Phase I/II study of 3-week cycle cisplatin-gemcitabine in advanced non-small cell lung cancer

Hitoshi Kusaba, Tomohide Tamura, Tatsu Shimoyama, Katsuyuki Hotta, Akira Inoue, Hiroshi Nokihara, Yutaka Ueda, Yoshiko Akiyama, Noboru Yamamoto, Ikuo Sekine, Hideo Kunitoh, Yuichiro Ohe, Tetsuro Kodama, Nagahiro Saijo

Research output: Contribution to journalArticle

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Abstract

Background: The combination of cisplatin and gemcitabine is one of the most active chemotherapy regimens against non-small cell lung cancer. However, the optimum schedule for this combination has not been determined. This study was performed to determine the maximum tolerated dose of gemcitabine combined with cisplatin in a 3-week cycle regimen and to observe safety and efficacy for Japanese patients with advanced non-small cell lung cancer. Methods: 80 mg/m2 of cisplatin on day 1 and escalated doses of gemcitabine on days 1 and 8 were administered every 3 weeks to patients with previously untreated, advanced non-small cell lung cancer. The initial dose of gemcitabine was 1000 mg/m2 and was escalated in 250 mg/m2 increments. Results: Twenty-four patients were enrolled between March and December 2000. In total, 64 courses were given. The main toxicities were neutropenia, thrombocytopenia and hepatotoxicity. The maximum tolerated dose was determined to be 1500 mg/m2 of gemcitabine combined with 80 mg/m2 of cisplatin. Nine of 24 patients (37.5%) achieved a partial response. Conclusion: This study demonstrates that the combination of cisplatin and gemcitabine repeated every three weeks is tolerable for Japanese patients with advanced non-small cell lung cancer. We determined 1250 mg/m2 of gemcitabine combined with 80 mg/m2 of cisplatin to be the recommended dose.

Original languageEnglish
Pages (from-to)43-47
Number of pages5
JournalJapanese journal of clinical oncology
Volume32
Issue number2
DOIs
Publication statusPublished - Feb 1 2002
Externally publishedYes

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gemcitabine
Non-Small Cell Lung Carcinoma
Cisplatin
Maximum Tolerated Dose
Neutropenia
Thrombocytopenia
Appointments and Schedules

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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Phase I/II study of 3-week cycle cisplatin-gemcitabine in advanced non-small cell lung cancer. / Kusaba, Hitoshi; Tamura, Tomohide; Shimoyama, Tatsu; Hotta, Katsuyuki; Inoue, Akira; Nokihara, Hiroshi; Ueda, Yutaka; Akiyama, Yoshiko; Yamamoto, Noboru; Sekine, Ikuo; Kunitoh, Hideo; Ohe, Yuichiro; Kodama, Tetsuro; Saijo, Nagahiro.

In: Japanese journal of clinical oncology, Vol. 32, No. 2, 01.02.2002, p. 43-47.

Research output: Contribution to journalArticle

Kusaba, H, Tamura, T, Shimoyama, T, Hotta, K, Inoue, A, Nokihara, H, Ueda, Y, Akiyama, Y, Yamamoto, N, Sekine, I, Kunitoh, H, Ohe, Y, Kodama, T & Saijo, N 2002, 'Phase I/II study of 3-week cycle cisplatin-gemcitabine in advanced non-small cell lung cancer', Japanese journal of clinical oncology, vol. 32, no. 2, pp. 43-47. https://doi.org/10.1093/jjco/hyf013
Kusaba, Hitoshi ; Tamura, Tomohide ; Shimoyama, Tatsu ; Hotta, Katsuyuki ; Inoue, Akira ; Nokihara, Hiroshi ; Ueda, Yutaka ; Akiyama, Yoshiko ; Yamamoto, Noboru ; Sekine, Ikuo ; Kunitoh, Hideo ; Ohe, Yuichiro ; Kodama, Tetsuro ; Saijo, Nagahiro. / Phase I/II study of 3-week cycle cisplatin-gemcitabine in advanced non-small cell lung cancer. In: Japanese journal of clinical oncology. 2002 ; Vol. 32, No. 2. pp. 43-47.
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AU - Tamura, Tomohide

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AU - Hotta, Katsuyuki

AU - Inoue, Akira

AU - Nokihara, Hiroshi

AU - Ueda, Yutaka

AU - Akiyama, Yoshiko

AU - Yamamoto, Noboru

AU - Sekine, Ikuo

AU - Kunitoh, Hideo

AU - Ohe, Yuichiro

AU - Kodama, Tetsuro

AU - Saijo, Nagahiro

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AB - Background: The combination of cisplatin and gemcitabine is one of the most active chemotherapy regimens against non-small cell lung cancer. However, the optimum schedule for this combination has not been determined. This study was performed to determine the maximum tolerated dose of gemcitabine combined with cisplatin in a 3-week cycle regimen and to observe safety and efficacy for Japanese patients with advanced non-small cell lung cancer. Methods: 80 mg/m2 of cisplatin on day 1 and escalated doses of gemcitabine on days 1 and 8 were administered every 3 weeks to patients with previously untreated, advanced non-small cell lung cancer. The initial dose of gemcitabine was 1000 mg/m2 and was escalated in 250 mg/m2 increments. Results: Twenty-four patients were enrolled between March and December 2000. In total, 64 courses were given. The main toxicities were neutropenia, thrombocytopenia and hepatotoxicity. The maximum tolerated dose was determined to be 1500 mg/m2 of gemcitabine combined with 80 mg/m2 of cisplatin. Nine of 24 patients (37.5%) achieved a partial response. Conclusion: This study demonstrates that the combination of cisplatin and gemcitabine repeated every three weeks is tolerable for Japanese patients with advanced non-small cell lung cancer. We determined 1250 mg/m2 of gemcitabine combined with 80 mg/m2 of cisplatin to be the recommended dose.

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