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 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.
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.
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%]).
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.
Intergroupe Francophone de Cancérologie Thoracique, Institut National du Cancer.
- Wiener klinische Wochenschrift Education 12/2013; 7(3-4). DOI:10.1007/s11812-012-0053-z
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ABSTRACT: The incidence of lung cancer in the elderly is increasing. In stage IV, amono-chemotherapy has been for a long time the standard of treatment. Recent data have demonstrated the superiority of a carboplatin-based bitherapy versus a monotherapy in terms of overall survival. However, this bitherapy remains dedicated to fit elderly patients. Unfortunately, in clinical trials, bitherapy selection criteria are usually not precise enough, which is a limitation for the application of the results in clinical practise. The use of a geriatric assessment is recommended in order to detect the vulnerability and the tolerance of treatments. The real impact of these geriatric tools is evaluated by prospective studies. They will also possibly help us to better define the more useful tools in the specific context of lung cancer and its treatments.Oncologie 05/2012; 14(5). DOI:10.1007/s10269-012-2155-8 · 0.08 Impact Factor
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ABSTRACT: In approximately the year 2000, the results of a number of important studies of non-small-cell lung cancer (NSCLC) were published. Between July 1992 and December 2003, 223 patients with NSCLC aged > or = 70 years received chemotherapy alone as their initial treatment at the National Cancer Center Hospital East. These patients were divided into 2 groups: those that began treatment between 1992 and 1999 (group A) and between 2000 and 2003 (group B). The details of chemotherapy regimens and outcomes were compared. In group A, 83% of patients received platinum-based chemotherapy, two-thirds of these regimens comprised platinum plus second-generation combination chemotherapy. In contrast, although 55% of patients received platinum-based chemotherapy in group B, 41% of patients received non-platinum-based chemotherapy. Among patients in group B, performance status was significantly associated with the selection of platinum-based or non-platinum-based chemotherapy; age was marginally associated with this selection. Median survival time (MST), 1-year survival rate, and 2-year survival rate were 6.7 months, 14%, and 7%, respectively, in group A, and 8.1 months, 35%, and 20% in group B (p=0.0109). Multivariate analysis revealed that clinical stage and administration of salvage chemotherapy were independent prognostic factors. In and after the year 2000, chemotherapy regimens changed greatly and survival of elderly patients significantly improved in our institute, and this improvement appears to be attributable mostly to the effect of salvage chemotherapy. These results suggest that even elderly patients should be offered salvage chemotherapy regardless of age, if possible.Respiratory medicine 11/2009; 104(3):434-9. DOI:10.1016/j.rmed.2009.10.020 · 2.92 Impact Factor