Phase II study of irinotecan (CPT-11) as salvage therapy for advanced nasopharyngeal carcinoma.

BACKGROUND: This Phase II study was designed to evaluate the efficacy and safety of irinotecan in patients with advanced nasopharyngeal carcinoma (NPC).
METHODS: Patients with disseminated, undifferentiated NPC that progressed during or within 3 months of platinum-based and/or taxane-based regimen were eligible. Irinotecan at a dose of 100 mg/m(2) was administered on Days 1, 8, and 15 every 28 days, up to a maximum of 6 cycles, until disease progression or the appearance of intolerable toxicity.
RESULTS: Twenty-eight patients were evaluable for toxicity and response. Patient characteristics were as follows: The median age was 46.5 years (range, 40.3-71.6 years), the median number of prior lines of chemotherapy was 2 (range, 1-9), the majority of patients (89%) had good Eastern Cooperative Oncology Group performance status (0-1), and the majority of patients (82.1%) had >/= 2 sites of distant metastases. A total of 79 cycles of irinotecan with a median of 3 cycles per patient were administered. Toxicity > Grade 3 included neutropenia in 5 patients (17%), anemia in 5 patients (17%), and diarrhea in 4 patients (14%). The best response outcomes were 4 patients (14%) who achieved partial responses and 1 patient (4%) who achieved stable disease. Global quality-of-life scores were stable during treatment. Using the Kaplan-Meier method, the median progression-free survival was 3.9 months, and the median overall survival was 11.4 months. The partial responders had a durable response (range, 5.7-12.2 months).
CONCLUSIONS: Results from this trial suggest that irinotecan is an active salvage agent with modest toxicity in patients with advanced NPC who are refractory to platinum/taxane-based chemotherapy. Studies combining irinotecan with other active agents in the first-line setting are warranted. (c) 2004 American Cancer Society