Abstract
BACKGROUND: In this open-label, Phase 1 study, we explore the safety and efficacy of E7389-LF (liposomal formulation of eribulin) in Japanese patients with advanced solid tumors. METHODS: This open-label, Phase 1 study enrolled Japanese adult patients to receive E7389-LF for the treatment of advanced solid tumors. Treatment with E7389-LF 2.0 mg/m(2) every 3 weeks (previously determined maximum tolerated dose) was tested for the treatment of adenoid cystic carcinoma, gastric cancer, esophageal cancer, or small lung cell cancer in the expansion part of this study. Secondary endpoints included safety, objective response rate, best overall response, and progression-free survival. RESULTS: As of October 16, 2020, 43 patients were enrolled (adenoid cystic carcinoma, n = 12; gastric cancer, n = 10; esophageal cancer, n = 11; small cell lung cancer, n = 10). Thirty-three patients experienced a Grade ≥3 treatment-related treatment-emergent adverse event, most commonly neutropenia (53.5%). Additionally, the incidence of hypersensitivity did not appear to change with a reduced number of infusion steps (2 vs. 4) and patients who were administered prophylactic pegylated granulocyte-colony stimulating factor had a noticeably lower incidence of Grade 3-4 neutropenia (although this did not have a proper control). The overall objective response rate was 11.6% (95% confidence interval: 3.9-25.1), corresponding to two partial responses in patients with adenoid cystic carcinoma, two partial responses in gastric cancer, and one partial response in esophageal cancer. Median progression-free survival was longer in the adenoid cystic carcinoma population (16.6 months) than in others. CONCLUSIONS: E7389-LF 2.0 mg/m(2) every 3 weeks was well tolerated for the treatment of several different tumor types, and larger studies in these populations are warranted.