title: Phase II study of neoadjuvant therapy with nab-paclitaxel and cisplatin followed by surgery in patients with locally advanced esophageal squamous cell carcinoma.
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/m2) on day 1, 8, 22 and 29, and cisplatin (75 mg/m2) 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China.|Key Laboratory Diagnosis and Treatment Technology on Thoracic Oncology and Cancer Research Institute, Hangzhou, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Fan
authors.affiliation: Department of Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Youhua
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: Department of Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Xinming
authors.initials: X
authors.lastname: Zhou
authors.affiliation: Department of Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Qixun
authors.initials: Q
authors.lastname: Chen
authors.affiliation: Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Zhiyu
authors.initials: Z
authors.lastname: Huang
authors.affiliation: Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Yanjun
authors.initials: Y
authors.lastname: Xu
authors.affiliation: Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Gong
authors.affiliation: Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Haifeng
authors.initials: H
authors.lastname: Yu
authors.affiliation: Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Haiyan
authors.initials: H
authors.lastname: Yang
authors.affiliation: Department of Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Jinshi
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Tao
authors.initials: T
authors.lastname: Lei
authors.affiliation: Department of Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Zhao
authors.affiliation: Department of Chemotherapy, Zhejiang Cancer Hospital, Hangzhou, China.|Key Laboratory Diagnosis and Treatment Technology on Thoracic Oncology and Cancer Research Institute, Hangzhou, China.
authors.forename: Weimin
authors.initials: W
authors.lastname: Mao
mesh_terms: D000368:Aged; D000418:Albumins / Q000737:chemistry; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D053758:Nanoparticles / Q000737:chemistry; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage*; D011379:Prognosis; D016896:Treatment Outcome
chemical_list: D000418:Albumins; D017239:Paclitaxel; D002945:Cisplatin
keywords: cisplatin; esophageal squamous cell carcinoma; esophagectomy; nab-paclitaxel; neoadjuvant chemotherapy