The substantial progression-free survival benefit provided by maintenance olaparib in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation is achieved with no detrimental effect on patients’ health-related quality of life (HRQOL), Australian researchers say.
According to the SOLO1 study – previously reported in the limbic – there was a 70% lower risk of disease progression or death with the PARP inhibitor than with placebo.
Now new data from the same trial, published in the Lancet Oncology, shows no difference in patient-reported FACT-O scores between women in the olaparib group and those in the placebo group.
The majority of women reported that they were not affected by side-effects and were content with their quality of life.
“In the minority of patients who were troubled by their symptoms, improvement was seen in both treatment groups over time,” the study said.
The mean time without significant symptoms of toxicity (TWiST) was 33·41 months (95% CI 31·19–35·62) with olaparib versus 20.50 months (17·37–23·63) with placebo.
The investigators, led by Professor Michael Friedlander from the University of New South Wales and Prince of Wales Hospital, said it was evident that a diagnosis of disease progression has devastating consequences for many people.
“In particular, disease progression imposed a psychological burden, with high levels of worsening anxiety and depression, as well as worsening in patients’ worry about death and their condition deteriorating, which is understandable, but has not been well documented in ovarian cancer trials so far.”
They said maintenance olaparib offered the potential benefits of delaying or preventing progression.
“These clinically meaningful patient-centred benefits support the primary endpoint of SOLO1 and the substantial increase in progression-free survival seen with maintenance olaparib in women with newly diagnosed advanced ovarian cancer and a BRCA mutation, after discounting the potential effect of adverse events on patients against the increase in progression-free survival.”
They said their findings were consistent with other studies in which maintenance therapy with other PARP inhibitors had no detrimental effect on mean HRQOL scores.