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

Surg Today. 2018 Jan;48(1):66-72. doi: 10.1007/s00595-017-1555-1. Epub 2017 Jun 20.

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

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Administration, Ophthalmic
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Chemotherapy, Adjuvant*
  • Colectomy
  • Colorectal Neoplasms / pathology*
  • Colorectal Neoplasms / therapy*
  • Combined Modality Therapy
  • Female
  • Humans
  • Leucovorin / administration & dosage*
  • Lymph Node Excision
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Proteoglycans / administration & dosage*
  • Tegafur / administration & dosage*
  • Treatment Outcome
  • Uracil / administration & dosage*
  • Young Adult

Substances

  • Proteoglycans
  • Tegafur
  • polysaccharide-K
  • Uracil
  • Leucovorin