| Title: |
Maintenance treatment with rucaparib for recurrent ovarian carcinoma in ARIEL3, a randomized phase 3 trial: The effects of best response to last platinum-based regimen and disease at baseline on efficacy and safety |
| Authors: |
Oaknin, A; Oza, AM; Lorusso, D; Aghajanian, C; Dean, A; Colombo, N; Weberpals, JI; Clamp, AR; Scambia, G; Leary, A; Holloway, RW; Amenedo Gancedo, M; Fong, PC; Goh, JC; O'Malley, DM; Armstrong, DK; Banerjee, S; García-Donas, J; Swisher, EM; Cameron, T; Maloney, L; Goble, S; Ledermann, JA; Coleman, RL |
| Source: |
Cancer Medicine (2021) (In press). |
| Publication Year: |
2021 |
| Collection: |
University College London: UCL Discovery |
| Subject Terms: |
Clinical trials; gyecological oncology; medical oncology; target therapy; women's cancer |
| Description: |
BACKGROUND: The efficacy and safety of rucaparib maintenance treatment in ARIEL3 were evaluated in subgroups based on best response to most recent platinum-based chemotherapy and baseline disease. METHODS: Patients were randomized 2:1 to receive either oral rucaparib at a dosage of 600 mg twice daily or placebo. Investigator-assessed PFS was assessed in prespecified, nested cohorts: BRCA-mutated, homologous recombination deficient (HRD; BRCA mutated or wild-type BRCA/high loss of heterozygosity), and the intent-to-treat (ITT) population. RESULTS: Median PFS for patients in the ITT population with a complete response to most recent platinum-based chemotherapy was 11.1 months in the rucaparib arm (126 patients) versus 5.6 months in the placebo arm (64 patients) (HR, 0.33 [95% CI, 0.23-0.48]), and in patients with a partial response (249 vs. 125), it was 9.0 versus 5.3 months (HR, 0.38 [0.30-0.49]). In subgroups of the ITT population based on baseline disease, median PFS was 8.2 versus 5.3 months (HR, 0.40 [0.28-0.57]) in patients with measurable disease (141 rucaparib vs. 66 placebo), 10.4 versus 4.5 months (HR, 0.31 [0.20-0.48]) in those with nonmeasurable but evaluable disease (104 vs. 56), and 14.1 versus 7.3 months (HR, 0.35 [0.24-0.51]) in those with no residual disease (130 vs. 67). Across subgroups, significantly longer median PFS was observed with rucaparib versus placebo in the BRCA-mutated and HRD cohorts. Objective responses were reported in patients with measurable disease and in patients with nonmeasurable but evaluable baseline disease. Safety was consistent across subgroups. CONCLUSION: Rucaparib maintenance treatment provided clinically meaningful efficacy benefits across subgroups based on response to last platinum-based chemotherapy or baseline disease. |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/10135859/1/Ledermann_Maintenance%20treatment%20with%20rucaparib%20for%20recurrent%20ovarian%20carcinoma%20in%20ARIEL3,%20a%20randomized%20phase%203%20trial_AOP.pdf; https://discovery.ucl.ac.uk/id/eprint/10135859/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/10135859/1/Ledermann_Maintenance%20treatment%20with%20rucaparib%20for%20recurrent%20ovarian%20carcinoma%20in%20ARIEL3,%20a%20randomized%20phase%203%20trial_AOP.pdf; https://discovery.ucl.ac.uk/id/eprint/10135859/ |
| Rights: |
open |
| Accession Number: |
edsbas.EF47F3B5 |
| Database: |
BASE |