Update for Patients on FOLFOX Using Calcium/Magnesium for Neurotoxic Side Effects

As reported in a C3 post on June 26, a phase IV clinical trial* was closed after an interim analysis indicated that the use of calcium/magnesium to reduce neuropathy caused by FOLFOX might also reduce the effectiveness of this chemotherapy treatment.

In this trial*, patients receiving FOLFOX and bevacizumab chemotherapy were also randomized to Magnesium Sulfate and Calcium Gluconate before and after oxaliplatin in a double-blind placebo controlled fashion.  The preliminary data from the first 174 patients on the trial showed that patients who had received calcium/magnesium had significantly less tumor shrinkage than patients who did not receive calcium/magnesium.  The data is based on scans of patients’ tumors.

As a result, the trial was closed and all patients on the trial will receive future treatment without calcium/magnesium.

The data will be verified as follows:

• An independent committee of expert radiologists is being convened;
• The committee will examine all scans from the trial. Their examination will be blinded (they will not know which patients received which treatment); and
• The results of their examinations will be analyzed, and compared to the preliminary data.

The verification process is expected to take several months.  Final results may be available in early 2008.

On July 31, the Journal of Clinical Oncology published a letter from the trial’s primary investigators.  The investigators say the following:

At present, bearing in mind the preliminary and unconfirmed nature of these data, we would like our colleagues to be aware of this unexpected finding. Oncologists should recognize the possibility that calcium and magnesium may reduce the activity of FOLFOX and bevacizumab in the treatment of colorectal cancer and exercise appropriate clinical judgment when using these agents in the neuroprotective setting until definitive data are available. For the time being, we would urge that calcium and magnesium salts particularly be avoided in the adjuvant setting, where reduced efficacy could lead to reduced benefit, and be reserved for those with symptomatic acute neurotoxicity.

Full letter text available here. 

C3 asked sanofi-aventis (the manufacturer of oxaliplatin) how this information was being disseminated to the oncology community. Sanofi-aventis indicated that its sales force was carrying the information to oncologists and oncology nurses, and that these efforts would continue.

WHAT THIS MEANS TO PATIENTS:
If you are receiving calcium-magnesium as treatment for neuropathy related to your FOLFOX regimen, talk to your doctor to be sure that s/he is aware of this preliminary data.  If your doctor is unaware, s/he can contact sanofi-aventis Medical Information Service at 1-800-633-1610 option 1 for additional information.

While this data is preliminary, patients and doctors should take it into account when planning treatment.

Source:
Sanofi-aventis website
Hochster et al, Journal of Clinical Oncology, July 31 2007

* CONCEPT Trial – a Phase IV, Randomized, Prospective Multicenter comparison of an Intermittent Schedule of Oxaliplatin combined with 5-Fluorouracil/Leucovorin (FOLFOX) / Bevacizumab Versus the Conventional Mode of Administration of FOLFOX/Bevacizumab PLUS Neuroprophylaxis With Calcium/Magnesium for the Optimization of First-Line Therapy of Metastatic Colorectal Cancer.  Available here.

Disclosure: C3 has accepted funding for projects and educational programs from sanofi-aventis in the form of charitable donations. C3 has ultimate authority over website content.

Posted by Nancy Roach on August 3rd, 2007
Posted in: Research & Treatment News | 1 Comment »

CMS issues decision on coverage of Erythropoiesis Stimulating Agents (ESAs), C3 Cited in Ruling

By Carlea Bauman, Executive Director

In May 2007, the Centers for Medicare and Medicaid Services (CMS) announced a proposal to discontinue coverage for Erythropoiesis Stimulating Agents (ESAs), a type of drug that plays a big role for some with colorectal cancer. See “Proposed Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications (CAG-00383N)”.

ESAs, better known under brand names, Procrit, Epogen and Aranesp, were approved by the Food and Drug Administration (FDA) to aid with chemotherapy-induced anemia.

C3 was concerned about several aspects of the proposed ruling and submitted comments to CMS on June 13, 2007. This past Monday, July 30th, CMS issued its final ruling on ESA coverage.

The concerns raised by C3 made a difference for the thousands of Americans who rely on Medicare for their colorectal cancer care. Every issue we raised in our comments impacted CMS’s final decision.

Continue reading…

Posted by Judi Sohn on August 1st, 2007
Posted in: Research & Treatment News | 2 Comments »

The Children’s Health and Medicare Protection Act Includes Colorectal Cancer Provision

Last week the House Energy and Commerce Committee attempted to Mark-up the Children’s Health and Medicare Protection Act of 2007 (CHAMP).

The CHAMP Act reauthorizes the existing Children’s Health Insurance Program. This program, created in 1997, has cut the low-income uninsured rate by one-third.

The CHAMP Act also affects the colorectal cancer community by clarifying a provision currently covered under Medicare Part A. This provision would waive the deductible for colorectal cancer screening tests regardless of coding, subsequent diagnosis, or ancillary tissue removal.

Because of inter-committee squabbles the Mark-up was adjourned and the bill was sent to the floor with no amendments attached to be voted on by the entire House this week.

President Bush has threatened to veto the legislation in its current form.

