A Phase II Study of Apatinib in Patients with Chemotherapy-Refractory Advanced Or Metastatic Esophageal Squamous Cell Carcinoma (ESO-Shanghai 11)
Mené sur 40 patients atteints d'un carcinome épidermoïde de l'oesophage de stade avancé ou métastatique et réfractaire à la chimiothérapie, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse et du taux de contrôle de la maladie, et la toxicité de l'apatinib
Background : The aim of this study was to evaluate the efficacy and adverse effects of the oral vascular endothelial growth factor receptor 2 (VEGFR‐2) tyrosine kinase inhibitor apatinib in patients with chemotherapy‐refractory esophageal squamous cell carcinoma (ESCC). Methods : We enrolled patients with chemotherapy‐refractory ESCC. All patients received continuous apatinib 500 mg once daily. Results : Between July 2017 and August 2018, 40 patients were recruited, of whom 5 (12.5%) had uncontrolled primary tumors. Additionally, 3 patients with partial response (PR) and 23 with stable disease (SD) were observed for overall response rate (ORR) of 7.5% and disease control rate (DCR) of 65.0% (Fig. 1). Median progression‐free survival (PFS) was 3.8 months (95% CI, 2.2–5.4); median overall survival (OS) was 5.8 months (95% CI, 3.2–8.4). Common adverse effects were fatigue (15%), hypertension (12.5%), and palmar‐plantar erythrodysesthesia syndrome (10%). Two cases of death due to massive bronchopulmonary hemorrhage were observed, and esophageal fistula occurred in another two patients. Notably, both patients with esophageal fistula and one patient with massive fatal bronchopulmonary hemorrhage were individuals with uncontrolled primary tumors (3/5, 60%). Fatal bronchopulmonary hemorrhage in a second patient was associated with major blood vessel invasion. Conclusion : Apatinib has potential as an effective and safe treatment for patients with chemotherapy‐refractory ESCC whose primary tumors are controlled and without severe invasion of trachea, bronchi, or major blood vessels.
The Oncologist 2021