← Back to Search
Enrollment Of Elderly Patients In Clinical Trials For Cancer Drug Registration: A 7-year Experience By The US Food And Drug Administration.
L. Talarico, G. Chen, R. Pazdur
Published 2004 · Medicine
Download PDFAnalyze on Scholarcy
PURPOSE To analyze the age-related enrollment of cancer patients onto registration trials of new drugs or new indications approved by the US Food and Drug Administration from 1995 to 2002. PATIENTS AND METHODS This study involved retrospective analyses of demographic data of cancer patients enrolled onto registration trials. The data on 28,766 cancer patients from 55 registration trials were analyzed according to age distributions of > or = 65, > or = 70, and > or = 75 years. The rates of enrollment in each age group for each cancer were compared with the corresponding rates in the US cancer population. The age distributions of the US cancer population were derived from the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute for the period 1995 to 1999 based on the 2000 US Census. RESULTS The proportions of the overall patient populations aged > or = 65, > or = 70, and > or = 75 years were 36%, 20%, and 9% compared with 60%, 46%, and 31%, respectively, in the US cancer population. Statistically significant under-representation of the elderly (P < .001) was noted in registration trials for all cancer treatment except for breast cancer hormonal therapies. Patients aged > or = 70 years accounted for most of the under-representation. CONCLUSION Elderly were under-represented in the registration trials of new cancer therapies. Various strategies may be needed to evaluate cancer therapies for the elderly in prospective clinical trials and to improve cancer care in the elderly population.
This paper references
Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment.
P. Lara (2001)
Factors used to select adjuvant therapy of breast cancer in the United States: an overview of age, race, and socioeconomic status.
H. Muss (2001)
Cancer burden in the aged
R. Yancik (1997)
Participation of patients 65 years of age or older in cancer clinical trials.
J. Lewis (2003)
Treatment tolerance of elderly cancer patients entered onto phase II clinical trials: an Illinois Cancer Center study.
S. Giovanazzi-Bannon (1994)
Meeting highlights: international consensus panel on the treatment of primary breast cancer.
A. Goldhirsch (1995)
Age, sex, and racial differences in the use of standard adjuvant therapy for colorectal cancer.
A. Potosky (2002)
Discrepancy between Consensus Recommendations and Actual Community Use of Adjuvant Chemotherapy in Women with Breast Cancer
X. Du (2003)
Older age--not a barrier to cancer treatment.
H. Muss (2001)
Management of cancer in the older person: a practical approach.
L. Balducci (2000)
Representation of older patients in cancer treatment trials
E. Trimble (1994)
Acute myelogenous leukemia and aging. Clinical interactions.
J. Lancet (2000)
Barriers to clinical trial participation by older women with breast cancer.
M. Kemeny (2003)
A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients.
D. Sargent (2001)
How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials.
W. Sateren (2002)
Meeting highlights: International Consensus Panel on the Treatment of Primary Breast Cancer. Seventh International Conference on Adjuvant Therapy of Primary Breast Cancer.
A. Goldhirsch (2001)
Enrollment of older patients in cancer treatment trials in Canada: why is age a barrier?
K. Yee (2003)
Survey of oncologists' perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials
A. Kornblith (2002)
Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature.
P. Ellis (2000)
Age-related prognostic factor analysis in non-Hodgkin's lymphoma.
A. Maksymiuk (1996)
Needed: clinical trials for older patients.
B. Kennedy (1991)
Dose-response effect of adjuvant chemotherapy in breast cancer.
G. Bonadonna (1981)
Patterns of chemotherapy use for women with ovarian cancer: a population-based study.
R. Cress (2003)
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.
D. Crivellari (2000)
Factors that predict the referral of breast cancer patients onto clinical trials by their surgeons and medical oncologists.
L. Siminoff (2000)
Underrepresentation of patients 65 years of age or older in cancer-treatment trials.
L. Hutchins (1999)
Determinants of cancer therapy in elderly patients
James S. Goodwin (1993)
Oncologists' reluctance to accrue patients onto clinical trials: an Illinois Cancer Center study.
