Phase I/II Study of S-1 plus Cisplatin combination chemotherapy in patients with advanced/recurrent head and neck cancer

Masato Fujii, Kitinobu Tomita, Wataru Nishijima, Mamoru Tsukuda, Yasuhisa Hasegawa, Junichi Ishitoya, Hideo Yamane, Akihiro Homma, Toshiki Tomita

研究成果: Article

11 引用 (Scopus)

抄録

Objective: The objectives of this study were to determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 plus cisplatin (CDDP) and to evaluate safety and efficacy using the defined RD in advanced/recurrent head and neck cancer (HNC). Methods: S-1 was administered orally at 40 mg/m2 twice daily for 14 consecutive days, and CDDP was infused on day 8 at a dose of 60 and 70 mg/m2. Each course was repeated every 4 weeks. Results: A total of 38 patients were registered, 10 patients for the Phase I study and an additional 28 patients for the Phase II study. Although no dose-limiting toxicity (DLT) was observed in the CDDP 60 mg/m2 (Level 1) group, two of six patients in the CDDP 70 mg/m2 (Level 2) group exhibited DLT (fatigue/diarrhea). The MTD was not achieved in the Phase I study. Level 2 was therefore determined as the RD. In the Phase II study, 34 patients, including 6 patients from the Phase I study, were evaluated. At the termination of treatment, the confirmed response rate was 44.1% (15/34, 95% CI: 27.4-60.8). The best response rate without an adequate duration time was 67.6% (95% CI: 51.9-83.4). The median survival period was 16.7 months, and the 1-year survival rate was 60.1%. The main toxicities of Grade 3 or above were anorexia (26.5%), nausea (14.7%), neutropenia/thrombocytopenia (11.8%) and anemia/fatigue (8.8%). Conclusions: This is considered to be an effective regimen with acceptable toxicities for HNC.

元の言語English
記事番号hyp153
ページ(範囲)214-221
ページ数8
ジャーナルJapanese Journal of Clinical Oncology
40
発行部数3
DOI
出版物ステータスPublished - 2009 11 23

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Head and Neck Neoplasms
Combination Drug Therapy
Cisplatin
Maximum Tolerated Dose
Fatigue
Anorexia
Neutropenia
Thrombocytopenia
Nausea
Anemia
Diarrhea
Survival Rate
Safety
Survival

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Radiology Nuclear Medicine and imaging

これを引用

Fujii, M., Tomita, K., Nishijima, W., Tsukuda, M., Hasegawa, Y., Ishitoya, J., ... Tomita, T. (2009). Phase I/II Study of S-1 plus Cisplatin combination chemotherapy in patients with advanced/recurrent head and neck cancer. Japanese Journal of Clinical Oncology, 40(3), 214-221. [hyp153]. https://doi.org/10.1093/jjco/hyp153

Phase I/II Study of S-1 plus Cisplatin combination chemotherapy in patients with advanced/recurrent head and neck cancer. / Fujii, Masato; Tomita, Kitinobu; Nishijima, Wataru; Tsukuda, Mamoru; Hasegawa, Yasuhisa; Ishitoya, Junichi; Yamane, Hideo; Homma, Akihiro; Tomita, Toshiki.

:: Japanese Journal of Clinical Oncology, 巻 40, 番号 3, hyp153, 23.11.2009, p. 214-221.

