Bevacizumab for non‐small‐cell lung cancer: A nested case control study of risk factors for hemoptysis

• DOI: 10.1111/cas.13096
• Publication Date: 2016-10-13T02:28:38Z
• Authors: Koichi Goto; Masahiro Endo; Masahiko Kusumoto; Nobuyuki Yamamoto; Yuichiro Ohe; Ayaka Shimizu; Masahiro Fukuoka
• Keywords: Univariate analysis; Nested case-control study; Concomitant

Potentially life‐threatening, serious hemoptysis is an adverse event associated with bevacizumab in non‐squamous non‐small‐cell lung cancer (NSCLC) trials. Suggested risk factors include central tumor location and cavitation; however, the profile of occurrence clinical practice still unclear. A nested case‐control study was conducted to assess onset for bevacizumab‐treated patients a real‐world setting Japan. After approved NSCLC, physicians registered all NSCLC scheduled therapy, from November 2009 August 2011. Patients developing grade 2 requiring injectable hemostatic agent or ≥3 were selected as case subjects, matched four control subjects each. Case report forms collected after observation period 24 weeks. Radiologists assessed blinded thoracic images. Risk by univariate stepwise multivariate analysis. Of 6774 registered, 23 (0.3%) experienced ≥2 drug‐related hemoptysis. total 104 (21 cases, 83 controls) analyzed reviewers occurrence. In analysis seven step‐wise analysis, prior radiotherapy ( P = 0.1844), presence exposure airway 0.0256) concomitant 0.1169) identified While incidence low Japan, three identified, radiotherapy, should be considered when selecting treatment. Although technically classed trial, non‐interventional surveillance analyzing receiving therefore it not phase II/III trial would be.