Enrollment of elderly patients in clinical trials for cancer drug registration: A 7-year experience by the US Food and Drug Administration

Journal of Clinical Oncology

Volumn 22, Issue 22, 2004, Pages 4626-4631

  Talarico, Lilia ^a   Chen, Gang ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGED; ARTICLE; BREAST CANCER; CANCER PATIENT; DEMOGRAPHY; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; GROUPS BY AGE; HORMONAL THERAPY; HUMAN; MAJOR CLINICAL STUDY; POPULATION DISTRIBUTION; PRIORITY JOURNAL; REGISTRATION; STATISTICAL ANALYSIS; UNITED STATES; AGE; CANCER REGISTRY; CLINICAL TRIAL; FEMALE; MALE; NEOPLASM; PATIENT SELECTION; RETROSPECTIVE STUDY; STATISTICS;

AGE FACTORS; AGED; AGED, 80 AND OVER; CLINICAL TRIALS; FEMALE; HUMANS; MALE; NEOPLASMS; PATIENT SELECTION; RETROSPECTIVE STUDIES; SEER PROGRAM; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 16544371710     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2004.02.175     Document Type: Article

References (36)

1. Yancik R: Cancer burden in the aged: An epidemiologic and demographic overview. Cancer 80:1273-1283, 1997
2. Trimble EL, Carter CL, Cain D, et al: Representation of older patients in cancer treatment trials. Cancer 74:2208-2214, 1994 (suppl 7)
3. 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
4. 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
5. Yee LWL, 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
6. Goodwin JS, Hunt WC, Samet JM: Determinants of cancer therapy in elderly patients. Cancer 72:594-601, 1993
7. Turner NJ, Haward RA, Mulley GP, et al: Cancer in old age - Is it inadequately investigated and treated? BMJ 319:309-312, 1999
8. Surveillance, Epidemiology, and End Results: http://seer.cancer.gov
9. United States Census Bureau: http:// census.gov
10. Facts and figures about cancer clinical trials, http://www.cancer.gov/ clinical trials/facts-and-figures
11. Lara PN, 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
12. Food and Drug Administration: July 1988 Guideline for the Format and Content of the Clinical and Statistical Section of New Drug Applications. Final Rule on Investigational New Drug Applications and New Drug Applications. Feb 1998-21 CFR parts 312 and 314. http:// www.fda.gov/cder/guidance/index.htm
13. Food and Drug Administration: 1983 Guideline for the Study and Evaluation of Special Populations: Geriatric, http://www.fda.gov/cder/ guidance/index.htm
14. Food and Drug Administration: November 1989 Guideline for the Study of Drugs Likely to Be Used in the Elderly. Fed Register 59:102: 39398-39400, 1994. http://www.fda.gov/cder/ guidance/index.htm
15. Kennedy BJ: Needed: Clinical trials for older patients. J Clin Oncol 9:718-720, 1991
16. 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
17. 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
18. Du XL, Key CR, Osborne C, et al: Discrepancy between consensus recommendations and actual community use of adjuvant chemotherapy in women with breast cancer. Ann Intern Med 138:90-97, 2003
19. Extermann M, Aapro M: Assessment of the older cancer patient: Hematol Oncol Clin North Am 14:63-77, 2000
20. Balducci L, Extermann M: Management of cancer in the older person: A practical approach. Oncologist 5:224-237, 2000
21. 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
22. Hayunga EG, Costello MD, Finn VW: Demographics of study populations. Appl Clin Trials 6:41-55, 1997
23. Sateren WB, Trimble EL, Abrams J, et al: How sociodemographics, presence of oncology specialists, and hospitals cancer programs affect accrual to cancer treatment trials. J Clin Oncol 20:2109-2117, 2002
24. Potosky AL, Harlan LC, Kaplan RS: Age, sex and racial differences in the use of standard adjuvant therapy for colorectal cancer. J Clin Oncol 20:1192-1202, 2002
25. Lancet JE, William CL, Bennett JM: Acute myelogenous leukemia and aging: Clinical interactions. Hematol Oncol Clin North Am 14:251-267, 2000
26. Maksymiuk AW, Haines C, Tan LK, et al: Age-related prognostic factor analysis in non-Hodgkin's lymphoma. Can J Oncol 6:435-442, 1996
27. Muss HB: Older age: Not a barrier to cancer treatment. N Engl J Med 345:1128-1129, 2001
28. Crivellari D, Bonetti M, Castiglione-Gertsch M. et al: Burdens and benefits of adjuvant cyclophosphamide, methotrexate and fluorouracil and tamoxifen for elderly patients with breast cancer: The international Breast Cancer Study Group Trial VII. J Clin Oncol 18:1412-1422, 2000
29. Giovannazzi-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
30. Bonadonna G, Valagusse P, Moliterni A, et al: Dose-response effect of adjuvant chemotherapy in breast cancer. N Engl J Med 304:10-15, 1981
31. Ellis PM: Attitudes towards and participation in randomized clinical trials in oncology: A review of the literature. Ann Oncol 11:939-945, 2000
32. Siminoff L, 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
33. Benson AB III, 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
34. 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
35. Kornblith AB, Kemeny M, Peterson BL, et al: Survey of oncologists' perception of barriers to accrual of older patients with breast carcinoma to clinical trials. Cancer 95:989-996, 2002
36. Goldhirsh A, Glick JH, Gelber RD, et al: Meeting highlights: International Consensus Panel on the treatment of primary breast cancer: J Clin Oncol 19:3817-3827, 2001