Systematic review of time to subsequent therapy as a candidate surrogate endpoint in advanced solid tumors

Author:

Agapow Paul1ORCID,Mulla Rob1,Markuzon Natasha2ORCID,Ottesen Lone H3ORCID,Meulendijks Didier3ORCID

Affiliation:

1. Oncology R&D ML & AI, AstraZeneca, City House, 130 Hills Rd, Cambridge, Cambridgeshire, CB2 1RE, UK

2. Oncology Data Science, AstraZeneca, 35 Gatehouse Drive, Waltham, MA 02451, USA

3. Late Development Oncology, AstraZeneca, City House, 130 Hills Rd, Cambridge, Cambridgeshire, CB2 1RE, UK

Abstract

Aim: Time to subsequent therapy (TST) is an end point that may complement progression-free survival (PFS) and overall survival (OS) in determining the treatment effect of anticancer drugs and may be a potential surrogate for PFS and OS. We systematically reviewed the correlation between TST and both PFS and OS in published phase 2/3 studies in advanced solid tumors. Materials & methods: Trial-level correlational analyses were performed for TST versus PFS (by investigator and/or central review) and TST versus OS. Results: Of 21 included studies, nine (43%) used ‘time to first subsequent therapy or death’ (TFST) as the TST end point; 11 (57%) used different definitions (‘other TST end points’). There was a strong correlation between TFST and PFS by investigator (medians: R2 = 0.88; hazard ratio [HR]: R2 = 0.91) and TFST versus PFS by central review (medians: R2 = 0.86; HRs: R2 = 0.84). For TFST versus OS there was medium/poor correlation for medians (R2 = 0.64) and HRs (R2 = 0.02). Conclusion: TFST strongly correlates with PFS, but not with OS.

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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