The paper is titled, "Rucaparib in Relapsed, Platinum-Sensitive High-Grade Ovarian Carcinoma (ARIEL2 Part 1): An International, Multicentre, Open-Label, Phase 2 Trial." This paper was recently published in the Lancet Oncology.
What this paper describes are the results of a phase 2 open-label trial that looked at the use of rucaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, in the management of patients with platinum-sensitive ovarian cancer. The study looked at a total of more than 200 patients and included individuals who had both BRCA mutation-positive germline as well as somatic mutation-positive tumors. Also, it looked at a potential biomarker for loss of heterozygosity, in addition to the question of whether there was a BRCA mutation.
e mutation-positive had a very high response rate to the PARP inhibitor. In fact, there was an objective response rate of 80% if one looks specifically at response evaluation criteria in solid tumors (RECIST) and 85% if RECIST plus CA125 was included in this population—that is, specifically the women with a known BRCA mutation in the germline. However, of particular importance, in the individuals with a somatic mutation, not a germline mutation, in BRCA, which included a total of 14 patients, the objective response rate by RECIST was 74%; and when that included CA125, the objective response rate increased to 84%.
Clearly, this is a very active drug in the high-grade serous ovarian cancer patient; it has recently led to the availability of this agent in the United States via FDA approval. This is the second PARP inhibitor that has been approved for use in the United States in the management of ovarian cancer, along with olaparib, and it is a very important addition to the armamentarium of oncologists caring for women with ovarian cancer.
It is clear that this class of agents is active in ovarian cancer, and future research in this area and results are awaited with great anticipation. This is clearly a classic drug, so it is going to have a very positive impact on both time-progression symptoms and survival in ovarian cancer.