A phase II trial of weekly irinotecan in cisplatin-refractory esophageal cancer.

Background: This study investigated the efficacy and toxicity of weekly single-agent irinotecan in patients with metastatic disease relapsing after cisplatin-based chemotherapy.

Patients And Methods: Fourteen patients were enrolled. A total number of 29 cycles (one cycle consisted of CPT-11 100 mg/m2 on days 1, 8, 15, qd 28) were applied. Irinotecan was continued until disease progression or unacceptable toxicity occurred. Where toxicity was less than WHO grade 3, the dose of irinotecan was escalated in 20 mg steps in subsequent cycles up to a maximum dose of 140 mg/m2. Patients were assessed for response according to WHO criteria every second cycle.

Results: Of the 13 evaluable patients, 2 achieved a partial response (PR) and 3 disease stabilisation (NC); progressive disease (PD) was noted in 8 patients. Median time to progression was 2 months (range: 1-8 months) and median survival from start of study treatment was 5 months (range: 2-16 months). Grade 3 toxicity consisted of diarrhea (n=3), fever (n=1) and pain (n=1).

Conclusion: Single-agent irinotecan has moderate activity in cisplatin-refractory esophageal cancer.