Show simple item record

dc.contributor.authorMorgan, Robert David
dc.contributor.authorBanerjee, S
dc.contributor.authorHall, M
dc.contributor.authorClamp, Andrew R
dc.contributor.authorZhou, Cong
dc.contributor.authorHasan, Jurjees
dc.contributor.authorOrbegoso, C
dc.contributor.authorTaylor, Sarah
dc.contributor.authorTugwood, Jonathan D
dc.contributor.authorLyon, AR
dc.contributor.authorDive, Caroline
dc.contributor.authorRustin, GJS
dc.contributor.authorJayson, Gordon C
dc.date.accessioned2020-02-27T16:55:21Z
dc.date.available2020-02-27T16:55:21Z
dc.date.issued2020en
dc.identifier.citationMolloy K, Jonak C, Sherida F, Woei A, Guenova E, Busschots A, et al. An overall response in skin is associated with improved HRQoL in patients with MF/SS enrolled in the PROCLIPI study. European Journal of Cancer. 2019;119:S39.en
dc.identifier.pmid31932108en
dc.identifier.doi10.1016/j.ygyno.2020.01.005en
dc.identifier.urihttp://hdl.handle.net/10541/622745
dc.description.abstractOBJECTIVE: Vascular co-option is a resistance mechanism to anti-angiogenic agents, but combinations of anti-vascular agents may overcome this resistance. We report a phase 1b and randomised phase 2 trial to determine the safety and efficacy of pazopanib with fosbretabulin. METHODS: Eligible patients had recurrent, epithelial ovarian cancer with a platinum-free interval (PFI) of 3 to 12 months. Patients were stratified according to PFI (>6 versus ?6 months) and prior bevacizumab use. RESULTS: Twelve patients were treated in the phase 1b. Commonest grade ? 2 adverse events (AEs) were hypertension (100%), neutropenia (50%), fatigue (50%), vomiting (50%). There was one DLT (grade 3 fatigue). The recommended phase 2 dose level was fosbretabulin 54 mg/m2 on days 1, 8 and 15 and pazopanib 600 mg once daily (od), every 28 days, which was then compared to pazopanib 800 mg od in a randomised phase 2 trial. Twenty-one patients were randomised (1:1) in the phase 2 trial. In phase 1b and phase 2, four patients treated with pazopanib and fosbretabulin developed reversible, treatment-related cardiac AEs, leading to premature discontinuation of the study. In the phase 2 trial, the median PFS was 7.6 months (95% CI 4.1-not estimated) versus 3.7 months (95% CI 1.0-8.1) in favour of the experimental arm (HR 0.30, 95% CI 0.09-1.03, P = .06). CONCLUSIONS: It remains unclear whether pazopanib with with fosbretabulin is an efficacious regimen to treat epithelial ovarian cancer. Effective cardiac risk mitigation is needed to increase the tolerability and maximize patient safety in future trials.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/j.ygyno.2020.01.005en
dc.titlePazopanib and fosbretabulin in recurrent ovarian cancer (PAZOFOS): A multi-centre, phase 1b and open-label, randomised phase 2 trialen
dc.typeArticleen
dc.contributor.departmentChristie NHS Foundation Trust, Manchester, UK; Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UKen
dc.identifier.journalGynecologic Oncologyen
dc.description.noteen]


Files in this item

This item appears in the following Collection(s)

Show simple item record