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Abstract - BMJ
Background:
Maintenance
monotherapy with the poly(ADP-ribose) polymerase inhibitor olaparib
significantly prolongs progression-free survival over placebo in
patients with platinum-sensitive relapsed serous ovarian cancer, with
greatest benefit seen in patients with a BRCA1/2
mutation (BRCAm). Preservation of health-related quality of life
(HRQoL) is important during maintenance therapy; we evaluated the effect
of olaparib on HRQoL in this Phase II trial (NCT00753545, Study 19).
Methods:
Patients received olaparib 400 mg
b.i.d. (capsules) or placebo until progression. Patient-reported HRQoL
and disease-related symptoms were evaluated using the FACT-Ovarian
(FACT-O) questionnaire (completed at baseline and every 28 days until
progression), the FACT/NCCN Ovarian Symptom Index (FOSI) and the Trial Outcome Index (TOI). TOI of the FACT-O was the primary measure.
Results:
Overall, 265 women were randomised to maintenance olaparib (n=136) or placebo (n=129). Compliance for HRQoL assessment was high (~80% over time). Most patients in both arms reported a best response of ‘no change’ on TOI (81%)
and other HRQoL measures. There were no statistically significant
differences in time to worsening or improvement rates of TOI, FOSI and
FACT-O scores in the overall, BRCAm and germline BRCAm populations.
Conclusions:
Maintenance
treatment with olaparib was well tolerated and had no adverse impact on
HRQoL in this study of patients with platinum-sensitive relapsed serous
ovarian cancer who had responded to their most recent platinum-based
therapy (partial or complete response). Interpretation of the HRQoL
results in this population may differ from patients who have not
responded to their most recent platinum-based therapy.
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