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Investigational Pharmacy Services for cancer patients

By Jacqueline Mason

Our doctors are dreamers. They dream of conquering cancer and adding meaningful years to our patients' lives. Our Investigational Pharmacy Services team helps them turn those dreams into reality.

This highly specialized team of eight pharmacists and 11 pharmacy technicians enables MD Anderson to have the largest clinical trials program in the world.

Every investigational drug that enters our institution travels through the Investigational Pharmacy Services area on Floor 1 of the Main Building. We have 1,100 clinical research protocols underway, involving more than 8,000 patients. That translates to 35,000 investigational doses a year, or one dose every 15 minutes.

By centralizing the way we administer investigational drug trials, the team enables breakthroughs in cancer care for doctors and researchers like Hagop Kantarjian, M.D.

Thyroid_Lockey_249.jpgBy Lori Baker

Hugh Lokey travels 497 miles each time he comes to MD Anderson for thyroid cancer treatment. Then it's 497 miles back home to Broken Arrow, Okla. He's been making the trip for five years, sometimes twice a month.

"It's been tremendously worth it," says Hugh, a 70-year-old Marine Corps veteran who's benefited from, and perhaps even survived because of, lenvatinib. This new thyroid cancer drug was tested here and approved by the Food and Drug Administration (FDA) in February.

Like Hugh, the drug had a long journey, and each step was taken at MD Anderson.

New hope after decades with one treatment
Until recently, patients with radioiodine-refractory thyroid cancer had only one treatment option. And it didn't work for more than half.

Their fates took a turn for the better in 2006.
"In 2006, we began testing a drug called E7080 and found that several tumor types responded," says David Hong, M.D., in Investigational Cancer Therapeutics. "The response was particularly remarkable in thyroid cancer patients."

Patient64.jpgJames (Jim) Boysen first met Jesse C. Selber, M.D., four years ago. The Austin-based software developer had come to MD Anderson for reconstructive surgery after successful treatment for leiomyosarcoma, a rare cancer of the smooth muscle, on his scalp had left him with a large, deep wound on his head.

But Jim, now age 55, didn't just need reconstructive surgery on his scalp and skull. He also needed another kidney and pancreas transplant. He'd previously received a kidney and pancreas transplant in 1992, due to complications from juvenile diabetes.

This presented a Catch-22 for Selber. The scalp and skull wound kept doctors from performing the second solid-organ transplant. Likewise, Jim's kidney and pancreas functions, along with his immunosuppression medications for his pancreas and kidney, complicated scalp reconstruction.

But Jim's wound, medication and organ failure ultimately became part of the solution. On May 22, he became the first person ever to receive a scalp and skull transplant simultaneously with solid organ transplants.

A transplant four years in the making
"When I first met Jim, I made the connection between him needing a new kidney and pancreas and the ongoing anti-rejection medication to support them, and receiving a full scalp and skull transplant at the same time that would be protected by those same medications," says Selber, who came up with the idea of performing the scalp and skull transplant at the same time as the kidney and pancreas transplant. "This was a unique situation that created the opportunity to perform this complex transplant."

cancer_vaccine_02 var.jpgYesterday, the Food and Drug Administration (FDA) approved a new vaccine targeting nine types of the Human Papillomavirus (HPV), including five types that haven't been covered by other HPV vaccines.

To better understand this new HPV vaccine, known as Gardasil 9 or HPV 9, and what it means for preventing HPV-related cancers, we spoke with Lois Ramondetta, M.D., in Gynecologic Oncology and Reproductive Medicine. Here's what she had to say.

What is the new HPV vaccine, and what does types of HPV does it guard against?

This is the third FDA-approved HPV vaccine. The previous HPV vaccine, known as Gardasil, only protected against four strains of HPV. This one protects against nine different strains of HPV that have been linked to several types of cancer, including cervical cancer, anal cancer, penile cancer, oral cancer and head and neck cancers

This is great news for cervical cancer prevention. Whereas Gardasil was expected to prevent 70% of all cervical cancers, the new HPV vaccine will prevent closer to 90% of cervical cancers.

Keep in mind that these vaccines only work to prevent HPV. So, if you already have HPV, you can't get the vaccine to treat the HPV or to prevent HPV-related cancers.

People across the world are mourning the death of Apple co-founder Steve Jobs, who passed away Wednesday, Oct 5, following a battle with pancreatic cancer. Jobs' death has turned attention to rare form of cancer, for which the U.S. Food and Drug Administration this May approved a new drug - the first new option in nearly 30 years. Learn more about the drug, everolimus, and how it's helping patients with pancreatic neuroendocrine tumors

By Lori Baker, MD Anderson Staff Writer

Not many emails make you cry. But tears of joy rolled down Carmen Jacobs' face when she read that the drug everolimus had been approved by the U.S. Food and Drug Administration (FDA) for patients with pancreatic neuroendocrine tumors (pNET).

She considers this treatment one of her biggest efforts as a research nurse, and this news meant it had just been delivered to patients everywhere. It's a much-anticipated arrival, since this is the first new treatment option for these patients in nearly 30 years.

"I was there when Dr. Yao treated the first patient in the very first clinical trial about six years ago," says Jacobs, research nurse supervisor, Gastrointestinal (GI) Medical Oncology, who also worked on each subsequent trial. "I was so happy when I got his message saying it was approved. Now all of these patients have access to a new treatment that provides more hope for a longer and better life."

By Katrina Burton, MD Anderson Staff Writer

A prostate cancer diagnosis has the ability to strike fear in the hearts of many men. The fear is a normal reaction as men diagnosed with the disease consider the potential side effects from treatment and how it may affect their sexual relationships.

