American Association for Cancer Research
ccr-22-3027_supplementary_table_s3_suppts3.pdf (117.79 kB)

Supplementary Table S3 from Phase I Study of the Liposomal Formulation of Eribulin (E7389-LF): Results from the Advanced Gastric Cancer Expansion Cohort

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posted on 2023-04-14, 08:21 authored by Kohei Shitara, Motohiro Hirao, Satoru Iwasa, Takashi Oshima, Yoshito Komatsu, Akihito Kawazoe, Yasuyoshi Sato, Takuya Hamakawa, Kan Yonemori, Nozomu Machida, Satoshi Yuki, Takuya Suzuki, Shiori Okumura, Takao Takase, Taro Semba, Bob Zimmermann, Angela Teng, Kensei Yamaguchi

Supplementary Table S3 provides a summary of infusion-related reactions during cycle 1, per premedication.


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In the dose-expansion part of this open-label, phase I study, we explored the efficacy and safety of E7389-LF (liposomal formulation of eribulin) in Japanese patients with advanced gastric cancer. Patients with advanced gastric cancer who had been previously treated with ≥2 lines of chemotherapy received E7389-LF 2.0 mg/m2 every 3 weeks (the previously determined maximum tolerated dose, the primary objective of Study 114). Secondary objectives included objective response rate (ORR), progression-free survival (PFS), and safety; exploratory objectives included disease control rate (DCR) and clinical benefit rate (CBR), as well as pharmacodynamic measurements of serum biomarkers. As of June 24, 2021, 34 patients were enrolled and treated (10 from the original dose-expansion cohort, expanded to include 24 additional patients). Six patients had partial responses, for an ORR of 17.6% [95% confidence interval (CI), 6.8–34.5], and the median PFS was 3.7 months (95% CI, 2.7–4.8). The DCR was 79.4% (95% CI, 62.1–91.3), and the CBR was 32.4% (95% CI, 17.4–50.5). Overall, 32 patients (94.1%) experienced treatment-related adverse events, and 26 patients (76.5%) experienced grade ≥3 events, most commonly neutropenia (41.2%) and leukopenia (29.4%). Of the 8 endothelial cell/vasculature markers tested in this study, 7 were significantly increased among patients treated with E7389-LF; these changes were generally consistent regardless of best overall response. E7389-LF 2.0 mg/m2 every 3 weeks was tolerable and showed preliminary activity for the treatment of patients with gastric cancer.

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