August, 2007
ArchivesEpidural pain control shows benefits after colorectal surgery
Reviewing studies of epidural analgesia to control pain after colon or rectal surgery, researchers in New Zealand and the United Kingdom found that it provided better pain control in most randomized trials.
In addition there were other benefits including
- Faster recovery of bowel functioning (less ileus).
- Better lung function
- Greater patient satisfaction
Length of hospital stay didn’t seem to be affected by epidurals, and there was not enough evidence to show a difference in blood clots or cardiovascular function.
There may be increased costs for epidurals over other pain management, however.
Writing in Colorectal Disease, K.A. Gendell and colleagues concluded,
Randomized controlled trials have shown a benefit for epidurals on postoperative pain relief, and ileus, and possibly respiratory complications. There is no proven benefit with regard to length of stay. There are a number of unresolved issues which further focused RCT’s may help clarify such as effects of epidural on complication rates after colorectal surgery.
SOURCE: Gendell et al, Colorectal Disease, Volume 9 Issue 7 Page 584-598, September 2007.
Posted by Kate Murphy on August 16th, 2007
Posted in: Research & Treatment News | 1 Comment »
C3 Supports U.S. Court of Appeals in Ruling Against Abigail Alliance and the Washington Legal Foundation
By Robert Erwin
Robert Erwin, founder of the Marti Nelson Cancer Foundation, is a member of the Board of Directors for C3: Colorectal Cancer Coalition. His first wife, Marti Nelson, M.D., died of breast cancer in 1994 after unsuccessful attempts to obtain access to the experimental drug now known as Herceptin.
Fifteen years ago, patients diagnosed with metastatic colorectal cancer lived an average of nine months after diagnosis. Today, the average is approximately two years – and that number is increasing. This was accomplished through well controlled and rigorously conducted clinical trials. Randomized clinical trials are the only way to truly tell if a particular drug or treatment works.
In 2003, the Abigail Alliance for Better Access to Developmental Drugs, a patient advocacy group, filed a lawsuit against the Food and Drug Administration, seeking to establish a Constitutional right for terminally ill patients to obtain experimental drugs that have passed only limited safety testing but have not been proven safe and effective.
On August 7, 2007, the U.S. Court of Appeals for the District of Columbia Circuit ruled against the Abigail Alliance and the Washington Legal Foundation, stating that terminally ill patients do not have a Constitutional right to experimental drugs.
Articles detailing this case can be found here:
C3 supports the Court’s ruling. We believe that it is vitally important to look past the emotion surrounding this case and do what is right for cancer patients – which is to support science, reason and evidence in the practice of medicine.
Additionally, C3 disagrees with the dissenting opinion of Judge Judith W. Rogers who sought to portray the issue before the Court as “the right to try to save one’s life.” Rather, we believe the Court correctly prevented the creation of a Constitutional right to profit from the marketing of unproven and potentially dangerous products to seriously ill people. We applaud the Court’s wisdom in ruling to sustain a functional regulatory system that keeps potentially toxic drugs off the market and out of the clinic.
Many of us at C3 have faced, or are currently facing, a terminal illness, either personally or through a close family member. We understand the desire to do all that can be done to save or prolong a life. However, we remain committed to the belief that reason must guide us beyond the emotional arguments that have characterized much of this debate to examine some of the realities of cancer and the development of drugs to treat cancer.
For those new to this issue, it is important to understand the five stages to drug study, as illustrated at the bottom of the this page here on C3’s site.
A recent Journal of Clinical Oncology article found that of 266 randomized Phase II cancer clinical trials conducted between 1986 and 2002, only 14 percent recommended or started Phase III studies. This unfortunate failure rate is not because of the lack of good science or poor trial design. It is simply because cancer drug development is complicated.
As we all know too well, cancer is tenacious. The fact of the matter is, even with the many advances in newer drugs and biologic agents, there still is no cure.
Hope for miracles forms the basis of much of the popular support for the position of the Abigail Alliance. Unfortunately, there are far too many money-motivated people willing to exploit this hope with offers of empty promises at high prices.
Effective cancer drug development is hard, slow work and seldom yields miracles. Most advances in treatment have been incremental and generally ineffective in reversing the inevitable course of terminal disease.
Still, progress is being made in the development of new drugs and biologic agents. The worst thing that could be done for cancer patients now would be to lower the standards for approval and create a system that produces profits without performance and replaces medical evidence with hope and faith.
