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Phase III trial comparing UFT + PSK to UFT + LV in stage IIB, III colorectal cancer (MCSGO-CCTG)

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Abstract

Purpose

Oral adjuvant uracil and tegafur plus leucovorin (UFT/LV) is not inferior to standard weekly fluorouracil and folinate for stage II/III colon cancer. However, protein-bound polysaccharide K (PSK) has been evaluated as postoperative adjuvant therapy for colorectal cancer. This report is the first of MCSGO-CCTG, which compared UFT/LV to UFT/PSK as adjuvant chemotherapy for stage IIB or III colorectal cancer in patients who had undergone Japanese D2/D3 lymph node dissection.

Methods

The primary endpoint was the 3-year disease-free survival (DFS). A randomized non-inferiority study compared UFT/LV to UFT/PSK. The overall survival, adverse events, compliance, and quality of life were also investigated as the secondary endpoints.

Results

Between March 2006 and December 2010, 357 patients were randomized to UFT/PSK (n = 178) or UFT/LV (n = 179) (median age 65 years, colon/rectum 67.4/32.6%, stage IIB/IIIA/IIIB/IIIC 11.1/15.7/55.0/18.2%). The 3-year DFS rate was 82.3% in those receiving UFT/LV and 72.1% in those receiving UFT/PSK. The non-inferiority of UFT/PSK adjuvant therapy to UFT/LV therapy was not verified (−9.06%, 90% confidence interval −17.06 to −1.06%). The 3-year overall survival rate was 95.4% in those receiving UFT/LV and 90.7% in those receiving UFT/PSK.

Conclusions

As adjuvant chemotherapy for stage IIB and III colorectal cancer patients, UFT/PSK adjuvant therapy was not non-inferior to UFT/LV therapy with respect to the DFS.

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Acknowledgements

This study was supported by a Grant from The Supporting Center for Clinical Research and Education (Osaka, Japan), a nonprofit foundation. We thank Dr. Yuko Ohno and Makoto Fujii for the statistical analysis. We also thank the patients for their participation in this study and the study management teams and staff at the individual study sites.

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Author notes

  1. Yasuhiro Miyake and Junichi Nishimura are co-first authors.

Authors and Affiliations

  1. Department of Surgery, Nishinomiya Municipal Hospital, Hayashidacho 8-24, Nishinomiya, Hyogo, 6638014, Japan

    Yasuhiro Miyake & Riichiro Nezu

  2. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Yamadaoka 2-2, Suita, Osaka, 5650871, Japan

    Junichi Nishimura, Taishi Hata, Ichiro Takemasa, Tsunekazu Mizushima, Hirofumi Yamamoto, Yuichiro Doki & Masaki Mori

  3. Department of Surgery, Kansai Rosai Hospital, 3-1-69 Inabasou, Amagasaki, Osaka, 6608511, Japan

    Takeshi Kato

  4. Department of Surgery, National Hospital Organization, Osaka National Hospital, Hoenzakka 2-1-14, Osaka, Osaka, 5400006, Japan

    Masataka Ikeda & Mitsugu Sekimoto

  5. Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, 13-9 Rokutanjicho, Nishinomiya, Hyogo, 6620918, Japan

    Masaki Tsujie

Authors
  1. Yasuhiro Miyake
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  2. Junichi Nishimura
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Consortia

Multi-center Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (MCSGO)

Corresponding author

Correspondence to Takeshi Kato.

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Conflict of interest

Yasuhiro Miyake, Junichi Nishimura, and other co-authors have no conflict of interest.

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Miyake, Y., Nishimura, J., Kato, T. et al. Phase III trial comparing UFT + PSK to UFT + LV in stage IIB, III colorectal cancer (MCSGO-CCTG). Surg Today 48, 66–72 (2018). https://doi.org/10.1007/s00595-017-1555-1

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  • DOI: https://doi.org/10.1007/s00595-017-1555-1

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