A. Benson (1991)
Cancer in old age—is it inadequately investigated and treated?
N. J. Turner (1999)
Assessment of the older cancer patient.
M. Extermann (2000)
This paper is referenced by
Modern Treatment Options for Elderly Patients with Multiple Myeloma
M. Görner (2008)
Discussions about clinical trials among patients with newly diagnosed lung and colorectal cancer.
K. Kehl (2014)
Thoracic Oncology Clinical Trial Eligibility Criteria and Requirements Continue to Increase in Number and Complexity
S. García (2017)
Early Breast Cancer in the Elderly
G. Albrand (2008)
Elderly lung cancer patients: what treatment strategies?
C. Gridelli (2007)
Low-dose capecitabine (Xeloda) for treatment for gastrointestinal cancer
Jasmine Miger (2014)
Special Considerations in Research
C. White (2007)
Randomized Clinical Trial Representativeness and Outcomes in Real-World Patients: Comparison of 6 Hallmark Randomized Clinical Trials of Relapsed/Refractory Multiple Myeloma.
A. Chari (2019)
Management of elderly patients.
A. Vergnenègre (2013)
Special Issues in Older Women with Breast Cancer.
A. Hurria (2015)
Pemetrexed plus carboplatin in elderly patients with malignant pleural mesothelioma: combined analysis of two phase II trials
G. Ceresoli (2008)
'Within a group of elderly patients of the same chronological age, some are fit and others are frail. Thus, in order to further individualize treatment choice in elderly patients, it is important to practice a comprehensive geriatric assessment…'
C. Gridelli (2007)
Considerations in the design and conduct of clinical drug trials in older cancer patients
A. Pallis (2012)
Effective Communication with Older Cancer Patients
Lodovico Balducci (2013)
Geriatrinen näkökulma iäkkään syöpäpotilaan hoidossa
Johanna Heikkilä (2015)
QTc Interval-Prolonging Medications Among Patients With Lung Cancer: Implications for Clinical Trial Eligibility and Clinical Care.
T. Le (2019)
Age Influences on the Molecular Presentation of Tumours
C. H. Li (2020)
The impact of comorbidity on overall survival in elderly nasopharyngeal carcinoma patients: a National Cancer Data Base analysis
Ying Huang (2018)
Temporal Trends and Predictors for Cancer Clinical Trial Availability for Medically Underserved Populations.
D. Gerber (2015)
Data Linkage to Improve Geriatric Oncology Research: A Feasibility Study
J. Lund (2017)
Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site.
P. Blanchard (2011)
Disparities in subgroup populations enrolled in lung cancer trials
Antonio Rossi (2012)
Michael J. Berg (2007)
Information for rational drug prescribing to older patients : Availability and applicability
E. Beers (2014)
Early treatment modifications improve chemotherapy adherence in ovarian cancer patients ≥70 years.
T. Heilmann (2019)
Applicability of trials in rheumatoid arthritis and osteoarthritis: A systematic review and meta-analysis of trial populations showing adequate proportion of women, but underrepresentation of elderly people.
A. Palmowski (2019)
Méta-analyses sur données individuelles d’essais randomisés dans les cancers des voies aéro-digestives supérieures. Développements méthodologiques et cliniques
P. Blanchard (2013)
Bridging the Gap Between Sorafinib Efficacy and Effectiveness in Advanced Hepatocellular Carcinoma
R. Nipp (2016)
Comprehensive geriatric assessment in older patients with cancer: an external validation of the multidimensional prognostic index in a French prospective cohort study
E. Liuu (2020)
Understanding Willingness to Participate in Cancer Clinical Trials Among Patients and Caregivers Attending a Minority-Serving Academic Cancer Center
Tamar Ginossar (2020)
Issues of aging and geriatric medicine: relevance to cancer treatment and hematopoietic reconstitution.
W. Ershler (2006)
Évaluation des structures de prise en charge du patient âgé atteint de cancer: la consultation d’oncogériatrie
C. Terret (2006)See more