Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results

Terufumi Kato (), Takashi Seto (), Makoto Nishio (), Koichi Goto (), Noboru Yamamoto (), Isamu Okamoto (), Liang Tao (), Wei Yu (), Tarik Khaznadar (), Kosei Tajima (), Masahiko Shibata (), Akihiro Seki () and Nobuyuki Yamamoto ()
Additional contact information
Terufumi Kato: Kanagawa Cancer Center
Takashi Seto: National Kyushu Cancer Center
Makoto Nishio: The Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Koichi Goto: National Cancer Center Hospital East
Noboru Yamamoto: National Cancer Center Hospital
Isamu Okamoto: Kyushu University
Liang Tao: Roche (China) Holding Ltd
Wei Yu: Genentech Inc.
Tarik Khaznadar: F. Hoffmann-La Roche Ltd
Kosei Tajima: Chugai Pharmaceutical Co. Ltd
Masahiko Shibata: Chugai Pharmaceutical Co. Ltd
Akihiro Seki: Chugai Pharmaceutical Co. Ltd
Nobuyuki Yamamoto: Wakayama Medical University

Drug Safety, 2018, vol. 41, issue 2, No 9, 229-237

Abstract: Abstract Introduction The phase II JO25567 study compared the efficacy and safety of erlotinib plus bevacizumab vs. erlotinib alone as first-line therapy for advanced epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Objective Our objective is to provide updated analyses of safety and the assessment of manageability of specific adverse events. Methods Patients with stage IIIB/IV or recurrent, non-squamous, EGFR mutation-positive NSCLC were randomized to receive erlotinib plus bevacizumab or erlotinib. The primary endpoint was progression-free survival. Adverse event frequency rates, predictability and manageability, reasons for discontinuation, time to onset, and outcomes of specific adverse events were analyzed. Results The safety analysis population comprised 152 randomized patients (75 erlotinib plus bevacizumab; 77 erlotinib) who received at least one dose of study drug between February 2011 and March 2012. There was no difference in overall incidence of serious adverse events between arms, but more grade 3 or higher adverse events were reported with erlotinib plus bevacizumab (90.7%) than with erlotinib (53.2%), primarily due to grade 3 hypertension. Hypertension was controllable with antihypertensive medications in most cases. Proteinuria and bleeding were also more frequently reported with erlotinib plus bevacizumab than with erlotinib but were manageable and did not lead to early discontinuations. Conclusions The addition of bevacizumab to erlotinib prolonged progression-free survival in EGFR mutation-positive NSCLC. Follow-up safety data were consistent with the known safety profiles of both erlotinib and bevacizumab in NSCLC; this combination appeared to be manageable, and treatment was well tolerated. JapicCTI-111390.

Date: 2018
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s40264-017-0596-0 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:41:y:2018:i:2:d:10.1007_s40264-017-0596-0

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-017-0596-0

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().