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Cited by 2,096

The DOI matches its Crossref record; 4 of the 4 references it cites were found in a registry or an index.

Lenvatinib versus Placebo in Radioiodine-Refractory Thyroid Cancer

Open access
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 H., Kim, Sung-Bae, Krzyzanowska, Monika K., Dutcus, Corina E., de las Heras, Begoña, Zhu, Junming, Sherman, Steven I.·2015·New England Journal of Medicine
DOI 10.1056/nejmoa1406470
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Abstract

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 α, 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. 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<0.001). A progression-free survival benefit associated with lenvatinib was observed in all prespecified subgroups. The response rate was 64.8% in the lenvatinib group (4 complete responses and 165 partial responses) and 1.5% in the placebo group (P<0.001). The median overall survival was not reached in either group. Treatment-related adverse effects of any grade, which occurred in more than 40% of patients in the lenvatinib group, were hypertension (in 67.8% of the patients), diarrhea (in 59.4%), fatigue or asthenia (in 59.0%), decreased appetite (in 50.2%), decreased weight (in 46.4%), and nausea (in 41.0%). Discontinuations of the study drug because of adverse effects occurred in 37 patients who received lenvatinib (14.2%) and 3 patients who received placebo (2.3%). In the lenvatinib group, 6 of 20 deaths that occurred during the treatment period were considered to be drug-related. 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.).

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Research works printed but not linked: 26

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Cited by

Metadata

Authors
Schlumberger, M., Tahara, M., Wirth, L. J., Robinson, B., Brose, M. S., Elisei, R., Habra, M. A., Newbold, K., Shah, M. H., Hoff, A. O., Gianoukakis, A. G., Kiyota, N., Taylor, M. H., Kim, S.-B., Krzyzanowska, M. K., Dutcus, C. E., de las Heras, B., Zhu, J., & Sherman, S. I.
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2015-02-12
Volume
372
Issue
7
Pages
621-630
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1406470
OpenAlex
W1967792499
Cited by
2,096
References
4
FWCI
133.91
Type
journal article
Language
en
Open access
bronze

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