Oxaliplatin, Irinotecan and Capecitabine (OCX) for First-Line Treatment of Advanced/Metastatic Colorectal Cancer: A Phase I Trial (SAKK 41/03)
Autor: | Lucas Widmer, Thomas Ruhstaller, Mathew Simcock, R. A. Popescu, Doris Lanz, Roger von Moos, Catrina Uhlmann, Dieter Köberle, Arnaud Roth, Richard Cathomas |
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Rok vydání: | 2010 |
Předmět: |
Male
Oncology Cancer Research medicine.medical_specialty Organoplatinum Compounds Colorectal cancer Camptothecin/administration & dosage/adverse effects/analogs & derivatives Irinotecan Deoxycytidine Disease-Free Survival Capecitabine health services administration Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Metastasis neoplasms Neoplasm Staging ddc:616 Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives business.industry Neoplasm Metastasis/pathology Hematology General Medicine Middle Aged medicine.disease digestive system diseases Oxaliplatin First line treatment Antineoplastic Combined Chemotherapy Protocols/adverse effects/ therapeutic use stomatognathic diseases Camptothecin Female Fluorouracil Colorectal Neoplasms/ drug therapy/pathology Colorectal Neoplasms Fluorouracil/administration & dosage/adverse effects/analogs & derivatives business therapeutics Organoplatinum Compounds/administration & dosage/adverse effects medicine.drug |
Zdroj: | Onkologie, Vol. 33, No 6 (2010) pp. 295-299 |
ISSN: | 1423-0240 0378-584X |
Popis: | BACKGROUND: A phase I multicentre trial was conducted to define the recommended dose of capecitabine in combination with oxaliplatin and irinotecan (OCX) in metastatic colorectal cancer. PATIENTS AND METHODS: Patients with performance status (PS) < 2 and adequate haematological, renal and liver function received oxaliplatin 70 mg/m(2) on days 1 and 15, irinotecan 100 mg/m(2) on days 8 and 22 and one of five dose levels (DL 1-5, between 800 and 1,600 mg/ m(2)) of capecitabine on days 1-29 every 5 weeks. RESULTS: 23 patients received a median of 3 cycles. 3 dose-limiting toxicities occurred (DL 1: grade 3 (G3) elevated alkaline phosphatase; DL 5: 1 patient G4 hyperglycaemia/G3 diarrhoea and 1 sudden death). The most common severe adverse event was G3 diarrhoea (13%). Severe haematotoxicity was rare. Therapy was stopped mainly due to metastasectomy or tumour progression (7 patients each). 8 patients reached a partial response. Median time to progression and overall survival (OS) were 8.0 and 21.9 months, respectively. CONCLUSIONS: The recommended capecitabine dose in this schedule is 1,400 mg/m(2) daily. The OCX regimen is well tolerated. The response rate was surprisingly low with progression-free survival (PFS) and OS within the range of a triple combination. Further studies in combination with targeted agents are warranted. |
Databáze: | OpenAIRE |
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