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Thursday, September 11, 2014

 

By Michael A. Thompson, MD, PhD

Medical Director Early Phase Cancer Research Program, Patient-Centered Research 

Co-PI, Aurora NCI Community Oncology Research Program (NCORP)

Aurora Research Institute

Aurora Cancer Care

 

The NCI Community Oncology Research Program (NCORP) includes these research bases: http://ncorp.cancer.gov/about/sites.html#research-bases

 

University of Rochester Cancer Center

The University of Rochester Cancer Center (URCC) is an NCORP Research Base (http://urcc-ccop.com/ccop). Gary Morrow, PhD, MS, is the Director, and kicked off the Inaugural URCC NCORP Meeting last week in Rochester, NY.

 

Our health system (Aurora NCORP) was a new site, so this was a new meeting for us. Some of the other previous CCOP sites had new principal investigators and staff. The URCC NCORP members have had impressive accrual over the history of the URCC CCOP research base.

 

URCC has an NIH R25 grant which is being used to train researchers in Cancer Care Delivery Research (CCDR).

 

URCC NCORP Active Protocols (selected)10055 Cognitive -- NCT01382082 -- Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment, Post-Treatment, and at Six Month Follow-Up (CANTAB)

 

12107 PSYCHED -- NCT02054715 -- Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials

 

13059 GAP70+ -- NCT02054741 -- an NIH RO1 study -- A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy for Advanced Cancer:  Reducing Chemotherapy Toxicity in Older Adults (amendments pending)

 

13070 COACH -- NCT02107443 -- Patient-Centered Outcome Research Institute (PCORI) funded -- A Geriatric Assessment Improving Communication for Chemotherapy: Addressing Concerns of Older Cancer Patients and Caregiver

 

Conclusions

Many active clinical trials and concepts were reviewed. A number of these involved energy balance, exercise, and symptom interventions. A few general thoughts:

 

Minority accrual has been and is consistently lower than wished at nearly all sites in the country (with a few exceptions).

Minority accrual ideally should be the same percentage as the prevalence of the minority population for that specific disease.

 

CCDR will be an increasingly important research strategy as the NCORP sites implement new studies. This will supplement new cancer control and cancer prevention studies.

 

Cross-disciplinary collaboration (e.g., Cardio-Oncology, neuropathy studies) will increase. How these studies are reviewed in siloed study sections is not clear.


Wednesday, September 10, 2014

By Joy Larsen Haidle, MS, CGC

President-elect, National Society of Genetic Counselors

Genetic Counselor, Humphrey Cancer Center, Minneapolis 

 

The Journal of the American Medical Association published a study on Sept. 8, 2014, by Mary-Claire King, PhD, which recommends that all U.S. women over the age of 30 receive genetic testing for BRCA1 and BRCA2 mutations, whether or not they have a family history of breast or ovarian cancer.

 

Over the years, I have been extremely impressed by the dedication and amazing scientific contributions of Dr. Mary-Claire King to help identify and support individuals at risk for hereditary breast cancer. She is a well-respected researcher and her opinion is important to consider. However, as a genetic counselor who has worked with and advocated for families at risk for hereditary cancer risk for close to 20 years, I have concerns regarding her recent recommendation.

 

First, the data utilized to support this recommendation was generated on a very specific high-risk population, Ashkenazi Jewish men from Israel. In the Ashkenazi Jewish population, approximately 1 in 40 people carry a mutation in BRCA1 or BRCA2 versus 1 in 300 to 1 in 500 individuals from the general population. It is very difficult to take data from a high-risk population and apply it to the average person in a meaningful way.

 

In addition, three founder mutations in BRCA1 and BRCA2 account for close to 90 percent of the mutations identified in individuals who are of Ashkenazi Jewish descent versus thousands of other mutations that have been identified in other populations. In this population, testing is often done for just these three mutations rather than full evaluation of both genes by sequencing and large rearrangements (deletions or duplications of the gene).

