Force Congress to Face the FAX About Cancer Research

Congress is deciding how to spend our tax dollars - the decisions could be made this week - and the House of Representatives is still considering a cut of $100,000,000 to cancer research funding.

C3 is a member of the [One Voice Against Cancer (OVAC)](http://www.ovaconline.org) coalition. OVAC has professionals in DC telling our Representatives that cancer matters at home. We must reinforce that message if we want our Representatives to listen.

C3 has set up an action alert in our [One Minute Advocate](http://www.kintera.org/siteapps/advocacy/index.aspx?c=cgKJLROyEpH&b=437949) so you can log in and send a fax to your elected representative - it’s automated and it’s free. All you need to do is enter your name and address (because Representatives ignore communications unless they come from constituents) - the system does the rest.

**Do it today.**

Posted by Nancy Roach on November 10th, 2005
Posted in: Policy & Advocacy News | No Comments »

ASCO updates colorectal cancer surveillance practice guidelines

An Expert Panel from the American Society of Clinical Oncology (ASCO) reviewed and updated practice guidelines for follow-up surveillance after treatment for colorectal cancer. The new guidelines were published online ahead of print on October 31, 2005 in the [*Journal of Clinical Oncology*](http://www.jco.org/cgi/reprint/JCO.2005.04.0063v1).

The guidelines were last updated in 2000. New recommendations embody research published since 1999, including three recent meta-analyses of randomized studies comparing *low-intensity* and *high-intensity* plans for post-treatment surveillance. The Panel also considered pooled information from clinical trials for treatment of colon or rectal cancer.

In light of evidence showing benefit of more intensive treatment follow-up, the panel changed several guideline recommendations.

One significant change is the **recommendation *for* an annual CT scan of the chest and abdomen for 3 years** for patients at high risk of recurrence who could be candidates for surgery to cure metastatic cancer. In addition, **pelvic CT scan** should be considered for rectal cancer patients, particularly those who did not undergo radiation. Previous guidelines recommended *against* such scans. Yearly chest x-rays are *not recommended* in either the new or old guidelines.

The panel added a new category to the guidelines in 2005: *Laboratory-Derived Prognostic and Predictive Factors*. This relates to molecular and cellular markers that may predict response to chemotherapy or influence prognosis. However, the Expert Panel decided that evidence was not yet strong enough to include them in the guidelines:

“Until prospective data are available, use of molecular or cellular markers should not influence the surveillance strategy”.

Briefly, the guidelines recommend:

+ **history and physical examination** every 3 to 6 months for the first 3 years, every 6 months during years 4 and 5, and subsequently at the discretion of the physician
+ **carcinoembryonic antigen** blood test every 3 months postoperatively for at least 3 years after diagnosis, if the patient is a candidate for surgery or systemic therapy should cancer recur
+ **annual computed tomography (CT)** of the chest and abdomen for 3 years
after primary therapy for patients who are at higher risk of recurrence and who could be
candidates for curative-intent surgery
+ **pelvic CT scan** for *rectal cancer* surveillance, especially for patients with several poor prognostic factors, including those have not been treated with radiation
+ **colonoscopy at 3 years** after operative treatment, and, if results are normal, every
5 years thereafter
+ **flexible protosigmoidoscopy** every 6 months for 5 years for *rectal cancer* patients who have not been treated with pelvic radiation
+ **Chest x-rays, CBCs, and liver function tests** are *not recommended*
+ **molecular or cellular markers** should *not influence* the surveillance strategy based on available evidence

Recommendations for colonoscopy mirror those of the American Gastroenterological Association — a colonoscopy at 3 years and then, if normal, then every five years thereafter. Patients with high-risk genetic syndromes should have colonoscopies according to the AGA schedule.

Panel members included:

+ Al B. Benson, MD, Co-Chair — Northwestern University Medical School
+ Christopher Desch, MD, Co-Chair — Virginia Cancer Institute
+ Patrick J. Flynn, MD — Minnesota Oncology Hematology P. A.
+ Carol Krause — Health Systems Research (Patient Representative)
+ Charles L. Loprinzi, MD — Mayo Clinic
+ Bruce D. Minsky, MD — Memorial Sloan-Kettering Cancer Center
+ Nicholas J. Petrelli, MD — Helen F. Graham Cancer Center
+ David Pfister, MD — Memorial Sloan-Kettering Cancer Center
+ Katherine S. Virgo, PhD — Saint Louis University Health Science Center
.
**UPDATE** Although originally published early online, the new Guidelines are now available in the November 20, 2005 edition of the [*Journal of Clinical Oncology](http://www.jco.org/cgi/reprint/23/33/8512)

Posted by Kate Murphy on November 8th, 2005
Posted in: Research & Treatment News | No Comments »

CMS announces 2006 Oncology Demonstration Program

On November 2, 2005 the Centers for Medicare and Medicaid Services (CMS) announced the [2006 Oncology Demonstration Program](http://www.cms.hhs.gov/media/press/release.asp?Counter=1717) designed to develop data on quality cancer patient care during visits for evaluation and disease management.

Medicare billing codes will be changed to take a broader outlook on supportive care visits beyond chemotherapy administration. Physicians who see a patient for an evaluation and management service (E & M) will be entitled to an additional $23 payment beyond the payment for the visit if they also iinclude the following information:

+ primary focus of the evaluation and management session
+ current disease state
+ whether current management adheres to clinical guidelines

For instance, the primary focus of the E & M service might be management of side effects, pain control or other palliative service, survelliance for cancer recurrence, or provision of end-of-life care. Doctors will be asked to characterize the spread of the cancer, as it is best known at the time.

