'Poker' association of weekly alternating 5-fluorouracil, irinotecan, bevacizumab and oxaliplatin (FIr-B/FOx) in first line treatment of metastatic colorectal cancer: a phase II study
| Autor: | Marianna Tudini, Corrado Ficorella, Paola Lanfiuti Baldi, Adelmo Antonucci, Federica De Galitiis, Katia Cannita, A. Santomaggio, Maria Vincenza Mancini, Paolo Marchetti, Enrico Ricevuto, Gemma Bruera |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Time Factors Organoplatinum Compounds Bevacizumab Colorectal cancer Phases of clinical research Antibodies Monoclonal Humanized Irinotecan lcsh:RC254-282 Disease-Free Survival Drug Administration Schedule Surgical oncology Internal medicine Antineoplastic Combined Chemotherapy Protocols Genetics medicine Humans Neoplasm Metastasis Aged business.industry Antibodies Monoclonal Middle Aged lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens medicine.disease Oxaliplatin Treatment Outcome Research Design Fluorouracil Camptothecin Colorectal Neoplasms business Research Article medicine.drug |
| Zdroj: | BMC Cancer BMC Cancer, Vol 10, Iss 1, p 567 (2010) |
| ISSN: | 1471-2407 |
| DOI: | 10.1186/1471-2407-10-567 |
| Popis: | Background This phase II study investigated efficacy and safety of weekly alternating Bevacizumab (BEV)/Irinotecan (CPT-11) or Oxaliplatin (OHP) associated to weekly 5-Fluorouracil (5-FU) in first line treatment of metastatic colorectal carcinoma (MCRC). Methods Simon two-step design: delta 20% (p0 50%, p1 70%), power 80%, α 5%, β 20%. Projected objective responses (ORR): I step, 8/15 patients (pts); II step 26/43 pts. Schedule: weekly 12 h-timed-flat-infusion/5-FU 900 mg/m2, days 1-2, 8-9, 15-16, 22-23; CPT-11 160 mg/m2 plus BEV 5 mg/kg, days 1,15; OHP at three dose-levels, 60-70-80 mg/m2, days 8, 22; every 4 weeks. Results Fifty consecutive, unselected pts < 75 years were enrolled: median age 63; young-elderly (yE) 24 (48%); liver metastases (LM) 33 pts, 66% Achieved OHP recommended dose, 80 mg/m2. ORR 82% intent-to-treat and 84% as-treated analysis. Median progression-free survival 12 months. Equivalent efficacy was obtained in yE pts. Liver metastasectomies were performed in 26% of all pts and in 39% of pts with LM. After a median follow-up of 21 months, median overall survival was 28 months. Cumulative G3-4 toxicities per patient: diarrhea 28%, mucositis 6%, neutropenia 10%, hypertension 2%. They were equivalent in yE pts. Limiting toxicity syndromes (LTS), consisting of the dose-limiting toxicity, associated or not to G2 or limiting toxicities: 44% overall, 46% in yE. Multiple versus single site LTS, respectively: overall, 24% versus 20%; yE pts, 37.5% versus 8%. Conclusion Poker combination shows high activity and efficacy in first line treatment of MCRC. It increases liver metastasectomies rate and can be safely administered. Trial registration Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali (OsSC) Agenzia Italiana del Farmaco (AIFA) Numero EudraCT 2007-004946-34 |
| Databáze: | OpenAIRE |
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