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4, 1 VOLUME 3, ISSUE 4 Winning towards better care and a cure Moving the fight against colorectal cancer FALL SUMMER 2008
PHOTO: JON NALICK
Huge Step Toward ‘Personalized’ Treatment
KRAS Gene Mutation Clarifies Colorectal Cancer Drug Choice
By Mary M. Miller
How big is the recent discovery of a gene mutation that helps define which patients might — and which patients will not — benefit from two new cancer drugs? “BIG!” shouts Dr. Heinz-Josef Lenz enthusiastically. “It’s the first established molecular marker that will be used in daily practice for colorectal cancer.” In less than two years, a leap has been made from research laboratory to doctor’s office. That’s enormously exciting to Dr. Lenz, who works in both worlds as scientific director of the Cancer Genetics Programs, and co-director of the Gastrointestinal Oncology Program at University of Southern California’s Norris Cancer Center. (He is also a member of C3: Colorectal Cancer Coalition’s Medical Review Network). At first glance, the news might seem negative: Among people with metastatic colorectal cancer, approximately 35 to 40 percent have a mutated KRAS gene. What this means is that somewhere in the process of cancer development, the normal gene has mutated and now is changing the way signals are communicated inside the cancer cell.
Nurse Practitioner Taline Khoukaz and Dr. Lenz
Several large analyses of clinical trials have found that colorectal cancer patients whose tumors have a mutated KRAS gene do not benefit from Erbitux® (cetuximab) or Vectibix™ (panitumumab). Despite this news, there is a positive side for patients with mutated KRAS, notes Kate Murphy, C3 Director of Research Communication and 25-year colon cancer survivor. “They will be able to avoid side effects and expense of these medicines, and avoid wasting crucial weeks” in ineffective treatment by moving right to other drug treatments. continued on page 6
IN THIS ISSUE
FROM THE PRESIDENT’S DESK ................. 2 ADVOCACY Heartland Advocates .................. 3 Battle for Cancer Dollars Likely to Spill into New Year ................. 4 PATIENT INFORMATION C3 Answer Line: A Personal Voice on the Phone .............................. 5 LEGAL FRONT Discrimination Based on Genetics Will Soon be Illegal ..................... 7
1225 King Street, 2nd Floor, Alexandria, VA 22314 (703) 548-1225 • www.FightColorectalCancer.org
FROM THE PRESIDENT’S DESK
Board of Directors
Nancy Roach, Board Chair Alan Balch, PhD, Vice Chair Greg Crafts, Treasurer Robert Erwin, Board Secretary Carlea Bauman, President Steven Depp, Ph.D. Andrew Giusti, Ph.D. Medical Review Network
Mace Rothenberg, MD (Chair) Vanderbilt University Medical Center Nancy Baxter, MD, FRCSC University of Toronto Al B. Benson III, MD, FACP Northwestern University Richard Goldberg, MD University of North Carolina Axel Grothey, MD Mayo Clinic College of Medicine Heinz-Joseph Lenz, MD, FACP University of Southern California John Marshall, MD Georgetown University Medical Center Howard McLeod, PharmD University of North Carolina Neal Meropol, MD Fox Chase Cancer Center Edith Mitchell, MD Thomas Jefferson University Daniel Sargent, PhD Mayo Clinic College of Medicine Joel Tepper, MD University of North Carolina
On the Hill
Is It All in the Genes?
By Carlea Bauman President
save $10,000 (the average cost of a month’s therapy of Erbitux or Vectibix) per patient? Should patients with the mutated KRAS gene have the right to choose a drug that will almost certainly not help them, but will almost certainly have side effects, some of which may be severe? At C3, we have been speaking with the various companies and agencies that will have an impact on the answers to these questions. We are making sure that as decisions are made, the needs of colorectal cancer patients are front and center. In keeping with a discussion about genes, one thing we do know now is that patients’ genetic information (such as KRAS mutational status) can no longer be used against them in situations of employment and health insurance coverage (see page 7). For that, thanks are due to the incredible work of the Genetic Alliance, a patient advocacy group based in Washington, DC. Genetic Alliance has been working for more than 10 years to get legislation passed that would protect patients. Their hard work finally paid off this spring when the Genetic Information Nondiscrimination Act was signed into law.
