Clinical impact of oral intake on second-line treatment of advanced gastric cancer.

Abstract

e16560 Background: Trifluridine/tipiracil, an oral drug, was approved in Japan for patients (pts) with advanced gastric cancer (AGC). Insufficient oral intake (INSUF) is one of the most common complications. We evaluated the clinical characteristics and impact of oral intake during 2nd line chemotherapy (CT). Methods: We retrospectively evaluated AGC pts receiving 2nd line CT from January 2012 to December 2018 at a single institution. We defined “INSUF” as a requirement for daily intravenous fluids or hyperalimentation and “improvement of oral intake (IMP)” as no such requirement for > 1 week. Exacerbation (EXA) was defined as a change from “sufficient oral intake (SUF)” to INSUF. Results: We enrolled 495 pts, of which 67 (13%) and 428 (87%) pts had INSUF and SUF at the start of 2nd line CT, respectively. Patient characteristics are summarized in the Table. There was no difference in the cytotoxic drugs of 2nd line CT. The causes of INSUF were peritoneal metastases (79%), cachexia (15%), and primary complications (3%). The objective response rates of INSUF and SUF pts were 9% and 26%, respectively. INSUF pts had poorer progression-free survival (PFS) (1.7 vs. 3.7 months [M]; adjusted HR [aHR], 1.51; p < 0.001) and overall survival (3.2 vs. 10.1 M; aHR, 2.01; p < 0.001) than SUF pts. At the end of 2nd line CT, 147 (32%) and 314 (68%) pts had INSUF and SUF, respectively. In SUF pts, the factors correlated with EXA were poor ECOG PS (odds ratio [OR], 5.26; p < 0.001), massive or moderate ascites (OR, 2.04; p = 0.031), palliative operation history (OR, 2.90; p = 0.007), and ramucirumab use (OR, 0.50; p = 0.034). Median PFS was shorter after CT in pts with EXA than in those without (1.7 vs. 4.2 M; aHR, 2.05; p < 0.001). Among INSUF pts, 11 pts (16%) achieved IMP; the rate of IMP did not differ according to regimen. Median PFS was shorter in pts without IMP than in pts with IMP (1.1 vs. 3.3 M; aHR, 4.97; p = 0.001). Subsequent CT was administered to 29% and 71% of INSUF and SUF pts, respectively. Conclusions: INSUF at the start of 2nd line CT was a poor prognostic factor. For appropriate use of oral drugs, CT should be changed in SUF pts with factors associated with EXA. [Table: see text]