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Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Vinorelbine Plus Cisplatin in the Treatment of Patients With Advanced Non–Small-Cell Lung Cancer: A Southwest Oncology Group Trial

From the University of Colorado, Denver, CO; Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Swedish Medical Center, and University of Washington, Seattle, WA; St Vincent Medical Center, Los Angeles Oncology Institute, and University of Southern California School of Medicine, Los Angeles; University of California Davis, Sacramento, CA; Wayne State University Medical Center, Detroit, MI; University of Texas Health Science Center San Antonio, San Antonio, TX; and Wichita Community Clinical Oncology Program, Wichita, KS.

Address reprint requests to Southwest Oncology Group (SWOG-9509), Operations Office, 14980 Omicron Dr, San Antonio, TX 78245-3217.

PURPOSE: This randomized trial was designed to determine whether paclitaxel plus carboplatin (PC) offered a survival advantage over vinorelbine plus cisplatin (VC) for patients with advanced non–small-cell lung cancer. Secondary objectives were to compare toxicity, tolerability, quality of life (QOL), and resource utilization.

PATIENTS AND METHODS: Two hundred two patients received VC (vinorelbine 25 mg/m²/wk and cisplatin 100 mg/m²/d, day 1 every 28 days) and 206 patients received PC (paclitaxel 225 mg/m² over 3 hours with carboplatin area under the curve of 6, day 1 every 21 days). Patients completed QOL questionnaires at baseline, 13 weeks, and 25 weeks. Resource utilization forms were completed at five time points through 24 months.

RESULTS: Patient characteristics were similar between the groups. The objective response rate was 28% in the VC arm and 25% in the PC arm. Median survival was 8 months in both arms, with 1-year survival rates of 36% and 38%, respectively. Grade 3 and 4 leukopenia (P = .002) and neutropenia (P = .008) occurred more frequently on the VC arm. Grade 3 nausea and vomiting were higher on the VC arm (P = .001, P = .007), and grade 3 peripheral neuropathy was higher on the PC arm (P < .001). More patients on the VC arm discontinued therapy because of toxicity (P = .001). No difference in QOL was observed. Overall costs on the PC arm were higher than on the VC arm because of drug costs.

CONCLUSION: PC is equally efficacious as VC for the treatment of advanced non–small-cell lung cancer. PC is less toxic and better tolerated but more expensive than VC. New treatment strategies should be pursued.

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				F. Cappuzzo, M. Varella-Garcia, H. Shigematsu, I. Domenichini, S. Bartolini, G. L. Ceresoli, E. Rossi, V. Ludovini, V. Gregorc, L. Toschi, et al. Increased HER2 Gene Copy Number Is Associated With Response to Gefitinib Therapy in Epidermal Growth Factor Receptor-Positive Non-Small-Cell Lung Cancer Patients J. Clin. Oncol., August 1, 2005; 23(22): 5007 - 5018. [Abstract] [Full Text] [PDF]

				P. Seve, S. Isaac, O. Tredan, P.-J. Souquet, Y. Pacheco, M. Perol, L. Lafanechere, A. Penet, E.-L. Peiller, and C. Dumontet Expression of Class III {beta}-Tubulin Is Predictive of Patient Outcome in Patients with Non-Small Cell Lung Cancer Receiving Vinorelbine-Based Chemotherapy Clin. Cancer Res., August 1, 2005; 11(15): 5481 - 5486. [Abstract] [Full Text] [PDF]

				Y.-M. Chen, R.-P. Perng, J.-F. Shih, C.-M. Tsai, and J. Whang-Peng Chemotherapy for Non-small Cell Lung Cancer in Elderly Patients Chest, July 1, 2005; 128(1): 132 - 139. [Abstract] [Full Text] [PDF]

				T. Kato, Y. Daigo, S. Hayama, N. Ishikawa, T. Yamabuki, T. Ito, M. Miyamoto, S. Kondo, and Y. Nakamura A Novel Human tRNA-Dihydrouridine Synthase Involved in Pulmonary Carcinogenesis Cancer Res., July 1, 2005; 65(13): 5638 - 5646. [Abstract] [Full Text] [PDF]

				C. P. Belani, J. S. Lee, M. A. Socinski, F. Robert, D. Waterhouse, K. Rowland, R. Ansari, R. Lilenbaum, and R. B. Natale Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer Ann. Onc., July 1, 2005; 16(7): 1069 - 1075. [Abstract] [Full Text] [PDF]

				T. Winton, R. Livingston, D. Johnson, J. Rigas, M. Johnston, C. Butts, Y. Cormier, G. Goss, R. Inculet, E. Vallieres, et al. Vinorelbine plus Cisplatin vs. Observation in Resected Non-Small-Cell Lung Cancer N. Engl. J. Med., June 23, 2005; 352(25): 2589 - 2597. [Abstract] [Full Text] [PDF]

				P. A. Janne, J. A. Engelman, and B. E. Johnson Epidermal Growth Factor Receptor Mutations in Non-Small-Cell Lung Cancer: Implications for Treatment and Tumor Biology J. Clin. Oncol., May 10, 2005; 23(14): 3227 - 3234. [Abstract] [Full Text] [PDF]

