@article{0e685e6672c44a4fab5903dbdc3cb296,
title = "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",
abstract = "Background: Patients with cancer who are treated with immune checkpoint modulators (ICMs) have their health-related quality of life (HRQOL) measured using general patient-reported outcome (PRO) tools. To the authors' knowledge, no instrument has been developed to date specifically for patients treated with ICMs. The objective of the current study was to develop a toxicity subscale PRO instrument for patients treated with ICMs to assess HRQOL. Methods: Input was collected from a systematic review as well as patients and physicians experienced with ICM treatment. Descriptive thematic analysis was used to evaluate the qualitative data obtained from patient focus groups and interviews, which informed an initial list of items that described ICM side effects and their impact on HRQOL. These inputs informed item generation and/or reduction to develop a toxicity subscale. Results: Focus groups and individual interviews with 37 ICM-treated patients generated an initial list of 176 items. After a first round of item reduction that produced a shortened list of 76 items, 16 physicians who care for patients who are treated with ICMs were surveyed with a list of 49 patient-reported side effects and 11 physicians participated in follow-up interviews. A second round of item reduction was informed by the physician responses to produce a list of 25 items. Conclusions: To the authors' knowledge, this 25-item list is the first HRQOL-focused toxicity subscale for patients treated with ICMs and was developed in accordance with US Food and Drug Administration guidelines, which prioritize patient input in developing PRO tools. The subscale will be combined with the Functional Assessment of Cancer Therapy–General (FACT-G) to form the FACT-ICM. Prior to recommending the formal use of this PRO instrument, the authors will evaluate its validity and reliability in longitudinal studies involving substantially more patients.",
keywords = "costimulatory antibodies, health-related quality of life (HRQOL), immune checkpoint inhibitor, immunotherapy, patient-reported outcomes (PROs)",
author = "Hansen, {Aaron R.} and Kari Ala-Leppilampi and Chris McKillop and Siu, {Lillian L.} and Bedard, {Philippe L.} and {Abdul Razak}, {Albiruni R.} and Anna Spreafico and Sridhar, {Srikala S.} and Natasha Leighl and Butler, {Marcus O.} and David Hogg and Adrian Sacher and Oza, {Amit M.} and Rany Al-Agha and Catherine Maurice and Chan, {Christopher T.} and Shane Shapera and Feld, {Jordan J.} and Rosane Nisenbaum and Kimberly Webster and David Cella and Janet Parsons",
note = "Funding Information: Supported by a Division of Medical Oncology, Department of Medicine, University of Toronto Strategic Innovation Grant. Funding Information: Aaron R. Hansen was supported by a Strategic Innovation Fund from the University of Toronto for work performed as part of the current study and received research funds to his institution from Karyopharm and Boston Biomedical and research funds to his institution and consulting/advising honoraria from Novartis, Genentech Inc, Hoffmann La Roche Inc, Merck Serono, GlaxoSmithKline, Bristol‐Myers Squibb, Boehringer Ingelheim International, AstraZeneca, Medimmune, and Pfizer for work performed outside of the current study. Lillian L. Siu has received personal fees from Merck, Pfizer, Celgene, AstraZeneca/Medimmune, MorphoSys, Roche/Genentech, GeneSeeq, Loxo, Oncorus, Symphogen, Seattle Genetics, GlaxoSmithKline, Voronoi, and Treadwell Therapeutics and institutional support for clinical trials from Novartis, Bristol‐Myers Squibb, Pfizer, Boehringer‐Ingelheim, GlaxoSmithKline, Roche/Genentech, Karyopharm, AstraZeneca/Medimmune, Merck, Celgene, Astellas Bayer, AbbVie, Amgen, Symphogen, Intensity Therapeutics, Mirati Therapeutics, Shattuck Laboratories Inc, and Avid Therapeutics for work performed outside of the current study. Philippe L. Bedard has received a grant to his institution from and acted as an uncompensated member of the advisory boards for Bristol‐Myers Squibb, Sanofi, and Genentech/Roche; has received grants to his institution from Seattle Genetics, Novartis, GlaxoSmithKline, Nektar Therapeutics, Merck, Eli Lilly, Servier, and PTC Therapeutics; has acted as an uncompensated member of the advisory board for Pfizer; and was Past Chair of the Investigational New Drug Committee of the Canadian Clinical Trials Group, Executive Board Member of the Breast International Group, Steering Committee Member of the American Association for Cancer Research Project GENIE, and a member of the NCI‐BIO Breast Cancer Immunotherapy Task Force for work performed outside of the current study. Anna Spreafico has received research support funding and personal fees from Novartis, Bristol‐Myers Squibb, Merck, and Janssen Oncology; research support funding from Symphogen, AstraZeneca, Bayer, Surface Oncology, Northern Biologics, Roche, Regeneron, Alkermes, and Array Biopharma; and personal fees from Oncorus for work performed outside of the current study. Natasha Leighl reports institutional research support from Array and AstraZeneca, institutional research support (drug only) and personal fees for continuing medical education lectures from MSD, institutional research support (drug only) from Pfizer, and other fees from Guardant Health for work performed outside of the current study. Marcus Butler has received grants/funds for a clinical trial and honorarium for a talk and acted as a paid member of the advisory board for Merck; acted as a paid member of the advisory board for Sanofi, EMD Serono, Regeneron, and Immunocore; acted as a paid member of the advisory board for and received honorarium for a talk from Bristol‐Myers Squibb and Novartis; acted as a member of the advisory board and Safety Committee for GlaxoSmithKline; acted as a member of the Safety Review Committee for Adaptimmune; and received funds for a clinical trial from Takara Bio for work performed outside of the current study. David Hogg has acted as a paid member of the advisory boards for Bristol‐Myers Squibb, Novartis, Roche, EMD Serono, and Merck for work performed as part of the current study. Adrian Sacher has acted as a paid member of the advisory board for and received honoraria from Bristol‐Myers Squibb, AstraZeneca, Kisoji, Genentech‐Roche, Merck, and Tesaro for work performed outside of the current study. Shane Shapera has received grants for investigator‐initiated research projects, participated in clinical trials, participated in advisory boards, and has been a speaker at continuing medical education events sponsored by Hoffman LaRoche Canada and Boehringer Ingelheim Canada; has received honoraria for speaking engagements from AstraZeneca Canada; and has participated in clinical trials as the site principal investigator for Prometric Canada, Sanofi‐Aventis, Gilead Pharmaceuticals, and Galapagos for work performed outside of the current study. Jordan J. Feld has acted as a paid scientific consultant for Abbott, Enanta Pharmaceuticals Inc, and Roche; has received grants from and acted as a paid scientific consultant and member of the advisory boards for AbbVie and Gilead; and has received grants from and acted as a paid member of the advisory board for Janssen and Wako/Fujifilm for work performed outside of the current study. Kimberly Webster is a co‐owner and Director of Communications for FACIT.org and FACITtrans LLC. David Cella is President of FACIT.org. The other authors made no disclosures. Publisher Copyright: {\textcopyright} 2019 American Cancer Society",
year = "2020",
month = apr,
day = "1",
doi = "10.1002/cncr.32692",
language = "English (US)",
volume = "126",
pages = "1550--1558",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "7",
}
