Holy Cross Cancer Blog

Clinical Trials 101

  • Posted Jul 15, 2009
  • Carol Brudenell

medicineI’ve talked a bit about clinical trials but in this column I want to describe the different phases of trials as that is the way the information is disseminated to physicians, nurses, other clinicians and patients. Below are the different categories, keep in mind for cancer related trials, patients always receive at least the standard of care treatment plus something else or in a different dosing schema. Phase I Trials – these cancer trials are typically the first time a drug or a treatment protocol is offered to humans. These trials are typically quite small in terms of enrollment and are generally only available in top notch cancer programs – we are just launching our Phase I clinical trial and we are excited to be one of the very few non-university based programs in the country to offer this to our patients. The goal of these trials is to determine toxicity levels of the medicine and determine the optimum dose. Phase II Trials- This level of trial is open to more patients and continues to test the safety of a medicine and starts to analyze how well that new medicine works. Phase III Trials – these trials compare the new drug or treatment regimen compared to the existing standard of care. Patients will usually be enrolled either in the group using the existing standard of care treatment alone or  the group using the standard of care plus the new type of treatment. These assignments are typically done without the knowledge of any of the people involved so that the results are not biased. Many people are enrolled in these trials and the intent is to then be able to move the new regimen into the main stream of treatment if the trial results are positive for the new regimen. Phase IV trials- these trials are usually conducted for drugs that have already been approved by the FDA. These trials have the largest enrollments and continue to test the safety, side effects and risks and benefits of the new medicines or regimens. They are also typically open for a long period of time and monitor patients for a long period of time. In another installment I’ll write about the different kinds of trials – treatment trials, prevention trials, screening trials, and quality of life trials.

Gail Model and BRCA 1 and 2

  • Posted Jun 17, 2009
  • Carol Brudenell

Greetings! I have asked one of our outstanding breast surgeons to step in and do a guest blog for me. Dr. Joseph Casey is a board certified general surgeon and a fellowship trained breast suregon who is a member of the oncology team at the Bienes Cancer Center. Here are some of his thoughts:

casey20josephWhen we take a history from a patient we always ask if they have any awareness of a relative with breast cancer.  This gives us a clue if there may be something in their genetic make-up that increases their risk of developing breast cancer.

 Of course the more relatives they can think of who have had breast cancer the more concern we have that they may be carrying a harmful genetic mutation.  This is especially true if we find out that those relatives were young or premenopausal when diagnosed with the disease.


There is a formula available online called the Gail model that helps put a number value on a woman’s breast cancer risk.  One of the elements in the calculation has to do with the number of first degree relatives who have had breast cancer.  First degree relatives would be mothers, sisters and daughters.  This number is then entered into the formula along with other parameters and the program gives a percentage number of the risk.  The average woman has a one in eight chance of developing breast cancer in her lifetime.  This would be about a 12% risk.  If the risk is calculated to be 20% or greater, it is considered high enough that the American Cancer Society recommends additional imaging such as MRI to be done.


Because the Gail model only considers first degree relatives in its formula it probably underestimates the genetic component of the risk.  It only makes sense that grandmothers, aunts, and even uncles with breast cancer confer additional risk.  The Gail model is therefore not perfect but at least it gives us a ballpark number to start with.  Good judgment, however, is still required!


If there appears to be a number of relatives with breast cancer and they are particularly young or if the patient herself is young (under fifty) we may be dealing with specific mutations known as BRCA1 and BRCA2.  These can be diagnosed with a blood test or more recently with an oral swab. But the BRCA mutations account for less than 10% of breast cancers.  They are most commonly found in families with Ashkenazi Jewish backgrounds.  However I personally have had African-American and Hispanic patients who have tested BRCA positive.


The BRCA testing is expensive and most insurances require formal genetic counseling before they will pay for it.  If the woman is BRCA positive the lifetime risk of breast cancer is as high as 60% to 80%.  There is also an increased risk for ovarian cancer, so many women in this situation will give serious consideration to both prophylactic mastectomies as well as removal of the ovaries before the cancer appears.


It’s important to remember that a negative BRCA test doesn’t mean you are not going to get breast cancer.  In fact most cases of breast cancer have no identifiable risk factors including genetics.  How many times have I heard a woman tell me she doesn’t need a mammogram because “it” doesn’t run in her family?  No one is immune although immunity is something I would like to work on! - Joe Casey, M.D.

Trials try to Light the way to a Cure

  • Posted May 11, 2009
  • Carol Brudenell

ks16947Clinical trials are the only road to new standards of care in medicine. Without their scientific rigor, we would not be able to move forward to improve and hopefully someday, eliminate diseases.


There are many different types of clinical trials in cancer care. Here at the Bienes Cancer Center, we do mainly treatment, screening and prevention trials. I want to share an example of a National Cancer Institute funded prevention trial that we are participating in.