				F. Cappuzzo, F. R. Hirsch, E. Rossi, S. Bartolini, G. L. Ceresoli, L. Bemis, J. Haney, S. Witta, K. Danenberg, I. Domenichini, et al. Epidermal Growth Factor Receptor Gene and Protein and Gefitinib Sensitivity in Non-Small-Cell Lung Cancer J Natl Cancer Inst, May 4, 2005; 97(9): 643 - 655. [Abstract] [Full Text] [PDF]

				V. Georgoulias, A. Ardavanis, X. Tsiafaki, A. Agelidou, P. Mixalopoulou, O. Anagnostopoulou, P. Ziotopoulos, M. Toubis, K. Syrigos, N. Samaras, et al. Vinorelbine Plus Cisplatin Versus Docetaxel Plus Gemcitabine in Advanced Non-Small-Cell Lung Cancer: A Phase III Randomized Trial J. Clin. Oncol., May 1, 2005; 23(13): 2937 - 2945. [Abstract] [Full Text] [PDF]

				J. R. Goffin, I. C. Anderson, J. G. Supko, J. P. Eder Jr., G. I. Shapiro, T. J. Lynch, M. Shipp, B. E. Johnson, and A. T. Skarin Phase I Trial of the Matrix Metalloproteinase Inhibitor Marimastat Combined with Carboplatin and Paclitaxel in Patients with Advanced Non-Small Cell Lung Cancer Clin. Cancer Res., May 1, 2005; 11(9): 3417 - 3424. [Abstract] [Full Text] [PDF]

				D. H. Lee, J.-Y. Han, H. G. Lee, J. J. Lee, E. K. Lee, H. Y. Kim, H. K. Kim, E. K. Hong, and J. S. Lee Gefitinib as a First-Line Therapy of Advanced or Metastatic Adenocarcinoma of the Lung in Never-Smokers Clin. Cancer Res., April 15, 2005; 11(8): 3032 - 3037. [Abstract] [Full Text] [PDF]

				I. Okamoto, E. Moriyama, S. Fujii, H. Kishi, M. Nomura, E. Goto, C. Kiyofuji, F. Imamura, T. Mori, and M. Matsumoto Phase II Study of Carboplatin-Paclitaxel Combination Chemotherapy in Elderly Patients with Advanced Non-small Cell Lung Cancer Jpn. J. Clin. Oncol., April 1, 2005; 35(4): 188 - 194. [Abstract] [Full Text] [PDF]

				J.-L. Pujol, J.-L. Breton, R. Gervais, P. Rebattu, A. Depierre, J.-F. Morere, B. Milleron, D. Debieuvre, D. Castera, P.-J. Souquet, et al. Gemcitabine-docetaxel versus cisplatin-vinorelbine in advanced or metastatic non-small-cell lung cancer: a phase III study addressing the case for cisplatin Ann. Onc., April 1, 2005; 16(4): 602 - 610. [Abstract] [Full Text] [PDF]

				H. S Sano, J A. Waddell, D. A Solimando Jr, P. Doulaveris, and R. Myhand Study of the effect of standardized chemotherapy order forms on prescribing errors and anti-emetic cost Journal of Oncology Pharmacy Practice, March 1, 2005; 11(1): 21 - 30. [Abstract] [PDF]

				G. V. Scagliotti, C. Kortsik, G. G. Dark, A. Price, C. Manegold, R. Rosell, M. O'Brien, P. M. Peterson, D. Castellano, G. Selvaggi, et al. Pemetrexed Combined with Oxaliplatin or Carboplatin as First-Line Treatment in Advanced Non-Small Cell Lung Cancer: A Multicenter, Randomized, Phase II Trial Clin. Cancer Res., January 15, 2005; 11(2): 690 - 696. [Abstract] [Full Text] [PDF]

				I. S. Choi, D.-Y. Oh, J. H. Kwon, S.-I. Kim, S. R. Park, J.-Y. Bak, J. H. Kim, D.-W. Kim, Y. T. Kim, T.-Y. Kim, et al. Paclitaxel/Platinum-based Perioperative Chemotherapy and Surgery in Stage IIIA Non-small Cell Lung Cancer Jpn. J. Clin. Oncol., January 1, 2005; 35(1): 6 - 12. [Abstract] [Full Text] [PDF]

				T. Hoang, R. Xu, J. H. Schiller, P. Bonomi, and D. H. Johnson Clinical Model to Predict Survival in Chemonaive Patients With Advanced Non-Small-Cell Lung Cancer Treated With Third-Generation Chemotherapy Regimens Based on Eastern Cooperative Oncology Group Data J. Clin. Oncol., January 1, 2005; 23(1): 175 - 183. [Abstract] [Full Text] [PDF]

				R. C. Lilenbaum, J. E. Herndon II, M. A. List, C. Desch, D. M. Watson, A. A. Miller, S. L. Graziano, M. C. Perry, W. Saville, P. Chahinian, et al. Single-Agent Versus Combination Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The Cancer and Leukemia Group B (study 9730) J. Clin. Oncol., January 1, 2005; 23(1): 190 - 196. [Abstract] [Full Text] [PDF]

