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Treatment Tolerance And Efficacy In Geriatric Oncology: A Systematic Review Of Phase III Randomized Trials Conducted By Five National Cancer Institute-sponsored Cooperative Groups.

A. Kumar, H. Soares, L. Balducci, B. Djulbegovic
Published 2007 · Medicine

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PURPOSE Elderly patients share the majority of the disease burden in cancer. Although 61% of new cancer cases occur among elderly, they comprise only 25% of the patients enrolled onto randomized clinical trials (RCTs). A systematic review to assess the accurate participation of elderly patients in RCTs has not been performed. PATIENTS AND METHODS We reviewed all consecutively completed phase III RCTs conducted by five National Cancer Institute-sponsored cooperative groups. Published papers and study protocols were used for data extraction. We used a cutoff age of 65 years to define elderly patients. For trials that did not exclusively enroll elderly, data were extracted on number of participants 65 years of age. Outcome between the innovative and the standard treatment was compared. RESULTS Of 345 studies, only one trial exclusively enrolled elderly patients (0.28%); 57% of the trials (n = 197) had no stratification by age, and 12% of the studies had a stratification age 65 years (n = 42). Overall survival in the trial exclusively enrolling elderly favored the newer treatments (hazard ratio [HR], 0.69; 95% CI, 0.47 to 1.02; P = .06). Additionally, in trials enrolling more than 40% of elderly, survival and event-free survival favored the innovative treatments (HR for survival, 0.91; 95% CI, 0.84 to 0.99; P = .03; HR for event-free survival, 0.85; 95% CI, 0.72 to 1.01; P = .07). Treatment-related mortality was similar in both the innovative and standard treatment groups (HR, 0.91; 95% CI, 0.47 to 1.78; P = .8). CONCLUSION Our data indicate that enrollment of elderly in experimental RCTs is not associated with increased harm to this patient population. Increased participation of elderly may help in finding new treatments that are clinically applicable specifically to this cohort of patients.
This paper references
Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group
H. Soares (2004)
Participation of patients 65 years of age or older in cancer clinical trials.
J. Lewis (2003)
Representation of older patients in cancer treatment trials
E. Trimble (1994)
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
D. Altman (2001)
Underrepresentation of patients 65 years of age or older in cancer-treatment trials.
L. Hutchins (1999)
Believing is seeing
L. Balducci (2004)
A case for geriatric oncology.
L. Repetto (2002)
The case for randomized trials in cancer treatment: new is not always better.
A. Grann (2005)
Enrollment of elderly patients in clinical trials for cancer drug registration: a 7-year experience by the US Food and Drug Administration.
L. Talarico (2004)
Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment.
P. Lara (2001)
Venous thromboembolism and cancer: new issues for an old topic.
M. Mandala (2003)
Obtaining Individual Patient Data from Randomised Controlled Trials
M. Clarke (2008)
Evaluation of new treatments in radiation oncology: are they better than standard treatments?
H. Soares (2005)
Assessing the Quality of Randomised Controlled Trials
P. Jüni (2008)
Evidence-based management of cancer in the elderly.
L. Balducci (2000)
Effect Measures for Meta‒Analysis of Trials with Binary Outcomes
J. Deeks (2008)
Oncologists' reluctance to accrue patients onto clinical trials: an Illinois Cancer Center study.
A. Benson (1991)
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.
D. Moore (2004)
Selection factors in clinical trials: results from the Community Clinical Oncology Program Physician's Patient Log.
C. Hunter (1987)
Optimizing cancer care in the elderly: progress in geriatric oncology.
M. Extermann (2003)
Too Few Older Patients in Cancer Trials
M. Mitka (2003)
Tamoxifen versus placebo: double-blind adjuvant trial in elderly women with stage II breast cancer.
F. Cummings (1986)
Forest plots: trying to see the wood and the trees
S. Lewis (2001)
Supportive care of the older cancer patient.
L. Balducci (2003)
Participation in cancer clinical trials: race-, sex-, and age-based disparities.
Vivek Murthy (2004)
Are experimental treatments for cancer in children superior to established treatments? Observational study of randomised controlled trials by the Children's Oncology Group
A. Kumar (2005)

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S. Crean (2007)
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Oral metronomic cyclophosphamide in elderly with metastatic melanoma
E. Borne (2009)
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A. Berger (2014)
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T. Karnakis (2015)
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