By Mary Brolley, MD Anderson Staff Writer
Talk to Cheryl Jolly for five minutes, and her sense of humor shines.
Despite a harrowing health crisis in the past four years, the Sugar Land, Texas, wife and mother of two young boys is quick to laugh about aspects of her extensive treatment for triple-negative metastatic breast cancer.
She recalls that her concerned husband Chad "passed out cold" in the doctor's office four years ago at the news she had cancer.
She jokes about the many types of treatment she's endured. "I rang the bell twice when I finished chemo and once when I finished radiation," she says. "I don't like the look of those bells any more."
And she makes light of the strain of keeping up with rambunctious sons Chase and Cole, now 7 and 4 years old, during nearly constant cancer treatments.
"If I didn't laugh at them, I'd kill them," she says wryly.
Out of the blue, a scary diagnosis
Jolly was 33 years old in the fall of 2006, with a toddler and an infant, when she thought she had developed a clogged milk duct. After weeks of pestering her physician and a local hospital, she got a mammogram, then an ultrasound, and was diagnosed with stage IIB ductal carcinoma.
Even more disturbing: Her tumor was characterized as "triple-negative" -- a subtype of breast cancer defined by what it lacks.
Accounting for 10% to 15% of the more than 192,000 cases of breast cancer diagnosed each year in the United States, triple-negative tumors are not driven by estrogen and progesterone hormones and do not express the HER2/neu protein.
Triple-negative characteristics limit treatment choices
About 20,000 to 25,000 American women are diagnosed annually with this aggressive subtype, which is more common in younger women and in those of African descent. Because several promising therapies for other types of breast cancer are ineffective due to the tumor's chemical characteristics, triple-negative status narrows a patient's treatment options.
Though the cancer is initially responsive to chemotherapy, relapse is often swift. For that reason, triple-negative breast cancer also accounts for far more than 10% to 15% of all deaths from breast cancer.
Jolly was treated with chemotherapy and radiation in 2006 and 2007, then was healthy for more than a year. But in January 2009, a bout of pneumonia revealed a tumor on her right lung. She had surgery to remove it, then received six more rounds of chemotherapy.
Still, nothing worked. Despite more chemotherapy, scans in the fall of 2009 revealed lesions on her liver.
PARP trial yields good news -- finally
Then, Jolly was accepted into a clinical trial at MD Anderson led by Jennifer Litton, M.D., assistant professor in the Department of Breast Medical Oncology. Limited to breast cancer patients with triple-negative metastatic disease, the Phase III trial involves the pairing of a poly (ADP-ribose) polymerase (PARP) inhibitor with targeted agents gemcitabine and carboplatin.
A protein, PARP is involved in a number of cellular processes involving DNA repair and programmed cell death. By preventing this repair, PARP inhibitors increase the effectiveness of other types of chemotherapy. (For more information, see link to the related story below.)
The treatment seems to be working for Jolly, who began the trial in February. Her scans have shown that the tumors are shrinking.
"It's been four years now with nothing but bad news. This was the first time we got good news. It's been life-changing," she says.
'What's driving us to live'
Her busy life now includes shuttling the boys to and from school and day care, taking care of the house and her family, and countless trips to and from MD Anderson for tests to make sure the treatment is safe and effective.
The boys are used to it, she says. "They understand that I spend a lot of time at MD Anderson. When a certain treatment might make me lose my hair, I say, 'Mommy's just sick, she's not going anywhere.'"
Jolly is a one-woman cheering section for her physicians, including Litton, as well as Ana Gonzalez-Angulo, M.D., associate professor in the Department of Breast Medical Oncology; Isadora Arzu, M.D., Ph.D., assistant professor in the Department of Radiation Oncology; and Stephen Swisher, M.D., professor and chair of the Department of Thoracic and Cardiovascular Surgery.
And don't get her started on her nurses, Silvia Hodge and Carol Stalzer.
"They're my advocates, my shoulders to cry on. I adore them."
Because of the intensity of the clinical trial and all she's been through in this "very emotional journey," Jolly feels a strong connection with her whole medical team, which she calls phenomenal.
"We talk. They know about my life, about Chad and Chase and Cole," she says, then pauses.
"We don't always want to talk about what's killing us, per se. We want to talk about what's driving us to live."
Q&A: New Treatment For Triple-Negative Breast Cancer
Early findings from Phase I and Phase II clinical trials using a new class of drug to treat patients with triple-negative breast cancer are showing promising results.
New treatments show promise for breast cancer patients
MD Anderson resources:
Genetic testing for breast cancer: Who should get tested?
Nellie B. Connolly Breast Cancer Center
September 2010 Archives
By Mary Brolley, MD Anderson Staff Writer
Early findings from Phase I and Phase II clinical trials using a new class of drug to treat patients with triple-negative breast cancer are showing promising results. Known as poly (ADP-ribose) polymerase, or PARP inhibitors, these new agents received considerable attention at the American Society of Clinical Oncology meeting in June.
Cheryl Jolly, in the related story, is now enrolled in a Phase III trial, and her tumor is shrinking.
Jennifer Litton, M.D., assistant professor in MD Anderson's Department of Breast Medical Oncology, answers questions about this new drug and why it is helping women with this aggressive type of breast cancer.
Exactly what is triple-negative breast cancer?
Triple-negative breast cancer is a subset of breast cancers that are not driven by estrogen or progesterone hormones. They also do not overexpress the HER-2/neu protein. Biologically, they are very aggressive and can grow more rapidly than other types of breast cancer.
Can someone be genetically at high risk for developing it?
Women who have been diagnosed with a BRCA1 deleterious (harmful) mutation as well as younger, premenopausal women and women of African-American descent, appear to have higher rates of developing triple-negative breast cancers, although triple-negative breast cancers can occur at any age and in any race. Women who are diagnosed premenopausally or have a family history of breast and/or ovarian cancers, especially at younger ages, should discuss with their oncologist whether or not they should meet with a genetic counselor.
What makes PARP a different type of treatment?
PARP inhibitors, such as olaparib and BSI-201, belong to a class of drugs that provide targeted therapy. They exploit a specific weakness in tumors stopping them from repairing damage in tumor DNA caused by chemotherapy. In addition, it also takes advantage of a further weakness, especially in tumors whose BRCA genes no longer work -- and causes that cell to die.
