Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations

Journal of Clinical Oncology

Volumn 32, Issue 24, 2014, Pages 2587-2594

  Hurria, Arti ^a   Dale, William ^b   Mooney, Margaret ^c   Rowland, Julia H ^c   Ballman, Karla V ^d   Cohen, Harvey J ^f   Muss, Hyman B ^h   Schilsky, Richard L ^b   Ferrell, Betty ^a   Extermann, Martine ⁱ   Schmader, Kenneth E ^f,g   Mohile, Supriya G ^e  

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

^b UNIVERSITY OF CHICAGO   (United States)

^c NATIONAL CANCER INSTITUTE   (United States)

^d MAYO CLINIC   (United States)

^e UNIVERSITY OF ROCHESTER   (United States)

^f DUKE UNIVERSITY   (United States)

^g DURHAM VA MEDICAL CENTER   (United States)

^h UNIVERSITY OF NORTH CAROLINA   (United States)

ⁱ H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGING; CANCER INCIDENCE; CANCER PATIENT; CANCER SURVIVOR; CANCER THERAPY; CLINICAL TRIAL (TOPIC); EVIDENCE BASED PRACTICE; FRAIL ELDERLY; GERIATRIC CARE; HUMAN; METHODOLOGY; PRIORITY JOURNAL; REVIEW; AGE; AGED; GERIATRICS; NEOPLASMS; ONCOLOGY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS; VERY ELDERLY;

AGE FACTORS; AGED; AGED, 80 AND OVER; CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; FRAIL ELDERLY; GERIATRICS; HUMANS; MEDICAL ONCOLOGY; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84906241905     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2013.55.0418     Document Type: Review

References (62)

