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Phase II multicenter study of adjuvant S-1 for colorectal liver metastasis: survival analysis of N-SOG 01 trial

Cancer Chemotherapy and Pharmacology volume 75, pages 1281–1288 (2015)Cite this article

Abstract

Purpose

We previously showed that S-1 after curative resection of colorectal liver metastasis had acceptable toxicity and a high rate of completion of therapy in a prospective phase II trial. We here reported the primary endpoint of disease-free survival (DFS).

Methods

Between October 2008 and August 2010, 60 patients were eligible for this study and received S-1 for 28 days followed by a 2-week rest period. Treatment was started within 8 weeks after surgery and repeated for eight cycles.

Results

Median follow-up was 41 months. Among 60 patients, 45 had solitary metastasis, and the median maximum tumor diameter was 2.6 cm. The 3-year DFS and overall survival were 47.4 and 80.0 %, respectively. Recurrences developed in 31 patients, with the remnant liver the most common site (19 patients). Multivariate analysis showed that positive lymph node metastasis around the primary site (p = 0.013) and early liver metastasis (synchronous disease or metachronous disease within 12 months) (p = 0.041) were independent poor prognostic factors for DFS. Patients having both risk factors had a significantly worse DFS than those without these risk factors (p < 0.001). Early liver metastasis was an independent indicator of early recurrence within 1 year.

Conclusions

S-1 after curative liver resection yielded promising survival in patients with a low tumor burden. Outcome in patients having both positive lymph node metastasis around the primary site and early liver metastasis was much worse than in patients without these conditions; therefore, they might warrant more aggressive therapy.

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Acknowledgments

We are grateful to many other participants of the Nagoya Surgical Oncology Group.

Conflict of interest

The authors declared no conflicts of interest and financial disclosure with respect to the authorship and/or publication of this article.

Author information

Affiliations

  1. Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65, Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan

    Takehiro Kato, Keisuke Uehara & Masato Nagino

  2. Department of Surgery, Ogaki Municipal Hospital, Gifu, Japan

    Atsuyuki Maeda

  3. Department of Surgery, Nagoya Daini Red Cross Hospital, Nagoya, Japan

    Eiji Sakamoto

  4. Department of Surgery, Toyohashi Municipal Hospital, Aichi, Japan

    Kazuhiro Hiramatsu

  5. Department of Surgery, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Japan

    Eiji Takeuchi

  6. Department of Surgery, Anjo Kosei Hospital, Aichi, Japan

    Hidenari Goto

  7. Department of Surgery, Chukyo Hospital, Nagoya, Japan

    Yuichiro Tojima

  8. Department of Public Health, School of Medicine, Fujita Health University, Aichi, Japan

    Hiroshi Yatsuya

Authors
  1. Takehiro Kato
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  2. Keisuke Uehara
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  3. Atsuyuki Maeda
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  4. Eiji Sakamoto
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  5. Kazuhiro Hiramatsu
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  6. Eiji Takeuchi
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  7. Hidenari Goto
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  8. Yuichiro Tojima
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  9. Hiroshi Yatsuya
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  10. Masato Nagino
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The Nagoya Surgical Oncology Group

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Correspondence to Keisuke Uehara.

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Kato, T., Uehara, K., Maeda, A. et al. Phase II multicenter study of adjuvant S-1 for colorectal liver metastasis: survival analysis of N-SOG 01 trial. Cancer Chemother Pharmacol 75, 1281–1288 (2015). https://doi.org/10.1007/s00280-015-2752-5

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  • DOI: https://doi.org/10.1007/s00280-015-2752-5

Keywords

  • Colorectal cancer
  • Liver metastasis
  • Adjuvant chemotherapy
  • S-1
  • Survival