Activity and Safety of Oxaliplatin with Weekly 5-Fluorouracil Bolus and Low-Dose Leucovorin as First-Line Treatment for Advanced Colorectal Cancer
| Autor: | Alberto Arcediano, Ricardo González del Val, Antonio Colmenarejo, Antonieta Salud, Xavier Marfà, Mauro Oruezabal, V. Guillem, Javier Cassinello, Pilar Escudero, Eduardo Pujol, José Valero, Fernando Marcos, Inés García, Ramón Pérez-Carrión |
|---|---|
| Rok vydání: | 2003 |
| Předmět: |
Adult
Diarrhea Male medicine.medical_specialty Neutropenia Organoplatinum Compounds Colorectal cancer Leucovorin Phases of clinical research Antineoplastic Agents Adenocarcinoma Gastroenterology Drug Administration Schedule Bolus (medicine) Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Infusions Intravenous Aged business.industry Middle Aged medicine.disease Oxaliplatin Regimen Treatment Outcome Oncology Tolerability Fluorouracil Anesthesia Injections Intravenous Disease Progression Female Colorectal Neoplasms business medicine.drug |
| Zdroj: | Clinical Colorectal Cancer. 3:108-112 |
| ISSN: | 1533-0028 |
| DOI: | 10.3816/ccc.2003.n.017 |
| Popis: | This study was designed to evaluate the safety and tolerability of oxaliplatin combined with weekly boluses of 5-fluorouracil (5-FU) and low doses of leucovorin (LV) and to determine objective response, progression-free survival, and overall survival of patients with previously untreated advanced colorectal cancer. Seventy-nine patients enrolled in an observational, multicenter, prospective, open-label phase II study received intravenous (I.V.) infusions of oxaliplatin 85 mg/m 2 over the course of 2 hours on days 1 and 14 and LV 20 mg/m 2 over the course of 2 hours and 5-FU 500 mg/m 2 as a bolus on days 1, 7, and 14 every 4 weeks until disease progression or unacceptable toxicity occurred. Seventy-nine patients were evaluable for safety, and data from 70 patients were used for efficacy analysis. The objective response rate was 51.4%. Complete responses occurred in 7 patients (10%), and partial responses occurred in 29 patients (41.4%). Disease control, defined as response or stable disease, was obtained in 56 of 70 patients (80%). The median duration of response was 8.34 weeks (range, 7.3-11.5 weeks). The median time to progression was 7.13 months (range, 6.28–7.72 months), and median overall survival time was 15 months (range, 12.32-18.37 months). Acute dose-limiting toxicities were grade 3/4 diarrhea and neutropenia, which occurred in 10.5% and 3.9% of patients, respectively. Among the 70 patients who experienced neurosensory toxicity, it was estimated that only 1.3% had grade 3 symptoms. Preliminary data showed that the regimen is at least as active as other regimens combining oxaliplatin and infusional schedules of 5-FU and might be more convenient for patients because it avoids the need for I.V. catheter implantation. |
| Databáze: | OpenAIRE |
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