Weekly TP regimen as a postoperative adjuvant chemotherapy for completely resected breast cancer in China: final result of a phase II trial.
OBJECTIVE
To investigate the safety and long-term survival with weekly paclitaxel combined with cisplatin (wTP) as a postoperative adjuvant chemotherapy regimen for breast cancer.


METHODS
Patients with breast cancer were treated postoperatively with paclitaxel 40 mg/m2 intravenously on days 1, 8 and 15, cisplatin 25 mg/ m2 also intravenously on days 1,8 and 15, repeated every 21-28 days as a cycle. Toxicity and survival rate were evaluated after chemotherapy.


RESULTS
Between September 1993 and August 2001, 20 patients were enrolled. Median age was 52 years (range, 35-71 years). According to the TNM stage system, all patients were staged II or III. Median number of chemotherapy cycles was 3 (range, 1-6), and 10 patients received 4 to 6 cycles of wTP. After a median follow-up of 83 months, 2 deaths and 6 relapses were documented. The five year overall survival rate was 90%. All patients could be evaluated with regard to toxicity. No treatment related deaths were recorded. Neutropenia occurred in 75% of patients during treatment, all recovering after G-CSF injection. Other symptoms included nausea/vomiting, elevation of transaminase, urea nitrogen/creatinine and alopecia.


CONCLUSIONS
wTP is safe and effective at the doses tested. However, a randomized clinical trial is needed to compare wTP with other conventional adjuvant regimens of breast cancer postoperatively.
Department of Chemotherapy, Jiangsu Cancer Hospital and Research Institute, Nanjing, China. huangxinen06@yahoo.com.cn
Xin-En
XE
Huang
Cheng-guang
CG
Li
Yin
Y
Li
Yan-Yan
YY
Lu
Jin-Hai
JH
Tang
Jin
J
Xiang
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D002681:China; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000150:complications; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D016179:Granulocyte Colony-Stimulating Factor; D017239:Paclitaxel; D002945:Cisplatin