Depression, negative body image and performance anxiety are some of the symptoms prostate cancer survivors face that can lead to a lack of intimacy and, ultimately, to sexual dysfunction.
The ability to have a satisfying sexual experience after treatment may vary, depending on the patient and treatment dynamics. The reality is that men are not the only ones affected by the diagnosis and treatment of prostate cancer.

Positive future
Leslie Schover, Ph.D. a behavioral scientist at MD Anderson, was lead investigator on the CAREss (Counseling About Regaining Erections and Sexual Satisfaction) trial that focused on determining whether couples counseling after prostate cancer treatment had a positive effect on sexual outcomes.

brontoyounes.jpgThis year, approximately 11,000 patients combined will be diagnosed with Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL). Compared to other cancers, such as breast and lung, these two lymphomas are considered relatively rare cancers. So, chances are, you didn't hear the news about brentuximab vedotin (SGN-35), which is now called Adcetris.  

HL and ALCL are potentially highly curable types of lymphoma when conventional chemotherapy regimens and radiation therapy are used. For this reason, no new drugs have been approved by the U.S. Food and Drug Administration for Hodgkin lymphoma since 1977.

But if you are one of the unlucky ones who aren't cured with these conventional regimens, today is a good day for you. Indeed, it's a good day for all of us. A good day for humanity.

A new drug has been approved

Today, the Oncologic Drugs Advisory Committee/ODAC, an FDA advisory panel, voted 10-0 to recommend accelerated approval for Adcetris to treat patients with relapsed Hodgkin lymphoma after having a stem cell transplant, and for patients with relapsed or resistant systemic ALCL.

younesJune11.jpgUp until now, the role of intensified therapy for newly diagnosed lymphoma in the rituximab era remained unknown. 

This week at ASCO, four independent randomized trials, looking at different strategies, reported that more intensive front-line therapy offers no added advantage over standard chemotherapy regimens in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). 

If you don't have the time to read this full report, all you need to know is that RCHOP-21 remains the standard of care.

By Jennifer Litton, M.D., assistant professor, Department of Breast Medical Oncology, MD Anderson Cancer Center

Litton1a.jpgAt ASCO, Canada's NCIC Clinical Trials Group released three-year results from a large randomized double-blind Phase III trial comparing Exemestane (Aromasin), an aromatase inhibitor, to placebo for postmenopausal women at high risk of developing breast cancer.

The study showed a 65% decrease in developing breast cancer when compared to placebo in high-risk, postmenopausal women.

Given how this drug works, it is only effective in women who are postmenopausal without ovarian estrogen production. Exemestane is a drug that has been used for years when treating women with early breast cancer and metastatic disease. Now, it may have another indication in preventing breast cancer.

This is not surprising, as we saw a decrease in second breast cancers that developed in the opposite breast in the early breast cancer trials from this class of drugs. Tamoxifen, which has been used in prevention for years, is a well-tolerated and very effective drug. However, only a small percentage of women choose to take the drug.

By Scott Merville and Laura Sussman, MD Anderson Staff Writers

Customized treatment that matches specialized cancer drugs to their targets on each patient's tumor has been found to increase survival of people with late-stage disease in a Phase I clinical trial at MD Anderson.

Researchers presented results today at the annual meeting of the American Society for Clinical Oncology in Chicago. ASCO also chose to highlight this project to the news media from among thousands submitted to the meeting.

Patients who enroll in Phase I clinical trials have no regular treatment options left and have advanced disease that has spread to other organs or can't be surgically removed. 


How this research was done
In this trial, patients' tumors were analyzed for genetic flaws and when there were drugs available to attack that defect, patients received those drugs rather than those thought to target their type of cancer, such as breast or lung. Patients with just about every type of solid tumor -- lung, breast, colorectal, prostate, brain, pancreas, liver, kidney, melanoma, thyroid and many others -- participated.

A new study published May 31 in the Journal of Clinical Oncology reports that beta-blocker use is associated with improved relapse-free survival in all patients with breast cancer, including those with triple-negative breast cancer (TNBC), a particularly aggressive form of the disease.

Previous epidemiological research has shown that breast cancer is potentially more likely to recur in the context of chronic stress and that beta-blockers -- a class of drugs that help in diminishing the effects of the stress pathway by blocking adrenergic stimulation -- may improve breast cancer relapse. These drugs are often used for cardioprotection after heart attacks and to control cardiac arrhythmias and hypertension.

This collaborative study led by Amal Melhem-Bertrandt, M.D., an assistant professor in the Department of Breast Medical Oncology at MD Anderson, found that the use of beta-blockers in patients with breast cancer was associated with an approximately 50% reduction in breast cancer relapse after three years when compared to patients who were not on beta-blockers. The associated improvement in three-year overall survival in the beta-blocker group, although not significant, was approximately 35%..

By Milind Javle, M.D., associate professor, Department of Gastrointestinal (GI) Medical Oncology, MD Anderson
Cancer Center

Recently, a clinical trial published in the New England Journal of Medicine has offered new hope for patients suffering from pancreatic cancer.

This trial enrolled over 300 patients with advanced cancer of the pancreas, who were treated with either the standard chemotherapy with gemcitabine or with a four-drug chemotherapy combination called FOLFIRINOX.

A five-month improvement in survival was noted with FOLFIRINOX; this regimen also delayed cancer progression. This study is important because for the first time a drug combination has been shown to extend survival of pancreatic cancer patients by a significant degree over that offered by gemcitabine, alone.


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