Posted by Joe Arite on July 30th, 2007
Posted in: Policy & Advocacy News | No Comments »

An Advocate’s Memories of Lisa Dubow

Editor’s Note: Rob Michelson is a 3-year survivor of stage IV Rectal Cancer. Rob writes of his memories of Ms. Dubow, a 9-year survivor of stage IV Colon Cancer, and a founder of C3, who passed away on July 24, 2007. Please visit the Lisa Dubow Colorectal Cancer Research Fund to make a contribution.

I remember the first time I came across Lisa Dubow’s name on C3’s website. The post outlined her diagnosis on Mother’s Day 1998, her use of the media to draw attention and awareness to Colorectal Cancer and the importance of colonoscopy. It went on to describe her participation in 2 clinical trials, her advice on being as informed a patient as possible, and her lobbying in Sacramento and DC.

My first thought is this must be superwoman. How is she doing this while still undergoing treatment? Will I be as brave and focused as she is?

I first heard Lisa’s voice on a conference call that C3 had organized for involved advocates such as myself. She described sitting in supermarkets to increase awareness and she went into great detail on how to get on local TV. Lisa mentioned her “modeling” work on the Colon Club colondar, where she was “Miss March 2007.” She said this was part of her calculated media campaign to draw attention to the “Lisa Fund.” She also said the motto of her campaign was “I am Still Here.” She had accomplished 8 years of advocacy work to that point, and she wanted people to know that she was still here. She needed help, funding, new treatments to remain here.

As a stage IV patient myself, I completely understood her need and desire to make a difference now – while “We are Still Here.” My cancer had metastasized to a rib, some vetebrae and to my liver, and I was having a difficult time understanding how breakthrough treatments were going to be developed. When I saw information about the “Lisa Fund,” it clicked right away what a meaningful Fund this is, and what a difference it will make.

I used my entire address book and sent an appeal out to everyone I knew to contribute to the Lisa Dubow research fund. This generated significant response from my friends and family.

Then I got an email from Lisa Dubow. She knew I was a New Yorker and she was planning a visit to New York to do some advocacy work, including speaking to the media. She wanted to know if it would be okay if “Miss March takes you out to dinner.” Who could say no to Miss March?

I met Lisa Dubow in person for the first time in December 2006, just before I went in for a rib resection. She knew I was concerned about my upcoming surgery, and she put me at ease right away with some stories of her own. We chatted for two hours. What a warm, knowledgeable, friendly, and determined woman she was. She was thinner than her photo in the Colondar and her face was thin, but she was in fantastic spirits. We drank wine, we ate, we laughed, and we shared our stories.

Lisa and I kept in touch by email and by phone. I saw Lisa again at the Call on Congress in March 2007. The first thing I thought was how thin she had gotten. The first thing she said to me was “My….how thin you have gotten.” I did not realize it until later, but she was right. I had dropped a significant amount of weight since my surgery, even though I was feeling okay. She did not look okay, yet she was worried about my weight. That is the kind of person Lisa was. That is how I will remember Lisa. Concerned for her own survival…but concerned more about those around her.

Lisa was special and she was inspiring. Goodbye Miss March…. how appropriate that your month on the Colondar is March – Colorectal Cancer Awareness Month. Your spirit “Is Still Here” and your fund will be a legacy to you. The Lisa Fund will perpetually help all of those with Colorectal Cancer.

To contribute to the legacy of Lisa Dubow, visit the Lisa Fund page.

Posted by Rob Michelson on July 27th, 2007
Posted in: Policy & Advocacy News | 3 Comments »

Congressman Boren (D-OK) Announces New Colorectal Cancer Legislation

C3: Colorectal Cancer Coalition is proud to support The Colorectal Cancer Screening and Detection Act of 2007 (HR 3060). Americans age 50-64 are a critical group when considering colorectal cancer. HR 3060 will provide the same protections to non-Medicare beneficiaries that are already provided to Medicare beneficiaries.

Congressman Boren lost his mother to colon cancer nine years ago, and personally understands the need for early detection of the disease.

“Cancer unfortunately has affected millions of lives across the United States,” Boren said. “Coverage is required for many other equally important preventative cancer screenings across the nation. With early detection leading to a 90 percent survival rate, a simple and proven procedure could save the lives of so many (of our) loved ones,” Boren said.

“Colorectal cancer patients have been neglected for too long,” said Carlea Bauman, Executive Director of C3: Colorectal Cancer Coalition. “By providing access to screenings for non-Medicare beneficiaries we will see progress against this terrible disease.”

Studies have shown the monthly cost per patient for full colorectal screening coverage is approximately $2.65, while the savings to the employer for medical and non-medical costs is almost $3.00. Once the patient has been diagnosed with the disease, the same monthly cost climbs to almost $5,000 per patient. Additionally, studies have also shown that doctors do not refer their patients for tests if those tests are not covered by insurance.

“Americans deserve these life saving medical benefits and should be able to count on these protections,” Boren said.

Currently, 22 states, including Texas and the District of Columbia, require coverage. Oklahoma does not currently require coverage of these cancer screenings.

Congressman Ralph Hall (R-TX) has join congressman Boren in his fight.

Posted by Joe Arite on July 24th, 2007
Posted in: Policy & Advocacy News | No Comments »