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    Colon Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Stage IV and Recurrent Colon Cancer Treatment



    When 5-FU was the only active chemotherapy drug, trials in patients with locally advanced, unresectable, or metastatic disease demonstrated partial responses and prolongation of the time-to-progression (TTP) of disease [45,46] as well as improved survival and quality of life for patients receiving chemotherapy, compared with the best supportive care.[47,48,49] Several trials have analyzed the activity and toxic effects of various 5-FU-leucovorin regimens using different doses and administration schedules and showed essentially equivalent results with a median survival time in the 12-month range.[50]


    Prior to the advent of multiagent chemotherapy, two randomized studies demonstrated that capecitabine was associated with equivalent efficacy when compared with the Mayo Clinic regimen of 5-FU-leucovorin.[51,52][Level of evidence: 1iiA]


    Three randomized studies demonstrated improved response rates, PFS, and OS when irinotecan or oxaliplatin was combined with 5-FU-leucovorin.[53,54,55]

    Evidence (irinotecan):

    1. An intergroup study (NCCTG-N9741) compared IFL with FOLFOX4 in first-line treatment for patients with metastatic colorectal cancer.
      • Patients assigned to FOLFOX4 experienced an improved PFS (median, 6.9 months vs. 8.7 months; P = .014; hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.61-0.89) and OS (15.0 months vs. 19.5 months, P = .001; HR, 0.66; 95% CI, 0.54-0.82) compared with patients randomly assigned to IFL.[Level of evidence: 1iiA]
    2. Subsequently, two studies compared FOLFOX with FOLFIRI, and patients were allowed to cross over upon progression on first-line therapy, respectively.[56,57][Level of evidence: 1iiDiii]
      • PFS and OS were identical between the treatment arms in both studies.
    3. The Bolus, Infusional, or Capecitabine with Camptosar-Celecoxib (BICC-C) trial evaluated several different irinotecan-based regimens in patients with previously untreated metastatic colorectal cancer, including FOLFIRI, mIFL, and Capecitabine/irinotecan (CAPIRI).[58][Level of evidence: 1iiA]
      • The study randomly assigned 430 patients and was closed early due to poor accrual.
      • The patients who received FOLFIRI had a better PFS than the patients who received either mIFL (7.6 months vs. 5.9 months, P = .004) or CAPIRI (7.6 months vs. 5.8 months, P = .015).
      • Patients who received CAPIRI had the highest grade 3 or higher rates of nausea, vomiting, diarrhea, dehydration, and hand-foot syndrome.
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