Improving the evidence base for treating older adults with cancer: American Society of Clinical Oncology statement

Journal of Clinical Oncology

Volumn 33, Issue 32, 2015, Pages 3826-3833

  Hurria, Arti ^a   Levit, Laura A ^d   Dale, William ^e   Mohile, Supriya G ^f   Muss, Hyman B ^h   Fehrenbacher, Louis ^b   Magnuson, Allison ^f   Lichtman, Stuart M ^g   Bruinooge, Suanna S ^d   Soto Perez De Celis, Enrique ^c   Tew, William P ^g   Postow, Michael A ^g   Cohen, Harvey J ⁱ  

^a CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^b KAISER PERMANENTE   (United States)

^c INSTITUTO NACIONAL DE CIENCIAS MÉDICAS Y NUTRICIÓN SALVADOR ZUBIRÁN   (Mexico)

^d AMERICAN SOCIETY OF CLINICAL ONCOLOGY   (United States)

^e UNIVERSITY OF CHICAGO   (United States)

^f UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^g MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^h UNIVERSITY OF NORTH CAROLINA   (United States)

ⁱ DUKE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGE DISTRIBUTION; AGED; ARTICLE; CANCER RESEARCH; CANCER THERAPY; CLINICAL PRACTICE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); COMPARATIVE EFFECTIVENESS; CURRENT PROCEDURAL TERMINOLOGY; EVIDENCE BASED PRACTICE; FOOD AND DRUG ADMINISTRATION; GERIATRIC ASSESSMENT; HEALTH CARE POLICY; HEALTH HAZARD; HUMAN; MALIGNANT NEOPLASTIC DISEASE; MEDICAL SOCIETY; MEDICARE; METHODOLOGY; OFF LABEL DRUG USE; PRACTICE GUIDELINE; PRIORITY JOURNAL; REIMBURSEMENT; STUDY DESIGN; AGING; EVIDENCE BASED MEDICINE; NEOPLASMS; ONCOLOGY; PATIENT SELECTION; PROCEDURES; PUBLICATION; PUBLISHING; RESEARCH; STANDARDS; TRENDS; UNITED STATES; VERY ELDERLY;

AGED; AGED, 80 AND OVER; AGING; CLINICAL TRIALS AS TOPIC; EDITORIAL POLICIES; EVIDENCE-BASED MEDICINE; HUMANS; MEDICAL ONCOLOGY; NEOPLASMS; PATIENT SELECTION; PERIODICALS AS TOPIC; RESEARCH DESIGN; RESEARCH REPORT; SOCIETIES, MEDICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84940121191     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.63.0319     Document Type: Article

References (90)

