Olaparib, durvalumab, and cyclophosphamide, and a prognostic blood signature in platinum-sensitive ovarian cancer: the randomized phase 2 SOLACE2 trial.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Lee Chee Khoon, Kartikasari Apriliana E R, Bound Nirashaa T, Francis Katherine E, Shield-Artin Kristy, Bedo Justin, Nesic Ksenija, Diamante Katrina, O'Connell Rachel L, Madondo Mutsa, Cox Momodou, Davies Claire, Deceneux Cyril, Goodchild Georgia, Jarratt Andrew, Cassar Emily, Amer Hina, Kariyawasam U G Imalki U, Lee Yeh Chen, Lombard Janine, Baron-Hay Sally, Antill Yoland, Shannon Catherine, Selva-Nayagam Sudarshan, Beale Philip, Zebic Danka, Simon Sandy, Linaker Anneliese, Quinn Michael A, Papenfuss Anthony T, Wakefield Matthew J, Vandenberg Cassandra J, Friedlander Michael, Scott Clare L, Plebanski Magdalena
Аннотация
SOLACE2 (ACTRN12618000686202) investigates whether 12-weeks of olaparib, or cyclophosphamide-olaparib priming, improves subsequent durvalumab-olaparib progression-free survival (PFS), and is superior to olaparib monotherapy without any priming, in platinum-sensitive recurrent ovarian cancer (n = 114). We also evaluate the utility of CUP-CC assay, an immune signature of C-C chemokine receptor type 4 up-regulation, chemokines, and cytokines. Priming with olaparib, or cyclophosphamide-olaparib, followed by durvalumab-olaparib, are both associated with longer PFS compared to olaparib monotherapy, but do not reach the pre-specified primary endpoint of 36-week trial threshold (PFS36). PFS36 rates are 47.4% (95% CI, 31.0-62.1; olaparib priming then olaparib-durvalumab), 48.7% (32.5-63.2; olaparib-cyclophosphamide then olaparib-durvalumab) and 35.1% (20.4-50.3; olaparib monotherapy). PFS is significantly longer for the homologous recombination deficient (N = 71) as compared to the proficient (HRP) (N = 29) subgroups (Hazard Ratio (HR) 0.55, 0.35-0.87). CUP-CC+ subgroup (N = 58) has a significantly longer PFS (HR 0.31, 0.19-0.49) than CUP-CC- (N = 46). Future studies should investigate whether CUP-CC has the potential to personalize poly (ADP-ribose) polymerase inhibitor therapies for patients who are BRCA wild-type, including HRP patients.