Each summer, the American Society of Clinical Oncology holds an annual meeting that brings together thousands of oncologists from around the world. This year’s meeting was abuzz with news about how the KRAS gene could tell colorectal cancer patients a lot about how their tumors will respond to epidermal growth factor receptor (EGFR) inhibitors. In one way, the news was simple: patients with tumors that have a mutated KRAS gene do not respond to Erbitux® or Vectibix™ (see page 1). This has been demonstrated consistently across many trials. But in another way, the news was layered and complicated and raised many more questions: Where would patients get tested? Who should get tested? Were the tests reliable? Would insurance cover the cost of the test? If a patient’s tumor had the mutation, would insurance companies refuse to pay for Erbitux and Vectibix? And where does the Food and Drug Administration (FDA) weigh in on this? C3 has answers to some of those questions in the KRAS section of its website (www.FightColorectalCancer. org/KRAS). Some answers to these questions, however, will take time. FDA is evaluating the data, which raises other questions. How much and what kind of data is required? Is this an issue of treatment efficacy or patient safety? Ultimately, will FDA require KRAS testing before those drugs are given to patients? Will private insurers and Medicare act before FDA does in an effort to
MARK YOUR CALENDAR
CALENDAR Dusty’s Recipe for Action
Now accepting pin and bracelet orders for Colorectal Cancer Awareness Month 2009
Order online at www.FightColorectalCancer.org
Thinking Ahead to the Holidays
Holidays bring challenges and opportunities for everyone, but especially to those fighting cancer during the holiday months. For the December issue of Momentum, we’d love to include ideas from you on how to achieve the best holiday gift we can give to ourselves and our families: Comfort and joy. What traditions, foods and attitudes create comfort for you and your family during this time? What brings joy into your home? Share with us and other readers. Send comments by Oct. 6 to Holidays@FightColorectalCancer.org
Save the Date:
Call-on Congress 2009 March 22nd – 25th Register online at www.FightColorectalCancer.org beginning October 15, 2008
ADVOCACY LEGISLATIVE BEAT
Heartland Advocates Lead the Charge
By Carlene Canton
“You’re the boss of Congress. Act like it.” That is the rallying cry that turns ordinary people into extraordinary advocates. “We see it happen all the time,” says Carlea Bauman, C3’s President. “At first, patients and caregivers focus on their personal situations. Then they realize that they can help others while helping themselves. They find the passion and the strength to take the shock of a cancer diagnosis and turn it into something positive. They become advocates.” C3’s outgoing Grassroots Coordinator Dusty Weaver knows this firsthand. From his experience with rectal cancer in 2000, Dusty learned that fighting colorectal cancer is emotionally trying, physically exhausting and mentally challenging. But he also learned that when he crossed that finish line, he had the power within himself to take those experiences and use them to help others. His first step as an advocate was signing up for C3’s advocacy training. He kept on stepping all the way to Washington, DC where he met with congressional representatives and learned to speak up for the resources and research that colorectal cancer patients need. He didn’t stop there. He began recruiting, helping other newcomers to the world of advocacy find their voices and take their own first steps. Suzanne Lindley is one of Dusty’s mentees. Suzanne’s journey as an advocate began 10 years ago when she was a 31-year-old mother of two young girls. After Suzanne realized that she could advocate for herself inside the medical system, she began to reach out and help others. With C3 and Dusty’s support, Suzanne has blossomed from a shy and quiet bystander into a savvy advocate who gets calls from Congressional offices, testifies before Congress and has made 12 trips to DC from her home in Texas in 2008 alone.
Dusty Weaver and Suzanne Lindley are both advocates extraordinaire.
“We’re regular people. I live in Conway, Arkansas and Suzanne lives in Canton, Texas. Regular people get cancer and they fight it and then they choose to do something constructive with their experience.”
