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

// Yun Fan 1,2 , Youhua Jiang 3 , Xinming Zhou 3 , Qixun Chen 3 , Zhiyu Huang 1 , Yanjun Xu 1 , Lei Gong 1 , Haifeng Yu 1 , Haiyan Yang 1 , Jinshi Liu 3 , Tao Lei 1 , Qiang Zhao 3 and Weimin Mao 1,2 1 Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China 2 Key Laboratory Diagnosis and Treatment Technology on Thoracic Oncology and Cancer Research Institute, Hangzhou, China 3 Department of Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China Correspondence to: Weimin Mao, email: // Keywords : esophageal squamous cell carcinoma; nab-paclitaxel; cisplatin; neoadjuvant chemotherapy; esophagectomy Received : February 13, 2016 Accepted : April 26, 2016 Published : May 23, 2016 Abstract Background: We carried out a phase II study to evaluate the efficiency and safety of the combination of nanoparticle albumin bound-paclitaxel (nab-paclitaxel) and cisplatin as preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma (ESCC) Results: From Oct 2011 to Dec 2012, 35 patients were enrolled and received neoadjuvant chemotherapy. Thirty patients underwent surgery and achieved a 100% R0 resection. Pathological complete response (pCR) rate was 13.3% and near pCR rate was 6.7%. Down-staging was achieved in 19 patients. With median follow-up of 37.8 months, 16 patients were still alive. One-, 2- and 3- year overall survival (OS) rate was 90.0%, 70.0% and 43.3%, respectively. This treatment resulted in a median disease-free survival (DFS) of 34.7 months and a median OS of 37.8 months. Median DFS and OS of down-staged patients were significantly longer than those of non-downstaged patients. The grade 4 toxicities during neoadjuvant chemotherapy were limited to neutropenia (2.9%) and vomiting (2.9%). Methods: Patients with locally advanced ESCC (stage IIA to IIIC) and performance status 0-1 were enrolled and received two cycles of nab-paclitaxel (100 mg/m 2 ) on day 1, 8, 22 and 29, and cisplatin (75 mg/m 2 ) on day 1 and 22, followed by resection. Two cycles of adjuvant chemotherapy with the same regimen were given. Postoperative radiotherapy was permitted and decided by radiation therapist. Conclusion: Weekly nab-paclitaxel with three-weekly cisplatin seems effective and safe as a neoadjuvant chemotherapy strategy for locally advanced ESCC. Down-staged patients have favorable outcome. ClinicalTrials.gov Identifier: NCT01258192