1545P - Phase II trial of endostar in combination with concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of esophagus

Background

To evaluate the efficacy and safety of Endostar combined with concurrent chemoradiotherapy (CCRT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC).

Methods

From May 2017 to February 2021, 92 patients with unresectable thoracic ESCC, clinical staged as IB to IVB disease based on the 8^th edition of the American Joint Committee on Cancer (stage IVB: Only metastasis to supraclavicular/celiac lymph nodes) and local recurrence, were enrolled and randomly allocated in Endostar plus concurrent chemoradiotherapy (CCRT)(intervention group; n=46) and concurrent chemoradiotherapy (CCRT) (control group; n=48). Five or six cycles of Endostar (7.5mg/m2/24h ×120h, 7 days/cycle) were delivered in intervention group. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), 1-year and 2-year overall survival rate and adverse events (AE).

Results

The median age was 63(interquartile range, 50-77) years in intervention group and 65(interquartile range, 52-79) years in control group. A total of 68 patients (74%) had stage III and IV disease. The intervention group had a significant higher complete response rate (ORR) than the control group (80% vs. 63.8%; P<0.05). The 1- and 2-year overall survival rates were 88.1% and 75.2% in intervention group, 87.4% and 62.3% in control group, respectively (P>0.05). The were no significant differences in the incidence of grade 3 or higher toxic effects between the intervention group and control group (P>0.05).

Conclusions

The median age was 63(interquartile range, 50-77) years in intervention group and 65(interquartile range, 52-79) years in control group. A total of 68 patients (74%) had stage III and IV disease. The intervention group had a significant higher complete response rate (ORR) than the control group (80% vs. 63.8%; P<0.05). The 1- and 2-year overall survival rates were 88.1% and 75.2% in intervention group, 87.4% and 62.3% in control group, respectively (P>0.05). The were no significant differences in the incidence of grade 3 or higher toxic effects between the intervention group and control group (P>0.05).

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.