The Selenium and Vitamin E Cancer Prevention Trial (SELECT) is a clinical trial to see if one or both of these dietary supplements prevent prostate cancer. Over 35,000 men were enrolled across the USA, Canada and Puerto Rico. The study was based on findings from two separate studies in the past for cancer prevention. One looked at the use of vitamin C in multiple cancers and it indicated a reduced incidence of prostate cancer with this vitamin. The other study was testing the use of vitamin E in the reduction of many cancers and it also showed a reduced incidence of prostate cancer.    


The Bienes Cancer Research department has enrolled 121 men into this study since its inception in 2001. Each subject was randomized to combinations of Vitamin E, selenium or placebo. The men took their pills daily, came into the clinic for annual PSA tests and digital rectal examinations by our physicians. They also received phone calls every six months to gather more health related information. Recently, another component has been added to gather information about the incidental findings for any men in this trial who happened to have had a colonoscopy.


The pills were stopped in August 2008 because the data showed that taking vitamin E and selenium alone or together does not prevent prostate cancer. The data also showed that vitamin E may slightly increase the chance of getting prostate cancer. Selenium may be associated with a slightly increased risk of developing diabetes mellitus. However, these findings are not statistically significant and may be due to chance alone.


These men will remain on trial for another 2-3 years as we gather more health related findings. Although this trial did not reach its goal of a 25% reduction in prostate cancer, it has shown that the previous findings concerning vitamin E & C in the prevention of prostate cancer were not verifiable. Six men, who were not having regular prostate exams and PSAs, were found to have early stage prostate cancer. To read more about this trial, please visit the NCI website. 


If you have been or are enrolled in this trial, we would love to hear about your personal experience and any thoughts you have about this or other prevention trials.

Clinical Trials: The Latest Cancer Treatment in Familiar Settings

  • Posted Apr 28, 2009
  • Carol Brudenell

clinical-trials-imageEach year the National Cancer Institute spends hundreds of millions of dollars on cancer-related clinical trials. In fact, in 2008 the number spent was over $483 billion.  Participating in NCI-sponsored clinical trials allows physicians in the community setting (like ours at Holy Cross) to participate in state-of-the-art scientific endeavors. These trials more importantly allow patients to benefit from access to the newest developments in oncology treatment while they remain at home and are cared for by their own oncologists and other physicians. Access to National Cancer Institute (NCI) funding is accomplished primarily through Cooperative Research Group Programs, Community Clinical Oncology Programs (CCOPs), and Cancer Trial Support Units (CTSUs). Cancer centers in community settings like the Bienes Cancer Center at Holy Cross must be committed to the investigative process and must invest in those programs on the front end. It is imperative that not only the physicians be involved and supportive of the clinical research being offered but there must be a trained nursing and support staff to insure the integrity of the clinical research being done. Here at the Bienes Cancer Center we offer many different trials for different tumor types and sites. These trials come from our CCOP affiliation as well as Gynecology Oncology Group, American College of Surgery Oncology Group and industry sponsored studies. Finally, our own physicians led by Dr. Martin Gutierrez have begun to write their own clinical research study projects.  Please feel free to visit our clinical trials page for more information or let me know if you have any questions.

Genetic Testing and Lynch Syndrome

  • Posted Apr 06, 2009
  • Carol Brudenell

DNALast month we talked about the “Red Flags” for Breast and Ovarian Cancer. I especially wanted to recognize the comment from Barbara Pfeiffer who is the voluntary director for FORCE: Facing Our Risk of Cancer Empowered. This is a vital organization that provides a wealth of knowledge and support to persons at high risk for breast and ovarian cancer. Thanks Barbara.


This month, let’s review the “Red Flags” for Lynch Syndrome or Hereditary Non-Polyposis Colorectal Cancer (HNPCC):


  1. Endometrial cancer before the age of 50
  2. Colorectal cancer before the age of 50
  3. 2 or more Lynch Syndrome cancers* in and individual
  4. A previously identified mutation


*Cancers associated with Lynch Syndrome are ovarian, stomach, kidney/urinary tract, brain, or small bowel cancers.


When looking at your family history it is important to remember these other cancers that may increase the risk of having mutations in the genes that are associated with HNPCC. If you have a family history of these cancers, it is important to talk to your healthcare practitioner about the need for testing and more careful screening for these cancers. For more information on genetics and Lynch Syndrome, visit the American Society of Clinical Oncology.


I would also suggest that you fill in the health history “tree” on the Surgeon Generals website and take it with you when you visit your doctor or nurse.  This health history tool is a must for everyone. It helps you and your caregiver focus on conditions or diseases for which you may be at risk. 


Looking forward to hear any comments, discussion or debate. 

The 411 On Clinical Trials at Holy Cross

  • Posted Mar 24, 2009
  • Carol Brudenell

Holy Cross Cancer Research Team A few weeks ago I discussed Genetics and today I am switching hats and bringing you greetings from myself and my colleagues in the Research Department at Holy Cross Hospital.

