title: Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer.
abstract: 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).
  
  
  
  The objective of the study was to characterize tumor size changes with lenvatinib treatment.
  
  
  
  SELECT was a phase 3, randomized, double-blind, multicenter study.
  
  
  
  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 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.
  
  
  
  Lenvatinib (24 mg once daily) or placebo in 28-day cycles until unacceptable toxicity, disease progression, or death.
  
  
  
  This was an exploratory analysis of key end points from SELECT, including PFS, overall response rate, and tumor reduction.
  
  
  
  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).
  
  
  
  The change in tumor size conferred by lenvatinib was characterized by two phases: an initial, rapid decline, followed by slower, continuous shrinkage.
authors.affiliation: 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.
authors.forename: Bruce
authors.initials: B
authors.lastname: Robinson
authors.affiliation: 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.
authors.forename: Martin
authors.initials: M
authors.lastname: Schlumberger
authors.affiliation: 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.
authors.forename: Lori J
authors.initials: LJ
authors.lastname: Wirth
authors.affiliation: 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.
authors.forename: Corina E
authors.initials: CE
authors.lastname: Dutcus
authors.affiliation: 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.
authors.forename: James
authors.initials: J
authors.lastname: Song
authors.affiliation: 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.
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Taylor
authors.affiliation: 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.
authors.forename: Sung-Bae
authors.initials: SB
authors.lastname: Kim
authors.affiliation: 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.
authors.forename: Monika K
authors.initials: MK
authors.lastname: Krzyzanowska
authors.affiliation: 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.
authors.forename: Jaume
authors.initials: J
authors.lastname: Capdevila
authors.affiliation: 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.
authors.forename: Steven I
authors.initials: SI
authors.lastname: Sherman
authors.affiliation: 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.
authors.forename: Makoto
authors.initials: M
authors.lastname: Tahara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010671:Phenylurea Compounds / Q000008:administration & dosage / Q000494:pharmacology*; D011804:Quinolines / Q000008:administration & dosage / Q000494:pharmacology*; D013964:Thyroid Neoplasms / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D011804:Quinolines; C531958:lenvatinib