Legislative Watch
Insurance for Clinical Trial Care a State-by-State Battle

Steffanie Collings’ best chance for surviving a brain cancer recurrence in 2006 was a clinical trial offering a stem cell transplant. Her parents faced a common dilemma: The trial covered the cost of the transplant, but their insurance company denied subsequent coverage of routine care, deeming it part of experimental treatment.

Steffanie, 18, got the transplant, but her parents are left with health care bills totaling nearly half a million dollars. Now, Oklahoma legislators and advocates are pushing for passage of a state bill, called Steffanie’s Law, which would require insurance carriers to provide coverage of routine costs associated with clinical trial participation.

Although treatment and lab work during a clinical trial are covered by the trial sponsor, the cost of subsequent routine care may be left to the patient. Nearly half the country has state laws requiring insurance carriers to cover routine care to patients in clinical trials, and Medicare patients have been covered since 2001.

Advocate Nancy Thomason, founder and president of the Oklahoma Brain Tumor Foundation, unsuccessfully pushed for a similar bill in 2001 after her son was denied coverage to participate in a clinical trial.

“It really limits the access to these clinical trials and these new agents coming out,” Thomason says. “Patients are concerned about leaving their family in debt, and most of the time, they just won’t do it.”

Steffanie’s Law will go before the full Oklahoma Senate for a vote in March. “I think we have a pretty good chance of getting it passed,” says Thomason.

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The Place to Be
We Can Weekend

The American Cancer Society’s We Can Weekend gives families the tools to cope with cancer by attending workshops that cover communication, intimacy, nutrition, and fatigue. The weekend will be held at Mount Holyoke College in South Hadley, Massachusetts, on June 6-8, 2008, and at River College in Nashua, New Hampshire, on August 1-3, 2008. The cost per family is $35 and scholarships are available. Find details at www.cancer.org or call 800-227-2345.

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People Report
Seventies Musicians Linked by Cancer

	Dan Fogelberg emphasized prostate cancer screening to fans prior to his death in December. Photo Courtesy of Henry Diltz/Mailboat Records

Folk singer Dan Fogelberg died of advanced prostate cancer on December 16 at age 56. Fogelberg’s “Leader of the Band” and “Same Old Lang Syne” helped define the soft-rock era of the 1970s and ’80s. Diagnosed in 2004, Fogelberg subsequently encouraged fans to be aware of prostate cancer and urged men over 50 to get screened. After Fogelberg’s death, his wife, Jean, released his “Sometimes A Song” and arranged for the proceeds to benefit the Prostate Cancer Foundation. Three years ago, Fogelberg had sent Jean the song and a dozen roses as a surprise on Valentine’s Day. It became a top download this past Valentine’s on numerous music sites.

During a Larry King Live interview following Fogelberg’s death, Graham Nash, of the folk-rock band Crosby, Stills, Nash, and Young, disclosed that bandmate Stephen Stills had been recently diagnosed with early-stage prostate cancer. Stills, 63, underwent surgery on January 3. According to his wife, Stills’ surgery was successful, and the two-time Rock and Roll Hall of Famer is still on schedule to promote his recent Just Roll Tape album in a solo tour this spring.

Country artist Garth Brooks joined forces with Susan G. Komen for the Cure by releasing a special three-disc Pink Edition of his Ultimate Hits album that includes information about breast cancer. Sold exclusively through Komen’s online Promise Shop, for every $15 Pink Edition sold, $10 goes to Komen.

Roy Scheider, who played the small-town police chief in the Jaws blockbusters, died of complications from multiple myeloma on February 10 at age 75. Scheider earned Oscar nominations for The French Connection and All That Jazz.

Pioneer cancer researcher Judah Folkman, MD, died of an apparent heart attack on January 14 at age 74. Director of the vascular biology program at Children’s Hospital Boston, Dr. Folkman established the field of anti-angiogenesis, a theory that tumor growth could be slowed or even reversed by cutting off the blood supply to tumors. Dr. Folkman’s work led to the development, testing, and ultimate approval of such effective cancer drugs as Avastin (bevacizumab) and Nexavar (sorafenib).

