PMID- 34498344 OWN - NLM STAT- MEDLINE DCOM- 20211221 LR - 20220531 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 26 IP - 12 DP - 2021 Dec TI - A Long-Term Extension Study of Bevacizumab in Patients With Solid Tumors. PG - e2254-e2264 LID - 10.1002/onco.13971 [doi] AB - 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. CI - (c) 2021 The Authors. The Oncologist published by Wiley Periodicals LLC on behalf of AlphaMed Press. FAU - Oza, Amit M AU - Oza AM AD - Princess Margaret Cancer Centre, University Health Network and Mt Sinai Health System, Toronto, Ontario, Canada. FAU - Dubois, Francois AU - Dubois F AD - Centre Hospitalier Regional Universitaire de Lille, Lille, France. FAU - Hegg, Roberto AU - Hegg R AD - Centro de Referencia da Saude da Mulher, Sao Paulo, Brazil. FAU - Hernandez, Carlos Alberto AU - Hernandez CA AD - Hospital Regional Presidente Juarez, Institute for Social Security and Services for State Workers, Oaxaca, Mexico. FAU - Finocchiaro, Gaetano AU - Finocchiaro G AD - Department of Neurology, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milano, Italy. FAU - Ghiringhelli, Francois AU - Ghiringhelli F AD - Department of Medical Oncology, Center Georges Francois Leclerc, Research Platform in Biological Oncology, Genetic and Immunology Medical Institute, University of Burgundy-Franche Comte, UMR INSERM 1231, Dijon, France. FAU - Zamagni, Claudio AU - Zamagni C AD - Istituto di Ricovero e Cura a Carattere Scientifico S Azienda Ospedaliero-universitaria di Bologna, via Albertoni 15, Bologna, Italy. FAU - Nick, Sonja AU - Nick S AD - F. Hoffmann-La Roche Ltd, Basel, Switzerland. FAU - Irahara, Natsumi AU - Irahara N AD - F. Hoffmann-La Roche Ltd, Basel, Switzerland. FAU - Perretti, Thomas AU - Perretti T AD - F. Hoffmann-La Roche Ltd, Basel, Switzerland. FAU - Colombo, Nicoletta AU - Colombo N AD - Universita Milano-Bicocca, and Programma Ginecologia, Istituto Europeo Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico, Milano, Italy. LA - eng SI - ClinicalTrials.gov/NCT01588184 PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20211004 PL - England TA - Oncologist JT - The oncologist JID - 9607837 RN - 2S9ZZM9Q9V (Bevacizumab) SB - IM MH - Bevacizumab/adverse effects MH - *Carcinoma, Non-Small-Cell Lung/drug therapy MH - Female MH - Humans MH - *Kidney Neoplasms MH - *Lung Neoplasms MH - *Ovarian Neoplasms PMC - PMC8649003 OTO - NOTNLM OT - Bevacizumab OT - Cancer OT - Long-term treatment OT - Safety OT - Solid tumor COIS- Disclosures of potential conflicts of interest may be found at the end of this article. EDAT- 2021/09/10 06:00 MHDA- 2021/12/22 06:00 PMCR- 2021/12/01 CRDT- 2021/09/09 07:09 PHST- 2021/05/08 00:00 [received] PHST- 2021/08/25 00:00 [accepted] PHST- 2021/09/10 06:00 [pubmed] PHST- 2021/12/22 06:00 [medline] PHST- 2021/09/09 07:09 [entrez] PHST- 2021/12/01 00:00 [pmc-release] AID - ONCO13971 [pii] AID - 10.1002/onco.13971 [doi] PST - ppublish SO - Oncologist. 2021 Dec;26(12):e2254-e2264. doi: 10.1002/onco.13971. Epub 2021 Oct 4.