title: A phase II trial of Endostar combined with gemcitabine and cisplatin chemotherapy in patients with metastatic nasopharyngeal carcinoma (NCT01612286).
abstract: Despite the efficacy of gemcitabine-cisplatin (GC) regimens, the outcome of patients with metastatic nasopharyngeal carcinoma (M NPC) is poor. We conducted a phase II trial to determine the safety and efficacy of Endostar, an endogenous inhibitor of angiogenesis, in combination with GC chemotherapy. A total of 30 patients with M NPC were enrolled. The treatment regimen was a combination of gemcitabine (1,000 mg/m(2)) on days 1 and 8, cisplatin (80 mg/m(2)) on day 1, and Endostar (15 mg/day) from day 1 to day 14 of a 21-day cycle for a maximum of four cycles. The primary endpoint was progression-free survival (PFS). The median follow-up was 13.1 months (range: 2.9-20.7 months). A total of 28 patients were evaluated. The median PFS was 19.4 months (95% CI, 13.6-25.1 months). The 1-year PFS rate was 69.8%. The confirmed objective response rate was 85.7% (95% CI, 66.4-95.3%), including complete response in 14 patients (50%). The 1-year overall survival rate was 90.2%. The most common grade 3/4 adverse events were neutropenia (46.4%) and thrombocytopenia (14.3%). Our results suggest that a combination of Endostar with GC chemotherapy can lead to effective tumor regression, control disease progression, and improve prognosis in M NPC. Therefore, a combined Endostar and GC regimen should be considered as a potential treatment for patients with M NPC.
authors.affiliation: Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, People's Republic of China.
authors.forename: Ting
authors.initials: T
authors.lastname: Jin
authors.forename: Bin
authors.initials: B
authors.lastname: Li
authors.forename: Xiao-Zhong
authors.initials: XZ
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D043169:Endostatins / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D009362:Neoplasm Metastasis; D011994:Recombinant Proteins; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043169:Endostatins; D011994:Recombinant Proteins; D003841:Deoxycytidine; C522911:endostar protein; D002945:Cisplatin; D000093542:Gemcitabine