Annals of Oncology Advance Access originally published online on January 22, 2009
Annals of Oncology 2009 20(5):835-841; doi:10.1093/annonc/mdn705
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lung cancer |
Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104)
1 Department of Clinical Oncology, Osaka City General Hospital, Osaka
2 Department of Internal Medicine, National Cancer Center Hospital, Tokyo
3 Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa
4 Department of Respiratory Medicine, Osaka City University Medical School, Osaka
5 Division of Pulmonary Medicine, Toneyama National Hospital, Toyonaka
6 Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic diseases, Habikino
7 Division of Respiratory Disease, Kumamoto Regional Medical Center, Kumamoto
8 Department of Medical Oncology, Kinki University School of Medicine, Osaka-Sayama
9 Department of Thoracic Oncology, Hyogo Cancer Center, Akashi
10 Department of Preventive Services, Kyoto University School of Public Health, Kyoto
11 JCOG Data Center, Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan
* Correspondence to: Dr K. Takeda, 2-13-22 Miyakojimahondohri, Miyakojima-ku, Osaka 534-0021, Japan. Tel: +81-6-6929-1221; Fax: +81-6-6929-1090; E-mail: kkk-take{at}ga2.so-net.ne.jp
Background: This trial evaluated whether a combination of docetaxel and gemcitabine provides better survival than docetaxel alone in patients with previously treated non-small-cell lung cancer (NSCLC).
Patients and methods: Eligibility included pathologically or cytologically proven NSCLC, failure of one platinum-based regimen, performance status of zero or one, 20–75 years old, and adequate organ function. Patients received docetaxel 60 mg/m2 (day 1) or docetaxel 60 mg/m2 (day 8) and gemcitabine 800 mg/m2 (days 1 and 8), both administered every 21 days until disease progression.
Results: Sixty-five patients participated in each arm. This trial was terminated early due to an unexpected high incidence of interstitial lung disease (ILD) and three treatment-related deaths due to ILD in the combination arm. Docetaxel plus gemcitabine compared with docetaxel-alone patients experienced similar grade and incidence of toxicity, except for ILD. No baseline factor was identified for predicting ILD. Median survival times were 10.3 and 10.1 months (one-sided P = 0.36) for docetaxel plus gemcitabine and docetaxel arms, respectively.
Conclusion: Docetaxel alone is still the standard second-line treatment for NSCLC. The incidence of ILD is higher for docetaxel combined with gemcitabine than for docetaxel alone in patients with previously treated NSCLC.
Key words: docetaxel, gemcitabine, non-small-cell lung cancer, platinum-refractory, second-line chemotherapy
Received for publication March 28, 2008. Revision received September 17, 2008. Accepted for publication October 8, 2008.