A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as second-line treatment for advanced colorectal cancer: A Japanese experience

Yutaka Ogata, Shoji Tokunaga, Yasunori Emi, Eiji Oki, Hiroshi Saeki, Ken Shirabe, Hirofumi Hasegawa, Noriaki Sadanaga, Hironori Samura, Fumihiko Fujita, Takaho Tanaka, Masaki Kitazono, Manabu Yamamoto, Tatsuma Morikita, Masafumi Inomata, Yoshihiro Kakeji, Kazuo Shirouzu, Yoshihiko Maehara

Research output: Contribution to journalArticle

Abstract

Purpose: This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin, levoforinate, and infusional 5-fluorouracil (FOLFOX4) as a second-line therapy for Japanese patients with unresectable advanced or metastatic colorectal cancer. Methods: A total of 53 patients with progressive disease after first-line chemotherapy were enrolled in the study. The treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred, or the patient chose to discontinue the treatment. Results: Four patients were ineligible and one did not receive the protocol therapy. Therefore, the response rate, overall survival (OS), and progression-free survival (PFS) were evaluated in 48 patients; toxicity was evaluated in 52 patients, excluding the patient who had not received the protocol therapy. A partial response was observed in 10 patients. The overall response rate was 20.8% (95% confidence interval [CI], 10.5%-35.0%). The median PFS was 5.6 months (95% CI, 4.1-7.0 months) and the median OS was 19.6 months (95% CI, 11.4-24.3 months). The most frequently encountered grade 3/4 hematological symptom was neutropenia (43.1%). The toxicity profile was generally predictable and manageable. Conclusion: The results showed good tolerability and efficacy for second-line FOLFOX4 in patients with advanced colorectal cancer, thus indicating the promise of this regimen as an effective second-line therapy for advanced colorectal cancer in the Japanese population.

Original languageEnglish
Pages (from-to)84-90
Number of pages7
JournalSurgery today
Volume41
Issue number1
DOIs
Publication statusPublished - Jan 1 2011

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oxaliplatin
Leucovorin
Combination Drug Therapy
Fluorouracil
Colorectal Neoplasms
Therapeutics
Confidence Intervals
Disease-Free Survival
Clinical Studies

All Science Journal Classification (ASJC) codes

  • Surgery

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A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as second-line treatment for advanced colorectal cancer : A Japanese experience. / Ogata, Yutaka; Tokunaga, Shoji; Emi, Yasunori; Oki, Eiji; Saeki, Hiroshi; Shirabe, Ken; Hasegawa, Hirofumi; Sadanaga, Noriaki; Samura, Hironori; Fujita, Fumihiko; Tanaka, Takaho; Kitazono, Masaki; Yamamoto, Manabu; Morikita, Tatsuma; Inomata, Masafumi; Kakeji, Yoshihiro; Shirouzu, Kazuo; Maehara, Yoshihiko.

In: Surgery today, Vol. 41, No. 1, 01.01.2011, p. 84-90.

Research output: Contribution to journalArticle

Ogata, Y, Tokunaga, S, Emi, Y, Oki, E, Saeki, H, Shirabe, K, Hasegawa, H, Sadanaga, N, Samura, H, Fujita, F, Tanaka, T, Kitazono, M, Yamamoto, M, Morikita, T, Inomata, M, Kakeji, Y, Shirouzu, K & Maehara, Y 2011, 'A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as second-line treatment for advanced colorectal cancer: A Japanese experience', Surgery today, vol. 41, no. 1, pp. 84-90. https://doi.org/10.1007/s00595-010-4418-6
Ogata, Yutaka ; Tokunaga, Shoji ; Emi, Yasunori ; Oki, Eiji ; Saeki, Hiroshi ; Shirabe, Ken ; Hasegawa, Hirofumi ; Sadanaga, Noriaki ; Samura, Hironori ; Fujita, Fumihiko ; Tanaka, Takaho ; Kitazono, Masaki ; Yamamoto, Manabu ; Morikita, Tatsuma ; Inomata, Masafumi ; Kakeji, Yoshihiro ; Shirouzu, Kazuo ; Maehara, Yoshihiko. / A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as second-line treatment for advanced colorectal cancer : A Japanese experience. In: Surgery today. 2011 ; Vol. 41, No. 1. pp. 84-90.
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abstract = "Purpose: This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin, levoforinate, and infusional 5-fluorouracil (FOLFOX4) as a second-line therapy for Japanese patients with unresectable advanced or metastatic colorectal cancer. Methods: A total of 53 patients with progressive disease after first-line chemotherapy were enrolled in the study. The treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred, or the patient chose to discontinue the treatment. Results: Four patients were ineligible and one did not receive the protocol therapy. Therefore, the response rate, overall survival (OS), and progression-free survival (PFS) were evaluated in 48 patients; toxicity was evaluated in 52 patients, excluding the patient who had not received the protocol therapy. A partial response was observed in 10 patients. The overall response rate was 20.8{\%} (95{\%} confidence interval [CI], 10.5{\%}-35.0{\%}). The median PFS was 5.6 months (95{\%} CI, 4.1-7.0 months) and the median OS was 19.6 months (95{\%} CI, 11.4-24.3 months). The most frequently encountered grade 3/4 hematological symptom was neutropenia (43.1{\%}). The toxicity profile was generally predictable and manageable. Conclusion: The results showed good tolerability and efficacy for second-line FOLFOX4 in patients with advanced colorectal cancer, thus indicating the promise of this regimen as an effective second-line therapy for advanced colorectal cancer in the Japanese population.",
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T1 - A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as second-line treatment for advanced colorectal cancer

