Salvage surgery with abdominoperineal excision of the rectum (APER) following loco-regional failure after chemoradiation (CRT) using mitomycin (MMC) or cisplatin (CisP), with or without maintenance 5FU/CisP chemotherapy (CT) in squamous cell carcinoma of the anus (SCCA) and the impact on long-term outcomes: Results of ACT II.

Authors

Robert Glynne-Jones

Robert Glynne-Jones

Mount Vernon Cancer Centre, Middlesex, United Kingdom

Robert Glynne-Jones , Helen Margaret Meadows , Andre Lopes , Richard A. Adams , Leslie M. Samuel , James Hill , Andrew Renehan , Maria A Hawkins , David Sebag-Montefiore

Organizations

Mount Vernon Cancer Centre, Middlesex, United Kingdom, Cancer Research UK & UCL Cancer Trials Centre, London, United Kingdom, Cancer Research UK and University College London Cancer Trials Centre, London, United Kingdom, Velindre Hospital NHS Foundation Trust, Cardiff, United Kingdom, Aberdeen Royal Infirmary, University of Aberdeen, Aberdeen, United Kingdom, Manchester Royal Infirmary, Manchester, United Kingdom, The Christie Hospital NHS Foundation Trust, Manchester, United Kingdom, University of Oxford, Oxford, United Kingdom, University of Leeds and Leeds Cancer Centre, Leeds, United Kingdom

Research Funding

Other

Background: Concurrent CRT is standard treatment for patients with SCCA. We explored the results of surgical salvage with APER in ACT II, which compared 5FU/CisP with 5FU/MMC concurrent with a uniform RT dose (50.4Gy, 28 daily fractions of 1.8Gy), and a second randomization to maintenance chemotherapy. Methods: The ACT II trial recruited 940 patients. We examined the overall survival of patients from the time of salvage surgery post CRT according to 4 time periods: Group A - operated ≤ 6 months of CRT (n = 19); Group B - between > 6 and ≤ 12 months (n = 36); Group C - between > 12 and ≤ 24 months (n = 28); Group D - after > 24 months (n = 18) respectively. Results: There were 291 disease failures (31%) overall - males, total radiation dose, and tumor stage were independent predictors of local failure. Of 291 relapses, surgical salvage with APER was attempted in 107 (37%) loco-regional failures of whom 101 were evaluable and 53 subsequently died. The 2-year OS rates after local disease failure from time of salvage APER to death from any cause was 54% (43%-63%). Rates of OS beyond 2 years are unreliable given the small number of patients at risk after 2 years. Death rate after salvage APER was 15/19(79%), 21/36(58%), 12/28(43%) and 5/18(28%) in Groups A, B, C and D. Conclusions: In the management of SCCA, local failure may benefit from early detection and salvage by radical surgery. Results of radical surgery performed in ACT II in 37% compare with 56% in ACT I. These observations suggest close imaging with MRI and clinical surveillance may be helpful in the first 2 years, and imply the need for a trial to test further systemic interventions such as chemotherapy peri-operatively. Clinical trial information: 26715889.

Time from salvage surgery until deathGroup A
N = 19
Group B
N = 36
Group C
N = 28
Group D
N = 18
Overall
N = 101
Median OS (months), IQR9.6 (5.8 to 26.3)21.1 (11.7 to 118.1)47.7 (15.7 to NR)NR30.3 (11.7 to 118.1)
Hazard Ratio (HR), (95% CI)1.00 (baseline)0.53 (0.27 to 1.03)0.33 (0.15 to 0.70)0.31 (0.11 to 0.85)HR, (95% CI)
p-value-0.0620.0040.024

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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Gastrointestinal (Colorectal) Cancer

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Anal Cancer

Clinical Trial Registration Number

26715889

Citation

J Clin Oncol 34, 2016 (suppl; abstr 3523)

DOI

10.1200/JCO.2016.34.15_suppl.3523

Abstract #

3523

Poster Bd #

220

Abstract Disclosures