SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

This is a retrospective international, multi-center, non-interventional cohort study based on use of data derived from established medical records and secondary analysis of archival tumor samples. The study will collect data on patient and tumor characteristics, PD-L1 status, patterns of treatment, and clinical outcomes, in up to 600 adult patients with recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases falling into specific ICD-10 or International Classification of Diseases, Ninth Revision (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor. For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as the index date. The patient selection period extends from the 1st March 2011 to the 30th June 2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5 years age, and ensures approximately 10 months follow-up for living patients recruited at last day of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC of the oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth), oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in the study (Figure 1). Patients will be identified and followed up through their medical records until death or end of data collection in approximately 20 centers in the US, Asia and Europe. Patients' demographic, clinical characteristics, and medical history will be described. Clinical outcomes including PFS, best response, duration of response, and ORR will be described for the first line and second line of therapy (if any), and OS will be collected A mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has more than one suitable tissue sample, the most recent sample will be used as the mandatory tissue sample. Where available, additional tumor samples obtained at any other time points of the disease will be also collected (optional). The enrolment target is up to 600 patients. Statistical analyses will be performed for the whole cohort, per PD-L1 status and for predefined subgroups.

Sex

All

Inclusion criteria:

1\. Provision of subject informed consent (or consent from next of kin/legal representative if applicable) for use of the data and retrieval of tumor sample, according to local regulations 2. Adult patient (≥ 18 years old) 3. Patient with histologically confirmed SCCHN of oral cavity (tongue, gum, floor of mouth, other/unspecified part of the mouth), oropharynx, hypopharynx or larynx 4. Patient with recurrent or metastatic SCCHN diagnosed between 01 March 2011 and 30 June 2015 5. Mandatory archival tissue sample (most recent) from the primary site, a lymph node or a distant metastatic site:

* Tissue sample less than 5 years old (compared to date of retrieval) if provided as complete block (preferred option) or as section cut within 60 days of shipment from site prior to testing 6. Optional archival tissue samples taken at other time points of the disease from the primary site, a lymph node or a distant metastatic site (where available):
* Tissue sample less than 5 years old (compared to date of retrieval) if provided as complete block (preferred option) or as section cut within 60 days of shipment from site prior to testing.

Exclusion criterion:

1\. Treatment for SCCHN with anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, or any other antibody with known immunomodulatory effect.

• DERIVEDPai SI, Cohen EEW, Lin D, Fountzilas G, Kim ES, Mehlhorn H, Baste N, Clayburgh D, Lipworth L, Resteghini C, Shara N, Fujii T, Zhang J, Stokes M, Wang H, Twumasi-Ankrah P, Wildsmith S, Khaliq A, Melillo G, Shire N. SUPREME-HN: a retrospective biomarker study assessing the prognostic value of PD-L1 expression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. J Transl Med. 2019 Dec 26;17(1):429. doi: 10.1186/s12967-019-02182-1. PMID 31878938