Chemotherapy regimens after 2000

A multicenter European study compared capecitabine (1,250 mg/m2) administered twice daily for days 1 to 14, then given every 21 days for eight cycles against the Mayo Clinic schedule of 5-FU and low-dose LV for patients with stage III colon cancer.[25]

A multicenter European study compared capecitabine (1,250 mg/m2) administered twice daily for days 1 to 14, then given every 21 days for eight cycles against the Mayo Clinic schedule of 5-FU and low-dose LV for patients with stage III colon cancer.[25]

The study demonstrated that DFS at 3 years is equivalent for patients who received capecitabine or 5-FU/LV (hazard ratio [HR], 0.87; P < .001).[25][Level of evidence B1]

A multicenter European study compared capecitabine (1,250 mg/m2) administered twice daily for days 1 to 14, then given every 21 days for eight cycles against the Mayo Clinic schedule of 5-FU and low-dose LV for patients with stage III colon cancer.[25]

Hand-foot syndrome and hyperbilirubinemia were significantly more common for patients receiving capecitabine, but diarrhea, nausea or vomiting, stomatitis, alopecia, and neutropenia were significantly less common.

A multicenter European study compared capecitabine (1,250 mg/m2) administered twice daily for days 1 to 14, then given every 21 days for eight cycles against the Mayo Clinic schedule of 5-FU and low-dose LV for patients with stage III colon cancer.[25]

Of patients receiving capecitabine, 57% required a dose modification.

A multicenter European study compared capecitabine (1,250 mg/m2) administered twice daily for days 1 to 14, then given every 21 days for eight cycles against the Mayo Clinic schedule of 5-FU and low-dose LV for patients with stage III colon cancer.[25]

For patients with stage III colon cancer in whom treatment with 5-FU/LV is planned, capecitabine is an equivalent alternative.

In the 2,246 patients with resected stage II or stage III colon cancer in the completed Multicenter International Study of Oxaliplatin/Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer study (MOSAIC [NCT00275210]), the toxic effects and efficacy of FOLFOX-4 (oxaliplatin/LV/5-FU) were compared with the same 5-FU/LV regimen without oxaliplatin administered for 6 months.[26] Based on results from the MOSAIC trial, adjuvant FOLFOX-4 demonstrated prolonged OS for patients with stage III colon cancer compared with patients receiving 5-FU/LV without oxaliplatin.[27]

In the 2,246 patients with resected stage II or stage III colon cancer in the completed Multicenter International Study of Oxaliplatin/Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer study (MOSAIC [NCT00275210]), the toxic effects and efficacy of FOLFOX-4 (oxaliplatin/LV/5-FU) were compared with the same 5-FU/LV regimen without oxaliplatin administered for 6 months.[26] Based on results from the MOSAIC trial, adjuvant FOLFOX-4 demonstrated prolonged OS for patients with stage III colon cancer compared with patients receiving 5-FU/LV without oxaliplatin.[27]

The preliminary results of the study with 37 months of follow-up demonstrated a significant improvement in DFS at 3 years (77.8% vs. 72.9%; P = .01) in favor of FOLFOX-4. When initially reported, there was no difference in OS.[27][Level of evidence B1]

In the 2,246 patients with resected stage II or stage III colon cancer in the completed Multicenter International Study of Oxaliplatin/Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer study (MOSAIC [NCT00275210]), the toxic effects and efficacy of FOLFOX-4 (oxaliplatin/LV/5-FU) were compared with the same 5-FU/LV regimen without oxaliplatin administered for 6 months.[26] Based on results from the MOSAIC trial, adjuvant FOLFOX-4 demonstrated prolonged OS for patients with stage III colon cancer compared with patients receiving 5-FU/LV without oxaliplatin.[27]

Further follow-up at 6 years demonstrated that the OS for all patients (both stage II and stage III) who entered the study was not significantly different (OS, 78.5% vs. 76.0%; HR, 0.84; 95% confidence interval [CI], 0.71–1.00). On subset analysis, the 6-year OS in patients with stage III colon cancer was 72.9% in the patients receiving FOLFOX-4 and 68.7% in the patients receiving 5-FU/LV (HR, 0.80; 95% CI, 0.65–0.97; P = .023).[27][Level of evidence A1]

In the 2,246 patients with resected stage II or stage III colon cancer in the completed Multicenter International Study of Oxaliplatin/Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer study (MOSAIC [NCT00275210]), the toxic effects and efficacy of FOLFOX-4 (oxaliplatin/LV/5-FU) were compared with the same 5-FU/LV regimen without oxaliplatin administered for 6 months.[26] Based on results from the MOSAIC trial, adjuvant FOLFOX-4 demonstrated prolonged OS for patients with stage III colon cancer compared with patients receiving 5-FU/LV without oxaliplatin.[27]

Patients treated with FOLFOX-4 experienced more frequent toxic effects consisting mainly of neutropenia (41% >grade 3) and reversible peripheral sensorial neuropathy (12.4% >grade 3).

In a randomized phase III study (NSABP C-07 [NCT00004931]), 2,407 patients with stage II or stage III colon cancer were randomly assigned to adjuvant 5-FU/LV or fluorouracil-leucovorin-oxaliplatin (FLOX) (weekly 5-FU/LV with oxaliplatin administered on weeks 1, 3, and 5 of each 6-week cycle). DFS was the primary end point of the study.[28]

In a randomized phase III study (NSABP C-07 [NCT00004931]), 2,407 patients with stage II or stage III colon cancer were randomly assigned to adjuvant 5-FU/LV or fluorouracil-leucovorin-oxaliplatin (FLOX) (weekly 5-FU/LV with oxaliplatin administered on weeks 1, 3, and 5 of each 6-week cycle). DFS was the primary end point of the study.[28]

DFS was significantly longer in the treatment group who received FLOX, but OS was not significantly different. The DFS rate was 69.4% for patients who received FLOX and 64.2% for patients who received 5-FU/LV (HR, 0.82; 95% CI, 0.72–0.93; P = .0034).

In a randomized phase III study (NSABP C-07 [NCT00004931]), 2,407 patients with stage II or stage III colon cancer were randomly assigned to adjuvant 5-FU/LV or fluorouracil-leucovorin-oxaliplatin (FLOX) (weekly 5-FU/LV with oxaliplatin administered on weeks 1, 3, and 5 of each 6-week cycle). DFS was the primary end point of the study.[28]

The OS rate at 5 years was 80.2% for patients who received FLOX and 78.4% for patients who received 5-FU/LV (HR, 0.88; 95% CI, 0.75–1.02; P = .08).[28][Level of evidence B1]

In a randomized phase III study (NSABP C-07 [NCT00004931]), 2,407 patients with stage II or stage III colon cancer were randomly assigned to adjuvant 5-FU/LV or fluorouracil-leucovorin-oxaliplatin (FLOX) (weekly 5-FU/LV with oxaliplatin administered on weeks 1, 3, and 5 of each 6-week cycle). DFS was the primary end point of the study.[28]

Grade 3 and grade 4 diarrhea was experienced by 36.9% of patients who received FLOX, and grade 3 and grade 4 dehydration was experienced by 16.1% of patients who received FLOX.