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Surgery Today

, Volume 48, Issue 1, pp 66–72 | Cite as

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

  • Yasuhiro Miyake
  • Junichi Nishimura
  • Takeshi KatoEmail author
  • Masataka Ikeda
  • Masaki Tsujie
  • Taishi Hata
  • Ichiro Takemasa
  • Tsunekazu Mizushima
  • Hirofumi Yamamoto
  • Mitsugu Sekimoto
  • Riichiro Nezu
  • Yuichiro Doki
  • Masaki Mori
  • Multi-center Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (MCSGO)
Original Article

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.

Keywords

Colorectal cancer Adjuvant therapy Protein-bound polysaccharide K UFT/LV Stage IIB Stage III 

Notes

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.

Compliance with ethical standards

Conflict of interest

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

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Copyright information

© Springer Japan KK 2017

Authors and Affiliations

  • Yasuhiro Miyake
    • 1
  • Junichi Nishimura
    • 2
  • Takeshi Kato
    • 3
    Email author
  • Masataka Ikeda
    • 4
  • Masaki Tsujie
    • 5
  • Taishi Hata
    • 2
  • Ichiro Takemasa
    • 2
  • Tsunekazu Mizushima
    • 2
  • Hirofumi Yamamoto
    • 2
  • Mitsugu Sekimoto
    • 4
  • Riichiro Nezu
    • 1
  • Yuichiro Doki
    • 2
  • Masaki Mori
    • 2
  • Multi-center Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (MCSGO)
  1. 1.Department of SurgeryNishinomiya Municipal HospitalNishinomiyaJapan
  2. 2.Department of Gastroenterological SurgeryOsaka University Graduate School of MedicineSuitaJapan
  3. 3.Department of SurgeryKansai Rosai HospitalAmagasakiJapan
  4. 4.Department of SurgeryNational Hospital Organization, Osaka National HospitalOsakaJapan
  5. 5.Department of SurgeryHyogo Prefectural Nishinomiya HospitalNishinomiyaJapan

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