A phase II study of docetaxel-irinotecan combination in advanced pancreatic cancer
Kurtz, J-Emmanuel.; Négrier, S.; Husseini, F.; Limacher, J-Marc.; Borel, C.; Wagner, J-Philippe.; Prévot, G.; Bergerat, J-Pierre.; Dufour, P.
Hepato-Gastroenterology 50(50): 567-570
2003
ISSN/ISBN: 0172-6390 PMID: 12749274 Document Number: 1344
Background/Aims: Chemotherapy provides dismal results in advanced pancreatic cancer patients, even when new compounds, such as gemcitabine, are used. Phase I studies of single-drug therapy with docetaxel or irinotecan suggested a response rate of about 15% in these patients. We report here a phase II study of docetaxel-irinotecan combination in advanced pancreatic cancer patients. Methodology: Docetaxel 60mg/m2 was given in combination with irinotecan 250mg/m2 every 3 weeks. Prednisolone premedication and anti-HT3 drugs were systematically administered. Hematopoietic growth factors were given in case of febrile neutropenia or grade 4 neutropenia at the previous cycle. Endpoints were response rate, progression-free survival, and tolerance. Results: Twenty-seven patients were enrolled, of whom 25 had metastatic disease. We observed 3 partial responses and 11 stabilizations. The median progression-free survival was 4.3 months. Myelosuppression was the main toxicity with 18% of patients experiencing a grade 3-4 event. One patient died of neglected febrile neutropenia. Gastrointestinal toxicity was well controlled. Other toxicities were mild. Conclusions: This combination has acceptable tolerance and, despite an 11% response rate, some partial responses and prolonged stabilizations were observed. The treatment induced clinical benefit in 33% of the patients. Further trials should focus on docetaxel or irinotecan, possibly used in combination with more conventional strategies (gemcitabine).
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