In a Phase II study of olaparib presented at the American Society of Clinical Oncology, women with BRCA1 or BRCA2 mutations and advanced breast cancer that persisted despite previous treatment, more than one-third of patients had tumor shrinkage.
BSI-201, in combination with conventional chemotherapy, significantly improved overall and progression-free survival in women with metastatic triple-negative breast cancer, compared with chemotherapy alone.
Why does it seem to work for women with triple-negative breast cancer?
This therapy appears to take advantage of weaknesses commonly seen within a triple-negative breast cancer cell. Also, paired with the right chemotherapy, its activity may not be limited to only triple-negative breast cancers.
What are the side effects of this treatment?
There are several PARP inhibitors currently in development. Some are pills while others are given intravenously. Although side effects differ from drug to drug, overall they are very well tolerated adding little extra toxicity to the accompanying chemotherapy.
What other cancers does it show promise for?
Right now PARP inhibitors are also being considered for other cancers such ovarian, uterine, brain and prostate cancers. As more clinical trial data become available, more tumors may be impacted by this class of drugs.
After Four Years of Bad News, Cautious Optimism for Breast Cancer
Despite a harrowing health crisis in the past four years, the Sugar Land, Texas, wife and mother of two young boys is quick to laugh about aspects of her extensive treatment for triple-negative metastatic breast cancer. Read Cheryl Jolly's Story
MD Anderson resources:
News Release - UT MD Anderson Study Finds Women with Both Triple Negative Breast Cancer and BRCA Mutations Have Lower Risk of Recurrence
Cancerwise blog posts by Jennifer Litton
More information on PARP inhibitors (NCI)
http://www.cancer.gov/drugdictionary/ enter "PARP" into the Search box
By Lana Maciel, MD Anderson Staff Writer
One body, one spirit, one mind. Reaching this peaceful balance is a state most people seek when practicing the ancient Indian philosophy of yoga. It's a disciplined spiritual practice that has recently played a more integral role in health care settings and through doctors' recommendations.
Originally perceived as a way to reach enlightenment, yoga integrates meditation, relaxation, physical postures and breathing techniques that many believe can improve one's fitness and health.
As a mind-body medicine practice, yoga has been known to reduce blood pressure, increase lung capacity, reduce stress and improve overall flexibility, physical fitness, mood and sense of well-being.
Such benefits are why some doctors are recommending yoga to their cancer patients during and after treatment. It is believed to help ease side effects of fatigue, depression and anxiety that often follow cancer diagnosis and treatment.
A closer look at yoga's benefits
In previous studies, cancer patients participating in yoga programs have reported reduced sleep disturbances, less fatigue and a better ability to engage in daily activities such as walk up a flight of stairs or carry a bag of groceries compared to those who did not do yoga.
Lorenzo Cohen, Ph.D., professor and director of MD Anderson's Integrative Medicine Program, recently received a $4.5 million grant from the National Cancer Institute to conduct a Phase III clinical trial studying the effects of yoga as part of breast cancer therapy.
"Research has shown that yoga and other types of mind-body practices, incorporated into the standard of care, can help improve patient outcomes, particularly quality of life," Cohen says. "However, none have become standard of care or are on the clinical care pathway for cancer patients. This clinical trial will allow us to definitively determine the benefit of incorporating yoga into a treatment plan for women with breast cancer undergoing radiation therapy."
Nearly 16 million Americans practice yoga today, a number that has increased dramatically in recent years. Its increased popularity and proven health benefits are a strong indication that yoga could soon play an integral role in cancer care.
MD Anderson resources:
Integrative Medicine Program
National Center for Complementary and Alternative Medicine
Office of Cancer Complementary and Alternative Medicine (National Cancer Institute)
Nearly five years ago, Dr. Walter Atkinson was diagnosed with prostate cancer. Here he shares his journey that led him to the MD Anderson Proton Therapy Center for treatment and describes his life after cancer.
By Dr. Walter Atkinson, Proton Therapy Center alumni
When my urologist told me that I had prostate cancer he insisted that I had to have surgery immediately. I astounded him by telling him that I did not have to have anything done. It was my cancer and I was going to be the one to decide what to do about it -- whether that included surgery or doing nothing. He didn't like that. He offered no other treatment options.
I began to read everything I could on the subject. I quickly found out about radiation seeds, IMRT radiation, and cryotherapy as options. As I read further, the choices looked grim since all carried side effect profiles that were less than enticing to consider. Impotence was one thing, but bowel or urinary incontinence issues alter your life in serious ways.
I continued to practice dentistry and enjoy life, knowing that it was not likely I would make it to 103 like Jiminy Cricket, but I was not going to wear a diaper. I was 57 years old and I was going out on my terms.
After a few months, I heard about proton therapy and its supposed low side effects. Why had none of the doctors I had consulted ever mentioned this before? It was certainly too good to be true.
I made an appointment for the following week and Dr. Lee informed me that I was, indeed, a candidate and fit the protocol for proton therapy. I was a Gleason 7, six of 12 biopsies positive with a PSA of about 5.7 and rising. I started hormone therapy since the center would not open for another six weeks.
I was in the earliest of groups of patients as soon as the center opened. Only one of the four gantries was operational and only one shift of treatment was ongoing. I and my buddies all learned together.
I was practicing dentistry in Baton Rouge, La., and flying my own airplane back and forth to Houston on a daily basis. Each day, I was seeing my own patients in Baton Rouge and having cancer treatment in Houston. It was a whirlwind. I never missed a treatment and I never missed a day of work. The proton therapy presented no ill effects that kept me from working. I joked with the proton therapy team that they should turn the machine on, since I wasn't feeling anything!
Time flew by in its own way. We each took our turn hitting the gong as we finished treatment.
Once my treatment was complete, life continued as it always had, except that I no longer had cancer and my family was no longer planning a funeral. I continued to partake in all of the activities I had always enjoyed. I had no side effects to report. I was not impotent, nor was I suffering any bowel or urinary side effects. Nothing.
