Thiago CarvalhoOn patient reported outcomes in adoptive cell therapy.
"Interestingly, only 6.8 % of the recently published CAR-T trials investigated PROs as a primary or secondary outcome measure,6 and none of the TIL-ACT clinical trials in solid tumors included PROs as corollary endpoints. Indeed, much of academia’s and industry’s efforts to date have been aimed at shifting the cost-effectiveness balance of these therapies by understanding biological features of efficacy (cancer target identification, T-cell product characteristics, biomarkers of response, etc), improving the manufacturing pipeline, and scalability. Surprisingly, limited efforts have been directed to understand patients’ perspectives during cell-therapy trials."
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Patient-reported outcomes in adoptive cell-therapy trials: mind the gap
Adoptive cell therapies (ACT) have demonstrated promise in the treatment of patients with cancer, leading to long-lasting responses and, in some cases, even cure. Technological advances have brought these individualized therapies closer to reality, establishing them as credible therapeutic option. However, to date, few efforts have been made to understand patients' experience during ACT trials. Patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs), which are instruments used to report PROs, are increasingly being used in oncology to capture patients’ perspective, provide real-world data on treatment safety, and support decision-making processes, such as health economic decisions. Due to the inherent complexity of ACT, the inclusion of PROMs in this field remains limited. In this commentary, we discuss the benefit of capturing PROs in ACT trials, the challenges of PROM administration and collection, and we propose simple and actionable recommendations to promote their adoption in ACT trials.
Nature