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:

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:


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


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%


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.

Mona Guo, OTF