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Movsas B , Langer CJ , Ross HJ , Wang LH , Jotte RM , Feigenberg S , Xu F , Huang CH , Monberg MJ , Obasaju CK
Randomized Phase II Trial of Cisplatin, Etoposide, and Radiation Followed by Gemcitabine Alone or by Combined Gemcitabine and Docetaxel in Stage III A/B Unresectable Non-small Cell Lung Cancer
Journal of Thoracic Oncology. 2010 May;5(5) :673-679
PMID: ISI:000277038200014   
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Purpose: Southwest Oncology Group 9504 demonstrated the feasibility and potential benefit of docetaxel consolidation after etoposide, cisplatin, and radiotherapy in patients with locally advanced non-small cell lung cancer. Our study assessed consolidation with either gemcitabine alone or with docetaxel after identical chemoradiation as used in Southwest Oncology Group 9504. Methods: Patients with stage III non-small cell lung cancer and good performance status were included. Treatment consisted of concurrent cisplatin 50 mg/m(2) on days 1 and 8 plus etoposide 50 mg/m(2) on days 1 to 5 for two 28-day cycles plus radiotherapy (62 Gy, 2 Gy daily in 31 fractions over 7 weeks), followed by randomization to either gemcitabine 1000 mg/m(2) on days 1 and 8 (G) or gemcitabine 1000 mg/m(2) on days 1 and 8 plus docetaxel 75 mg/m(2) on day 1 (GD) every 21 days for three cycles. Results: Eighty-three patients were entered, 81 received induction therapy, and 64 were randomized (32 in each arm). Grade 3 or four events, including neutropenia (56.3% vs. 28.1%, p = 0.03), anemia (18.8% vs. 3.1%, p = 0.05), and fatigue (15.6% vs. 6.3%, p = NS), were more frequent with GD compared with G. Among all patients, median survival from registration was 20.8 months (95% confidence interval: 16.4-33.8), and 2-year survival was 46.7% (95% confidence interval: 35.6-57.1). From randomization, median progression-free survival was 5.4 months for G and 13.4 months for GD, and median survival was 16.1 months for G and 29.5 months for GD. Two-year survival rates were 40.6% for G and 55.7% for GD. Conclusion: The doublet, as expected, resulted in more toxicity, particularly myelosuppression and fatigue. Survival associated with the GD treatment arm of this trial exceeds that of previously reported trials.
Movsas, Benjamin Langer, Corey J. Ross, Helen J. Wang, Luhua Jotte, Robert M. Feigenberg, Steve Xu, Feng Huang, Chao H. Monberg, Matthew J. Obasaju, Coleman K. Lilly USA, LLC Supported by Lilly USA, LLC. The authors thank the following investigators for their contributions to this study: Dr. William Waterfield, Franklin Square Hospital (Baltimore, MD); Dr. John Eckardt, The Center for Cancer Care and Research (St Louis, MO); Dr. Walter Urba, Providence Portland Medical Center (Portland, OR); Dr. Rafat Ansari, Northern Indiana Research Consortium (South Bend, IN); Dr. Timothy Lopez, Cancer Institute of New Mexico (Santa Fe, NM); Dr. Robert Jotte, Rocky Mountain Cancer Center (Denver, CO); Dr. Li-Fen Chang, Oncology Institute of Greater Lafayette (Lafayette, IN); Dr. Mukund Shah, Antelope Valley Cancer Center (Lancaster, CA); Dr. Afshin Dowlati, University Hospitals of Cleveland (Cleveland, OH); Dr. Jeffrey Letzer, Kalamazoo Hematology and Oncology (Kalamazoo, MI); Dr. Lee Schwartzberg, The West Cancer Clinic (Memphis, TN); Dr. Fein, Centro Oncologico de Rosario (Rosario, Argentina); Dr. Zarba, Centro Medico San Roque (San Miguel de Tucuman Argentina); Dr. Hoon Kyo, St. Vincent Hospital (Suwon, Korea); and Dr. Kim, Asan Medical Center (Seoul, Korea). 24 Lippincott williams & wilkins; 530 walnut st, philadelphia, pa 19106-3621 usa 588am