Olaparib Efficacy, Safety Unaffected by Old Age Among Patients With Ovarian Cancer

Older age did not affect the safety or efficacy of olaparib plus bevacizumab for patients with ovarian cancer, according to results from the PAOLA-1/ENGOT-ov25 study.

Renaud Sabatier, MD, PhD, Paoli-Calmettes Institute, Marseille, France, and colleagues explained, “Olaparib specificities such as its oral formulation and low rates of high-grade adverse events offer an attractive approach for the treatment of ovarian cancer in older patients,” but, due to a lack of representation of older patients in current trials, there is limited insight into use of olaparib in this patient population.

The phase 3 PAOLA-1/ENGOT-ov25 trial previously associated the addition of olaparib to bevacizumab with improved progression-free survival (PFS) in patients with advanced ovarian cancer. The current study used those results to assess baseline clinical and molecular data and PFS between older (aged ≥65 years) and younger patients (<65 years) to evaluate olaparib efficacy and safety in these age subgroups. Of 806 patients in the study, 292 (36.2%) were ≥65 years of age. Patients in the ≥65 years cohort were less likely than younger patients to have upfront surgery (42% vs 55.7%), a BRCA1/2 mutation (17.1% vs 36.7%) or homologous recombination deficiency-positive status (34.1% vs 55.7%).

With a median follow-up duration of 22.1 months, the median PFS of older patients treated with olaparib was 21.6 months vs 16.6 months with placebo (hazard ratio [HR] 0.55; 95% confidence interval [CI], 0.41 to 0.75). This was comparable to the median PFS of 22.9 versus 16.9 months in the younger population (HR 0.61; 95% CI, 0.49 to 0.77). The incidence rates of olaparib-related grade ≥3 adverse events in older patients were similar to younger patients (36.8% vs 31.7%), though hypertension, and anemia were more common in older patients. No treatment-related deaths occurred in older patients receiving olaparib.

“Our findings support the efficacy of bevacizumab-olaparib maintenance after first-line chemotherapy in patients aged ≥65 years. Additional data are warranted to confirm these results in unselected older patients,” Dr Sabatier et al concluded.

Source:

Sabatier R, Rousseau F, Joly F, et al. Efficacy and safety of maintenance olaparib and bevacizumab in ovarian cancer patients aged ≥65 years from the PAOLA-1/ENGOT-ov25 trial. Eur J Cancer. 2023;181:42-52. doi:10.1016/j.ejca.2022.11.029