Phase II study of combination therapy with S-1 and irinotecan for advanced non-small cell lung cancer: West japan thoracic oncology group 3505

Isamu Okamoto, Takashi Nishimura, Masaki Miyazaki, Hiroshige Yoshioka, Akihito Kubo, Koji Takeda, Noriyuki Ebi, Shunichi Sugawara, Nobuyuki Katakami, Masahiro Fukuoka, Kazuhiko Nakagawa

Research output: Contribution to journalArticle

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Abstract

Purpose: To evaluate the efficacy and toxicity of combination therapy with the oral fluoropyrimdiine formulation S-1 and irinotecan for patients with advanced NSCLC. Experimental Design: Chemotherapy-naive patients with advanced NSCLC were treated with i.v. irinotecan (150 mg/m2) on day 1 and with oral S-1 (80 mg/m2) on days 1 to 14 every 3 weeks. Results: Fifty-six patients (median age, 63 years; range, 40-74 years) received a total of 286 treatment cycles (median, 5; range, 1-15). No complete responses and 16 partial responses were observed, giving an overall response rate of 28.6% [95% confidence interval (95% CI), 17.3-42.2%].Twenty-four patients (42.9%) had stable disease and 12 patients (21.4%) had progressive disease as the best response. The overall disease control rate (complete response + partial response + stable disease) was thus 71.4% (95% CI, 57.8-82.7%). Median progression-free survival was 4.9 months (95% CI, 4.0-6.4 months), whereas median overall survival was 15 months. Hematologic toxicities of grade 3 or 4 included neutropenia (25%), thrombocytopenia (3.6%), and anemia (3.6%), with febrile neutropenia being observed in four patients (7.1%). The most common nonhematologic toxicities of grade 3 or 4 included anorexia (14.3%), fatigue (8.9%), and diarrhea (8.9%). There were no deaths attributed to treatment. Conclusions: The combination of S-1 and irinotecan is a potential alternative option with a favorable toxicity profile for the treatment of advanced NSCLC. This nonplatinum regimen warrants further evaluation in randomized trials.

Original languageEnglish
Pages (from-to)5250-5254
Number of pages5
JournalClinical Cancer Research
Volume14
Issue number16
DOIs
Publication statusPublished - Aug 15 2008
Externally publishedYes

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irinotecan
Non-Small Cell Lung Carcinoma
Japan
Thorax
Confidence Intervals
Therapeutics
Febrile Neutropenia
Anorexia
Neutropenia
Thrombocytopenia
Disease-Free Survival
Fatigue
Anemia
Diarrhea
Research Design

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Phase II study of combination therapy with S-1 and irinotecan for advanced non-small cell lung cancer : West japan thoracic oncology group 3505. / Okamoto, Isamu; Nishimura, Takashi; Miyazaki, Masaki; Yoshioka, Hiroshige; Kubo, Akihito; Takeda, Koji; Ebi, Noriyuki; Sugawara, Shunichi; Katakami, Nobuyuki; Fukuoka, Masahiro; Nakagawa, Kazuhiko.

In: Clinical Cancer Research, Vol. 14, No. 16, 15.08.2008, p. 5250-5254.

Research output: Contribution to journalArticle

Okamoto, I, Nishimura, T, Miyazaki, M, Yoshioka, H, Kubo, A, Takeda, K, Ebi, N, Sugawara, S, Katakami, N, Fukuoka, M & Nakagawa, K 2008, 'Phase II study of combination therapy with S-1 and irinotecan for advanced non-small cell lung cancer: West japan thoracic oncology group 3505', Clinical Cancer Research, vol. 14, no. 16, pp. 5250-5254. https://doi.org/10.1158/1078-0432.CCR-08-0511
Okamoto, Isamu ; Nishimura, Takashi ; Miyazaki, Masaki ; Yoshioka, Hiroshige ; Kubo, Akihito ; Takeda, Koji ; Ebi, Noriyuki ; Sugawara, Shunichi ; Katakami, Nobuyuki ; Fukuoka, Masahiro ; Nakagawa, Kazuhiko. / Phase II study of combination therapy with S-1 and irinotecan for advanced non-small cell lung cancer : West japan thoracic oncology group 3505. In: Clinical Cancer Research. 2008 ; Vol. 14, No. 16. pp. 5250-5254.
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abstract = "Purpose: To evaluate the efficacy and toxicity of combination therapy with the oral fluoropyrimdiine formulation S-1 and irinotecan for patients with advanced NSCLC. Experimental Design: Chemotherapy-naive patients with advanced NSCLC were treated with i.v. irinotecan (150 mg/m2) on day 1 and with oral S-1 (80 mg/m2) on days 1 to 14 every 3 weeks. Results: Fifty-six patients (median age, 63 years; range, 40-74 years) received a total of 286 treatment cycles (median, 5; range, 1-15). No complete responses and 16 partial responses were observed, giving an overall response rate of 28.6{\%} [95{\%} confidence interval (95{\%} CI), 17.3-42.2{\%}].Twenty-four patients (42.9{\%}) had stable disease and 12 patients (21.4{\%}) had progressive disease as the best response. The overall disease control rate (complete response + partial response + stable disease) was thus 71.4{\%} (95{\%} CI, 57.8-82.7{\%}). Median progression-free survival was 4.9 months (95{\%} CI, 4.0-6.4 months), whereas median overall survival was 15 months. Hematologic toxicities of grade 3 or 4 included neutropenia (25{\%}), thrombocytopenia (3.6{\%}), and anemia (3.6{\%}), with febrile neutropenia being observed in four patients (7.1{\%}). The most common nonhematologic toxicities of grade 3 or 4 included anorexia (14.3{\%}), fatigue (8.9{\%}), and diarrhea (8.9{\%}). There were no deaths attributed to treatment. Conclusions: The combination of S-1 and irinotecan is a potential alternative option with a favorable toxicity profile for the treatment of advanced NSCLC. This nonplatinum regimen warrants further evaluation in randomized trials.",
author = "Isamu Okamoto and Takashi Nishimura and Masaki Miyazaki and Hiroshige Yoshioka and Akihito Kubo and Koji Takeda and Noriyuki Ebi and Shunichi Sugawara and Nobuyuki Katakami and Masahiro Fukuoka and Kazuhiko Nakagawa",
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T1 - Phase II study of combination therapy with S-1 and irinotecan for advanced non-small cell lung cancer

