Health-related quality-of-life assessment of patients with solid tumors on immuno-oncology therapies

被引:17
作者
Voon, Pei Jye [1 ,2 ]
Cella, David [3 ]
Hansen, Aaron R. [1 ,2 ]
机构
[1] Univ Hlth Network, Princess Margaret Canc Ctr, Toronto, ON, Canada
[2] Univ Toronto, Div Med Oncol & Hematol, Dept Med, Toronto, ON, Canada
[3] Northwestern Univ, Dept Med Social Sci, Chicago, IL 60611 USA
关键词
Functional Assessment of Cancer Therapy‐ Immune Checkpoint Modulators (FACT‐ ICM); Immunotherapy (FACT‐ Immunotherapy); health‐ related quality of life (HRQOL); immune‐ related adverse events; immuno‐ oncology therapies; patient‐ reported outcome; CANCER CLINICAL-TRIALS; REPORTED OUTCOMES; FUNCTIONAL ASSESSMENT; ADVERSE EVENTS; EUROPEAN-ORGANIZATION; DOUBLE-BLIND; PEMBROLIZUMAB; CHEMOTHERAPY; VALIDATION; IPILIMUMAB;
D O I
10.1002/cncr.33457
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Immuno-oncology therapies have been approved for various solid tumors; however, the high cost of these treatments and their potential toxicities require a thorough assessment of their risks and benefits. Collection of data directly from patients through patient-reported outcome instruments can improve the precision and reliability of adverse event detection, assess tolerability of adverse events, and provide an evaluation of health-related quality of life (HRQOL) changes from immuno-oncology therapies. There is robust development in HRQOL tools specifically for patients treated with immuno-oncology agents. This review examines the history and basic concepts of HRQOL and patient-reported outcome assessments commonly used in oncological trials, highlighting the strengths and weaknesses of current approaches when applied to immunotherapies, as well as some of the current efforts to develop tools for this field and opportunities for future research. Lay Summary Immuno-oncology (IO) therapies are costly and carry potential toxicities known as immune-related adverse events. Evaluation of health-related quality of life (HRQOL) can impact the risk-benefit assessment of IO therapies. Integration of HRQOL end points and patient-reported outcome data for IO therapies are urgently needed. Ongoing robust development of patient-reported outcome tools specific to IO therapies are currently underway and will permit the evaluation of HRQOL for IO agents. Improvement in precision and reliability of HRQOL evaluation will enhance the ultimate true value of these expensive and effective drugs.
引用
收藏
页码:1360 / 1368
页数:9
相关论文
共 54 条
  • [1] THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY
    AARONSON, NK
    AHMEDZAI, S
    BERGMAN, B
    BULLINGER, M
    CULL, A
    DUEZ, NJ
    FILIBERTI, A
    FLECHTNER, H
    FLEISHMAN, SB
    DEHAES, JCJM
    KAASA, S
    KLEE, M
    OSOBA, D
    RAZAVI, D
    ROFE, PB
    SCHRAUB, S
    SNEEUW, K
    SULLIVAN, M
    TAKEDA, F
    [J]. JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1993, 85 (05) : 365 - 376
  • [2] Cancer patients' experiences with immune checkpoint modulators: A qualitative study
    Ala-Leppilampi, Kari
    Baker, Natalie A.
    McKillop, Chris
    Butler, Marcus O.
    Siu, Lillian L.
    Spreafico, Anna
    Abdul Razak, Albiruni R.
    Joshua, Anthony M.
    Hogg, David
    Bedard, Philippe L.
    Leighl, Natasha
    Oza, Amit M.
    Parsons, Janet A.
    Hansen, Aaron R.
    [J]. CANCER MEDICINE, 2020, 9 (09): : 3015 - 3022
  • [3] [Anonymous], FDA APPR CANC CURR B
  • [4] Health-related quality of life (HR-QOL) and regulatory issues - An assessment of the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the use of HR-QOL measures in drug approval
    Apolone, G
    De Carli, G
    Brunetti, M
    Garattini, S
    [J]. PHARMACOECONOMICS, 2001, 19 (02) : 187 - 195
  • [5] Development of the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
    Basch, Ethan
    Reeve, Bryce B.
    Mitchell, Sandra A.
    Clauser, Steven B.
    Minasian, Lori M.
    Dueck, Amylou C.
    Mendoza, Tito R.
    Hay, Jennifer
    Atkinson, Thomas M.
    Abernethy, Amy P.
    Bruner, Deborah W.
    Cleeland, Charles S.
    Sloan, Jeff A.
    Chilukuri, Ram
    Baumgartner, Paul
    Denicoff, Andrea
    St Germain, Diane
    O'Mara, Ann M.
    Chen, Alice
    Kelaghan, Joseph
    Bennett, Antonia V.
    Sit, Laura
    Rogak, Lauren
    Barz, Allison
    Paul, Diane B.
    Schrag, Deborah
    [J]. JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2014, 106 (09):
  • [6] Practical and statistical issues in missing data for longitudinal patient-reported outcomes
    Bell, Melanie L.
    Fairclough, Diane L.
    [J]. STATISTICAL METHODS IN MEDICAL RESEARCH, 2014, 23 (05) : 440 - 459
  • [7] Health-related quality-of-life results for pembrolizumab versus chemotherapy in advanced, PD-L1-positive NSCLC (KEYNOTE-024): a multicentre, international, randomised, open-label phase 3 trial
    Brahmer, Julie R.
    Rodriguez-Abreu, Delvys
    Robinson, Andrew G.
    Hui, Rina
    Csoszi, Tibor
    Fulop, Andrea
    Gottfried, Maya
    Peled, Nir
    Tafreshi, Ali
    Cuffe, Sinead
    O'Brien, Mary
    Rao, Suman
    Hotta, Katsuyuki
    Zhang, Jin
    Lubiniecki, Gregory M.
    Deitz, Anne C.
    Rangwala, Reshma
    Reck, Martin
    [J]. LANCET ONCOLOGY, 2017, 18 (12) : 1600 - 1609
  • [8] Safety and Activity of Anti-PD-L1 Antibody in Patients with Advanced Cancer
    Brahmer, Julie R.
    Tykodi, Scott S.
    Chow, Laura Q. M.
    Hwu, Wen-Jen
    Topalian, Suzanne L.
    Hwu, Patrick
    Drake, Charles G.
    Camacho, Luis H.
    Kauh, John
    Odunsi, Kunle
    Pitot, Henry C.
    Hamid, Omid
    Bhatia, Shailender
    Martins, Renato
    Eaton, Keith
    Chen, Shuming
    Salay, Theresa M.
    Alaparthy, Suresh
    Grosso, Joseph F.
    Korman, Alan J.
    Parker, Susan M.
    Agrawal, Shruti
    Goldberg, Stacie M.
    Pardoll, Drew M.
    Gupta, Ashok
    Wigginton, Jon M.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2012, 366 (26) : 2455 - 2465
  • [9] Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols The SPIRIT-PRO Extension
    Calvert, Melanie
    Kyte, Derek
    Mercieca-Bebber, Rebecca
    Slade, Anita
    Chan, An-Wen
    King, Madeleine T.
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2018, 319 (05): : 483 - 494
  • [10] Reporting of Patient-Reported Outcomes in Randomized Trials The CONSORT PRO Extension
    Calvert, Melanie
    Blazeby, Jane
    Altman, Douglas G.
    Revicki, Dennis A.
    Moher, David
    Brundage, Michael D.
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2013, 309 (08): : 814 - 822