooperative Oncology Group

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Abstract
Background: This phase III study was designed to compare the combination paclitaxel (Taxol)–gemcitabine (PG) versus carboplatin–gemcitabine (CG) in patients with advanced inoperable non-small-cell lung cancer. Methods: Chemotherapy-naive patients with performance status of zero or one were randomized to gemcitabine 1 gm/m2 on days 1 and 8 plus either paclitaxel 200 mg/m2 on day 1 (arm A) or carboplatin at an area under the concentration–time curve of 6 mg on day 1 (arm B) every 3 weeks. Primary end point was overall survival (OS). Secondary end points included objective response (OR), time to progression and toxicity. Results: A total of 512 patients were enrolled and 452 eligible (arm A, 225; arm B, 227) were analyzed. All characteristics were well balanced with the exception of vena cava obstruction symptoms and lymph node involvement. Median survival was 9.97 months [95% confidence interval (CI) 8.74–12.0] for group A and 10.49 (95% CI 9.04–11.94) for group B. There was no difference in the OS, 1-year survival, OR and TtP. However, statistically significant differences were seen in toxicity. Conclusion: The two regimens are equally active. Myelotoxicity is worse in the CG group whereas alopecia, myalgia and neurotoxicity worse in the PG group.

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