Rationale and Design of a Randomized Phase 2 Trial of Gefitinib Plus Bevacizumab vs Gefitinib Alone in Patients with Epidermal Growth Factor Receptor Mutant Non-Squamous Non-Small-Cell Lung Cancer: Study Protocol

• Published in: Kurume medical journal Vol. 65; no. 2; pp. 77 - 81
• Main Authors: KITAGAWA, CHIYOE, KADA, AKIKO, SAKA, HIDEO, SAITO, AKIKO M., ICHINOSE, YUKITO
• Format: Journal Article
• Language: English
• Published: Japan Kurume University School of Medicine 30.06.2018
• Subjects: Adult; Aged; Antineoplastic Agents - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; bevacizumab; Bevacizumab - administration & dosage; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - genetics; Clinical Trials, Phase II as Topic; epidermal growth factor receptor; ErbB Receptors - genetics; Female; gefitinib; Gefitinib - administration & dosage; Humans; Japan; Lung Neoplasms - drug therapy; Lung Neoplasms - genetics; Male; Middle Aged; Mutation; non-small-cell lung cancer; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome; Young Adult; Japan; bevacizumab; gefitinib; epidermal growth factor receptor; non-small-cell lung cancer
• ISSN: 0023-5679; 1881-2090; 1881-2090
• DOI: 10.2739/kurumemedj.MS652001

Combination chemotherapy with platinum preparations is the standard first-line treatment for stage IIIB/IV non-small-cell lung cancer. However, the median survival in patients receiving this therapy is 8 to 10 months, and it is essential to improve the results of chemotherapy in non-small-cell lung cancer. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors hinder EGFR signal transmission by binding to the adenosine triphosphate binding site of intracellular tyrosine kinase and inhibiting the autophospholylation of EGFR. They are a standard initial treatment option in EGFR gene mutation-positive patients. In Japan, gefitinib is routinely used. A combination of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and another antineoplastic drug may be a strategy to further improve treatment outcomes. We planned a randomized phase 2 trial to assess the efficacy and safety of gefitinib plus bevacizumab in such patients. In this study, subjects will be assigned to receive monotherapy with gefitinib (GEF group) or combination therapy with gefitinib and beva cizumab (GEF+BEV group) as the initial treatment at a ratio of 1:1. EGFR gene mutations are frequently detected in Asian patients with non-small-cell lung cancer. This study may be significant for establishing a new standard treatment.