FOLFOX4 plus cetuximab administered weekly or every second week in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer: a randomized phase II CECOG study
| Autor: | G. Purkalne, Damir Vrbanec, Einat Shacham-Shmueli, Thomas Brodowicz, Davorin Radosavljevic, Tudor-Eliade Ciuleanu, D. Messinger, Magdolna Dank, S. Plate, Christoph C. Zielinski, Zrinka Mrsic-Krmpotic |
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| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty Genotype Organoplatinum Compounds Colorectal cancer Leucovorin Cetuximab Phases of clinical research Kaplan-Meier Estimate Adenocarcinoma Neutropenia Antibodies Monoclonal Humanized medicine.disease_cause Gastroenterology Disease-Free Survival Drug Administration Schedule colorectal cancer FOLFOX4 cetuximab Proto-Oncogene Proteins p21(ras) Proto-Oncogene Proteins Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Aged Proportional Hazards Models Aged 80 and over business.industry Liver Neoplasms Hazard ratio Hematology Odds ratio Middle Aged medicine.disease Surgery Oxaliplatin Treatment Outcome Oncology ras Proteins Female Fluorouracil KRAS Colorectal Neoplasms business medicine.drug |
| Popis: | Background This randomized phase II study investigated first-line chemotherapy plus cetuximab administered every second week in KRAS wild-type metastatic colorectal cancer. Patients and methods Patients received FOLFOX4 plus either standard weekly cetuximab (arm 1) or cetuximab (500 mg/m2) every second week (arm 2), until disease progression or unacceptable toxicity. Primary end point was the objective response rate (ORR). Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety were also investigated. The study was not powered to establish non-inferiority, but aimed at the estimation of treatment differences. Results Of 152 randomized eligible patients, 75 were treated in arm 1 and 77 in arm 2; ORRs [53% versus 62%, odds ratio 1.40, 95% confidence interval (CI) 0.74–2.66], PFS [median 9.5 versus 9.2 months, hazard ratio (HR) 0.92, 95% CI 0.63–1.34], OS (median 25.8 versus 23.0 months, HR 0.86, 95% CI 0.56–1.30) and DCR (87%) were comparable. HRs adjusted for baseline factors were 1.01 and 0.99 for PFS and OS, respectively. Frequencies of grade 3/4 adverse events in arms 1 versus 2 were similar: most common were neutropenia (28% versus 34%) and rash (15% versus 17%). Conclusions Activity and safety of FOLFOX4 plus either cetuximab administered weekly or every second week were similar. |
| Databáze: | OpenAIRE |
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