Nanoparticle albumin-bound paclitaxel combined with cisplatin as the first-line treatment for metastatic esophageal squamous cell carcinoma

Abstract

Esophageal cancer is a major health hazard in many parts of the world and is often diagnosed late. The objective of this study was to explore the efficacy and safety of nanoparticle albumin-bound paclitaxel (Nab-PTX) combined with cisplatin (DDP) in patients with metastatic esophageal squamous cell carcinoma (ESCC). Patients with histologically confirmed ESCC were treated with Nab-PTX 250 mg/m2 and DDP 75 mg/m2 intravenously on day 1, every 21 days. Evaluation was performed after every two cycles of therapy and the therapy was continued until disease progression or unacceptable toxicity. From April 2010 to December 2012, 33 patients were enrolled. Ten patients had recurrent and metastatic tumors after surgery and 23 patients were diagnosed with unresectable metastatic disease. Patients received a median of four cycles of therapy (ranging from two to six cycles). Twenty patients achieved partial response and nine patients achieved stable disease; no complete response was observed. The objective response rate was 60.6% and the disease control rate was 87.9%. The median progression-free survival was 6.2 months (95% confidence interval: 4.0 to 8.4 months) and the median overall survival was 15.5 months (95% CI: 7.6 to 23.4 months). Only four patients experienced grade 3 adverse events, including vomiting, neutropenia, and sensory neuropathy. The most common adverse events were nausea/vomiting (81.8%), neutropenia (63.6%), leucopenia (48.5%), anemia (24.2%) and sensory neuropathy (24.2%). In conclusion, the combination of Nab-PTX and DDP is a highly effective and well-tolerated first-line treatment in metastatic ESCC.

Phase II study of neoadjuvant therapy with nab-paclitaxel and cisplatin followed by surgery in patients with locally advanced esophageal squamous cell carcinoma

“…Weekly nab-PC outclassed sb-PC resulting in a significantly improved overall response rate (ORR) in advanced NSCLC [17]. Moreover, the combination of nab-PC and cisplatin had already been realized as a highly effective and well-tolerated first-line treatment in metastatic ESCC [18]. Based on the hot issues in locally advanced esophageal cancer therapy, we carried out a phase II clinical study to determine the pathological response rate, efficacy and safety of preoperative neoadjuvant chemotherapy with weekly nab-PC and cisplatin in treating locally advanced ESCC.…”

Efficacy of Taxane-Based Regimens in a First-line Setting for Recurrent and/or Metastatic Chinese Patients with Esophageal Cancer

“…However, the small patients' sample (33 patients) and subsequent treatments for most patients (87.9% patients receiving subsequent treatment after progression) may have contributed to better OS in the study (Shi, et al, 2013). In our project, albeit the differences in PFS or OS were not statistically significant for all regimens, the two endpoints tended to be better in Nab-PTX based and TPF than TP regimen.…”

“…Recently, an one-armed study illuminated the efficacy of Nab-PTX by evaluating the OS, PFS, and ORR in Chinese metastatic esophageal squamous cell cancer patients (Shi, et al, 2013), concluded with a longer median OS (15.5 months) and corresponding ORR and PFS compared with other traditional taxanes based regimens. However, the small patients' sample (33 patients) and subsequent treatments for most patients (87.9% patients receiving subsequent treatment after progression) may have contributed to better OS in the study (Shi, et al, 2013).…”

“…Several studies elucidated the superiority of Nab-PTX in pharmacokinetics (Al-Hajeili, et al, 2014), particularly the intratumoral accumulation, absorption, binding to the endothelial cells, and transportation were higher compared with paclitaxel as well as better tolerance in breast cancer, lung cancer, ovarian cancer, pancreatic cancer (Desai, et al, 2006;Desai, et al, 2008;Von Hoff, et al, 2013). However, rare effort to study nab-PTX efficacy was focused on metastatic and/or recurrent esophageal cancer (Shi, et al, 2013).…”

“…and Kang., 2011;Zhao, et al, 2012), which differ from esophageal cancer patients in the western countries where has the rising incidence of adenocarcinoma of the lower esophagus with escalating rates of obesity, gastroesophageal reflux disease, and Barrett's esophagus (Vizcaino, et al, 2002;Dubecz, et al, 2014). To our knowledge, taxanes-based regimens were not fully studied in Chinese esophageal cancer (Huang, et al, 2004;Zhang, et al, 2007;Wang, et al, 2010;Wu, et al, 2012;Ji, et al, 2013), especially Nab-PTX (Shi, et al, 2013), even this new medicine was seldom reported in East Asian countries as Japan and South Korea. This retrospective study was conducted to evaluate the efficacy of taxanes-based regimens in Chinese patients with recurrent and/or metastatic esophageal cancer, compare the efficacy of TP with TPF regimen, and Nab-PTX based regimen with traditional taxanes including PTX and DTX-based regimen separately.…”