Finally, physicians will be asked to report whether or not the patient’s management follows practice guidelines established by either the [American Society of Clinical Oncology](http://asco.org/ac/1,1003,_12-002130,00.asp) or the [National Comprehensive Cancer Network](http://www.nccn.org/professionals/physician_gls/default.asp). Guidelines may be reported as followed or not followed for a reason such a clinical trial protocol, patient preference or desire for a different treatment, or physician disagreement with the guidelines.

In a [Fact Sheet](http://www.cms.hhs.gov/media/press/release.asp?Counter=1717) released by CMS, designers of the demonstration project described its goals:

The 2006 demonstration meets our objective of having oncology payments increasingly focused on patient-centered care, rather than chemotherapy administration. In the 2006 demonstration, data collection and payments are linked to E&M provided by physicians to patients, rather than chemotherapy administration that may occur in the absence of an involved visit between doctor and patient. This demonstration also meets the objective of helping us learn to what extent Medicare beneficiaries are being treated in a manner that yields the best outcomes, understand clinical cancer scenarios where there is not clinical consensus among physicians on the relevance of specific guidelines, and ensure that due emphasis is placed on a multi-disciplinary, comprehensive approach to palliation and end of life care. Also, by focusing on evidence based practices, there is the potential that unnecessary services and tests will be reduced, lowering program costs and yielding better quality of life for Medicare beneficiaries with cancer.

A similar project in 2005 measured patient outcomes for three side effects of chemotherapy — controlling pain, managing nausea and vomiting, and reducing fatigue.

Posted by Kate Murphy on November 8th, 2005
Posted in: Research & Treatment News | No Comments »

Disease-free survival at 3 years predicts overall survival from colon cancer at 5 years

Traditionally, overall survival five years after treatment has been the standard for measuring outcome of adjuvant clinical trials for colon cancer. However, a [meta-analysis](http://www.jco.org/cgi/content/abstract/JCO.2005.01.6071v1) of 18 randomized Phase III clinical trials evaluating adjuvant treatment involving nearly 21,000 patients found a close correlation between lack of recurrence at 3 years and overall survival at 5 years.

Eighty percent (80%) of recurrences occurred within the first 3 years, and 91% of patients who had cancer return within 3 years had died by the 5-year mark. Correlation between disease-free survival at 3 years (DFS) and overall survival at 5 years (OS) was 0.89.

In the pooled data. 12% of recurrences happened in the first year, 14% in the second, 8% in the third, 5% in the fourth, and 3% in the fifth year.

The research team, headed by Dr. Daniel J. Sargent, believes that the study provides evidence for using three-year disease free survival as a surrogate measure for overall survival. This would enable adjuvant research to be completed more quickly, providing critical answers to the best treatment for patients with stage 2 and 3 colon cancer.

In a [*Journal of Clinical Oncology* early release article](http://www.jco.org/cgi/content/abstract/JCO.2005.01.6071v1), published on the internet on October 31, 2005, they concluded:

In patients treated on phase III adjuvant colon clinical trials, DFS and OS are highly correlated, both within patients and across trials. These results suggest that DFS after 3 years of median follow-up is an appropriate end point for adjuvant colon cancer clinical trials of fluorouracil-based regimens, although marginally significant DFS improvements may not translate into significant OS benefits.

In the same issue of the *Journal of Clinical Oncology* Judith Abrahms from the Karmanos Cancer Institute at Wayne State University writes a [commentary](http://www.jco.org/cgi/reprint/JCO.2005.03.6186v1) that warns against over-generalizing the study results to all cancers or to all trials for colon cancer:

Although future studies of FU-based adjuvant therapy
for patients with stages II and III colon cancer may comfortably
use DFS3 years as a primary end point replacing OS5 years,
casual readers are cautioned against generalizing these results
to all colon cancer trials or to cancer clinical trials in
general. These results depend on specific features of the
disease and the current state of diagnosis and therapy.

Posted by Kate Murphy on November 5th, 2005
Posted in: Research & Treatment News | No Comments »

MedWatch warns of alcohol use while on Avinza extended release morphine

The FDA and Ligard Pharmaceuticals notified health professionals and consumers of [label changes for Avinza™](http://www.fda.gov/medwatch/safety/2005/safety05.htm#Avinza) on November 3, 2005. Avinza™ is an extended release form of morphine sulfate provided in capsules. Alcohol can cause a potentially fatal overdose of the drug. FDA MedWatch said,

“Ligand Pharmaceuticals Inc. and FDA notified healthcare professionals of revisions to BOXED WARNING, WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY, and DOSAGE AND ADMINISTRATION sections of the prescribing information to highlight and strengthen the warning that patients should not consume alcohol while taking Avinza. Additionally, patients must not use prescription or non-prescription medications containing alcohol while on Avinza therapy.

Ligard Pharmaceuticals, manufactures of Avinza™ issued a [Dear Health Professional Letter](http://www.fda.gov/medwatch/safety/2005/Avinza-ltr.pdf) to let them know of changes in the labeling. Included in that letter was the following addition to the *Black Box Warning* on the Avinza™ label.

Patients must not consume alcoholic beverages while on AVINZA therapy.
Additionally, patients must not use prescription or non-prescription medications
containing alcohol while on AVINZA therapy. Consumption of alcohol while taking
AVINZA may result in the rapid release and absorption of a potentially fatal dose of morphine.

The [new Avinza label](http://www.fda.gov/medwatch/safety/2005/avinza_PI.pdf) with changes highlighted in yellow can be downloaded as a PDF.

Posted by Kate Murphy on November 5th, 2005
Posted in: Research & Treatment News | No Comments »