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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 Kawahara1*, Harue Tada2, Akihiro Tokoro3, Satoshi Teramukai2, Hideki Origasa4, Kaoru Kubota5, Tetsu Shinkai6, Masanori Fukushima7 and Kiyoyuki Furuse8

Author Affiliations

1 Otemae Hospital, 1-5-3 Otemae, Chuo-ku, Osaka, 540-0008, Japan

2 Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan

3 National Hospital Organization, Kinki-chuo Chest Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai, 591-8555, Japan

4 Department of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School, 2630 Sugitani, Toyama, 930-0194, Japan

5 National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

6 National Hospital Organization Shikoku Cancer Center, 160 Minami Umemoto-cho, Matsuyama, 791-0280, Japan

7 Translational Research Informatics Center, 1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe, 650-0047, Japan

8 The Japan Multinational Trial Organization, 474 Uehonnojimae-cho, Teramachi-Oike agaru, Nakagyo-ku, Kyoto, 604-0925, Japan

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BMC Cancer 2011, 11:356  doi:10.1186/1471-2407-11-356

Published: 17 August 2011



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.


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.


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.


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