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.