Recent data published in Gynecologic Oncology has confirmed the safety of olaparib for the treatment of advanced, BRCA-mutated, newly diagnosed ovarian cancer. This data came from the Phase 3 SOLO1 trial, which evaluated olaparib in 391 patients who responded to first-line platinum-based chemotherapy.
About the Study
The 391 participants were randomized 2:1, with 260 patients receiving olaparib and 131 receiving placebo. In terms of median duration of treatment, the olaparib group saw a duration of 24.6 months, which can be compared to the placebo group’s 13.9 months.
- 5-year progression-free survival (PFS) rate
- 48.3% in olaparib group
- 20.5% in placebo group
- Incidence of serious adverse events (AEs)
- 20.8% in olaparib group
- 12.3% in placebo group
- Incidence of AEs up to 30 days post-treatment
- 98.5% in olaparib group
- 92.3% in placebo group
- No new safety signals
- The most common AEs include fatigue, anemia, thrombocytopenia, nausea, vomiting, and neutropenia
- Most AEs within the olaparib arm of the trial were manageable with changes to dosage or supportive treatment
- No new cases of acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) in either arm of the trial
This data is positive for researchers and patients, as it may lead to another treatment option for ovarian cancer patients.
About Ovarian Cancer
Ovarian cancer forms in the ovaries, which are reproductive organs. There are four types of this cancer: epithelial tumors, stromal carcinoma tumors, germ cell carcinoma tumors, and small cell carcinoma of the ovary (SCCO). This cancer may also be BRCA-mutated, meaning a patient has a mutated version of the BRCA1 or BRCA2 gene. When one has this genetic mutation, they live at a higher risk of ovarian and breast cancer.
Symptoms of ovarian cancer include pelvic pain, swelling in the abdomen, urinary symptoms, bloating, and loss of appetite. Symptoms specific to SCCO are an irregular menstrual cycle, vaginal secretions, tender breasts, abnormal uterine bleeding, increased abdominal girth and mass, endometrial hyperplasia, and virilizing symptoms. Medical professionals are unsure as to what causes this cancer, but they do know that the BRCA1 and BRCA2 genes can play a role. Treatment typically consists of surgically removing the ovaries, fallopian tubes, uterus, nearby lymph nodes, and the omentum. In certain cases, only one ovary and/or fallopian tube may be removed. Chemotherapy, radiation therapy, and other medications may also be utilized.
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