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Japanese Journal of Clinical Oncology 2005 35(4):181-187; doi:10.1093/jjco/hyi057
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© 2005 Foundation for Promotion of Cancer Research

A Phase I/II Study Comparing Regimen Schedules of Gemcitabine and Docetaxel in Japanese Patients with Stage IIIB/IV Non-small Cell Lung Cancer

Kaoru Matsui1, Tomonori Hirashima1, Takashi Nitta1, Masashi Kobayashi1, Yoshitaka Ogata1, Mitsugi Furukawa1, Shinzoh Kudoh2, Naruo Yoshimura2, Toru Mukohara2, Setsuko Yamauchi2, Satoshi Shiraishi2, Hiroshi Kamoi2, Syunichi Negoro3, Kouji Takeda3, Kazuhiko Nakagawa4, Minoru Takada5, Takashi Yana5 and Masahiro Fukuoka4

1 Medical Center for Respiratory and Allergic Diseases of Osaka Prefecture, Osaka, 2 Osaka City University Medical School, Osaka, 3 Osaka Municipal General Medical Center, Osaka, 4 Kinki University School of Medicine, Osaka and 5 Rinku General Medical Center, Osaka, Japan

For reprints and all correspondence: Kaoru Matsui, Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases. 3-7-1 Habikino, Habikino City, Osaka 583-8588, Japan. E-mail: kmatsui{at}hbk.pref.osaka.jp

Received October 7, 2004; accepted January 31, 2005

Objective: Gemcitabine and docetaxel are non-platinum agents with activity in non-small cell lung cancer (NSCLC). This study was conducted to determine and evaluate the recommended regimen of gemcitabine–docetaxel and evaluated its efficacy and safety in chemonaive Japanese NSCLC patients.

Methods: In phase I, patients with stage IIIB/IV NSCLC were randomized and received either gemcitabine on days 1 and 8 plus docetaxel on day 1 or gemcitabine on days 1 and 8 plus docetaxel on day 8. The recommended regimen was the dose level preceding the maximum tolerated dose; once determined, patients were enrolled in phase II. Efficacy and toxicity were evaluated in all patients.

Results: Twenty-five patients were enrolled in phase I and six patients were given the recommended regimen; gemcitabine 1000 mg/m2 on days 1 and 8 plus docetaxel 50 mg/m2 on day 8. An additional 34 patients were enrolled into phase II and administered with the recommended regimen. The response rate was 32.2% [95% confidence interval (CI) 20.6–45.6%] overall and 30.0% (95% CI 16.6–46.5%) in patients with the recommended regimen (40 patients). Although grade 3 interstitial pneumonia was observed in two patients (5.0%) who received the recommended regimen, both recovered shortly after steroid treatment. No unexpected events were observed throughout this study.

Conclusions: Gemcitabine 1000 mg/m2 on days 1 and 8 plus docetaxel 50 mg/m2 on day 8 has comparable efficacy and more tolerable toxicities than previously reported platinum-based regimens. These results should be verified by a phase III study.

Key Words: docetaxel • gemcitabine • non-small cell lung cancer

Present addresses: S. Negoro, Hyogo Medical Center for Adults, Hyogo, Japan; M. Takada, Kinki-chuo Chest Medical Center, Osaka, Japan; T. Yana, Otemae Hospital, Osaka, Japan


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