Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer.

BACKGROUND: We investigated the efficacy of cetuximab plus irinotecan, fluorouracil, and leucovorin (FOLFIRI) as first-line treatment for metastatic colorectal cancer and sought associations between the mutation status of the KRAS gene in tumors and clinical response to cetuximab. METHODS: We randomly assigned patients with epidermal growth factor receptor-positive colorectal cancer with unresectable metastases to receive FOLFIRI either alone or in combination with cetuximab. The primary end point was progression-free survival. RESULTS: A total of 599 patients received cetuximab plus FOLFIRI, and 599 received FOLFIRI alone. The hazard ratio for progression-free survival in the cetuximab-FOLFIRI group as compared with the FOLFIRI group was 0.85 (95% confidence interval [CI], 0.72 to 0.99; P=0.048). There was no significant difference in the overall survival between the two treatment groups (hazard ratio, 0.93; 95% CI, 0.81 to 1.07; P=0.31). There was a significant interaction between treatment group and KRAS mutation status for tumor response (P=0.03) but not for progression-free survival (P=0.07) or overall survival (P=0.44). The hazard ratio for progression-free survival among patients with wild-type-KRAS tumors was 0.68 (95% CI, 0.50 to 0.94), in favor of the cetuximab-FOLFIRI group. The following grade 3 or 4 adverse events were more frequent with cetuximab plus FOLFIRI than with FOLFIRI alone: skin reactions (which were grade 3 only) (in 19.7% vs. 0.2% of patients, P<0.001), infusion-related reactions (in 2.5% vs. 0%, P<0.001), and diarrhea (in 15.7% vs. 10.5%, P=0.008). CONCLUSIONS: First-line treatment with cetuximab plus FOLFIRI, as compared with FOLFIRI alone, reduced the risk of progression of metastatic colorectal cancer. The benefit of cetuximab was limited to patients with KRAS wild-type tumors. (ClinicalTrials.gov number, NCT00154102.)

Evaluation of contrast-enhanced computed tomographic colonography in detection of local recurrent colorectal cancer.

AIM: To evaluate the diagnostic accuracy, sensitivity, specificity of contrast-enhanced computed tomographic colonography in detecting local recurrence of colorectal cancer. METHODS: From January 2000 to December 2004, 434 patients after potentially curative resection for invasive colorectal cancer were followed up for a period ranging from 20 to 55 mo. Eighty of the four hundred and thirty-four patients showing strong clinical evidence for recurring colorectal cancer during the last follow-up were enrolled in this study. Each patient underwent contrast-enhanced computed tomographic colonography and colonoscopy on the same day. Any lesions, biopsies, identified during the colonoscopic examination, immediate complications and the duration of the procedure were recorded. The results of contrast-enhanced computed tomographic colonography were evaluated by comparing to those of colonoscopy, surgical finding, and clinical follow-up. RESULTS: Contrast-enhanced computed tomographic colonography had a sensitivity of 100%, a specificity of 83% and an overall accuracy of 94% in detecting local recurrent colorectal cancer. CONCLUSION: Conventional colonoscopy and contrast-enhanced tomographic colonography can complement each other in detecting local recurrence of colorectal cancer.

Cetuximab y quimioterapia como tratamiento inicial para el cáncer colorrectal metastásico / Cetuximab and quimiotherapy as inicial treatment for metastasic colorrectal cancer

Antecedentes: Se investigó la eficacia de cetuximab más irinotecan, fluorouracilo y leucovorina (FOLFIRI) como tratamiento metastásico y las asociaciones buscadas entre el estado de mutación del gen KRAS en tumores y la respuesta clínica a cetuximab. Métodos: Se asignaro en forma aleatoria pacientes con cáncer colorrectal con expresión positiva del receptor de factor de crecimiento epidérmico, con metástasis irresecables para recibir FOLFIRI, ya sea solo o en combinación con cetuximab. El criterio de valoración primario fue la supervivencia libre de progresión. Conclusión: El tratamiento de primera línea con cetuximab más FOLFIRI, comparado con FOLFIRI solo, redujo el riesgo de progresión del cáncer colorrectal metastásico. El beneficio de cetuximab resultó limitado para pacientes con tumores con KRAS no mutado.