Lenvatinib as Second-Line Treatment after Atezolizumab plus Bevacizumab for Unresectable Hepatocellular Carcinoma: Clinical Results Show Importance of Hepatic Reserve Function

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Abstract

Introduction: Lack of an established methodology for post-progression systemic treatment following atezolizumab plus bevacizumab (Atez/Bev) administration is an important clinical issue. The present study aimed to elucidate the potential of lenvatinib as a second-line treatment option after Atez/Bev failure. Methods: From 2020 to 2022, 101 patients who received lenvatinib as second-line treatment were enrolled (median 72 years, males 77, Child-Pugh A 82, BCLC-A:B:C:D = 1:35:61:4), while 29 treated with another molecular targeting agent (MTA) during the period as second-line treatment were enrolled as controls. The therapeutic efficacy of lenvatinib given as second-line treatment was retrospectively evaluated. Results: Median progression-free survival/median overall survival for all patients was 4.4/15.7 months and for those with Child-Pugh A was 4.7 months/not-reached. When prognosis was compared with patients who received another MTA, there was no significant difference for PFS (3.5 months, p = 0.557) or OS (13.6 months, p = 0.992), and also no significant differences regarding clinical background factors. mRECIST findings showed that objective response and disease control rates in patients treated with lenvatinib were 23.9% and 70.4%, respectively (CR:PR:SD:PD = 3:14:33:21), while those shown by RECIST, ver. 1.1, were 15.4% and 66.2%, respectively (CR:PR:SD:PD = 1:10:36:24). Adverse events (any grade ≥10%) were appetite loss (26.7%) (grade 1:2:3 = 2:15:10), general fatigue (21.8%) (grade 1:2:3 = 3:13:6), protein in urine (16.8%) (grade 1:2:3 = 0:4:13), and hypertension (13.9%) (grade 1:2:3 = 1:8:5). Conclusion: Although lenvatinib treatment might not provide a pseudo-combination immunotherapy effect following Atez/Bev failure, lenvatinib when used as second-line treatment after Atez/Bev failure might be expected to be comparable as compared to its use as first-line treatment.

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Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

Ahmedin Jemal, Lindsey A Torre, Rebecca Siegel … (2018)

This article provides a status report on the global burden of cancer worldwide using the GLOBOCAN 2018 estimates of cancer incidence and mortality produced by the International Agency for Research on Cancer, with a focus on geographic variability across 20 world regions. There will be an estimated 18.1 million new cancer cases (17.0 million excluding nonmelanoma skin cancer) and 9.6 million cancer deaths (9.5 million excluding nonmelanoma skin cancer) in 2018. In both sexes combined, lung cancer is the most commonly diagnosed cancer (11.6% of the total cases) and the leading cause of cancer death (18.4% of the total cancer deaths), closely followed by female breast cancer (11.6%), prostate cancer (7.1%), and colorectal cancer (6.1%) for incidence and colorectal cancer (9.2%), stomach cancer (8.2%), and liver cancer (8.2%) for mortality. Lung cancer is the most frequent cancer and the leading cause of cancer death among males, followed by prostate and colorectal cancer (for incidence) and liver and stomach cancer (for mortality). Among females, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death, followed by colorectal and lung cancer (for incidence), and vice versa (for mortality); cervical cancer ranks fourth for both incidence and mortality. The most frequently diagnosed cancer and the leading cause of cancer death, however, substantially vary across countries and within each country depending on the degree of economic development and associated social and life style factors. It is noteworthy that high-quality cancer registry data, the basis for planning and implementing evidence-based cancer control programs, are not available in most low- and middle-income countries. The Global Initiative for Cancer Registry Development is an international partnership that supports better estimation, as well as the collection and use of local data, to prioritize and evaluate national cancer control efforts. CA: A Cancer Journal for Clinicians 2018;0:1-31. © 2018 American Cancer Society.

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Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews. HIGHLIGHTS OF REVISED RECIST 1.1: Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of 15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to <10mm short axis are considered normal. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes 'unequivocal progression' of non-measurable/non-target disease, a source of confusion in the original RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions. A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.

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Investigation of the freely available easy-to-use software ‘EZR' for medical statistics

Y Kanda (2012)

Although there are many commercially available statistical software packages, only a few implement a competing risk analysis or a proportional hazards regression model with time-dependent covariates, which are necessary in studies on hematopoietic SCT. In addition, most packages are not clinician friendly, as they require that commands be written based on statistical languages. This report describes the statistical software ‘EZR' (Easy R), which is based on R and R commander. EZR enables the application of statistical functions that are frequently used in clinical studies, such as survival analyses, including competing risk analyses and the use of time-dependent covariates, receiver operating characteristics analyses, meta-analyses, sample size calculation and so on, by point-and-click access. EZR is freely available on our website (http://www.jichi.ac.jp/saitama-sct/SaitamaHP.files/statmed.html) and runs on both Windows (Microsoft Corporation, USA) and Mac OS X (Apple, USA). This report provides instructions for the installation and operation of EZR.

