NEW YORK (Reuters Health) – Adding camrelizumab to chemotherapy improves overall survival and progression-free survival when used as first-line therapy for advanced or metastatic esophageal squamous cell carcinoma (ESCC), according to results of the ESCORT-1st study conducted in China.
ESCC is the most common histological subtype of esophageal cancer in Asia. Current standard first-line therapy is chemotherapy, but prognosis “remains poor,” the study team notes in JAMA.
Camrelizumab is a humanized anti-PD-1 monoclonal antibody made by Jiangsu Hengrui Pharmaceuticals Co, Ltd, which funded the study.
In the earlier ESCORT study, camrelizumab significantly improved overall survival when used as second-line therapy in patients with advanced or metastatic ESCC. Results of the study led to the drug’s approval in China for second-line treatment in this population.
The ESCORT-1st study compared camrelizumab plus chemotherapy and chemotherapy alone for first-line therapy of untreated advanced ESCC.
A total of 596 patients (mean age, 62 years) were randomized (1:1) to camrelizumab or placebo, combined with up to six cycles of paclitaxel and cisplatin. All treatments were given intravenously every three weeks.
At a median follow-up of 10.8 months, median overall survival was 15.3 months with camrelizumab plus chemotherapy versus 12.0 months with placebo plus chemotherapy (hazard ratio, 0.70; 95% confidence interval, 0.56 to 0.88), report Dr. Rui-Hua Xu of Sun Yat-sen University Cancer Center in Guangzhou and colleagues.
The median progression-free survival was 6.9 months with camrelizumab versus 5.6 months without (HR, 0.56; 95% CI, 0.46 to 0.68).
“Subgroup analyses suggested generally consistent benefits in both overall survival and progression-free survival with camrelizumab plus chemotherapy over placebo plus chemotherapy, although the small number of patients in some subgroups precluded accurate interpretation of the benefits,” the researchers report.
The data suggest a potentially better overall survival benefit in patients with baseline PD-L1 of at least 1% or higher, “but the test for interaction was not statistically significant and no definite correlation between PD-L1 expression and efficacy of camrelizumab can be concluded on the basis of this study,” they note.
Treatment-related adverse events occurred in 99.3% of patients in the camrelizumab-chemotherapy group and 97.0% of those in the placebo-chemotherapy group. Treatment-related adverse events of grade 3 or higher occurred in 63.4% of those in the camrelizumab-chemotherapy group and 67.7% of those in the control group, including treatment-related deaths among nine (3.0%) and 11 patients (3.7%), respectively.
The researchers say the adverse-event profile was in line with that observed with camrelizumab plus chemotherapy in other tumor types and “no new adverse event signal was identified.”
Health-related quality of life assessment up to 36 weeks showed statistically significant results in favor of camrelizumab based on the European Organization for Research and Treatment of Cancer (EORTC) quality of life core 30 (QLQ-C30) scale including global health status, pain after treatment, trouble swallowing saliva and choking when swallowing.
This finding is noteworthy, the researchers say, as patients with advanced or metastatic esophageal cancer often have poor health-related quality of life due to the disease itself and relevant treatments.
This study was funded by Jiangsu Hengrui Pharmaceuticals Co, Ltd. Several authors have disclosed financial relationships with the company.
SOURCE: https://bit.ly/2VFoWDP JAMA, online September 14, 2021.
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