研究成果: Article

Fujii, M, Tomita, K, Nishijima, W, Tsukuda, M, Hasegawa, Y, Ishitoya, J, Yamane, H, Homma, A & Tomita, T 2009, 'Phase I/II Study of S-1 plus Cisplatin combination chemotherapy in patients with advanced/recurrent head and neck cancer', Japanese Journal of Clinical Oncology, 巻. 40, 番号 3, hyp153, pp. 214-221. https://doi.org/10.1093/jjco/hyp153
Fujii, Masato ; Tomita, Kitinobu ; Nishijima, Wataru ; Tsukuda, Mamoru ; Hasegawa, Yasuhisa ; Ishitoya, Junichi ; Yamane, Hideo ; Homma, Akihiro ; Tomita, Toshiki. / Phase I/II Study of S-1 plus Cisplatin combination chemotherapy in patients with advanced/recurrent head and neck cancer. :: Japanese Journal of Clinical Oncology. 2009 ; 巻 40, 番号 3. pp. 214-221.
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title = "Phase I/II Study of S-1 plus Cisplatin combination chemotherapy in patients with advanced/recurrent head and neck cancer",
abstract = "Objective: The objectives of this study were to determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 plus cisplatin (CDDP) and to evaluate safety and efficacy using the defined RD in advanced/recurrent head and neck cancer (HNC). Methods: S-1 was administered orally at 40 mg/m2 twice daily for 14 consecutive days, and CDDP was infused on day 8 at a dose of 60 and 70 mg/m2. Each course was repeated every 4 weeks. Results: A total of 38 patients were registered, 10 patients for the Phase I study and an additional 28 patients for the Phase II study. Although no dose-limiting toxicity (DLT) was observed in the CDDP 60 mg/m2 (Level 1) group, two of six patients in the CDDP 70 mg/m2 (Level 2) group exhibited DLT (fatigue/diarrhea). The MTD was not achieved in the Phase I study. Level 2 was therefore determined as the RD. In the Phase II study, 34 patients, including 6 patients from the Phase I study, were evaluated. At the termination of treatment, the confirmed response rate was 44.1{\%} (15/34, 95{\%} CI: 27.4-60.8). The best response rate without an adequate duration time was 67.6{\%} (95{\%} CI: 51.9-83.4). The median survival period was 16.7 months, and the 1-year survival rate was 60.1{\%}. The main toxicities of Grade 3 or above were anorexia (26.5{\%}), nausea (14.7{\%}), neutropenia/thrombocytopenia (11.8{\%}) and anemia/fatigue (8.8{\%}). Conclusions: This is considered to be an effective regimen with acceptable toxicities for HNC.",
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AU - Tomita, Kitinobu

AU - Nishijima, Wataru

AU - Tsukuda, Mamoru

AU - Hasegawa, Yasuhisa

AU - Ishitoya, Junichi

AU - Yamane, Hideo

AU - Homma, Akihiro

AU - Tomita, Toshiki

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N2 - Objective: The objectives of this study were to determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 plus cisplatin (CDDP) and to evaluate safety and efficacy using the defined RD in advanced/recurrent head and neck cancer (HNC). Methods: S-1 was administered orally at 40 mg/m2 twice daily for 14 consecutive days, and CDDP was infused on day 8 at a dose of 60 and 70 mg/m2. Each course was repeated every 4 weeks. Results: A total of 38 patients were registered, 10 patients for the Phase I study and an additional 28 patients for the Phase II study. Although no dose-limiting toxicity (DLT) was observed in the CDDP 60 mg/m2 (Level 1) group, two of six patients in the CDDP 70 mg/m2 (Level 2) group exhibited DLT (fatigue/diarrhea). The MTD was not achieved in the Phase I study. Level 2 was therefore determined as the RD. In the Phase II study, 34 patients, including 6 patients from the Phase I study, were evaluated. At the termination of treatment, the confirmed response rate was 44.1% (15/34, 95% CI: 27.4-60.8). The best response rate without an adequate duration time was 67.6% (95% CI: 51.9-83.4). The median survival period was 16.7 months, and the 1-year survival rate was 60.1%. The main toxicities of Grade 3 or above were anorexia (26.5%), nausea (14.7%), neutropenia/thrombocytopenia (11.8%) and anemia/fatigue (8.8%). Conclusions: This is considered to be an effective regimen with acceptable toxicities for HNC.

AB - Objective: The objectives of this study were to determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 plus cisplatin (CDDP) and to evaluate safety and efficacy using the defined RD in advanced/recurrent head and neck cancer (HNC). Methods: S-1 was administered orally at 40 mg/m2 twice daily for 14 consecutive days, and CDDP was infused on day 8 at a dose of 60 and 70 mg/m2. Each course was repeated every 4 weeks. Results: A total of 38 patients were registered, 10 patients for the Phase I study and an additional 28 patients for the Phase II study. Although no dose-limiting toxicity (DLT) was observed in the CDDP 60 mg/m2 (Level 1) group, two of six patients in the CDDP 70 mg/m2 (Level 2) group exhibited DLT (fatigue/diarrhea). The MTD was not achieved in the Phase I study. Level 2 was therefore determined as the RD. In the Phase II study, 34 patients, including 6 patients from the Phase I study, were evaluated. At the termination of treatment, the confirmed response rate was 44.1% (15/34, 95% CI: 27.4-60.8). The best response rate without an adequate duration time was 67.6% (95% CI: 51.9-83.4). The median survival period was 16.7 months, and the 1-year survival rate was 60.1%. The main toxicities of Grade 3 or above were anorexia (26.5%), nausea (14.7%), neutropenia/thrombocytopenia (11.8%) and anemia/fatigue (8.8%). Conclusions: This is considered to be an effective regimen with acceptable toxicities for HNC.

KW - CDDP

KW - Chemotherapy

KW - Head and neck cancer

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