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Prevention [web exclusive]
Breast Cancer Risk May be Overstated in BRCA Carriers

The risk for breast cancer may not be as high as previously thought for women who carry a BRCA mutation. Many studies report the risk to be as high as 80 percent, but new research published in January in the Journal of the American Medical Association suggests the risk may be exaggerated for some carriers.

The study showed the risk of developing breast cancer by age 70 ranges from 36 percent to 52 percent, depending on the age a first-degree relative was diagnosed with breast cancer, and these "average" risks are likely to be further influenced by additional genetic factors. Women with first-degree relatives who developed breast cancer before age 35 were at a higher risk, noted researchers.

Colin Begg, PhD, chairman of epidemiology and biostatistics at Memorial Sloan-Kettering Cancer Center in New York and coauthor of the study, says the research supports evidence that risk varies from family to family and carrier to carrier.

“It’s certainly probable that if you happen to be in a family that has a strong family history of breast cancer, then your risk is probably in the high end,” he says. “But on the opposite extreme, if you are screened and are found to be a carrier with no family history, you [may be] at the low spectrum of risk.”

Whether this initial study affects prevention strategies in BRCA carriers, such as surgical removal of the breasts or ovaries to prevent cancer, remains to be seen. “The decision to take preventive measures, such as prophylactic mastectomy, is a personal decision that a woman makes when she finds she is a carrier,” Begg says. “But it’s really important that when they are making these decisions, women carriers are apprised of accurate estimates of risk, because that’s really quite crucial.”

Researchers say the variation in breast cancer risk among BRCA-carrying families may depend on additional cancer-causing mutations and, probably to a lesser degree, variations in each BRCA mutation. Lifestyle, environmental, and individual factors, such as age of first childbirth, may also affect risk. Studies are looking at so-called modifier genes and other factors that may more precisely estimate risk of cancer.

“It’s a mistake to feel that everyone has this high 80 percent risk,” Begg says. “That’s the number they see, and it may not be applicable to all carriers.”

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House Call [web exclusive]
Q&A: Predicting Breast Cancer Recurrence

Q: How do I know if I need additional therapy after breast cancer surgery?

A major advance in the treatment of cancer has been the use of what’s called “adjuvant” therapy to prevent recurrence after primary treatment with surgery and radiation therapy.

Until recently, we didn’t have tools that helped us predict which breast cancer patients really needed the additional treatment. If we did have such tests, we could avoid the risks, costs, and inconvenience of adjuvant hormonal therapy and chemotherapy in many women diagnosed with breast cancer.

In this new genomic era, we are able to look at the genes in breast cancer tissue and predict which women are at higher risk of recurrence. Two tests, which use these new technologies, have recently become available.

Mammaprint is a test that analyzes 70 genes from surgically removed breast cancer tissue to help predict recurrence. It is available for women with stage 1 or 2 invasive breast cancer with no lymph node involvement. Another test, OncotypeDX, analyzes 21 genes, but only for estrogen receptor-positive breast cancers that will be treated with hormonal therapy. Recent studies have shown both tests can also predict recurrence risk of cancer that has spread to nearby lymph nodes, but the standard use of these tests is still for node-negative cases.

Although the tests represent exciting breakthroughs and provide valuable information, they are still not perfect. Some doctors routinely run these tests to provide recurrence risk details to patients, who may then base treatment decisions regarding adjuvant chemotherapy on the results. But other doctors don’t believe the tests are sufficiently accurate to make those decisions.

Currently, clinical trials are under way with both tests to answer the question of how effective they are as a guide for whether or not a woman needs adjuvant therapy for breast cancer. The trials will take several years to complete, so until then, patients and doctors must decide for themselves if either test is appropriate, and how much it should influence their treatment decision.

In the not-too-distant future, more accurate tests will allow doctors to more precisely target which breast cancer patients really need adjuvant treatment and which drugs are best to use.

