Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Proffered paper session - Head and neck cancer

5398 - A phase II window of opportunity study of preoperative olaparib (O) with cisplatin (C) or durvalumab (D) or olaparib alone in in patients with operable squamous cell head and neck carcinoma (HNSCC) (OPHELIA)


22 Oct 2018


Proffered paper session - Head and neck cancer


Cytotoxic Therapy;  Immunotherapy

Tumour Site

Head and Neck Cancers


Amanda Psyrri


Annals of Oncology (2018) 29 (suppl_8): viii372-viii399. 10.1093/annonc/mdy287


A. Psyrri1, P. Economopoulou2, I. Kotsantis3, G. Koutsodontis3, M. Cheila4, G. Papaxoinis5, D.G. Pectasides6, G. Fountzilas7, L. Krikoni8, V. Souliotis8

Author affiliations

  • 1 Internal Medicine/medical Oncology, Attikon University Hospital, 12462 - Athens/GR
  • 2 Medical Oncology, Attikon University Hospital, 12461 - Athens/GR
  • 3 Medical Oncology, Attikon University Hospital, 12462 - Athens/GR
  • 4 Internal Medicine/medical Oncology, Attikon University Hospital, 12461 - Athens/GR
  • 5 Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 6 2nd Department Of Internal Medicine, Hippokration General Hospital, 115 27 - Athens/GR
  • 7 Medical Oncology, Papageorgiou Hospital Aristotle University of Thessaloniki, 564 29 - Thessaloniki/GR
  • 8 Biology, Institute of Biology, Medicinal Chemistry and Biotechnology (IBMCB), 10676 - Athens/GR


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 5398


There is substantial evidence that tumors use PARP to repair platinum- induced DNA damage and escape apoptosis. In addition, unifying model emerges with DNA Damage Response/Repair (DDR/R) and immune response systems being activated in concert.


OPHELIA is phase II trial in which pts are randomized 3:3:3:1 to C 60 mg/m2 on d1 followed by O 75mg d 1-5, O 300 mg bid for 21-28 days, D 1500 mg on d1 followed by O 600mg daily for 21-28 days and no treatment. The D arm will be activated in 9/2018. PBMCs were isolated from blood obtained from pts at diagnosis as well as 24h and 3 weeks following treatment. Double Stranded Brakes/Repair (DSB/R) was measured using phosphorylation of histone H2AX by immunofluorescence and confocal laser microscope analysis, and/or comet assay while Nucleotide Excision Repair (NER) efficiency was measured by southern blotting.


The study continues to recruit pts. Characteristics of 23 enrolled pts were: median age 61.2 years, tobacco use 87%, cT1 (n = 4), cT2 (n = 4), cT3 (n = 2), cT4 (n = 11), cTx (n = 2) and cN0/1 (n = 15), cN2 (n = 8).12 pts were randomized to O, 8 pts to C+O, and 3 pts to no treatment. Preliminary results have demonstrated: 1) No serious study drug-related adverse events or unexpected surgical delays/complications, 2) 4 pts (17%), 3 in O arm and 1 in C+O arm with clinical or pathologic downstaging. 1 pt on O arm had pCR. 15 pts had SD post treatment, 2 pts had PD and 1 had PR. Results are not yet available for 2 pts. 3. Significantly increased ongoing spontaneous DNA damage was obtained in PBMCs from untreated pts compared to healthy controls. Differences in C-induced DNA damage levels were found among pts. Similar formation of monoadducts was found at 3-h ex-vivo C treatment of PBMCs from untreated pts; thereafter, their levels were decreased, with removal capacity being higher in healthy controls than in pts.


Neoadjuvant O with or without C was well tolerated and induced promising antitumor responses. Higher levels of spontaneous ongoing DNA damage were noted in HNSCC pts compared to controls; this feature may serve as a candidate biomarker for response to immunotherapy in HNSCC.

Clinical trial identification

NCT02882308 First posted: August 29, 2016.

Legal entity responsible for the study

Hellenic Cooperative Oncology Group.



Editorial Acknowledgement


A. Psyrri: Advisory board: AstraZeneca; Honoraria: AstraZeneca. G. Fountzilas: Research funding: AstraZeneca. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.