|The following article features coverage from the Society of Gynecologic Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
The efficacy and safety of rucaparib maintenance therapy was similar across 3 age-specific subgroups of women with advanced ovarian cancer, according to results of a post-hoc exploratory analysis of the phase 3 ARIEL3 trial. These findings were presented at the Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer.
In the ARIEL3 trial (ClinicalTrial.gov Identifier: NCT01968213), patients were randomly assigned to rucaparib, a poly ADP ribose polymerase (PARP) inhibitor, or placebo in a 2:1 ratio. Median PFS in the intention-to-treat (ITT) population for rucaparib compared with placebo arms for each of the 3 subgroups was as follows: 11.1 months vs 5.4 months (hazard ratio = 0.33; 95% CI, 0.25-0.43) for women younger than 65 years; 8.3 months vs 5.3 months (hazard ratio = 0.43; 95% CI, 0.29-0.64) for women aged 65 to 74 years, and 9.2 months vs 5.5 months (hazard ratio = 0.47; 95% CI, 0.16-1.35) for women aged 75 years and older. Of note, the oldest age subgroup included substantially fewer patients (33 patients) compared with the 65 years of age and younger (354 patients) and 65 to 74 years of age (237 patients) subgroups.
Interestingly, the respective percentages of women with deleterious germline or somatic BRCA mutations receiving rucaparib compared with placebo differed across the age subgroups; 40.5% vs 41.9% for women younger than 65 years; 25.7% vs 23.4% for women aged 65 to 74 years, and 20.0% vs 25.0% for women aged 75 years and older.
With respect to the safety profile of rucaparib maintenance therapy, consistent results were generally observed across the 3 groups. The most common rucaparib treatment- emergent nonhematologic adverse events were nausea, asthenia, and vomiting. Hematologic adverse events included and anemia and thrombocytopenia.
Read more of Cancer Therapy Advisor‘s coverage of the SGO 2019 meeting by visiting the conference page.
- Ledermann JA, Oza AM, Lorusso D, et al. The effect of age on efficacy and safety outcomes with rucaparib: a post hoc exploratory analysis of ARIEL3, a phase III, randomized, placebo-controlled maintenance study in patients with recurrent ovarian carcinoma. Presented at: Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer, Honolulu, Hawaii; March 16-19, 2019. Abstract 4.