I am now four years out of treatment and retired from dentistry. Jiminy Cricket never had it so good. I live in Colorado where I am a ski instructor in Vail and enjoy all of the physical activities anyone could ask for. I sailed an oceanic sailboat race this summer and hiked to the top of Mt. Elbert at 14,333 feet, the second highest mountain in North America. I have been building furniture, am restoring an old Jeep and ride my bike regularly. It's a good day to be alive.
Thank you, Dr. Lee, and all of the fine people at MD Anderson who made this possible. Now, if you guys will just do the workout I need to do each day to get ready for another ski season ...
One afternoon last February, Miguel Gonzalez, an executive assistant in the Communications Office, handed me a slip of paper containing Adelea Ibsen's name and phone number.
"She wants to tell her story," he said.
I called her the next morning, and though she was in the middle of something, the 32-year-old mother of two charmed me over the next 20 minutes with her honesty, wit, intelligence and laughter.
We arranged to meet the next time she was at MD Anderson for treatment.
We had a marvelous conversation a few days later. She was even lovelier in person. With sparkling blue eyes, short, stylish hair, wearing a simple but beautiful sundress, she had a smile that lit up the waiting room.
She obviously adored her husband Kent, whom I met briefly, and her young daughters Pia and Nella, back in Austin, Texas, with her mother.
She told me of her diagnosis with stage IV breast cancer in August of 2008. The family was living in Germany when Adelea, nursing Nella, noticed a change in her breast. Immediately after the shocking diagnosis, the family moved back to Texas so she could be treated at
To share her experiences as a young cancer patient, Adelea offered to contribute posts to Cancerwise. She became one of our first patient bloggers, and her honesty, humor and authenticity made her a favorite with readers. One of her posts concerned the fact that the clinical trial she'd been on had failed. With typical honesty and humanity, she recounted the anger and sorrow she felt after learning that yet another trial had been unable to stop the progression of her cancer.
She concluded with: "So we start again with a new trial. This time, we will attempt again the emotional tightrope of having immense hope but no expectations."
Though her health declined in the past two months, it never dampened her sense of humor or resilience. A Facebook post at the end of August mentioned that she'd been "hit on" in a drugstore by a guy "who digs bald chicks. "
"I've still got it," she added wryly.
The lovely and luminous Adelea died last Monday.
We are humbled by the generous impulse that spurred her to share aspects of her story with Cancerwise readers.
A colleague who also met her said this morning, "Who wants to die in fear? Adelea went with hope. To the last, she went with hope."
Contributions in memory of Adelea Ibsen may be made to her daughters' school, St. George's Episcopal School, 4301 IH-35, Austin, Texas, 78722.
Read posts by Adela Ibsen
Mondays are for Chemo Tuesdays are for Sleep
My Trial Failed
As a group of patients and siblings from the Children's Cancer Hospital arrived at MD Anderson's Camp A.O.K. in August, they had no idea of the surprise in store for them. Traditionally, the camp ends with a special prom night, but this year the Rachael Ray Show dropped in and surprised the teens with a "prom makeover."
Late Wednesday night as the campers settled into their cabins, a crew from the Rachael Ray Show, MD Anderson Children's Cancer Hospital and Deerfoot Youth Camp gathered to put their plan into action. Kicking into gear at midnight, they transformed the recreation hall into a boutique full of new dresses, tuxes, shoes and accessories donated by JC Penney.
The next morning, it was business as usual as the campers made their way to the dining hall for breakfast. After breakfast the surprise was unveiled via a video message from Rachael Ray herself. Ray sent one of her celebrity friends, Kyan Douglas, to start the makeovers.
Douglas assisted the campers as they chose their dress or tux as well as their accessories. The bonus was that these items were theirs to take home after camp. Seamstresses were on hand to make any alterations, and hair and makeup stylists from the Upper Hand Salon arrived in the afternoon to begin their work. The biggest surprise of the day came when the old school buses that normally transport the kids to prom pulled out and three stretch limos drove down the path to pick up the decked-out teens.
As they arrived at The Woodlands Resort and Conference Center, the campers were ushered into the banquet hall that had been decorated by the highly acclaimed Darryl & Co. The DJ kept the music going all night and Terry Foss captured the evening camera as the patients, siblings and staff hit the dance floor and made memories they would never forget.
"After a week of making friends and having fun, the teens always look forward to prom night at the end of camp," says Linda Blankenship, program manager for the Children's Cancer Hospital and camp director. "I think the extra surprises from Rachael Ray made this year's prom even more special."
Following camp, pediatric patient Emily Garcia was flown up to be on the show with Rachael Ray. The segment will air on Monday, Sept. 27 on Houston's KTBU, Ch. 55, at 6 p.m.
Camp A.O.K. is funded by the Children's Art Project and staffed by volunteers and MD Anderson employees. More than 50 campers between the ages of 13 to 18 attend the week-long camp at Deerfoot Youth Camp in Magnolia, Texas.
MD Anderson was well represented at the International Union for Cancer Control (UCCI) World Cancer Congress held Aug. 17-21 in Shenzhen, China. The Congress was attended by 3,222 participants from 92 countries. Dr. Xishan Hao, president of MD Anderson sister institution Tianjin Medical University Cancer Institute and Hospital, served as the leader of the congress. Several MD Anderson faculty including Wei Zhang, Ph.D., and Qingyi Wei, M.D., Ph.D., were among the speakers.
The conference included sessions focused on cancer prevention, cancer treatment, supportive and palliative care and tobacco control.
While many of the topics are ones that are addressed at every biannual congress, one of the newer themes highlighted this year was the impact of diet, nutrition and exercise on cancer risk. The goal of the UICC is to reduce the global cancer burden by bringing together advocates, policy-makers, physicians, scientists and donor communities. The event also featured 61 exhibitors focused on cancer control.
The UICC has written a World Cancer Declaration outlining 11 specific targets that will help improve cancer control and the related priority actions needed to achieve those targets by 2020.
After a long and successful career in broadcast journalism in
Houston, north Texas and Oklahoma, Judy Overton joined MD Anderson in
2008 as a senior communications specialist. Her husband, Tom, was treated
at MD Anderson for renal cancer. He died in April 2007. Judy's
occasional posts will cover aspects of the cancer experience from the
Read more posts in this series
Labor Day marked the sixth anniversary of Tom's diagnosis. Although his illness caught us off guard and reeled us from our comfortable spot in the universe, I can't recall that we ever asked, "Why us? Why Tom?"
