Top Line: Could concurrent immunotherapy improve the response rate for unresectable esophageal SCC treated with definitive chemoradiation?
The Study: A single arm Japanese trial showed that the complete response rate for resectable ESCC treated with definitive chemoradiation is as high as 59%. Could immunotherapy improve these outcomes? EC-CRT-001 was a single arm, single center phase 2 trial from China that tested the safety and efficacy of adding the PD-1 inhibitor toripalimab to chemoradiation for locally advanced esophageal SCC. 42 patients with unresectable esophageal SCC were treated with definitive radiation (50.4 Gy in 28 fractions) and 5 cycles of concurrent cisplatin and paclitaxel plus two cycles of toripalimab. Of note, they did not treat elective lymph node volumes due to the uncertainty of additional toxicity with immunotherapy. A year of maintenance toripalimab was given after chemoradiation. At 3 months after treatment, the rate of complete clinical response was 62%. Most of the patients with an initial complete response (77%) maintained that response for 12 months, so the complete response rate at 12 months was 48%. At 1 year, the OS rate was 78.4% and the PFS rate was 54.5%. Again, this was a single-arm study, so we don’t know whether toripalimab improved response rate compared to standard chemoradiation.
TBL: Larger randomized trials will tell the tale of whether concurrent and maintenance immunotherapy improves treatment outcomes for unresectable esophageal SCC. | Zhu, Lancet Oncol 2023
The Study: A single arm Japanese trial showed that the complete response rate for resectable ESCC treated with definitive chemoradiation is as high as 59%. Could immunotherapy improve these outcomes? EC-CRT-001 was a single arm, single center phase 2 trial from China that tested the safety and efficacy of adding the PD-1 inhibitor toripalimab to chemoradiation for locally advanced esophageal SCC. 42 patients with unresectable esophageal SCC were treated with definitive radiation (50.4 Gy in 28 fractions) and 5 cycles of concurrent cisplatin and paclitaxel plus two cycles of toripalimab. Of note, they did not treat elective lymph node volumes due to the uncertainty of additional toxicity with immunotherapy. A year of maintenance toripalimab was given after chemoradiation. At 3 months after treatment, the rate of complete clinical response was 62%. Most of the patients with an initial complete response (77%) maintained that response for 12 months, so the complete response rate at 12 months was 48%. At 1 year, the OS rate was 78.4% and the PFS rate was 54.5%. Again, this was a single-arm study, so we don’t know whether toripalimab improved response rate compared to standard chemoradiation.
TBL: Larger randomized trials will tell the tale of whether concurrent and maintenance immunotherapy improves treatment outcomes for unresectable esophageal SCC. | Zhu, Lancet Oncol 2023