Abstract 186P
Background
Immune checkpoint inhibitors (ICIs) expanded choices of early-line therapies in advanced gastric (G)/gastro-esophageal junction (GEJ) cancer. In addition, it' s observed that early-line ICI therapy, compared to chemotherapy, could enhance the efficacy of VEGFR inhibitors with chemotherapy in late lines. This single-center prospective clinical trial was aimed to explore the efficacy and safety of fruquintinib with nab-paclitaxel as second-line in patients (pts) with G/GEJ cancer exposed to ICIs in early lines.
Methods
Pts with advanced G/GEJ cancer who had been exposed to ICIs before the second line were eligible. 42 pts would receive 100g/m2 nab-paclitaxel on day 1 and day 8 every 3 weeks, and 4mg fruquintinib from day 1 to day 14 every 3 weeks. Progression-free survival (PFS) was set as the primary endpoint. The Kaplan–Meier method would be used to evaluate time-to-event outcomes.
Results
Up to Aug 10, 2023, 25 pts had been enrolled, 23 of whom were evaluable. 14 (60.9%) pts in evaluable set were male. All these pts was with stage Ⅳ of TNM staging. The median age was 58 (range: 33-74), and 6 (26.1%) pts were elder than 65 yr. 12 (63.2%) pts were with PD-L1 CPS greater than 1, 9 (47.4%) pts greater than 5, and 4 (17.4%) pts greater than 10. PD-L1 CPS of 4 pts was unknown. The pts had received a median of 5 (range: 1-20) cycles in early-line ICI therapy. 17 (73.9%) pts suffered metastasis in retroperitoneal lymph node and 7 (30.4%) pts in liver. With a median follow up time of 5.6 (range: 2.1-16.6) mo, the PFS achieved 4.8 (95% CI: 4.6-NA) mo. Despite the immatureness of overall survival (OS), the 1-year OS rate was 56.25% (95% CI: 17.27%-95.23%). The ORR was 47.8% (n=11), and DCR was 100% (n=23). As to safety, the most common (≥20%) AEs of all grades were white blood cell decrease, peripheral sensory neuropathy, and neutrophil count decrease, while that of grade≥3 was white blood cell decrease.
Conclusions
Fruquintinib with nab-paclitaxel as second-line therapy demonstrated good efficacy and safety in advanced G/GEJ cancer after exposure to ICIs. ICIs might increase benefit from this therapy, which warrants further investigations in a large cohort.
Clinical trial identification
ChiCTR2200059976.
Editorial acknowledgement
The authors acknowledge the editorial assistance from Chao Zhao, Shuang Xue, and Zheng Wang from HUTCHMED Ltd.
Legal entity responsible for the study
The authors.
Funding
Chinese Society of Clinical Oncology.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
62P - Combination of chemotherapy with endocrinal therapy as upfront treatment of metastatic breast cancer in hormone receptor- positive, HER2 -negative disease: A phase II randomised clinical trial
Presenter: Mariam Saleh
Session: Poster Display
Resources:
Abstract
63P - Efficacy and safety of eribulin plus carboplatin combination for HER2-negative metastatic breast cancer
Presenter: Mengqian Ni
Session: Poster Display
Resources:
Abstract
64P - Unmet needs following metastatic breast cancer in a middle-income Asian country
Presenter: Nirmala Bhoo-Pathy
Session: Poster Display
Resources:
Abstract
66P - Utidelone-based therapy in metastatic solid tumors after failure of standard therapies: A prospective, multicenter, single-arm trial
Presenter: Jianjun Zhang
Session: Poster Display
Resources:
Abstract
67P - Efficacy and safety of trastuzumab biosimilar in HER2+ve metastatic breast cancer: A multicenter phase III study
Presenter: krishna Mohan
Session: Poster Display
Resources:
Abstract
68P - Neratinib in combination with fulvestrant and or palbociclib can overcome endocrine resistance in HER2-low/ ER+ breast cancer
Presenter: Maryam Arshad
Session: Poster Display
Resources:
Abstract
69P - A multicenter, retrospective, real-world study of inetetamab combined with pyrotinib and vinorelbine as treatment for HER2-positive metastatic breast cancer
Presenter: Nan Jin
Session: Poster Display
Resources:
Abstract
70P - Overall survival of eribulin, trastuzumab, and pertuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer: A phase II, single-arm clinical trial
Presenter: Kenichi Inoue
Session: Poster Display
Resources:
Abstract
71P - Efficacy and safety of disitamab vedotin after trastuzumab for HER2 -positive breast cancer: A real-world data of retrospective study
Presenter: Chao Li
Session: Poster Display
Resources:
Abstract
72P - Real-world data on the efficacy of T-DM1 biosimilar for the treatment of HER2-positive metastatic breast cancer patients: Outcomes from a single center retrospective study in India
Presenter: Kaushal Patel
Session: Poster Display
Resources:
Abstract