Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2010 Mar 30;102(7):1123-8.
doi: 10.1038/sj.bjc.6605605. Epub 2010 Mar 16.

Chemoradiation for the treatment of epidermoid anal cancer: 13-year follow-up of the first randomised UKCCCR Anal Cancer Trial (ACT I)

J Northover  1 , R Glynne-Jones, D Sebag-Montefiore, R James, H Meadows, S Wan, M Jitlal, J Ledermann
Affiliations
Randomized Controlled Trial

Chemoradiation for the treatment of epidermoid anal cancer: 13-year follow-up of the first randomised UKCCCR Anal Cancer Trial (ACT I)

J Northover et al. Br J Cancer. .

Abstract

Background: The first UKCCCR Anal Cancer Trial (1996) demonstrated the benefit of chemoradiation over radiotherapy (RT) alone for treating epidermoid anal cancer, and it became the standard treatment. Patients in this trial have now been followed up for a median of 13 years.

Methods: A total of 577 patients were randomised to receive RT alone or combined modality therapy using 5-fluorouracil and mitomycin C. All patients were scheduled to receive 45 Gy by external beam irradiation. Patients who responded to treatment were recommended to have boost RT, with either an iridium implant or external beam irradiation. Data on relapse and deaths were obtained until October 2007.

Results: Twelve years after treatment, for every 100 patients treated with chemoradiation, there are an expected 25.3 fewer patients with locoregional relapse (95% confidence interval (CI): 17.5-32.0 fewer) and 12.5 fewer anal cancer deaths (95% CI: 4.3-19.7 fewer), compared with 100 patients given RT alone. There was a 9.1% increase in non-anal cancer deaths in the first 5 years of chemoradiation (95% CI +3.6 to +14.6), which disappeared by 10 years.

Conclusions: The clear benefit of chemoradiation outweighs an early excess risk of non-anal cancer deaths, and can still be seen 12 years after treatment. Only 11 patients suffered a locoregional relapse as a first event after 5 years, which may influence the choice of end points in future studies.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
(A) Risk of locoregional relapse, by treatment. Estimates shown are the absolute risk differences: combined modality therapy (CMT) minus radiotherapy (RT) alone (95% confidence interval (CI)). Number of locoregional relapses: RT alone: 151; CMT: 84 (excludes deaths and relapses within 6 weeks from the end of initial treatment). Hazard ratio (HR): 0.46 (95% CI: 0.35–0.60). (B) Relapse-free survival, by treatment. Estimates shown are the absolute risk differences: CMT minus RT alone (95% CI). Median: RT alone: 1.3 years; CMT: 4.6 years. HR: 0.70 (95% CI: 0.58–0.84).
Figure 2
Figure 2
Overall survival, by treatment. The estimates shown are the absolute risk differences: combined modality therapy (CMT) minus RT alone (95% confidence interval (CI)). Median: RT alone: 5.4 years; CMT: 7.6 years. Hazard ratio (HR): 0.86 (95% CI: 0.70–1.04).
Figure 3
Figure 3
Risk of death due to anal cancer, by treatment. Estimates shown are the absolute risk differences: combined modality therapy (CMT) minus RT alone (95% confidence interval (CI)). Hazard ratio (HR): 0.67 (95% CI: 0.51–0.88).
Figure 4
Figure 4
Risk of death due to causes other than anal cancer, by treatment. Estimates shown are the absolute risk differences: combined modality therapy (CMT) minus RT alone (95% confidence interval (CI)).
Figure A1
Figure A1
Colostomy-free survival, by treatment. Estimates shown are the absolute risk differences: combined modality therapy (CMT) minus RT alone (95% confidence interval (CI)). Median: RT alone: 1.8 years; CMT: 4.7 years. Hazard ratio (HR): 0.76 (95% CI: 0.63–0.91).
See this image and copyright information in PMC

References

    1. Ajani JA, Winter KA, Gunderson LL, Pedersen J, Benson III AB, Thomas Jr CR, Mayer RJ, Haddock MG, Rich TA, Willett C (2008) Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA 299: 1914–1921 - PubMed
    1. Bartelink H, Roelofsen F, Eschwege F, Rougier P, Bosset JF, Gonzalez DG, Peiffert D, van Glabbeke M, Pierart M (1997) Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the European Organization for Research and Treatment of Cancer Radiotherapy and Gastrointestinal Cooperative Groups. J Clin Oncol 15: 2040–2049 - PubMed
    1. Cancer Research UK (2008) Risks and causes of anal cancer. http://www.cancerhelp.org.uk/type/anal-cancer/about/risks-and-causes-of-.... Accessed on 19 June, 2009. Ref Type: Electronic Citation
    1. Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR, for the Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom (2008) Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 358: 36–46 - PubMed
    1. Daher IN, Yeh ET (2008) Vascular complications of selected cancer therapies. Nat Clin Pract Cardiovasc Med 5: 797–805 - PubMed

Publication types

MeSH terms