Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial.

Elisabeth Quoix (1) , Gérard Zalcman (2) , Jean-Philippe Oster , Virginie Westeel (3) , Eric Pichon (4) , Armelle Lavolé , Jérôme Dauba , Didier Debieuvre (5) , Pierre-Jean Souquet (6) , Laurence Bigay-Game , Eric Dansin , Michel Poudenx , Olivier Molinier , Fabien Vaylet , Denis Moro-Sibilot (7, 8, 9) , Dominique Herman , Jaafar Bennouna , Jean Tredaniel , Alain Ducoloné , Marie-Paule Lebitasy , Laurence Baudrin , Silvy Laporte (10) , Bernard Milleron (11) , Non Renseigné

1 Service de pneumologie
2 Service de pneumologie [CHU Caen]
3 CEF2P / CARCINO - Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181)
4 Général Electric Médical
5 Service de Pneumologie
6 Service de pneumologie [Centre Hospitalier Lyon Sud - HCL]
7 INSERM U823 - Institut d'oncologie/développement Albert Bonniot de Grenoble
8 IFCT - Intergroupe Francophone de Cancérologie Thoracique [Paris]
9 Pôle Médecine Aigüe Communautaire Pneumologie
10 GRT - Groupe de recherche sur la thrombose, pharmacologie des antithrombotiques et situations à risque
11 CHU Tenon [AP-HP]

BACKGROUND: Platinum-based doublet chemotherapy is recommended to treat advanced non-small-cell lung cancer (NSCLC) in fit, non-elderly adults, but monotherapy is recommended for patients older than 70 years. We compared a carboplatin and paclitaxel doublet chemotherapy regimen with monotherapy in elderly patients with advanced NSCLC. METHODS: In this multicentre, open-label, phase 3, randomised trial we recruited patients aged 70-89 years with locally advanced or metastatic NSCLC and WHO performance status scores of 0-2. Patients received either four cycles (3 weeks on treatment, 1 week off treatment) of carboplatin (on day 1) plus paclitaxel (on days 1, 8, and 15) or five cycles (2 weeks on treatment, 1 week off treatment) of vinorelbine or gemcitabine monotherapy. Randomisation was done centrally with the minimisation method. The primary endpoint was overall survival, and analysis was done by intention to treat. This trial is registered, number NCT00298415. FINDINGS: 451 patients were enrolled. 226 were randomly assigned monotherapy and 225 doublet chemotherapy. Median age was 77 years and median follow-up was 30.3 months (range 8.6-45.2). Median overall survival was 10.3 months for doublet chemotherapy and 6.2 months for monotherapy (hazard ratio 0.64, 95% CI 0.52-0.78; p<0.0001); 1-year survival was 44.5% (95% CI 37.9-50.9) and 25.4% (19.9-31.3), respectively. Toxic effects were more frequent in the doublet chemotherapy group than in the monotherapy group (most frequent, decreased neutrophil count (108 [48.4%] vs 28 [12.4%]; asthenia 23 [10.3%] vs 13 [5.8%]). INTERPRETATION: Despite increased toxic effects, platinum-based doublet chemotherapy was associated with survival benefits compared with vinorelbine or gemcitabine monotherapy in elderly patients with NSCLC. We feel that the current treatment paradigm for these patients should be reconsidered. FUNDING: Intergroupe Francophone de Cancérologie Thoracique, Institut National du Cancer.

Domaines: Cancer

Elisabeth Quoix, Gérard Zalcman, Jean-Philippe Oster, Virginie Westeel, Eric Pichon, et al.. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial.. The Lancet, 2011, 378 (9796), pp.1079-1088. ⟨10.1016/S0140-6736(11)60780-0⟩. ⟨hal-00718837⟩