126P - A phase II study of rh-endostatin combined with irinotecan plus cisplatin as the second-line treatment for advanced esophageal squamous cell carcinoma (ESCC)

Background

For patients (pts) with advanced ESCC, there is lack of effective treatment. Rh-endostatin (endostar) has shown clinical activity when combined with chemoradiotherapy in treating locally advanced ESCC. This single-arm phase II study aimed to assess the efficacy and safety of endostar combined with irinotecan and cisplatin as the second-line treatment for pts with advanced ESCC.

Methods

Eligible pts were histologically proven stage IV ESCC; 18-75 years old; had progressive disease after first line treatment or chemoradiation within a year; at least one measureable lesion according to RECIST 1.1; ECOG PS 0-1. Endostar (15 mg/m2/day, continuous infusion, day 1-7) plus irinotecan (60 mg/m2, day 1, 8) and cisplatin (60 mg/m2, day 1) were administered every 3 weeks for 4-6 cycles. Primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).

Results

From May 2017 to Jun 2020, 52 pts were enrolled and 1 patient withdrawn consent before receiving treatment, 1 patient was excluded due to concurrent radiotherapy. The mean cycle of treatment was 3.4 (range 1 to 6) in 46 patients with study discontinuation, while 4 patients remain receiving investigational treatment. Among these patients, 46 pts (90.2%) were male, and the median age was 60 (47-73). 47 pts were assessable for response. A total of 13 pts achieved partial response and 18 pts had stable disease. ORR was 27.7% and DCR was 66.0%. To date, 42 PFS events and 22 OS events have occurred. The median PFS and OS were 3.8 months (95% CI 2.4-5.3 months) and 12.3 months (95% CI 7.0-17.6 months), respectively. The most common AEs observed during this study were anemia (35.3%), neutropenia (29.4%), abdominal distension (29.4%), fatigue (27.5%), anorexia (19.6%). The most common Grade 3/4 AEs observed were neutropenia (15.7) and diarrhea (9.8%).

Conclusions

The combination of endostar plus irinotecan and cisplatin is a well-tolerated treatment option with promising activity in the second line treatment of advanced ESCC. Its efficacy and safety profile warranted further study in randomized trials.

Clinical trial identification

NCT03797625.

Editorial acknowledgement

Legal entity responsible for the study

Fudan University Shanghai Cancer Center.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.