Phase II trial of combination docetaxel and cisplatin in patients with locally advanced nasopharyngeal carcinoma

Abstract

6044 Background: The standard treatment of locally advanced nasopharyngeal carcinoma is cisplatin-based 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). Methods: Previously untreated patients (pts) with histologically diagnosed locally advanced nasopharyngeal carcinoma (stages IVA and IVB, TNM/UICC 1997) received D 75 mg/m2 and C 75 mg/m2 both on day 1, with cycles repeated every 21 days. All pts received three cycles in a neoadjuvant setting before radiotherapy (4 to 6 weeks after the third cycle of DC, 65–70 Gy 5 fractions/week). Pts were evaluated by clinical examination, CT scan of the nasopharynx, and nasofibroscopy with biopsy. The primary end point was tumor response. Secondary end points were disease-free survival (DFS), toxicity, and overall survival (OS). Results: 93 pts (65 male, 28 female) were enrolled. Median age was 42 years (range 18–69), WHO performance status was 0–1 in 87 pts and 2 in 6 pts. 75 pts (81%) had an undifferentiated carcinoma of nasopharyngeal type (UCNT) and 18 pts (19%) a differenciated carcinoma of the nasopharynx. 31 pts had stage IVA disease and 62 pts had stage IVB. Toxicity, tumor response, and survival at 5 years (median follow up 49.5 months) were assessable in 90 pts. After 270 cycles, grade 3–4 toxicities (WHO) were: neutropenia (12 %), febrile neutropenia (2%), anemia (1%), nausea and vomiting (23%), diarrhea (8%), mucositis (1%), reversible alopecia (70%). Two pts had onycholysis. Response rates for the 90 pts were: complete response 32.2% (29 pts), partial response 54.4% (49 pts), stable disease 11.1% (10 pts), and progressive disease 2.2% (2 pts). The overall response rate (ORR) was 86.6% and 89% amongst the UCNT. After radiotherapy, 88 pts had a complete response and one patient had stable disease. DFS and OS at 5 years were 52% and 55%, respectively. Conclusions: DC chemotherapy followed by radiation therapy is an effective regimen for the treatment of advanced UCNT and has an acceptable safety profile. These data need to be compared with concurrent chemoradiotherapy to assess the best strategy for the management of advanced UCNT. No significant financial relationships to disclose.