Hiroaki Akamatsu1, Yuichi Ozawa2, Jun Oyanagi2, Daichi Fujimoto3, Akito Hata4, Nobuyuki Katakami3,5, Keisuke Tomii3, Eriko Murakami2, Takeya Sugimoto2, Toshio Shimokawa6, Yasuhiro Koh2, Nobuyuki Yamamoto2. 1. Internal Medicine III, Wakayama Medical University, Wakayama, Japan; hiroakiakamatsu@gmail.com. 2. Internal Medicine III, Wakayama Medical University, Wakayama, Japan. 3. Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan. 4. Department of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan. 5. Department of Medical Oncology, Takarazuka City Hospital, Takarazuka, Japan. 6. Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
Abstract
BACKGROUND/AIM: To explore the safety of osimertinib plus ramucirumab in patients with EGFR-mutated lung adenocarcinoma. PATIENTS AND METHODS: Six advanced lung adenocarcinoma patients with EGFR mutation were treated with osimertinib 80 mg/day plus ramucirumab 10 mg/kg, every two weeks. Defined dose-limiting toxicity (DLT) was assessed within the first two treatment cycles. RESULTS: Of those enrolled, five patients had both EGFR exon 20 T790M mutation and sensitizing mutation. DLT was observed in one patient (grade 3 appetite loss). During the entire period, no other severe adverse event was observed. Five patients showed partial response and one disease progression. Median progression-free survival for patients with EGFR T790M was 9.2 months. In an exploratory analysis, changes of cell-free DNA at 2 weeks predicted radiological tumor responses. CONCLUSION: The safety results of osimertinib plus ramucirumab in Japanese lung adenocarcinoma patients with EGFR mutation will lead to further efficacy investigation.
BACKGROUND/AIM: To explore the safety of osimertinib plus ramucirumab in patients with EGFR-mutated lung adenocarcinoma. PATIENTS AND METHODS: Six advanced lung adenocarcinoma patients with EGFR mutation were treated with osimertinib 80 mg/day plus ramucirumab 10 mg/kg, every two weeks. Defined dose-limiting toxicity (DLT) was assessed within the first two treatment cycles. RESULTS: Of those enrolled, five patients had both EGFR exon 20 T790M mutation and sensitizing mutation. DLT was observed in one patient (grade 3 appetite loss). During the entire period, no other severe adverse event was observed. Five patients showed partial response and one disease progression. Median progression-free survival for patients with EGFR T790M was 9.2 months. In an exploratory analysis, changes of cell-free DNA at 2 weeks predicted radiological tumor responses. CONCLUSION: The safety results of osimertinib plus ramucirumab in Japanese lung adenocarcinoma patients with EGFR mutation will lead to further efficacy investigation.