1. Institute of Medicine: Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. Washington, DC, National Academies Press, 2013
2. National Cancer Institute: SEER Stat fact sheets: All cancer sites. http://seer.cancer.gov/statfacts/html/all.html
3. Heron M: Deaths: Leading Causes for 2010. http://www.cdc.gov/nchs/data/nvsr/nvsr62/nvsr62-06.pdf
4. American Cancer Society: Cancer Treatment & Survivorship: Facts & Figures-2014-2015. http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-042801.pdf
5. Dale W, Mohile SG, Eldadah BA, et al: Biological, clinical, and psychosocial correlates at the interface of cancer and aging research. J Natl Cancer Inst 104:581-589, 2012
6. Vincent GK, Velkoff VA: The Next Four Decades: The Older Population in the United States-2010 to 2050: Population Estimates and Projections. http://www.census.gov/prod/2010pubs/p25-1138.pdf
7. Talarico L, Chen G, Pazdur R: Enrollment of elderly patients in clinical trials for cancer drug registration: A 7-year experience by the US Food and Drug Administration. J Clin Oncol 22:4626-4631, 2004
8. Scher KS, Hurria A: Under-representation of older adults in cancer registration trials: Known problem, little progress. J Clin Oncol 30:2036-2038, 2012
9. Trimble EL, Carter CL, Cain D, et al: Representation of older patients in cancer treatment trials. Cancer 74:2208-2214, 1994(suppl)
10. Hutchins LF, Unger JM, Crowley JJ, et al: Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 341:2061-2067, 1999
11. Lewis JH, Kilgore ML, Goldman DP, et al: Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol 21:1383-1389, 2003
12. Murthy VH, Krumholz HM, Gross CP: Participation in cancer clinical trials: Race-, sex-, and agebased disparities. JAMA 291:2720-2726, 2004
13. Stewart JH, Bertoni AG, Staten JL, et al: Participation in surgical oncology clinical trials: Gender-, race/ethnicity-, and age-based disparities. Ann Surg Oncol 14:3328-3334, 2007
14. Kumar A, Soares HP, Balducci L, et al: Treatment tolerance and efficacy in geriatric oncology: A systematic review of phase III randomized trials conducted by five National Cancer Institute-sponsored cooperative groups. J Clin Oncol 25:1272-1276, 2007
15. Hurria A, Dale W, Mooney M, et al: Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations. J Clin Oncol 32:2587-2594, 2014
16. Centers for Disease Control and Prevention: Healthy Aging: Helping People to Live Long and Productive Lives and Enjoy a Good Quality of Life. http://stacks.cdc.gov/view/cdc/6114
17. Cerreta F, Eichler HG, Rasi G: Drug policy for an aging population: The European Medicines Agency's geriatric medicines strategy. N Engl J Med 367:1972-1974, 2012
18. Dhruva SS, Redberg RF: Variations between clinical trial participants and Medicare beneficiaries in evidence used for Medicare national coverage decisions. Arch Intern Med 168:136-140, 2008
19. Van Spall HG, Toren A, Kiss A, et al: Eligibility criteria of randomized controlled trials published in high-impact general medical journals: A systematic sampling review. JAMA 297:1233-1240, 2007
20. Fried TR, Bradley EH, Towle VR, et al: Understanding the treatment preferences of seriously ill patients. N Engl J Med 346:1061-1066, 2002
21. Wildiers H, Mauer M, Pallis A, et al: End points and trial design in geriatric oncology research: A joint European Organisation for Research and Treatment of Cancer-Alliance for Clinical Trials in Oncology-International Society of Geriatric Oncology position article. J Clin Oncol 31:3711-3718, 2013
22. Juliusson G, Antunovic P, Derolf A, et al: Age and acute myeloid leukemia: Real world data on decision to treat and outcomes from the Swedish Acute Leukemia Registry. Blood 113:4179-4187, 2009
23. Muss HB: Factors used to select adjuvant therapy of breast cancer in the United States: An overview of age, race, and socioeconomic status. J Natl Cancer Inst Monogr 30:52-55, 2001
24. Giovanazzi-Bannon S, Rademaker A, Lai G, et al: Treatment tolerance of elderly cancer patients entered onto phase II clinical trials: An Illinois Cancer Center study. J Clin Oncol 12:2447-2452, 1994
25. Chen H, Cantor A, Meyer J, et al: Can older cancer patients tolerate chemotherapy? A prospective pilot study. Cancer 97:1107-1114, 2003
26. Bonadonna G, Valagussa P: Dose-response effect of adjuvant chemotherapy in breast cancer. N Engl J Med 304:10-15, 1981
27. Berry MF, Worni M, Pietrobon R, et al: Variability in the treatment of elderly patients with stage IIIA (N2) non-small-cell lung cancer. J Thorac Oncol 8:744-752, 2013
28. Hurria A, Wong FL, Villaluna D, et al: Role of age and health in treatment recommendations for older adults with breast cancer: The perspective of oncologists and primary care providers. J Clin Oncol 26:5386-5392, 2008
29. Mandelblatt JS, Sheppard VB, Hurria A, et al: Breast cancer adjuvant chemotherapy decisions in older women: The role of patient preference and interactions with physicians. J Clin Oncol 28:3146-3153, 2010
