Camrelizumab, apatinib safe, efficacious in advanced esophageal squamous cell carcinoma
Camrelizumab combined with apatinib may potentially be used as a second-line treatment for advanced esophageal squamous cell carcinoma, according to phase 2 results published in The Lancet Gastroenterology & Hepatology.
“Second-line or later-line therapy with apatinib, a selective tyrosine kinase inhibitor of VEGF [receptor 2], showed antitumor activity in patients with advanced esophageal squamous cell carcinoma, with acceptable toxicity,” Xiangrui Meng, of The First Affiliated Hospital of Zhengzhou University in China, and colleagues wrote. “A phase 1 study recommended apatinib at a dose of 250 mg when combined with camrelizumab in advanced cancers. Phase 2 studies of camrelizumab plus apatinib have been further conducted in many solid tumors with encouraging efficacy and manageable safety.”
Given these findings, Meng and colleagues conducted a single-arm, open-label trial to determine the safety and efficacy of camrelizumab and apatinib in patients with advanced esophageal squamous cell carcinoma. They recruited patients, aged 18 to 75 years, who had unresectable locally advanced, locally recurrent or metastatic esophageal squamous cell carcinoma and whose disease had progressed or was intolerant to first-line chemotherapy.
Participants received 200 mg of camrelizumab intravenously every 2 weeks and 250 mg of apatinib orally every day for a 28-day cycle.
Of 52 enrolled patients, 18 had confirmed objective responses (34.6%), eight of whom had greater than 50% tumor regression. In addition, four patients had confirmed complete responses, 14 had confirmed partial responses and 23 experienced stable disease.
Only 44 participants were included for efficacy analysis, 15 (29%) of whom continued treatment at the data cutoff date, and 33 (75%) of whom had tumor shrinkage from baseline, the researchers wrote.
Treatment-related adverse events were reported in 41 patients, with grade 3 or 4 events observed in 23 patients (44%). The most common grade 3 or 4 events were increased aspartate aminotransferase (19%), increased gamma-glutamyltransferase (19%) and increased alanine aminotransferase (10%). There were no treatment-related deaths.
Limitations included study design and enrollment of patients without previous immunotherapy, though Meng and colleagues wrote that a cohort of patients with previous immunotherapy was being recruited.
“This combination could be a potential second-line treatment option for patients with advanced esophageal squamous cell carcinoma and warrants phase 3 trials to validate the potential benefits of this regimen,” the researchers wrote. “First-line use of camrelizumab plus apatinib should be further explored for esophageal squamous cell carcinoma.”