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Clinical Trial
. 2004 Aug 2;91(3):489-97.
doi: 10.1038/sj.bjc.6602011.

Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients

P Comella  1 , G Frasci, P Carnicelli, B Massidda, F Buzzi, G Filippelli, L Maiorino, M Guida, N Panza, S Mancarella, R Cioffi
Affiliations
Clinical Trial

Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients

P Comella et al. Br J Cancer. .

Abstract

The aim of this study was to assess whether a combination of gemcitabine (GEM) with either paclitaxel (PTX) or vinorelbine (VNR) could be more effective than GEM or PTX alone in elderly or unfit advanced non-small-cell lung cancer (NSCLC) patients. A total of 264 NSCLC patients aged >70 years with ECOG performance status (PS)< or =2, or younger with PS=2, were randomly treated with: GEM 1200 mg m(-2) on days 1, 8 and 15 every 28 days; PTX 100 mg m(-2) on days 1, 8 and 15 every 28 days; GEM 1000 mg m(-2) plus PTX 80 mg m(-2) (GT) on days 1 and 8 every 21 days; GEM 1000 mg m(-2) plus VNR 25 mg m(-2) (GV) on days 1 and 8 every 21 days. In all arms, an intra-patients dose escalation was applied over the first three courses, provided that no toxicity of WHO grade > or =2 had previously occurred. At present time, 217 (82%) patients had died. The median (months) and 1-year survival probability were 5.1 and 29% for GEM, 6.4 and 25% for PTX, 9.2 and 44% for GT, and 9.7 and 32% for GV. Multivariate analysis showed that PS< or =1 (hazard ratio (HR)=0.67; 95% CI 0.51-0.90), and doublet treatments (HR=0.76; 95% CI 0.59-0.99) were significantly associated with longer survival. Doublets produced no more toxicity than single agents. GT should be considered a reference regimen for elderly NSCLC patients with PS< or =1.

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Figures

Figure 1
Figure 1
Consolidation of Standards for Reporting Trials (CONSORT) flow chart of the study.
Figure 2
Figure 2
Actuarial survival curves of patients according to the four arms of the trial: GEM arm (black diamond), PTX arm (white diamond), GV arm (open circle), GT arm (close circle). The differences did not reach a significant P-value.
Figure 3
Figure 3
Actuarial survival curves of patients treated with either single agent (thin line) or with either doublet (thick line). The difference was significant at the log-rank test (P=0.028).
Figure 4
Figure 4
Actuarial failure-free survival curves of patients according to the four arms of the trial: GEM arm (black diamond), PTX arm (white diamond), GV arm (white circle), or GT arm (black circle). The differences did not reach a significant P-value.
See this image and copyright information in PMC

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