© 2005 European Society for Medical Oncology
Original article |
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
1 Centre René Gauducheau, Saint Herblain; 2 Centre François Baclesse, Caen; 3 CHU Hotel Dieu, Nantes; 4 CHG Chubert, Vannes; 5 CHG Georges Renon, Niort; 6 Centre Alexis Vautrin, Vandoeuvre-les-Nancy; 7 Centre GF Leclerc, Dijon; 8 CHU Gabriel Montpied, Clermont-Ferrand; 9 CHG André Boulloche, Montbeliard; 10 CHU Pasteur, Nice; 11 CHG, Cholet; 12 CH J C
ur, Bourges; 13 Laboratoire Aventis, Paris, France
* Correspondence to: Professor J.-Y. Douillard, Centre René Gauducheau, Boulevard J Monod, 44805 Saint Herblain, France. Tel: +33-2-40-67-99-78; Fax: +33-2-40-67-97-76; Email: jy-douillard{at}nantes.fnclcc.fr
Background: This phase II trial compared docetaxel–cisplatin (DC) with vinorelbine–cisplatin (VC), both as first-line therapy followed by cross-over at progression to single-agent vinorelbine or docetaxel in advanced non-small-cell lung cancer (NSCLC).
Methods: Overall, 115 patients received DC (docetaxel 75 mg/m2 and cisplatin 100 mg/m2 both on day 1, every 3 weeks, arm A1) and 118 VC (vinorelbine 30 mg/m2/week on days 1 and 8 and cisplatin 100 mg/m2 on day 1, every 3 weeks, arm B1) for six cycles, and subsequently maintained by monotherapy with docetaxel (A1) or vinorelbine (B1) with cross-over on disease progression to vinorelbine 30 mg/m2 days 1 and 8 (A2), or docetaxel 100 mg/m2, day 1, both every 3 weeks (B2). The primary end point was overall response rate (ORR).
Results: Patient characteristics were balanced; median follow-up was 8.8 months. First-line response rate was 33.9% with DC and 26.3% with VC (P=0.20). In arms A1 and B1, respectively: duration of response was similar (8.2 versus 8.4 months); median time to progression was 5 months in both; median survival was 8 versus 9 months (P=0.38); 1-, 2- and 3-year survival was 36% versus 35%, 17% versus 10% and 13% versus 6% (P not significant). However, with a low number of long-term survivors, statistical significance was not reached. Overall, almost half of the patients crossed over to second-line therapy; there were no response with vinorelbine and 6 (11.2%) partial responses with docetaxel. Considering the safety profile, the occurrence of febrile neutropenia was 9.6% with DC and 26.3% with VC. Treatment-related mortality was 2.5% with DC and 8.5% with VC.
Conclusions: The trend in favour of the DC arm in ORR, even though statistical significance was not reached, is consistent with previous reports. This study suggests an activity of first-line DC in advanced NSCLC, and that second-line vinorelbine does not provide additional clinical benefit. As already shown in other studies, the use of DC in first-line should provide a better percentage of long-term survivors, despite the absence of efficacy of the second-line in our study.
Key words: chemotherapy, docetaxel, first-line, non-small-cell lung cancer
CiteULike 
Connotea 
Del.icio.us 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]
|
|