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Journal of Clinical Oncology, Vol 20, Issue 1 (January), 2002: 247-253
© 2002 American Society for Clinical Oncology

Preoperative Chemotherapy Followed by Surgery Compared With Primary Surgery in Resectable Stage I (Except T1N0), II, and IIIa Non–Small-Cell Lung Cancer

By Alain Depierre, Bernard Milleron, Denis Moro-Sibilot, Sylvie Chevret, Elisabeth Quoix, Bernard Lebeau, Denis Braun, Jean-Luc Breton, Etienne Lemarié, Sylvie Gouva, Nadine Paillot, Jeanne-Marie Bréchot, Henri Janicot, François-Xavier Lebas, Philippe Terrioux, Jean Clavier, Pascal Foucher, Michel Monchâtre, Daniel Coëtmeur, Marie-Claude Level, Pascal Leclerc, François Blanchon, Jean-Michel Rodier, Luc Thiberville, Anne Villeneuve, Virginie Westeel, Claude Chastang from the French Thoracic Cooperative Group

From the J Minjoz University Hospital, Besançon; Tenon University Hospital, Paris; St Louis University Hospital; St Antoine University Hospital; Hôtel Dieu Univesity Hospital; and Bichat University Hospital, Paris; Michalon University Hospital, Grenoble; University Hospital, Strasbourg; General Hospital, Briey; General Hospital, Belfort; Bretonneau University Hospital, Tours; A. Morvan University Hospital, Brest; General Hospital, Metz; University Hospital, Clermont-Ferrand; General Hospital, Le Mans; University Hospital, Dijon; Claude Bernard Clinic, Ermont; General Hospital, St-Brieuc; General Hospital, Verdun; General Hospital, St Germain-en-Laye; General Hospital, Meaux; Charles Nicolle University Hospital, Rouen; and Asta Medica, Mérignac, France.

Address reprint requests to A. Depierre, MD, Chest Disease Department, J. Minjoz University Hospital, 25030 Besançon Cedex, France; email: pneumo-depierre{at}ufc-chu.univ-fcomte.fr

PURPOSE: To evaluate whether preoperative chemotherapy (PCT) could improve survival in resectable stage I (except T1N0), II, and IIIA non–small-cell lung cancer (NSCLC).

PATIENTS AND METHODS: A randomized trial compared PCT to primary surgery (PRS). PCT consisted of two cycles of mitomycin (6 mg/m2, day 1), ifosfamide (1.5 g/m2, days 1 to 3) and cisplatin (30 mg/m2, days 1 to 3), and two additional postoperative cycles for responding patients. In both arms, patients with pT3 or pN2 disease received thoracic radiotherapy.

RESULTS: Three hundred fifty-five eligible patients were randomized. Overall response to PCT was 64%. There were two preoperative toxic deaths. Postoperative mortality was 6.7% in the PCT arm and 4.5% in the PRS arm (P = .38). Median survival was 37 months (95% confidence interval [CI], 26.7 to 48.3) for PCT and 26.0 months (95% CI, 19.8 to 33.6) for PRS (P = .15). Survival differences between both arms increased from 3.8% (95% CI, 1.3% to 25.1%) at 1 year to 8.6% (95% CI, 2.64% to 24.4%) at 4 years. A quantitative interaction between N status and treatment was observed, with benefit confined to N0 to N1 disease (relative risk [RR], 0.68; 95% CI, 0.49 to 0.96; P = .027). After a nonsignificant excess of deaths during treatment, the effect of PCT was significantly favorable on survival (RR, 0.74; 95% CI, 0.56 to 0.99; P = .044). Disease-free survival time was significantly longer in the PCT arm (P = .033).

CONCLUSION: Although impressive differences in median, 3-year, and 4-year survival were observed, they were not statistically significant, except for stage I and II disease.

Presented in part at the Thirty-Fifth Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, May 15-18, 1999.


