Lenvatinib versus placebo in radioiodine-refractory thyroid cancer

Martin Schlumberger, Makoto Tahara, Lori J. Wirth, Bruce Robinson, Marcia S. Brose, Rossella Elisei, Mouhammed Amir Habra, Kate Newbold, Manisha H. Shah, Ana O. Hoff, Andrew G. Gianoukakis, Naomi Kiyota, Matthew Taylor, Sung Bae Kim, Monika K. Krzyzanowska, Corina E. Dutcus, Begoña De Las Heras, Junming Zhu, Steven I. Sherman

    Research output: Contribution to journalArticle

    431 Citations (Scopus)

    Abstract

    Results The median progression-free survival was 18.3 months in the lenvatinib group and 3.6 months in the placebo group (hazard ratio for progression or death, 0.21; 99% confidence interval, 0.14 to 0.31; P

    Conclusions Lenvatinib, as compared with placebo, was associated with significant improvements in progression-free survival and the response rate among patients with iodine-131-refractory thyroid cancer. Patients who received lenvatinib had more adverse effects. (Funded by Eisai; SELECT ClinicalTrials.gov number, NCT01321554.)

    Background Lenvatinib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, fibroblast growth factor receptors 1 through 4, platelet-derived growth factor receptor á, RET, and KIT, showed clinical activity in a phase 2 study involving patients with differentiated thyroid cancer that was refractory to radioiodine (iodine-131).

    Methods In our phase 3, randomized, double-blind, multicenter study involving patients with progressive thyroid cancer that was refractory to iodine-131, we randomly assigned 261 patients to receive lenvatinib (at a daily dose of 24 mg per day in 28-day cycles) and 131 patients to receive placebo. At the time of disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was progression-free survival. Secondary end points included the response rate, overall survival, and safety.

    Original languageEnglish (US)
    Pages (from-to)621-630
    Number of pages10
    JournalNew England Journal of Medicine
    Volume372
    Issue number7
    DOIs
    StatePublished - Feb 12 2015

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    Thyroid Neoplasms
    Placebos
    Iodine
    Disease-Free Survival
    Survival Rate
    Vascular Endothelial Growth Factor Receptor-3
    Receptor, Fibroblast Growth Factor, Type 1
    Vascular Endothelial Growth Factor Receptor-1
    Platelet-Derived Growth Factor Receptors
    Vascular Endothelial Growth Factor Receptor-2
    lenvatinib
    Double-Blind Method
    Multicenter Studies
    Disease Progression
    Confidence Intervals
    Safety

    ASJC Scopus subject areas

    • Medicine(all)

    Cite this

    Schlumberger, M., Tahara, M., Wirth, L. J., Robinson, B., Brose, M. S., Elisei, R., ... Sherman, S. I. (2015). Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. New England Journal of Medicine, 372(7), 621-630. https://doi.org/10.1056/NEJMoa1406470

    Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. / Schlumberger, Martin; Tahara, Makoto; Wirth, Lori J.; Robinson, Bruce; Brose, Marcia S.; Elisei, Rossella; Habra, Mouhammed Amir; Newbold, Kate; Shah, Manisha H.; Hoff, Ana O.; Gianoukakis, Andrew G.; Kiyota, Naomi; Taylor, Matthew; Kim, Sung Bae; Krzyzanowska, Monika K.; Dutcus, Corina E.; De Las Heras, Begoña; Zhu, Junming; Sherman, Steven I.

    In: New England Journal of Medicine, Vol. 372, No. 7, 12.02.2015, p. 621-630.