She has even been asked to provide feedback by Texas Senator Kay Bailey Hutchison on funding for the National Institutes of Health and on the Comprehensive Cancer Care Improvements Act (CCCIA), which is currently pending in Congress. Suzanne also discovered that she was more effective if she was willing to make some of her personal experiences public. Suzanne credits Dusty with inspiring her to join the advocacy world and share her experiences. “Early on he told me, ‘You have a story. Put it to good use,’’’ Suzanne said. “His face just lights up when he’s working. His passion for this is contagious.”
Dusty applauds the work of Joe Arite, C3’s Director of Policy for helping advocates find their voices. “Joe knows how things work and knows how people’s energy can be most effectively spent,” Dusty said. “We don’t need to re-invent the wheel. Joe shows us where to focus our work.” Dusty has served as C3’s volunteer Grassroots Coordinator since the organization formed in 2005. Momentum readers have enjoyed “Dusty’s Recipe for Action” in each newsletter. This fall, he will step down from the position and allow another advocate to take the lead – but that doesn’t mean his days of colorectal cancer advocacy are over. In fact, he will be speaking to colorectal cancer patients about advocacy this fall as part of a program C3 is doing with The Wellness Community (see box, page 7). “What people see in Suzanne and me is that we’re regular people,” Dusty said. “I live in Conway, Arkansas and Suzanne lives in Canton, Texas. We represent stories that are repeated over and over again. Regular people get cancer and they fight it and then they choose to do something constructive with their experience.” For Dusty and Suzanne, that’s the power of advocacy.
continued on page 7
C3 Momentum Fall 2008
Battle for Cancer Dollars Likely to Spill into New Year
By Joe Arite Director of Policy
Senate Appropriations Chairman Robert C. Byrd (D-WV). “This Committee will not look the other way. We will look forward.” Subcommittee Chairman Tom Harkin (D-IA) added, “The choices we made today will reap benefits for generations of Americans. We made investments in cancer research… The bill supports the National Institutes of Health with $30 billion for life-saving biomedical research.” Fiscal Year 2009 begins October 1, 2008, but appropriations work on Capitol Hill is not expected to be completed by then. Congress will probably pass a “continuing resolution” this fall that continues funding at current 2008 levels. A final vote on 2009 appropriations bills will most likely be delayed until a new administration and Congress are in place next January.
Kick Your Advocacy Up a Notch
C3’s Advocacy Toolbox, a new website resource, is a collection of ideas, advice and information designed to help advocates focus their energies and make the most of their time and efforts (www.FightColorectalCancer.org/toolbox). Joe Arite, C3’s Director of Policy, works closely with C3’s team of advocates. “It’s normal for people to be a little nervous about speaking up or taking action for the first time,” he said. But compared to what cancer survivors have already been through, “nervous shouldn’t even be in their vocabulary.” And when advocates credit Joe with giving them the strength to tell their stories for the greater good, he responds: “We just gave you a little information. The courage and the strength you already had.”
The battle over the federal budget for Fiscal Year 2009 is in full swing. With a new administration right around the corner, 2009 could be a good year to start funding cancer the way it needs to be funded. New legislation has been written that would begin to do just that. But chances are it will be put on hold until a new administration is in place. The improvements are sorely needed. The Bush Administration’s proposed 2009 budget freezes funding for the National Institutes of Health (NIH) at 2008 levels, which could result in 6,000 medical research scientists losing their funding. There is some hope. The House Appropriations Committee, led by Representative Dave Obey (D-WI), created a bill that would provide a $1.2 billion increase over last year’s total budget of $28.9 billion for the NIH. This increase is the largest in the last six years and will support more than 1,000 new research grants. The Senate Appropriations Committee is following suit. At the end of June, the Senate Committee approved a 2009 budget increase of $9.5 million above the President’s proposal for NIH, aimed at investing in some of our nation’s most important medical issues. “This legislation is an aggressive effort to place real dollars in programs that are vital to strengthening the foundation of this country,” said
The Online Advocacy Tool Box includes:
• A sample Letter to the Editor. Members of Congress pay attention to public opinion back in their home districts, so sending letters to your local paper is a way to express your opinion loudly. The Tool Box sample letter is just a guide. “We encourage people to personalize it with their own stories,” Joe says. • A website banner. This can be added to blogs, webpages, and e-newsletters to help spread the word and look professional. • Petitions. If you carry a petition with you during the course of the day you can ask friends, coworkers, and others you meet to sign it. It’s simple and direct. C3 will personally deliver all the signatures to Congressional leadership to illustrate nationwide support for colorectal cancer screening legislation. • C3 position papers. If you want more than the quick read, here’s your chance to dive deeper into C3’s positions on legislation that matters to people touched by colorectal cancer. For information on C3 trainings for advocates, please contact Joe Arite, C3’s Director of Policy, at Joe.Arite@FightColorectalCancer.org.
