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Journal of Clinical Oncology, Vol 12, 360-367, Copyright © 1994 by American Society of Clinical Oncology

ARTICLES

Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients

T Le Chevalier, D Brisgand, JY Douillard, JL Pujol, V Alberola, A Monnier, A Riviere, P Lianes, P Chomy and S Cigolari
Department of Medicine, Institut Gustave-Roussy, Villejuif, France.

PURPOSE: We designed a prospective randomized trial to compare vinorelbine and cisplatin (NVB-P) with vindesine and cisplatin (VDS-P) and to evaluate whether the best of these regimens affords a survival benefit compared with vinorelbine alone (NVB), an outpatient regimen, in patients with non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Forty-five centers included 612 patients in this study: 206 on NVB-P, 200 on VDS-P, and 206 on NVB. Vinorelbine was administered at a dose of 30 mg/m2 weekly, cisplatin at 120 mg/m2 on days 1 and 29 and then every 6 weeks, and vindesine at 3 mg/m2 weekly for 6 weeks and then every other week. Treatment was continued until progression or toxicity. Four percent of the patients entered were ineligible and 59% had metastatic disease. RESULTS: An objective response rate was observed in 30% of patients in the NVB-P arm versus 19% in the VDS-P arm (P = .02) and 14% in the NVB arm (P < .001). The median duration of survival was 40 weeks in the NVB-P arm, compared with 32 weeks in the VDS-P arm and 31 weeks in the NVB arm. Comparison of survival among the three groups demonstrated an advantage for NVB-P compared with VDS-P (P = .04) and NVB (P = .01). Neutropenia was significantly higher in the NVB-P group (P < .001), and neurotoxicity was more frequent with VDS-P (P < .004). CONCLUSION: Since our results have demonstrated that NVB-P yields a longer survival duration and a higher response rate than VDS-P or NVB alone, with acceptable toxicity, this combination should be considered a relevant regimen in advanced NSCLC.
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G.V. Scagliotti, F. De Marinis, M. Rinaldi, L. Crino, C. Gridelli, S. Ricci, E. Matano, C. Boni, M. Marangolo, G. Failla, et al.
Phase III Randomized Trial Comparing Three Platinum-Based Doublets in Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., November 1, 2002; 20(21): 4285 - 4291.
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E. E. Vokes, J. E. Herndon II, J. Crawford, K. A. Leopold, M. C. Perry, A. A. Miller, and M. R. Green
Randomized Phase II Study of Cisplatin With Gemcitabine or Paclitaxel or Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemoradiotherapy for Stage IIIB Non-Small-Cell Lung Cancer: Cancer and Leukemia Group B Study 9431
J. Clin. Oncol., October 15, 2002; 20(20): 4191 - 4198.
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P. A. Bunn Jr
Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Who, What, When, Why?
J. Clin. Oncol., September 15, 2002; 20(90001): 23s - 33.
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J. D. Hainsworth, J. R. Gray, L. H. Morrissey, L. A. Kalman, J. K. Hon, and F. A. Greco
Long-Term Follow-Up of Patients Treated With Paclitaxel/Carboplatin-Based Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Sequential Phase II Trials of the Minnie Pearl Cancer Research Network
J. Clin. Oncol., July 1, 2002; 20(13): 2937 - 2942.
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M. A. Socinski, M. J. Schell, A. Peterman, K. Bakri, S. Yates, R. Gitten, P. Unger, J. Lee, J.-H. Lee, M. Tynan, et al.
Phase III Trial Comparing a Defined Duration of Therapy Versus Continuous Therapy Followed by Second-Line Therapy in Advanced-Stage IIIB/IV Non-Small-Cell Lung Cancer
J. Clin. Oncol., March 1, 2002; 20(5): 1335 - 1343.
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I. Monnet, H. d. Cremoux, P. Soulie, S. Saltiel-Voisin, M. Bekradda, J.-C. Saltiel, E. Brain, O. Rixe, Y. Yataghene, J.-L. Misset, et al.
