The BAROCCO Study (Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib): an Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib With Continuous Schedule vs. Cediranib-Olaparib With Intermittent Schedule in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

Trial ID # NCT03314740; BAROCCO
Phase II
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
Drugs in Trial Cediranib, Olaparib, Paclitaxel
Eligible Participant

Platinum-resistant ovarian cancer

Patients Enrolled

123 (median platinum-free interval 1.8 months; 59% of patients had > 3 prior therapies)

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

PFS, evaluated per RECIST

Biomarkers

Exploratory: BRCA status

Efficacy

Ola+Ced (continuous) vs Ola+Ced (intermittent) vs Pac:

PFS: 5.7 vs 3.8 vs 3.1 months, HR: 0.76 (0.49-1.17, p = 0.28); HR:1.08 (0.71-1.64, p = 0.76)

Exploratory analysis:
gBRCA WT (n=109): PFS: 5.8 vs 3.8 vs 2.1 months, HR: 0.63 (0.36-1.10, p = 0.10)

Clinically Significant Adverse Events

Ola+Ced (continuous) vs Ola+Ced (intermittent) vs Pac:
Serious AE: 2 deaths; 1 in Ola+Ced (continous), 1 in Pac
Grade 3-4 AE:

Conclusion

Olaparib+cediranib (continuous dosing) shows a promising trend towards improved PFS in comparison with weekly paclitaxel, in particular in BRCA WT patients

Reference

Colombo N et al. BAROCCO: A randomized phase II study of weekly paclitaxel vs cediranib-olaparib combination given with continuous or intermittent schedule in patients with recurrent platinum resistant ovarian cancer (PROC). ESMO (2019) Abstr LBA58
https://cslide.ctimeetingtech.com/esmo2019/attendee/confcal/presentation/list?q=barocco