Overall survival and progression-free survival were improved with first-line treatment of camrelizumab with chemotherapy in patients with advanced or metastatic esophageal squamous-cell carcinoma (ESCC).
Esophageal cancer is usually diagnosed in the locally advanced unresectable or metastatic stage when palliative chemotherapy is the standard treatment.1 Prognosis for esophageal cancer remains poor, with a median overall survival (OS) of 11 months and a 5-year survival rate of approximately 5%.1 Esophageal squamous-cell carcinoma (ESCC) and esophageal adenocarcinoma are the main esophageal cancer subtypes.1 ESCC occurs primarily in the upper and mid-esophageal areas.1 Smoking and alcohol use are known risk factors for ESCC.1 Due to the low survival rate, other treatments are being sought to improve patient outcomes. The PD-1 antibody camrelizumab demonstrated antitumor activity in clinical trials investigating previously treated advanced or metastatic ESCC.
The ESCORT-1st randomized, phase 3 clinical trial enrolled 596 patients in 60 centers in China with untreated advanced or metastatic ESCC. Most patients were male (87.8%), and the median age was 62 years. Patients received either 200 mg camrelizumab or a placebo. This was combined with chemotherapy of 175 mg/m2 paclitaxel and 75 mg/m2 cisplatin for up to 6 cycles. Treatments were administered intravenously every 3 weeks. The camrelizumab group and placebo group each had 298 patients. The primary study end points were OS and progression-free survival (PFS). Median follow-up was 10.8 months and 490 patients discontinued the study treatment.
OS analysis revealed patients in the camrelizumab group had a median OS of 15.3 months, whereas the placebo group OS was 12.0 months. The camrelizumab group had 135 deaths, compared with 174 deaths in the placebo group. The camrelizumab group had a median PFS of 6.9 months compared with a median PFS of 5.6 months for the placebo group. Objective response rate in the camrelizumab group was 72.1% and 62.1% in the placebo group.
Treatment-related adverse events (TRAEs) were also evaluated. Grade ≥3 TRAEs occurred in 189 patients in the camrelizumab group, and 9 patients died from TRAEs. In the placebo group, 201 patients had grade ≥3 TRAEs and 11 patients died from TRAEs. The most common TRAEs reported were decreased neutrophils, decreased white blood cell count, and anemia. Pneumonitis was the most common serious TRAE, occurring in 30.2% of the camrelizumab group and 23.2% of the placebo group. Treatment interruption occurred in 45.3% of patients in the camrelizumab group and in 23.9% of the placebo group due to TRAEs.
The addition of camrelizumab to chemotherapy significantly improved OS and PFS in patients with advanced or metastatic ESCC.
Source: Luo H, Lu J, Bai Y, et al. Effect of camrelizumab vs placebo added to chemotherapy on survival and progression-free survival in patients with advanced or metastatic esophageal squamous cell carcinoma: the ESCORT-1st randomized clinical trial. JAMA. 2021;326:916-925.
Reference
- DaSilva LL, Aguiar PN Jr, de Lima Lopes G. Immunotherapy for advanced esophageal squamous cell carcinoma-renewed enthusiasm and a lingering challenge [published online ahead of print, September 14, 2021]. JAMA Oncol. 2021;10.