Multi-maintenance olaparib in relapsed, platinum-sensitive BRCA-mutant high-grade serous ovarian carcinoma (MOLTO): A phase II feasibility study
Authors
Morgan, Robert DavidClamp, Andrew R
Ryder, W. D. J.
Wheeler, C.
Buckley, E.
Truelove, J.
Murphy, A. D.
Hasan, Jurjees
Mitchell, Claire L
Burghel, G. J.
White, Daniel J
Price, M.
Bhaskar, S. S.
Shaw, J.
Dive, Caroline
Wallace, A. J.
O'Connor, James P B
Rothwell, Dominic G
Edmondson, R. J.
Jayson, Gordon C
Affiliation
Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UKIssue Date
2021
Metadata
Show full item recordAbstract
Background Relapsed, platinum-sensitive high-grade serous ovarian carcinoma (RPS-HGSOC) is treated with platinum re-challenge. One course of olaparib maintenance monotherapy (OLAP1) improves PFS in RPS-HGSOC. It is unclear whether a second olaparib maintenance monotherapy course (OLAP2) in RPS-HGSOC following platinum re-challenge (PLAT2) is feasible. Methods Single centre, non-randomised, phase II study to determine feasibility of OLAP2 after response to PLAT2 in BRCAm RPS-HGSOC. Co-primary endpoints: 1) percentage of patients that started PLAT2 who received one dose of OLAP2 (N3/N2) and; 2) percentage of patients who received OLAP2+/-Cediranib ?6 months (N4/N3). Two trial entry points (EPs) pre-PLAT: 1) olaparib-na�ve (EP1, Pre-PLAT1) and; 2) OLAP1 pre-treated (EP2, Pre-PLAT2). If PFI ?6months on OLAP1, patient offered OLAP2. If PFI <6months on OLAP1, patient offered OLAP2+Cediranib. Results Between May 2017 and September 2019, 27 patients were enrolled (N1;EP1=17; EP2=10). BRCA1:BRCA2 22:5. Age range: 44-78 years. Three (median) lines of platinum chemotherapy prior to OLAP1. N=23 responded to PLAT1 and received OLAP1. N=18 received PLAT2 (N2) and N=11 achieved RECIST CR/PR/SD to PLAT2 and subsequently received OLAP2+/-Cediranib (N3/N2=61%). N=4 completed ?6 months OLAP2 (N4/N3=36%). Commonest grade 2-3 AEs during OLAP2 were anaemia (n=3 G2, n=1 G3), abdominal pain (n=1 G2, n=2 G3), fatigue (n=1 G2, n=2 G3), nausea (n=3 G2). No cases of AML/MDS, pneumonitis/ILD or new secondary malignancy were reported. Key efficacy endpoints in the table. Tumour and ctDNA HRD/CNV-based concurrent biomarker study will also be presented. Conclusions No new safety concerns with OLAP2. OLAP2 demonstrated modest efficacy compared to OLAP1.Citation
Morgan RD, Clamp AR, Ryder WDJ, Wheeler C, Buckley E, Truelove J, et al. 731P Multi-maintenance olaparib in relapsed, platinum-sensitive BRCA-mutant high-grade serous ovarian carcinoma (MOLTO): A phase II feasibility study. Vol. 32, Annals of Oncology. Elsevier BV; 2021. p. S733�4.Journal
Annals of OncologyDOI
10.1016/j.annonc.2021.08.1174Additional Links
https://dx.doi.org/10.1016/j.annonc.2021.08.1174Type
OtherLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.annonc.2021.08.1174