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J Clin Endocrinol Metab. 2016 Nov;101(11):4103-4109. Epub 2016 Aug 22.

Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer.

Author information

1
Kolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia; Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France; Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114; Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677; Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239; Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea; Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9; Department of Medical Oncology (J.C.), Vall d'Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain; Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030; and Department of Head and Neck Medical Oncology (M.T.), National Cancer Center Hospital East, Kashiwa 277-8577, Japan.

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, tumor assessments of lenvatinib (n = 261) and placebo-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 (24 mg once daily) or placebo in 28-day cycles until unacceptable toxicity, disease progression, or death.

MAIN OUTCOME MEASURES:

This was an exploratory analysis of key end points from SELECT, including PFS, overall response rate, and tumor reduction.

RESULTS:

The median maximum percentage 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 8 wk 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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01321554.

PMID:
27548104
PMCID:
PMC5095235
DOI:
10.1210/jc.2015-3989
[Indexed for MEDLINE]
Free PMC Article

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