There was plenty of time for questions as we waited for his surgery later that week.
The surgery to remove the mass and Tom's left kidney would be a challenge because of the size of the tumor, said urologist John Hairston, M.D., when he paid a last visit to Tom's room. Dr. Hairston also mentioned the possibility that extensive bleeding could occur, although he said he'd never experienced it during one of his surgeries.
Never say never, as the saying goes.
Around noon, Tom was taken to pre-op, where our son and I joined him until he would be moved to the operating room. To mask my tears, I kept my camera in front of my eyes to capture the moment. Tom and I were avid amateur photographers, and we'd chronicled every stage of our lives since we'd first met in the late 1970s. So taking photographs wasn't unusual for me -- nor were my tears. (I can attend the wedding or funeral of a complete stranger and still cry.)
Once Tom went into the operating room, several members of his family and a couple of our friends joined the vigil.
Time in the waiting room seemed to run in slow motion. Despite the void of information, my thoughts were focused solely on what was going on in the operating room.
By late afternoon, we learned the surgery had been successful. I made several calls to the recovery room to get more information, and was told the surgeon would be out to see us. When Dr. Hairston appeared, he looked weary as he told us there'd been a need to give Tom a transfusion. But Tom had made it through, he assured us, and was OK. Soon he would be sent to the ICU.
By early evening I was alone in the ICU waiting area while I called other family members and Tom's colleagues. Around 10 p.m., I learned that Tom was asking for me. I didn't know what to expect as I walked toward ICU. But I felt as though I were swathed in a warm, nurturing blanket held by an angel, because I was calm and in control as I approached his bed.
With a thick plastic breathing tube down his throat, he seemed agitated as he tried to communicate, instead expressing himself with his beautiful blue eyes. He grabbed the pad and pen someone had given him, and scribbled questions that were almost illegible.
I still have the paper for a keepsake.
"But what's happening? I also have an overactive gland in my mouth," (not realizing he had a breathing tube down his throat).
After a nurse made adjustments to the tube, he scribbled, "It feels much better, but hurts. When may I move it? Thirsty."
Later: "Explain why I'm here, and when do I go back to my room?"
I answered those questions and others the best I could.
But never once did he -- or we -- ask why this was happening to him.
Tom would only raise the question later in ICU in reference to the young woman lying in a coma in the bed next to him. The victim of a one-car accident on her 21st birthday, the only child of two grieving parents would eventually succumb to her injuries.
"Why did she die and I survived?" Tom asked.
Though many challenges lay ahead of us, I'm so grateful we had more time together.
I can't imagine what it's like to lose someone without having a chance to say goodbye. I hope I never do.
By: James D. Cox, M.D., MD Anderson Proton Therapy Center
The MD Anderson Proton Therapy Center recently celebrated a milestone. We treated our 2,000th patient -- and what a journey it has been.
When I started out in this discipline more than three decades ago, we gave radiation to incredibly large fields of the body because we couldn't determine the exact location of the tumor. Now, with the evolution of CTs, PET scans and other imaging techniques, we can pinpoint exactly where the tumor is and plan the depth of the radiation to the tumor, allowing us to offer patients higher doses with fewer side effects.
Developing a $130 million facility such as the Proton Therapy Center, however, was no small endeavor. Dr. (John) Mendelsohn listened to our arguments, endorsed the concept and convinced The University of Texas System Board of Regents to approve its development. A public-private partnership was formed to finance the endeavor. With Hitachi chosen as the manufacturer, ground was broken in 2003. Almost exactly three years later, the first patient was treated.
The technology has actually been around for more than 40 years, but mostly for the treatment of rare diseases. At MD Anderson, we are committed to expanding its use to any and all diseases where high doses are required to control tumors and X-ray treatments are limited because of the sensitivities of the surrounding normal tissues.
Whether at the Proton Therapy Center or any other department within MD Anderson, our goal is to always deliver patients the best, most advanced treatment in the most compassionate manner. The physicians who care for proton patients, their colleagues in other specialties, and even many patients have all developed a passion for proton therapy. They recognize the lack of side effects from the treatment and want to tell all who will listen about this relatively new and powerful therapy.
Moreover, we are just beginning to extend proton therapy to all patients who might benefit. MD Anderson is the only proton center in the country to offer an even more specialized form of proton therapy known as pencil beam scanning. Also called spot scanning, this technology makes it possible to paint a sub-millimeter beam of protons into the tumor and avoid normal tissues with even greater precision. When pencil beam scanning is fully developed, we hope to treat patients with cancer in the head and neck, pancreas, rectum and breast, as well as brain tumors in adults and sarcomas.
At MD Anderson we are rapidly developing and expanding our proton therapy practice. There is so much more to be done for our proton patients, and we are passionately committed to achieving the maximal, best use of this special resource for all patients who might benefit.
By: Ralph Freedman, M.D., Clinical Professor, Gynecologic Oncology
HOUSTON CHRONICLE Sept. 18, 2010
Suppose you are ill with a serious or chronic condition -- cancer, diabetes, psoriasis or any of a number of diseases -- and your doctor suggests you consider taking part in a "clinical trial" of a new therapy that may or may not prove better than the current standard of care. How do you decide if this is a good idea for you or not?
Especially in Houston, where so much groundbreaking biomedical research is under way, such a choice is not uncommon. At MD Anderson, for example, more than 11,000 patients opt to take part each year in clinical trials of potential new cancer therapies.
If the option of a clinical trial ever comes your way, there will be a lot to think about, so let's consider a few of the basics.
1. What is a clinical trial? A clinical trial is a research study with people. Trials involve the use of untested or partially tested new drugs, or novel combinations of previously tested drugs, or new pieces of medical equipment or diagnostic tests. Clinical trials are done in a carefully prescribed manner, with every step written down in a "protocol" that details what will be done in the trial and why.
