Clinical Research Papers:

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, Youhua Jiang, Xinming Zhou, Qixun Chen, Zhiyu Huang, Yanjun Xu, Lei Gong, Haifeng Yu, Haiyan Yang, Jinshi Liu, Tao Lei, Qiang Zhao and Weimin Mao _

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Oncotarget. 2016; 7:50624-50634. https://doi.org/10.18632/oncotarget.9562

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Yun Fan1,2, Youhua Jiang3, Xinming Zhou3, Qixun Chen3, Zhiyu Huang1, Yanjun Xu1, Lei Gong1, Haifeng Yu1, Haiyan Yang1, Jinshi Liu3, Tao Lei1, Qiang Zhao3 and Weimin Mao1,2

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


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.

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

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