Health-Related Quality-Of-Life (Hrqol) Results From The Fast Study: A Phase Ii Trial Of Epirubicin, Oxaliplatin, And Capecitabine With Or Without Imab362 In Patients With Advanced Cldn18.2+Gastric And Gastroesophageal Junction Adenocarcinoma.

JOURNAL OF CLINICAL ONCOLOGY(2018)

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摘要
54Background: In the FAST study, IMAB362 (loading dose 800 mg/m2 then 600 mg/m2 d1 qd21) plus EOX (epirubicin 50 mg/m2 and oxaliplatin 130 mg/m2 d1, and capecitabine 625 mg/m2 bid) was compared with EOX alone in patients with advanced/metastatic gastric (GA), gastroesophageal (GE), and gastroesophageal junction (GEJ) adenocarcinoma. The FAST study exhibited a clinically relevant benefit in PFS and OS with a manageable safety profile in patients treated with IMAB362. Here we present the HRQoL results from the FAST study. Methods: CLDN18.2-positive patients (intermediate/strong membrane staining in ≥40% of cells) with advanced/metastatic GA/GE/GEJ adenocarcinoma were randomized 1:1 to first-line EOX for a maximum of 8 cycles with or without 600 mg/m2 q3w IMAB362, which after 8 cycles could be continued as monotherapy until disease progression (DP). The EORTC QLQC30 and a gastric cancer specific measure EORTC STO22 were collected at baseline (BL), Cycle 5, end of EOX therapy (EOT) and post-EOT every 12 weeks...
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