| The following article features coverage from the Society of Gynecologic Oncology’s 50th Annual Meeting on Women’s Cancer. Click here to read more of Cancer Therapy Advisor‘s conference coverage. |
An analysis of the QUADRA trial (ClinicalTrial.gov Identifier: NCT02354586) revealed that while baseline platelet count and body weight were predictive of a higher frequency of grade 3/4 adverse events in heavily pretreated women with recurrent ovarian cancer receiving maintenance therapy with niraparib, efficacy was not compromised for patients in this subgroup who received a dose reduction. This study was presented at the Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer.
Of the 463 women enrolled in the safety population of the phase 2, single-arm QUADRA trial, 316 (68%) had either a baseline platelet count of less than 150,000/µL or a body weight less than 77 kg. This subgroup of patients experienced higher rates of grade 3/4 adverse events compared with remaining patients, including grade 3/4 thrombocytopenia (30% vs 14%; P <.0001), grade 3/4 neutropenia (12% vs 5%; P <.02), and grade 3/4 anemia (9% vs 3%; P <.02).
In a post-hoc analysis of efficacy data for the subgroup of women with either a low baseline platelet count or low body weight, the objective response rate (ORR), disease-control rate (DCR), and clinical benefit rate at 24 weeks (CBR24) for those who received a mean daily niraparib dose of 200 mg or less compared with more than 200 mg, were 8% vs 7%, 58% vs 39%, and 19% vs 15%, respectively. For the remaining patients without low baseline platelet count or low body weight who received a mean daily niraparib dose of 200 mg or less compared with more than 200 mg, ORR, DCR, and CBR24 were 9% vs 11%, 59% vs 57%, and 21% vs 23%, respectively.
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Reference
- Matulonis, UA, Monk BJ, Secord AA, et al. Baseline platelet count and body weight as predictors of early dose modification in the QUADRA trial of niraparib monotherapy for the treatment of heavily pretreated (≥4th line), advanced, recurrent high-grade serous ovarian cancer. Presented at: Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer; Honolulu, Hawaii; March 16-19, 2019. Abstract 2.
