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Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer.
- Source :
-
Gynecologic oncology [Gynecol Oncol] 2022 Mar; Vol. 164 (3), pp. 505-513. Date of Electronic Publication: 2022 Jan 19. - Publication Year :
- 2022
-
Abstract
- Background: Previous findings showed that cediranib-olaparib increased PFS in women with recurrent platinum-sensitive ovarian cancer compared to olaparib alone.<br />Methods: BAROCCO trial randomized 123 patients: 80mg/m2 paclitaxel weekly up to 24 weeks (control), olaparib 300mg tablets twice daily together with 20mg cediranib daily (continuous schedule) or with 20mg cediranib 5 days/week (intermittent schedule) until progression. The primary objective was the PFS comparison between each experimental arm and the control (alpha one-sided 5%; power 80%; HR 0.5).<br />Results: The median platinum-free interval was 1.9 months, 60% of patients had been pretreated with 3 or more chemotherapy lines. Median PFS for paclitaxel, the continuous, and the intermittent schedules were 3.1, 5.6, and 3.8 months. The HR for PFS in the continuous arm vs control was 0.76 (90% CI: 0.50-1.14, p = 0.265). The HR for PFS in the intermittent arm vs control was 1.03 (90% CI: 0.68-1.55, p = 0.904). Treatment was discontinued due to adverse events in 15%, 20%, and 5% of patients in the control, continuous and intermittent arms. Grade ≥ 3 anemia and diarrhea and hypertension of any grade occurred only in the experimental arms, and peripheral neuropathies and alopecia only in the control arm. Five serious adverse drug reactions occurred and two were fatal: one in the control and one in the continuous arm.<br />Conclusions: The combination of cediranib-olaparib was not superior to chemotherapy in terms of PFS in heavily pretreated platinum-resistant ovarian cancer patients. However, this oral doublet, is active and may offer a non-chemotherapy option in this difficult to treat population.<br />Clinical Trial Identification: IRFMN-OVA-7289, EudraCT: 2016-003964-38, NCT03314740.<br /> (Copyright © 2022 Elsevier Inc. All rights reserved.)
- Subjects :
- Antineoplastic Combined Chemotherapy Protocols adverse effects
Carcinoma, Ovarian Epithelial drug therapy
Carcinoma, Ovarian Epithelial etiology
Female
Humans
Neoplasm Recurrence, Local drug therapy
Paclitaxel
Phthalazines
Piperazines
Quinazolines
Ovarian Neoplasms drug therapy
Ovarian Neoplasms etiology
Peripheral Nervous System Diseases
Subjects
Details
- Language :
- English
- ISSN :
- 1095-6859
- Volume :
- 164
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Gynecologic oncology
- Publication Type :
- Academic Journal
- Accession number :
- 35063281
- Full Text :
- https://doi.org/10.1016/j.ygyno.2022.01.015