1252P Update results of anlotinib combined with nab-paclitaxel and cisplatin as neoadjuvant treatment for esophageal squamous cell carcinoma (ESCC): A single-arm, open-label phase Ⅱ clinical trial

Abstract

Due to the intolerability of concurrent chemoradiotherapy, novel neoadjuvant treatments are being explored. Anlotinib was an effective second-line monotherapy for ESCC in China and the combination therapy might be a promising strategy. The preliminary results of nab-paclitaxel and cisplatin combined with anlotinib as neoadjuvant treatment for ESCC had been reported in 2022 ASCO (e16015). Here, the update results were reported. ESCC patients (pts) with preoperative clinical stage II-III and radical potential were recruited. Eligible pts received anlotinib (12mg, po, d1∼14, q3w), nab-paclitaxel (175mg/m2, iv, q3w) and cisplatin (20mg/m2, iv, d1∼3, q3w) for 2 cycles during neoadjuvant therapy. 4 weeks later, pts underwent radical surgery after exclusion of contraindications. Tumor response was assessed by investigator per RECIST 1.1. The calculated sample size was 62. The primary endpoint was ORR, secondary endpoints were R0 resection rate, DFS, OS, DCR and safety. From Apr 2021 to Apr 2022, 33 eligible pts were enrolled. Among them, 22 pts underwent surgery after 2 cycles of neoadjuvant therapy, 4 pts chose other treatment options, and 7 pts are still receiving neoadjuvant therapy. Pts who had received surgery (n=22) were included in this analysis. In best overall response assessment, ORR was 86.4% (95%CI: 65.1∼98.5%) and DCR was 100.0% (95%CI: 84.6∼100.0%). At the data cut-off date (April 10, 2022), 22 pts (100.0%) had underwent R0 resection. Among them, 4 pts (18.2%) were confirmed to be pCR. And the median DFS was not yet available. The safety profile suggested that the most common treatment-emergent adverse events were gastrointestinal reactions (81.8%), liver damage (18.2%), hypokalemia (15.2%), nausea (15.2%) and myelosuppression (12.1%). One patient experienced grade 3 neutropenia (3.0%). Preliminary results suggested that anlotinib combined with nab-paclitaxel and cisplatin in neoadjuvant treatment of ESCC exhibited encouraging efficacy and manageable adverse events. The conclusion should be validated in more patients included subsequently.