The following is a summary of “Effect of Age on Safety and Efficacy of Novel Cancer Drugs Investigated in Early-Phase Clinical Trials,” published in the June 2024 issue of Oncology by Nicolò et al.

Elderly patients are often underrepresented in early-phase clinical trials despite constituting a significant proportion of patients with cancer. This retrospective study aimed to evaluate the safety and efficacy of novel anti-cancer therapies investigated in such trials, comparing outcomes between younger (≤ 65 years) and elderly (>65 years) patients.

Methods Data from 419 patients enrolled in the center’s phase I/II trials between January 2014 and April 2021 were analyzed. Clinicopathologic characteristics, treatment-related toxicity, and clinical efficacy were assessed, with patients stratified by age into younger and elderly groups.

The cohort’s median age was 56 years, with 107 patients (26%) classified as elderly. Predominant cancers included breast (48%), lung (10%), and melanoma (5%), with treatments primarily consisting of immunotherapy-based (47%) or targeted therapy-based (45%) regimens. Elderly patients exhibited poorer ECOG performance status (P = 0.001) and fewer prior therapy lines (P = 0.01) than their younger counterparts. Rates of grade ≥ 3 adverse events (AEs) were similar between age groups overall (31% younger vs 33% elderly; P = 0.7), but elderly patients experienced higher incidences of AEs with antibody-drug conjugates (56% vs. 14% in younger patients; P = 0.036) and were more likely to discontinue treatment due to toxicity (15% vs. 7%; P = 0.011). There were no significant age-related differences in response rates and survival outcomes across treatment modalities, except for immunotherapy-based regimens, where elderly patients demonstrated higher response rates, disease control rates, and prolonged progression-free survival.

The study underscores that elderly patients in early-phase clinical trials for novel cancer drugs experience comparable safety and efficacy outcomes to their younger counterparts. These findings emphasize the critical need for inclusivity of elderly populations in phase I/II trials to ensure broader applicability of trial results and mitigate disparities in age-related cancer treatment access.

Source: sciencedirect.com/science/article/abs/pii/S0959804924008372