Characterization of tumor size changes over time from the phase 3 study of lenvatinib in thyroid cancer

Bruce Robinson, Martin Schlumberger, Lori J. Wirth, Corina E. Dutcus, James Song, Matthew H. Taylor, Sung Bae Kim, Monika K. Krzyzanowska, Jaume Capdevila, Steven I. Sherman, Makoto Tahara

    Research output: Research - peer-reviewArticle

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    Abstract

    Context: Lenvatinib improved the progression-free survival (PFS) and overall response rate of patients with radioiodine-refractory differentiated thyroid cancer vs placebo in the Phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT). Objective: The objective of the study was to characterize tumor size changes with lenvatinib treatment. Design: SELECT was a phase 3, randomized, double-blind, multicenter study. Setting: In this clinical trial,tumorassessments of lenvatinib (n=261)andplacebo-treated (n=131) patients were performed by independent radiological review per Response Evaluation Criteria in Solid Tumors version, 1.1 at 8-week intervals. Patients: Patients with complete or partial response were defined as responders to lenvatinib (n= 169). Of the 92 nonresponders, 76 had at least one postbaseline tumor assessment and were included in this analysis. Interventions: Lenvatinib (24mgonce daily) or placebo in 28-day cycles until unacceptable toxicity, disease progression, or death. MainOutcomeMeasures: Thiswasanexploratory analysis of keyendpoints from SELECT, including PFS, overall response rate, and tumor reduction. Results: The medianmaximumpercentage change in tumor size was-42.9%for patients receiving lenvatinib (responders,-51.9%; nonresponders,-20.2%). Tumor size reduction was most pronounced at first assessment (median,-24.7%at 8wk after randomization); thereafter, the rate of change was slower but continuous (-1.3%per mo). In a multivariate model, percentage change in tumor size at the first assessment was a marginally significant positive predictor for PFS P= .06). Conclusions: The change in tumor size conferred by lenvatinib was characterized by two phases: an initial, rapid decline, followed by slower, continuous shrinkage. (J Clin Endocrinol Metab 101: 4103-4109, 2016).

    LanguageEnglish (US)
    Pages4103-4109
    Number of pages7
    JournalJournal of Clinical Endocrinology and Metabolism
    Volume101
    Issue number11
    DOIs
    StatePublished - Nov 1 2016

    Fingerprint

    Thyroid Neoplasms
    Neoplasms
    lenvatinib
    Tumors
    Disease-Free Survival
    Placebos
    Random Allocation
    Double-Blind Method
    Multicenter Studies
    Disease Progression
    Clinical Trials
    Therapeutics
    Response Evaluation Criteria in Solid Tumors
    Refractory materials
    Toxicity

    ASJC Scopus subject areas

    • Endocrinology, Diabetes and Metabolism
    • Biochemistry
    • Endocrinology
    • Clinical Biochemistry
    • Biochemistry, medical

    Cite this

    Characterization of tumor size changes over time from the phase 3 study of lenvatinib in thyroid cancer. / Robinson, Bruce; Schlumberger, Martin; Wirth, Lori J.; Dutcus, Corina E.; Song, James; Taylor, Matthew H.; Kim, Sung Bae; Krzyzanowska, Monika K.; Capdevila, Jaume; Sherman, Steven I.; Tahara, Makoto.

    In: Journal of Clinical Endocrinology and Metabolism, Vol. 101, No. 11, 01.11.2016, p. 4103-4109.