1. Howlander N, Noone NA, Krapcho M, et al (eds): Cancer Statistics Review, 1975-2010. http://seer.cancer.gov/csr/1975-2010/
2. Smith BD, Smith GL, Hurria A, et al: Future of cancer incidence in the United States: Burdens upon an aging, changing nation. J Clin Oncol 27:2758-2765, 2009
3. Parry C, Kent EE, Mariotto AB, et al: Cancer survivors: A booming population. Cancer Epidemiol Biomarkers Prev 20:1996-2005, 2011
4. Kennedy BJ: Aging and cancer. J Clin Oncol 6:1903-1911, 1988
5. Yancik R, Carbone PP (eds): Perspectives on Prevention and Treatment of Cancer in the Elderly. New York, NY, Raven Press, 1983
6. 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 (Pubitemid 30035956)
7. Mooney MM: Older patients in NCI-sponsored clinical treatment trials. http://meetinglibrary.asco.org/content/68859?media-vm
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. Appelbaum FR, Gundacker H, Head DR, et al: Age and acute myeloid leukemia. Blood 107:3481-3485, 2006
10. Fröhling 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
11. 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 (Pubitemid 29361842)
12. DeMichele A, Putt M, Zhang Y, et al: Older age predicts a decline in adjuvant chemotherapy recommendations for patients with breast carcinoma: Evidence from a tertiary care cohort of chemotherapy-eligible patients. Cancer 97:2150-2159, 2003 (Pubitemid 36444055)
13. Bouchardy C, Rapiti E, Fioretta G, et al: Undertreatment strongly decreases prognosis of breast cancer in elderly women. J Clin Oncol 21:3580-3587, 2003 (Pubitemid 46594049)
14. Smith TJ, Penberthy L, Desch CE, et al: Differences in initial treatment patterns and outcomes of lung cancer in the elderly. Lung Cancer 13:235-252, 1995 (Pubitemid 26022990)
15. Houterman S, Janssen-Heijnen ML, Verheij CD, et al: Greater influence of age than co-morbidity on primary treatment and complications of prostate cancer patients: An in-depth population-based study. Prostate Cancer Prostatic Dis 9:179-184, 2006 (Pubitemid 43970968)
16. Schwartz KL, Alibhai SM, Tomlinson G, et al: Continued undertreatment of older men with localized prostate cancer. Urology 62:860-865, 2003 (Pubitemid 37421232)
17. 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
18. 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 (Pubitemid 32590779)
19. 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
20. 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
21. 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
22. 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
23. 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
24. 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
25. 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
26. Extermann M, Wedding U: Comorbidity and geriatric assessment for older patients with hematologic malignancies: A review of the evidence. J Geriatr Oncol 3:49-57, 2012
27. Trimble EL, Carter CL, Cain D, et al: Representation of older patients in cancer treatment trials. Cancer 74:2208-2214, 1994 (suppl) (Pubitemid 24304400)
28. 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 (Pubitemid 41185131)
29. 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
30. Hurria A, Mohile SG, Dale W: Research priorities in geriatric oncology: Addressing the needs of an aging population. J Natl Compr Canc Netw 10: 286-288, 2012
31. Mohile S, Dale W, Hurria A: Geriatric oncology research to improve clinical care. Nat Rev Clin Oncol 9:571-578, 2012
32. Gross CP, Herrin J, Wong N, et al: Enrolling older persons in cancer trials: The effect of sociodemographic, protocol, and recruitment center characteristics. J Clin Oncol 23:4755-4763, 2005 (Pubitemid 46224079)
33. Fried LP, Tangen CM, Walston J, et al: Frailty in older adults: Evidence for a phenotype. J Gerontol A Biol Sci Med Sci 56:M146-M157, 2001
34. Walston J, Hadley EC, Ferrucci L, et al: Research agenda for frailty in older adults: Toward a better understanding of physiology and etiology-Summary from the American Geriatrics Society/National Institute on Aging Research Conference on Frailty in Older Adults. J Am Geriatr Soc 54:991-1001, 2006 (Pubitemid 43847040)
35. Rockwood K, Mitnitski A: Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci 62:722-727, 2007 (Pubitemid 350143602)
36. Fried TR, Bradley EH, Towle VR, et al: Understanding the treatment preferences of seriously ill patients. N Engl J Med 346:1061-1066, 2002 (Pubitemid 34984621)
37. Muss HB, Berry DA, Cirrincione CT, et al: Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med 360:2055-2065, 2009
38. 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
39. National Cancer Institute: Sorafenib tosylate and chemotherapy in treating older patients with acute myeloid leukemia. http://clinicaltrials.gov/ ct2/show/study/NCT01253070
40. Lichtman SM, Hollis D, Miller AA, et al: Prospective evaluation of the relationship of patient age and paclitaxel clinical pharmacology: Cancer and Leukemia Group B (CALGB 9762). J Clin Oncol 24:1846-1851, 2006 (Pubitemid 46638982)
41. Seymour MT, Thompson LC, Wasan HS, et al: Chemotherapy options in elderly and frail patients with metastatic colorectal cancer (MRC FOCUS2): An open-label, randomised factorial trial. Lancet 377:1749-1759, 2011
42. Puts MT, Hardt J, Monette J, et al: Use of geriatric assessment for older adults in the oncology setting: A systematic review. J Natl Cancer Inst 104:1133-1163, 2012
43. Yee KW, Pater JL, Pho L, et al: Enrollment of older patients in cancer treatment trials in Canada: Why is age a barrier? J Clin Oncol 21:1618-1623, 2003 (Pubitemid 46594117)
44. 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 (Pubitemid 46621862)
45. Horn L, Keedy VL, Campbell N, et al: Identifying barriers associated with enrollment of patients with lung cancer into clinical trials. Clin Lung Cancer 14:14-18, 2013
46. Eads J: Identification of barriers to clinical trials: The impact of education level. J Clin Oncol 29:384s, 2011 (suppl; abstr CRA6003)
47. Spaar A, Frey M, Turk A, et al: Recruitment barriers in a randomized controlled trial from the physicians' perspective: A postal survey. BMC Med Res Methodol 9:14, 2009
48. Howerton MW, Gibbons MC, Baffi CR, et al: Provider roles in the recruitment of underrepresented populations to cancer clinical trials. Cancer 109:465-476, 2007 (Pubitemid 46190954)
49. Gross CP, Murthy V, Li Y, et al: Cancer trial enrollment after state-mandated reimbursement. J Natl Cancer Inst 96:1063-1069, 2004 (Pubitemid 39172407)
50. Gross CP, Wong N, Dubin JA, et al: Enrollment of older persons in cancer trials after the medicare reimbursement policy change. Arch Intern Med 165:1514-1520, 2005 (Pubitemid 41058032)
51. Cooley ME, Sarna L, Brown JK, et al: Challenges of recruitment and retention in multisite clinical research. Cancer Nurs 26:376-384, 2003; quiz 385-386
52. Lara PN Jr, Higdon R, Lim N, et al: Prospective evaluation of cancer clinical trial accrual patterns: Identifying potential barriers to enrollment. J Clin Oncol 19:1728-1733, 2001 (Pubitemid 32230874)
53. Baggstrom MQ, Waqar SN, Sezhiyan AK, et al: Barriers to enrollment in non-small cell lung cancer therapeutic clinical trials. J Thorac Oncol 6:98-102, 2011
54. 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 (Pubitemid 46224135)
55. Penberthy L, Brown R, Wilson-Genderson M, et al: Barriers to therapeutic clinical trials enrollment: Differences between African-American and White cancer patients identified at the time of eligibility assessment. Clin Trials 9:788-797, 2012
56. Basche M, Barón AE, Eckhardt SG, et al: Barriers to enrollment of elderly adults in early-phase cancer clinical trials. J Oncol Pract 4:162-168, 2008
57. Comis RL, Miller JD, Aldigé CR, et al: Public attitudes toward participation in cancer clinical trials. J Clin Oncol 21:830-835, 2003 (Pubitemid 46606442)
58. 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
59. Hartocollis A: For the elderly, emergency rooms of their own. New York Times, April 10, 2012:A1
60. Hwang U, Morrison RS: The geriatric emergency department. J Am Geriatr Soc 55:1873-1876, 2007 (Pubitemid 350043772)
61. de Moor JS, Mariotto AB, Parry C, et al: Cancer survivors in the United States: Prevalence across the survivorship trajectory and implications for care. Cancer Epidemiol Biomarkers Prev 22:561-570, 2013
62. Mariotto AB, Rowland JH, Ries LA, et al: Multiple cancer prevalence: A growing challenge in long-term survivorship. Cancer Epidemiol Biomarkers Prev 16:566-571, 2007 (Pubitemid 46548662)