Phase III study comparing bevacizumab plus erlotinib to erlotinib in patients with untreated NSCLC harboring activating EGFR mutations: NEJ026
| Autor: | Morihito Okada, Ou Yamaguchi, Haruhiro Saito, Kouzou Yoshimori, Tatsuro Fukuhara, Koichi Hagiwara, Shunichiro Iwasawa, Ichiro Nakachi, Satoshi Morita, Yoshio Tsunezuka, Naoki Furuya, Kunihiko Kobayashi, Akihiko Gemma, Koichi Azuma, Makoto Maemondo, Toshihiro Nukiwa, Shunichi Sugawara, Kana Watanabe |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Oncology Cancer Research medicine.medical_specialty Bevacizumab business.industry Afatinib Hazard ratio medicine.disease respiratory tract diseases 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Gefitinib 030220 oncology & carcinogenesis Statistical significance Internal medicine Clinical endpoint Medicine Erlotinib business Lung cancer neoplasms medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 36:9006-9006 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2018.36.15_suppl.9006 |
| Popis: | 9006Background: Development of treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) had been focused on monotherapy of gefitinib, erlotinib, or afatinib. Combinations of EGFR-TKIs and VEGF inhibitors are one of candidates for next strategy for EGFR-mutated tumor. We conducted a phase III study comparing BE to E. Methods: Chemotherapy-naive pts with advanced non-squamous NSCLC harbouring EGFR-mutation were randomly assigned to receive either combination with erlotinib (150 mg daily) plus bevacizumab (15 mg/kg iv q3w) or erlotinib (150 mg daily). Status of EGFR mutations in plasma samples were monitored routinely during the study treatment and a second-line treatment. The primary endpoint was PFS. Secondary endpoints were OS, RR, safety, and QoL. We hypothesized that hazard ratio of PFS was 0.63. It was estimated that 147 events would be needed for the study to have a power of 80% and a two-sided significance level of 5%. Accordingly, this study was planned to enroll 214 pts in total. Results: Betw... |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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