Randomized comparison of prophylactic antidiarrheal treatment versus no prophylactic antidiarrheal treatment in patients receiving CPT-11 (irinotecan) for advanced 5-FU-resistant colorectal cancer: an open-label multicenter phase II study
| Autor: | Patrick Dufour, Mireille Mousseau, Dominique Mignard, Jean-Yves Douillard, J. L. Wendling, F. Burki, Philippe Rougier, Michel Marty, Antoine Adenis, Marc Ychou |
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| Rok vydání: | 2000 |
| Předmět: |
Adult
Diarrhea Male Cancer Research medicine.medical_specialty Time Factors medicine.medical_treatment Phases of clinical research Irinotecan Racecadotril Gastroenterology Severity of Illness Index Group B law.invention Randomized controlled trial law Internal medicine Medicine Humans Aged Chemotherapy business.industry Middle Aged Antineoplastic Agents Phytogenic Surgery Treatment Outcome Oncology Fluorouracil Drug Resistance Neoplasm Camptothecin Female medicine.symptom business Colorectal Neoplasms medicine.drug |
| Zdroj: | American journal of clinical oncology. 23(2) |
| ISSN: | 0277-3732 |
| Popis: | Delayed diarrhea is the main toxicity of irinotecan at the currently recommended dose of 350 mg/m 2 30-minute intravenous infusion, once every 3 weeks. This phase II, multicenter, open-label, randomized study was primarily designed to evaluate the effect of a 15-day Tiorfan (racecadotril) treatment on the incidence and severity of irinotecan-induced delayed diarrhea. One hundred thirty-six patients with metastatic colorectal cancer who failed to respond to a 5-fluorouracil-based treatment received 714 cycles of irinotecan. The patients were randomly allocated either to group A (68 patients) and received Tiorfan (300 mg/day) from DO to D15 or to group B (68 patients) with no prophylactic treatment. Delayed diarrhea occurred in 197 of 355 cycles (55%) in Group A and 203 of 344 cycles (59%) in Group B. grade III-IV diarrhea was reported in 17 of 40 compliant patients (42%) in group A and 31 of 68 evaluable patients (45%) in group B. No difference was observed between the two groups for delayed diarrhea characteristics, incidence, or severity. The response rate in 99 evaluable patients was 12.1% (6.4%-20.2%). This study has shown that Tiorfan given prophylactically at 300 mg/day has no effect on delayed diarrhea. |
| Databáze: | OpenAIRE |
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