This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Smit, E. F. Articles by Giaccone, G. Search for Related Content PubMed PubMed Citation Articles by Smit, E. F. Articles by Giaccone, G. Social Bookmarking                            What's this?

Three-Arm Randomized Study of Two Cisplatin-Based Regimens and Paclitaxel Plus Gemcitabine in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group—EORTC 08975

Egbert F. Smit, Jan P.A.M. van Meerbeeck, Pilar Lianes, Channa Debruyne, Catherine Legrand, Franz Schramel, Hans Smit, Rabab Gaafar, Bonne Biesma, Chris Manegold, Niels Neymark, Giuseppe Giaccone

From the Departments of Pulmonology and Medical Oncology, Vrije Universiteit Medical Center, Amsterdam; Department of Pulmonology, Erasmus Medical Centre, Rotterdam; Department of Pulmonology, St Antonius Ziekenhuis, Nieuwegein; Department of Pulmonology, Rijnstate Hospital, Arnhem; and Bosch, s’Hertogenbosch, the Netherlands; Department of Medical Oncology, Matero, Spain; European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium; National Cancer Institute, Cairo, Egypt; and Thoraxklinik, Heidelberg, Germany.

Address reprint requests to E.F. Smit, MD, PhD, Department of Pulmonology, Martini Hospital, PO Box 30033,9700 RM Groningen, the Netherlands; e-mail: e.f.smit{at}mzh.nl.

Purpose: To compare the therapeutic efficacy of paclitaxel plus cisplatin (arm A) versus gemcitabine plus cisplatin (arm B) and arm A versus paclitaxel plus gemcitabine (arm C) in chemotherapy-naive patients with advanced non–small-cell lung cancer (NSCLC).

Materials and Methods: Patients were randomly assigned to receive either paclitaxel 175 mg/m² (3-hour infusion, day 1) or gemcitabine 1,250 mg/m² (days 1 and 8) both combined with cisplatin 80 mg/m² (day 1) or paclitaxel 175 mg/m² (3-hour infusion, day 1) combined with gemcitabine 1,250 mg/m² (days 1 and 8). Primary end point was comparison of overall survival for B versus A and C versus A. Secondary end points included response rate and duration, progression-free survival, toxicities, quality of life [QoL], and cost of treatment.

Results: Four hundred eighty patients (arm A, 159; arm B, 160; arm C, 161 patients) were enrolled; all baseline characteristics were balanced. Median survival times were as follows: arm A, 8.1 months; arm B, 8.9 months; arm C, 6.7 months. Response rates were 31.8% for arm A, 36.6% for arm B, and 27.7% for arm C. Other than myelosuppression (B v A, P < .005), no statistically or clinically significant differences were observed for secondary end points. The average treatment costs were 25% higher in arm C as compared with arms A and B.

Conclusion: Gemcitabine plus cisplatin and paclitaxel plus gemcitabine do not increase overall survival in patients with advanced NSCLC as compared with paclitaxel plus cisplatin. Treatment was well tolerated, and most QoL parameters were similar, but costs associated with the nonplatinum arm were highest.

Supported by grant Nos. 2U10 CA11488-28, 5U10 CA11488-29, and 5U10 CA11488-30 from the National Cancer Institute, Bethesda, MD.

Presented in part at the Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, 2001, and the European Conference on Clinical Oncology, Lisbon, Portugal, 2001.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute. Authors’ disclosures of potential conflicts of interest are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				F. Grossi, M. Aita, C. Defferrari, F. Rosetti, A. Brianti, G. Fasola, O. Vinante, P. Pronzato, and G. Pappagallo Impact of Third-Generation Drugs on the Activity of First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Meta-Analytical Approach Oncologist, May 1, 2009; 14(5): 497 - 510. [Abstract] [Full Text] [PDF]

				J-P. Sculier and D. Moro-Sibilot First- and second-line therapy for advanced nonsmall cell lung cancer Eur. Respir. J., April 1, 2009; 33(4): 915 - 930. [Abstract] [Full Text] [PDF]

				M. Reck, J. von Pawel, P. Zatloukal, R. Ramlau, V. Gorbounova, V. Hirsh, N. Leighl, J. Mezger, V. Archer, N. Moore, et al. Phase III Trial of Cisplatin Plus Gemcitabine With Either Placebo or Bevacizumab As First-Line Therapy for Nonsquamous Non-Small-Cell Lung Cancer: AVAiL J. Clin. Oncol., March 10, 2009; 27(8): 1227 - 1234. [Abstract] [Full Text] [PDF]

