199P - Efficacy of endostar in combination with concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of esophagus: A randomized, open-label, phase II trial

Background

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

Methods

From May 2017 to February 2021, 90 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 chemoradiothery (CCRT)(intervention group; n=44) and concurrent chemoradiothery (CCRT)(control group; n=46). 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 end-points 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 67 patients (74%) had stage III and IV disease. The Endostar-combined group had a significant higher complete response rate(ORR) than the control group((80% vs. 63.8%; P=0.084). Survival patients had a median follow-up of 51.5 months(interquartile range: 48.2-54.8 months). The median overall survival were 16.7m in Endostar-combined group and 12.8m in control group, respectively(p=0.054). The Endostar-combined group had a significantly higher 5-year overall survival rate(13.6% vs 0%; p=0.014). 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

This trial shows the combination of Endostar with concurrent chemoradiotheray (CCRT) was tolerable and provided higher ORR and 5-year overall survival rate over concurrent chemoradiothery (CCRT), and is very likely to provide promising survival benefit in patients with locally advanced ESCC.

Clinical trial identification

ChiCTR-IPR-16009926.

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.