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Patients with newly diagnosed advanced ovarian cancer still have a high unmet need for treatment that can increase long-term remission rates and potential cure opportunities
.
In the main analysis of the SOLO1/GOG 3004 trial, the PARP inhibitor olaparib significantly improved the progression-free survival of ovarian cancer patients with BRCA mutations compared with placebo
Ovarian cancer
This article reports the latest analysis results of the trial after 5 years of follow-up
.
The SOLO1 trial is a randomized, double-blind, placebo-controlled phase 3 trial carried out in 118 medical centers in 15 countries.
Newly diagnosed patients with advanced high-grade serous or endometrioid ovarian cancer who have achieved complete or partial remission after platinum-based chemotherapy
.
The test patients were randomly (2:1) divided into two groups and received olaparib (300 mg, 2/day) or placebo as a single-agent maintenance treatment for 2 years
Progression-free survival in both groups
Progression-free survival in both groupsFrom September 3, 2013 to March 6, 2015, a total of 260 patients were randomly assigned to the olaparib group and 131 patients were assigned to the placebo group
.
The median duration of treatment in the olaparib group and the placebo group were 24.
The median progression-free survival of the olaparib and placebo groups were 56.
Some side effects occur
Some side effects occurThe most common grade 3-4 side effects were anemia (Olapali group vs placebo group: 22% vs 2%) and neutropenia (8% vs 5%); Olapali group and placebo group The incidence of serious side effects in the drug group was 21% and 13%, respectively
.
During the treatment period and within 30 days after stopping the drug, there were no deaths caused by treatment-related side effects in both groups
The most common grade 3-4 side effects were anemia (Olapali group vs placebo group: 22% vs 2%) and neutropenia (8% vs 5%); Olapali group and placebo group The incidence of serious side effects in the drug group was 21% and 13%, respectively
It is understood that the study is the longest follow-up of randomized controlled trials on PARP inhibitor treatment carried BRCA mutations in newly diagnosed advanced ovarian cancer, the study results show that, using maintenance therapy paclitaxel Ola 2 years, can not be The progression survival period was extended to as long as 4.
5 years
.
The results of this study support the use of olaparib maintenance therapy as the standard treatment for these patients
Maintenance treatment with olaparib for 2 years can extend the progression-free survival to as long as 4.
Original source:
Susanna Banerjee, et al.
Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1 / GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial in this message