Oxaliplatin plus vinorelbine in advanced non-small-cell lung cancer: final results of a multicenter phase II study
Ann. Onc., January 19, 2002; 13(1): 103 - 107.
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G. P. Stathopoulos, S. K. Rigatos, N. Pergantas, D. Tsavdarides, I. Athanasiadis, N. A. Malamos, and J. G. Stathopoulos
Phase II Trial of Biweekly Administration of Vinorelbine and Gemcitabine in Pretreated Advanced Breast Cancer
J. Clin. Oncol., January 1, 2002; 20(1): 37 - 41.
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A Clegg, D A Scott, P Hewitson, M Sidhu, and N Waugh
Clinical and cost effectiveness of paclitaxel, docetaxel, gemcitabine, and vinorelbine in non-small cell lung cancer: a systematic review
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K. Hotta, I. Sekine, T. Tamura, M. Sawada, H. Watanabe, H. Kusaba, Y. Akiyama, A. Inoue, T. Shimoyama, H. Nokihara, et al.
A Phase I/II Study of Cisplatin and Vinorelbine Chemotherapy in Patients with Advanced Non-small Cell Lung Cancer
Jpn. J. Clin. Oncol., December 1, 2001; 31(12): 596 - 600.
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P. Fidias, J. G. Supko, R. Martins, A. Boral, R. Carey, M. Grossbard, G. Shapiro, P. Ostler, J. Lucca, B. E. Johnson, et al.
A Phase II Study of Weekly Paclitaxel in Elderly Patients with Advanced Non-Small Cell Lung Cancer
Clin. Cancer Res., December 1, 2001; 7(12): 3942 - 3949.
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T. L. Evans and T. J. Lynch Jr.
Lung Cancer
Oncologist, October 1, 2001; 6(5): 407 - 414.
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J. L. Pater, G. P. Browman, M. C. Brouwers, M. F. Nefsky, W. K. Evans, and D. H. Cowan
Funding New Cancer Drugs in Ontario: Closing the Loop in the Practice Guidelines Development Cycle
J. Clin. Oncol., July 15, 2001; 19(14): 3392 - 3396.
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A. Inoue and N. Saijo
Recent Advances in the Chemotherapy of Non-small Cell Lung Cancer
Jpn. J. Clin. Oncol., July 1, 2001; 31(7): 299 - 304.
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K. Kelly, J. Crowley, P. A. Bunn Jr, C. A. Presant, P. K. Grevstad, C. M. Moinpour, S. D. Ramsey, A. J. Wozniak, G. R. Weiss, D. F. Moore, et al.
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
J. Clin. Oncol., July 1, 2001; 19(13): 3210 - 3218.
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F. R. Khuri, J. R. Rigas, R. A. Figlin, R. J. Gralla, D. M. Shin, R. Munden, N. Fox, M. R. Huyghe, Y. Kean, S. D. Reich, et al.
Multi-Institutional Phase I/II Trial of Oral Bexarotene in Combination With Cisplatin and Vinorelbine in Previously Untreated Patients With Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., May 15, 2001; 19(10): 2626 - 2637.
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D. Isla, R. Rosell, J. J. Sanchez, A. Carrato, E. Felip, C. Camps, A. Artal, J. L. Gonzalez-Larriba, P. Azagra, V. Alberola, et al.
Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
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M. J. Edelman
New Directions in the Treatment of Non-Small Cell Lung Cancer: An Overview
Oncologist, February 1, 2001; 6(2008): 1 - 3.
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C. Gridelli
The ELVIS Trial: A Phase III Study of Single-Agent Vinorelbine as First-Line Treatment in Elderly Patients with Advanced Non-Small Cell Lung Cancer
Oncologist, February 1, 2001; 6(2008): 4 - 7.
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G. Masters
Carboplatin and Vinorelbine in Advanced Non-Small Cell Lung Cancer: A Phase I/II Study
Oncologist, February 1, 2001; 6(2008): 12 - 15.