2. When is a clinical trial called for? An orderly sequence of clinical trials determines whether a drug or device may eventually be used in routine medical practice. Phase I trials determine the initial safety, a preferred dose and schedule for a new drug; Phase II trials determine if the new drug works; and Phase III trials determine if the drug works better and is at least as safe as the current standard. Phase I trials involve small groups of patients; Phase III trials include many patients, often at several participating research centers.
3. What are some possible benefits to me in taking part? Many trials may offer clinical benefits that would not otherwise be available if the patient was receiving standard therapy that is not very effective. This is especially true in Phase III trials when a promising new treatment is compared to an older one. Even in early-phase clinical trials, patients may experience limited or temporary benefits while also contributing to knowledge that will help other patients in the future.
Read the full story in the editorial section of today's Houston Chronicle
4. What are some possible risks to me? Risks of harm are usually more predictable in a Phase III trial that compares a new treatment to the current standard of care treatment. In contrast, risks can be less predictable in a first-in-humans clinical trial (Phase I) of a drug that has only undergone animal testing. Toxicities can be affected by the dose level and by how the drug is metabolized, so Phase I participants may receive a dose that is either more toxic or less effective than ideal. Phase I studies also may require more time by participants because of increased safety monitoring and pharmacology studies.
5. How do I decide whether or not to take part? That decision begins with a face-to-face discussion with the physician researcher, who should explain the purpose and details of the trial clearly and answer questions directly. The nurse assigned to the clinical trial also can be very helpful with information and explanations. A confidante or family member can help by taking notes or recording the conversation for later review. Part of the decision-making process involves the review and signing of an informed consent document, which includes detailed information about the design and purpose of the trial, its potential benefits and risks, known frequencies and severities of side effects, the rights of participants, and much more. The informed consent document should be signed only when the participant feels comfortable with the facts and can make a voluntary decision.
Freedman is a professor of gynecologic oncology and clinical research authority at The University of Texas MD Anderson Cancer Center.
Patients taking a study drug in an MD Anderson Cancer Center clinical trial put on the pounds -- lots of them. Up to 50 pounds. And no one is complaining.
In fact, it's a welcome sign that their treatment for myelofibrosis -- a debilitating and lethal bone marrow disorder that causes anemia and malnutrition -- is working.
"This drug saved my life, basically," says Robert Lipnick of Alexandria, Va. He was wheelchair-bound when he arrived at MD Anderson in 2008 to start the clinical trial for INCB018424, a pill taken daily. His weight had fallen from 155 pounds to 125, chronic pain required daily narcotics, and he suffered from night sweats and pruritis, an unpleasant, consistent itch.
Today, the retired scientist can walk for miles along the beach boardwalk using only a cane and is completely off pain medication. No night sweats, no itching. His appetite is back and he's up to 170 pounds. "How good it is to go to a restaurant and actually eat what you order."
There are no approved therapies for myelofibrosis, says Srdan Verstovsek, M.D., Ph.D., associate professor, Leukemia, and principal investigator and lead author of a study out today in the New England Journal of Medicine. Average life expectancy for people with this disease is five to seven years. End-stage patients resemble the severely malnourished, with bloated abdomens and thin limbs.
Verstovsek is careful to note that the study drug, INCB018424, is not a cure, but it is the first drug to target an underlying cause of the disease. It deals with two of the three main symptoms:
- Greatly enlarged spleens, which cause severe malnutrition and weight loss
- Poor quality of life
The drug, developed by Incyte Corporation and co-marketed with Novartis Pharmaceuticals, shrinks the spleen and vastly improves quality of life, Verstovsek notes.
About those spleens. Myelofibrosis is caused by the build-up of malignant bone marrow cells that trigger an inflammatory response, scarring the bone marrow and limiting its ability to produce blood, leading to anemia. Renegade cells pile up in the spleen, which also attempts to make up for the anemia by producing bone marrow inside of itself and making new blood cells.
"The growing spleen causes significant problems for the patient, and not just because it's painful. It compresses the stomach and bowels, so patients suffer malnutrition and lose weight," Verstovsek says. "The ability to walk and to bend is affected, and the body deteriorates overall."
The study drug cut spleen size by more than 50% in about half of patients. Shrinkage for most occurred within the first two months and endured, with 75% of the 153 participants still on the study.
Virginia Murrell of Spring City, Tenn., felt "immediate relief," when her spleen noticeably shrank within two weeks of starting therapy.
She has retrieved 40 lost pounds, baby-sits her grandchildren, works a few days a week in her son's garden center business and is highly active again in her church. "I can do everything I want to do," she notes.
Phase III clinical trials of INCB018424 are wrapping up. If the early findings hold, myelofibrosis will have its first approved treatment in a year or two. Next, finding a drug that boosts blood cell counts to combine with INCB018424 will provide the key to control and perhaps cure of myelofibrosis.
Val Marshall's cancer journey began in May of 2009 when her son Addison was diagnosed with acute lymphocytic leukemia. A visit to the family doctor for what they thought was a simple high school football injury turned out to be so much more.
Inspired by her son's strength and hope, Val strives to be a voice to help connect other parents on this journey. Her series will share insight into her life as a mom of a typical teenager who just happens to be fighting leukemia.
Addison Marshall Crush Cancer
By: Val Marshall
Addison and I traveled east to the "Anderson Day Spa" for a three-day rest and relaxation trip with a chemo spritzer on the side. I was determined to put on a happy face that even Addie couldn't see through.
The night before, I woke up in a panic thinking of the 33 miners in Chile as they are holding on for dear life. I can't imagine being buried alive without light, water, food or space to move. My heart breaks for them and their families, and the hours must feel like decades to freedom. I told Addie that perception is truly reality as I bet each of those miners would love a minute to be in a hospital room with a large window, room service, icy air conditioning and turn-down service.
Funny, how I would have described a hospital stay before my perception change. I would have said, "We are going to jail and staying in a tiny, freezing room with hospital food." I was prepared for the teenage eye roll but Addie said, "I am lucky just to be in the hospital for only three days with food, water and a bed to sleep in. Oh, yeah, and a big TV in the teen room."
