Impact of Adverse Events on the Progression-Free Survival of Patients with Advanced Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Retrospective Study
Abstract Background and Objective Experience of the use of lenvatinib (LEN) in the clinical setting remains limited. We conducted this study to elucidate the factors associated with progression-free survival (PFS) in patients with advanced HCC treated with LEN. Methods In this multicenter retrospect...
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doaj-a0fbba4ad7974a68962730adec11987e2021-02-14T12:09:50ZengAdis, Springer HealthcareDrugs - Real World Outcomes2199-11542198-97882020-02-017214114910.1007/s40801-020-00179-7Impact of Adverse Events on the Progression-Free Survival of Patients with Advanced Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Retrospective StudyTakamasa Ohki0Koki Sato1Mayuko Kondo2Eriko Goto3Takahisa Sato4Yuji Kondo5Masatoshi Akamatsu6Shinpei Sato7Hideo Yoshida8Yukihiro Koike9Shuntaro Obi10Department of Gastroenterology, Mitsui Memorial HospitalDepartment of Gastroenterology, Mitsui Memorial HospitalDepartment of Gastroenterology, Mitsui Memorial HospitalDepartment of Gastroenterology, Kanto Central HospitalDepartment of Gastroenterology, Teikyo University Medical CenterDepartment of Gastroenterology and Hepatology, Kyoundo HospitalDepartment of Gastroenterology, JR Tokyo General HospitalDepartment of Gastroenterology and Hepatology, Kyoundo HospitalDepartment of Gastroenterology, Japanese Red Cross Medical CenterDepartment of Gastroenterology, Kanto Central HospitalDepartment of Gastroenterology, Teikyo University Medical CenterAbstract Background and Objective Experience of the use of lenvatinib (LEN) in the clinical setting remains limited. We conducted this study to elucidate the factors associated with progression-free survival (PFS) in patients with advanced HCC treated with LEN. Methods In this multicenter retrospective study, we analyzed data on patient characteristics, treatment outcomes, and adverse events (AEs) for 77 patients with advanced hepatocellular carcinoma (HCC). We also analyzed PFS and factors that influence PFS. Results The response rate to LEN was 29.9% and the disease control rate was 77.9%. Patients who achieved relative dose intensities of more than 70% had better outcomes (response rate 45.2% vs. 11.4%, P < 0.01). Appetite loss, fatigue, diarrhea, hypertension, and thyroid dysfunction were the most frequent AEs. Twenty-three patients (29.9%) had grade 3 or 4 AEs. Fifty-two patients (67.5%) required a dose reduction and 47 (61.0%) stopped taking the drug due to AEs. The PFS rates at 3, 6, and 12 months were 81.2%, 49.8%, and 34.8%, respectively. The median PFS was 5.6 months. Multivariate analysis showed that thyroid dysfunction of grade ≥ 2 (hazard ratio [HR] 4.57, 95% confidence interval [CI] 2.05–10.2, P < 0.01), appetite loss (HR 3.58, 95% CI 1.72–7.52, P < 0.01), and tumor diameter ≥ 40 mm (HR: 2.27, 95% CI 1.17–4.40, P = 0.015) were independent factors associated with poor PFS. On the other hand, Child–Pugh class 5A (HR 0.41, 95% CI 0.19–0.90, P = 0.027) and complete or partial response (HR 0.40, 95% CI 0.17–0.95, P = 0.039) were independent factors associated with better PFS. Conclusions Thyroid dysfunction and appetite loss after the administration of LEN were independent factors associated with shorter PFS, so these AEs should be carefully managed after administering LEN.https://doi.org/10.1007/s40801-020-00179-7 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Takamasa Ohki Koki Sato Mayuko Kondo Eriko Goto Takahisa Sato Yuji Kondo Masatoshi Akamatsu Shinpei Sato Hideo Yoshida Yukihiro Koike Shuntaro Obi |
spellingShingle |
Takamasa Ohki Koki Sato Mayuko Kondo Eriko Goto Takahisa Sato Yuji Kondo Masatoshi Akamatsu Shinpei Sato Hideo Yoshida Yukihiro Koike Shuntaro Obi Impact of Adverse Events on the Progression-Free Survival of Patients with Advanced Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Retrospective Study Drugs - Real World Outcomes |
author_facet |
Takamasa Ohki Koki Sato Mayuko Kondo Eriko Goto Takahisa Sato Yuji Kondo Masatoshi Akamatsu Shinpei Sato Hideo Yoshida Yukihiro Koike Shuntaro Obi |
author_sort |
Takamasa Ohki |
title |
Impact of Adverse Events on the Progression-Free Survival of Patients with Advanced Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Retrospective Study |
title_short |
Impact of Adverse Events on the Progression-Free Survival of Patients with Advanced Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Retrospective Study |
title_full |
Impact of Adverse Events on the Progression-Free Survival of Patients with Advanced Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Retrospective Study |
title_fullStr |
Impact of Adverse Events on the Progression-Free Survival of Patients with Advanced Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Retrospective Study |
title_full_unstemmed |
Impact of Adverse Events on the Progression-Free Survival of Patients with Advanced Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Retrospective Study |
title_sort |
impact of adverse events on the progression-free survival of patients with advanced hepatocellular carcinoma treated with lenvatinib: a multicenter retrospective study |
publisher |
Adis, Springer Healthcare |
series |
Drugs - Real World Outcomes |
issn |
2199-1154 2198-9788 |
publishDate |
2020-02-01 |
description |
Abstract Background and Objective Experience of the use of lenvatinib (LEN) in the clinical setting remains limited. We conducted this study to elucidate the factors associated with progression-free survival (PFS) in patients with advanced HCC treated with LEN. Methods In this multicenter retrospective study, we analyzed data on patient characteristics, treatment outcomes, and adverse events (AEs) for 77 patients with advanced hepatocellular carcinoma (HCC). We also analyzed PFS and factors that influence PFS. Results The response rate to LEN was 29.9% and the disease control rate was 77.9%. Patients who achieved relative dose intensities of more than 70% had better outcomes (response rate 45.2% vs. 11.4%, P < 0.01). Appetite loss, fatigue, diarrhea, hypertension, and thyroid dysfunction were the most frequent AEs. Twenty-three patients (29.9%) had grade 3 or 4 AEs. Fifty-two patients (67.5%) required a dose reduction and 47 (61.0%) stopped taking the drug due to AEs. The PFS rates at 3, 6, and 12 months were 81.2%, 49.8%, and 34.8%, respectively. The median PFS was 5.6 months. Multivariate analysis showed that thyroid dysfunction of grade ≥ 2 (hazard ratio [HR] 4.57, 95% confidence interval [CI] 2.05–10.2, P < 0.01), appetite loss (HR 3.58, 95% CI 1.72–7.52, P < 0.01), and tumor diameter ≥ 40 mm (HR: 2.27, 95% CI 1.17–4.40, P = 0.015) were independent factors associated with poor PFS. On the other hand, Child–Pugh class 5A (HR 0.41, 95% CI 0.19–0.90, P = 0.027) and complete or partial response (HR 0.40, 95% CI 0.17–0.95, P = 0.039) were independent factors associated with better PFS. Conclusions Thyroid dysfunction and appetite loss after the administration of LEN were independent factors associated with shorter PFS, so these AEs should be carefully managed after administering LEN. |
url |
https://doi.org/10.1007/s40801-020-00179-7 |
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