KEY TAKEAWAYS
- The study aimed to investigate the safety and efficacy of pembrolizumab + cisplatin and 5-fluorouracil as 1L therapy in patients with T4b ESCC.
- Researchers noted significant tumor reduction with fewer AEs, supporting pembrolizumab + chemo for T4b ESCC induction therapy.
Nobukazu Hokamura and the team aimed to focus on evaluating the safety and efficacy of pembrolizumab combined with cisplatin and 5-fluorouracil as first-line (1L) therapy in patients with advanced esophageal squamous cell carcinoma (ESCC).
Previous research has indicated that this regimen offers a better objective response and improved survival rates compared to conventional chemotherapy, while also resulting in fewer severe hematological adverse events. Given these promising outcomes, the study specifically targeted patients with T4b ESCC, a particularly advanced stage of the disease, to determine the potential benefits of this combination therapy.
They performed an inclusive analysis of 8 consecutive patients with T4b ESCC who received pembrolizumab combined with cisplatin and 5-fluorouracil as induction therapy, following the KEYNOTE-590 protocol. The patients were evaluated after receiving 1 to 3 courses of treatment.
In addition, the programmed death-ligand 1 (PD-L1) combined positive score (CPS) was assessed prior to the initiation of chemotherapy. The efficacy of the treatment on the primary tumor was determined using a specialized formula developed to calculate the tumor reduction rate.
The clinical outcomes, the numbers of patients with partial response (PR), stable disease, and progressive disease (PD) were 5, 1, and 2, respectively. The tumor reduction rate ranged from 69 to 87% in PR patients, and all PR patients experienced relief from T4b. Two patients underwent conversion surgery with R0 resection. The PD-L1 CPS was over 90 in 2 PR patients, but under 10 in 2 other PR patients.
PD-L1 CPS was under 10 in PD patients and 1 patient experienced hyperprogression, leading to the development of an esophago-pulmonary fistula. Adverse events (AEs) greater than grade 3 included a bleeding gastric ulcer in 1 patient (12.5%), neutropenia without G-CSF in 3 patients (37.5%), and hypopotassemia in 1 patient (12.5%). No patient developed febrile neutropenia.
The study concluded that marked tumor reduction was confirmed in 62.5% of patients receiving pembrolizumab + cisplatin and 5-fluorouracil, with fewer AEs compared to conventional treatments. This regimen demonstrates potential as an effective induction chemotherapy option for patients with T4b ESCC.
No funding information was given for this source.
Source: https://pubmed.ncbi.nlm.nih.gov/39223478/
Hokamura N, Fukagawa T, Fukushima R, et al. (2024). “Evaluation of pembrolizumab plus cisplatin and fluorouracil in radical treatment for patients with T4b esophageal squamous cell carcinoma.” BMC Gastroenterol. 2024;24(1):295. Published 2024 Sep 2. doi:10.1186/s12876-024-03382-w
