Women with BRCA-mutated relapsed serous ovarian cancer who received AstraZeneca’s Lynparza (olaparib) as a maintenance therapy after responding to platinum-based chemotherapy took an average 14 months to see their disease progress, compared to 7.3 months among patients receiving placebo.
Additionally, the quality of life (QoL) in the two groups was similar, according to ratings by the patients.
The results came from the SOLO-2 Phase 3 clinical trial (NCT01874353), summarized in the presentation “Health-related quality of life (HRQOL) and patient-centered outcomes with maintenance olaparib compared with placebo following chemotherapy in patients with germline (g) BRCA-mutated (m) platinum-sensitive relapsed serous ovarian cancer (PSR SOC): SOLO2 phase III trial.”
The study, presented at the June 2-6 American Society of Clinical Oncology (ASCO) 2017 Annual Meeting in Chicago, evaluated patients’ time to disease progression (PFS), quality of life (QoL) and time without symptoms of disease or toxicity (TWiST), along with the safety profile. Patients were observed for up to 27 months after the beginning of the trial, which randomized 295 patients into test and placebo groups.
All women had been treated at least twice with platinum-based chemotherapy and had partially or completely responded to their most recent treatment. The women had BRCA1 or BRCA2 breast cancer gene mutations in their DNA. BCRA proteins normally repair DNA, but mutations in the genes that code for them can leave DNA without repair, causing cancer.
Women taking Lynparza reported a similar QoL as those receiving placebo on rating scales assessing function, physical well-being and symptoms. Also, TWiST was an average of 6.29 months longer in the treated group (13.5 months) than in the untreated group (7.21 months). PFS was an average of 13.96 months in the treated group, compared to 7.28 months in the placebo group, or 6.68 months longer.
Trial participants received a total of four Lynparza tablets (300 mg) daily and the safety profile was found to be similar to treatment with Lynparza capsules.
Severe to life-threatening adverse events were reported in 36.9 percent of the treated group and in 18.2 percent of the untreated group. Other adverse events were nausea, fatigue, vomiting, diarrhea and abdominal pain, while 19.5 percent of treated patients reported anemia..
“This is very good news for patients, because it suggests that olaparib not only has the potential to significantly prolong the amount of time they have before their disease progresses, but that additional time does not come at the cost of their quality of life,” Eric Pujade-Lauraine, principal investigator of SOLO-2 and head of the Women Cancers and Clinical Research Department at Hôpitaux Universitaires in Paris, said in a press release.
“This may mean patients feel more able to adhere to maintenance treatment,” he added. “This contrasts with what we have seen in the past with chemotherapy where the price of longer progression-free survival is often reduced quality of life leading to poor adherence to treatment.”