title: [Phase II multicenter clinical trial of nedaplatin in the treatment of malignant tumors].
abstract: OBJECTIVE
  To evaluate and compare the efficacy and safety of Nedaplatin (NDP)-based regimen and cisplatin (DDP)-based regimen for head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), esophageal cancer and ovary epithelial cell carcinoma.
  
  
  METHODS
  Single agent group: NDP was administered at a dose of 100 mg/m(2) on D1, every 3 weeks for at least 2 cycles. Combination chemotherapy group: combined with 5-Fu, NVB, VDS + 5-Fu, PTX or CTX respectively, NDP 80 mg/m(2) on D1 or DDP 30 mg/m(2) on D1-3, every 3 weeks for at least 2 cycles was given.
  
  
  RESULTS
  Of 237 patients in this trial, 37 were treated by single Nedaplatin, 139 by NDP-based regimen, 61 by DDP-based regimen in the control group. The response rate of single Nedaplatin chemotherapy for advanced NSCLC was 10.5% (2/19), for ovary carcinoma (1/3) and HNSCC (1/1). For NSCLC and ovary carcinoma patients who had failed in the previous DDP-based chemotherapy, the response rates by single NDP chemotherapy were still 9.1% and 33.3%. The response rate of NDP-based combination regimen for NSCLC, ovary carcinoma, HNSCC and esophageal cancer was 33.9% (21/62), 44.8% (13/29), 20.0% (3/15) and 18.2% (4/22), respectively, which was not statistically different from the rate of controlled group treated by DDP-based regimen. For chemonaive NSCLC, the effect of NDP-based combination regimen (35.7%) was significantly superior to the effect of DDP-based regimen (17.1%) (P = 0.045). The most common adverse events of nedaplatin were myelosuppression (leukopenia, thrombocytopenia, anemia), nausea and vomiting. The myelosuppression and renal toxicity of NDP-based regimen were similar to that of DDP-based regimen, but vomiting was milder than that of DDP-based regimen (54% vs. 75.4%), and grade I/II liver toxicity was more common in the NDP-based regimen than in DDP-based regimen (10.8% vs. 0).
  
  
  CONCLUSIONS
  Nedaplatin is effective in the treatment for HNSCC, NSCLC and ovary carcinoma. Compared with the control group treated by DDP-based regimen, nedaplatin-based combination chemotherapy has similar effect on HNSCC, NSCLC, ovary carcinoma and esophageal cancer. Gastrointestinal reaction of nedaplatin is milder than that of cisplatin but the liver function during chemotherapy must be monitored closely.
authors.affiliation: Department of Medical Oncology, Cancer Institute (Hospital), Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100021, China.
authors.forename: Pin
authors.initials: P
authors.lastname: Zhang
authors.forename: Feng-yi
authors.initials: FY
authors.lastname: Feng
authors.forename: Ling-ying
authors.initials: LY
authors.lastname: Wu
authors.forename: Yi
authors.initials: Y
authors.lastname: Hu
authors.forename: Ji-wei
authors.initials: JW
authors.lastname: Liu
authors.forename: Ya-jie
authors.initials: YJ
authors.lastname: Gao
authors.forename: Xiao-qian
authors.initials: XQ
authors.lastname: Guan
authors.forename: Ke-jun
authors.initials: KJ
authors.lastname: Nan
authors.forename: Ai-li
authors.initials: AL
authors.lastname: Suo
authors.forename: Xiu-wen
authors.initials: XW
authors.lastname: Wang
authors.forename: Mao-hong
authors.initials: MH
authors.lastname: Zhang
authors.forename: Wen-dong
authors.initials: WD
authors.lastname: Zhang
authors.forename: Chao-wu
authors.initials: CW
authors.lastname: Li
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhang
authors.forename: Jin-bo
authors.initials: JB
authors.lastname: Zhao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D004938:Esophageal Neoplasms / Q000188:drug therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D010051:Ovarian Neoplasms / Q000188:drug therapy; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D014747:Vinblastine; C053989:nedaplatin; D002945:Cisplatin; D000077235:Vinorelbine; D005472:Fluorouracil