				J.-Y. Douillard, R. Gervais, G. Dabouis, A. Le Groumellec, M. D'Arlhac, D. Spaeth, B. Coudert, D. Caillaud, A. Monnier, C. Clary, et al. Sequential two-line strategy for stage IV non-small-cell lung cancer: docetaxel-cisplatin versus vinorelbine-cisplatin followed by cross-over to single-agent docetaxel or vinorelbine at progression: final results of a randomised phase II study Ann. Onc., January 1, 2005; 16(1): 81 - 89. [Abstract] [Full Text] [PDF]

				S. D. Ramsey, N. Howlader, R. D. Etzioni, and B. Donato Chemotherapy Use, Outcomes, and Costs for Older Persons With Advanced Non-Small-Cell Lung Cancer: Evidence From Surveillance, Epidemiology and End Results-Medicare J. Clin. Oncol., December 15, 2004; 22(24): 4971 - 4978. [Abstract] [Full Text] [PDF]

				S. Kakiuchi, Y. Daigo, N. Ishikawa, C. Furukawa, T. Tsunoda, S. Yano, K. Nakagawa, T. Tsuruo, N. Kohno, M. Fukuoka, et al. Prediction of sensitivity of advanced non-small cell lung cancers to gefitinib (Iressa, ZD1839) Hum. Mol. Genet., December 15, 2004; 13(24): 3029 - 3043. [Abstract] [Full Text] [PDF]

				S.-F. Huang, H.-P. Liu, L.-H. Li, Y.-C. Ku, Y.-N. Fu, H.-Y. Tsai, Y.-T. Chen, Y.-F. Lin, W.-C. Chang, H.-P. Kuo, et al. High Frequency of Epidermal Growth Factor Receptor Mutations with Complex Patterns in Non-Small Cell Lung Cancers Related to Gefitinib Responsiveness in Taiwan Clin. Cancer Res., December 15, 2004; 10(24): 8195 - 8203. [Abstract] [Full Text] [PDF]

				N. Ishikawa, Y. Daigo, W. Yasui, K. Inai, H. Nishimura, E. Tsuchiya, N. Kohno, and Y. Nakamura ADAM8 as a Novel Serological and Histochemical Marker for Lung Cancer Clin. Cancer Res., December 15, 2004; 10(24): 8363 - 8370. [Abstract] [Full Text] [PDF]

				Y. Ichinose, K. Yoshimori, H. Sakai, Y. Nakai, T. Sugiura, M. Kawahara, and H. Niitani S-1 Plus Cisplatin Combination Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer: A Multi-Institutional Phase II Trial Clin. Cancer Res., December 1, 2004; 10(23): 7860 - 7864. [Abstract] [Full Text] [PDF]

				Y. H. Kim, G. Ishii, K. Goto, K. Nagai, K. Tsuta, S. Shiono, J. Nitadori, T. Kodama, Y. Nishiwaki, and A. Ochiai Dominant Papillary Subtype Is a Significant Predictor of the Response to Gefitinib in Adenocarcinoma of the Lung Clin. Cancer Res., November 1, 2004; 10(21): 7311 - 7317. [Abstract] [Full Text] [PDF]

				M. Mazumdar Group Sequential Design for Comparative Diagnostic Accuracy Studies: Implications and Guidelines for Practitioners Med Decis Making, October 1, 2004; 24(5): 525 - 533. [Abstract] [PDF]

				K. Hotta, K. Matsuo, H. Ueoka, K. Kiura, M. Tabata, and M. Tanimoto Meta-Analysis of Randomized Clinical Trials Comparing Cisplatin to Carboplatin in Patients With Advanced Non-Small-Cell Lung Cancer J. Clin. Oncol., October 1, 2004; 22(19): 3852 - 3859. [Abstract] [Full Text] [PDF]

				M. Mikawa, H. Wang, L. Guo, R. Liu, J. Marik, Y. Takada, K. Lam, and D. Lau Novel peptide ligands for integrin {alpha}4{beta}1 overexpressed in cancer cells Mol. Cancer Ther., October 1, 2004; 3(10): 1329 - 1334. [Abstract] [Full Text] [PDF]

				J. Kikuchi, K. Yamazaki, I. Kinoshita, H. Asahina, M. Imura, E. Kikuchi, J. Konishi, N. Shinagawa, H. Oki, H. Dosaka-Akita, et al. Phase I Trial of Carboplatin and Weekly Paclitaxel in Patients With Advanced Non-small-cell Lung Cancer Jpn. J. Clin. Oncol., September 1, 2004; 34(9): 505 - 509. [Abstract] [Full Text] [PDF]

				C. Monnerat, T. Le Chevalier, K. Kelly, C. K. Obasaju, J. Brahmer, S. Novello, T. Nakamura, A. M. Liepa, L. Bozec, P. A. Bunn Jr, et al. Phase II Study of Pemetrexed-Gemcitabine Combination in Patients with Advanced-Stage Non-Small Cell Lung Cancer Clin. Cancer Res., August 15, 2004; 10(16): 5439 - 5446. [Abstract] [Full Text] [PDF]