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ARIEL3

Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial

Date of Publication:

October 28, 2017

Pubmed Link:
ncbi.nlm.nih.gov/pmc/articles/PMC5901715/pdf/nihms956813.pdf
Hypothesis:

Does Rucaparib maintenance  improve PFS for patients with high-grade, platinum-sensitive recurrent ovarian carcinoma who have responded to second-line or later platinum-based chemotherapy?

Control Arm(s):

Placebo BID continuous 28 day cycles until progression

Experimental Arm(s):

Rucaparib 600mg BID continuous 28 day cycles until progression

Primary End Point:

PFS

Inclusion Criteria:

Platinum sensitive recurrent HGS or endometriod ovarian carcinoma

>2 prior platinum-based chemo regimens w/complete or partial response. After 11/2014, amendment: most recent chemo needed to be platinum-based doublet for 4+ cycles

normal CA125

Exclusion Criteria:

Prior PARP treatment

Prior bevacizumab maintenance

Symptomatic/untreated CNS metastasis

Results:

Rucaparib vs Placebo:

median PFS BRCAm: 16.6 vs 5.4 mos (SS)

medain PFS BRCAwt HRD: 13.6 vs 5.4 mos (SS)

grade 3+ adverse events: 56% vs 15% (anemia, AST/ALT elevation)

MDS/AML: 1% of rucabarib pts

dose reduction: 55% vs 4%

Conclusions:

Rucaparib maintenance significantly improves PFS compared to placebo in women with recurrent ovarian carcinoma after a complete or partial response to platinum-based therapy, with the greatest effect in BRCAm and BRCAwt/HRD patients.

Reviewer:
Mona Guo, OTF