Frequently overlooked or dismissed in this debate is the fact that the FDA has proposed rules for providing seriously ill patients with access to experimental drugs. These rules:
- Do not allow commercial marketing of unapproved drugs;
- Provide a mechanism for companies to recover the actual cost of supplying a patient with experimental drugs; and
- Reduce financial barriers to patients seeking access to experimental drugs before they are approved for marketing.
While seldom used, properly designed expanded access protocols do not interfere with enrollment in clinical trials and can be administered relatively easily by companies who value compassion. The sad fact is, even in these cases, many sick patients do not receive the clinical benefit they need.
C3 will work with the FDA and industry to strengthen expanded access programs and efforts to increase awareness that such programs exist and are waiting to be utilized.
Posted by Judi Sohn on August 12th, 2007
Posted in: Research & Treatment News | 2 Comments »
Living with Colorectal Cancer in the White House
Tony Snow, White House Press Secretary, speaks to David Gregory from MSNBC about living with colorectal cancer.
Click here to watch this interview.
Posted by Joe Arite on August 8th, 2007
Posted in: Policy & Advocacy News | No Comments »
Obesity increases risk for recurrence of colorectal polyps in men
While obesity is a known risk factor for polyps that can progress to colon or rectal cancer, researchers have found that it also increases the risk that more polyps will occur. Men whose body mass index (BMI) was over 30 were about one third more likely to have a new polyp (adenoma) three years after previous polyps were removed.
There was no similar effect in women.
Risk of an advanced adenoma was also higher. The highest increase of all was for obese men or women who had a family history of colorectal cancer. They had more than twice the chance of developing a new polyps during the average 3 year follow-up time.
Odds ratios for developing additional polyps with BMI higher than 30:
- Overall men and women: 1.17 or 17%, which wasn’t significant.
- Women: 0.90
- Men: 1.36 or 36% higher risk
- Non-advanced polyps in men: 1.26
- Advanced polyps in men: 1.62
- Men and women with no family history: 1.00 (no change in risk)
- Men and women with a family history: 2.25
Elizabeth Jacobs Ph.D. and her colleagues at the University of Arizona at Tucson concluded,
Our results support obesity as a risk factor for subsequent short-interval (mean follow-up time 3.1 years) development of colorectal adenomas, particularly among men and persons with a family history of colorectal cancer. Furthermore, obesity in men appears to be strongly associated with the development of clinically advanced lesions.
SOURCE: Jacobs et. al. Clinical Gastroenterology and Hepatology, Volume 5, Issue 8, Pages 982-990, August 2007
Posted by Kate Murphy on August 6th, 2007
Posted in: Research & Treatment News | No Comments »
Adding erlotinib to FOLFOX and bevacizumab may be too toxic for patients to tolerate
In a phase II study of patients with previously untreated colorectal cancer, doctors added Tarceva® (erlotinib) to standard FOLFOX plus Avastin® treatment.
Tarceva blocks epidermal growth factor (EGFR) pathways in the cancer cell reducing its ability to divide and grow. Avastin (bevacizumab) acts on other cellular pathways reducing the ability of the tumor to develop a blood supply. Scientists thought that attacking both pathways at the same might shrink tumors and increase the time until the cancer began growing (progression).
However, none of the 35 enrolled patients were able to remain in the trial until cancer progression. More than half were removed from the study because of adverse events, another 25 percent asked to stop the treatment because the side effects were too difficult to tolerate. Overall 86 percent of patients had at least one grade three or four adverse event.
Serious side effects included rash, neuropathy, and diarrhea.
About a third of patients had some tumor shrinkage during the trial, but the effectiveness of the treatment could not be fully assessed because of the high number of study withdrawals.
Concluding, J.A. Meyerhardt M.D.and colleagues wrote,
The combination of FOLFOX, bevacizumab and erlotinib led to higher than expected early withdrawal due to toxicity, limiting conclusions regarding efficacy. These findings raise concern regarding the tolerability of adding more agents to already complex combination regimens for metastatic colorectal cancer.
Preliminary information from the study was presented at ASCO 2006 by Dr. Meyerhardt.
SOURCE: Meyerhardt et al. Annals of Oncology, Volume 18, Number 7, Pages 1185-1189, July 2007.
Posted by Kate Murphy on August 5th, 2007
Posted in: Research & Treatment News | No Comments »
