دورية أكاديمية
Sequential versus combination chemotherapy for the treatment of advanced colorectal cancer (FFCD 2000-05): an open-label, randomised, phase 3 trial
| العنوان: | Sequential versus combination chemotherapy for the treatment of advanced colorectal cancer (FFCD 2000-05): an open-label, randomised, phase 3 trial |
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| المؤلفون: | Ducreux, Michel, Malka, David, Mendiboure, Jean, Etienne, Pierre-Luc, Texereau, Patrick, Auby, Dominique, Rougier, Philippe, Gasmi, Mohamed, Castaing, Marine, Abbas, Moncef, Michel, Pierre, Gargot, Dany, Azzedine, Ahmed, Lombard-Bohas, Catherine, Geoffroy, Patrick, Denis, Bernard, Pignon, Jean-Pierre, Bedenne, Laurent, Bouché, Olivier, Fédération Francophone de Cancérologie Digestive (ffcd) 2000-05 Collaborative Group, . |
| المساهمون: | Hémodynamique, Interaction Fibrose et Invasivité tumorales Hépatiques (HIFIH), Université d'Angers (UA) |
| المصدر: | ISSN: 1470-2045. |
| بيانات النشر: | HAL CCSD Elsevier |
| سنة النشر: | 2011 |
| مصطلحات موضوعية: | Aged, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Chi-Square Distribution, Colorectal Neoplasms, Disease-Free Survival, Drug Administration Schedule, Female, Fluorouracil, France, Humans, Kaplan-Meier Estimate, Leucovorin, Male, Middle Aged, Organoplatinum Compounds, Proportional Hazards Models, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, [SDV]Life Sciences [q-bio] |
| الوصف: | International audience ; BACKGROUND: The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined. Our aim was to investigate whether combination treatment is better than the sequential administration of the same drugs in patients with advanced colorectal cancer. METHODS: In this open-label, randomised, phase 3 trial, we randomly assigned patients (1:1 ratio) with advanced, measurable, non-resectable colorectal cancer and WHO performance status 0-2 to receive either first-line treatment with bolus (400 mg/m(2)) and infusional (2400 mg/m(2)) fluorouracil plus leucovorin (400 mg/m(2)) (simplified LV5FU2 regimen), second-line LV5FU2 plus oxaliplatin (100 mg/m(2)) (FOLFOX6), and third-line LV5FU2 plus irinotecan (180 mg/m(2)) (FOLFIRI) or first-line FOLFOX6 and second-line FOLFIRI. Chemotherapy was administered every 2 weeks. Randomisation was done centrally using minimisation (minimisation factors were WHO performance status, previous adjuvant chemotherapy, number of disease sites, and centre). The primary endpoint was progression-free survival after two lines of treatment. Analyses were by intention-to-treat. This trial is registered at ClinicalTrials.gov, NCT00126256. FINDINGS: 205 patients were randomly assigned to the sequential group and 205 to the combination group. 161 (79%) patients in the sequential group and 161 (79%) in the combination group died during the study. Median progression-free survival after two lines was 10·5 months (95% CI 9·6-11·5) in the sequential group and 10·3 months (9·0-11·9) in the combination group (hazard ratio 0·95, 95% CI 0·77-1·16; p=0·61). All six deaths caused by toxic effects of treatment occurred in the combination group. During first-line chemotherapy, significantly fewer severe (grade 3-4) haematological adverse events (12 events in 203 patients in sequential group vs 83 events in 203 patients in combination group; p<0·0001) and non-haematological adverse events (26 events vs 186 events; p<0·0001) occurred in the sequential group than in the ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | hal-03329055; https://univ-angers.hal.science/hal-03329055Test; OKINA: ua12839 |
| DOI: | 10.1016/S1470-2045(11)70199-1 |
| الإتاحة: | https://doi.org/10.1016/S1470-2045Test(11)70199-1 https://univ-angers.hal.science/hal-03329055Test |
| رقم الانضمام: | edsbas.4ABC7528 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S1470-2045(11)70199-1 |
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