LBA34 Association of homologous recombination deficiency (HRD) with clinical outcomes in a phase III study of olaparib or cediranib and olaparib compared to platinum-based chemotherapy in recurrent platinum-sensitive ovarian cancer (PSOC): Biomarker analyses from NRG-GY004

Swisher, Elizabeth M.; Miller, Austin; Kohn, Elise C.; Brady, Mark F.; Radke, Marc R.; Pennil, Christopher C.; Khasnavis, Nithisha; Buscema, Joseph; Tew, William P.; Muller, Carolyn Y.; Hill, Emily K.; Moore, Richard G.; Michelin, David P.; Waggoner, Steven; Geller, Melissa A.; D’Andre, Stacy D.; Liu, J.; Birrer, Michael J.

doi:10.1016/j.annonc.2021.08.2111

Cited by 5 publications

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“…Recent analysis from the GY0004 trial, presented at ESMO 2021, did not demonstrate a predictive correlation between HR status and response to olaparib and cediranib [ 22 ]. TIE2 has been shown to be predictive of a response to anti-angiogenic agents in biliary and colorectal cancer [ 23 ] and is currently being evaluated in the frontline setting in ovarian cancer in the VALTIVE 1 trial (NCT 04523116).…”

Section: Discussionmentioning

confidence: 99%

Results of a randomised Phase II trial of olaparib, chemotherapy or olaparib and cediranib in patients with platinum-resistant ovarian cancer

Nicum,

McGregor,

Austin

et al. 2024

Br J Cancer

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Background OCTOVA compared the efficacy of olaparib (O) versus weekly paclitaxel (wP) or olaparib + cediranib (O + C) in recurrent ovarian cancer (OC). Aims The main aim of the OCTOVA trial was to determine the progression-free survival (PFS) of olaparib (O) versus the oral combination of olaparib plus cediranib (O + C) and weekly paclitaxel (wP) in recurrent ovarian cancer (OC). Methods In total, 139 participants who had relapsed within 12 months of platinum therapy were randomised to O (300 mg twice daily), wP (80 mg/m2 d1,8,15, q28) or O + C (300 mg twice daily/20 mg daily, respectively). The primary endpoint was progression-free survival (PFS) of olaparib (O) versus olaparib plus cediranib (O + C) or weekly paclitaxel (wP). The sample size was calculated to observe a PFS hazard ratio (HR) 0.64 in favour of O + C compared to O (20% one-sided type I error, 80% power). Results The majority had platinum-resistant disease (90%), 22% prior PARPi, 34% prior anti-angiogenic therapy, 30% germline BRCA1/2 mutations. The PFS was increased for O + C vs O (O + C 5.4 mo (2.3, 9.6): O 3.7 mo (1.8, 7.6) HR = 0.73; 60% CI: 0.59, 0.89; P = 0.1) and no different between wP and O (wP 3.9 m (1.9, 9.1); O 3.7 mo (1.8, 7.6) HR = 0.89, 60% CI: 0.72, 1.09; P = 0.69). The main treatment-related adverse events included manageable diarrhoea (4% Grade 3) and hypertension (4% Grade 3) in the O + C arm. Discussion OCTOVA demonstrated the activity of O + C in women with recurrent disease, offering a potential non-chemotherapy option. Trial registration ISRCTN14784018, registered on 19th January 2018 http://www.isrctn.com/ISRCTN14784018.

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Section: Discussionmentioning

confidence: 99%