Senate adds low-income screening
In addition to the increased overall funding for NIH, the Senate Appropriations Committee bill provides more than $38 million specifically for colorectal cancer prevention efforts. Included in this amount is $25 million to establish a national surveillance campaign to screen low-income Americans. That’s huge. It’s the first time there has been a line-item request for lowincome colorectal cancer screening included in a budget request. C3 thanks both the House and Senate Committees for taking the steps needed to fight this terrible disease. The final bill still has to go through Congress and be signed by the President.
C3 Answer Line: A Personal Voice on the Phone
by Carlene Canton
“When my father was diagnosed with advanced colorectal cancer in 2000, we had many more questions than answers. While his doctors were great, sometimes we needed more information to help us make good decisions, and some of our questions were about non-medical matters. We didn’t really know where to turn.” Those are the words of Kim Ryan, C3’s Director of Patient Information Services. One thing every patient is sure to wind up with after a cancer diagnosis or a treatment plan is questions. Kim knows first-hand what it’s like to have questions. So many questions they make your head spin. So many questions you sometimes don’t even know where to begin to get answers. This is why she is in such an excellent position to help patients who call into the C3 Answer Line at 877-4CRC-111 (877-427-2111). C3’s new Answer Line has answers, and best of all, a real person ready to talk with you.
Kim Ryan, pictured with her pooch Mason, is here to help answer your questions about colorectal cancer.
takes calls while her yellow Labrador Retriever, Mason, sits at her feet. “Half of the benefit is that a real person picks up the phone and says hello to answer the call. When a patient or caregiver is drowning in questions, connecting with someone who is willing and eager to help is a significant lifeline.” Eventually Kim will have a team of associates answering questions with an array of data at their fingertips. Building that kind of structure takes time. For now, Kim is taking it one question at a time. C3’s Answer Line is not intended to be a substitute for medical care, Kim explains to callers. But helping people make sense of a diagnosis, understand a treatment plan or point them in the right direction to find financial resources can make their lives a lot easier at a very difficult time. The program is still in its infancy, but initial emails offering feedback frequently commented, “You have no idea how much you’ve helped my family,” Kim reports. “Our offer to
help and our follow-through obviously strikes a chord with them.” Kim will conduct follow-up calls and patient satisfaction surveys to improve the Answer Line’s effectiveness. Kim has spent 16 years in pharmaceutical sales, marketing, communication, and advocacy. The last six of those years have been working in the field of oncology. Sadly, her father died from his colorectal cancer in 2005. “I’ve lived it,” she said. “I have the science in my head and in my heart I know right where the callers are coming from and just how hard it really is. It’s rewarding to know that by working with C3, I can help in a very real way.” Give the Answer Line a Call If you’re looking for answers to questions about screening, diagnosis, treatment or access to care, call the C3 Answer Line at 877-427-2111. The Answer Line also provides referrals to organizations that can help with financial needs and insurance problems.
“…connecting with a real person willing and eager to help is a significant lifeline.”
