FDA approves Xeloda for stage III colon cancer

On June 15, 2005 the Food and Drug Administration announced approval for the use of Xeloda (capecitabine) for the treatment of stage III (Dukes C) colon cancer. Approval was based on the results of the X-ACT trial which showed that oral Xeloda was equivalent to intravenous administration 5FU (fluorouracil) and leucovorin in preventing recurrence of colon cancer after surgery.

The approval gives another choice to those patients for whom treatment with fluoropyrimidine therapy alone is indicated. However, the addition of oxaliplatin to 5FU modified by leucovorin has been shown to improve disease-free survival and FOLFOX (oxaliplatin, 5FU, and leucovorin) is now standard treatment for stage III colon cancer.

There were fewer gastrointestinal side effects -- diarrhea, vomiting, nausea -- with Xeloda than with 5FU, but 60% of patients taking Xeloda experienced redness and peeling skin on their hands and feet. Hand-foot syndrome was much less common for those getting IV 5FU. Xeloda also reduced mouth sores, although fatigue was about the same for both groups of patients.

Read about the approval on Drugs.com.

Read an article from the American Cancer Society.

Gabapentin (Neurontin) does not help the pain of chemo-induced peripheral neuropathy

From the 2005 Annual Meeting of the American Society of Clinical Oncology

Patients with neuropathic pain in their extremities caused by chemotherapy randomly received either gabapentin or a placebo for six weeks. Two weeks later they were switched to the opposite regimen. They kept careful track of their pain and other symptoms of sensory neuropathy.

Over the six weeks of treatment there was no difference in either pain or other sensory neuropathy between those who took gabapentin and those on placebo. Gabapentin did cause more dizziness and nystagmus (jerky, eye movements) than placebo.

Gilbert V. Wong reported the results of the study.

A second study led by Paul Mitchell also reported at ASCO found similar results -- gabapentin showed no effectiveness in reducing neuropathy when added to FOLFOX.

Read the Wong study abstract from ASCO and connect to a audio and slide presentation.

Read the Mitchell abstract with slides.

Exercise reduces recurrence and improves overall survival after stage III colon cancer

From the 2005 Meeting of the American Society of Clinical Oncology

An hour's walk at a moderate pace each day significantly reduces the risk that stage III colon cancer will return or that patients will die from their disease. Swimming, jogging, stair-climbing, or other physical activity equivalant to the energy expended in a daily walk also reduced recurrenca and dath.

Patients enrolled in a chemotherapy clinical trial completely detailed questionnaires about their physical activity halfway through their treatment and again 6 months later. Their health was followed for at least three years.

Jeffrey A. Meyerhardt, MD, MPH led the research effort for CALGB -- the Cancer and Leukemia Group B. Given that exercise has also been shown to reduce some chemotherapy side effects and improve overall mood and quality of life during chemotherapy,. Dr. Meyerhardt suggested that exercise be part of doctors' recommendations for patients with colon cancer when they begin adjuvant treatment.

"I think if these results are confirmed, they provide a recommendation that we (doctors) should provide patients after the diagnosis of colon cancer in addition to standard treatments," he said.

Read the ASCO abstract and connect to slides of Dr. Meyerhardt's presentation.

Read an article about the study from the American Cancer Society News.

Single radiation treatment as effective as 10 treatment series in relieving pain from bone mets

Over 800 patients with bone metastases from breast or prostate cancer were randomized to receive either one 8 gy radiation treatment or 10 treatments over two weeks totalling 30 gy. After three months there was no difference in pain relief and about 1/3 of patients no longer needed narcotic pain medication.

There were no significant differences in complete or partial response rates or in the rate of fractures. Acute toxicity was significantly worse in the longer treatment regimen although there was no difference in long term side effects.

Patients who received a single dose of radiation were more likely to require a second treatment than those who were on the two-week therapy (18% vs. 9%).

William Hartsell MD and his colleagues report their findings in the June 1, 2005 issue of the Journal of the National Cancer Institute.

