A Long-Term Extension Study of Bevacizumab in Patients With Solid Tumors

The oncologist

article

Amit M. Oza¹  François Dubois²  Roberto Hegg³  Carlos Alberto Hernández⁴  Gaetano Finocchiaro⁵  François Ghiringhelli⁶  Claudio Zamagni⁷  Sonja Nick⁸  Natsumi Irahara⁸  Thomas Perretti⁸  Nicoletta Colombo⁹ 

[1]Princess Margaret Cancer Centre, University Health Network and Mt Sinai Health System

[2]Centre Hospitalier Régional Universitaire de Lille

[3]Centro de Referência da Saúde da Mulher

[4]Hospital Regional Presidente Juárez, Institute for Social Security and Services for State Workers

[5]Department of Neurology, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele

[6]Department of Medical Oncology, Center Georges François Leclerc, Research Platform in Biological Oncology, Genetic and Immunology Medical Institute, University of Burgundy-Franche Comté

[7]Istituto di Ricovero e Cura a Carattere Scientifico S Azienda Ospedaliero-universitaria di Bologna

[8]F. Hoffmann-La Roche Ltd

[9]Università Milano-Bicocca, and Programma Ginecologia, Istituto Europeo Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico

关键词: Bevacizumab;    Cancer;    Long-term treatment;    Safety;    Solid tumor;   

DOI  :  10.1002/onco.13971

学科分类：地质学

来源: AlphaMed Press Incorporated

【 摘 要 】

Background Bevacizumab has been studied in numerous clinical trials in multiple types of cancer; however, patients may receive bevacizumab over an extended period of time. This study assessed the long-term safety and tolerability of bevacizumab among patients with solid tumors. Materials and Methods Patients enrolled in a Roche/Genentech-sponsored trial who had derived benefit from bevacizumab therapy as monotherapy or in combination with anticancer drugs were eligible for continuation of bevacizumab in this long-term extension (LTE) study. The primary endpoints were the incidence of adverse events (AEs) of Common Terminology Criteria for AEs (CTCAE) grade ≥3 related to bevacizumab treatment, serious AEs (SAEs), and deaths. Results Ninety-five patients with the following cancer types were enrolled in the LTE: ovarian cancer or peritoneal carcinoma ( n  = 41), non-small cell lung cancer ( n  = 16), glioblastoma multiforme ( n  = 14), breast cancer ( n  = 11), colorectal cancer ( n  = 7), or renal cell carcinoma ( n  = 6). The median (range) duration of bevacizumab treatment was 15.6 (0.0–81.0) months during the LTE and 57.5 (16.4–134.9) months overall (parent trial + LTE), with three patients receiving bevacizumab for >10 years. Overall, 17 patients (17.9%) experienced SAEs, and 21 (22.1%) had a bevacizumab-related AE of CTCAE grade ≥3 (proteinuria and hypertension were the most common). Four patients died: three from disease progression and one from an AE considered unrelated to bevacizumab. Conclusion The safety outcomes observed support the tolerability of long-term bevacizumab in patients with various solid tumors, with a median extended treatment duration of almost 5 years overall and >10 years in some individual patients. ClinicalTrials.gov identifier: NCT01588184. Implications for Practice In this long-term extension study of patients with solid tumors, the median duration of bevacizumab treatment (including parent trials) was just under 5 years, with a long-term exposure in some patients of 7 to >10 years. Grade ≥3 adverse events related to bevacizumab were consistent with the established safety profile, with proteinuria and hypertension being the most common. Patients received bevacizumab over an extended period of time (beyond the length of most clinical trials), and the overall safety outcomes observed support the tolerability of long-term bevacizumab treatment in patients with solid tumors, with clinical benefit achieved over an extended period.

【 授权许可】

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