A phase I/II study of cisplatin and vinorelbine chemotherapy in patients with advanced non-small cell lung cancer

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

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Abstract

Background: A combination of cisplatin and vinorelbine chemotherapy is effective in cases of advanced non-small cell lung cancer, but the optimum administration schedule for both drugs has not yet been defined. The aim of this study was to determine the maximum dose of vinorelbine that can be tolerated while receiving a fixed dose of cisplatin every 3 weeks and to observe the response in Japanese patients with advanced non-small cell lung cancer who had not previously received chemotherapy. Methods: Cisplatin was given at a dose of 80 mg/m2 on day 1. Vinorelbine was administered on days 1 and 8 at a starting dose of 25 mg/m2 that was then increased by 5 mg/m2 increments. This treatment was repeated every 3 weeks. Results: Twenty-one patients received a total of 54 chemotherapy cycles consisting of three different vinorelbine dosages. Toxicity and efficacy were evaluated in all of the patients. The main dose-limiting toxicity was neutropenia. Grades 3-4 leukopenia and neutropenia were observed in 57% and 86% of all cycles, respectively. These conditions were reversible and did not result in death from toxicity. The most severe non-hematological toxicity symptom was a grade 3 infection and reaction at the site of injection. The maximum tolerated dose of vinorelbine was 35 mg/m2. The objective response was noted in one of six patients at dose level 1, in four of 12 patients at dose level 2 and in two of three patients at dose level 3. Conclusion: The recommended doses were 80 mg/m2 for cisplatin and 30 mg/m2 for vinorelbine. The combination of cisplatin and vinorelbine repeated every 3 weeks is well tolerated and has shown promising anti-tumor activity against non-small cell lung cancer.

Original languageEnglish
Pages (from-to)596-600
Number of pages5
JournalJapanese Journal of Clinical Oncology
Volume31
Issue number12
Publication statusPublished - 2001
Externally publishedYes

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Non-Small Cell Lung Carcinoma
Cisplatin
Drug Therapy
Neutropenia
Drug Administration Schedule
Maximum Tolerated Dose
Leukopenia
vinorelbine
Injections
Infection
Neoplasms

Keywords

  • Cisplatin
  • Non-small cell lung cancer
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology

Cite this

Hotta, K., Sekine, I., Tamura, T., Sawada, M., Watanabe, H., Kusaba, H., ... Saijo, N. (2001). A phase I/II study of cisplatin and vinorelbine chemotherapy in patients with advanced non-small cell lung cancer. Japanese Journal of Clinical Oncology, 31(12), 596-600.

A phase I/II study of cisplatin and vinorelbine chemotherapy in patients with advanced non-small cell lung cancer. / Hotta, Katsuyuki; Sekine, Ikuo; Tamura, Tomohide; Sawada, Masahiro; Watanabe, Hirokazu; Kusaba, Hitoshi; Akiyama, Yoshiko; Inoue, Akira; Shimoyama, Tatsu; Nokihara, Hiroshi; Ueda, Yutaka; Yamamoto, Noboru; Kunitoh, Hideo; Ohe, Yuichiro; Kodama, Tetsuro; Saijo, Nagahiro.

In: Japanese Journal of Clinical Oncology, Vol. 31, No. 12, 2001, p. 596-600.