Our conversation set a great tone that continued until breakout on Wednesday night at 10:00 p.m. Addie told the nurses that if he wasn't released by Wednesday night he would be up with the residents in the early morning to "lean on someone," as he had to be at school by 8:00 a.m. Thursday morning. I guess he had an appointment he couldn't miss! All the nurses on the ninth floor moved heaven and earth to abide by his wishes, but still stressed that they are protecting his kidneys first and his schedule second. Dr. (Robert) Wells adjusted the orders slightly, as long as Addie assisted the fluid flush. Addie said, "Dr. Wells is the man."
Addie watched my CNN interview and exclaimed, "Cool, can you go get my school supplies at Walmart now?" Kids, the original buzz kill! That is one of the things I love about Addie. He is a straight shooter and doesn't care for much melodrama.
We attended the high school football game on Friday night and we were unprepared for the pain of watching Addison on the sidelines. I remember a time when I really enjoyed school football games but I have to be honest, now it just showcases rough times in our life. Now, when I see Addie meandering along the sidelines without a position, it pains my momma bear heart.
Funny, that thing called perception. When Addie arrived home after the game, he was down because of the loss and the painful injury of one of his teammates. Addie so understands how quickly your life can change in an instant. Here all three of us looked at Addie as a victim not able to play football, yet he was mourning the sadness of his friend's injury like he was every bit a part of Falcon football. Addie's perception was the warmth of friends on an almost cool fall Friday night. It was a treasure to be included whether he played on the gridiron or was on water boy duty!
Another sign of hope was found in getting the opportunity to meet with all of Addie's teachers last week. Once again, this team of compassionate professionals offered words of encouragement, books and reassurance that they will help Addie throughout his junior year. I I walked into one classroom pleased to see my older son Aussie's physics teacher; Addie was fortunate to land in her class this year. She has been so supportive to our family through the crisis du jour. After a full week teaching, she was at the game with a smile on her face and kindness in her eyes hawking pompoms and decals for the school. The commitment of these teachers never ebbs and we are so grateful for their unrelenting support for all of our kids.
I am trusting that God is supplying Addie with the strength of Atlas to weather this long monsoon called cancer. "The voyage of discovery is not in seeking new landscapes but in having new eyes." -- Marcel Proust
People often do not make a distinction between the terms integrative medicine and alternative medicine. Below is the mission statement of the Society for Integrative Oncology:
The Society for Integrative Oncology (SIO) is a non-profit, multi-disciplinary organization of professionals dedicated to studying and facilitating cancer treatment and the recovery process through the use of integrated complementary therapeutic options. Such options include natural and botanical products, nutrition, acupuncture, massage, mind-body therapies, and other complementary modalities. Our mission is to educate oncology professionals, patients, caregivers, and relevant others about the scientific validity, clinical benefits, toxicities, and limitations of state-of-the-art integrative therapies. SIO provides a forum for presentation, discussion, and peer review of evidence-based research in the discipline. We advocate for responsible public policy and the highest standards of practice in integrative medicine through appropriate training and the certification of health care professionals.
You will note that the word "alternative" is not contained in the mission statement because the SIO is not a proponent of alternative therapies in lieu of conventional evidenced-based medicine. This is also true of most academic organizations including MD Anderson, Memorial Sloan-Kettering Cancer Center, Dana-Farber Cancer Institute, University of California, San Francisco, and others.
Supporters of integrative medicine never advocate withholding proven interventions. As a matter of course, they embrace only the utilization of viable evidence-based treatments. We are wholly committed to quality research in the area of integrative cancer therapies.
While additional research is needed in the area of integrative oncology, there is nonetheless a sizeable and growing body of well-designed, high-quality science that clearly supports specific interventions as evidence-based (http://www.ncbi.nlm.nih.gov/pubmed/19706235). Locating well-conducted randomized trials of integrative therapies in oncology is not a difficult matter.
As funding for this area of research is relatively new and not supported by big pharma, many of the trials are small Phase II studies and lack appropriate control groups (often just usual care). As more positive Phase I and II trials are completed, we will start to see the larger, necessary, better-controlled Phase II and III trials to know the true benefits of some of these treatments.
One of the other challenges of research in this area is that with the exception of the natural product clinical trials, it is difficult to develop studies using the gold standard double-blind, placebo-controlled design. However, even using single-blind designs, it is possible to at least determine if the patients remained blinded to group assignment and assess patients' baseline treatment expectations. This can help to account for placebo effects.
It is uncommon to find scientists or practitioners who support evidence-based medicine unsupportive of well-designed clinical trials. However, this can sometimes still happen in designing, conducting and publishing integrative oncology clinical trials. Scientific observation should never be trumped by a personal belief. In fact, substituting one's own belief instead of supporting rigorous research and scientific observation is similar to what alternative medicine practitioners advocate -- deliver or withhold treatments without evidence to support that action.
If we simply followed people's predictions and beliefs then the field of medicine would not be where it is today, as many medical discoveries went against what was commonly believed and/or predicted. A good historical example of this is the story of Dr. Ignaz Semmelweis who documented that washing hands with chlorinated lime solution prior to delivering a baby dramatically decreased the rate of puerperal fever. The germ theory of disease had not been developed at the time and Dr. Semmelweis was largely ignored, rejected or ridiculed.
Another good example in oncology is the late Dr. Judah Folkman, who discovered angiogenesis and pioneered anti-angiogenic treatments. He also was initially dismissed and ridiculed by the medical community due to his ideas, which are now, of course, widely accepted.
As the majority of cancer patients use some form of complementary and even alternative medicine, it is the medical establishment's responsibility to provide proper medical advice in this area. Good research is what is needed to determine what is beneficial and what is not beneficial to provide practitioners and patients the information they need to make informed decisions about medical care.
The field of integrative oncology continues its ascent as medicine shifts toward a more personalized care model. Delivering many common and accepted modalities such as diet, exercise and stress management using a patient-centered, comprehensive approach is what distinguishes integrative medicine from reductionist and fragmented models of care. As more and more cancer survivors proactively participate in a patient-centered wellness approach, integrative oncology practitioners will continue to grow in numbers to meet this demand.
We invite all interested oncology professionals to join us for the 7th International Conference for the Society of Integrative Oncology at the New York Academy of Medicine, Nov. 11-13.
