1403P - A phase II study of tislelizumab combined with chemotherapy as neoadjuvant therapy for surgically resectable esophageal cancer: Long-term follow-up outcomes of TD-NICE

Background

Several phase II/III studies have shown that neoadjuvant immunotherapy have promising efficacy in patients with resectable esophageal squamous cell carcinoma (ESCC). In our previous reported TD-NICE study, 36 of 45 patients who received neoadjuvant tislelizumab combined with chemotherapy and surgery, major pathological response (MPR) and pathological complete response (pCR) is 72.0% and 50.0%. Here, we report update long-term follow-up data.

Methods

Treatment-naïve patients with resectable ESCC were enrolled. Patients received 3 cycles (3 weeks/cycle) tislelizumab (200 mg, D1), carboplatin (AUC=5, D1), and albumin-bound paclitaxel (130 mg/m2 on D1,8). The primary endpoint was MPR, secondary endpoint included pCR, R0 rate, tumor downstaging rate and safety.

Results

By April 2024, with a median follow-up of 39.2 months, 17 patients (37.8%) had died (11 in the surgery group and 6 in the non- surgery group). The median OS of the ITT group and the surgery group was not reached, and the median OS of the non- surgery group was 32.9m. The 1-year, 2-year and 3-year OS rates were 86.7%, 71.1% and 64.3% in all patients, 88.9%, 77.8%, 69.3% and 66.7%, 55.6%, 44.4% in the surgery and non- surgery groups, respectively. The OS results of R0 resection, pCR and MPR subgroups are shown in the table below. The mOS of R1 & R2 group was 20.5 months, which was statistically lower compared with R0 group (p=0.034), while there was no statistically significant difference among other subgroups. The EFS at 1 year, 2 years and 3 years were 88.9%, 75.0% and 69.3%. The trends of EFS were similar as OS.

Table: 1403P

Conclusions

Neoadjuvant tislelizumab combined with chemotherapy showed long-term survival benefit in ESCC patients, especially in R0 resection and surgery patients.

Clinical trial identification

ChiCTR2000037488.

Editorial acknowledgement

Legal entity responsible for the study

The Second Affiliated Hospital of Air Force Medical University.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.