Phase II trial of alternating mFOLFOX6 and FOLFIRI regimens in the first-line treatment for unresectable or metastatic colorectal cancer (KSCC0701) Kyushu study group of clinical cancer

Eiji Oki, Yasunori Emi, Yoshito Akagi, Shoji Tokunaga, Noriaki Sadanaga, Takaho Tanaka, Yutaka Ogata, Hiroshi Saeki, Yoshihiro Kakeji, Hideo Baba, Tadashi Nishimaki, Shoji Natsugoe, Kazuo Shirouzu, Yoshihiko Maehara

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Abstract

Objective: This phase II study examined the efficacy and safety of alternating regimens of mFOLFOX6 and FOLFIRI as a first-line treatment for unresectable or metastatic colorectal cancer. Patients and Methods: Forty-eight patients were enrolled in this study. Patients received an alternating regimen of 4 cycles of mFOLFOX6 followed by 4 cycles of FOLFIRI. Results: The characteristics of the study population were as follows: males/females 34/12, median age 66 years (range 43-75) and Eastern Cooperative Oncology Group performance status 0/1/2 in 37/9/0 patients. The overall response rate was 58.7% [95% confidence interval (CI) 43.9-73.5]. The median progression-free survival was 10.3 months (95% CI 7.5-11.9), and the median overall survival was 28.4 months (95% CI 22.5-35.7). Among the 47 patients evaluated for toxicity, the most common grade 3-4 adverse events were leukopenia (26%), neutropenia (55%), anemia (4%), neurotoxicity (0%), diarrhea (2%), febrile neutropenia (4%), nausea (4%), vomiting (2%), and hypersensitivity (0%). Conclusions: The results of this phase II study indicate that this alternating schedule is effective and well tolerated as a first-line treatment for unresectable or metastatic colorectal cancer. The low rate of grade 3 neurotoxicity is also promising.

Original languageEnglish
Pages (from-to)233-239
Number of pages7
JournalOncology (Switzerland)
Volume84
Issue number4
DOIs
Publication statusPublished - Mar 1 2013

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Colorectal Neoplasms
Confidence Intervals
Neoplasms
Therapeutics
Febrile Neutropenia
Leukopenia
Population Characteristics
Neutropenia
Nausea
Disease-Free Survival
Vomiting
Anemia
Diarrhea
Appointments and Schedules
Hypersensitivity
Clinical Studies
Safety
Survival

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Phase II trial of alternating mFOLFOX6 and FOLFIRI regimens in the first-line treatment for unresectable or metastatic colorectal cancer (KSCC0701) Kyushu study group of clinical cancer. / Oki, Eiji; Emi, Yasunori; Akagi, Yoshito; Tokunaga, Shoji; Sadanaga, Noriaki; Tanaka, Takaho; Ogata, Yutaka; Saeki, Hiroshi; Kakeji, Yoshihiro; Baba, Hideo; Nishimaki, Tadashi; Natsugoe, Shoji; Shirouzu, Kazuo; Maehara, Yoshihiko.

In: Oncology (Switzerland), Vol. 84, No. 4, 01.03.2013, p. 233-239.

