Screening failure in clinical trials for patients with head and neck squamous cell carcinoma: A retrospective analysis.

Pablo Jiménez Labaig Head and Neck Unit, The Royal Marsden NHS Foundation Trust, London, United Kingdom info_outline Pablo Jiménez Labaig, Sandra Llop, Antonio Rullan, Ben O'Leary, Kate Newbold, Kee Howe Wong, Shreerang Bhide, Christopher Nutting, Kevin Joseph Harrington

Authors Pablo Jiménez Labaig Head and Neck Unit, The Royal Marsden NHS Foundation Trust, London, United Kingdom info_outline Pablo Jiménez Labaig, Sandra Llop, Antonio Rullan, Ben O'Leary, Kate Newbold, Kee Howe Wong, Shreerang Bhide, Christopher Nutting, Kevin Joseph Harrington Organizations Head and Neck Unit, The Royal Marsden NHS Foundation Trust, London, United Kingdom, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, United Kingdom, The Institute of Cancer Research, London, United Kingdom, The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom, The Royal Marsden NHS Foundation Trust, London, United Kingdom, Royal Marsden Hospital and Institute of Cancer Research, Sutton, United Kingdom, The Institute of Cancer Research/The Royal Marsden Hospital, London, United Kingdom Abstract Disclosures Research Funding No funding sources reported Background: Clinical trials drive improvements in patient care with head and neck squamous cell carcinoma (HNSCC), presenting opportunities for optimizing clinical outcomes. However, a significant number of patients (pts) miss out on new therapeutic opportunities due to screen failure (SF) after signing the informed consent form. Understanding the circumstances leading to SF might improve enrollment processes. Methods: Retrospective cohort analysis of pts with HNSCC intended for treatment within a clinical trial at the Royal Marsden Cancer Centre but who experienced SF between Jan 2016 and Jan 2024. Demographic and cancer-related characteristics, comorbidities, consent and SF dates, SF causes, and subsequent outcomes after SF were analyzed. Results: 76 pts who experienced SF were identified across 33 different trials. Cohort characteristics and type of trials offered are described in the table. The largest number of SFs was due to exclusion criteria being met in screening tests in 37 pts (49%): Pathology sample did not meet the quality standards in 11 pts (14%); abnormal laboratory tests in 5pts (6%); abnormal echocardiogram/reduced ejection fraction in 5 pts (6%); vessel invasion/ encasement in 4 pts (5%); non-measurable disease in 2 pts (3%); abnormal audiometry in 1pt (1%) among other reasons. The next commonest cause of SF was rapid progression during screening in 28 pts (37%): 11% compromised airway; 11% active bleeding; 5% central nervous system progression and 7% other rapid progression causes. Other causes of SF included: withdrawn consent in 7 pts (9%), comorbidity-related complication in 3 pts (5%) and study termination by sponsor in 2 pts (3%). The median time between consenting and SF was 20 days (range 4-42). After SF, 8% reconsented for the same trial, 56% received standard therapy, and 36% received best supportive care. Conclusions: This study reveals abnormal screening tests and rapid progression as primary causes for SF in patients with HNSCC. Timely referral , airway assessments and improved tissue acquisition could improve enrollment and minimize SF. Cohort characteristics. Variable n (%) Age: median (range) 62 (30-87) Gender Male vs Female 63 (83%) vs 13 (17%) Referral site -Royal Marsden Cancer Centre -External centre 36 (47%) 40 (53%) Location -Oropharynx -Oral cavity -Larynx -Hypopharynx -Unknown HNSCC 37 (49%) 19 (25%) 11 (14%) 6 (8%) 3 (4%) ECOG: 0 vs 1 32 (42%) vs 44 (58%) Disease location:* Local // regional // Distant 22 (21%) // 45 (42%) // 39 (37%) Trial setting: Palliative setting First-line treatment Second-line or beyond Curative setting 68 (90%) 41 (53%) 27 (37%) 8 (10%) Clinical trial phase: Phase I Phase II Phase III 7 (9%) 24 (32%) 45 (59%) Type of treatment: * Includes immunotherapy Includes targeted therapy Includes intratumoural injection 63 (83%) 11 (14%) 7 (9%) *Overlapping characteristics in some patients.