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MUNICH – A randomized trial has shown an "unprecedented" improvement in progression-free survival (PFS) in women with newly diagnosed advanced stage ovarian cancer, with an inhibitor of PARP .
After 3 years, 60.4% of patients remained alive without disease progression after maintenance treatment with olaparib (Lynparza), as a result of chemotherapy and treatment. a surgery. According to Kathleen Moore, MD, of Stephenson Oklahoma Cancer Center in Oklahoma City, this is 26.9% of the group who received standard treatment without anti-PARP treatment.
Perhaps even more impressive, the maintenance treatment stopped after 2 years, but the survival curve of women who received the PARP inhibitor remained stable until the third year of follow-up , suggesting a persistence of the effect of treatment.
"We believe that the SOLO-1 trial demonstrated an unprecedented improvement in progression-free survival in patients with a BRCA mutation and advanced ovarian cancer when the "Olaparib is incorporated after platinum-based chemotherapy," said Moore at the European Society of Medical Oncology's congress. "It seems that the benefit of maintenance of olaparib is extended beyond the two-year period during which patients were receiving treatment."
"We believe that SOLO1 data promises to change the standards of care for women with advanced ovarian cancer carriers with a BRCA mutation, and we hope that they will be coming soon." available for patients, "she added.
The results suggest that the benefits of PARP inhibitor therapy in recurrent ovarian cancer could extend to the foreground, said Jonathan Ledermann, MD, of University College London, in a statement. response to results.
"When patients have a recurrence, it ends up becoming a life-threatening disease," said Ledermann. "Although we prolong the survival or the time that the disease is controlled, they will die of the disease.The real goal of our treatment must now be very focused on the prevention of this first recurrence, which occurs in 70% of patients. "
"If you look at all the tests that have been done and the drugs developed in recent years, we have made very little impression on the first-line treatment of women with ovarian cancer", did he declare. "The possibility of introducing a PARP inhibitor into the first-line therapeutic setting was a very interesting opportunity, especially for women with a BRCA mutation." We know that PARP inhibitors are more effective in patients carrying a BRCA mutation. "
The last word on the success of the test expects data on overall survival, which could be a long wait, Ledermann added. As a group, patients with BRCA mutated ovarian cancer live longer than those with unmutated disease, and the "awesome" lengthening of the 39, recurrence-free interval associated with maintenance treatment by olaparib could prolong the life span.
"There is no doubt that it is a big step forward for patients with ovarian cancer being mutated by BRCA," said Ledermann.
The primary objective of the international phase III randomized study SOLO-1 was to prolong the recurrence-free interval in women with newly diagnosed advanced ovarian cancer associated with a BRCA gene mutation. As Moore and Ledermann pointed out, most patients initially respond to treatment, but the vast majority of them end up having a relapse, from which the disease becomes incurable.
The investigators hypothesized that after primary treatment with 2 years of maintenance therapy with olaparib, it could prolong the period without recurrence, or even increase the number of women cured. Olaparib is already widely used for the treatment of recurrent ovarian cancer, after studies have shown that treatment significantly increases PFS.
SOLO-1 included patients with high-grade ovarian cancer of the newly diagnosed stage III-IV stage III-IV stain or endometrioid associated with germline BRCA mutations or somatic. All patients underwent cytoreductive surgery and received platinum-based chemotherapy. The investigators then randomized patients 2: 1 to receive olaparib – based maintenance treatment or placebo for 2 years.
Moore reported results after a median follow-up of 41 months. The primary analysis included 391 patients.
The analysis revealed an absolute difference of 33% between PFS in three years, resulting in a 70% reduction in the risk of death or progression of the disease with olaparib (95% CI: 0 , from 23 to 0.41, P<0.0001). The placebo group had a median PFS of 13.6 months, while the median had not yet been reached in the olaparib group. Nevertheless, statistical projections indicate that the median PFS of the olaparib group will be about 3 years longer than that of the placebo group, Moore said.
Analysis of the second interval of SSP (SSP2) and time to first subsequent treatment or death also favored the olaparib arm.
"The statistically significant improvement in PFS2 suggests that there is no disadvantage in using olaparib after first-line chemotherapy in patients who re-offend and require further treatment." said Mr. Moore.
The adverse effects were generally low grade and corresponded to clinical experience with olaparib.
The study was funded by AstraZeneca, Merck, Myriad Genetics and the Gynecologic Oncology Group.
Moore has revealed relevant relationships with AstraZeneca, Advaxis, Clovis, Tesaro, Genentech / Roche, Immunogen, LAV Therapeutics, Merck and Janssen.
2018-10-21T16: 30: 00-0400
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