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Stage IV and Recurrent Rectal Cancer

Treatment options for local control:

  1. Resection of locally recurrent rectal cancer may be curative in selected patients.[1]
  2. Palliative surgical resection with either low-anterior resection (LAR) or abdominoperineal resection (APR).[1]
  3. Palliative radiation therapy.[2,3]
  4. Palliative chemotherapy.[4,5,6,7,8,9,10]
  5. Palliative chemoradiation.[11,12]
  6. Chemotherapy alone for local control.
  7. Palliative, endoscopic-placed stents to relieve obstruction.[13]

Treatment options for systemic control:

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  1. Resection of liver metastases in selected patients (5-year cure rate with resection of solitary metastases exceeds 20%).[14,15,16,17,18,19,20,21,22,23]
  2. Resection of isolated pulmonary or ovarian metastases.
  3. Systemic chemotherapy (see below).
  4. Clinical trials evaluating new drugs.

Metastatic Rectal Cancer

Treatment of patients with recurrent or advanced colorectal cancer depends on the location of the disease. For patients with locally recurrent and/or liver-only and/or lung-only metastatic disease, surgical resection, if feasible, is the only potentially curative treatment. Hepatic metastasis may be considered to be resectable based on the following:[17,21,24,25,26,27]

  • Limited number of lesions.
  • Intrahepatic locations of lesions.
  • Lack of major vascular involvement.
  • Absent or limited extrahepatic disease.
  • Sufficient functional hepatic reserve.

For patients with hepatic metastasis considered to be resectable, a negative margin resection has been associated with 5-year survival rates of 25% to 40% in mostly nonrandomized studies (such as the North Central Cancer Treatment Group trial, NCCTG-934653).[28,29,30,31,32][Level of evidence: 3iiiDiv] Better surgical techniques and advances in preoperative imaging have improved patient selection for resection. In addition, multiple studies with multiagent chemotherapy have demonstrated that patients with metastatic disease isolated to the liver, which historically would be considered unresectable, can occasionally be made resectable after the administration of chemotherapy.[33]

Currently, there are seven active and approved drugs for patients with metastatic colorectal cancer:

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,[5,34] as well as improved survival and quality of life for patients receiving chemotherapy compared with best supportive care.[35,36,37] Several trials have analyzed the activity and toxic effects of various 5-FU-leucovorin (5-FU/LV) regimens, using different doses and administration schedules, and showed essentially equivalent results with a median survival time in the 12-month range.[38] 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/LV.[39,40][Level of evidence: 1iiA]

Drug combinations described in this section include the following:

  • The Arbeitsgemeinschaft Internische Onkologie (AIO) or German AIO regimen (folic acid, 5-FU, and irinotecan):
    • Irinotecan (100 mg/m2) administered as a 2-hour infusion on day 1; LV (500 mg/m2) administered as a 2-hour infusion on day 1; followed by 5-FU (2,000 mg/m2) intravenous (IV) bolus via ambulatory pump administered for a period of 24 hours on a weekly basis four times a year (52 weeks).
  • The CAPOX regimen (capecitabine and oxaliplatin):
    • Capecitabine (1,000 mg/m2) twice a day on days 1 through 14 plus oxaliplatin (70 mg/m2) on days 1 and 8 every 3 weeks.
  • The Douillard regimen (folic acid, 5-FU, and irinotecan):
    • Irinotecan (180 mg/m2) administered as a 2-hour infusion on day 1; LV (200 mg/m2) administered as a 2-hour infusion on day 1 and day 2; followed by a loading dose of 5-FU (400 mg/m2) IV bolus, then 5-FU (600 mg/m2) via ambulatory pump administered for a period of 22 hours on day 1 and day 2 every 2 weeks.
  • The FOLFOX4 regimen (oxaliplatin, LV, and 5-FU):
    • Oxaliplatin (85 mg/m2) administered as a 2-hour infusion on day 1; LV (200 mg/m2) administered as a 2-hour infusion on day 1 and day 2; followed by a loading dose of 5-FU (400 mg/m2) IV bolus, then 5-FU (600 mg/m2) administered via ambulatory pump for a period of 22 hours on day 1 and day 2 every 2 weeks.
  • The FOLFOX6 regimen (oxaliplatin, LV, and 5-FU):
    • Oxaliplatin (85–100 mg/m2) administered as a 2-hour infusion on day 1; LV (400 mg/m2) administered as a 2-hour infusion on day 1; followed by a loading dose of 5-FU (400 mg/m2) IV bolus on day 1, then 5-FU (2,400–3,000 mg/m2) administered via ambulatory pump for a period of 46 hours every 2 weeks.
  • The FOLFIRI regimen (LV, 5-FU, and irinotecan):
    • Irinotecan (180 mg/m2) administered as a 2-hour infusion on day 1; LV (400 mg/m2) administered as a 2-hour infusion on day 1; followed by a loading dose of 5-FU (400 mg/m2) IV bolus administered on day 1, then 5-FU (2,400–3,000 mg/m2) administered via ambulatory pump for a period of 46 hours every 2 weeks.
  • The FUFOX regimen (fluorouracil, LV, and oxaliplatin):
    • Oxaliplatin (50 mg/m2) plus LV (500 mg/m2) plus 5-FU (2,000 mg/m2) as a 22-hour continuous infusion on days 1, 8, 22, and 29 every 36 days.
  • The FUOX regimen (fluorouracil plus oxaliplatin):
    • Continuous infusion 5-FU (2,250 mg/m2) during 48 hours on days 1, 8, 15, 22, 29 and 36 plus oxaliplatin (85 mg/m2) on days 1, 15, and 29 every 6 weeks.
  • IFL (or Saltz) regimen (irinotecan, 5-FU, and LV):
    • Irinotecan (125 mg/m2), 5-FU (500 mg/m2) IV bolus, and LV (20 mg/m2) IV bolus administered weekly for 4 out of 6 weeks.
  • The XELOX regimen (capecitabine plus oxaliplatin):
    • Oral capecitabine (1,000 mg/m2) twice a day for 14 days plus oxaliplatin (130 mg/m2) on day 1 every 3 weeks.
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