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

A Japanese experience

Hideo Baba, Naoko Hayashi, Yasunori Emi, Yoshihiro Kakeji, Akinori Egashira, Eiji Oki, Ken Shirabe, Tetsuo Toyama, Takefumi Ohga, Manabu Yamamoto, Hirofumi Hasegawa, Fumiko Kohakura, Hidefumi Higashi, Kiyoshi Niwa, Fumihiko Fujita, Yutaka Ogata, Shunji Kohnoe, Masafumi Inomata, Hironori Samura, Shoji Tokunaga & 1 others Yoshihiko Maehara

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Purpose: This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin in combination with levofolinate and infusion 5-fluorouracil (FOLFOX4) as first-line therapy for Japanese patients with unresectable metastatic colorectal cancer. Methods: Sixty consecutive patients with histologically confirmed advanced or metastatic colorectal cancer were enrolled in the study. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred. Results: Two patients were ineligible. Toxicity was evaluated in 60 patients, who had received a part or all of the protocol therapy. A partial response was observed in 20 patients. The overall response rate was 34.5% (95% CI, 22.5%-48.1%) and the tumor control rate (partial response + stable disease) was 82.8%. The median progression-free survival was 6.9 months (95% CI, 5.1-9.8 months), and the median overall survival was 31.5 months (95% CI, 18.1-40.1 months). There were no toxicity-related deaths. Grade 3 or 4 neutropenia occurred in 48.3% of patients and often caused a delay in the subsequent treatment course. Mild to moderate cumulative peripheral sensory neuropathy affected 71.7% of patients. Conclusion: The results showed good tolerability and efficacy for first-line FOLFOX4 in the treatment of patients with advanced colorectal cancer, indicating the promise of this regimen as first-line therapy for advanced colorectal cancer in the Japanese population.

Original languageEnglish
Pages (from-to)1610-1616
Number of pages7
JournalSurgery today
Volume41
Issue number12
DOIs
Publication statusPublished - Dec 1 2011

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oxaliplatin
Leucovorin
Combination Drug Therapy
Fluorouracil
Colorectal Neoplasms
Therapeutics
Clinical Studies
Peripheral Nervous System Diseases
Neutropenia

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 first-line treatment for advanced colorectal cancer : A Japanese experience. / Baba, Hideo; Hayashi, Naoko; Emi, Yasunori; Kakeji, Yoshihiro; Egashira, Akinori; Oki, Eiji; Shirabe, Ken; Toyama, Tetsuo; Ohga, Takefumi; Yamamoto, Manabu; Hasegawa, Hirofumi; Kohakura, Fumiko; Higashi, Hidefumi; Niwa, Kiyoshi; Fujita, Fumihiko; Ogata, Yutaka; Kohnoe, Shunji; Inomata, Masafumi; Samura, Hironori; Tokunaga, Shoji; Maehara, Yoshihiko.

In: Surgery today, Vol. 41, No. 12, 01.12.2011, p. 1610-1616.

