ACT II trial sees further analysis published

The CTC-led ACT II trial, a large randomised anal cancer study which took place in the UK between 2001-2008, has this month seen further ad-hoc analysis of its data published in the medical journal Annals of Oncology.
The trial’s predecessor, ACT I, led to chemoradiation becoming the standard of care for patients with anal cancer. ACT II was funded by Cancer Research UK and recruited 940 patients with localised squamous cell carcinoma of the anus (SCCA). The study looked to investigate whether replacing mitomycin with cisplatin in the chemoradiation schedule improves complete response rate, as well as the impact of maintenance chemotherapy using fluorouracil (5FU)/cisplatin after chemoradiation. The results showed that 5FU and mitomycin with 50.4 Gy radiotherapy in 28 fractions should remain standard practice for treatment of SCCA in the UK.
Since the first paper was published in The Lancet Oncology in 2013, several retrospective reviews have been conducted on the ACT II trial data. This latest review, whose findings can now be read online, looked at correlations between treatment compliance and long-term patient outcomes.
The main findings from the analysis were:
• Compliance to chemotherapy and radiotherapy in radical chemoradiotherapy regimens should be considered as a prognostic factor in future studies
• Poor compliance to week 5 chemotherapy is associated with inferior progression free survival (PFS) and overall (OS)
• Extending overall treatment time of radical chemoradiotherapy (50.4 Gy total radiotherapy dose) in anal cancer is associated with poorer outcomes (PFS and OS)
• Careful patient selection and close monitoring during treatment is advised to maintain treatment compliance, especially renal function and adverse event/toxicity monitoring
The full analysis can be found at the Annals of Oncology website.
Links:
- From Annals of Oncology, June 2020: 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
- From The Lancet Oncology, April 2013: Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2×2 factorial trial