Hepatic arterial infusion with irinotecan in patients with liver metastases of colorectal cancer: results of an extended phase I study
Autor: | R Hammerstingl, T J Vogl, S Zangos, Katrin Eichler, T Dufas, T Gruber-Rouh |
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Rok vydání: | 2012 |
Předmět: |
Oncology
Male medicine.medical_specialty Colorectal cancer medicine.medical_treatment Irinotecan Gastroenterology Drug Administration Schedule Cohort Studies Hepatic arterial infusion hemic and lymphatic diseases Internal medicine Drug Discovery medicine Humans Pharmacology (medical) neoplasms Survival analysis Aged Pharmacology Chemotherapy medicine.diagnostic_test Dose-Response Relationship Drug business.industry Liver Neoplasms Magnetic resonance imaging General Medicine Middle Aged medicine.disease Antineoplastic Agents Phytogenic Magnetic Resonance Imaging Survival Analysis digestive system diseases respiratory tract diseases Clinical trial Infectious Diseases Tolerability Injections Intra-Arterial Camptothecin Female business Colorectal Neoplasms Tomography X-Ray Computed therapeutics medicine.drug Agranulocytosis |
Zdroj: | Chemotherapy. 59(1) |
ISSN: | 1421-9794 |
Popis: | Background: To define the maximum tolerated dose (MTD) tolerability and efficacy of intra-arterial chemotherapy with irinotecan in patients with liver metastases of colorectal carcinoma (CRC). Methods: Superselective intra-arterial irinotecan was applied on days 1, 14, 28 and 42. The initial dose was 140 mg/m2 with escalation in the subsequent patient group to 160 mg/m2. The final protocol toxicity evaluation was 260 mg/m2. Patients required histologically proven disease and adequate bone marrow, liver and renal function, no extrahepatic metastasis and a life expectancy >12 weeks. Results: Thirty-three patients were enrolled (median age 65, range 49-78 years). On dose level VI (240 mg/m2), 1 case of dose-limiting toxicity (DLT) (granulocytopenia) was observed, leading to an enlarged cohort of 6 patients. As no additional DLT was detected on this level, an escalation to level VII was performed. On the dose level of 260 mg/m2, irinotecan DLTs were observed, resulting in the termination of escalation and the declaration of dose level VI as MTD. Imaging follow-up with Response Evaluation Criteria in Solid Tumors (RECIST) criteria revealed a complete response in 1 patient, stable disease in 31 patients, and progressed disease in 1 patient. The median time to progression was 4.7 months, the median overall survival 15.6 months. Conclusion: The method of intra-arterial chemotherapy with irinotecan is well tolerated and shows promising local response rates in liver metastases of CRC. |
Databáze: | OpenAIRE |
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