T2 - West japan thoracic oncology group 3505

AU - Okamoto, Isamu

AU - Nishimura, Takashi

AU - Miyazaki, Masaki

AU - Yoshioka, Hiroshige

AU - Kubo, Akihito

AU - Takeda, Koji

AU - Ebi, Noriyuki

AU - Sugawara, Shunichi

AU - Katakami, Nobuyuki

AU - Fukuoka, Masahiro

AU - Nakagawa, Kazuhiko

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N2 - Purpose: To evaluate the efficacy and toxicity of combination therapy with the oral fluoropyrimdiine formulation S-1 and irinotecan for patients with advanced NSCLC. Experimental Design: Chemotherapy-naive patients with advanced NSCLC were treated with i.v. irinotecan (150 mg/m2) on day 1 and with oral S-1 (80 mg/m2) on days 1 to 14 every 3 weeks. Results: Fifty-six patients (median age, 63 years; range, 40-74 years) received a total of 286 treatment cycles (median, 5; range, 1-15). No complete responses and 16 partial responses were observed, giving an overall response rate of 28.6% [95% confidence interval (95% CI), 17.3-42.2%].Twenty-four patients (42.9%) had stable disease and 12 patients (21.4%) had progressive disease as the best response. The overall disease control rate (complete response + partial response + stable disease) was thus 71.4% (95% CI, 57.8-82.7%). Median progression-free survival was 4.9 months (95% CI, 4.0-6.4 months), whereas median overall survival was 15 months. Hematologic toxicities of grade 3 or 4 included neutropenia (25%), thrombocytopenia (3.6%), and anemia (3.6%), with febrile neutropenia being observed in four patients (7.1%). The most common nonhematologic toxicities of grade 3 or 4 included anorexia (14.3%), fatigue (8.9%), and diarrhea (8.9%). There were no deaths attributed to treatment. Conclusions: The combination of S-1 and irinotecan is a potential alternative option with a favorable toxicity profile for the treatment of advanced NSCLC. This nonplatinum regimen warrants further evaluation in randomized trials.

AB - Purpose: To evaluate the efficacy and toxicity of combination therapy with the oral fluoropyrimdiine formulation S-1 and irinotecan for patients with advanced NSCLC. Experimental Design: Chemotherapy-naive patients with advanced NSCLC were treated with i.v. irinotecan (150 mg/m2) on day 1 and with oral S-1 (80 mg/m2) on days 1 to 14 every 3 weeks. Results: Fifty-six patients (median age, 63 years; range, 40-74 years) received a total of 286 treatment cycles (median, 5; range, 1-15). No complete responses and 16 partial responses were observed, giving an overall response rate of 28.6% [95% confidence interval (95% CI), 17.3-42.2%].Twenty-four patients (42.9%) had stable disease and 12 patients (21.4%) had progressive disease as the best response. The overall disease control rate (complete response + partial response + stable disease) was thus 71.4% (95% CI, 57.8-82.7%). Median progression-free survival was 4.9 months (95% CI, 4.0-6.4 months), whereas median overall survival was 15 months. Hematologic toxicities of grade 3 or 4 included neutropenia (25%), thrombocytopenia (3.6%), and anemia (3.6%), with febrile neutropenia being observed in four patients (7.1%). The most common nonhematologic toxicities of grade 3 or 4 included anorexia (14.3%), fatigue (8.9%), and diarrhea (8.9%). There were no deaths attributed to treatment. Conclusions: The combination of S-1 and irinotecan is a potential alternative option with a favorable toxicity profile for the treatment of advanced NSCLC. This nonplatinum regimen warrants further evaluation in randomized trials.

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