National cohort evaluation of Capecitabine vs. 5-Fluorouracil as concurrent therapy with Mitomycin-C & intensity modulated radiotherapy in the radical treatment of anal cancer


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Christopher Jones1,Richard Adams2,Amy Downing1,Rob Glynne-Jones3,Mark Harrison3,Maria Hawkins4,David Sebag-Montefiore1,Duncan Gilbert5,Rebecca Muirhead6
1University of Leeds,2Centre for Trials Research, Cardiff University,3Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital,4CRUK MRC Oxford Institute for Radiation Oncology, University of Oxford,5Sussex Cancer Centre, Royal Sussex County Hospital,6Oxford Cancer & Haematology Centre, Oxford University Hospitals

Abstract

Background

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.

Method

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.

Results

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).

Conclusion

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.