The Answer Line picks up where C3’s website leaves off. If patients are looking for more information about their specific diagnosis, treatment, screening, or just about anything else relating to their experience with colorectal cancer, they can call the C3 Answer Line. The Answer Line also provides referrals to organizations that can help with financial needs and insurance problems. “The personal touch makes the difference,” says Kim, who often
C3 Momentum Fall 2008
continued from page 1
The other good news is that people with advanced cancer whose tumor cells don’t have the KRAS mutation may benefit more than previously thought from Erbitux or Vectibix. ‘The future is now’ It’s a first step toward matching colorectal cancer treatments to individuals. The new world of “personalized medicine” will mean that patients’ treatment is chosen according to molecular-level events, rather than just on where a tumor is located or how big it is. “Colorectal cancer treatments have been based on the classical staging system which defines stages by how deep a tumor has grown into the intestinal wall, if it’s in lymph nodes, or if it’s spread to other organs,” explains Dr. Lenz. “We rely on this staging system to discuss the benefit of chemotherapy—but it doesn’t tell me which chemotherapy to use. You can have two patients with the same tumor appearance and staging, but the tumors still may behave differently, leading to different outcomes. The identification of molecular markers that tell us more about the tumor’s behavior and drug sensitivity will be critical in the development of personalized chemotherapy.” “We’ve known for a long time that… colorectal cancer isn’t one disease,” says C3’s Kate Murphy. Drug treatments have increased from one in 1995 to six approved drugs now. “But too often the only way to know if a treatment would work for a patient was to give it to them and wait to see if it worked.” Weeks and months matter People with advanced cancer don’t want to waste time with ineffective treatment that often has tough side effects, according to Nurse Practitioner Taline Khoukaz, who
What is this KRAS mutation?
“We’re able to treat people with medicines more tailored specifically to get the right fit for their specific cancer.”
—Taline Khoukaz, Nurse Practitioner
The KRAS mutation happens very early in colon cancer: It is already found in an adenomatous polyp before it becomes cancerous. Mutation of KRAS is “almost like putting a foot on the gas pedal, with no way to take it off,” explains Dr. Heinz-Josef Lenz. The KRAS signaling is part of a complex pathway between a cell’s outside membrane and the nucleus directing cell growth. Erbitux and Vectibix block epidermal growth factor (EGF), a protein that stimulates cell growth. “Erbitux can block the EGF signal, but in people who have the KRAS mutation deeper inside the cancer cell, you still have your foot on the gas pedal,” Lenz explains.
works with Dr. Lenz. “Patients are focused on survival, reaching another milestone — a grandchild born, a child finishing kindergarten. We don’t want to waste a few weeks trying something that is not likely to work.” Although clinical studies of new cancer drugs often add only a few months of survival, those added months are as important to scientists as they are to patients, because they provide vital clues. Using new technology, researchers peer deep inside tumor cells to compare genetic mutations and enzyme levels, for example, in the patients who respond and don’t respond to a drug. That’s one way to learn more about the many different cell events involved with colorectal cancer—which will lead to clearer diagnosis, successfully targeted treatments, and ultimately prevention. Nurse practitioner Khoukaz notes that even for those having the KRAS mutation, this discovery is still a step forward. “We’re able to treat people with medicines more tailored specifically to get the right fit for their specific cancer,” she says Stay tuned: For the latest updates on KRAS, log onto www.FightColorectalCancer.org and enter “KRAS” in the search box.
Who should get tested?
You should discuss KRAS testing and treatment options with your doctor: • If you are currently being treated with Erbitux® (cetuximab) or Vectibix® (panitumumab) for metastatic colorectal cancer • Before beginning Erbitux or Vectibix alone or in combination with Avastin® (bevacizumab) • When you are first diagnosed with advanced colon or rectal cancer, in planning treatment strategy.
How is it done?
You won’t need a new biopsy. Your doctor will send a small sample from the tumor that was removed and preserved at your first surgery to a special laboratory. For a list of laboratories that test for KRAS, type “Where to get KRAS testing” in the search box at www.FightColorectalCancer.org.
Does insurance cover the test?
