144P Tislelizumab combined with chemotherapy as neoadjuvant therapy for surgically resectable esophageal cancer (TD-NICE): A single arm, phase II study

Abstract

BackgroundThe clinical benefit of neoadjuvant treatment involving immune checkpoint inhibitors in resectable esophageal squamous cell carcinoma (ESCC) remains unclear. This study evaluated the efficacy and safety of preoperative PD-1 inhibitor tislelizumab combined with chemotherapy in resectable ESCC.MethodsThis is a prospective, single-arm, phase II clinical trial. Treatment-naïve patients with resectable ESCC received tislelizumab (200 mg on day 1), carboplatin (area under the curve = 5 on day 1) and nab-paclitaxel (130 mg/m2 on day 1 and 8) once every 3 weeks for 3 cycles. Within 3-6 weeks after neoadjuvant therapy, patients underwent Mckeown or IvorLewis esophagectomy. The primary endpoint was major pathological response (MPR) rate. The secondary endpoints included pathological complete response (pCR) rate, radical resection (R0) rate, tumor downstaging rate and safety.ResultsTable: 144PSubgroup analyses of MPR and pCRMPR (N=36)pCR (N=36)Yes (26)No (10)P valueYes (18)No (18)P valueTPS%0.3100.059<1%19 (73.1%)10 (100%)12 (66.7%)17 (94.4%)1-49%3 (11.5%)0 (0%)2 (11.1%)1 (5.6%)≥50%4 (15.4%)0 (0%)4 (22.2%)0 (0%)Downstaging<0.0010.001Yes25 (96.2%)2 (20.0%)18 (100%)9 (50.0%)No1 (3.8%)8 (80.0%)0 (0%)9 (50.0%)CPS0.2500.255<114 (53.8%)5 (50%)10 (55.6%)9 (50%)1-104 (15.4%)4 (40%)2 (11.1%)6 (33.3%)≥108 (30.8%)1 (10%)6 (33.3%)3 (16.7%)TPS, tumor proportion score; CPS, combined positive score. Open table in a new tab ConclusionsTislelizumab plus chemotherapy as neoadjuvant therapy demonstrates promising anti-tumor activity for resectable ESCC with high rates of MPR, pCR and R0 resection, as well as an acceptable tolerability.Clinical trial identificationChiCTR2000037488.Legal entity responsible for the studyThe authors.FundingBeiGene (Beijing) Co. Ltd.DisclosureAll authors have declared no conflicts of interest. BackgroundThe clinical benefit of neoadjuvant treatment involving immune checkpoint inhibitors in resectable esophageal squamous cell carcinoma (ESCC) remains unclear. This study evaluated the efficacy and safety of preoperative PD-1 inhibitor tislelizumab combined with chemotherapy in resectable ESCC. The clinical benefit of neoadjuvant treatment involving immune checkpoint inhibitors in resectable esophageal squamous cell carcinoma (ESCC) remains unclear. This study evaluated the efficacy and safety of preoperative PD-1 inhibitor tislelizumab combined with chemotherapy in resectable ESCC. MethodsThis is a prospective, single-arm, phase II clinical trial. Treatment-naïve patients with resectable ESCC received tislelizumab (200 mg on day 1), carboplatin (area under the curve = 5 on day 1) and nab-paclitaxel (130 mg/m2 on day 1 and 8) once every 3 weeks for 3 cycles. Within 3-6 weeks after neoadjuvant therapy, patients underwent Mckeown or IvorLewis esophagectomy. The primary endpoint was major pathological response (MPR) rate. The secondary endpoints included pathological complete response (pCR) rate, radical resection (R0) rate, tumor downstaging rate and safety. This is a prospective, single-arm, phase II clinical trial. Treatment-naïve patients with resectable ESCC received tislelizumab (200 mg on day 1), carboplatin (area under the curve = 5 on day 1) and nab-paclitaxel (130 mg/m2 on day 1 and 8) once every 3 weeks for 3 cycles. Within 3-6 weeks after neoadjuvant therapy, patients underwent Mckeown or IvorLewis esophagectomy. The primary endpoint was major pathological response (MPR) rate. The secondary endpoints included pathological complete response (pCR) rate, radical resection (R0) rate, tumor downstaging rate and safety. ResultsTable: 144PSubgroup analyses of MPR and pCRMPR (N=36)pCR (N=36)Yes (26)No (10)P valueYes (18)No (18)P valueTPS%0.3100.059<1%19 (73.1%)10 (100%)12 (66.7%)17 (94.4%)1-49%3 (11.5%)0 (0%)2 (11.1%)1 (5.6%)≥50%4 (15.4%)0 (0%)4 (22.2%)0 (0%)Downstaging<0.0010.001Yes25 (96.2%)2 (20.0%)18 (100%)9 (50.0%)No1 (3.8%)8 (80.0%)0 (0%)9 (50.0%)CPS0.2500.255<114 (53.8%)5 (50%)10 (55.6%)9 (50%)1-104 (15.4%)4 (40%)2 (11.1%)6 (33.3%)≥108 (30.8%)1 (10%)6 (33.3%)3 (16.7%)TPS, tumor proportion score; CPS, combined positive score. Open table in a new tab TPS, tumor proportion score; CPS, combined positive score. ConclusionsTislelizumab plus chemotherapy as neoadjuvant therapy demonstrates promising anti-tumor activity for resectable ESCC with high rates of MPR, pCR and R0 resection, as well as an acceptable tolerability. Tislelizumab plus chemotherapy as neoadjuvant therapy demonstrates promising anti-tumor activity for resectable ESCC with high rates of MPR, pCR and R0 resection, as well as an acceptable tolerability.