 

This is a difference in cost from roughly $475 versus $2,000-$4,000. Without a personal or family history suggestive of a potential inherited risk, the cost of the test would likely not be covered by most insurance companies as the average person would not meet current coverage criteria. These are very important factors impacting the ability to offer quality, easy-to-interpret testing in a cost-effective manner.

 

Many laboratories suggest a roughly 4 percent variant of uncertain significance rate on BRCA1/BRCA2 DNA testing. These are results where the meaning is unknown and the results should not be used in medical management decisions. However, it is a test result that is often misinterpreted and misunderstood, and has the potential to cause unnecessary anxiety and harm.

 

In Dr. King’s commentary regarding the article, she suggests that laboratories only report clear normal or clearly harmful results and withhold variant results. The reason to withhold the variant results is to decrease confusion or misinterpretation of the results by patients or providers, but it also reveals a need for greater preparation and education of providers and the public before the value of general population screening could be fully realized. In addition, it emphasizes the importance of risk assessment and genetic counseling by an expert such as a genetic counselor.

 

I understand Dr. King’s concept and her concerns that have led her to recommend universal screening, but the current system needs to do a better job at collecting sufficient family history information to accurately identify and triage patients who might benefit from genetic counseling and/or genetic testing. Without a systematic process to collect this information and without significant education for providers and the general public, many individuals may not have their mutation identified until after a cancer has occurred.

 

It is premature to suggest that the medical system is prepared to implement general population screening of BRCA1 and BRCA2 mutations, and more harm than good can happen as a result. A significant amount of work must be done to get the medical system and providers ready to handle the volume of patients, ensure that patients receive high-quality care and understand their results, ensure the psychosocial issues associated with genetic testing are addressed, and guarantee access to experts before making potentially life-changing medical decisions. In addition, significant education is needed for the medical community and the lay public to fully realize the benefits of the technology to reduce cancer risks. 

 

The data from Dr. King’s study is important and I am grateful that she has initiated a conversation about how the population might maximize the benefit from genetic screening. It is imperative, however, that genetic counseling and risk assessment remain a part of the process for patients to make the best health choices for themselves. It is premature to make this leap without putting the safeguards in place to protect the patients utilizing the DNA testing and resources to ensure the information is used well.

 


Friday, September 05, 2014
 

BY MICHAEL A. THOMPSON, MD, PHD

Medical Director, Early Phase Cancer Research Program and Patient-Centered Research Co-PI,

Aurora NCI Community Oncology Research Program (NCORP),

Aurora Research Institute, Aurora Cancer Care

 

As noted in OT's 9/10/14 issuethe NCI Community Oncology Research Program (NCORP) replaces the previous Community Clinical Oncology Program (CCOP) and NCI Community Cancer Centers Program (NCCCP) for community-based mechanisms for deploying NCI Clinical Trial Network (NCTN) research. There has been a consolidation of NCI cooperative groups into the new NCTN including ECOG-ACRIN (#EAOnc), SWOG (#SWOGOnc), Alliance (#AllianceNCTN), NRG (#NRGOncology), and COG, as well as the University of Rochester and Wake Forest (ref: http://ow.ly/zScPb). The NCORP integrates prior networks (NCCCP & CCOP) into one new program to preserve & enhance community cancer research.

 

The current NCORP sites can be seen here: http://ncorp.cancer.gov/about/sites.html; and the following are the links for the NCTN research bases:

The NCORP budget is basically flat at $93M compared with prior NCI-supported community oncology research, so this is a consolidation of sites and resources rather than an expansion. It is rather shocking that this is so despite the fact that approximately 50% of NCI clinical trial accrual is in the community setting (Ref: Minasian -- http://ow.ly/rTkA0).

 

To get even more of a sense of what that amount is: $93M is about the cost of resurfacing 93 miles of road (Ref: http://capitolfax.com/summary.pdf). Roads are important infrastructure for maintaining commerce, security, and standard of living, but maintaining or expanding the community cancer clinical research infrastructure is also important for continuing to develop new drugs, understand value, and support new investigators.

