title: A phase II study of biweekly paclitaxel and cisplatin chemotherapy for recurrent or metastatic esophageal squamous cell carcinoma: ERCC1 expression predicts response to chemotherapy.
abstract: Recurrent or metastatic esophageal cancer has poor prognosis. This study was to assess the efficacy and safety of biweekly paclitaxel and cisplatin combination for patients with recurrent or metastatic esophageal squamous cell carcinoma. The excision repair cross-complementation group 1 (ERCC1) expression to predict response is also assessed. Forty-six eligible patients were enrolled. Paclitaxel was given at 150 mg/m(2) over 3 h on day 1, and cisplatin was given at 50 mg/m(2) on day 2, every 2 weeks as one cycle. ERCC1 protein expression was assessed by immunohistochemistry staining. The overall response rate was 56.5 % (26/46, 95 % CI 42.2-70.8 %). Progression-free survival was 5.6 months (95 % CI, 2.8-8.4 months), and the median actuarial survival time was 17.0 months (95 % CI, 12.3-21.7 months). There was a significant difference in median actuarial survival between the patients with a response compared to the non-responders (22.8 months vs. 7.4 months, P < 0.0001). Overall survival at 1 year was 65.0 %, and at 2 years was 34.0 %, respectively. The most frequent toxicity for all patients was neutropenia (37.0 and 23.9 % for grades 3 and 4, respectively). Patients with ERCC1 negative tumors had a higher treatment response than the ERCC1 positive group (radiological response rates; 92.3 % vs.50 %, P = 0.013). Biweekly chemotherapy with paclitaxel and cisplatin was found to be active and generally well tolerated. Our study indicates that the expression of ERCC1 evaluated by immunohistochemistry is a promising predictive marker for response in patients with metastatic ESCC receiving cisplatin-paclitaxel regimen.
authors.affiliation: Department of Medical Oncology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS & PUMC), Beijing 100021, China. huangjingwg@163.com
authors.forename: Jing
authors.initials: J
authors.lastname: Huang
authors.forename: Yi
authors.initials: Y
authors.lastname: Zhou
authors.forename: Hongtu
authors.initials: H
authors.lastname: Zhang
authors.forename: Tao
authors.initials: T
authors.lastname: Qu
authors.forename: Yousheng
authors.initials: Y
authors.lastname: Mao
authors.forename: Hongxia
authors.initials: H
authors.lastname: Zhu
authors.forename: Lanping
authors.initials: L
authors.lastname: Quan
authors.forename: Puyuan
authors.initials: P
authors.lastname: Xing
authors.forename: Jinwan
authors.initials: J
authors.lastname: Wang
authors.forename: Jie
authors.initials: J
authors.lastname: He
authors.forename: Ningzhi
authors.initials: N
authors.lastname: Xu
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D014408:Biomarkers, Tumor / Q000032:analysis; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000378:metabolism* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004268:DNA-Binding Proteins / Q000096:biosynthesis*; D018572:Disease-Free Survival; D004720:Endonucleases / Q000096:biosynthesis*; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000378:metabolism* / Q000473:pathology; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000378:metabolism / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D014408:Biomarkers, Tumor; D004268:DNA-Binding Proteins; C071447:ERCC1 protein, human; D004720:Endonucleases; D017239:Paclitaxel; D002945:Cisplatin