Ovarian cancer patients who responded to platinum-based chemotherapy after failing at least one prior treatment may take Lynparza (olaparib) as maintenance therapy without worrying about their quality of life, a new study shows.
The treatment is already approved for preventing disease progression or a relapse, and additional analysis shows that quality of life is not affected. If anything, patients experience meaningful benefits, researchers say.
The study, “Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial,” was published in The Lancet Oncology.
The SOLO-1 (NCT01844986) and SOLO-2 (NCT01874353) Phase 3 studies have shown that women with BRCA-mutated ovarian cancer who partially or completely responded to platinum-based chemotherapy lived significantly longer if treated with Lynparza maintenance before their disease worsened.
While SOLO-1 was for women who responded to first-line platinum-based chemotherapy, SOLO-2 studied the maintenance treatment in women who had failed prior treatment approaches.
The delay in death and disease progression is expected to make treatment worthwhile, but researchers need to make sure the adverse effects of treatment do not detract from health-related quality of life. This is particularly important in patients receiving maintenance treatments, as most are well and have no cancer-related symptoms.
Researchers set out to examine the impact of Lynparza in the quality of life of patients included in SOLO-2.
The trial’s 295 patients were given either Lynparza or a placebo after responding to platinum-based chemotherapy. For each patient receiving the placebo, two were given the active drug.
Lynparza extended the time a patient lived without disease worsening from a median of 5.5 months to 19.1 months, representing a 70% reduction in the risk of disease progression or death.
Now, researchers hypothesized that this maintenance therapy would not have a negative effect on a patient’s health-related quality of life.
In a pre-specified analysis, investigators evaluated the change during the first year of treatment in the Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Trial Outcome Index (TOI) score.
FACT-O is a well-validated questionnaire used to assess quality of life in women with ovarian cancer, also focusing on treatment-induced adverse effects.
TOI summarizes physical and functional well-being and scores key symptoms assessed in the FACT-O questionnaire from 0 to 100, with higher scores meaning better health-related quality of life.
Patients filled out the FACT-O questionnaire at the beginning of the trial, and at weeks 5, 13, and every 12 weeks until the study ended.
Researchers also analyzed the duration of good quality of life, defined as the time without significant symptoms of toxicity (TWiST) and quality-adjusted progression-free survival (QAPFS). QAPFS incorporates progression-free survival and health state into a single measure.
In the first year of treatment, patients receiving Lynparza or the placebo had similar changes in TOI scores, meaning that their health-related quality of life was similar.
However, patients receiving Lynparza had higher QAPFS and TWiST scores, suggesting they fared better and remained without significant symptoms of toxicity for longer periods.
“These results support the primary outcome of SOLO2 and indicate that the significant prolongation of progression-free survival with [Lynparza] in this patient population was achieved with no appreciable detrimental effect on patients’ [quality of life] and supported by additional patient-centered benefits,” the researchers wrote.