title: A Cisplatin and vinorelbine (NP) regimen as a postoperative adjuvant chemotherapy for completely resected breast cancers in China: final results of a phase II clinical trial.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of cisplatin and vinorelbine (NP) for postoperative adjuvant chemotherapy of completely resected breast cancers.
  
  
  METHODS
  Between September 1994 and April 2005, 91 Chinese breast cancer patients, with pathologically-confirmed adenocarcinoma in Jiangsu Cancer Hospital and Research Institute, were enrolled. They received postoperative vinorelbine at 25 mg/m² on days 1 and 8, and cisplatin 25mg/m2 on days 1 to 3, this regimen being repeated every 3 weeks.
  
  
  RESULTS
  Median age was 49 years (range, 25-69 years). According to the TNM stage system, stage I, II, IIIA patients accounted for 7.7%, 58.2% and 34.1%, respectively. The median number of chemotherapy cycles was 4.5 (range, 1-8), over half of the patients receiving 4 to 6 NP cycles. After a median follow-up of 48 months, 11 deaths and 29 relapses were documented. Median disease-free survival was 45 months, with disease-free and overall survival at 5 years being 76% and 88.7%, respectively. All patients could be evaluated with regard to toxicity, 17 (18.7%) developing grade III neutropenia during treatment, but all recovering after recombinant human granulocyte colony stimulating factor (G-CSF) injection, 3 suffering thrombocytopenia (3.3%), 5 anemia (5.5%) and 5 nausea/vomiting (5.5%). No treatment related deaths occurred.
  
  
  CONCLUSIONS
  NP is an effective and feasible treatment for completely resected breast cancer cases at the doses tested. A randomized clinical trial is now needed to compare NP with other conventional regimens.
authors.affiliation: Department of Chemotherapy, Jiangsu Cancer Hospital and Research Institute, Nanjing, China.
authors.forename: Li-Li
authors.initials: LL
authors.lastname: Gao
authors.forename: Xin-En
authors.initials: XE
authors.lastname: Huang
authors.forename: Qian
authors.initials: Q
authors.lastname: Zhang
authors.forename: Jin-Hai
authors.initials: JH
authors.lastname: Tang
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D002681:China; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011182:Postoperative Care / Q000379:methods; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine