1. Tumour- and treatment-related colostomy rates following mitomycin C or cisplatin chemoradiation with or without maintenance chemotherapy in squamous cell carcinoma of the anus in the ACT II trial.
- Author
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Glynne-Jones R, Kadalayil L, Meadows HM, Cunningham D, Samuel L, Geh JI, Lowdell C, James R, Beare S, Begum R, Ledermann JA, and Sebag-Montefiore D
- Subjects
- Anal Canal pathology, Anal Canal surgery, Anus Neoplasms epidemiology, Anus Neoplasms pathology, Carcinoma, Squamous Cell epidemiology, Carcinoma, Squamous Cell pathology, Disease-Free Survival, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local epidemiology, Neoplasm Recurrence, Local therapy, Neoplasms, Second Primary epidemiology, Neoplasms, Second Primary surgery, Anus Neoplasms therapy, Carcinoma, Squamous Cell therapy, Chemoradiotherapy, Adjuvant adverse effects, Cisplatin administration & dosage, Colostomy statistics & numerical data, Maintenance Chemotherapy adverse effects, Mitomycin administration & dosage
- Abstract
Background: Squamous cell carcinoma of the anus (SCCA) is highly sensitive to chemoradiation (CRT) which achieves good loco-regional control and preserves anal function. However, some patients require permanent stoma formation either as a result of surgery on relapse, poor anal function or treatment-related symptoms. Our aim was to determine patient, tumour and treatment-related colostomy rates following CRT and maintenance chemotherapy in the ACT II trial., Patients and Methods: The ACT II trial recruited 940 patients comparing 5FU-based CRT using cisplatin (CisP) or mitomycin C (MMC) with or without additional maintenance chemotherapy. We investigated the association between colostomy-free survival (CFS) and progression-free survival (PFS) with age, gender, T-stage, N-stage, treatment and baseline haemoglobin., Results: The median follow-up was 5.1 years (n = 884 evaluable/940); tumour site canal (84%), margin (14%); stage T1/T2 (52%), T3/T4 (46%); N+ (32%), N0 (62%). Twenty out of 118 (17%) colostomies fashioned before CRT were reversed within 8 months. One hundred and twelve patients had a post-treatment colostomy due to persistent disease (98) or morbidity (14). Fifty-two per cent (61/118) of all pre-treatment colostomies were never reversed. The 5-year CFS rates were 68% MMC/Maint, 70% CisP/Maint, 68% MMC/No-maint and 65% CisP/No-maint. CRT with CisP did not improve CFS when compared with MMC (hazard ratio: 1.04, 95% confidence interval: 0.82-1.31, P = 0.74). The 5-year CFS rates were higher for T1/T2 (79%) than T3/T4 (54%) tumours and higher for node-negative (72%) than node-positive (60%) patients. Significant predictors of CFS were gender, T-stage and haemoglobin, while treatment factors had no impact on outcome. Similar associations were found between PFS and tumour/treatment-related factors., Conclusions: The majority (52%) of pre-treatment colostomies were never reversed. Neither CRT with 5FU/CisP nor maintenance chemotherapy impacted on CFS. The low risk of colostomy for late effects (1.7%) is likely to be associated with the modest total radiotherapy dose. The predictive factors for CFS were T-stage, gender and baseline haemoglobin., Clinical Trial Registration Number: ISRCTN 26715889., (© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2014
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