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A drug that shrinks a tumour by half but leaves the resistant sub-population untouched will fail. Trials should measure whether every sub-population is cleared, not just overall size.
Response criteria (RECIST) measure bulk diameter; ctDNA endpoints measure total variant allele fraction. Neither captures whether all subclones are suppressed. A clonal clearance endpoint, defined as undetectable plasma signal for every baseline-identified subclone at a fixed timepoint, could be validated as a surrogate and used in early-phase trials to distinguish drugs that shrink from drugs that eradicate.
Shares RECIST, Progression-free survival (PFS), Circulating tumour DNA (ctDNA), Trial design, endpoints and cost.
Shares RECIST, Progression-free survival (PFS), Circulating tumour DNA (ctDNA), Trial design, endpoints and cost.
Shares Tumour heterogeneity and clonal evolution, Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA).
Shares RECIST, Progression-free survival (PFS), Trial design, endpoints and cost.
Shares RECIST, Progression-free survival (PFS), Trial design, endpoints and cost.
Shares RECIST, Progression-free survival (PFS), Circulating tumour DNA (ctDNA).
Shares RECIST, Progression-free survival (PFS).
Shares RECIST, Progression-free survival (PFS).