T2 - A Japanese experience

AU - Ogata, Yutaka

AU - Tokunaga, Shoji

AU - Emi, Yasunori

AU - Oki, Eiji

AU - Saeki, Hiroshi

AU - Shirabe, Ken

AU - Hasegawa, Hirofumi

AU - Sadanaga, Noriaki

AU - Samura, Hironori

AU - Fujita, Fumihiko

AU - Tanaka, Takaho

AU - Kitazono, Masaki

AU - Yamamoto, Manabu

AU - Morikita, Tatsuma

AU - Inomata, Masafumi

AU - Kakeji, Yoshihiro

AU - Shirouzu, Kazuo

AU - Maehara, Yoshihiko

PY - 2011/1/1

Y1 - 2011/1/1

N2 - Purpose: This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin, levoforinate, and infusional 5-fluorouracil (FOLFOX4) as a second-line therapy for Japanese patients with unresectable advanced or metastatic colorectal cancer. Methods: A total of 53 patients with progressive disease after first-line chemotherapy were enrolled in the study. The treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred, or the patient chose to discontinue the treatment. Results: Four patients were ineligible and one did not receive the protocol therapy. Therefore, the response rate, overall survival (OS), and progression-free survival (PFS) were evaluated in 48 patients; toxicity was evaluated in 52 patients, excluding the patient who had not received the protocol therapy. A partial response was observed in 10 patients. The overall response rate was 20.8% (95% confidence interval [CI], 10.5%-35.0%). The median PFS was 5.6 months (95% CI, 4.1-7.0 months) and the median OS was 19.6 months (95% CI, 11.4-24.3 months). The most frequently encountered grade 3/4 hematological symptom was neutropenia (43.1%). The toxicity profile was generally predictable and manageable. Conclusion: The results showed good tolerability and efficacy for second-line FOLFOX4 in patients with advanced colorectal cancer, thus indicating the promise of this regimen as an effective second-line therapy for advanced colorectal cancer in the Japanese population.

AB - Purpose: This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin, levoforinate, and infusional 5-fluorouracil (FOLFOX4) as a second-line therapy for Japanese patients with unresectable advanced or metastatic colorectal cancer. Methods: A total of 53 patients with progressive disease after first-line chemotherapy were enrolled in the study. The treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred, or the patient chose to discontinue the treatment. Results: Four patients were ineligible and one did not receive the protocol therapy. Therefore, the response rate, overall survival (OS), and progression-free survival (PFS) were evaluated in 48 patients; toxicity was evaluated in 52 patients, excluding the patient who had not received the protocol therapy. A partial response was observed in 10 patients. The overall response rate was 20.8% (95% confidence interval [CI], 10.5%-35.0%). The median PFS was 5.6 months (95% CI, 4.1-7.0 months) and the median OS was 19.6 months (95% CI, 11.4-24.3 months). The most frequently encountered grade 3/4 hematological symptom was neutropenia (43.1%). The toxicity profile was generally predictable and manageable. Conclusion: The results showed good tolerability and efficacy for second-line FOLFOX4 in patients with advanced colorectal cancer, thus indicating the promise of this regimen as an effective second-line therapy for advanced colorectal cancer in the Japanese population.

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