title: Multicenter randomized phase 2 clinical trial of a recombinant human endostatin adenovirus in patients with advanced head and neck carcinoma.
abstract: A randomized, open-label, phase 2, multicenter clinical trial was conducted to evaluate the efficacy and safety of the addition of a recombinant human endostatin adenovirus (E10A) to cisplatin and paclitaxel in patients with advanced head and neck squamous cell carcinoma or nasopharyngeal carcinoma. Patients with locally advanced or metastatic head and neck squamous cell carcinoma or nasopharyngeal carcinoma not suitable for operation or radiotherapy were randomly assigned to receive E10A plus chemotherapy every 3 weeks for a maximum of six cycles or to receive chemotherapy only. One hundred and thirty-six eligible patients were randomly assigned. The addition of E10A did not significantly improve the objective response rate (29.9 versus 39.7%, P = 0.154). However, patients who received endostatin had longer progression-free survival (7.03 versus 3.60 months, P = 0.006; hazard ratio: 0.55). The combination of E10A with chemotherapy benefited prior chemotherapy-treated patients and those who received three to four treatment cycles (6.50 versus 3.43 months, P = 0.003; 8.27 versus 4.27 months, P = 0.018; respectively). The overall disease control rate significantly increased from 80.6% in the control group to 92.6% in the test group (P = 0.034). Except for fever, no adverse events were associated with the E10A treatment. In summary, E10A plus chemotherapy is a safe and effective therapeutic approach in patients with advanced head and neck squamous cell carcinoma or nasopharyngeal carcinoma.
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Ye
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Ranyi
authors.initials: R
authors.lastname: Liu
authors.affiliation: Medical Oncology, Sichuan Cancer Hospital and Institute, Chengdu, China.
authors.forename: Changchuan
authors.initials: C
authors.lastname: Pan
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Wenqi
authors.initials: W
authors.lastname: Jiang
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Zhongzhen
authors.initials: Z
authors.lastname: Guan
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Jiangxue
authors.initials: J
authors.lastname: Wu
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Xiaofang
authors.initials: X
authors.lastname: Ying
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Lixia
authors.initials: L
authors.lastname: Li
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Su
authors.initials: S
authors.lastname: Li
authors.affiliation: School of Bioscience and Bioengineering, South China University of Technology, Guangzhou, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Tan
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Musheng
authors.initials: M
authors.lastname: Zeng
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Tiebang
authors.initials: T
authors.lastname: Kang
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Liu
authors.affiliation: Marsala Biotech, Winnipeg, Canada.
authors.forename: George R
authors.initials: GR
authors.lastname: Thomas
authors.affiliation: Guangdong Provincial Key Laboratory of Tumor-targeted Drug, Guangzhou Enterprise Key Laboratory of Gene Medicine, Guangzhou Doublle Bioproducts, Guangzhou, China.
authors.forename: Manli
authors.initials: M
authors.lastname: Huang
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
authors.forename: Wuguo
authors.initials: W
authors.lastname: Deng
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China; CAS Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Science, Beijing, China. Electronic address: huangwl@sysucc.org.cn.
authors.forename: Wenlin
authors.initials: W
authors.lastname: Huang
mesh_terms: D000256:Adenoviridae / Q000235:genetics; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy* / Q000821:virology; D002945:Cisplatin / Q000009:adverse effects*; D003131:Combined Modality Therapy; D043169:Endostatins / Q000009:adverse effects*; D015316:Genetic Therapy; D005822:Genetic Vectors / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000628:therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000473:pathology / Q000628:therapy* / Q000821:virology; D009362:Neoplasm Metastasis / Q000473:pathology / Q000628:therapy*; D009364:Neoplasm Recurrence, Local; D017239:Paclitaxel / Q000009:adverse effects; D011994:Recombinant Proteins / Q000009:adverse effects; D000077195:Squamous Cell Carcinoma of Head and Neck; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D043169:Endostatins; D011994:Recombinant Proteins; D017239:Paclitaxel; D002945:Cisplatin