Phase II window study of olaparib alone or with cisplatin or durvalumab in operable Head and Neck Cancer

نویسندگان

چکیده

Abstract Purpose:We conducted a phase II randomized non-comparative window of opportunity trial to evaluate the inhibition cellular proliferation and modulation immune microenvironment after treatment with Olaparib alone or in combination Cisplatin Durvalumab operable Head Neck Squamous Cell Carcinoma (HNSCC) patients. Patients Methods:Forty-one HNSCC patients were plus (Arm A), B), no C) D). The primary endpoint was percentage each arm that achieved reduction at least 25% Ki67. Secondary endpoints included objective response rate (ORR), safety pathologic complete (pCR). Paired baseline resection tumor biopsies blood samples evaluated for pre-specified biomarkers. Results:A decrease Ki67 observed 44.8% treated patients, as measured by quantitative immunofluorescence (QIF). ORR among 12.1%. pCR 2 Two serious adverse events occurred PD-L1 levels significantly higher arms (A) (D). Expression CD163 Colony Stimulating Factor 1 Receptor (CSF1R) genes, markers M2 macrophages, increased posttreatment whereas expression CD80 marker M1 macrophages decreased. Conclusions:Preoperative safe preoperative setting led Olaparib-based modulates leading upregulation induction pro-tumor features macrophages.

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ژورنال

عنوان ژورنال: Cancer research communications

سال: 2023

ISSN: ['2767-9764']

DOI: https://doi.org/10.1158/2767-9764.crc-23-0051