[Preliminary results of ifosfamide and doxorubicin regimen in treatment of patients with recurrent and metastatic nasopharyngeal carcinoma].
OBJECTIVE
DDP + 5-Fu and DDP + 5-FU/CF is the standard regimen for the treatment of the patients with recurrent and metastatic nasopharyngeal carcinoma at the present time. The response rate and complete response(CR) rate are still low with short duration of response. More effective regimen was needed. This clinical trial was designed to evaluate the efficacy and toxicity of ifosfamide(IFO) and doxorubicin(ADM) regimen for treatment of the patients with recurrent and metastatic nasopharyngeal carcinoma (NPC) after radiotherapy.


METHODS
Ifosfamide was administered intravenously at the dose of 1,200 mg/m2 from day 1 to day 5 with uroprotection of Mesna in fusion at 0, 3, and 6 hours following initiation of IFO. Doxorubicin was given at the dose of 50 mg/m2 intravenously(or Epirubicin 60 mg/m2) at day 1. This combination was repeated every 3 to 4 weeks.


RESULTS
Thirty-six patients with recurrent and metastatic NPC following radiotherapy were enrolled, in which 16 patients previously treated by systemic chemotherapy. Thirty-four patients were evaluable for response. The response rate for whole group was 67.6% with CR rate of 14.7%. Median duration of response was 6 months. The response rate of previously patients-treated with and without chemotherapy were 50.0% and 83.3%, respectively, and the median duration of response were 5 months and 8 months, respectively. A total of 109 courses of chemotherapy were administered for 34 patients. The major toxicity was myelosuppression. The incidence of leucopenia was 94.8% with 33.1% of grade 3/4. Febrile leucopenia account for 14.6% and G-CSF was necessary in 24.8% cycles without severe systemic infection and thromocytopenia 8.4%, anemia 11.5%. Meanwhile, other toxicities included loss of appetite, nausea/vomiting, stomatitis, and alopecia were observed.


CONCLUSIONS
Ifosfomide and Doxorubicine is an effective regimen for the patients with recurrent and metastatic nasopharyngeal carcinoma. This combination may be considered as salvage therapy for NPC patients who fail to DDP-5-Fu treatment and warranted further clinical study.
Huang
Hui-qiang
HQ
Department of Medical Oncology, Cancer Center, Sun Yat-sen University, Guangzhou 510060, P. R. China. huanghq@public.guangzhou.gd.cn
Zhou
Zhong-mei
ZM
Li
Yu-hong
YH
Jiang
Wen-qi
WQ
He
You-jian
YJ
Teng
Xiao-yu
XY
Guan
Zhong-zhen
ZZ
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D009362:Neoplasm Metastasis; D055502:Secondary Prevention
D004317:Doxorubicin; D007069:Ifosfamide