Time to progression ratio in cancer patients enrolled in early phase clinical trials: time for new guidelines?

Sarah Watson, Jessica Menis, Capucine Baldini, Patricia Martin-Romano, Jean Marie Michot, Antoine Hollebecque, Jean Pierre Armand, Christophe Massard, Jean Charles Soria, Sophie Postel-Vinay, Xavier Paoletti

    Research output: Contribution to journalArticlepeer-review

    6 Citations (Scopus)

    Abstract

    Background: Reliable evaluation of treatment benefit in early phase clinical trials is necessary. The time to progression ratio (TTPr), which compares successive TTP in a single patient, is a powerful criteria for determining targeted or immune therapies efficacy. Methods: We evaluated 205 TTPr in a large cohort of 177 advanced cancer patients enrolled in at least two Phase 1/1b trials (out of 2827 phase 1/1b-treated patients) at Gustave Roussy. Results: This first wide description of TTPr showed that, under the hypothesis of overall absence of treatment line effect, the median TTPr was 0.7 and that 25% of patients presented a TTPr above the conventional efficacy threshold of 1.3. Conclusions: A higher median TTPr and a larger proportion of patients above the 1.3 threshold should therefore be achieved to conclude to drug efficacy. New guidelines for TTPr interpretation and calibration are proposed, which warrant independent prospective validation.

    Original languageEnglish
    Pages (from-to)937-939
    Number of pages3
    JournalBritish Journal of Cancer
    Volume119
    Issue number8
    DOIs
    Publication statusPublished - 16 Oct 2018

    Cite this