National cohort evaluation of Capecitabine vs. 5-Fluorouracil as concurrent therapy with Mitomycin-C & intensity modulated radiotherapy in the radical treatment of anal cancer
Session type: Poster / e-Poster / Silent Theatre session
Chemoradiotherapy (CRT) with mitomycin-C (MMC) and 5-fluorouracil (5-FU) is the standard of care for anal squamous cell carcinoma (ASCC). Use of the oral fluoropyrimidine-derivative capecitabine in place of 5-FU is emerging and supported by international guidelines despite only limited evidence for its use. We report toxicity and outcomes of capecitabine versus 5-FU in a national cohort of patients managed using a standardised intensity-modulated radiotherapy (IMRT) technique.
All 56 UK radiotherapy centres were asked to contribute consecutive patients treated for anal cancer between February-July 2015. We selected for analysis patients with ASCC managed in accordance with UK guidance (www.analimrtguidance.co.uk) with IMRT and single-dose MMC (12mg/m2) with either 5-FU (1000 mg/m2 on days 1-4, 29-32) or daily capecitabine (825 mg/m2 B.I.D.). Toxicity data were prospectively recorded. Propensity score matching was used to balance treatment groups.
40 (71%) centres participated, contributing 52 patients treated with capecitabine and 95 with 5-FU. There was no evidence of a significant difference in overall grade 3/4 toxicity rates, however the toxicity profile differed as detailed in Table 1. 90% of the 5-FU group completed planned chemotherapy, compared with 81% for capecitabine (p=0.21). Outcome data were available for 42 patients treated with capecitabine and 58 managed with 5-FU; achieving respective 6-month complete response of 88.1% vs. 91.4% (p=0.74) and at 1-year relapse-free survival of 76.2% vs. 79.3% (p=0.80) and colostomy-free survival of 77.5% vs. 90.7% (p=0.09).
In this large cohort study use of capecitabine resulted in similar overall rates but different patterns of grade 3/4 toxicity to 5-FU. There was no evidence of a difference in early outcomes. Prospective studies with long-term follow-up are required to confirm these data.