The addition of Eloxatin® (oxaliplatin) to adjuvant (post-surgery) chemotherapy with fluorouracil and leucovorin improves survival among patients with Stage II or Stage III colon cancer. The results of this Phase III clinical trial were published in the Journal of Clinical Oncology.
Stage II colon cancer is considered an early-stage cancer. It refers to cancer that has penetrated the wall of the colon but has not spread to local lymph nodes or distant parts of the body. Treatment of Stage II colon cancer often involves surgery. Surgery may be followed by chemotherapy, although the role of chemotherapy in patients with Stage II colon cancer has not yet been firmly established.
Stage III colon cancer is considered a more advanced cancer than Stage II colon cancer. It refers to cancer that has spread to local lymph nodes but not to distant parts of the body. Several studies have reported that adjuvant (post-surgery) chemotherapy improves outcomes among patients with Stage III colon cancer.
Historically, the standard adjuvant chemotherapy regimen for patients with Stage II or Stage III colon cancer consisted of 5-fluorouracil (5-FU) and leucovorin (LV). However, among patients with metastatic colon cancer (cancer that has spread to distant parts of the body), the addition of the chemotherapy drug Eloxatin to 5-FU/LV was shown to result in better outcomes than 5-FU/LV alone. This prompted interest in the role of Eloxatin among patients with earlier-stage cancer.
The evaluate the effectiveness of Eloxatin in combination with 5-FU/LV among patients with Stage II or Stage III colon cancer, researchers conducted a Phase III clinical trial known as MOSAIC (Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer).
The study enrolled 2,246 patients. After surgery, patients received six months of chemotherapy with either 5-FU/LV or Eloxatin/5-FU/LV. The combination of Eloxatin and 5-FU/LV that was evaluated in this study is also known as FOLFOX4.
- Five-year survival without cancer recurrence was 73.3% among patients treated with FOLFOX4 compared with 67.4% among patients treated with 5-FU/LV alone.
- Six-year overall survival was 78.5% among patients treated with FOLFOX4 compared with 76% among patients treated with 5-FU/LV alone. The survival benefit among patients treated with FOLFOX4 appeared to be limited to patients with Stage III cancer.
The researchers conclude that adding Eloxatin to 5-FU/LV significantly improved both disease-free and overall survival in this study of patients with Stage II or Stage III colon cancer. They note that this treatment combination should be considered after surgery for patients with Stage III colon cancer.
Another chemotherapy combination that has been evaluated in the adjuvant setting is Camptosar® (irinotecan) plus 5-FU/LV. In a separate study published in the same issue of the Journal of Clinical Oncology, Camptosar plus 5-FU/LV was no more effective than 5-FU/LV alone.
 Andre T, Boni C, Mavarro M et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in Stage II or III colon cancer in the MOSAIC trial. Journal of Clinical Oncology [early online publication]. May 18, 2009
 Van Cutsem E, Labianca R, Bodoky G et al. Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3. Journal of Clinical Oncology [early online publication]. May 18, 2009.
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