203P - Neoadjuvant durvalumab plus chemotherapy for resectable locally advanced esophageal squamous cell carcinoma (ESCC)

Background

Esophageal squamous cell carcinoma (ESCC) is the main subtype of esophageal cancer in China. We conducted a prospective clinical trial of preoperative Durvalumab combined chemotherapy in patients with locally advanced ESCC.

Methods

Clinical resectable IIB-IVA ESCC patients were enrolled in the study. Patient received neoadjuvant Durvalumab 750mg combined chemotherapy (docetaxel 75mg/m2 plus cisplatin 75mg/m2 or carboplatin area under curve 4-5) every 3 weeks for 4 cycles before surgery. The primary endpoint was the pathological complete response rate (pCR) and the radical resection rate (R0).

Results

26 eligible patients were enrolled in the study and all completed four cycles of neoadjuvant therapy. The objective response rate is 80.8%, and the disease control rate was 100%. Among the 22 resectable tumor patients, 20 received McKeown MIE, and the other 2 patients who achieved response (1 PR and 1 CR) refused surgery due to concerns about complications. 20 patients underwent esophagectomy within 33-60 days (median 47 days) after neoadjuvant therapy, and 19 patients underwent radical resection with a R0 resection rate of 95%. pCR (ypT0N0) was observed in 3 patients (15.8%). 2 patients (10.5%) achieved complete remission of the primary tumor (ypT0N1). 1 patient (5.3%) had an American Society of Pathologists (CAP) score of 1, 7 patients (36.8%) had a CAP score of 2, and 8 patients (6/19, 31.6%) had a CAP score of 3. Most treatment-related AEs (TRAEs) were grade 1 or 2. 8 cases (30.8%), 13 cases (50%), and 1 case (3.8%) developed leukopenia, decreased neutrophil count, and dermatitis, respectively ¾ Level TRAE. In terms of surgical complications, 2 patients had anastomotic leakage (10%), and 1 patient had recurrent laryngeal nerve injury (5%).

Conclusions

The combination of neoadjuvant Durvalumab chemotherapy has achieved satisfactory initial efficacy and safety results in locally advanced ESCC. Neoadjuvant immunotherapy does not increase perioperative complications and can achieve higher pathological remission rates, which may lead to better PFS and OS in the future. This study is currently the first clinical trial to use PD-L1 inhibitors in the treatment of esophageal squamous cell carcinoma.

Clinical trial identification

NCT04568200.

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.