 

We must remember one of my favorite quotes: "Without clinical trials, cancer treatment would always remain the same"--via @TomBeer in @OncologyTimes -- ow.ly/fmaKk

 

Upcoming 2014 NCORP Meetings

NCORP meetings for the rest of this year are scheduled as follows:

  • 9/4-5:   University of Rochester NCORP Research Base, Rochester, NY
  • 9/22:  NCI NCORP Meeting, Rockville, MD
  • 10/16-18:  Wake Forest NCORP Research Base, Wilmington, NC
  • 11/5-8:  Alliance, Rosemont, IL
  • 11/13-15: ECOG-ACRIN, Orlando, FL

If there are others, please comment below to let us know, and we’ll add them to the list.

NCORP Resources:


Wednesday, July 30, 2014

BY JEFFREY M. HARTOG, DMD, MD

 

In my experience over the years, radiation therapy as part of the overall treatment of breast cancer has notably decreased the risk of recurrence and improved overall survival for advanced breast cancer in women undergoing mastectomies. There is also some evidence that it may be beneficial in less advanced cases, as well. In addition, more and more frequently, patients are choosing breast-sparing surgery for breast cancer treatment, and radiation therapy is an essential component of this approach.

 

Although radiation therapy may be beneficial in terms of the treatment of the cancer itself, we in the medical profession should consider the problems it can create for women seeking breast reconstruction – for example, increased complications, complete failure of breast reconstruction with either implants or tissue flaps, and poor aesthetic outcomes. The radiation may also increase the deformity of the breast in women undergoing lumpectomies due to scarring and contraction of the tissues.

 

In most cases, women who have undergone lumpectomies followed by radiation are not offered reconstruction at all, despite the fact that they are frequently left with moderate or severe breast deformities and significant breast asymmetry as it relates to the other, untreated breast. Despite the effectiveness in treating breast cancer, radiation therapy results in increasing fibrosis of the tissues and adversely affects the body’s ability to heal itself in the radiated areas.

 

Fortunately, we now have an effective way to reverse the deleterious effects of radiation therapy, improve outcomes and decrease complications in women undergoing breast reconstruction. Furthermore, women with lumpectomies now have a viable option to reconstruct their breasts and improve symmetry with the opposite side. I have found fat transfer, or fat grafting, to be an effective method to restore the vitality of radiated tissue, facilitate breast reconstruction, and reconstruct breasts treated with lumpectomies followed by radiation.

 

Technique

The fat transfer technique is simple, involves no incisions, and is a 100-percent outpatient procedure. The fat is harvested with a standard gentle liposuction procedure, and then simply injected into the radiated areas using meticulous micrografting techniques. Usually, more than one procedure is required to restore the tissue quality and the breast defect, but now we can simplify the procedure by banking fat harvested with a single liposuction procedure, making subsequent micrografting injection procedures much easier.

 

Fat grafting works in two ways to restore radiation-damaged tissue. The first and most obvious way is that the fat replaces the scarred and fibrotic tissue and restores the tissue quality and volume. The second, more subtle manner is due to the stem and regenerative cells contained in the fat, which improve the ability of the tissue to heal itself. There is strong evidence that one of the effects of radiation is to destroy and deplete the stem and regenerative cells that normally exist in tissues, and this is one of the factors promoting increased scarring and contraction of radiated tissues. It’s also a possible mechanism of the increased complication rate when breast reconstruction is attempted, particularly with implants.

 

Depending on the situation, we can use fat transfer alone, as in most lumpectomy patients, or we can use it in combination with implants, as in mastectomy patients. The procedure can also salvage failed or compromised breast reconstructions with flap procedures.

 

Fat transfer is an essential component in reconstruction of breasts treated with radiation and can make the difference between success or failure. In certain situations, even mastectomy patients who have been heavily radiated may not be considered as candidates for breast reconstruction at all. Frequently, fat transfer can provide a method for reconstruction even for these patients, who have been told that reconstruction is not an option by most plastic surgeons.

 

Of course, fat transfer is also an option for women who choose not to have reconstruction with artificial implants or tissue flaps requiring major invasive procedures to harvest the flaps from other parts of their bodies.

