Abstract | OBJECTIVE: This study assessed the efficacy of lenvatinib, a multitargeted tyrosine kinase inhibitor, as second-line therapy in patients with unresectable endometrial cancer. The primary end point was the objective response rate (ORR) as assessed by independent radiologic review ( IRR). Secondary end points included median progression-free survival (PFS), overall survival (OS), and clinical benefit rate. Exploratory end points examined the association of baseline levels of plasma biomarkers (50 circulating cytokine and/or angiogenic factors measured by immunoassays) with efficacy outcomes. METHODS: An international, open-label, single-arm, multicenter, phase 2 trial was conducted. Eligible patients had histologically confirmed unresectable endometrial cancer that relapsed after 1 prior systemic platinum-based chemotherapy. Patients received once-daily oral lenvatinib 24 mg in a 28-day dosing cycle. RESULTS: There were 133 patients in the study. By IRR, 19 patients had a confirmed objective response for an ORR of 14.3% (95% CI: 8.8-21.4). Durable stable disease (≥23 weeks) was observed in 31 patients (23.3%) and the clinical benefit rate was 37.6% (95% CI: 29.3-46.4). Median PFS was 5.6 months (95% CI: 3.7-6.3), and median OS was 10.6 months (95% CI: 8.9-14.9). The most common (any grade) treatment-related adverse events were fatigue/ asthenia (48%), hypertension (49%), nausea/ vomiting (32%), decreased appetite (32%), and diarrhea (31%). Lower baseline levels of angiopoietin-2 were associated with longer PFS, OS, and a higher ORR. CONCLUSIONS: Patients with recurrent endometrial cancer treated with second-line lenvatinib experienced modest antitumor activity and treatment was generally well tolerated, with a safety profile consistent with previous studies.
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Authors | Ignace Vergote, Matthew A Powell, Michael G Teneriello, David S Miller, Agustin A Garcia, Olga N Mikheeva, Mariusz Bidzinski, Cristina Ligia Cebotaru, Corina E Dutcus, Min Ren, Tadashi Kadowaki, Yasuhiro Funahashi, Richard T Penson |
Journal | Gynecologic oncology
(Gynecol Oncol)
Vol. 156
Issue 3
Pg. 575-582
(03 2020)
ISSN: 1095-6859 [Electronic] United States |
PMID | 31955859
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Antineoplastic Agents
- Biomarkers, Tumor
- Phenylurea Compounds
- Protein Kinase Inhibitors
- Quinolines
- lenvatinib
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Biomarkers, Tumor
(blood)
- Endometrial Neoplasms
(blood, drug therapy, pathology)
- Female
- Humans
- Kaplan-Meier Estimate
- Middle Aged
- Neoplasm Recurrence, Local
(blood, drug therapy, pathology)
- Phenylurea Compounds
(adverse effects, therapeutic use)
- Protein Kinase Inhibitors
(adverse effects, therapeutic use)
- Quinolines
(adverse effects, therapeutic use)
- Survival Rate
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