The initial phases of developing a patient-reported outcome (PRO) tool to assess for treatment-related side effects (SEs) experienced by patients with cancer receiving immune checkpoint modulators (ICMs) was described in an article published in Cancer.

Immune-related adverse events (irAEs), possibly related to underlying immune dysregulation, can affect multiple organs, including the skin, gastrointestinal tract, lungs, and endocrine and cardiovascular systems of patients treated with ICMs. Furthermore, the impact of these irAEs on patients treated with ICMs can complicate treatment, negatively affect patient quality of life (QOL) and limit the use of these agents in patients with cancer.

 “To the best of our knowledge no specific tool has been developed to date to measure health-related quality of life (HRQOL) from treatment-related SEs in patients receiving ICM treatment. This is a major research and practice gap,” the study authors commented.

This initiative involved use of the Functional Assessment of Cancer Illness Therapy (FACIT) measurement system, which has been used in the development and validation of general QOL tools within specific disease settings (eg, Functional Assessment of Cancer Therapy-Prostate [FACT-Prostate]), to develop a PRO instrument (ie, FACT-ICM) for the assessment of toxicity in patients with cancer treated with ICMs that can be used in conjunction with the FACT-G (General) assessment tool.

For this study, 37 adult patients treated with either inhibitory or stimulatory ICMs for advanced, incurable cancer were recruited from a large tertiary care cancer treatment center in Toronto Ontario, Canada, and interviewed individually or within focus groups. Also enrolled were 16 physicians who treated patients with ICMs and/or were involved in managing treatment-related SEs of patients receiving these agents who participated in interviews and/or completed online surveys.

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An iterative process involving information gained from a systematic review of the medical literature, physician surveys, and interviews was used to refine a list of 176 items initially generated through patient discussions. The final list of 25 questions was then tested with an independent set of 11 patients who also received ICMs for the treatment of advanced cancer. 

“The initial set of items was not informed by preexisting assumptions but was deduced directly from patient statements,” the study authors explained.

“The approach used herein is consistent with the guidance of the US Food and Drug Administration regarding the development of PROs, which emphasizes meaningful patient input from the outset, rather than after-the-fact endorsement,” they clarified.

The FACT-ICM tool will need to be validated in large patient samples, and the study authors recommended that the “toxicity subscale should be validated first before use in clinical care or in trials with QOL as a primary or secondary endpoint.”


Hansen AR, Ala-Leppilampi K, McKillop C, et al. Development of the functional assessment of cancer therapy-immune checkpoint modulator (FACT-ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs [published online January 6, 2020]. Cancer. doi: 10.1002/cncr.32692