Also in an editorial in the same issue, radiation oncologists Lisa Kacnik MD and Laurence Berk MD discuss other clinical trials that showed similar results. They question how much more evidence is necessary to change the standard of care for treating painful bone metastases with radiation. They wrote:

"In conclusion, three very large randomized trials—the Dutch Bone Metastases Study with 1171 patients, the BPTWG with 765 patients, and the RTOG trial reported in this issue with 898 patients—have all demonstrated that single-fraction radiation therapy is sufficient to achieve palliation of painful bone metastases. It remains to be seen if this approach will become standard of care in the United States."

They further challenge,

"The outcome may distinguish whether radiation oncologists in the United States practice evidence-based or remuneration-based medicine."

Read the study abstract in the Journal of the National Cancer Institute.

Read an article about the study from Reuters Health.

Read the full text of the JNCI editorial.

ASCO releases news for consumers from the 2005 Annual Meeting

From the 2005 Meeting of the American Society of Clinical Oncology

ASCO highlights and summarizes information for consumers from studies reported at this year's annual meeting in Cancer Advances.

Reports of special interest to people with colorectal cancer include:

• Two Studies Assess Benefit of Two Different Drugs Used to Lower the Risk of Colorectal Cancer Returning

Oxaliplatin was found in a second randomized study to improve disease-free survival in Stage II and III patients when given in addition to 5FU after surgery. However, two studies showed no significant difference when irinotecan was added to 5FU treatment for Stage III patients. There was a small difference (13%) in one irinotecan study when both Stage II and III groups were considered together.

• Taking Aspirin Regularly Lowers the Risk of Colorectal Cancer Returning and Improves Survival

Among patients who answered questionnaires about their use of aspirin during and after chemotherapy for Stage III colon cancer, there was about a 50% decrease in the risk of cancer returning. A smaller group of patients taking COX-2 inhibitors such as Celebrex or Vioxx had a 44% decrease in recurrence risk. Tylenol (acetaminophen) showed no difference in risk.

However, researchers said that it was too early to recommend aspirin use for patients after chemotherapy and that more and better studies were needed.

• Many Cancer Survivors Say Their Nonmedical Needs Are Not Met

Nearly half of cancer survivors responding to a survey by the Lance Armstrong Foundation said that their nonmedical needs were not being met. More than half said that emotional needs were more difficult to cope with than physical needs -- 70% had depression at some time due to cancer. Financial needs and sexual side effects were also going unmet.

Second major trial confirms value of oxaliplatin as adjuvant colon cancer treatment

From the 2005 Meeting of the American Society of Clinical Oncology

Adding oxaliplatin to a bolus regimen of 5FU with leucovorin increased disease-free survival at three years after surgery for stage II and III colon cancer.

Norman Wolmark M.D. announced the results at the 2005 annual meeting of the American Society of Clinical Oncology in Orlando on behalf of the National Surgical Breast and Bowel Project which conducted the randomized trial.

Patients in the study were randomly chosen to receive bolus 5FU along with an infusion of leucovorin (FULV) or FULV with oxaliplatin (FLOX). After three years, 76.5% of patients on the FLOX arm of the study were alive and had not experienced a recurrence of their cancer. In comparison, 71.6% of those on the FULV arm, who received only bolus 5FU and leucovorin, were alive and disease-free. Those patients taking oxaliplatin had a 21% improvement in disease-free survival.

The results were comparable to 3-year disease survival in the MOSAIC trial, which was updated with four year follow-up results at ASCO. The MOSAIC trial delivered fluorouracil with an infusional pump over two days while the NSABP regimen used weekly bolus injections.

Oxaliplatin caused some degree of neuropathy in the hands and feet of most patients, however only 8% experienced the most difficult grade 3 side effect which involved pain or loss of function. This effect had disappeared in almost all by the end of 12 months.

The researchers concluded:

The addition of oxaliplatin to weekly FULV significantly improved 3-year DFS in patients with Stage II and III colon cancer.

Read the study abstract on the ASCO web site.

See and hear Dr. Wolmark's presentation on the ASCO Virtual Meeting site.