30. Schrag D, Cramer LD, Bach PB, et al: Age and adjuvant chemotherapy use after surgery for stage III colon cancer. J Natl Cancer Inst 93:850-857, 2001
31. Sargent DJ, Goldberg RM, Jacobson SD, et al: A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. N Engl J Med 345:1091-1097, 2001
32. Gupta SK, Lamont EB: Patterns of presentation, diagnosis, and treatment in older patients with colon cancer and comorbid dementia. J Am Geriatr Soc 52:1681-1687, 2004
33. Lyman GH, Dale DC, Friedberg J, et al: Incidence and predictors of low chemotherapy doseintensity in aggressive non-Hodgkin's lymphoma: A nationwide study. J Clin Oncol 22:4302-4311, 2004
34. Cress RD, O'Malley CD, Leiserowitz GS, et al: Patterns of chemotherapy use for women with ovarian cancer: A population-based study. J Clin Oncol 21:1530-1535, 2003
35. Merchant TE, McCormick B, Yahalom J, et al: The influence of older age on breast cancer treatment decisions and outcome. Int J Radiat Oncol Biol Phys 34:565-570, 1996
36. Javid SH, Unger JM, Gralow JR, et al: A prospective analysis of the influence of older age on physician and patient decision-making when considering enrollment in breast cancer clinical trials (SWOG S0316). Oncologist 17:1180-1190, 2012
37. Townsley CA, Selby R, Siu LL: Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol 23:3112-3124, 2005
38. Moore DH, Kauderer JT, Bell J, et al: An assessment of age and other factors influencing protocol versus alternative treatments for patients with epithelial ovarian cancer referred to member institutions: A Gynecologic Oncology Group study. Gynecol Oncol 94:368-374, 2004
39. Bellera C, Praud D, Petit-Monéger A, et al: Barriers to inclusion of older adults in randomised controlled clinical trials on Non-Hodgkin's lymphoma: A systematic review. Cancer Treat Rev 39:812-817, 2013
40. Institute of Medicine: Transforming Clinical Research in the United States: Challenges and Opportunities-Workshop Summary. Washington, DC, National Academies Press, 2010
41. Malakoff D: Clinical trials and tribulations: Spiraling costs threaten gridlock. Science 322:210-213, 2008
42. Melisko ME, Hassin F, Metzroth L, et al: Patient and physician attitudes toward breast cancer clinical trials: Developing interventions based on understanding barriers. Clin Breast Cancer 6:45-54, 2005
43. Institute of Medicine: A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. Washington, DC, National Academies Press, 2010
44. 43a. Kim ES, Bernstein D, Hilsenbeck SG, et al: Modernizing eligibility criteria for molecularly driven trials. J Clin Oncol 33:2815-2820, 2015
45. George SL: Reducing patient eligibility criteria in cancer clinical trials. J Clin Oncol 14:1364-1370, 1996
46. De La Cruz M, Bruera E: Approach to the older patient with cancer. BMC Med 11:218, 2013
47. Ramjaun A, Nassif MO, Krotneva S, et al: Improved targeting of cancer care for older patients: A systematic review of the utility of comprehensive geriatric assessment. J Geriatr Oncol 4:271-281, 2013
48. Wildes TM, Ruwe AP, Fournier C, et al: Geriatric assessment is associated with completion of chemotherapy, toxicity, and survival in older adults with cancer. J Geriatr Oncol 4:227-234, 2013
49. Aparicio T, Jouve JL, Teillet L, et al: Geriatric factors predict chemotherapy feasibility: Ancillary results of FFCD 2001-02 phase III study in first-line chemotherapy for metastatic colorectal cancer in elderly patients. J Clin Oncol 31:1464-1470, 2013
50. Hurria A, Togawa K, Mohile SG, et al: Predicting chemotherapy toxicity in older adults with cancer: A prospective multicenter study. J Clin Oncol 29:3457-3465, 2011
51. Hurria A, Cohen HJ, Extermann M: Geriatric oncology research in the cooperative groups: A report of a SIOG special meeting. J Geriatr Oncol 1:40-44, 2010
52. Extermann M, Boler I, Reich RR, et al: Predicting the risk of chemotherapy toxicity in older patients: The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score. Cancer 118:3377-3386, 2012
53. Hurria A: Incorporation of geriatric principles in oncology clinical trials. J Clin Oncol 25:5350-5351, 2007
54. Hurria A, Naylor M, Cohen HJ: Improving the quality of cancer care in an aging population: Recommendations from an IOM report. JAMA 310:1795-1796, 2013
55. Hurria A, Cirrincione CT, Muss HB, et al: Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401. J Clin Oncol 29:1290-1296, 2011
56. Leith CP, Kopecky KJ, Chen IM, et al: Frequency and clinical significance of the expression of the multidrug resistance proteins MDR1/P-glycoprotein, MRP1, and LRP in acute myeloid leukemia: A Southwest Oncology Group study. Blood 94:1086-1099, 1999
57. Klepin HD, Rao AV, Pardee TS: Acute myeloid leukemia and myelodysplastic syndromes in older adults. J Clin Oncol 32:2541-2552, 2014
58. Appelbaum FR, Gundacker H, Head DR, et al: Age and acute myeloid leukemia. Blood 107:3481-3485, 2006
59. Frohling S, Schlenk RF, Kayser S, et al: Cytogenetics and age are major determinants of outcome in intensively treated acute myeloid leukemia patients older than 60 years: Results from AMLSG trial AML HD98-B. Blood 108:3280-3288, 2006