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Childhood Cancer [web exclusive]
Exploring the Origin of Childhood Leukemia

By examining the cells of identical twin sisters—one with childhood leukemia and the other without—scientists are trying to pinpoint how certain cells develop into leukemia, which may ultimately lead to better, more targeted therapies against the disease, according to research in a January issue of Science.

It’s known that the fusion of two genes, TEL and AML1, found in about 20 to 25 percent of childhood acute lymphoblastic leukemia (ALL) cases, is a very early—if not first—step in cancer development. While the fusion protein has been found at birth in children who later develop ALL, which suggests the alteration occurs in utero, it usually takes a series of other genetic mutations to jumpstart cancer, which explains why one identical twin develops leukemia and the other does not.

The new research involved examination of cells in the blood of identical twins Olivia, who was diagnosed at age 2 with ALL that contains the TEL-AML1 mutation, and Isabella, who is healthy. Although Isabella does not have cancer, scientists found a small number of pre-leukemia stem cells, some of which carried the TEL-AML1 mutation. After 18 months of observation, Isabella never developed ALL, leading researchers to hypothesize that her sister acquired additional mutations that led to her cancer.

Various studies have been conducted with ALL in twins, but this marks the first time researchers have been able to pinpoint when pre-leukemia stem cells develop into full-blown leukemia stem cells—resilient cancer cells that may linger after therapy. The authors of the Science paper hope their research leads to better drugs that specifically target pre-leukemia and leukemia stem cells.           

The overall risk of leukemia for siblings of childhood leukemia patients is very low at two to four times the risk of the normal population. However, the risk is much higher for identical twins—if one twin develops leukemia, the other twin has about a 20 percent risk of developing leukemia. The risk is higher if the cancer develops in the first year of life.

Acute lymphoblastic leukemia, the most common type of childhood leukemia, is diagnosed in about 2,500 children annually in the United States, usually striking between the ages of 2 and 4. Due to treatment advances, the five-year survival rate has steadily increased to above 80 percent.

—Elizabeth Whittington

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Destination [web exclusive]
Journeys Through Cancer: Art of Healing & Hope

The Cancer Institute at St. Joseph Medical Center in Towson, Maryland, will display a compilation of art pieces created by those affected by cancer in an exhibit called “Journeys Through Cancer: Art of Healing & Hope.” The art exhibit is a collaboration between the Institute and the American Cancer Society, and will be open to the public April 3 to May 11.

Christine Langr, creative services consultant for St. Joseph Medical Center, says the Institute plans to purchase artwork for viewing in public areas. “We believe in the healing power of art,” she says, particularly if it is created by patients and caregivers who have experienced cancer firsthand.

“The act of creating artwork about their experience got them through a very difficult time in their lives,” Langr says. “Their artwork became an integral element in their lives, and started them on another journey that they never could have imagined taking.”

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On the Web
www.cancer.gov/bcrisktool

The National Cancer Institute’s Breast Cancer Risk Assessment Tool received an upgrade in early February to better predict risk in African-American women. The tool previously calculated risk based on research in white women.

Although studies show African-American women have a lower incidence of breast cancer, their risk of dying from the disease is actually higher. Incidence for Latino and Asian-American women is similar to whites, while American Indian women have a lower incidence rate.

The NCI constructed the original online model, made available in the late 1990s, for white women, ages 20 to 89. The institute based the new model on information from the Women’s Contraceptive Reproductive Experiences, or CARE, study and confirmed it with data from the Women’s Health Initiative, or WHI, and the Study of Tamoxifen and Raloxifene, known as the STAR trial. Based on the CARE model, about 30 percent of African-American women have a significant five-year risk of invasive breast cancer, compared with 14.5 percent based on the older models.

“We think the predictions are better for all African-American women,” says Mitchell Gail, MD, PhD, a senior investigator with the NCI’s department of epidemiology and genetics who developed the original and refined model.

Other factors that may affect risk, such as previous radiation therapy to the chest, are not included in the calculation. The new model only changes the assessment of African-American women, but the NCI has plans to expand the model as data for specific ethnic groups become available from screening trials. “We are actively exploring data for Asian women now,” says Dr. Gail.

