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

被引：429

作者：

Quoix, Elisabeth ^{[1
]}

Zalcman, Gerard ^{[2
,3
]}

Oster, Jean-Philippe ^{[4
]}

Westeel, Virginie ^{[5
]}

Pichon, Eric ^{[6
]}

Lavole, Armelle ^{[7
]}

Dauba, Jerome ^{[8
]}

Debieuvre, Didier ^{[9
]}

Souquet, Pierre-Jean ^{[10
]}

Bigay-Game, Laurence ^{[11
]}

Dansin, Eric ^{[12
]}

Poudenx, Michel ^{[13
]}

Molinier, Olivier ^{[14
]}

Vaylet, Fabien ^{[15
]}

Moro-Sibilot, Denis ^{[16
]}

Herman, Dominique ^{[17
]}

Bennouna, Jaafar ^{[18
]}

Tredaniel, Jean ^{[19
]}

Ducolone, Alain ^{[20
]}

Lebitasy, Marie-Paule ^{[21
]}

Baudrin, Laurence ^{[21
]}

Laporte, Silvy ^{[22
]}

Milleron, Bernard ^{[7
,21
]}

机构：

[1] Univ Strasbourg, Hop Univ Strasbourg, Serv Pneumol, Dept Chest Dis, F-67091 Strasbourg, France

[2] CHU Caen, Serv Pneumol, F-14000 Caen, France

[3] Univ Caen Basse Normandie, Caen, France

[4] Hop Colmar, Serv Pneumol, Colmar, France

[5] CHU Besancon, Serv Pneumol, F-25030 Besancon, France

[6] CHRU Tours, Serv Pneumol, Tours, France

[7] Hop Tenon, Serv Pneumol, F-75970 Paris, France

[8] Hop Layne, Med Oncol Serv, Mont De Marsan, France

[9] Ctr Hosp Paul Morel, Serv Pneumol, Vesoul, France

[10] Ctr Hosp Lyon Sud, Serv Pneumol, F-69310 Pierre Benite, France

[11] Hop Larrey, Serv Pneumol, Toulouse, France

[12] Ctr Oscar Lambret, Dept Med Oncol, F-59020 Lille, France

[13] Ctr Antoine Lacassagne, F-06054 Nice, France

[14] Ctr Hosp, Serv Malad Resp, Le Mans, France

[15] Hop Instruct Armees Percy, Serv Malad Resp, Clamart, France

[16] CHU Grenoble, Serv Pneumol, F-38043 Grenoble, France

[17] Ctr Hosp, Serv Pneumol, Nevers, France

[18] Ctr Rene Gauducheau, Med Oncol Serv, F-44035 Nantes, France

[19] Grp Hosp Paris St Joseph, Serv Oncopneumol, Paris, France

[20] NHC, Serv Pneumol, Strasbourg, France

[21] Intergrp Francophone Cancerol Thorac, Paris, France

[22] CHU St Etienne, Unite Pharmacol Clin, St Etienne, France

来源：

LANCET | 2011年 / 378卷 / 9796期

关键词：

INTERNATIONAL-SOCIETY; GERIATRIC ASSESSMENT; OLDER; AGE; COMBINATION; MANAGEMENT; COMORBIDITY; UNDERREPRESENTATION; SURVIVAL; OUTCOMES;

D O I：

10.1016/S0140-6736(11)60780-0

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1079 / 1088

页数：10

共 43 条

[21] Chemotherapy for elderly patients with advanced non-small-cell lung cancer:: The Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial [J].