60. Diab SG, Elledge RM, Clark GM: Tumor characteristics and clinical outcome of elderly women with breast cancer. J Natl Cancer Inst 92:550-556, 2000
61. Institute of Medicine: Initial National Priorities for Comparative Effectiveness Research. Washington, DC, National Academies Press, 2009
62. Institute of Medicine: Finding What Works in Health Care: Standards for Systematic Reviews Washington, DC, National Academies Press, 2011
63. Institute of Medicine: Knowing What Works in Health Care: A Roadmapforthe Nation. Washington, DC, National Academies Press, 2008
64. Abernethy AP, Etheredge LM, Ganz PA, et al Rapid-learning system for cancer care. J Clin Oncol 28:4268-4274, 2010
65. Medicare Payment Advisory Commission Report to the Congress: Aligning Incentives in Medicare. http://www.medpac.gov/documents/reports/Jun10-EntireReport.pdf?sfvrsn=0
66. Emanuel EA, Abernethy AP, Bekelman JE, et al: A plan to fix cancer care. New York Times, March 23, 2013: SR13
67. Center for Medical Technology Policy: Issue Brief: Coverage for Evidence Development-A Conceptual Framework. http://www.cmtpnet.org/docs/resources/CED-Issue-Brief.pdf
68. Centers for Medicare and Medicaid Services: Anticancer chemotherapy for colorectal cancer. http://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Anti-Cancer-Chemotherapy-for-Colorectal-Cancer-11017-.html
69. Unger JM, Coltman CA Jr, Crowley JJ, et al: Impact of the year 2000 Medicare policy change on older patient enrollment to cancer clinical trials J Clin Oncol 24:141-144, 2006
70. US Food and Drug Administration: Content and format of an application: 21 CFR 314.50 (2012) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.50
71. US Food and Drug Administration: Requirements on content and format of labeling for human prescription drug and biological products: 21 CFR 201.56 (2007). http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.56
72. Center for Drug Evaluation and Research: Guideline for the Study of Drugs Likely to Be Used in the Elderly. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072048.pdf
73. US Food and Drug Administration: Guidance for Industry: E7 Studies in Support of Special Populations-Geriatrics: Questions and Answers. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatory information/guidances/ucm189544.pdf
74. Government Accountability Office: Elderly persons in clinical drug trials. http://www.gao.gov/assets/100/95182.pdf
75. Steinmetz KL, Coley KC, Pollock BG: Assessment of geriatric information on the drug label for commonly prescribed drugs in older people. J Am Geriatr Soc 53:891-894, 2005
76. Institute of Medicine: Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Washington, DC, National Academies Press, 2012
77. Kesselheim AS: An empirical review of major legislation affecting drug development: Past experiences, effects, and unintended consequences. Milbank Q 89:450-502, 2011
78. Grabowski HG, Di Masi JA, Long G: The roles of patents and research and development incentives in biopharmaceutical innovation. Health Aff (Millwood) 34:302-310, 2015
79. European Medicines Agency: EMA Geriatric Medicines Strategy. http://www.ema.europa.eu/docs/en-GB/document-library/Other/2011/02/WC500102291.pdf
80. US Food and Drug Administration: Oncologic Drugs Advisory Committee. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee
81. Kaźmierska J: Do we protect or discriminate? Representation of senior adults in clinical trials. Rep Pract Oncol Radiother 18:6-10, 2012
82. Ellis PM: Attitudes towards and participation in randomised clinical trials in oncology: A review of the literature. Ann Oncol 11:939-945, 2000
83. Siminoff LA, Zhang A, Colabianchi N, et al: Factors that predict the referral of breast cancer patients onto clinical trials by their surgeons and medical oncologists. J Clin Oncol 18:1203-1211, 2000
84. Benson AB 3rd, Pregler JP, Bean JA, et al: Oncologists' reluctance to accrue patients onto clinical trials: An Illinois Cancer Center study. J Clin Oncol 9:2067-2075, 1991
85. Kemeny MM, Peterson BL, Kornblith AB, et al: Barriers to clinical trial participation by older women with breast cancer. J Clin Oncol 21:2268-2275, 2003
86. Simon MS, Du W, Flaherty L, et al: Factors associated with breast cancer clinical trials participation and enrollment at a large academic medical center. J Clin Oncol 22:2046-2052, 2004
87. Kornblith AB, Kemeny M, Peterson BL, et al: Survey of oncologists' perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials. Cancer 95:989-996, 2002
88. Townsley CA, Chan KK, Pond GR, et al: Understanding the attitudes of the elderly towards enrolment into cancer clinical trials. BMC Cancer 6:34, 2006
89. Comis RL, Miller JD, Aldigé CR, et al: Public attitudes toward participation in cancer clinical trials. J Clin Oncol 21:830-835, 2003
90. Mansour EG: Barriers to clinical trials: Part III-Knowledge and attitudes of health care providers. Cancer 74:2672-2675, 1994(suppl)