We are a group of five research specialists who work together with our Cancer Care Team to find our patients the best in cancer treatment tailored to their specific needs. We have a large slate of clinical trials from which to choose that can take cancer treatment from standard of care in the community to cutting edge research that may offer a better result than could have been expected. And it’s all right here, close to friends and family. Our menu includes both Phase II and Phase III  clinical trials for various types of cancer. Most of our clinical studies come from the Community Clinical Oncology Program funded by the National Cancer Institutes. Others are selectively chosen from industry leaders who are studying promising new drugs which have shown response in earlier trials.

In my future posts on Clinical Trials, I would like to expand on why they are so important to patients as well as the barriers to clinical trial enrollment. In the meantime, please refer to the excellent articles on the National Cancer Insitute website about taking part in Clinical Trials.

Hope you will share with us your clinical trial thoughts and experiences. We know they are not for everyone but for some they are the definitive answer.

Genetic testing, hereditary breast and ovarian cancer

  • Posted Mar 12, 2009
  • Carol Brudenell

carol-b-ons_edited-for-blog Greetings to all readers: I have been an oncology nurse since 1985 and have worked as a staff nurse, nurse manager, clinical nurse specialist and now as a clinical trial manager and genetic counselor. Having had these lived experiences along the way, I would like to share my knowledge with you but also, it is my hope that this blog will be interactive and I will hear about your experiences and ideas. One of the topics closest to my heart is the need for and benefits of genetic counseling and sometimes testing for persons with cancer and/or a family history of cancer. There are “Red Flags” that have been identified for the public and health care practitioners that indicate the need for an exploration of the family health history and genetic counseling. Today, let’s look at the indicators for hereditary breast and ovarian cancer: -Breast Cancer before age 50 -Ovarian cancer at any age -Bilateral breast cancer at any age -Both breast and ovarian cancer at any age -Male breast cancer at any age -Ashkenazi Jewish ancestry with breast or ovarian cancer at any age. Testing for mutations in the BRCA 1 or 2 genes is often indicated if you have some or all of these “red flags” to determine if you have an inherited susceptibility to breast or ovarian cancer. This genetic information can be used to make health care management decisions that will benefit you and your family. A definitive source of more information on this subject can be found at http://www.cancer.gov/cancertopics/factsheet/risk/brca. Let me know your thoughts and experiences with genetic counseling and/or testing.


Below is a commentary from Maureen G. Mann, MS, MBA, FACHE, Executive Director of the Michael and Dianne Bienes Cancer Center at Holy Cross Hospital, urging lawmakers to oppose House Bill 169. 

"...I am a very involved volunteer with the American Cancer Society...so this particular bill causes me great concern. Please see the notes below and VOTE NO when this bill comes to the floor...

Oppose House Bill 169
Nicotine Products & Nicotine Dispensing Device

Originally, the intent of HB 169 was to prohibit the sale of nicotine products and nicotine dispensing devices (e-cigarettes) to minors. However, added amendment language would strip local governments of their ability to regulate all tobacco products and e-cigarettes, overturn existing ordinances, and block future opportunities to protect kids in the retail environment. For example, many of the product placement ordinances we currently have in Florida go beyond the minimum standards set by the US Food and Drug Administration (FDA), requiring that ALL tobacco products are placed behind the counter at retail stores, not just cigarettes and smokeless tobacco. With the preemption language, the bill now does more harm than good in the fight to keep Florida’s children tobacco free.

Key Points
Many of the ordinances we currently have in Florida deal with product placement, requiring that all tobacco, not just cigarettes and smokeless tobacco, are placed behind the counter at retail stores. They are stronger than the minimum standards required by the FDA and are all meant to keep tobacco
products out of the hands of children.

In-store tobacco displays serve to increase product availability, visibility and brand awareness and stimulate trial and purchase of products.1 Product placement laws limit youth access to tobacco via illegal sales and shoplifting.
Proponents for preemption claim that we need a uniform state law that covers all businesses rather than a patchwork of local ordinances. The fact is retailers are used to complying with a variety of local laws, including zoning, traffic restrictions, health regulations and even alcohol sales. Tobacco regulations
are no different than other regulations that vary from jurisdiction to jurisdiction.        
Local governments are more flexible and responsive than state government in effectively dealing with emerging problems and finding innovative solutions. Local governments are closer to the community and have been more effective than the state or federal government in addressing the problem of
tobacco use.

My Position
State laws should serve as a minimum standard for a policy objective while allowing communities to enact stronger ordinances to protect their youth and residents in the most appropriate manner. The American Cancer Society Cancer Action Network, American Lung Association, American Heart Association, Campaign for Tobacco-Free Kids and our partners ask that you oppose HB 169 and prevent the dismantlement of effective local tobacco ordinances around the state."


About the Center

The Michael & Dianne Bienes Comprehensive Cancer Center in Fort Lauderdale, Florida is the Cancer Care Leader in Broward County. Dedicated to providing patients with precise diagnosis, the latest and most advanced treatment and aftercare options, we offer a multidisciplinary approach to care, a compassionate and spiritual healing environment, and an affiliation with the National Cancer Institute. We are also working together with Massachusetts General Hospital Cancer Center to provide South Florida residents with rapid access to specialized cancer care and genetics counseling.

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