The Latest Drug News in Colorectal Cancer

By Jennifer Klem, PhD & Amy D'Orazio, PhD

Major Advances in Postsurgical Colon Cancer Treatment

At the end of 2004, the Food and Drug Administration (FDA) approved an additional use for Eloxatin™ (oxaliplatin) in patients with advanced colon cancer that has not spread to other organs.

Eloxatin was originally approved as an anticancer drug after it was shown to improve survival of patients with metastatic colon cancer when combined with conventional chemotherapy. Following this approval, Eloxatin’s potential as postsurgical treatment has been investigated in patients with less advanced disease.

The trial that led to its second FDA approval enrolled more than 2,000 patients with stage 2 (lymph nodes free of cancer) or 3 (lymph nodes have cancer) colon cancer who had already undergone surgery to remove the tumor. Patients received either conventional chemotherapy alone or in combination with Eloxatin. Four years after treatment, more patients receiving Eloxatin were free of disease than those who received only chemotherapy. This was particularly true of the patients with stage 3 disease. However, even though patients who received Eloxatin had more time without recurrence, they did not live longer than patients who did not receive Eloxatin.

During this trial, it was shown that the addition of Eloxatin resulted in more serious side effects (70 percent versus 31 percent). The most common side effect was peripheral neuropathy, which can be painful or cause a loss of sensation in the extremities. Fortunately, 18 months after surgery, less than 1 percent of patients who received Eloxatin had serious peripheral neuropathy, demonstrating this side effect is largely reversible. For more information about Eloxatin, visit www.eloxatin.com.

Xeloda® (capecitabine), a convenient oral drug, has also been shown to be an effective choice for patients with surgically-resected colon cancer. For more about Xeloda, visit www.xeloda.com.

Avastin—Not Just a One-Hit Wonder

The treatment of patients with newly diagnosed colorectal cancer experienced a major boon earlier this year with the approval of the novel drug therapy AvastinTM (bevacizumab), a drug that proved to substantially prolong life in patients with colorectal cancer by nearly five months. This key trial that led to Avastin’s approval involved more than 800 patients who were treated with Camptosar® (irinotecan) plus 5-FU/leucovorin with or without Avastin.

Since that time, physicians and patients alike have wondered about some of the many other regimens used for patients with colorectal cancer, including regimens with Eloxatin™ (oxaliplatin [FOLFOX4]). Others have wondered about patients who have relapsed disease and how effective Avastin would be for them.

The answers became clear with the recent release of a randomized clinical trial comparing FOLFOX4 alone to FOLFOX4 with Avastin in patients with relapsed colorectal cancer. The results of this study, conducted by the Eastern Cooperative Oncology Group, showed that adding Avastin to chemotherapy with FOLFOX, even in patients with relapsed disease, resulted in a 26 percent reduction in the risk of dying from the disease, and prolonged the median survival by almost two months.

The results are music to patients’ ears because they represent a second major breakthrough for both newly diagnosed patients and patients on a second round of treatment. And the benefit is there regardless of the regimen used.
For more information about Avastin, visit www.avastin.com.