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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

Ambuj Kumar, Heloisa P. Soares, Lodovico Balducci, Benjamin Djulbegovic

From the H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa, FL

Address reprint requests to Benjamin Djulbegovic, MD, PhD, H. Lee Moffitt Cancer Center, 12902 Magnolia Dr, MRC, Tampa, FL 33612; e-mail: djulbebm{at}moffitt.usf.edu

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.

Supported by National Cancer Institute Grant No. P20 CA 103676 (Moffitt Cancer Center Aging and Cancer Pilot Research Grant) and National Institute of Health, Office of Research Integrity Grants No. 1R01 NS052956-01 and 1R01 NS 44417-01.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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Related Correspondence

• Reliable Evidence of Safety and Efficacy of Elderly Patients in Randomized Clinical Trials Still Needed
  Sheila M. Crean, Matthew W. Reynolds, and Christin A. Dematto
  JCO 2007 25: 4027-4028 [Full Text]

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