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R. Lilenbaum
Options in Advanced Non-Small Cell Lung Cancer: A Review and Report on a Phase II Study of Vinorelbine Plus Gemcitabine
Oncologist, February 1, 2001; 6(2008): 16 - 19.
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E. E. Vokes
Induction Chemotherapy Followed by Concomitant Chemoradiotherapy for Non-Small Cell Lung Cancer
Oncologist, February 1, 2001; 6(2008): 25 - 27.
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I. Monnet, P. Soulie, H. de Cremoux, S. Saltiel-Voisin, M. Bekradda, J.-C. Saltiel, E. Brain, G. Dupont-Andre, and E. Cvitkovic
Phase I/II Study of Escalating Doses of Vinorelbine in Combination With Oxaliplatin in Patients With Advanced Non-Small-Cell Lung Cancer
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M. H. Jagasia, C. J. Langer, D. H. Johnson, F. Yunus, J. S. Rodgers, L. L. Schlabach, A. G. Cohen, Y. Shyr, D. P. Carbone, and R. F. DeVore
Weekly Irinotecan and Cisplatin in Advanced Non-Small Cell Lung Cancer: A Multicenter Phase II Study
Clin. Cancer Res., January 1, 2001; 7(1): 68 - 73.
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J. P. C. Steele, J. Shamash, M. T. Evans, N. H. Gower, M. D. Tischkowitz, and R. M. Rudd
Phase II Study of Vinorelbine in Patients With Malignant Pleural Mesothelioma
J. Clin. Oncol., December 1, 2000; 18(23): 3912 - 3917.
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F. A. Shepherd
Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Modest Progress, Many Choices
J. Clin. Oncol., November 1, 2000; 18(90001): 35s - 38.
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J.-Y. Han, K. W. Kim, J. A. Kim, J. H. Kang, J.-Y. Jin, Y. S. Hong, S. Y. Park, J.-S. Song, J. W. Park, H.-K. Kim, et al.
A Phase II Study of a Daily 4 Schedule of Vinorelbine Plus Cisplatin for Advanced Non-small Cell Lung Cancer
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J.-M. Berthelot, B. P. Will, W. K. Evans, D. Coyle, C. C. Earle, and L. Bordeleau
Decision Framework for Chemotherapeutic Interventions for Metastatic Non-Small-Cell Lung Cancer
J Natl Cancer Inst, August 16, 2000; 92(16): 1321 - 1329.
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 ChestHome page
Y.-M. Chen, R.-P. Perng, K.-Y. Yang, T.-W. Liu, C.-M. Tsai, J. Ming-Liu, and J. Whang-Peng
A Multicenter Phase II Trial of Vinorelbine Plus Gemcitabine in Previously Untreated Inoperable (Stage IIIB/IV) Non-small Cell Lung Cancer
Chest, June 1, 2000; 117(6): 1583 - 1589.
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S. Julien, P. Jacoulet, A. Dubiez, V. Westeel, and A. Depierre
Non-Small Cell Lung Cancer: A Study of Long-Term Survival after Vinorelbine Monotherapy
Oncologist, April 1, 2000; 5(2): 115 - 119.
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A. Segura, M. Pastor, A. Santaballa, A. Yuste, P. López, and J. Aparicio
Cisplatin Plus Vinorelbine for Patients with Advanced Head and Neck Squamous Cell Carcinoma
Oncologist, April 1, 2000; 5(2): 177 - 178.
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D. H. Johnson
Locally Advanced, Unresectable Non-Small Cell Lung Cancer : New Treatment Strategies
Chest, April 1, 2000; 117 (2009): 123S - 126S.
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D. H. Johnson
Evolution of Cisplatin-Based Chemotherapy in Non-Small Cell Lung Cancer : A Historical Perspective and The Eastern Cooperative Oncology Group Experience
Chest, April 1, 2000; 117 (2009): 133S - 137S.
