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

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.

• Authors: Yasuhiro Miyake, Junichi Nishimura, Takeshi Kato, 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)
• Journal: Surgery today (Surg Today) Vol. 48 Issue 1 Pg. 66-72 (Jan 2018) ISSN: 1436-2813 [Electronic] Japan
• PMID: 28634730 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study)

Chemical References

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

Topics

• Administration, Ophthalmic
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Chemotherapy, Adjuvant
• Colectomy
• Colorectal Neoplasms (pathology, 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