Thierry André1, C. Boni1, Matilde Navarro1, Josep Tabernero1, Tamas Hickish1, C. Topham1, Andrea Bonetti1, Philip R. Clingan1, John Bridgewater1, F. Rivera1, Aimery de Gramont1
1From the Hôpital Pitié-Salpêtrière; Université Paris 06; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) Oncology Multidisciplinary Group; Hôpital Saint-Antoine and L'Institut National de la Santé et de la Recherche Médicale, Paris, France; Arcispedale Santa Maria Nuova, Reggio Emilia; Ospedale Mater Salutis, Legnago, Italy; Institut Català d'Oncologia, l'Hospitalet de Llobregat, Llobregat; Valle d'Hebron University Hospital, Barcelona; Hospital Marqués de Valdecilla, Santander, Spain; Dorset...
Tóm tắt
Purpose Three-year disease-free survival (DFS) was significantly improved in patients who had undergone resection with curative intent for stage II or III colon cancer who received bolus plus continuous-infusion fluorouracil plus leucovorin (LV5FU2) with the addition of oxaliplatin (FOLFOX4). Final results of the study, including 6-year overall survival (OS) and 5-year updated DFS, are reported. Patients and Methods A total of 2,246 patients were randomly assigned to receive LV5FU2 or FOLFOX4 for 6 months. The primary end point was DFS. Secondary end points were OS and safety. Results Five-year DFS rates were 73.3% and 67.4% in the FOLFOX4 and LV5FU2 groups, respectively (hazard ratio [HR] = 0.80; 95% CI, 0.68 to 0.93; P = .003). Six-year OS rates were 78.5% and 76.0% in the FOLFOX4 and LV5FU2 groups, respectively (HR = 0.84; 95% CI, 0.71 to 1.00; P = .046); corresponding 6-year OS rates for patients with stage III disease were 72.9% and 68.7%, respectively (HR = 0.80; 95% CI, 0.65 to 0.97; P = .023). No difference in OS was seen in the stage II population. The incidence of second noncolorectal cancers was 5.5% and 6.1% in the FOLFOX4 and LV5FU2 groups, respectively. Among patients receiving oxaliplatin, the frequency of grade 3 peripheral sensory neuropathy was 1.3% 12 months after treatment and 0.7% at 48 months. Conclusion Adding oxaliplatin to LV5FU2 significantly improved 5-year DFS and 6-year OS in the adjuvant treatment of stage II or III colon cancer and should be considered after surgery for patients with stage III disease.
