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
Abstract
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.
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One study comparing monthly carboplatin plus weekly paclitaxel versus single-agent vinorelbine or gemcitabine in patients aged 70-89 with PS 0-2 found a survival advantage for combination therapy.
“Among the largest prospective phase III trials in elderly patients, one study comparing monthly carboplatin plus weekly paclitaxel versus single-agent vinorelbine or gemcitabine in patients aged 70-89 with PS 0-2 found a survival advantage for combination therapy [66].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [66]
The superiority of carboplatin-based combinations over monotherapy in PS 2 patients has been identified in a subgroup analysis within large phase III trials, with an acceptable toxicity profile.
“In addition, the superiority of carboplatin-based combinations over monotherapy in PS 2 patients has been identified in a subgroup analysis within large phase III trials, with an acceptable toxicity profile [66].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [66]
The studies found in the current systematic review included the IFCT 0501 trial, the largest prospective trial to successfully compare a platinum-based combination regimen with single-agent chemotherapy in an elderly population.
“The studies found in the current systematic review included the French multicenter randomized phase III trial Intergroupe Francophone de Cancérologie Thoracique (IFCT) 0501,53 the largest prospective trial to successfully compare a platinum-based combination regimen with single-agent chemotherapy in an elderly population.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [53]
In IFCT 0501, the OS of patients with PS 2 was inferior to that of patients with PS 0 to 1 in multivariable analysis.
“However, the OS of patients with PS 2 was inferior to that of patients with PS 0 to 1 in multivariable analysis.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [53]
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- Authors
- 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.
- Affiliations
- Centre Hospitalier Universitaire de Caen Normandie (FR)
- Hopitaux Civils de Colmar (FR)
- Centre Hospitalier Universitaire de Besançon (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Hôpital Lyon Sud (FR)
- Hôpital Larrey (FR)
- Centre Antoine Lacassagne (FR)
- Centre Hospitalier du Mans (FR)
- Hôpital d'instruction des Armées Percy (FR)
- Centre Hospitalier de l'Agglomération de Nevers (FR)
- Hôpitaux Universitaires de Strasbourg (FR)
- Intergroupe Francophone de Cancérologie Thoracique (FR)
- Centre Hospitalier Universitaire de Saint-Étienne (FR)
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2011-09
- Volume
- 378
- Issue
- 9796
- Pages
- 1079-1088
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2121095198
- Cited by
- 566
- References
- 47
- Citations by year
- 2026: 4 · 2025: 18 · 2024: 17 · 2023: 19 · 2022: 26 · 2021: 37 · 2020: 46 · 2019: 28 · 2018: 52 · 2017: 39 · 2016: 50 · 2015: 61 · 2014: 47 · 2013: 57 · 2012: 50
- FWCI
- 44.87
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- IRIS (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- Funders
- British Microcirculation Society
- Roche
- Les Laboratories Pierre Fabre
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- non-small cell lung cancer, elderly patients, carboplatin, paclitaxel, doublet chemotherapy, gemcitabine monotherapy, overall survival, platinum-based chemotherapy, chemotherapy toxicity, neutropenia, metastatic lung cancer, locally advanced lung cancer, performance status
- MeSH terms
- Vinorelbine, Gemcitabine, Adenocarcinoma, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Deoxycytidine, Drug Administration Schedule, Female, Humans, Lung Neoplasms, Male, Vinblastine, Survival Rate, Carboplatin, Paclitaxel
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