A multicenter randomized open-label phase 2 study investigating optimal antiemetic therapy for patients with advanced/recurrent gastric cancer treated with trastuzumab deruxtecan: the EN-hance study

• DOI: 10.1007/s10147-025-02748-8
• Publication Date: 2025-04-28T07:03:46Z
• Authors: Toru Aoyama; Akira Ooki; Koji Oba; Kazuhiro Nishikawa; Ryohei Kawabata; Michitaka Honda; Hiromichi Maeda; Mitsuro Kanda; Keiji Sugiyama; Akitaka Makiyama; Kenki Segami; Masazumi Takahashi; Yoshiaki Shindo; Tsutomu Namikawa; Takashi Oshima; Aya Katayama; Kazuhito Shiosakai; Junichi Sakamoto
• Keywords: Palonosetron; Aprepitant; Regimen; Clinical endpoint

Abstract Background Trastuzumab deruxtecan (T-DXd) has been approved for the treatment of human epidermal growth factor receptor-2 (HER2)-positive gastric cancer and other indications in several countries is considered moderately or highly emetogenic. The management nausea vomiting associated with T-DXd not fully evaluated effectiveness conventional prophylaxis remains unknown. Methods This open-label, randomized, multicenter, phase 2 study aimed to investigate optimal antiemetic therapy Japanese patients undergoing treatment. Patients were randomized a doublet regimen group (dexamethasone palonosetron) triplet (aprepitant, dexamethasone, at ratio one one, stratified by sex, gastrectomy status, institution. Both treatments administered from day 1 before administration, emetic events observed 21 days. primary endpoint was complete response (CR) rate assess control based on voluntary patient-reported outcomes (PROs) during cycle (1–21 days). Results Of 60 enrolled patients, 58 eligible inclusion this analysis (29 each group). overall CR rates regimens 41.4% (12/29 patients) 37.9% (11/29 patients), respectively, neither met pre-specified threshold (> 18/29 patients). acute (0–24 h) 86.2% (25/29 both regimens, delayed (2–21 days) respectively. Conclusions Given that met, further research needed better characterize tailor an anti-emetic suits needs patients.