Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer

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.

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.

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.

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