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A. B. Sandler, J. Nemunaitis, C. Denham, J. von Pawel, Y. Cormier, U. Gatzemeier, K. Mattson, Ch. Manegold, M. C. Palmer, A. Gregor, et al.
Phase III Trial of Gemcitabine Plus Cisplatin Versus Cisplatin Alone in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
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D. R. Gandara, E. Vokes, M. Green, P. Bonomi, R. Devore, R. Comis, D. Carbone, D. Karp, and C. Belani
Activity of Docetaxel in Platinum-Treated Non-Small-Cell Lung Cancer: Results of a Phase II Multicenter Trial
J. Clin. Oncol., January 5, 2000; 18(1): 131 - 131.
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L. Crino, G. V. Scagliotti, S. Ricci, F. De Marinis, M. Rinaldi, C. Gridelli, A. Ceribelli, R. Bianco, M. Marangolo, F. Di Costanzo, et al.
Gemcitabine and Cisplatin Versus Mitomycin, Ifosfamide, and Cisplatin in Advanced Non-Small-Cell Lung Cancer: A Randomized Phase III Study of the Italian Lung Cancer Project
J. Clin. Oncol., November 1, 1999; 17(11): 3522 - 3530.
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M. H. Cullen, L. J. Billingham, C. M. Woodroffe, A. D. Chetiyawardana, N. H. Gower, R. Joshi, D. R. Ferry, R. M. Rudd, S. G. Spiro, J. E. Cook, et al.
Mitomycin, Ifosfamide, and Cisplatin in Unresectable Non–Small-Cell Lung Cancer: Effects on Survival and Quality of Life
J. Clin. Oncol., October 1, 1999; 17(10): 3188 - 3194.
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K. Furuse, M. Kawahara, Y. Nishiwaki, M. Fukuoka, M. Takada, M. Miyashita, and Y. Ohashi
Phase I/II Study of Vinorelbine, Mitomycin, and Cisplatin for Stage IIIB or IV Non–Small-Cell Lung Cancer
J. Clin. Oncol., October 1, 1999; 17(10): 3195 - 3200.
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G. Frasci, N. Panza, G. Comella, and G. Pacilio
Is There Any Impact of New Drugs on the Outcome of Advanced NSCLC? An Overview of the Southern Italy Cooperative Oncology Group Trials
Oncologist, October 1, 1999; 4(5): 379 - 385.
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R. F. DeVore, D. H. Johnson, J. Crawford, J. Garst, I. W. Dimery, J. Eckardt, S. G. Eckhardt, G. L. Elfring, L. J. Schaaf, C. K. Hanover, et al.
Phase II Study of Irinotecan Plus Cisplatin in Patients With Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., September 1, 1999; 17(9): 2710 - 2710.
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R. J. Gralla
Silk Purse in Atlanta: A Commentary on SWOG 9509, An Advanced Non-Small Cell Lung Cancer Trial
Oncologist, June 1, 1999; 4(3): 188 - 190.
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P. Comella, G. Frasci, N. Panza, L. Manzione, V. Lorusso, G. Di Rienzo, R. Cioffi, G. De Cataldis, L. Maiorino, D. Bilancia, et al.
Cisplatin, Gemcitabine, and Vinorelbine Combination Therapy in Advanced Non–Small-Cell Lung Cancer: A Phase II Randomized Study of the Southern Italy Cooperative Oncology Group
J. Clin. Oncol., May 1, 1999; 17(5): 1526 - 1526.
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S. Pignata, G. Silvestro, E. Ferrari, L. Selvaggi, F. Perrone, A. Maffeo, P. Frezza, G. Di Vagno, G. Casella, P. Ricchi, et al.
Phase II Study of Cisplatin and Vinorelbine as First-Line Chemotherapy in Patients With Carcinoma of the Uterine Cervix
J. Clin. Oncol., March 1, 1999; 17(3): 756 - 756.
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