Page 65 - Read Online

Webster et al. J Cancer Metastasis Treat 2020;6:8 I http://dx.doi.org/10.20517/2394-4722.2019.38 Page 13 of 14

8. Fox J, Janda M, Bennett F, Langbecker D. An outreach telephone program for advanced melanoma supportive care: acceptability and
feasibility. Eur J Oncol Nurs 2019;42:110-5.
9. Haanen J, Carbonnel F, Robert C, Kerr KM, Peters S, et al. Management of toxicities from immunotherapy: ESMO Clinical Practice
Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2017;28:iv119-42.
10. Puzanov I, Diab A, Abdallah K, Bingham CO, Brogdon C, et al. Managing toxicities associated with immune checkpoint inhibitors:
consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group. J Immunother
Cancer 2017;5:95.
11. Chen TW, Razak AR, Bedard PL, Siu LL, Hansen AR. A systematic review of immune-related adverse event reporting in clinical trials of
immune checkpoint inhibitors. Ann Oncol 2015;26:1824-9.
12. Kottschade LA. Incidence and management of immune-related adverse events in patients undergoing treatment with immune checkpoint
inhibitors. Curr Oncol Rep 2018;20:24.
13. Michot JM, Bigenwald C, Champiat S, Collins M, Carbonnel F, et al. Immune-related adverse events with immune checkpoint blockade:
a comprehensive review. Eur J Cancer 2016;54:139-48.
14. Postow MA, Sidlow R, Hellmann MD. Immune-related adverse events associated with immune checkpoint blockade. N Engl J Med
2018;378:158-68.
15. Suarez-Almazor ME, Kim ST, Abdel-Wahab N, Diab A. Review: immune-related adverse events with use of checkpoint inhibitors for
immunotherapy of cancer. Arthritis Rheumatol 2017;69:687-99.
16. Anagnostou V, Yarchoan M, Hansen AR, Wang H, Verde F, et al. Immuno-oncology trial endpoints: capturing clinically meaningful
activity. Clin Cancer Res 2017;23:4959-69.
17. US Department of Health and Human Services - FDA Center for Drug Evaluation and Research. Guidance for industry: patient-
reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes
2006;4:79.
18. Cella D, Wagner L. Re-personalizing precision medicine: is there a role for patient-reported outcomes? J Community Supp Oncol
2015;13:275-7.
19. Cella D, Grünwald V, Escudier B, Hammers HJ, George S, et al. Patient-reported outcomes of patients with advanced renal cell carcinoma
treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial. Lancet Oncol 2019;20:297-310.
20. Cella D, McKendrick J, Kudlac A, Palumbo A, Oukessou A, et al. Impact of elotuzumab treatment on pain and health-related quality of
life in patients with relapsed or refractory multiple myeloma: results from the ELOQUENT-2 study. Ann Hematol 2018;97:2455-63.
21. Bouchard LC, Aaronson N, Gondek K, Cella D. Cancer symptom response as an oncology clinical trial end point. Expert Rev Qual Life
Cancer Care 2018;3:35-46.
22. Cella D, Escudier B, Tannir NM, Powles T, Donskov F, et al. Quality of life outcomes for cabozantinib versus everolimus in patients with
metastatic renal cell carcinoma: METEOR phase III randomized trial. J Clin Oncol 2018;36:757-64.
23. Basch E, Iasonos A, Barz A, Culkin A, Kris MG, et al. Long-term toxicity monitoring via electronic patient-reported outcomes in patients
receiving chemotherapy. J Clin Oncol 2007;25:5374-80.
24. Atkinson TM, Rogak LJ, Heon N, Ryan SJ, Shaw M, et al. Exploring differences in adverse symptom event grading thresholds between
clinicians and patients in the clinical trial setting. J Cancer Res Clin Oncol 2017;143:735-43.
25. Basch E, Jia X, Heller G, Barz A, Sit L, et al. Adverse symptom event reporting by patients vs clinicians: relationships with clinical
outcomes. J Natl Cancer Inst 2009;101:1624-32.
26. Cella D, Hahn EA, Jensen SE, Butt Z, Nowinski CJ, et al. Patient-reported outcomes in performance measurement. Research Triangle
Park (NC): RTI Press; 2015. pp. 1.
27. Jim HS, McLeod HL. American society of clinical oncology value framework: importance of accurate toxicity data. J Clin Oncol
2017;35:1133-4.
28. Webster K, Cella D, Yost K. The functional assessment of chronic illness therapy (FACIT) measurement system: properties, applications,
and interpretation. Health Qual Life Outcomes 2003;1:79.
29. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, et al. The European Organization for Research and Treatment of Cancer
QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-76.
30. Cella D, Riley W, Stone A, Rothrock N, Reeve B, et al. The patient-reported outcomes measurement information system (PROMIS)
developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol 2010;63:1179-94.
31. Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, et al. Development of the National Cancer Institute’s patient-reported
outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst 2014;106.
32. Hall ET, Singhal S, Dickerson J, Gabster B, Wong HN, et al. Patient-reported outcomes for cancer patients receiving checkpoint
inhibitors: opportunities for palliative care-a systematic review. J Pain Symptom Manage 2019;58:137-56.e1.
33. King-Kallimanis BL, Howie LJ, Roydhouse JK, Singh H, Theoret MR, et al. Patient reported outcomes in anti-PD-1/PD-L1 inhibitor
immunotherapy registration trials: FDA analysis of data submitted and future directions. Clin Trials 2019;16:322-6.
34. Rand Corporation. Delphi Method. Available from: http://www.rand.org/topics/delphi-method.html [Last accessed on 4 Mar 2020]
35. Keeney S, Hasson F, Mckenna H. The delphi technique in nursing and health research. Hoboken, New Jersey: Wiley-Blackwell; 2010.
36. Functional assessment of chronic illness therapy (FACIT) searchable library and custom form developer (Build-a-PRO). Available from:
https://wizard.facit.org/ [Last accessed on 4 Mar 2020]
37. Bonomi AE, Cella DF, Hahn EA, Bjordal K, Sperner-Unterweger B, et al. Multilingual translation of the functional assessment of cancer
therapy (FACT) quality of life measurement system. Qual Life Res 1996;5:309-20.