Research output: Contribution to journalArticle

Baba, H, Hayashi, N, Emi, Y, Kakeji, Y, Egashira, A, Oki, E, Shirabe, K, Toyama, T, Ohga, T, Yamamoto, M, Hasegawa, H, Kohakura, F, Higashi, H, Niwa, K, Fujita, F, Ogata, Y, Kohnoe, S, Inomata, M, Samura, H, Tokunaga, S & Maehara, Y 2011, 'A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as first-line treatment for advanced colorectal cancer: A Japanese experience', Surgery today, vol. 41, no. 12, pp. 1610-1616. https://doi.org/10.1007/s00595-011-4589-9
Baba, Hideo ; Hayashi, Naoko ; Emi, Yasunori ; Kakeji, Yoshihiro ; Egashira, Akinori ; Oki, Eiji ; Shirabe, Ken ; Toyama, Tetsuo ; Ohga, Takefumi ; Yamamoto, Manabu ; Hasegawa, Hirofumi ; Kohakura, Fumiko ; Higashi, Hidefumi ; Niwa, Kiyoshi ; Fujita, Fumihiko ; Ogata, Yutaka ; Kohnoe, Shunji ; Inomata, Masafumi ; Samura, Hironori ; Tokunaga, Shoji ; Maehara, Yoshihiko. / A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as first-line treatment for advanced colorectal cancer : A Japanese experience. In: Surgery today. 2011 ; Vol. 41, No. 12. pp. 1610-1616.
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abstract = "Purpose: This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin in combination with levofolinate and infusion 5-fluorouracil (FOLFOX4) as first-line therapy for Japanese patients with unresectable metastatic colorectal cancer. Methods: Sixty consecutive patients with histologically confirmed advanced or metastatic colorectal cancer were enrolled in the study. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred. Results: Two patients were ineligible. Toxicity was evaluated in 60 patients, who had received a part or all of the protocol therapy. A partial response was observed in 20 patients. The overall response rate was 34.5{\%} (95{\%} CI, 22.5{\%}-48.1{\%}) and the tumor control rate (partial response + stable disease) was 82.8{\%}. The median progression-free survival was 6.9 months (95{\%} CI, 5.1-9.8 months), and the median overall survival was 31.5 months (95{\%} CI, 18.1-40.1 months). There were no toxicity-related deaths. Grade 3 or 4 neutropenia occurred in 48.3{\%} of patients and often caused a delay in the subsequent treatment course. Mild to moderate cumulative peripheral sensory neuropathy affected 71.7{\%} of patients. Conclusion: The results showed good tolerability and efficacy for first-line FOLFOX4 in the treatment of patients with advanced colorectal cancer, indicating the promise of this regimen as first-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 first-line treatment for advanced colorectal cancer

T2 - A Japanese experience

AU - Baba, Hideo

AU - Hayashi, Naoko

AU - Emi, Yasunori

AU - Kakeji, Yoshihiro

AU - Egashira, Akinori

AU - Oki, Eiji

AU - Shirabe, Ken

AU - Toyama, Tetsuo

AU - Ohga, Takefumi

AU - Yamamoto, Manabu

AU - Hasegawa, Hirofumi

AU - Kohakura, Fumiko

AU - Higashi, Hidefumi

AU - Niwa, Kiyoshi

AU - Fujita, Fumihiko

AU - Ogata, Yutaka

AU - Kohnoe, Shunji

AU - Inomata, Masafumi

AU - Samura, Hironori

AU - Tokunaga, Shoji

AU - Maehara, Yoshihiko

PY - 2011/12/1

Y1 - 2011/12/1

N2 - Purpose: This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin in combination with levofolinate and infusion 5-fluorouracil (FOLFOX4) as first-line therapy for Japanese patients with unresectable metastatic colorectal cancer. Methods: Sixty consecutive patients with histologically confirmed advanced or metastatic colorectal cancer were enrolled in the study. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred. Results: Two patients were ineligible. Toxicity was evaluated in 60 patients, who had received a part or all of the protocol therapy. A partial response was observed in 20 patients. The overall response rate was 34.5% (95% CI, 22.5%-48.1%) and the tumor control rate (partial response + stable disease) was 82.8%. The median progression-free survival was 6.9 months (95% CI, 5.1-9.8 months), and the median overall survival was 31.5 months (95% CI, 18.1-40.1 months). There were no toxicity-related deaths. Grade 3 or 4 neutropenia occurred in 48.3% of patients and often caused a delay in the subsequent treatment course. Mild to moderate cumulative peripheral sensory neuropathy affected 71.7% of patients. Conclusion: The results showed good tolerability and efficacy for first-line FOLFOX4 in the treatment of patients with advanced colorectal cancer, indicating the promise of this regimen as first-line therapy for advanced colorectal cancer in the Japanese population.

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