A phase II trial of docetaxel and cisplatin combination in patients with locally advanced undifferentiated carcinoma of nasopharygeal type (UCNT)

Abstract

5599 Background: The standard treatment of locally advanced UCNT is chemotherapy followed by locoregional radiotherapy. The purpose of this study is to assess the antitumor activity and toxicity of a new neoadjuvant chemotherapy regimen combining docetaxel (D) and cisplatin (C). Patients and Methods: Previously untreated patients (pts) with histologically diagnosed locally advanced UCNT (Stages IVA and IVB TNM/UICC 1997) received D 75 mg/m2 and C 75 mg/m2 both on day 1, cycles were repeated every 21 days. Every pts received three cycles in a neoadjuvant setting before radiotherapy (4 to 6 weeks after the third cycle of DC). Pts were evaluated by clinical examination, nasofibroscopy with biopsy and CT scan of nasopharynx. Results: Toxicity, tumor response and survival over one year were assessable in all pts. There are 75 pts (54 male, 21 female) with a median age of 41 years (range 18 - 69) and a WHO performance status of 0 - 1 in 71 pts, 2 in 4 pts. 19 pts had stage IVA and 56 pts had stage IVB. After 225 cycles, grade 3 & 4 toxicity (WHO) were: neutropenia (12 %), febrile neutropenia (2%), anemia (1%), nausea and vomiting (23%), diarrhea (8%), mucositis (1%), reversible alopecia (70%). Two pts had onycolysis. Response rates for the 75 pts were: complete pathologic response 37 % (28 pts), partial response 52% (39 pts), stable disease 8% (6 pts) and progression 3% (2 pts) . The overall response rate (ORR) was 89%. 72 pts had complete response after radiotherapy and one patient had stable disease. 18 patients had recurence: 16 locoregional, 1 hepatic metastasis and 1 cerebral metastasis. Disease free survival and overall survival at 1 year were respectively 76 % and 85 % and the median survival was 19 months. The complete response after chemotherapy appear as an important factor predicting recurrence. Conclusion: DC is an effective regimen with an acceptable safety profile in locally advanced UCNT. No significant financial relationships to disclose.