Elderly Patients and Treatment Tolerance in Phase 1 Trials
Study results suggest that carefully selected elderly patients with recurrent or refractory gynecologic malignancy should be enrolled in phase 1 trials.
Elderly patients demonstrate a similar incidence of toxicity compared with younger patients in phase 1 trials, according to a retrospective study presented at the 2017 Society of Gynecologic Oncology Annual Meeting.1
Evidence suggests that elderly patients are less likely to tolerate treatment of primary gynecologic malignancies and are less likely to be enrolled in clinical trials. Their ability to tolerate treatment of recurrent or refractory disease is not, however, well-studied. The purpose of this study was to determine whether outcomes differ between younger and older patients treated for recurrent or refractory disease while participating in phase 1 trials.
This single-center, retrospective study included data from 267 patients who were enrolled in phase 1 trials during 2010 to 2016. Elderly patients (aged at least 70) accounted for 20% of the overall cohort; baseline demographics were similar between the elderly and younger cohorts.
The incidence of grade 3 to 4 hematologic and nonhematologic toxicities were similar between the elderly (22% and 26%, respectively) and younger cohorts (24% and 28%, respectively). Elderly patients, however, trended toward being less likely to discontinue treatment due to toxicity compared with younger patients (9% vs 18%; P = .25).
There was no significant difference in survival rates between the 2 cohorts. Among elderly patients, the response rate was 16%, and 63% achieved clinical benefit.
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The results of this study suggest that carefully selected elderly patients with recurrent or refractory gynecologic malignancy should be enrolled in phase 1 trials, as their incidence of toxicity associated with treatment is similar to that of younger patients.
- Buechel ME, McGinnis A, Wade KS, et al. Observed toxicities in elderly gynecologic cancer patients treated on phase I clinical trials: the University of Oklahoma Health Sciences Center experience. Paper presented at: 48th Annual Meeting of the Society of Gynecologic Oncology; March 12-15, 2017; National Harbor, MD.