By: Katy Hewson, LCSW
The first question that naturally comes to mind when someone is diagnosed with cancer is, "Am I going to die?" How do we face this cancer and its quest to invade our bodies, wreck our minds, and ravage our souls?
Everyone has this weapon at their disposal. It's called hope. At the point of diagnosis, our thoughts are usually focused on hope for one thing: a cure. Hope, in some shape or form, is essential throughout the cancer journey. Sometimes it is the only thing that gets us out of bed in the morning. But what if your physician tells you there is no cure? Or informs you that you might have six months to live? How do you have hope then?
Hope is dynamic, ever-changing and evolving. Your hope may look different from day to day or even hour to hour. There is a continuum of hope that many cancer survivors walk through, sometimes unintentionally but usually it is deliberate. I find that those who have the most difficulty along their cancer journey are those who feel they have "lost hope." This is when depression and despair creeps in and hopelessness pervades. I believe that hope is never lost; it just needs to be re-framed at different times during the journey.
There are different forms of hope as a person's illness progresses and refocusing this hope will help survivors cope throughout the cancer journey.
Hope of a miracle cure or spontaneous disease remission
Hope of living longer than expected
Hope of controlling disease progression
Hope of making it to certain events
Hope of every day living
Hope in a person's worth as an individual and finding meaning in their own life
Hope in the healing of relationships and having special times with family and friends
Hope of good pain and symptom control
Hope of being well cared for and supported
Hope in finding spiritual meaning
Hope of a peaceful death
Examine where you or your loved one is on the battlefield of cancer. And then look at the weapon of hope you have been given and ask yourself today, "What am I hopeful for?"
For a lot of patients and their families exploring ways to find hope in the midst of a cancer diagnosis can be an overwhelming process. If you feel that talking with a licensed professional social worker could help you or your loved ones cope during this time, please contact the Department of Social Work at 713-792-6195 to find out what free support services are offered to patients and families at MD Anderson Cancer Center.
References: Clayton, Josephine; Butow, Phyllis; et. al, "Fostering Coping and Nurturing Hope When Discussing the Future with Terminally Ill Cancer Patients and Their Caregivers," American Cancer Society, March 2005
Turn on your television tonight between 7 and 8 p.m. and it will be hard to miss the second ambitious fundraiser for cancer research by Stand Up to Cancer.
The show, central to an entertainment industry initiative to fund research that moves new treatments to patients more quickly, will air simultaneously on ABC, CBS, FOX, NBC, Bio, Current TV, Discovery Health, E!, G4, HBO, HBO Latino, MLB Network, mun2, Showtime, Smithsonian Channel, The Style Network, TV One and VH1.
Network news anchors Katie Couric, Diane Sawyer and Brian Williams will be hosts for the program, which also will feature George Clooney, Gwyneth Paltrow, Will Smith, Denzel Washington, Renée Zellweger, Sir Richard Branson, Reese Witherspoon and many others.
Musical guests include Aaron Neville, Stevie Wonder, Billie Joe Armstrong of Green Day, Neil Diamond, The Edge, Delta Goodrem, Herbie Hancock, Natasha Bedingfield, Martina McBride, Dave Stewart, Kris Kristofferson, Lady Antebellum, Leona Lewis, Orianthi and Ann Wilson and Nancy Wilson of Heart.
Tonight's program also features updates from the five research Dream Teams funded by the initiative last year. SU2C awarded $73.6 million to form teams composed of the top researchers in a variety of areas, scientists who in the past were more likely to compete with than collaborate with each other.
"Stand Up to Cancer and its dedicated founders have brought new energy, new perspectives and a fresh approach to cancer research," says Raymond DuBois, M.D., Ph.D., provost and executive vice president at MD Anderson. "The Dream Teams were built to make rapid advances and they have made promising progress in their first year."
DuBois and Waun Ki Hong, M.D., head of MD Anderson's Division of Cancer Medicine, serve on the SU2C scientific advisory committee.
MD Anderson researchers play vital roles on three of the Dream Teams. Jean-Pierre Issa, M.D., professor, Leukemia; Roy Herbst, M.D., Ph.D., professor, Thoracic/Head and Neck Medical Oncology, and Gordon Mills, M.D., Ph.D., professor and chair, Systems Biology, each update their Dream Teams' progress in videos below.
Video interviews of MD Anderson researchers
Issa is on a team that studies how epigenetics -- biochemical regulation of genes rather than actual damage to or mutation of DNA -- can be applied to treat cancer.
Herbst's team evaluates the use of tumor cells circulating in the blood to direct personalized therapy to lung cancer patients through the second round of MD Anderson's innovative BATTLE research program.
Mills and colleagues are exploring ways to direct new drugs at a molecular pathway that fuels the growth of many types of cancers. Their first clinical trials targeting the PI3K pathway focus on breast, ovarian and endometrial cancers.
By: Alex De Alvarado, Lisa Gower and Lorenzo Cohen, Ph.D.
As cancer survivors know, there is much more involved in the cancer journey than just the treatment of the disease. Patients are searching for ways to be active participants in their recovery to ultimately improve their health and quality of life; this is the goal of an integrative approach to oncology care.
The Integrative Medicine Program at MD Anderson focuses on three main areas: education, research and patient care. The seeds for the program we have today began in the early 1990s when overflow crowds attended workshops involving meditation, music therapy and yoga at the annual Anderson Network Cancer Survivorship Conference.
In the beginning
In 1998 MD Anderson established Place ... of wellness, a center offering complementary therapies. In addition, caregivers, family members and anyone who has been touched by cancer can attend programs (most at no cost). At that time, Place ... of wellness was the first of its kind located on the campus of a comprehensive cancer center. Participant attendance for the first year was just under 2,000.
The education component of the Integrative Medicine Program was established by Stephen Tomasovic, Ph.D., senior vice president, Academic Affairs in 2001 to better educate faculty and staff on complementary and alternative therapies. The Complementary and Integrative Medicine Education Resources (CIMER) website was created to disseminate evidence-based information on complementary and alternative therapies to help patients and health care professionals decide how best to integrate such therapies into cancer care. A monthly lecture series also was established to have expert speakers from around the world present state-of-the-art research and clinical programs in the area of integrative medicine.
