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

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• 作者：Elisabeth  ; Quoix ProfMD^a ;   ; ^{elisabeth.quoix@chru-strasbourg.fr} ; Gé ; rard  ; Zalcman ProfMD^b ; Jean-Philippe  ; Oster MD^c ; Virginie  ; Westeel ProfMD^d ; Eric  ; Pichon MD^e ; Armelle  ; Lavolé ; MD^f ; Jé ; rô ; me  ; Dauba MD^g ; Didier  ; Debieuvre MD^h ; Pierre-Jean  ; Souquet MDⁱ ; Laurence  ; Bigay-Game MD^j ; Eric  ; Dansin MD^k ; Michel  ; Poudenx MD^l ; Olivier  ; Molinier MD^m ; Fabien  ; Vaylet MDⁿ ; Denis  ; Moro-Sibilot ProfMD^o ; Dominique  ; Herman MD^p ; Jaafar  ; Bennouna MD^q ; Jean  ; Tredaniel ProfMD^r ; Alain  ; Ducoloné ; MD^s ; Marie-Paule  ; Lebitasy MD^t ; Laurence  ; Baudrin MSc^t ; Silvy  ; Laporte PhD^u ; Bernard  ; Milleron MD^f ;   ; ^t ; on behalf of Intergroupe Francophone de Cancé ; rologie Thoracique
• 刊名：The Lancet
• 出版年：2011
• 出版时间：17-23 September 2011
• 年：2011
• 卷：378
• 期：9796
• 页码：1079-1088
• 全文大小：273 K

文摘

Summary

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?9 years with locally advanced or metastatic NSCLC and WHO performance status scores of 0?. 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 .

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?5¡¤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?¡¤78; p<0¡¤0001); 1-year survival was 44¡¤5 % (95 % CI 37¡¤9?0¡¤9) and 25¡¤4 % (19¡¤9?1¡¤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 Canc¨¦rologie Thoracique, Institut National du Cancer.