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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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