A Randomized Phase 2 Study Comparing the Combination of Ficlatuzumab and Gefitinib with Gefitinib Alone in Asian Patients with Advanced Stage Pulmonary Adenocarcinoma
Publication in refereed journal

香港中文大學研究人員

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摘要INTRODUCTION:
A randomized phase 2 study was designed to compare the combination of ficlatuzumab (AV-299), a humanized hepatocyte growth factor-neutralizing monoclonal antibody, plus gefitinib versus gefitinib monotherapy in a pulmonary adenocarcinoma population clinically enriched for EFGR tyrosine kinase inhibitor-sensitizing mutations.
METHODS:
A total of 188 patients were randomized 1:1 to receive either gefitinib or ficlatuzumab plus gefitinib treatment. Patients who demonstrated disease control in the single-agent gefitinib arm were allowed to cross over to ficlatuzumab plus gefitinib treatment upon disease progression. Molecular analyses included tumor EGFR mutation status and retrospective proteomic testing using VeriStrat, a multivariate test based on mass spectrometry.
RESULTS:
The addition of ficlatuzumab to gefitinib did not provide significant improvement over gefitinib monotherapy for the primary end point of overall response rate or the secondary end points of progression-free survival and overall survival. In the subgroup classified as VeriStrat poor, the addition of ficlatuzumab to gefitinib showed significant improvement in both progression-free survival and overall survival in both the intent-to-treat population and the subgroup with EGFR tyrosine kinase inhibitor-sensitizing mutations. For all patients, the most frequent adverse events were diarrhea, dermatitis acneiform, and paronychia.
CONCLUSIONS:
Although the trial showed no significant benefit from the addition of ficlatuzumab to gefitinib in the overall population of Asian patients with advanced-stage pulmonary adenocarcinoma, the biomarker data suggest that patients classified as VeriStrat poor may benefit from ficlatuzumab combination therapy.
著者MOK Shu Kam Tony, GEATER Sarayut Lucien, SU Wu Chou, TAN Eng Huat, YANG James Chi Hsin, CHANG Gee Chen, HAN May, KOMARNITSKY Philip, PAYUMO Francis, GARRUS Jennifer E, CLOSE Sandra, PARK Keunchil
期刊名稱Journal of Thoracic Oncology
出版年份2016
月份10
卷號11
期次10
出版社Lippincott, Williams & Wilkins
頁次1736 - 1744
國際標準期刊號1556-0864
電子國際標準期刊號1556-1380
語言英式英語
關鍵詞ADVANCED STAGE PULMONARY ADENOCARCINOMA; GEFITINIB

上次更新時間 2021-17-01 於 01:07