				M. Berhoune, E. Banu, F. Scotte, P. Prognon, S. Oudard, and B. Bonan Therapeutic Strategy for Treatment of Metastatic Non-Small Cell Lung Cancer Ann. Pharmacother., November 1, 2008; 42(11): 1640 - 1652. [Abstract] [Full Text] [PDF]

				C. Manegold, D. Gravenor, D. Woytowitz, J. Mezger, V. Hirsh, G. Albert, M. Al-Adhami, D. Readett, A. M. Krieg, and C. G. Leichman Randomized Phase II Trial of a Toll-Like Receptor 9 Agonist Oligodeoxynucleotide, PF-3512676, in Combination With First-Line Taxane Plus Platinum Chemotherapy for Advanced-Stage Non-Small-Cell Lung Cancer J. Clin. Oncol., August 20, 2008; 26(24): 3979 - 3986. [Abstract] [Full Text] [PDF]

				S. Ramalingam and C. Belani Systemic Chemotherapy for Advanced Non-Small Cell Lung Cancer: Recent Advances and Future Directions Oncologist, January 1, 2008; 13(suppl_1): 5 - 13. [Abstract] [Full Text] [PDF]

				D. -W. Kim, S. -Y. Kim, H. -K. Kim, S. -W. Kim, S. W. Shin, J. S. Kim, K. Park, M. Y. Lee, and D. S. Heo Multicenter phase II trial of Genexol-PM, a novel Cremophor-free, polymeric micelle formulation of paclitaxel, with cisplatin in patients with advanced non-small-cell lung cancer Ann. Onc., December 1, 2007; 18(12): 2009 - 2014. [Abstract] [Full Text] [PDF]

				G. Simon, A. Sharma, X. Li, T. Hazelton, F. Walsh, C. Williams, A. Chiappori, E. Haura, T. Tanvetyanon, S. Antonia, et al. Feasibility and Efficacy of Molecular Analysis-Directed Individualized Therapy in Advanced Non-Small-Cell Lung Cancer J. Clin. Oncol., July 1, 2007; 25(19): 2741 - 2746. [Abstract] [Full Text] [PDF]

				U. Gatzemeier, A. Pluzanska, A. Szczesna, E. Kaukel, J. Roubec, F. De Rosa, J. Milanowski, H. Karnicka-Mlodkowski, M. Pesek, P. Serwatowski, et al. Phase III Study of Erlotinib in Combination With Cisplatin and Gemcitabine in Advanced Non-Small-Cell Lung Cancer: The Tarceva Lung Cancer Investigation Trial J. Clin. Oncol., April 20, 2007; 25(12): 1545 - 1552. [Abstract] [Full Text] [PDF]

				C. Langer, S. Li, J. Schiller, W. Tester, B. L. Rapoport, and D. H. Johnson Randomized Phase II Trial of Paclitaxel Plus Carboplatin or Gemcitabine Plus Cisplatin in Eastern Cooperative Oncology Group Performance Status 2 Non-Small-Cell Lung Cancer Patients: ECOG 1599 J. Clin. Oncol., February 1, 2007; 25(4): 418 - 423. [Abstract] [Full Text] [PDF]

				F Efficace, A Bottomley, E. Smit, P Lianes, C Legrand, C Debruyne, F Schramel, H. Smit, R Gaafar, B Biesma, et al. Is a patient's self-reported health-related quality of life a prognostic factor for survival in non-small-cell lung cancer patients? A multivariate analysis of prognostic factors of EORTC study 08975 Ann. Onc., November 1, 2006; 17(11): 1698 - 1704. [Abstract] [Full Text] [PDF]

				G. Bepler, I. Kusmartseva, S. Sharma, A. Gautam, A. Cantor, A. Sharma, and G. Simon RRM1 Modulated In Vitro and In Vivo Efficacy of Gemcitabine and Platinum in Non-Small-Cell Lung Cancer J. Clin. Oncol., October 10, 2006; 24(29): 4731 - 4737. [Abstract] [Full Text] [PDF]