    Research output: Contribution to journalArticle

    Schlumberger, M, Tahara, M, Wirth, LJ, Robinson, B, Brose, MS, Elisei, R, Habra, MA, Newbold, K, Shah, MH, Hoff, AO, Gianoukakis, AG, Kiyota, N, Taylor, M, Kim, SB, Krzyzanowska, MK, Dutcus, CE, De Las Heras, B, Zhu, J & Sherman, SI 2015, 'Lenvatinib versus placebo in radioiodine-refractory thyroid cancer', New England Journal of Medicine, vol. 372, no. 7, pp. 621-630. https://doi.org/10.1056/NEJMoa1406470
    Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. New England Journal of Medicine. 2015 Feb 12;372(7):621-630. https://doi.org/10.1056/NEJMoa1406470
    Schlumberger, Martin ; Tahara, Makoto ; Wirth, Lori J. ; Robinson, Bruce ; Brose, Marcia S. ; Elisei, Rossella ; Habra, Mouhammed Amir ; Newbold, Kate ; Shah, Manisha H. ; Hoff, Ana O. ; Gianoukakis, Andrew G. ; Kiyota, Naomi ; Taylor, Matthew ; Kim, Sung Bae ; Krzyzanowska, Monika K. ; Dutcus, Corina E. ; De Las Heras, Begoña ; Zhu, Junming ; Sherman, Steven I. / Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. In: New England Journal of Medicine. 2015 ; Vol. 372, No. 7. pp. 621-630.
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    abstract = "Results The median progression-free survival was 18.3 months in the lenvatinib group and 3.6 months in the placebo group (hazard ratio for progression or death, 0.21; 99{\%} confidence interval, 0.14 to 0.31; PConclusions Lenvatinib, as compared with placebo, was associated with significant improvements in progression-free survival and the response rate among patients with iodine-131-refractory thyroid cancer. Patients who received lenvatinib had more adverse effects. (Funded by Eisai; SELECT ClinicalTrials.gov number, NCT01321554.)Background Lenvatinib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, fibroblast growth factor receptors 1 through 4, platelet-derived growth factor receptor {\'a}, RET, and KIT, showed clinical activity in a phase 2 study involving patients with differentiated thyroid cancer that was refractory to radioiodine (iodine-131).Methods In our phase 3, randomized, double-blind, multicenter study involving patients with progressive thyroid cancer that was refractory to iodine-131, we randomly assigned 261 patients to receive lenvatinib (at a daily dose of 24 mg per day in 28-day cycles) and 131 patients to receive placebo. At the time of disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was progression-free survival. Secondary end points included the response rate, overall survival, and safety.",
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    T1 - Lenvatinib versus placebo in radioiodine-refractory thyroid cancer

    AU - Schlumberger, Martin

    AU - Tahara, Makoto

    AU - Wirth, Lori J.

    AU - Robinson, Bruce

    AU - Brose, Marcia S.

    AU - Elisei, Rossella

    AU - Habra, Mouhammed Amir

    AU - Newbold, Kate

    AU - Shah, Manisha H.

    AU - Hoff, Ana O.

    AU - Gianoukakis, Andrew G.

    AU - Kiyota, Naomi

    AU - Taylor, Matthew

    AU - Kim, Sung Bae

    AU - Krzyzanowska, Monika K.

    AU - Dutcus, Corina E.

    AU - De Las Heras, Begoña

    AU - Zhu, Junming

    AU - Sherman, Steven I.

    PY - 2015/2/12

    Y1 - 2015/2/12

    N2 - Results The median progression-free survival was 18.3 months in the lenvatinib group and 3.6 months in the placebo group (hazard ratio for progression or death, 0.21; 99% confidence interval, 0.14 to 0.31; PConclusions Lenvatinib, as compared with placebo, was associated with significant improvements in progression-free survival and the response rate among patients with iodine-131-refractory thyroid cancer. Patients who received lenvatinib had more adverse effects. (Funded by Eisai; SELECT ClinicalTrials.gov number, NCT01321554.)Background Lenvatinib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, fibroblast growth factor receptors 1 through 4, platelet-derived growth factor receptor á, RET, and KIT, showed clinical activity in a phase 2 study involving patients with differentiated thyroid cancer that was refractory to radioiodine (iodine-131).Methods In our phase 3, randomized, double-blind, multicenter study involving patients with progressive thyroid cancer that was refractory to iodine-131, we randomly assigned 261 patients to receive lenvatinib (at a daily dose of 24 mg per day in 28-day cycles) and 131 patients to receive placebo. At the time of disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was progression-free survival. Secondary end points included the response rate, overall survival, and safety.

    AB - Results The median progression-free survival was 18.3 months in the lenvatinib group and 3.6 months in the placebo group (hazard ratio for progression or death, 0.21; 99% confidence interval, 0.14 to 0.31; PConclusions Lenvatinib, as compared with placebo, was associated with significant improvements in progression-free survival and the response rate among patients with iodine-131-refractory thyroid cancer. Patients who received lenvatinib had more adverse effects. (Funded by Eisai; SELECT ClinicalTrials.gov number, NCT01321554.)Background Lenvatinib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, fibroblast growth factor receptors 1 through 4, platelet-derived growth factor receptor á, RET, and KIT, showed clinical activity in a phase 2 study involving patients with differentiated thyroid cancer that was refractory to radioiodine (iodine-131).Methods In our phase 3, randomized, double-blind, multicenter study involving patients with progressive thyroid cancer that was refractory to iodine-131, we randomly assigned 261 patients to receive lenvatinib (at a daily dose of 24 mg per day in 28-day cycles) and 131 patients to receive placebo. At the time of disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was progression-free survival. Secondary end points included the response rate, overall survival, and safety.

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