Phase II randomized clinical trial comparing albumin-bound docetaxel vs. docetaxel in patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma.
Authors: Wang Zhiqiang , Chen Dongliang , Li Hongli , Yang Mudan , Lin Rongbo , Cheng Ying , Li Zhiwei , Huang Xiwen , Wang Wei , Li Hui , Liu Hao , Dai Youguo , Wang Jufeng , Zhao Xin , Yang Yan , Qu Xiujuan , Zhao Jun , Zhang Zhe , Zeng Yanyan , Xu Rui-Hua 
Published: July 2024

e16018

Background: Albumin-bound docetaxel (HB1801) is a new kind of taxane and has many advantages compared with docetaxel. Previous phase I study has demonstrated that HB1801 showed preliminary efficacy in patients with gastric cancer. Here we presented the efficacy and safety of HB1801 in patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Methods: In this phase II study, eligible patients were aged 18-75 years with histologically confirmed G/GEJ adenocarcinoma, who progressed on at least first line of combined chemotherapy of platinum and fluorouracil. Patients were randomized (1:1) to receive HB1801 (100 mg/m2) or docetaxel (Taxotere, 75 mg/m2) administered every 3 weeks by intravenous infusion. Stratified factors included previous treatment with immunotherapy (yes or no) and ECOG PS (0 or 1). Primary endpoint was progression free survival (PFS) per RECIST version 1.1 assessed by independent review committee. Secondary endpoints included overall survival, objective response rate (ORR), disease control rate (DCR), duration of response (DOR) and safety. Results: As of December 31, 2023, 125 patients were enrolled and randomized to HB1801group ( n= 63) or docetaxel group ( n= 62). The two groups were comparable on baseline characteristics. Overall, the median age was 59.0 (range 27-75) years, 98 (78.4%) patients had ECOG PS of 1. 73 (58.4%), 7 (5.6%) and 6 (4.8%) patients had received previous treatment with immunotherapy, antiangiogenic agents and anti-HER2 therapy. 45 patients in HB1801 group and 47 patients in docetaxel group were evaluable for efficacy. ORR and DCR were 24.4% (11 PRs, 95%CI 12.88-39.54) and 57.8% (15SDs, 95%CI 42.15-72.34) for HB1801 group, 14.9% (1 CR+6 PRs, 95%CI 6.20-28.31) and 46.8% (15 SDs, 95%CI 32.11-61.92) for docetaxel group. Patients in HB1801 group had a numerically longer DOR than those docetaxel group (median DOR: 2.9 months (95% CI 1.41-NA) vs 1.5 months (95% CI 1.41-NA)). Treatment-related adverse events (TRAEs) occurred in 87.1% of patients receiving HB1801, and 82.3% of patients receiving docetaxel. Alopecia (38.7% vs. 37.1%) and anemia (33.9% vs 35.5%) were the most predominant TRAEs in both groups, fatigue (38.7% vs 17.7%), hypoalbuminemia (27.4% vs 8.1%), decreased appetite (17.7% vs 12.9%), peripheral edema (16.1% vs 4.8%) were also observed in HB1801 group and docetaxel group. 14 patients (22.6%) in HB1801 group and 15 patients (24.2%) in docetaxel group experienced ≥grade 3 TRAEs, with the most common being anemia, leukopenia, decreased appetite, fatigue and lymphopenia. There were no treatment-related deaths. No new safety signal was observed in HB1801 group. Conclusions: These preliminary results suggest that HB1801 had manageable safety profile and promising efficacy in patients with previously treated advanced G/GEJ cancer. Clinical trial information: NCT05705635 .