A retrospective study of ICIs by French investigators found manageable toxicity in patients over age 70, and survival outcomes comparable to younger patients.
Immune checkpoint inhibitors (ICIs) are an acceptable treatment option for older cancer patients, according to a study in European Journal of Cancer. A new analysis has found that grades 3 and 4 toxicity rates and efficacy profiles in adults over the age of 70 are similar to those of their younger counterparts.
Senior investigator Capucine Baldini, MD, of Gustave Roussy, UniversitÃ© Paris-Saclay, Villejuif, France, and colleagues conducted a retrospective review of 220 patients, 20% of whom were over 70 years of age (N = 46). They found that efficacy was comparable between the group of patients over age of 70 and the patients who were younger than 70. Toxicity of immunotherapy in older patients was found to be manageable. There was an increased proportion of grades 2 and 3 adverse events (AEs), and AEs occurred sooner in older patients than in younger ones (16 days vs 36 days). However, the data suggest that age should not be a deciding factor when considering treatment with ICIs.
The authors noted that aging is associated with an increased risk of cancer. Yet, older patients are underrepresented in clinical trials. Trials often have restrictive inclusion criteria that exclude patients due to comorbidities and polypharmacy. The current study examined tolerability and efficacy of immunotherapy in older patients in phase I trials.
Baldini and colleagues retrospectively reviewed all cases of patients enrolled in immunotherapy phase I trials between January 2012 and December 2016 at a single institution. They conducted a case–control analysis in patients ≥ 70 years matched to younger patients < 70 years by trial and treatment dose. The team compared cumulative incidence, grade, and type of immune-related adverse events (IrAEs) and survival outcomes.
Polymedication (more than 5 medications) was much more common in older patients (57%) compared with younger patients (38%). The most common tumor types in the study group were bladder carcinoma (22%), non–small-cell lung cancer (19%), gastrointestinal cancer (14%), gynecologic cancer (12%), head and neck carcinoma (10%), breast cancer (7%), and renal cell carcinoma (6%).
They found the cumulative incidence of grades 1 and 2 IrAEs was significantly higher in the older patients than in the younger patients. With respect to grades 3 and 4 IrAEs, however, they found no significant difference between the two groups. The study showed that age did not matter in terms of dose intensity. Importantly, no significant differences were found in median progression-free survival (PFS) or median overall survival (OS) between the two groups. The overall response rate was 14% for older patients and 18.5% for younger patients.
The investigators concluded that immune checkpoint blockade appears to be an acceptable treatment option for older patients in the setting of phase I trials. However, they also write that specific guidelines should be established and there should be dedicated studies with older cancer patients.