Research output: Contribution to journalArticle

Oki, E, Emi, Y, Akagi, Y, Tokunaga, S, Sadanaga, N, Tanaka, T, Ogata, Y, Saeki, H, Kakeji, Y, Baba, H, Nishimaki, T, Natsugoe, S, Shirouzu, K & Maehara, Y 2013, 'Phase II trial of alternating mFOLFOX6 and FOLFIRI regimens in the first-line treatment for unresectable or metastatic colorectal cancer (KSCC0701) Kyushu study group of clinical cancer', Oncology (Switzerland), vol. 84, no. 4, pp. 233-239. https://doi.org/10.1159/000346690
Oki, Eiji ; Emi, Yasunori ; Akagi, Yoshito ; Tokunaga, Shoji ; Sadanaga, Noriaki ; Tanaka, Takaho ; Ogata, Yutaka ; Saeki, Hiroshi ; Kakeji, Yoshihiro ; Baba, Hideo ; Nishimaki, Tadashi ; Natsugoe, Shoji ; Shirouzu, Kazuo ; Maehara, Yoshihiko. / Phase II trial of alternating mFOLFOX6 and FOLFIRI regimens in the first-line treatment for unresectable or metastatic colorectal cancer (KSCC0701) Kyushu study group of clinical cancer. In: Oncology (Switzerland). 2013 ; Vol. 84, No. 4. pp. 233-239.
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abstract = "Objective: This phase II study examined the efficacy and safety of alternating regimens of mFOLFOX6 and FOLFIRI as a first-line treatment for unresectable or metastatic colorectal cancer. Patients and Methods: Forty-eight patients were enrolled in this study. Patients received an alternating regimen of 4 cycles of mFOLFOX6 followed by 4 cycles of FOLFIRI. Results: The characteristics of the study population were as follows: males/females 34/12, median age 66 years (range 43-75) and Eastern Cooperative Oncology Group performance status 0/1/2 in 37/9/0 patients. The overall response rate was 58.7{\%} [95{\%} confidence interval (CI) 43.9-73.5]. The median progression-free survival was 10.3 months (95{\%} CI 7.5-11.9), and the median overall survival was 28.4 months (95{\%} CI 22.5-35.7). Among the 47 patients evaluated for toxicity, the most common grade 3-4 adverse events were leukopenia (26{\%}), neutropenia (55{\%}), anemia (4{\%}), neurotoxicity (0{\%}), diarrhea (2{\%}), febrile neutropenia (4{\%}), nausea (4{\%}), vomiting (2{\%}), and hypersensitivity (0{\%}). Conclusions: The results of this phase II study indicate that this alternating schedule is effective and well tolerated as a first-line treatment for unresectable or metastatic colorectal cancer. The low rate of grade 3 neurotoxicity is also promising.",
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T1 - Phase II trial of alternating mFOLFOX6 and FOLFIRI regimens in the first-line treatment for unresectable or metastatic colorectal cancer (KSCC0701) Kyushu study group of clinical cancer

AU - Oki, Eiji

AU - Emi, Yasunori

AU - Akagi, Yoshito

AU - Tokunaga, Shoji

AU - Sadanaga, Noriaki

AU - Tanaka, Takaho

AU - Ogata, Yutaka

AU - Saeki, Hiroshi

AU - Kakeji, Yoshihiro

AU - Baba, Hideo

AU - Nishimaki, Tadashi

AU - Natsugoe, Shoji

AU - Shirouzu, Kazuo

AU - Maehara, Yoshihiko

PY - 2013/3/1

Y1 - 2013/3/1

N2 - Objective: This phase II study examined the efficacy and safety of alternating regimens of mFOLFOX6 and FOLFIRI as a first-line treatment for unresectable or metastatic colorectal cancer. Patients and Methods: Forty-eight patients were enrolled in this study. Patients received an alternating regimen of 4 cycles of mFOLFOX6 followed by 4 cycles of FOLFIRI. Results: The characteristics of the study population were as follows: males/females 34/12, median age 66 years (range 43-75) and Eastern Cooperative Oncology Group performance status 0/1/2 in 37/9/0 patients. The overall response rate was 58.7% [95% confidence interval (CI) 43.9-73.5]. The median progression-free survival was 10.3 months (95% CI 7.5-11.9), and the median overall survival was 28.4 months (95% CI 22.5-35.7). Among the 47 patients evaluated for toxicity, the most common grade 3-4 adverse events were leukopenia (26%), neutropenia (55%), anemia (4%), neurotoxicity (0%), diarrhea (2%), febrile neutropenia (4%), nausea (4%), vomiting (2%), and hypersensitivity (0%). Conclusions: The results of this phase II study indicate that this alternating schedule is effective and well tolerated as a first-line treatment for unresectable or metastatic colorectal cancer. The low rate of grade 3 neurotoxicity is also promising.

AB - Objective: This phase II study examined the efficacy and safety of alternating regimens of mFOLFOX6 and FOLFIRI as a first-line treatment for unresectable or metastatic colorectal cancer. Patients and Methods: Forty-eight patients were enrolled in this study. Patients received an alternating regimen of 4 cycles of mFOLFOX6 followed by 4 cycles of FOLFIRI. Results: The characteristics of the study population were as follows: males/females 34/12, median age 66 years (range 43-75) and Eastern Cooperative Oncology Group performance status 0/1/2 in 37/9/0 patients. The overall response rate was 58.7% [95% confidence interval (CI) 43.9-73.5]. The median progression-free survival was 10.3 months (95% CI 7.5-11.9), and the median overall survival was 28.4 months (95% CI 22.5-35.7). Among the 47 patients evaluated for toxicity, the most common grade 3-4 adverse events were leukopenia (26%), neutropenia (55%), anemia (4%), neurotoxicity (0%), diarrhea (2%), febrile neutropenia (4%), nausea (4%), vomiting (2%), and hypersensitivity (0%). Conclusions: The results of this phase II study indicate that this alternating schedule is effective and well tolerated as a first-line treatment for unresectable or metastatic colorectal cancer. The low rate of grade 3 neurotoxicity is also promising.

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