TY - JOUR
T1 - Second-line lenvatinib in patients with recurrent endometrial cancer
AU - Vergote, Ignace
AU - Powell, Matthew A.
AU - Teneriello, Michael G.
AU - Miller, David S.
AU - Garcia, Agustin A.
AU - Mikheeva, Olga N.
AU - Bidzinski, Mariusz
AU - Cebotaru, Cristina Ligia
AU - Dutcus, Corina E.
AU - Ren, Min
AU - Kadowaki, Tadashi
AU - Funahashi, Yasuhiro
AU - Penson, Richard T.
N1 - Publisher Copyright:
© 2020 The Authors
PY - 2020/3
Y1 - 2020/3
N2 - 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.
AB - 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.
KW - Endometrial cancer
KW - Lenvatinib
KW - Multikinase inhibitor
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U2 - 10.1016/j.ygyno.2019.12.039
DO - 10.1016/j.ygyno.2019.12.039
M3 - Article
C2 - 31955859
AN - SCOPUS:85077924505
SN - 0090-8258
VL - 156
SP - 575
EP - 582
JO - Gynecologic oncology
JF - Gynecologic oncology
IS - 3
ER -