Abstract 112P
Background
Early phase cancer trials (EPCT) are vital to establish the safety and preliminary efficacy of novel investigational medicinal products (IMPs). While some patients may achieve a response from these IMPs, the majority will participate without achieving survival benefit. The relationship between hospital attendance (time toxicity) and outcomes has been poorly characterised in EPCT participants.
Methods
We retrospectively analysed characteristics and outcomes of 80 EPCT participants recruited between 01/2020 - 12/2022. To quantify time toxicity, we used the ratio between recorded hospital attendance and time on trial, defined as the interval between screening and end of study. We differentiated between planned (protocol-mandated) vs. unplanned attendance and tested whether patients requiring additional attendance had different overall survival (OS) outcomes. Prognostically meaningful cut-off values for attendance were tested in uni- and multivariable models.
Results
Out of 212 EPCT referrals, 80 patients were treated. Median age was 62 years (IQR: 51.5-72.0); 45.7% male; 56.8% performance status ≥1. Treatment included immunotherapy (n=46), targeted therapy (n=12), and chemotherapy (n=24). The median time on trial for the cohort was 105 days (95%CI: 79-142), with 6 pts on trial at data cut-off. The median planned attendance was 13.5 days (IQR: 9-21) while median overall attendance was 16 days (IQR 12-22). In total, 45 patients attended >1 day over protocol-mandated visits. Increased attendance was not influenced by performance status (p=0.22), age (p=0.72), primary tumour type (p=0.45), type of IMP (immunotherapy vs. other, p=0.15) or emergence of treatment-related adverse events (p=0.24). Increased attendance was also not associated with worse OS (204 vs. 363 days HR 1.66 95%CI:0.91-3.03, p=0.0937).
Conclusions
In unselected EPCT participants, intensity of attendance is low when adjusted for time on trial, likely due to protracted exposure to effective therapy in responding patients. Increased attendance is unrelated to treatment-related toxicity and does not adversely impact survival. This data promotes prospective reporting of time toxicity in patients receiving experimental therapies for cancer.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Imperial College London.
Funding
Has not received any funding.
Disclosure
A. D'Alessio: Financial Interests, Personal, Sponsor/Funding, Educational support for congress attendance: Roche; Financial Interests, Personal, Other, Consultancy fee: Roche, AstraZeneca, Chugai. C. Celsa: Financial Interests, Personal, Invited Speaker: AstraZeneca, Eisai, Merck Sharp & Dohme, Ipsen; Financial Interests, Personal, Funding, Travel support: Roche. A. Cortellini: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, OncoC4, Ardelis Health, Access Infinity; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, EISAI, BMS, Pierre-Fabre; Financial Interests, Personal, Expert Testimony: AlphaSight. D.J. Pinato: Financial Interests, Personal, Advisory Board: Mina Therapeutics, EISAI, Exact Sciences, MURSLA, H3B, DaVolterra, AstraZeneca, Bayer Healthcare; Financial Interests, Personal, Invited Speaker: BMS, IPSEN, Roche; Financial Interests, Personal, Other, Editor in Chief role: Wiley; Financial Interests, Institutional, Research Grant: BMS, MSD; Non-Financial Interests, Personal, Principal Investigator: Incyte, H3B, Starpharma, Roche, Ribon Therapeutics, Turning Point Therapeutics, Apollomics; Non-Financial Interests, Personal, Other, Charity Trustee: Cancer Treatment and Research Trust. All other authors have declared no conflicts of interest.