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Phase II study of FOLFOX4 with “wait and go” strategy as first-line treatment for metastatic colorectal cancer

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Abstract

Purpose

To evaluate the efficacy and safety of FOLFOX4 using “wait and go” strategy in treating metastatic colorectal cancer.

Methods

The conventional FOLFOX4 was repeated every 2 weeks. We waited until the recovery of symptoms from persistent neurotoxicity within an added period of 2 weeks, before performing the next cycle (“wait and go” strategy).

Results

We enrolled 58 patients, in whom a total of 481 cycles were administered (median 8 per patient; range 1–16). Toxicity was evaluated in 58 patients and response in 55. The major toxic effect was grade 3/4 neutropenia (33%). Painful paresthesia or persistent functional impairment was observed in 4 patients (7%). The response rate was 40% (95% confidence interval; 27.1–52.9%). The median progression-free survival time was 10.2 months, the 1-year survival rate was 89%, and the median overall survival time was 27.6 months.

Conclusions

These findings indicate that this “wait and go” strategy reduces the frequency of persistent neuropathy while maintaining efficacy against metastatic colorectal cancer.

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Acknowledgments

We are grateful to W. Koizumi, Y. Shimada, and S. Maetani for their kind advice and to M. Kurihara, H. Takahashi, and A. Kawano who constituted out the independent review committee. We also thank S. Koyama and Y. Kakehashi for their data managements. This study has been presented in part at the 7th Annual Meeting of the Japanese Society of Medical Oncology, Aichi, Japan, 2009. This study was supported by the Japan Clinical Cancer Research Organization (JACCRO). The authors are indebted to Prof. J. Patrick Barron of the Department of International Medical Communications of Tokyo Medical University for his review of this manuscript.

Conflict of interest

No authors have any conflict of interest.

Author information

Authors and Affiliations

  1. Department of Digestive Surgery, Nihon University School of Medicine, 30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo, 173-8610, Japan

    Mitsugu Kochi & Masashi Fujii

  2. Department of Clinical Oncology, National Defense Medical College, 3-2 Namiki, Tokorozawa, Saitama, 359-8513, Japan

    Wataru Ichikawa

  3. Department of Surgery, Hakodate Goryokaku Hospital, 38-3, Goryokaku-cho, Hakodate, Hokkaido, 040-8611, Japan

    Eiji Meguro

  4. Department of Clinical Oncology, Institute of Development, Aging and Cancer, Tohoku University, 4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan

    Hiroyuki Shibata

  5. Department of Surgery, Midori Municipal Hospital, 1-77, Shiomigaoka, Midori-ku, Nagoya, Aichi, 458-0037, Japan

    Takuji Fukui

  6. Department of Clinical Oncology, Jichi Medical University School of Medicine, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan

    Michitaka Nagase

  7. Department of Organ Regenerative Surgery, Fukushima Medical University, Hikarigaoka, Fukushima, Fukushima, 960-1295, Japan

    Yutaka Hoshino

  8. Division of Biostatistics, Kitasato University School of Pharmaceutical Sciences, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan

    Masahiro Takeuchi

  9. Japan Clinical Cancer Research Organization, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan

    Toshifusa Nakajima

Authors
  1. Mitsugu Kochi
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  2. Wataru Ichikawa
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  3. Eiji Meguro
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  4. Hiroyuki Shibata
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  6. Michitaka Nagase
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  7. Yutaka Hoshino
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  8. Masahiro Takeuchi
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  9. Masashi Fujii
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  10. Toshifusa Nakajima
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Corresponding author

Correspondence to Wataru Ichikawa.

Appendix

Appendix

The following investigators participated in the study: Mitsugu Kochi, Ken Hagiwara (Nihon University School of Medicine, Tokyo, Japan); Yuki Tanabe (Asahikawa Medical University, Hokkaido, Japan); Eiji Meguro, Akinori Takagane, Makoto Kobayashi (Hakodate Goryokaku Hospital, Hokkaido, Japan); Hiroyuki Shibata, Kou Miura (Tohoku University, Miyagi, Japan); Masayuki Sato (Miyagi Cancer Center, Miyagi, Japan);, Yutaka Hoshino, Fumihiko Osuka (Fukushima Medical University, Fukushima, Japan); Michitaka Nagase (Jichi Medical University, Tochigi, Japan); Miki Adachi (IUHW Mita Hospital, Tokyo, Japan); Kenji Katsumata (Tokyo Medical University, Tokyo, Japan); Masanori Yoshino (Nippon Medical School Musashi Kosugi Hospital, Kanagawa, Japan); Reiji Aotake, Koji Doi (Fukui Red Cross Hospital, Fukui, Japan); and Takuji Fukui (Midori Municipal Hospital, Aichi, Japan).

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Kochi, M., Ichikawa, W., Meguro, E. et al. Phase II study of FOLFOX4 with “wait and go” strategy as first-line treatment for metastatic colorectal cancer. Cancer Chemother Pharmacol 68, 1215–1222 (2011). https://doi.org/10.1007/s00280-011-1605-0

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