 

Because breast reconstruction with fat transfer can be tedious and requires meticulous specialized techniques as well as some patience on the part of the patient, who may need two or more fat transfer procedures, many plastic surgeons do not even offer this procedure to their patients. However, to me, it is unacceptable to expect women to walk away after such life-changing procedures without being offered the option of breast reconstruction.

 

Women should know they don’t have to live with deformed breasts after radiation. Oncologists should present breast reconstruction options to their patients, including the natural fat transfer procedure.

 

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JEFFREY M. HARTOG, DMD, MD, Director of the Bougainvillea Clinique in Winter Park, Florida, specializes in fat transfer to the breast and presents nationally and internationally on the subject.


Tuesday, July 29, 2014

by Scott D. Siegel, PhD; and Darcy Burbage, RN, MSN, AOCN, CBCN

 

In the July 10 issue, the article “Deadline for Survivorship Care Plan Compliance Being Rethought” notes that the Commission on Cancer (CoC) is “revisiting the [survivorship care plan] requirement since many institutions have been having trouble complying.” Respectfully, in loyal opposition, we say it’s about time the CoC is giving this standard second thought. The OT piece highlighted the feasibility question: is it even possible to meet the requirements of this standard? As we will review below, it was foreseeable from the outset that this was an unattainable standard. But more important than the question of “Can we?” is the question of “Should we?” That is, even putting aside the very real challenges this standard imposes on cancer programs, do treatment summaries and care plans actually offer any real value? The evidence challenges the assumption that if we could just find a way to implement this standard, it would improve care for survivors.

 

First, to the feasibility question: how does a cancer program go about providing a “comprehensive care summary and follow-up plan” to all cancer patients completing treatment? The simple answer is to hire someone (or several people, depending on the number of patients being treated) to complete these documents and then review them with cancer survivors. This is typically too time-consuming a task to ask existing staff to handle. To put this in perspective, at our program we have a very experienced Advanced Oncology Certified Nurse in the role of “survivorship nurse navigator,”  and it takes her (DB) on average 45 minutes to an hour to just complete a treatment summary/care plan for one patient (not reimbursable). Then it takes another 30 minutes to review the summary/care plan with the patient.

 

If our survivorship navigator only completed and reviewed summaries/care plans with our survivors, never taking a day off or even a break, never offering any other survivorship service, she could reach about 1,400 survivors per year. Our cancer program sees over 3,000 new cancer cases per year. While we are very fortunate to have a full-time position devoted to survivorship issues, something many other community programs are not able to fund, we are certainly not in a position to hire multiple survivorship navigators.

 

To get around the time and labor issues, some have suggested that cancer programs can rely on software to prepopulate treatment summary fields with data from the tumor registry or the electronic health record (EHR).  Unfortunately tumor registries are often several months behind. But even if the tumor registry was “real-time,” it tracks things like whether a patient received chemotherapy (yes or no) and not the specific types of chemotherapy a patient received, thus falling short of the CoC standard requirements. Using software to pull data from EHRs is also not as straightforward as it might seem. Most cancer care in this country is delivered in the community setting where there is often a hybrid model of employed and private physician offices, typically with multiple EHRs. It is unusual for EHRs to talk well with one another, and treatment summary software has yet to overcome most of these hurdles. Because the software either does not exist or the computer programming necessary to make it all work would be prohibitively expensive, for most sites, treatment summaries/care plans must be completed manually—hence the compliance concerns.

 

Next let’s turn to the question of whether we should attempt to meet this standard, feasibility issues aside. The theory goes that treatment summaries/care plans will help bridge the gap between oncology and primary care.  Oncologists cannot follow their patients forever; at some point survivors need to transition back to their PCP. If survivors just had this document, with all the treatments they received, and handed it to their other physicians, no one would be “lost in transition” anymore, to borrow from the Institute of Medicine (IOM) report.1

 

The flaw in this theory is that it sounds so intuitive no one really bothered to test it before mandating treatment summaries for all survivors. As it turns out, even with this document in hand, survey research has revealed that PCPs do not feel adequately trained to manage cancer survivors.2-4 The research also shows that medical oncologists don’t trust PCPs to follow their patients, which is why medical oncologists are so reluctant to discharge. And the survivors, too, say they would rather be followed by their medical oncologist.

