Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer.

Purpose: The phase II study was conducted to evaluate the efficacy and safety of irinotecan as salvage single-agent chemotherapy in patients with advanced pancreatic cancer.

Methods: Patients with measurable metastatic pancreatic cancer, progressive after previous gemcitabine-based chemotherapy were treated with irinotecan 150 mg/m(2) every 2 weeks. Treatment was repeated until disease progression or unacceptable toxicity.

Results: Between March 2004 to February 2007, 33 patients were registered and treated with irinotecan monotherapy. The patients' median age was 59 years (range 36-70) and two had an ECOG performance status of 2. A total of 167 chemotherapy cycles were delivered (median, 4; range 2-12). In an intent-to-treat analysis, three (9%) confirmed partial response and 13 patients with stable disease were observed for a disease control rate of 48%. The median progression-free and overall survivals were 2.0 months (95% CI, 0.7-3.3) and 6.6 months (95% CI, 5.8-7.4), respectively. Toxic effects were mainly gastrointestinal (nausea in 64% of patients, diarrhea in 36%), Toxicity profiles were generally predictable and manageable, and there was no treatment-related death.

Conclusions: Second-line chemotherapy with single-agent irinotecan is marginally effective and well tolerated regimen for gemcitabine-pretreated patients with advanced pancreatic cancer.