KRAS testing is new, but insurers are expected to cover the test for patients being considered for Erbitux or Vectibix treatment. Those who are underinsured or uninsured can call the C3 Answer Line at 877-427-2111 for information about financial assistance.
ON THE LEGAL FRONT
Discrimination Based on Genetics Will Soon be Illegal
by Mary Miller
It’s the new law of the land: Health insurers cannot deny coverage or raise premiums based on genetic information, and employers cannot make hiring, firing, or promotion decisions based on a person’s genes. The Genetic Information Nondiscrimination Act—better known as GINA— helps remove the fear of reprisal or discrimination based on genetic information that increasingly helps diagnose, treat, and even prevent diseases based on an individual’s genetic makeup or family history. Personalized medicine based on genetics has quickly become a civilrights issue, says Sharon Terry, president of the Genetic Alliance. “Just like gender or race, our genes are something we can’t control,” she explains. “Since all of us are predisposed to at least a few genetic-based disorders, we are all potential victims of genetic discrimination,” says Congresswoman Louise Slaughter (D-NY), who championed the entire 13-year struggle to get the law passed. The law takes effect for health insurers next May and for employers in November 2009. Throughout the 1970s, African Americans were denied jobs, education or health insurance if they were sickle cell anemia carriers—even though they did not have the disease, reports Slaughter. Genetic Alliance’s president Terry recalls the woman who went to get a BRAC test for the breast cancer gene: “This woman didn’t even get test results. She came back after getting the test on her lunch hour, and her employer said, ‘We’ve got to let you go.’”
What GINA says:
• Health insurers cannot make decisions on eligibility, coverage, or premium costs based on genetic information alone (tests or family history). The law applies to all insurers providing group, Medigap or individual coverage and employers’ selfinsured plans. • Employers cannot base hiring, firing, promotion, or job requirements on genetic information. GINA applies to employers of all sized companies, employment agencies, and labor organizations. • “Genetic information” includes results of genetic tests of a person or family member, or family history of a medical condition.
Sharon Terry, President, Genetic Alliance
Dr. Francis Collins, head of the National Institute of Health’s (NIH) National Human Genome Research Institute, told the New England Journal of Medicine that it’s common for people getting genetic tests to give a false name, or ask their doctor to omit both the test order and the results in their medical record. It’s also been difficult, he added, to recruit patients for clinical trials involving gene testing. “Colorectal cancer is a poster child for this law,” Terry notes, because paying attention to genetic and family history can mean early diagnosis and saved lives. From 20 to 30 percent of people with colon cancer have a family history of the disease. Of those, about 5 percent have hereditary non-polyposis colon cancer (HNPCC), now known as Lynch syndrome. “Since certain types of inherited colon cancers…appear at a much younger age and develop much more quickly, putting off testing can mean that cancer isn’t discovered until late and dangerous stages,” explains Kate Murphy, a C3 staff member who has Lynch syndrome herself. “Fear of not being able to get health insurance has kept many people from pursuing genetic testing that could save their lives.”
GINA does not apply to:
• Life, disability, or long-term-care insurance • Members of the military • Existing health conditions or preexisting disease. If a colonoscopy finds adenomatous polyps, GINA rules would not apply to subsequent insurer or employer decisions.
continued from page 3
Join Dusty at The Wellness Community’s “Frankly Speaking About Colorectal Cancer” workshops in the following cities this fall. For more information, call 888-793-WELL. Phoenix, AZ October 19, 2008 San Francisco, CA November 18, 2008 Cincinnati, OH Date TBD
C3 Momentum Fall 2008
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Information for Patients and Caregivers
http://FightColorectalCancer.org/awareness/patients Learn all you can about colorectal cancer diagnoses and treatments, how to manage side effects, and how to cope with life with CRC. Discover resources for support and strength on the internet and in your community
Win the Fight Against Colorectal Cancer by Changing the Political Landscape
Visit Advocacy.FightCRC.org to learn about C3’s activities on Capitol Hill, including our efforts to increase funding for cancer research and to pass colorectal cancer screening legislation. Download C3’s position papers on issues that impact colorectal cancer patients.
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