Weimin Mao¹  Yun Fan²  Youhua Jiang¹  Xinming Zhou¹  Qixun Chen¹, Zhiyu Huang²  Lei Gong²  Haifeng Yu²  Haiyan Yang²  Jinshi Liu¹, Pengcheng Chen¹  Qiang Zhao¹

¹HangZhou Zhejiang CancerHospitalthoracic tumor department

²HangZhou Zhejiang CancerHospital chemotherapy department

Objective: Thecombination of nab-paclitaxel and cisplatin as preoperative treatment foresophageal squamous cell carcinoma (ESCC) has not been investigated. We carriedout a phase II feasibility and efficiency study of preoperative chemotherapywith nab-paclitaxel and cisplatin for locally advanced ESCC. Method: BetweenJanuary 2011 and October 2012，35patients，from stage ⅡAto ⅢC，performancestatus 0-1，with 31 male and 4 females，wereincluded in the study. All pts received nab-paclitaxel (100mg/m², d1,d8, d22 and d29) and cisplatin (75mg/m², d1 and d22) as neoadjuvant chemotherapy,followed by esophagectomy. Two cycles of adjuvant chemotherapy with sameregimen was given in 4-6 weeks after the resection. Result: Overallresponse rate (ORR) evaluation was performed at the end of cycle 2. Out of the35 enrolled patients, 30 were malesand 4 females; Three (8.6%), 5(14.3%), 10(28.6%), 8 (22.9%) and 9 (25.7%) patients were in ⅡA,ⅡB,ⅢA,ⅢB,ⅢC,respectively. 5 patients did not going to surgery, as 2 patients withprogressive disease and another 3 patients refused. 30/35 patients wenttosurgery (85.7%) and all had R0 resection (100%). Pathological completeresponse (pCR) was achieved in 4 patients (13.3%). Near pCR (microfoci of tumorcells onthe primary tumor without lymph nodal metastases) in 2 patients (6.7%).Down-staging was observed in 19 of 30 patients (63.3%). 24/30 (80.0%) patients receivedadjuvant chemotherapy; among, 7 patients (23.3%) received adjuvantchemoradiotherapy. Only 1 (3.3%) patient appeared surgical complication with anastomoticleaks. The most frequent G3-G4 toxicity included neutropenia (11.4%), anemia(8.6%), thrombocytopenia (5.7%), nausea/vomiting (14.3%), neutropenia fever(8.6%), asthenia (20.0%). With median follow up of 27.1months，the16/30 patients(50.4%) still alive, and a median disease-free times(DFS) of22.5months (95% CI 14.2-29.8) were observed. Median overall survival times andDFS of down-staging patients were significantly longer than non-down-stagingpatients (Hazard Ratio 0.30, 95% CI: 0.074- 0.75 and Hazard Ratio 0.27, 95% CI:0.071-0.59, respectively) (P=0.0158 and P=0.0037, respectively). Conclusion:Weekly nab-paclitaxel and cisplatin is effective as a neoadjuvantchemotherapy for local advanced ESCC, and its adverse effects are tolerable, down-stagingpatients have favorable outcome than non-down-staging patients.

Key Words: nabpaclitaxel  neoadjuvant chemotherapy  esophageal