Impact of compliance to chemoradiation on long-term outcomes in squamous cell carcinoma of the anus. Results of a post-hoc analysis from the randomized phase III ACT II trial.

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Concurrent chemoradiation is standard-of-care for patients with squamous cell carcinoma of the anus (SCCA). Poor compliance to chemotherapy, radiotherapy treatment interruptions and unplanned breaks may impact adversely on long-term outcomes.The ACT II trial recruited 940 patients with localized SCCA, and assigned patients to mitomycin (week 1) or cisplatin (weeks 1 and 5), with fluorouracil (weeks 1 & 5) and radiotherapy (50·4Gy in 28 fractions over 38 days). This post-hoc analysis examined the association between baseline factors (age, gender, site, T-stage and N-stage), and compliance to treatment (radiotherapy and chemotherapy), and their effects on loco-regional failure-free survival (LRFFS), progression-free survival (PFS) and overall survival (OS). Compliance was categorized into groups. Radiotherapy: 6 groups according to total dose (TD) and overall treatment time (OTT). Chemotherapy: 3 groups (A = per-protocol; B = dose reduction or delay; C = omitted).931/940 patients were evaluable for radiotherapy and 936 for chemotherapy compliance. Baseline Glomerular filtration rate (GR) <60 mL/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (p 0.003 and 0.02, respectively). Omission of week 5 chemotherapy was associated with significantly worse LRFFS (HR 2.53 [1.33 to 4.82] p=0.005). Dose reductions/delays or omission of week 5 chemotherapy were associated with significantly worse FPFS (HR: 1.56 [95%CI: 1.18-2.06], p=0.002 and HR: 2.39 [95%CI: 1.44-3.98}, p=0.001, respectively) and OS (HR: 1.92 [95%CI: 1.41-2.63], p<0.001 and (HR: 2.88 [95%CI: 1.63-5.08], p<0.001, respectively). Receiving the target radiotherapy dose in >42 days is associated with worse PFS and OS (HR:1.72 (95%CI:1.17-2.54), p=0.006).Poor compliance to chemotherapy and radiotherapy were associated with worse LRFFS, PFS and OS. Treatment interruptions should be minimized, and OTT and TD maintained.


Click here to read the full article @ Annals of oncology : official journal of the European Society for Medical Oncology

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