Camptosar Injection has been approved for the treatment of metastatic colorectal cancer that has recurred or progressed after standard therapy with the anticancer agent fluorouracil.
The most consistent responses were observed in subjects beginning treatment at the recommended 125 mg/m2 starting dose. Of the 193 subjects treated at this dose level, 29 experienced a positive response for an overall response rate of 15%. Response refers to the complete disappearance of a tumor (two of the 29 subjects) or a reduction of its size by at least 50% (27 of the 29 patients).
Camptosar has been associated with severe diarrhea and severe myelosuppression (a reduction of white blood cells, which could increase risk of infection). Other side effects of medical importance are nausea and vomiting. Aggressive administration of loperamide reduced the incidence of serious diarrhea.
Colorectal cancer is the third leading cancer killer of U.S. men (after lung cancer and prostate cancer). It is the third leading cancer killer of U.S. women (after lung cancer and breast cancer). It is the second leading cancer killer of U.S. men and women combined (after lung cancer).
Each year colorectal cancer is diagnosed in about 133,500 people in the United States. In half of these cases, the disease has spread from the colon or rectum to other parts of the body (metastasized). The standard drug treatment for subjects with metastatic colorectal cancer is fluorouracil (5-FU). About 20% of the people who receive this medicine respond favorably. However, in all of these cases, the cancer will eventually progress.