AuthorsYosuke Kawashima, MD[url=]a[/url] ∙ Tatsuro Fukuhara, MD[url=]b[/url] ∙ Haruhiro Saito, MD[url=]c[/url] ∙ Naoki Furuya, MD[url=]d[/url] ∙ Kana Watanabe, MD[url=]b[/url] ∙ Shunichi Sugawara, MD[url=]a[/url] ∙ Shunichiro Iwasawa, MD[url=]e[/url] ∙ Yoshio Tsunezuka, MD[url=]f[/url] ∙ Ou Yamaguchi, MD[url=]g[/url] ∙ Prof Morihito Okada, MD[url=]h[/url] ∙ Kozo Yoshimori, MD[url=]i[/url] ∙ Ichiro Nakachi, MD[url=]j[/url] ∙ Prof Masahiro Seike, MD[url=]k[/url] ∙ Koichi Azuma, MD[url=]l[/url] ∙ Futoshi Kurimoto, MD[url=]m[/url] ∙ Yukari Tsubata, MD[url=]n[/url] ∙ Yuka Fujita, MD[url=]o[/url] ∙ Hiromi Nagashima, MD[url=]p[/url] ∙ Gyo Asai, MD[url=]q[/url] ∙ Satoshi Watanabe, MD[url=]r[/url] ∙ Masaki Miyazaki, MD[url=]s[/url] ∙ Prof Koichi Hagiwara, MD[url=]t[/url] ∙ Toshihiro Nukiwa, MD[url=]u[/url] ∙ Prof Satoshi Morita, PhD[url=]v[/url] ∙ Prof Kunihiko Kobayashi, MD[url=]g[/url] ∙ Prof Makoto Maemondo, MD[url=]p[/url]
BackgroundBevacizumab is a promising candidate for combination treatment with epidermal growth factor receptor tyrosine-kinase inhibitors (eg, erlotinib), which could improve outcomes for patients with metastatic EGFR-mutant non-small-cell lung cancer (NSCLC). We have previously shown in NEJ026, a phase 3 trial, that the combination of bevacizumab plus erlotinib significantly prolonged progression-free survival compared with erlotinib alone in these patients. In further analyses, we aimed to examine the effects of bevacizumab每erlotinib on overall survival, time from enrolment to progressive disease during second-line treatment or death, and quality of life.
MethodsThis open-label, randomised, multicentre, phase 3 trial (NEJ026) was done in 69 hospitals and medical, community-based centres across Japan. Eligible patients had stage IIIB, stage IV, or postoperative recurrent, EGFR-mutant (exon 19 deletion or exon 21 Leu858Arg point mutation) NSCLC, had not previously received systemic chemotherapy, and were randomly assigned (1:1) by a computer-generated randomisation sequence and minimisation to receive either 150 mg oral erlotinib once daily plus 15 mg/kg intravenous bevacizumab once every 21 days, or 150 mg oral erlotinib once daily, until disease progression or intolerable toxicity. Randomisation was stratified according to sex, smoking status, EGFR mutation subtype, and clinical disease stage. All participants, investigators, and study personnel (including those assessing outcomes) were unmasked to treatment allocation. We report the secondary outcomes of overall survival and quality of life (the period from enrolment to confirmation of a minimally important difference on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ]-C30), and the exploratory outcome of time from enrolment to progressive disease during second-line treatment or death. Overall survival and the exploratory outcome were analysed in the modified intention-to-treat population, which comprised all randomly assigned patients who received at least one dose of the study drug and had response evaluations. Quality of life was analysed in patients in the modified intention-to-treat population who had completed the quality of life questionnaires. The trial is registered with the University Hospital Medical Information Network Clinical Trials Registry, UMIN000017069, and the Japan Registry of Clinical Trials, jRCTs031180056, and is currently closed.
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Patient blood management in critically ill children undergoing cardiac surgery: A cohort study
