Oxaliplatin in Combination With Infusional 5-Fluorouracil as First-Line Chemotherapy for Elderly Patients With Metastatic Colorectal Cancer: A Phase II Study of the Spanish Cooperative Group for the Treatment of Digestive Tumors
| Autor: | Carles Pericay, Ma José Gómez, Bernardo Queralt, R. Dueñas, Bartomeu Massuti, Alfredo Carrato, Eugenio Marcuello, Inmaculada Guasch, J. Alfaro, A. Gomez, Arantxa Etxeberría, Manuel Benavides, Jorge Aparicio, Enrique Aranda, Enrique Cabrera, Manuel Valladares-Ayerbes, Silvia Gil-Calle, Juan José Reina, J. M. Campos, Encarna González-Flores |
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| Rok vydání: | 2012 |
| Předmět: |
Diarrhea
Male medicine.medical_specialty Lung Neoplasms Neutropenia Organoplatinum Compounds Colorectal cancer Population Phases of clinical research Kaplan-Meier Estimate Gastroenterology Disease-Free Survival Diabetes Complications Pulmonary Disease Chronic Obstructive Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Infusions Intravenous education Prospective cohort study Aged Aged 80 and over education.field_of_study business.industry Liver Neoplasms medicine.disease Oxaliplatin Surgery Irinotecan Treatment Outcome Oncology Fluorouracil Lymphatic Metastasis Hypertension Female Neurotoxicity Syndromes Colorectal Neoplasms business medicine.drug |
| Zdroj: | Clinical Colorectal Cancer. 11:200-206 |
| ISSN: | 1533-0028 |
| DOI: | 10.1016/j.clcc.2012.01.003 |
| Popis: | Background We previously reported a 35% overall response rate (ORR) with biweekly 5-fluorouracil (5-FU) continuous infusion (TTD [Spanish Cooperative Group for Digestive Tumour Therapy] schedule) plus irinotecan as first-line therapy in elderly patients with metastatic colorectal cancer (mCRC). The present study also was carried out in elderly patients to determine the efficacy and safety of the same 5-FU schedule plus oxaliplatin. Patients and Methods Patients (aged ≥72 years old) with mCRC, measurable disease, ECOG (Eastern Cooperative Oncology Group) ≤2, and no prior treatment were treated with oxaliplatin 85 mg/m 2 plus 5-FU 3000 mg/m 2 as a 48-hour infusion every 2 weeks. Results The study included 134 patients, of whom, 129 were eligible. The main comorbidities were hypertension (44%), diabetes (17%), and chronic obstructive pulmonary disease (11%). The ORR and disease control rate (ORR plus stable disease) were 52% and 80%, respectively. With a median follow-up of 14 months, the median progression-free survival and overall survival were 9.1 and 16.3 months, respectively. The most frequent grade 3/4 adverse events included neutropenia (16%), diarrhea (11%), and grade 3 neurotoxicity (18%). No correlation was found between efficacy or safety and comorbidities. Conclusions To our knowledge, this is the largest phase II prospective study in elderly patients with mCRC. The observed efficacy and safety of this schedule compared favorably with those reported in this population, including regimens with monoclonal antibodies. |
| Databáze: | OpenAIRE |
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