    Research output: Research - peer-reviewArticle

    Robinson, B, Schlumberger, M, Wirth, LJ, Dutcus, CE, Song, J, Taylor, MH, Kim, SB, Krzyzanowska, MK, Capdevila, J, Sherman, SI & Tahara, M 2016, 'Characterization of tumor size changes over time from the phase 3 study of lenvatinib in thyroid cancer' Journal of Clinical Endocrinology and Metabolism, vol 101, no. 11, pp. 4103-4109. DOI: 10.1210/jc.2015-3989
    Robinson, Bruce ; Schlumberger, Martin ; Wirth, Lori J. ; Dutcus, Corina E. ; Song, James ; Taylor, Matthew H. ; Kim, Sung Bae ; Krzyzanowska, Monika K. ; Capdevila, Jaume ; Sherman, Steven I. ; Tahara, Makoto. / Characterization of tumor size changes over time from the phase 3 study of lenvatinib in thyroid cancer. In: Journal of Clinical Endocrinology and Metabolism. 2016 ; Vol. 101, No. 11. pp. 4103-4109
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    abstract = "Context: Lenvatinib improved the progression-free survival (PFS) and overall response rate of patients with radioiodine-refractory differentiated thyroid cancer vs placebo in the Phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT). Objective: The objective of the study was to characterize tumor size changes with lenvatinib treatment. Design: SELECT was a phase 3, randomized, double-blind, multicenter study. Setting: In this clinical trial,tumorassessments of lenvatinib (n=261)andplacebo-treated (n=131) patients were performed by independent radiological review per Response Evaluation Criteria in Solid Tumors version, 1.1 at 8-week intervals. Patients: Patients with complete or partial response were defined as responders to lenvatinib (n= 169). Of the 92 nonresponders, 76 had at least one postbaseline tumor assessment and were included in this analysis. Interventions: Lenvatinib (24mgonce daily) or placebo in 28-day cycles until unacceptable toxicity, disease progression, or death. MainOutcomeMeasures: Thiswasanexploratory analysis of keyendpoints from SELECT, including PFS, overall response rate, and tumor reduction. Results: The medianmaximumpercentage change in tumor size was-42.9%for patients receiving lenvatinib (responders,-51.9%; nonresponders,-20.2%). Tumor size reduction was most pronounced at first assessment (median,-24.7%at 8wk after randomization); thereafter, the rate of change was slower but continuous (-1.3%per mo). In a multivariate model, percentage change in tumor size at the first assessment was a marginally significant positive predictor for PFS P= .06). Conclusions: The change in tumor size conferred by lenvatinib was characterized by two phases: an initial, rapid decline, followed by slower, continuous shrinkage. (J Clin Endocrinol Metab 101: 4103-4109, 2016).",
    author = "Bruce Robinson and Martin Schlumberger and Wirth, {Lori J.} and Dutcus, {Corina E.} and James Song and Taylor, {Matthew H.} and Kim, {Sung Bae} and Krzyzanowska, {Monika K.} and Jaume Capdevila and Sherman, {Steven I.} and Makoto Tahara",
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    AU - Robinson,Bruce

    AU - Schlumberger,Martin

    AU - Wirth,Lori J.

    AU - Dutcus,Corina E.

    AU - Song,James

    AU - Taylor,Matthew H.

    AU - Kim,Sung Bae

    AU - Krzyzanowska,Monika K.

    AU - Capdevila,Jaume

    AU - Sherman,Steven I.

    AU - Tahara,Makoto

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    N2 - Context: Lenvatinib improved the progression-free survival (PFS) and overall response rate of patients with radioiodine-refractory differentiated thyroid cancer vs placebo in the Phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT). Objective: The objective of the study was to characterize tumor size changes with lenvatinib treatment. Design: SELECT was a phase 3, randomized, double-blind, multicenter study. Setting: In this clinical trial,tumorassessments of lenvatinib (n=261)andplacebo-treated (n=131) patients were performed by independent radiological review per Response Evaluation Criteria in Solid Tumors version, 1.1 at 8-week intervals. Patients: Patients with complete or partial response were defined as responders to lenvatinib (n= 169). Of the 92 nonresponders, 76 had at least one postbaseline tumor assessment and were included in this analysis. Interventions: Lenvatinib (24mgonce daily) or placebo in 28-day cycles until unacceptable toxicity, disease progression, or death. MainOutcomeMeasures: Thiswasanexploratory analysis of keyendpoints from SELECT, including PFS, overall response rate, and tumor reduction. Results: The medianmaximumpercentage change in tumor size was-42.9%for patients receiving lenvatinib (responders,-51.9%; nonresponders,-20.2%). Tumor size reduction was most pronounced at first assessment (median,-24.7%at 8wk after randomization); thereafter, the rate of change was slower but continuous (-1.3%per mo). In a multivariate model, percentage change in tumor size at the first assessment was a marginally significant positive predictor for PFS P= .06). Conclusions: The change in tumor size conferred by lenvatinib was characterized by two phases: an initial, rapid decline, followed by slower, continuous shrinkage. (J Clin Endocrinol Metab 101: 4103-4109, 2016).

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