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N. Engl. J. Med., January 22, 2004; 350(4): 379 - 392.
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D. G. Pfister, D. H. Johnson, C. G. Azzoli, W. Sause, T. J. Smith, S. Baker Jr, J. Olak, D. Stover, J. R. Strawn, A. T. Turrisi, et al.
American Society of Clinical Oncology Treatment of Unresectable Non-Small-Cell Lung Cancer Guideline: Update 2003
J. Clin. Oncol., January 15, 2004; 22(2): 330 - 353.
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 J. Thorac. Cardiovasc. Surg.Home page
M. Machtay, J. H. Lee, J. P. Stevenson, J. B. Shrager, K. M. Algazy, J. Treat, and L. R. Kaiser
Two commonly used neoadjuvant chemoradiotherapy regimens for locally advanced stage III non-small cell lung carcinoma: Long-term results and associations with pathologic response
J. Thorac. Cardiovasc. Surg., January 1, 2004; 127(1): 108 - 113.
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F. Barlesi, C. Doddoli, B. Chetaille, J.-P. Torre, R. Giudicelli, P. Thomas, J.-P. Kleisbauer, and P. Fuentes
Survival and postoperative complication in daily practice after neoadjuvant therapy in resectable stage IIIA-N2 non-small cell lung cancer
Interactive CardioVascular and Thoracic Surgery, December 1, 2003; 2(4): 558 - 562.
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G. Castaldo, R. Tomaiuolo, A. Sanduzzi, A. Ponticiello, I. Marchetiello, and F. Salvatore
Carcinoembryonic antigen mRNA analysis detects micrometastatic cells in blood from lung cancer patients
Eur. Respir. J., September 1, 2003; 22(3): 418 - 421.
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N.K. Altorki, R.S. Keresztes, J.L. Port, D.M. Libby, R.J. Korst, D.B. Flieder, C.A. Ferrara, D.F. Yankelevitz, K. Subbaramaiah, M.W. Pasmantier, et al.
Celecoxib, a Selective Cyclo-Oxygenase-2 Inhibitor, Enhances the Response to Preoperative Paclitaxel and Carboplatin in Early-Stage Non-Small-Cell Lung Cancer
J. Clin. Oncol., July 15, 2003; 21(14): 2645 - 2650.
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F. C. Detterbeck
Changes in the treatment of Pancoast tumors
Ann. Thorac. Surg., June 1, 2003; 75(6): 1990 - 1997.
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A Price
Lung cancer * 5: State of the art radiotherapy for lung cancer
Thorax, May 1, 2003; 58(5): 447 - 452.
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D. Lardinois, A. Schallberger, D. Betticher, and H.-B. Ris
Postinduction video-mediastinoscopy is as accurate and safe as video-mediastinoscopy in patients without pretreatment for potentially operable non-small cell lung cancer
Ann. Thorac. Surg., April 1, 2003; 75(4): 1102 - 1106.
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Y. Sakao, T. Sakuragi, M. Natsuaki, and T. Itoh
Clinicopathological analysis of prognostic factors in clinical IA peripheral adenocarcinoma of the lung
Ann. Thorac. Surg., April 1, 2003; 75(4): 1113 - 1117.
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S.G. Spiro
Surgery for nonsmall cell lung cancer: can improvements be made?
Eur. Respir. J., January 1, 2003; 21(39_suppl): 52S - 56s.
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W. J. Scott, J. Howington, and B. Movsas
Treatment of Stage II Non-small Cell Lung Cancer
Chest, January 1, 2003; 123 (2009): 188S - 201S.
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S. G. Spiro and J. C. Porter
Lung Cancer--Where Are We Today?: Current Advances in Staging and Nonsurgical Treatment
Am. J. Respir. Crit. Care Med., November 1, 2002; 166(9): 1166 - 1196.
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T. De Pas, U. Pastorino, L. Spaggiari, G. Curigliano, F. de Braud, and C. Robertson
Preoperative Chemotherapy in Non-Small-Cell Lung Cancer: Nothing New in N2 Disease
J. Clin. Oncol., May 15, 2002; 20(10): 2603 - 2604.
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T. S.K. Mok, B. Zee, A. Depierre, V. Westeel, B. Milleron, D. Moro-Sibilot, E. Quoix, D. Braun, and B. Lebeau
Adequate Lymph Node Staging Is Fundamental to Comparative Study on Resectable Non-Small-Cell Lung Cancer
J. Clin. Oncol., May 15, 2002; 20(10): 2604 - 2605.
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