Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa-2a in colon carcinoma: National Surgical Adjuvant Breast and Bowel Project protocol C-05
- PMID: 9839521
- DOI: 10.1093/jnci/90.23.1810
Adjuvant 5-fluorouracil and leucovorin with or without interferon alfa-2a in colon carcinoma: National Surgical Adjuvant Breast and Bowel Project protocol C-05
Abstract
Background: National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol C-03 showed a benefit from leucovorin (LV)-modulated 5-fluorouracil (5-FU) adjuvant therapy (5-FU + LV) in patients with Dukes' stage B or C carcinoma of the colon. Preclinical and clinical phase I/II data suggested that interferon alfa-2a (IFN) enhanced the efficacy of 5-FU therapy. Accordingly, in NSABP protocol C-05, the addition of recombinant IFN to 5-FU + LV adjuvant therapy was evaluated.
Methods: Data are presented for 2176 patients with Dukes' stage B or C cancer entered onto protocol C-05 during the period from October 1991 through February 1994. Individuals with an Eastern Cooperative Oncology Group performance status of 0-2 (ranges from fully active to ambulatory and capable of self-care but unable to work), a life expectancy of at least 10 years, and curative resection were stratified by sex, disease stage, and number of involved lymph nodes and were randomly assigned to receive either 5-FU + LV or 5-FU + LV + IFN; the mean time on the study as of June 30, 1997, was 54 months. All statistical tests were two-sided.
Results: There was no statistically significant difference in either disease-free survival (5-FU + LV, 69%; 5-FU + LV + IFN, 70%) or overall survival (5-FU + LV, 80%; 5-FU + LV + IFN, 81%) at 4 years of follow-up. Toxic effects of grade 3 or higher were observed in 61.8% of subjects in the group treated with 5-FU + LV and in 72.1% of subjects in the group treated with 5-FU + LV + IFN; fewer patients in the latter group completed protocol-mandated 5-FU + LV therapy than in the former group (77.1% versus 88.5%).
Conclusion: The addition of IFN to 5-FU + LV adjuvant therapy confers no statistically significant benefit, but it does increase toxicity.
Similar articles
-
[Progression of adjuvant chemotherapy for colon cancer].Ai Zheng. 2005 Dec;24(12):1546-9. Ai Zheng. 2005. PMID: 16351811 Review. Chinese.
-
An overview of adjuvant systemic chemotherapy for colon cancer.Clin Colorectal Cancer. 2004 Jun;4 Suppl 1:S22-8. Clin Colorectal Cancer. 2004. PMID: 15212702 Review.
-
Fluorouracil and leucovorin with or without interferon alfa-2a as adjuvant treatment, in patients with high-risk colon cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group.Oncology. 2000 Apr;58(3):227-36. doi: 10.1159/000012105. Oncology. 2000. PMID: 10765125 Clinical Trial.
-
Randomized trial of postoperative adjuvant chemotherapy with or without radiotherapy for carcinoma of the rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02.J Natl Cancer Inst. 2000 Mar 1;92(5):388-96. doi: 10.1093/jnci/92.5.388. J Natl Cancer Inst. 2000. PMID: 10699069 Clinical Trial.
-
Clinical trial to assess the relative efficacy of fluorouracil and leucovorin, fluorouracil and levamisole, and fluorouracil, leucovorin, and levamisole in patients with Dukes' B and C carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project C-04.J Clin Oncol. 1999 Nov;17(11):3553-9. doi: 10.1200/JCO.1999.17.11.3553. J Clin Oncol. 1999. PMID: 10550154 Clinical Trial.
Cited by
-
Impact of timing of adjuvant chemotherapy on survival in stage III colon cancer: a population-based study.BMC Cancer. 2018 Mar 1;18(1):234. doi: 10.1186/s12885-018-4138-7. BMC Cancer. 2018. PMID: 29490625 Free PMC article.
-
Quality of life and symptoms in long-term survivors of colorectal cancer: results from NSABP protocol LTS-01.J Cancer Surviv. 2017 Feb;11(1):111-118. doi: 10.1007/s11764-016-0567-y. Epub 2016 Aug 25. J Cancer Surviv. 2017. PMID: 27562475 Free PMC article.
-
Association Between Time (Initiation and Length) and Oncological Outcomes for the Patients with Colon Cancer Treated with Adjuvant Chemotherapy.Indian J Surg. 2015 Dec;77(Suppl 3):1252-7. doi: 10.1007/s12262-015-1270-3. Epub 2015 Apr 23. Indian J Surg. 2015. PMID: 27011547 Free PMC article.
-
tRNA modifying enzymes, NSUN2 and METTL1, determine sensitivity to 5-fluorouracil in HeLa cells.PLoS Genet. 2014 Sep 18;10(9):e1004639. doi: 10.1371/journal.pgen.1004639. eCollection 2014 Sep. PLoS Genet. 2014. PMID: 25233213 Free PMC article.
-
Association between adherence to National Comprehensive Cancer Network treatment guidelines and improved survival in patients with colon cancer.Cancer. 2013 Apr 15;119(8):1593-601. doi: 10.1002/cncr.27935. Epub 2012 Dec 21. Cancer. 2013. PMID: 23280510 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources