PMID- 24827136 OWN - NLM STAT- MEDLINE DCOM- 20151116 LR - 20240210 IS - 1569-8041 (Electronic) IS - 0923-7534 (Linking) VI - 25 IP - 8 DP - 2014 Aug TI - 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. PG - 1616-22 LID - 10.1093/annonc/mdu188 [doi] AB - 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. CI - (c) 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. FAU - Glynne-Jones, R AU - Glynne-Jones R AD - Department of Medical Oncology, Mount Vernon Centre for Cancer Treatment, Northwood rob.glynnejones@nhs.net. FAU - Kadalayil, L AU - Kadalayil L AD - Cancer Research UK and University College London Cancer Trials Centre, London. FAU - Meadows, H M AU - Meadows HM AD - Cancer Research UK and University College London Cancer Trials Centre, London. FAU - Cunningham, D AU - Cunningham D AD - Royal Marsden Hospital, London. FAU - Samuel, L AU - Samuel L AD - Department of Clinical Oncology, Aberdeen Royal Infirmary, Aberdeen. FAU - Geh, J I AU - Geh JI AD - Department of Oncology, Queen Elizabeth Hospital, Birmingham. FAU - Lowdell, C AU - Lowdell C AD - Department of Oncology, Imperial College Healthcare NHS Trust, London. FAU - James, R AU - James R AD - The Kent Cancer Centre, Tonbridge, Maidstone. FAU - Beare, S AU - Beare S AD - Cancer Research UK and University College London Cancer Trials Centre, London. FAU - Begum, R AU - Begum R AD - Cancer Research UK and University College London Cancer Trials Centre, London. FAU - Ledermann, J A AU - Ledermann JA AD - Cancer Research UK and University College London Cancer Trials Centre, London. FAU - Sebag-Montefiore, D AU - Sebag-Montefiore D AD - University of Leeds, St James's Institute of Oncology, Leeds, UK. CN - ACT II Study Group LA - eng SI - ISRCTN/ISRCTN26715889 GR - 15953/CRUK_/Cancer Research UK/United Kingdom GR - C444/A628/CRUK_/Cancer Research UK/United Kingdom PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140514 PL - England TA - Ann Oncol JT - Annals of oncology : official journal of the European Society for Medical Oncology JID - 9007735 RN - 50SG953SK6 (Mitomycin) RN - Q20Q21Q62J (Cisplatin) SB - IM MH - Anal Canal/pathology/surgery MH - Anus Neoplasms/epidemiology/pathology/*therapy MH - Carcinoma, Squamous Cell/epidemiology/pathology/*therapy MH - *Chemoradiotherapy, Adjuvant/adverse effects MH - Cisplatin/*administration & dosage MH - Colostomy/*statistics & numerical data MH - Disease-Free Survival MH - Female MH - Humans MH - *Maintenance Chemotherapy/adverse effects MH - Male MH - Middle Aged MH - Mitomycin/*administration & dosage MH - Neoplasm Recurrence, Local/epidemiology/therapy MH - Neoplasms, Second Primary/epidemiology/surgery OTO - NOTNLM OT - anal cancer OT - chemoradiation OT - colostomy-free survival OT - loco-regional control OT - risk factors OT - squamous cell carcinoma EDAT- 2014/05/16 06:00 MHDA- 2015/11/17 06:00 CRDT- 2014/05/16 06:00 PHST- 2014/05/16 06:00 [entrez] PHST- 2014/05/16 06:00 [pubmed] PHST- 2015/11/17 06:00 [medline] AID - S0923-7534(19)34824-0 [pii] AID - 10.1093/annonc/mdu188 [doi] PST - ppublish SO - Ann Oncol. 2014 Aug;25(8):1616-22. doi: 10.1093/annonc/mdu188. Epub 2014 May 14.