				R. Booton, P. Lorigan, H. Anderson, S. Baka, L. Ashcroft, M. Nicolson, M. O'Brien, D. Dunlop, K. O'Byrne, V. Laurence, et al. A phase III trial of docetaxel/carboplatin versus mitomycin C/ifosfamide/cisplatin (MIC) or mitomycin C/vinblastine/cisplatin (MVP) in patients with advanced non-small-cell lung cancer: a randomised multicentre trial of the British Thoracic Oncology Group (BTOG1) Ann. Onc., July 1, 2006; 17(7): 1111 - 1119. [Abstract] [Full Text] [PDF]

				D. S. Ettinger Clinical Implications of EGFR Expression in the Development and Progression of Solid Tumors: Focus on Non-Small Cell Lung Cancer. Oncologist, April 1, 2006; 11(4): 358 - 373. [Abstract] [Full Text] [PDF]

				J. R. Wright, S. Bouma, I. Dayes, J. Sussman, M. R. Simunovic, M. N. Levine, and T. J. Whelan The Importance of Reporting Patient Recruitment Details in Phase III Trials J. Clin. Oncol., February 20, 2006; 24(6): 843 - 845. [Full Text] [PDF]

				A. Paccagnella, F. Oniga, A. Bearz, A. Favaretto, M. Clerici, F. Barbieri, A. Riccardi, A. Chella, U. Tirelli, G. Ceresoli, et al. Adding Gemcitabine to Paclitaxel/Carboplatin Combination Increases Survival in Advanced Non-Small-Cell Lung Cancer: Results of a Phase II-III Study J. Clin. Oncol., February 1, 2006; 24(4): 681 - 687. [Abstract] [Full Text] [PDF]

				S. Niho, K. Kubota, K. Goto, K. Yoh, H. Ohmatsu, R. Kakinuma, N. Saijo, and Y. Nishiwaki First-Line Single Agent Treatment With Gefitinib in Patients With Advanced Non-Small-Cell Lung Cancer: A Phase II Study J. Clin. Oncol., January 1, 2006; 24(1): 64 - 69. [Abstract] [Full Text] [PDF]

				N. Ramnath, E. Sommers, L. Robinson, C. Nwogu, A. Sharma, A. Cantor, and G. Bepler Phase II Study of Neoadjuvant Chemotherapy With Gemcitabine and Vinorelbine in Resectable Non-small Cell Lung Cancer Chest, November 1, 2005; 128(5): 3467 - 3474. [Abstract] [Full Text] [PDF]

				C. X. Ma, S. Nair, S. Thomas, S. J. Mandrekar, D. A. Nikcevich, K. M. Rowland, T. R. Fitch, H. E. Windschitl, S. L. Hillman, S. E. Schild, et al. Randomized Phase II Trial of Three Schedules of Pemetrexed and Gemcitabine As Front-Line Therapy for Advanced Non-Small-Cell Lung Cancer J. Clin. Oncol., September 1, 2005; 23(25): 5929 - 5937. [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]

				R. C. Lilenbaum, C.-S. Chen, T. Chidiac, P. O. Schwarzenberger, M. Thant, M. Versola, and S. R. Lane Phase II randomized trial of vinorelbine and gemcitabine versus carboplatin and paclitaxel in advanced non-small-cell lung cancer Ann. Onc., January 1, 2005; 16(1): 97 - 101. [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]

				G. P. Stathopoulos, M. Veslemes, N. Georgatou, D. Antoniou, P. Giamboudakis, K. Katis, D. Tsavdaridis, S. K. Rigatos, I. Dimitroulis, S. Bastani, et al. Front-line paclitaxel-vinorelbine versus paclitaxel-carboplatin in patients with advanced non-small-cell lung cancer: a randomized phase III trial Ann. Onc., July 1, 2004; 15(7): 1048 - 1055. [Abstract] [Full Text] [PDF]

				C. J. Langer Dilemmas in Management: The Controversial Role of Chemotherapy in PS 2 Advanced NSCLC and the Potential Role of CT-2103 (XyotaxTM) Oncologist, July 1, 2004; 9(4): 398 - 405. [Abstract] [Full Text] [PDF]

				B. C. Jacobson, M. K. Gould, G. A. Silvestri, F. Detterbeck, A. Papagiannis, A. Buyukcelik, B. Yalcin, G. Utkan, A. Spira, and D. S. Ettinger Multidisciplinary Management of Lung Cancer N. Engl. J. Med., May 6, 2004; 350(19): 2008 - 2010. [Full Text] [PDF]