A phase II trial of induction chemotherapy with cisplatin, docetaxel, and capecitabine followed by concurrent cisplatin-radiotherapy in advanced nasopharyngeal carcinoma.

Abstract

5543 Background: The purpose of this study is to assess the antitumor activity and toxicity of a induction chemotherapy regimen combining docetaxel (T), cisplatin (C) and capecitabine (X) followed by concurrent chemoradiotherapy in advanced nasopharyngeal carcinoma. Methods: Previously untreated patients (pts) with histologically diagnosed locally advanced nasopharyngeal carcinoma (Stages IVA and IVB, III TNM/UICC 2002) received T 75 mg/m2, P 75 mg/m2 both on day 1 and X 1000 mg/m²/d, days 1-14, with cycles repeated every 3 weeks. All pts received four cycles in a neoadjuvant setting before concurrent C 75 mg/m² day 1, 22, 42 and radiotherapy (4 to 6 weeks after the third cycle of PTX). Pts were evaluated by clinical examination, CT scan of the nasopharynx, the primary end point was tumor response. Results: 89 pts (64 male and 25 female) were enrolled. Median age was 45 years (range 18-67), ECOG performance status was 0-1 in all pts. 68 pts (76%) had an undifferentiated carcinoma of nasopharyngeal type (UCNT) and 21 pts (24%) a poorly differentiated nasopharyngeal carcinoma. 18 pts had stage III disease, 35 pts stage IVA disease and 36 pts stage IVB. Toxicity and tumor response were assessable in 89 pts. After 344 cycles, grade 3-4 toxicities (NCI-CTC 3.0) were: neutropenia (18 %), anemia (10.5%), nausea and vomiting (28%), diarrhea (8%), mucositis (3%), reversible alopecia (100%) and fatigue (10%). No febrile neutropenia was noted. 2 pts had G3 renal toxicity and only one patient had hand-foot syndrome. Response rates for the 89 pts were: complete response 48%, partial response 49% and stable disease 3%. All pts had a complete response after radiotherapy. The disease free survival (DFS) and overall survival at two years was respectively 78 % and 83 %. Conclusions: PTX induction chemotherapy resulted on a high response rate with manageable toxicity. This results need to be confronted with DFS and overall survival after longer follow-up.