The value of immune checkpoint inhibitor (ICI) combined with chemotherapy in the first line treatment of locally advanced/metastatic esophageal cancer has been confirmed by several clinical studies with the regimens of 5-fluorouracil plus cisplatin（FP）or Paclitaxel plus cisplatin (TP) which were most commonly used in the protocol. However, retrospective study had shown that nedaplatin combined with nab-paclitaxel was more effective than other chemotherapy regimens with fewer adverse events. Here we report the efficacy and safety of ICI combined with nedaplatin and nab-paclitaxel in ESCC.
Clinical outcomes of 35 patients with metastatic ESCC in Changhai hospital from March 2020 to September 2021 were included in this study. All patients received pembrolizumab 200mg on day 1, albumin-bound paclitaxel 130 mg/m2 on day 1 and 8, and nedaplatin 70 mg/m2 on day 1. The treatment was repeated every 21 days. Evaluation of tumor response was performed according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1). Toxicities were graded using version 5.0 of the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
All patients were available for evaluation. Of the 35 patients, 4 patients (11.4%) had complete response(CR), 21 patients (60.0%) were partial response (PR), 10 patients (28.6%) achieved stable disease (SD) and no patients had progression disease (PD). The objective response rate (ORR) and disease control rate (DCR) were 71.4% and 100% respectively. The median progression free survival (PFS) was 13.4 months. Main toxicities include hematological toxicity, thyroid dysfunction, rash, fever, arthralgia, myalgia and alopecia. Treatment-related adverse events of grade 3 or higher occurred in 3 patients (8.6%).
Pembrolizumab plus albumin-bound paclitaxel and nedaplatin as first-line treatment demonstrated promising anti-tumor activity and manageable safety in patients with advanced ESCC. Randomized trials to evaluate this new combination strategy are warranted.
The authors.
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All authors have declared no conflicts of interest.