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Journal of Clinical Oncology, Vol 20, Issue 17 (September), 2002: 3578-3585
© 2002 American Society for Clinical Oncology

Paclitaxel Plus Carboplatin Versus Gemcitabine Plus Paclitaxel in Advanced Non–Small-Cell Lung Cancer: A Phase III Randomized Trial

By Paris Kosmidis, Nick Mylonakis, Costas Nicolaides, Charalabos Kalophonos, Epaminontas Samantas, John Boukovinas, George Fountzilas, Dimosthenis Skarlos, Theophanis Economopoulos, Dimitrios Tsavdaridis, Pavlos Papakostas, Charalabos Bacoyiannis, Meletios Dimopoulos for the Hellenic Cooperative Oncology Group

From the Second Medical Oncology Department, Hygeia Hospital, Athens, Greece.

Address reprint requests to Paris A. Kosmidis, MD, 2nd Medical Oncology Department, Hygeia Hospital, 2 An Tsoha & Vas Sofias Ave, 11521 Athens, Greece; email: parkosmi{at}otenet.gr

PURPOSE: We conducted this randomized study comparing the activity and toxicity of paclitaxel and gemcitabine (PG) and paclitaxel and carboplatin (PC) combinations for the treatment of advanced non–small-cell lung cancer (NSCLC).

PATIENTS AND METHODS: Chemotherapy-naive patients were randomized to paclitaxel 200 mg/m2 on day 1 plus either carboplatin at an area under the concentration-time curve of 6 on day 1 (group A) or gemcitabine 1,000 mg/m2 on days 1 and 8 (group B) every 3 weeks. A retrospective cost analysis was conducted using Student’s t test to compare independent samples between groups.

RESULTS: A total of 509 patients (group A, 252 patients; group B, 257 patients) were enrolled; all characteristics were well balanced. The median survival time was 10.4 months (95% confidence interval [CI], 8.8 to 12 months) for group A and 9.8 months (95% CI, 8.0 to 11.7 months) for group B (P = .32). Respective 1-year survival rates were 41.7% and 41.4%. The response rate for group A was 28.0% (2% complete response [CR], 26% partial response [PR] [95% CI, 22% to 34%]), and the response rate for group B was 35.0% (5% CR, 30% PR) [95% CI, 29% to 41%]) (P = .12). Toxicity was mild. Grades 3/4 neutropenia, thrombocytopenia, and anemia for groups A and B were seen in 15% and 15%, 2% and 1%, and 5% and 2%, respectively. The mean total cost (outpatient clinic visits plus chemotherapy drug fee) for group A ({euro} 7,612.64) versus group B ({euro} 7,484.77) was not statistically significant (P < .66).

CONCLUSION: The PG combination is as equally active and well tolerated as the PC combination in patients with advanced NSCLC.


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