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Study 19

Olaparib Maintenance Therapy in Platinum-Sensitive Relapsed Ovarian Cancer

Date of Publication:

April 12, 2012

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/22452356/
Hypothesis:

Will the addition of olaparib maintenance therapy prolong PFS in platinum-sensitive recurrent ovarian cancer that responded to conventional chemotherapy?

Control Arm(s):

Placebo

Experimental Arm(s):

Olaparib 400mg PO BID

Primary End Point:

PFS

Inclusion Criteria:

Recurrent, high-grade serous ovarian cancer

2+ platinum-containing treatment regimens

Exclusion Criteria:

Prior PARP

Results:

Olaparib vs. Placebo:

median treatment duration ~7 months

median PFS: 8.4 vs. 4.8 months (SS)

AEs higher with olaparib: nausea, fatigue, vomiting, & anemia

Conclusions:

Olaparib maintenance prolonged PFS in women with recurrent platinum-sensitive ovarian cancer regardless of BRCA status with manageable toxicity.

Reviewer:
Ross Harrison, OTF