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- Title
Adjuvant chemoradiotherapy of advanced resectable rectal cancer: results of a randomised trial comparing modulation of 5-fluorouracil with folinic acid or with interferon-α.
- Authors
Kornmann, Marko; Staib, L.; Wiegel, T.; Kreuser, E.-D.; Kron, M.; Baumann, W.; Henne-Bruns, D.; Link, K.-H.; Kornmann, M
- Abstract
<bold>Background: </bold>Standard adjuvant chemoradiotherapy of rectal cancer still consists of 5-fluorouracil (5-FU) only. Its cytotoxicity is enhanced by folinic acid (FA) and interferon-α (INFα). In this trial, the effects of FA and IFNα on adjuvant 5-FU chemoradiotherapy in locally advanced rectal cancer were investigated.<bold>Methods: </bold>Patients with R(0)-resected rectal cancer (UICC stage II and III) were stratified and randomised to a 12-month adjuvant chemoradiotherapy with 5-FU, 5-FU+FA, or 5-FU+IFNα. All patients received levamisol and local irradiation with 50.4 Gy.<bold>Results: </bold>Median follow-up was 4.9 years (n=796). Toxicities (WHO III+IV) were observed in 32, 28, and 58% of patients receiving 5-FU, 5-FU+FA, and 5-FU+IFNα, respectively. No differences between the groups were observed for local or distant recurrence. Five-year overall survival (OS) rates were 60.3% (95% confidence interval (CI): 54.3-65.8), 60.4% (54.4-65.8), and 59.9% (53.0-66.1) for 5-FU, 5-FU+FA, and 5-FU+IFNα, respectively. A subgroup analysis in stage II (pT3/4pN0) disease (n=271) revealed that the addition of FA tended to reduce the 5-year local recurrence (LR) rate by 55% and increase recurrence-free survival and OS rates by 12 and 13%, respectively, relative to 5-FU alone.<bold>Conclusions: </bold>Interferon-α cannot be recommended for adjuvant chemoradiotherapy of rectal cancer. In UICC stage II disease, the addition of FA tended to lower LR and increased survival. The addition of FA to 5-FU may be an effective option for adjuvant chemoradiotherapy of UICC stage II rectal cancer.
- Subjects
RECTAL cancer; FOLINIC acid; INTERFERONS; CANCER chemotherapy; ADJUVANT treatment of cancer; COLONOSCOPY; RADIOTHERAPY; TOXICITY testing; THERAPEUTIC use of antineoplastic agents; ADENOCARCINOMA; DISEASE progression; PROTEINS; RESEARCH; RECTUM tumors; RESEARCH methodology; ANTINEOPLASTIC agents; MEDICAL cooperation; EVALUATION research; FLUOROURACIL; COMPARATIVE studies; RANDOMIZED controlled trials; COMBINED modality therapy; ALGORITHMS
- Publication
British Journal of Cancer, 2010, Vol 103, Issue 8, p1163
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/sj.bjc.6605871