Compliance to chemoradiation (CRT) using mitomycin (MMC) or cisplatin (CisP), with or without maintenance 5FU/CisP chemotherapy (CT) in squamous cell carcinoma of the anus (SCCA) according to radiotherapy (RT) dose, overall treatment time (OTT) and chemotherapy (CT) and their impact on long-term outcome: Results of ACT II.

Authors

Robert Glynne-Jones

Robert Glynne-Jones

Mount Vernon Centre for Cancer Treatment, London, United Kingdom

Robert Glynne-Jones , Helen Margaret Meadows , Andre Lopes , Richard A. Adams , David Sebag-Montefiore

Organizations

Mount Vernon Centre for Cancer Treatment, London, United Kingdom, Cancer Research UK & UCL Cancer Trials Centre, London, United Kingdom, Velindre Hospital NHS Foundation Trust, Cardiff, United Kingdom, St. James's Institute of Oncology, St. James's University Hospital, Leeds, United Kingdom

Research Funding

Other

Background: Concurrent CRT is standard treatment for patients with SCCA. We explored CRT compliance in ACT II, which compared 5FU/CisP with 5FU/MMC (wks 1 & 5) of a uniform RT dose (50.4Gy, 28 daily fractions (F) of 1.8Gy). Methods: We investigated the association between poor compliance and baseline factors (age, sex, site, T & N stage), type of CT (MMC/CisP) with progression free survival (PFS). Compliance was categorized as follows: RT, 5 groups: A = per protocol (50.4Gy in 28F in 38-42 days), B = ≤ 40Gy, C = 40-48.6Gy in 23-27F, D = 50.4Gy in > 42 days, E > 52.2Gy. CT, 2 groups: 1 = wks1 & 5 & 2 = wk1 only. Results: 933 and 862 of 940 pts were evaluable for RT & CT compliance respectively. Median follow-up was 5.1 yrs. Baseline characteristics of evaluable patients were similar to all 940 ACT II patients. Canal tumors, CisP, GFR<60 & WBC < 11 were borderline significant predictors of poor wk5 CT compliance (p 0.09, 0.07, 0.06 & 0.08 respectively). Poor CT compliance at wk5 impacted significantly on PFS (treatment adjusted HR: 1.63 (95% CI: 1.23-2.17), p = 0.001). No baseline factors analyzed, or chemotherapy type, were significant independent predictors of poor RT compliance. Conclusions: In ACT II poor CT & RT compliance (lower dose/prolonged OTT) adversely impacted on PFS. Treatment interruptions should be minimized and prolonged OTT compensated by hyperfractionation or possibly additional dose. Intensity Modulated RT may improve compliance. Patients with poor compliance to RT/CT may need closer monitoring following treatment. Clinical trial information: 26715889.

Impact of RT compliance on PFS (N=933).

GroupTotal events/
No of pts
3 y PFS rate %Treatment-adjusted HR
(95% CI)
P-value
A221/786761.000.0001
B11/18443.71 (2.01-6.82)
C11/21562.26 (1.23-4.14)
D39/93621.62 (1.15-2.28)
E6/15591.60 (0.71-3.61)

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Abstract Details

Meeting

2015 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 33, 2015 (suppl; abstr 3518)

DOI

10.1200/jco.2015.33.15_suppl.3518

Abstract #

3518

Poster Bd #

10

Abstract Disclosures