In fall 2002, a working group recommended to senior administration that MD Anderson develop a formalized integrative medicine program. The goal was to unify and expand the areas of clinical care, education and research being conducted in integrative medicine across the institution. Under the direction of Lorenzo Cohen, Ph.D., the program was formally established.
Fast forward to 2010
Since those early years, the Integrative Medicine Program has expanded to include two centers and provides acupuncture, massage and music therapy services, as well as a host of classes on everything from yoga and Tibetan meditation to art classes. Participants have grown to more than 10,000 last year alone.
In addition to these patient services, the Integrative Medicine Clinic, which began consultation services in 2007 (started by Moshe Frenkel, M.D.), is led by Richard T. Lee, M.D., medical director of the Integrative Medicine Program. Dr. Lee, along with a team of health care professionals, provides guidance to patients who wish to integrate complementary and integrative medicine into their conventional cancer care.
Ongoing clinical trials funded by the National Cancer Institute are being conducted in the area of mind-body medicine (meditation, Indian-based yoga, Tibetan yoga, Tai Chi/Qigong), preclinical and clinical trials of natural products, and acupuncture. In addition to the CIMER website and monthly lecture series, the educational component offers an array of courses and training opportunities including: introduction and overview to integrative medicine; rotations for medical students; training courses for massage therapists; and an internship training program for undergraduate and graduate students. Observers and visitors come from around the world to learn about what we are doing.
Integrative medicine is now firmly established at MD Anderson and it is now time to expand the clinical services, research and education across the cancer care continuum.
On Friday, Sept. 24, Dr. Cohen will be the keynote speaker at the annual Anderson Network Cancer Survivorship Conference presenting "Improving outcomes in cancer care: Integrative Oncology and the Power of Lifestyle Change." Conference participants also will have the opportunity to attend breakout sessions and workshops with Integrative Medicine practitioners. The conference is open to anyone wishing to learn more about all aspects of cancer survivorship, new treatments, complementary therapies and breakthrough research, and to connect with others who have been touched by cancer.
by Laura Nathan-Garner, MD Anderson Staff Writer
You've probably seen in recent news reports: Actor Michael Douglas is undergoing treatment for throat cancer. News of his diagnosis has led many people to seek information about throat cancer -- its symptoms, its causes and whether they're at risk.
Douglas, for the record, says he believes alcohol is most likely to blame for his cancer.
His story offers a good reminder for all men -- there's no time like the present to start making changes to improve your health.
Cancer, after all, is the second-leading cause of death among men in the United States, right behind heart disease. Luckily, by exercising, eating healthy, seeing a doctor regularly and getting routine cancer screenings, men can boost their odds of beating this disease. Men can find tips to help monitor their health and stay active in this month's issue of Focused on Health, MD Anderson's online healthy living newsletter.
Get our recommendations for some of the best group fitness classes for men, as well as helpful advice for encouraging doctor-wary men to get the lifesaving medical tests they need. You'll also learn how to use the PSA test to track trends over time and get answers from an MD Anderson expert on common prostate health questions.
For more tips on how to protect your body from diseases like prostate cancer, follow us on Twitter and join our conversations on Facebook.
After a long and successful career in broadcast journalism in
Houston, North Texas and Oklahoma, Judy Overton joined MD Anderson in
2008 as a senior communications specialist. Her husband, Tom, was treated
at MD Anderson for renal cancer. He died in April 2007. Judy's
occasional posts will cover aspects of the cancer experience from the
Read more posts in this series
Once Tom was admitted to Houston's Memorial Hermann Hospital, a urologist and a team of medical personnel examined him. The lead doctor said the surgery to remove the mass and his left kidney would take place on Friday.
"Why wait three days?" I asked. "We don't want to rush into it," is what I recall him saying, although I'm certain he seemed perturbed that I asked.
He also confirmed that the mass was estimated to weigh 7-9 pounds. No wonder Tom's waistline had expanded to the extent that he looked like a miniature version of Henry VIII, I reflected. Shamefully, I had thought it was his consumption of alcohol that caused this, though perhaps that was partly responsible for this predicament.
Were there other warning signs we had both ignored?
Tom spent most of the day slightly medicated while the large tumor sloshed about, ready to leap out of his body at the first opportunity. I was coiled up on a chair that pulled out as a daybed, having an all-day pity party.
I believe this is where my deep grieving began. I simply could not stop crying. The only time I maintained control of my emotions was when a nurse stopped by to check Tom's vitals or the doctor stopped by.
How could I have overlooked this? I remembered hugging Tom a few weeks earlier, and being startled that his stomach seemed extremely tight. But I shrugged it off, because he often consumed a few beers when he got home, and sometimes had a Scotch and water before calling it a night.
There were other red flags, if our eyes had been wide open.
On another occasion, we had grabbed hamburgers for a weekend meal. I've always had a ravenous appetite, and quickly downed my food. Tom was almost apologetic when he said, "I haven't been able to eat a whole hamburger lately." I was surprised to see he barely finished half of it.
Before you assume that Tom mirrored the statistics that indicate men don't have checkups as frequently as women, let me stop you there. He actually was better about visiting his doctor than I.
Because of Tom's weight, the doctor often sent him home with a prescribed diet.
But Tom was never grossly overweight. In fact, when we first met, he was almost too thin, weighing in at 164 pounds on his big-boned, 6-foot-1-inch frame. In recent years, Tom weighed around 215. Men tend to gain weight after a few years of marriage and good home cooking, right?
He was on medication for high blood pressure, which might've been a symptom of his current situation. But he thought it was hereditary, since both his parents were treated for high blood pressure.
One Saturday, after his latest doctor's appointment, I'd glanced over at him in his skivvies. Suddenly, he reminded me of Akhenaten, the pharaoh immortalized in a Houston Grand Opera production in 1983. Akhenaten had a slender body, with the exception of a protruding tummy.
I held my tongue. Too many times in the past I had suggested he lose weight. "Let him alone," I thought. "He's fine just the way he is."
The other ailment Tom was experiencing was throwing up every morning after breakfast. It was like clockwork. He'd eat, head out the door, and before stepping into his car, he'd regurgitate everything.
Why hadn't I been more inquisitive? Was I not caring enough?
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