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

Objective: To evaluate the efficacy and toxicity of cisplatin and vinorelbine (NP) for postoperative adjuvantchemotherapy of completely resected breast cancers.
Methods: Between September 1994 and April 2005, 91Chinese breast cancer patients, with pathologically-confirmed adenocarcinoma in Jiangsu Cancer Hospitaland Research Institute, were enrolled. They received postoperative vinorelbine at 25mg/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 49years (range, 25-69 years). A ccording 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 ofthe patients receiving 4 to 6 NP cycles. After a median follow-up of 48 months, 11 deaths and 29 relapses weredocumented. Median disease-free survival was 45 months, with disease-free and overall survival at 5 years being76% and 88.7%, respectively. All patients could be evaluated with regard to toxicity, 17 (18.7%) developing gradeⅢ neutropenia during treatment, but all recovering after recombinant human granulocyte colony stimulatingfactor (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 completelyresected breast cancer cases at the doses tested. A randomized clinical trial is now needed to compare NP withother conventional regimens.