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Bookshelf [web exclusive]
Cancer on $5 a Day (*chemo not included): How Humor Got Me Through the Toughest Journey of My Life

By Robert Schimmel
Da Capo Press, 2008

I hadn’t heard of comedian Robert Schimmel when I received his book for review, but I hope most of you will know his name soon, because if you like to laugh, this is the book to read. Well, let me amend that statement: If you like to laugh at cancer and you don’t mind what my mother would have called “potty mouth” and references to genitalia and sex acts, then this is the book to read.

Cancer humor is hard to pull off, but when someone can do it, it’s wonderful. Because if you’re laughing, it’s a few seconds when whatever the real world is throwing at you has to take a back seat. Schimmel turned a first chemo session into a hilarious introduction to the cranky guy in the chair next to him, and had me loving both of them in an instant.

Schimmel is funny in a wonderfully irreverent way about something anyone can identify with—a complete loss of control. Indeed, Schimmel was finally on a straight shot to fame and fortune in 2000 when he got the news that he had stage 3 non-Hodgkin’s lymphoma at age 50. But instead of getting grumpy, Schimmel turned to his life’s elixir—humor. He decided it was his job to make everyone around him laugh, which, when you think about it, means an audience of oncology types and other people with cancer who are grumpy.

I liked Schimmel’s book because it made me laugh out loud, but after I read the book’s introduction, I also found myself liking the man. Professional comedians find humor in life and work it as a profession. After Schimmel finished treatment and returned to the stage, he didn’t leave behind his experience—he took it with him, drawing cancer survivors and caregivers to his shows. I honor anyone who will stand in front of a Las Vegas audience and talk about going through cancer. Schimmel is advancing cancer education as well as finding ways to make a horrific experience something to laugh about.

An excerpt of Cancer on $5 a Day will be featured in the Summer issue of Heal’s Laughing Out Loud.

—Kathy LaTour

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The Advocate
Lu Sipos—Friend in Need: Chemo Duck

	Lu Sipos created Chemo Duck as a learning tool for her son, Gabe (above), during his treatment.

When Lu Sipos’ 1-year-old son, Gabe, was diagnosed with rhabdomyosarcoma in 2002, he didn’t understand the diagnosis or his treatment, which is why Sipos transformed a stuffed animal into Chemo Duck, complete with scrubs, a bandana, and chemotherapy port. The toy became not only a source of comfort for Gabe, but also a learning tool.

“It was just so difficult with one so little to try to get him to understand what his treatment was about,” Sipos says. “I thought it would be a great way to help him.” Other parents at Monroe Carell Jr. Children’s Hospital at Vanderbilt—where Gabe was being treated—began asking her to make their children a Chemo Duck.

“At first, I didn’t realize how powerful it was when I made it. After we received so many requests from other parents for a duck, we started to make them at home and give them to friends. And then it reached a point when the project was much bigger than we had originally anticipated.”

Sipos created a nonprofit organization, Gabe’s My Heart, and talked with administrators and staff at Children’s Hospital to develop a program to offer the toy to children undergoing cancer treatment. And while the duck was created for young children, Sipos says they’ve received requests from adult cancer patients, either because the duck brings them joy or to educate their children about treatment.

The toy comes with either a central line or a port, and an arm immobilizer to teach the child not to pull the line or bandage and to keep the arm straight if there’s a peripheral I.V. An educational book and DVD are also included.

The new goal of Gabe’s My Heart, Sipos says, is to launch the program nationwide. And Chemo Duck has now become a three-pronged educational tool, which not only teaches the child and parents, but also educates the public on childhood cancer issues.

“We want to throw some light on [children’s] stories and let people know that there are so many children living with the after-effects of cancer,” she says. “We want to make sure the public knows that these children will spend the rest of their lives dealing with late effects.

“It’s never over … . We just want to let everyone know how brave these kids really are.”

For more on Chemo Duck, go to www.gabesmyheart.com.

Do you know a patient, survivor, or caregiver we should highlight in The Advocate? If so, e-mail your nomination to editor@curetoday.com.

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