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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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Název: 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.
Autoři: Quoix, E., Zalcman, G., Oster, J.P., Westeel, V., Pichon, E., Lavolé, A., Dauba, J., Debieuvre, D., Souquet, P.J., Bigay-Game, L., Dansin, E., Poudenx, M., Molinier, O., Vaylet, F., Moro-Sibilot, D., Herman, D., Bennouna, J., Tredaniel, J., Ducoloné, A., Lebitasy, M.P., Baudrin, L., Laporte, S., Milleron, B.
Přispěvatelé: Intergroupe Francophone de Cancérologie Thoracique, Laize, H., Masson, P., Duhamel, JP., Derollez, M., Martinet, Y., Vidal, C., Gentil-lepecq, B., Bombaron, P., Prevost, A., Coëtmeur, D., Galichet, C., Labrune, S., Zaegel, M., Bonnefoy, P., Vannetzel, JM., Paillot, N., Pujol, JL., Meunier£££Jérôme£££ J., Stach, B., Schneider, S., Braun, D., Gautier-Felizot, L., Lebargy, F., Nouyrigat, P., Farny, M., Sarda, C., Martin, F., Hermann, J., Fraboulet, G., Richard, P., Friard, S., Goutorbe, F., Levy, A., Duval, Y., Angebault, M., Charvolin, P., Roa, M., Vincent, M., Larive, S., Jacot, W., Boutemy, M., Le Flour, N.
Rok vydání: 2025
Sbírka: Université de Lausanne (UNIL): Serval - Serveur académique lausannois
Témata: Adenocarcinoma/drug therapy, Adenocarcinoma/mortality, Aged, 80 and over, Antineoplastic Agents/adverse effects, Antineoplastic Agents/therapeutic use, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Carboplatin/administration & dosage, Carboplatin/adverse effects, Carcinoma, Non-Small-Cell Lung/drug therapy, Non-Small-Cell Lung/mortality, Squamous Cell/drug therapy, Squamous Cell/mortality, Deoxycytidine/administration & dosage, Deoxycytidine/analogs & derivatives, Drug Administration Schedule, Female, Humans, Lung Neoplasms/drug therapy, Lung Neoplasms/mortality, Male, Paclitaxel/administration & dosage, Paclitaxel/adverse effects, Survival Rate, Vinblastine/administration & dosage, Vinblastine/analogs & derivatives
Popis: 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.
Druh dokumentu: article in journal/newspaper
Jazyk: English
ISSN: 1474-547X
Relation: The Lancet; https://iris.unil.ch/handle/iris/180046; serval:BIB_E0AEE46B6996; 000295548900024
DOI: 10.1016/S0140-6736(11)60780-0
Dostupnost: https://iris.unil.ch/handle/iris/180046
https://doi.org/10.1016/S0140-6736(11)60780-0
Přístupové číslo: edsbas.BE59CDA0
Databáze: BASE
Popis
Abstrakt: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.
ISSN:1474547X
DOI:10.1016/S0140-6736(11)60780-0