Quality-of-life evaluation for advanced non-small-cell lung cancer: a comparison between vinorelbine plus gemcitabine followed by docetaxel versus paclitaxel plus carboplatin regimens in a randomized trial: Japan Multinational Trial Organization LC00-03 (BRI LC03-01)

Masaaki Kawahara, Harue Tada, Akihiro Tokoro, Satoshi Teramukai, Hideki Origasa, Kaoru Kubota, Tetsu Shinkai, Masanori Fukushima, Kiyoyuki Furuse, Masaaki Kawahara, Harue Tada, Akihiro Tokoro, Satoshi Teramukai, Hideki Origasa, Kaoru Kubota, Tetsu Shinkai, Masanori Fukushima, Kiyoyuki Furuse

Abstract

Background: A randomized trial of vinorelbine plus gemcitabine followed by docetaxel (VGD) versus paclitaxel plus carboplatin (PC) in patients with advanced non-small-cell lung cancer showed no difference in overall survival (median survival time: 13.6 versus 14.1 months) between the two treatment groups. We report here the results of quality-of-life (QOL) study initiated in the mid-course of this randomized trial.

Methods: The patients themselves assessed the Functional Assessment of Cancer Therapy (FACT)-Lung (FACT-L), FACT-Taxane and the Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp) QOL instruments at baseline and 6, 12 and 18 weeks after the treatment. The primary endpoint was a comparison of total QOL score for each assessment instrument between the two groups.

Results: Sixty-eight patients from the trial (VGD, 34; PC, 34) who submitted baseline questionnaires and at least one questionnaire over the course of treatment were eligible. Longitudinal analysis showed a significant difference in slope of the FACT-Taxane score (p = 0.004) between treatment regimens over time, but no difference was found in FACT-L score (p = 0.311) and FACIT-Sp score (p = 0.466) between the two groups.

Conclusions: The significant difference in slope of FACT-Taxane score favored the VGD regimen. These data should be considered in treatment decision-making for patients with advanced non-small-cell lung cancer.

Trial registration: NCT00242983.

Figures

Figure 1
Figure 1
Trial profile.
Figure 2
Figure 2
Changes in FACT-L score.
Figure 3
Figure 3
Changes in FACT-Taxane score.
Figure 4
Figure 4
Changes in FACIT-Sp score.

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