Research output: Contribution to journalArticle

Hotta, K, Sekine, I, Tamura, T, Sawada, M, Watanabe, H, Kusaba, H, Akiyama, Y, Inoue, A, Shimoyama, T, Nokihara, H, Ueda, Y, Yamamoto, N, Kunitoh, H, Ohe, Y, Kodama, T & Saijo, N 2001, 'A phase I/II study of cisplatin and vinorelbine chemotherapy in patients with advanced non-small cell lung cancer', Japanese Journal of Clinical Oncology, vol. 31, no. 12, pp. 596-600.
Hotta, Katsuyuki ; Sekine, Ikuo ; Tamura, Tomohide ; Sawada, Masahiro ; Watanabe, Hirokazu ; Kusaba, Hitoshi ; Akiyama, Yoshiko ; Inoue, Akira ; Shimoyama, Tatsu ; Nokihara, Hiroshi ; Ueda, Yutaka ; Yamamoto, Noboru ; Kunitoh, Hideo ; Ohe, Yuichiro ; Kodama, Tetsuro ; Saijo, Nagahiro. / A phase I/II study of cisplatin and vinorelbine chemotherapy in patients with advanced non-small cell lung cancer. In: Japanese Journal of Clinical Oncology. 2001 ; Vol. 31, No. 12. pp. 596-600.
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abstract = "Background: A combination of cisplatin and vinorelbine chemotherapy is effective in cases of advanced non-small cell lung cancer, but the optimum administration schedule for both drugs has not yet been defined. The aim of this study was to determine the maximum dose of vinorelbine that can be tolerated while receiving a fixed dose of cisplatin every 3 weeks and to observe the response in Japanese patients with advanced non-small cell lung cancer who had not previously received chemotherapy. Methods: Cisplatin was given at a dose of 80 mg/m2 on day 1. Vinorelbine was administered on days 1 and 8 at a starting dose of 25 mg/m2 that was then increased by 5 mg/m2 increments. This treatment was repeated every 3 weeks. Results: Twenty-one patients received a total of 54 chemotherapy cycles consisting of three different vinorelbine dosages. Toxicity and efficacy were evaluated in all of the patients. The main dose-limiting toxicity was neutropenia. Grades 3-4 leukopenia and neutropenia were observed in 57{\%} and 86{\%} of all cycles, respectively. These conditions were reversible and did not result in death from toxicity. The most severe non-hematological toxicity symptom was a grade 3 infection and reaction at the site of injection. The maximum tolerated dose of vinorelbine was 35 mg/m2. The objective response was noted in one of six patients at dose level 1, in four of 12 patients at dose level 2 and in two of three patients at dose level 3. Conclusion: The recommended doses were 80 mg/m2 for cisplatin and 30 mg/m2 for vinorelbine. The combination of cisplatin and vinorelbine repeated every 3 weeks is well tolerated and has shown promising anti-tumor activity against non-small cell lung cancer.",
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T1 - A phase I/II study of cisplatin and vinorelbine chemotherapy in patients with advanced non-small cell lung cancer

AU - Hotta, Katsuyuki

AU - Sekine, Ikuo

AU - Tamura, Tomohide

AU - Sawada, Masahiro

AU - Watanabe, Hirokazu

AU - Kusaba, Hitoshi

AU - Akiyama, Yoshiko

AU - Inoue, Akira

AU - Shimoyama, Tatsu

AU - Nokihara, Hiroshi

AU - Ueda, Yutaka

AU - Yamamoto, Noboru

AU - Kunitoh, Hideo

AU - Ohe, Yuichiro

AU - Kodama, Tetsuro

AU - Saijo, Nagahiro

PY - 2001

Y1 - 2001

N2 - Background: A combination of cisplatin and vinorelbine chemotherapy is effective in cases of advanced non-small cell lung cancer, but the optimum administration schedule for both drugs has not yet been defined. The aim of this study was to determine the maximum dose of vinorelbine that can be tolerated while receiving a fixed dose of cisplatin every 3 weeks and to observe the response in Japanese patients with advanced non-small cell lung cancer who had not previously received chemotherapy. Methods: Cisplatin was given at a dose of 80 mg/m2 on day 1. Vinorelbine was administered on days 1 and 8 at a starting dose of 25 mg/m2 that was then increased by 5 mg/m2 increments. This treatment was repeated every 3 weeks. Results: Twenty-one patients received a total of 54 chemotherapy cycles consisting of three different vinorelbine dosages. Toxicity and efficacy were evaluated in all of the patients. The main dose-limiting toxicity was neutropenia. Grades 3-4 leukopenia and neutropenia were observed in 57% and 86% of all cycles, respectively. These conditions were reversible and did not result in death from toxicity. The most severe non-hematological toxicity symptom was a grade 3 infection and reaction at the site of injection. The maximum tolerated dose of vinorelbine was 35 mg/m2. The objective response was noted in one of six patients at dose level 1, in four of 12 patients at dose level 2 and in two of three patients at dose level 3. Conclusion: The recommended doses were 80 mg/m2 for cisplatin and 30 mg/m2 for vinorelbine. The combination of cisplatin and vinorelbine repeated every 3 weeks is well tolerated and has shown promising anti-tumor activity against non-small cell lung cancer.

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KW - Cisplatin

KW - Non-small cell lung cancer

KW - Vinorelbine

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