This maintenance therapy approach approved progression-free survival without a major impact on quality of life in patients with newly diagnosed ovarian cancer with a BRCA mutation who recently responded to chemotherapy.
Maintenance therapy with Lynparza (Olaparib) substantially prolonged progression-free survival without impacting health-related quality of life in patients with newly diagnosed ovarian cancer with a BRCA mutation who responded to platinum-based chemotherapy, according to a study published in Lancet Oncology.
“Radiological disease progression was associated with worsening health status, highlighting the effect of disease progression on the health status of patients and the potential benefits of delaying or preventing progression with maintenance (Lynparza),” the study authors wrote.
In this phase 3 international trial, researchers aimed to assess health-related quality of life and patient-centered outcomes in 391 patients with newly diagnosed ovarian cancer with a BRCA mutation and who had a partial or complete response to platinum-based chemotherapy. Within eight weeks of completing chemotherapy, patients were assigned either 300 milligrams of Lynparza (260 patients; median age, 53 years) or placebo (131 patients; median age, 53 years) twice per day for up to two years.
MRIs and CT scans were performed at the start of the study and every 12 weeks for up to three years, then every 24 weeks until disease progression. Researchers analyzed health-related quality of life (a patient’s perceived mental and physical health over time) through a score that ranged from zero to 100, with higher scores indicating better health-related quality of life. A meaningful change in this score was indicated by a difference of at least 10 points. Other factors assessed in this trial included progression-free survival and time without significant symptoms of toxicity. Follow-up was conducted for a median of 40.7 months in the Lynparza group compared with 41.2 months in the placebo group.
At 24 months, clinically meaningful changes in health-related quality of life scores were not observed within or between patients assigned Lynparza (adjusted mean change in score, 0.3 points) or those assigned placebo (adjusted mean change in score, 3.3 points).
Patients in the Lynparza group has significantly longer progression-free survival versus those in the placebo group (29.75 months versus 17.58 months). This was also seen when assessing time without significant symptoms of toxicity (33.15 months versus 20.24 months).
“Although challenging, collection of longitudinal data on (health-related quality of life) in clinical trials over time and beyond progression is important to understand the (health-related quality of life) benefits of maintenance (Lynparza) to patients associated with delaying progression and increasing the time to first subsequent lines of chemotherapy,” the study authors wrote.
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