 

A single document, no matter how comprehensive, does not make up for the fact that most PCPs did not receive training on survivorship care when they attended medical school. And to the concern that we don’t have enough medical oncologists to follow the ever-growing population of cancer survivors, we don’t have enough PCPs either.5 This is a serious problem, certainly, but not one that treatment summaries/care plans fix.

 

The other argument frequently offered in support of treatment summaries/care plans is that it “empowers” survivors. With treatment summaries, survivors will have more knowledge, and with knowledge comes power. In our practice, despite making it as pleasant as possible an experience for our survivors to review their treatment summary (we coordinate with other appointments, do not bill, and the survivorship navigator offers to discuss the treatment summary only after establishing a good rapport), two-thirds of our survivors decline the service.6

 

Far from feeling empowered, the feedback we typically receive is: “That’s too much right now,” “I have other worries,” “Can’t my doctors just talk about this with each other?” And to the point of having other worries, when we survey our survivors – and the research again supports our findings7,8 – they ask for help with things like returning to work, managing long-term side effects -- and perhaps most of all, managing their fear of recurrence. These are the very kinds of concerns our program seeks to address with our survivors, but our reach is limited by the time and resources we must devote to treatment summaries/care plans. 

 

Somewhere along the way survivorship care became synonymous with treatment summaries/care plans. We find this unfortunate. And this is not what the IOM report recommended, by the way. Treatment summaries were but a small part of the overall approach to survivorship care the IOM report was advocating (and something that should be reimbursable at that, which currently is not).  The other IOM recommendations included a greater focus on symptom and side-effect management and developing and testing new models of care for survivors. 

 

The real harm is that by focusing exclusively on treatment summaries we divert precious resources away from the kinds of services survivors actually want and need so that we can complete a document that sounds good in theory.  This is hardly evidence-based care. This is hardly survivor-centered care. And as people who consider themselves strong advocates for cancer survivors, we say it’s about time we rethought things. 

 

References

1.  Hewitt M, Greenfield S, Stovall E. (2005). From cancer patient to cancer survivor: Lost in transition. Washington, DC; National Academies Press.  

2.  Grunfield E, Julian J, Pond G, et al. (2011). Evaluating survivorship care plans: Results of a randomized, clinical trial of patients with breast cancer. Journal of Clinical Oncology 29:4755-4762.

3.   McCabe M, Bhatia S, Oeffinger K, et al. (2013). American Society of Clinical Oncology statement:  Achieving high-quality cancer survivorship care. Journal of Clinical Oncology 31, 631-640. doi: 10.1200/JCO.2012.46.6854.

4.  Grunfield E, Earle C. (2010). The interface between primary and oncology specialty care: Treatment through survivorship. Journal of the National Cancer Institute Monographs 40, 25-30.  

5.   Klabunde C, Han P, Earle C, et al. (2013). Physician roles in the cancer related follow-up care of cancer survivors. Family Medicine 45, 463-474.

6.   Burbage D, Siegel S (in review). Implementing the role of a survivorship nurse navigator in a community cancer center.

7.   Miller L (2012). Sources of uncertainty in cancer survivorship. Journal of Cancer Survivorship 6, 431-440.

8.   Ness S, Kokal J, Fee-Schroeder K, et al (2013). Concerns across the survivorship trajectory: Results from a survey of cancer survivors. Oncology Nursing Forum 40, 35-42.

 

 

Scott D. Siegel, PhD, a licensed psychologist, is Director of Psychosocial Oncology & Survivorship at the Helen F. Graham Cancer Center & Research Institute in the Christiana Care Health System. Darcy Burbage, RN, MSN, AOCN, CBCN, is Survivorship Nurse Navigator at the Helen F. Graham Cancer Center and Research Institute.