Acute toxicity and patient‐reported outcomes in anal canal cancer: results of a pilot study

INTRODUCTION: Anal canal cancer (ACC) is uncommon. The gold standard of care is chemoradiotherapy treatment. However, this treatment is associated with considerable acute and late side effects. The aim of this pilot study was to evaluate acute toxicity and patient‐reported outcomes (PRO) in these patients from planning to 3 months after treatment. METHODS: Sixteen patients were recruited to this prospective observational study from March 2015 to December 2017. All patients received volumetric modulated arc therapy (VMAT) in 30#. Toxicity data were graded by a Radiation Oncologist using the Common Terminology Criteria for Adverse Effects (CTCAE) version 4 at planning, weekly during treatment, 6‐week and 3‐month post‐treatment. PRO data were collected using the EORTC QLQ C30 and CR29 questionnaires completed by patients at planning, mid and end treatment and 3‐month post‐treatment. RESULTS: The majority of toxicity and PRO items peaked in severity at the end of treatment (week 6). Skin was the only item where >50% of patients had ≥ grade 2 toxicity at any point with 75% having ≥ grade 2 at week 6. Patient‐reported embarrassment significantly increased over time (P < 0.001). No meaningful relationships were found between PRO and CTCAE results. CONCLUSION: After reaching their maximum severity at the end of treatment, the majority of toxicity and PRO items approached baseline levels by 3‐month post‐treatment. The results of this study suggest that PROs are an important complementary tool to CTCAE and provide greater understanding of patients' perception of treatment side effects.