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Author and article information

Journal

Journal ID (publisher-id): OCL

Journal ID (nlm-ta): Oncology

Journal ID (doi): 10.1159/issn.0030-2414

Title: Oncology

Abbreviated Title: Oncology

Publisher: S. Karger AG

ISSN (Print): 0030-2414

ISSN (Electronic): 1423-0232

Publication date Subscription-year: 2023

Publication date (Print): October 2023

Publication date (Electronic): 12 June 2023

Volume: 101

Issue: 10

Pages: 624-633

Affiliations

[_a] _aGastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan

[_b] _bDepartment of Nursing, Gifu Kyoritsu University, Ogaki, Japan

[_c] _cDepartment of Internal Medicine, Japanese Red Cross Himeji Hospital, Himeji, Japan

[_d] _dDepartment of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon, Japan

[_e] _eDepartment of Hepatology, Okayama City Hospital, Okayama, Japan

[_f] _fDepartment of Gastroenterology and Hepatology, Kagawa University, Takamatsu, Japan

[_g] _gDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan

[_h] _hDepartment of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan

[_i] _iDepartment of Gastroenterology, Asahi General Hospital, Asahi, Japan

[_j] _jDepartment of Gastroenterology, Osaka Medical and Pharmaceutical University, Osaka, Japan

[_k] _kCenter of Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan

[_l] _lDepartment of Gastroenterology, Saiseikai Niigata Hospital, Niigata, Japan

[_m] _mDepartment of Gastroenterology, Toyama University Hospital, Toyama, Japan

[_n] _nHepato-biliary Center, Japanese Red Cross Matsuyama Hospital, Matsuyama, Japan

[_o] _oDepartment of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan

[_p] _pDepartment of Gastroenterology, Japanese Red Cross Takamatsu Hospital, Takamatsu, Japan

[_q] _qDepartment of Gastroenterology and Hepatology, Hyogo Medical University, Nishinomiya, Japan

[_r] _rDepartment of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Maebashi, Japan

[_s] _sDepartment of Clinical Research, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan

[_t] _tDivision of Gastroenterology and Hepatology, Otakanomori Hospital, Kashiwa, Japan

[_u] _uHepatology Division, Department of Internal Medicine II, Hamamatsu University School of Medicine, Hamamatsu, Japan

[_v] _vDepartment of Gastroenterology, National Hospital Organization Takasaki General Medical Center, Takasaki, Japan

[_w] _wDepartment of Surgery, Kansai Medical University, Hirakata, Japan

[_x] _xDepartment of Hepatology, St. Mary’s Hospital, Himeji, Japan

[_y] _yDivision of Hepatology, Department of Internal Medicine, Iwate Medical University, School of Medicine, Morioka, Japan

[_z] _zDepartment of Gastroenterology, Hanwa Memorial Hospital, Osaka, Japan

Author information

Kazuya Kariyama https://orcid.org/0000-0003-3996-7502

Joji Tani https://orcid.org/0000-0001-8801-2505

Chikara Ogawa https://orcid.org/0000-0002-4534-6692

Takashi Nishimura https://orcid.org/0000-0002-5517-8303

Hisashi Kosaka https://orcid.org/0000-0002-2926-9973

Hidekatsu Kuroda https://orcid.org/0000-0002-1471-1087

Yutaka Yata https://orcid.org/0000-0002-4592-3509

Kazuhiro Nouso https://orcid.org/0000-0002-2018-0008

Masaki Kaibori https://orcid.org/0000-0002-0577-3921

Article

Publisher ID: 531316 Other ID: Oncology 2023;101:624–633

DOI: 10.1159/000531316

PubMed ID: 37307798

SO-VID: e1a79016-d090-48b2-88f9-2a00beafe64c

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Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.

History

Date received : 12 January 2023

Date accepted : 23 May 2023

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Figures: 4, Tables: 3, Pages: 10

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None to declare.

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Lenvatinib as Second-Line Treatment after Atezolizumab plus Bevacizumab for Unresectable Hepatocellular Carcinoma: Clinical Results Show Importance of Hepatic Reserve Function

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Karger: Oncology

Most cited references 32

Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

Investigation of the freely available easy-to-use software ‘EZR' for medical statistics

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