Historically, older persons with cancer were not deemed fit to withstand the rigors of early-phase clinical trials where toxicity prevalence and tolerance were identified endpoints. Under-representation of this vulnerable population in early-stage drug development has been precluded by the co-occurrence of noncancer chronic illness and related functional impairment which deemed them ineligible for clinical trial participation. Yet with a growing number of elderly facing cancer, this cohortís experience is increasingly important to understand particularly as the reality of comorbidity and polypharmacy will most likely prevail in the future.
Researchers within MD Andersonís phase I clinical trials program reviewed their experience with older patients participating in early-phase clinical trials at their center.1
A total of 347 elderly patient experiences were reviewed which included therapies received within 78 phase I protocols. The majority of antineoplastics received were targeted therapies. The review revealed that older patients on multiagent regimens had a higher incidence of grade 3/4 toxicity than younger patients. The authors suggested that a more conservative approach (i.e., single-agent therapy) may be optimum therapeutic regimens for older adults who have metastatic disease and comorbidity.
The treatment experience of older cancer patients is finally receiving more scrutiny. This critical analysis is long overdue. A shift towards senior stratification is evolving recognizing that this age group is a very heterogeneous one.
Older adults deserve the appropriate matching of treatment options with individual risk estimation as cancer therapies are developed and treatment approaches are designed. Geriatric oncology is finally coming of age.
- Subbiah IM, Wheler JJ, Hess KR, et al. Outcomes of patients ≥65 years old with advanced cancer treated on phase I trials at MD ANDERSON CANCER CENTER. Int J Cancer. 2017 Jan 1;140(1):208-215.