	Patients with ductal carcinoma in situ (DCIS) who received an MRI added to mammography before or immediately after receiving a lumpectomy did not experience an improvement in the rate of disease recurrence, according to the results of a large, retrospective study (

	Although no published clinical guidelines currently exist for the use of MRI in patients with newly diagnosed breast cancer, the screening is often ordered to determine whether a clinician missed any areas of cancer or to determine if there was a discrepancy between a mammogram and a physical exam.

	“Theoretically, treating this additional disease found by MRI could result in lower rates of local recurrence or contralateral breast cancer down the road,” said Melissa L. Pilewskie, MD, a breast surgeon at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City, and first author of the study.

	Since no formal guidelines exist, the use of MRI in newly diagnosed patients varies widely among doctors and hospitals, although a recent survey of US surgeons found that 37% of them routinely use MRI for patients with DCIS. Pilewskie and colleagues hypothesized that this test may be unnecessary since studies have not shown decreased rates of re-excision, with some studies even reporting unnecessary increases in mastectomy rates.

	In this study, researchers looked at locoregional recurrence (LRR) rates in women with DCIS and compared the rates in patients who received a perioperative MRI with those who did not. A prospectively maintained database at MSKCC included data on all women who underwent breast-conserving surgery for DCIS between 1997 and 2010, and identified 2321 cases for inclusion in the study. Of those cases, 596 received MRI and 1725 did not.

	At a median follow-up of 57 months, there were 184 instances of ipsilateral breast tumor recurrence. The 5-year LRR rates were 8.5% in patients who received MRI and 7.2% in patients who did not, and this difference was not statistically significant (P = .52). At 8 years, LRR rates were 14.6% and 10.2%, respectively. When adjusting for age, menopausal status, family history, presentation, adjuvant ther-apy, margin status, number of excisions, and year of surgery, the researchers did not find that MRI was associated with lower LRR rates. This was also true for patients who received radiation therapy.

	Additionally, the researchers looked at contralateral breast cancer event-free rates. At 5 years, both groups had the same event-free rates of 3.5%, and at 8 years, the rate in the group that received MRI was 3.5% compared with 5.1% in patients who did not receive MRI (

	In the entire cohort, patients who received an MRI did not experience a lower rate of events, whereas patients who received endocrine therapy and had a negative margin status did see improvements in their LRRs, which Pilewskie said was to be expected.

	“We did not find an association between perioperative breast MRI and decreased rates of either locoregional recurrence or contralateral breast cancer,” Pilewskie said. “In the absence of evidence that MRI is improving our surgical management or, as we show here, long-term outcomes, the routine use of this test for DCIS should be questioned.”

		Nurse Perspective on Perioperative Breast MRI

	Presently, guidelines for the use of breast MRI in the perioperative setting for treatment of DCIS are lacking. In this retrospective cohort study conducted by Melissa Pilewskie, MD, at Memorial Sloan-Kettering Cancer Center, perioperative breast MRI with DCIS did not reduce the rate of locoregional recurrence of breast cancer. Certainly, practical application of the use of breast MRI in this setting should be reconsidered.

	Breast MRI can be a costly, difficult procedure for some patients and often results in an associated higher mastectomy rate. Some researchers hypothesize that the use of known, effective treatments for DCIS (radiation therapy, systemic endocrine therapy, and adequate surgical margin status) are effective at eradicating occult disease and that perioperative breast MRI does not contribute additional advantages to treatment.

	The outcomes of this retrospective study are hypothesis-provoking, and additional randomized trials are needed to investigate whether breast MRI has a role in the management of DCIS.

Articles

Patients with ductal carcinoma in situ (DCIS) who received an MRI added to mammography before or immediately after receiving a lumpectomy did not experience an improvement in the rate of disease recurrence

Perioperative Breast MRI Does Not Lower Recurrence Risk for Early-Stage Patients

The FDA has announced the approval of the first generic version of the drug Doxil (doxorubicin hydrochloride liposome injection). The approval is expected to help alleviate a shortage of the drug that has continued since November 2011.

The FDA’s Office of Generic Drugs has implemented a priority review system in order to expedite the consideration of generic versions of drugs that appear on the national shortage list. Doxil is currently approved in combination with bortezomib to treat multiple myeloma in patients who have received prior chemotherapy, and it’s also approved to treat ovarian cancer that has progressed or recurred after prior chemotherapy.

“The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them,” said Captain Valerie Jensen, RPh, director of the drug shortage staff at the FDA’s Center for Drug Evaluation and Research, in a statement. “For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted.”

In November 2011, Ben Venue Laboratories, the third-party manufacturer that produces Doxil for Janssen Pharmaceuticals, reported it would indefinitely extend a voluntary suspension of production at its Bedford, Ohio, facility, so it could implement “any appropriate corrective actions that may be needed.” In November and December of that year, the FDA inspected the facility and reported that preventive maintenance was not being performed on time; that the company had failed to properly investigate complaints of metal particles in sestamibi, a product used in nuclear-medicine imaging; and that Ben Venue took too long to investigate a 10-gallon can of liquid in a storage area that was found to contain urine.

The production suspension resulted in a lack of available Doxil through late 2012.

Nearly one year ago, in February 2012, the FDA announced that it would take aggressive steps to alleviate the shortage of Doxil. The federal agency temporarily allowed for the importation of LipoDox, doxorubicin hydrochloride liposome injection that was manufactured in India by Sun Pharma Global FZE (Sun) and distributed by Caraco Pharmaceutical Laboratories Ltd. This generic is not approved in the United States.

Additionally, one lot of Doxil that was made by Janssen under an unapproved manufacturing process was allowed to be released. Finally, the FDA assisted drug manufacturer Pfizer in relaunching different sterile injectable oncology drugs that could be used as substitutes.

The generic that has just been approved by the FDA is also made by manufacturer Sun. The intravenous generic will be available in 20 mg and 50 mg vials. Approved generic drugs must have the same quality and strength as brand-name drugs, and the sites where they are made and packaged must pass the same quality standards as those that process brand-name drugs.

In the announcement, the FDA noted that it is still allowing the importation of LipoDox, and that limited supplies of Doxil are available. Once the newly approved generic is available in amounts that meet demand, the agency will no longer exercise its enforcement discretion on LipoDox or any unapproved doxorubicin product.

The FDA has announced the approval of the first generic version of Doxil, which is expected to help alleviate a shortage of the drug that has continued since November 2011.

Generic Doxil Approved, Expected to Help Resolve Shortage

A pair of studies could change the way patients are evaluated for mutations of 

, two cancer susceptibility genes closely associated with breast and ovarian cancers, as well as other tumor types. From an inexpensive screening method, to extremely accurate next-generation sequencing, the methods described in the studies could allow more patients to be screened and sequenced with greater accuracy at a reduced cost.

mutations are five times more likely to develop breast cancer over the course of a lifetime, according to the National Cancer Institute. Additionally, women with these mutations are at higher risk of developing early-onset breast and ovarian cancer.

 mutations are identified through full gene sequencing. Although the existing method is relatively accurate when it comes to identifying mutations, it might not always be able to tell which mutations are actually harmful and could lead to the development of cancer.

Additionally, there are some important limitations with this existing method of sequencing, according to Ellen T. Matloff, MS, CGC, certified genetic counselor and Director of Cancer Genetic Counseling at Yale Cancer Center in New Haven, Connecticut.

“It’s time-consuming,” Matloff said. “It takes approximately three weeks for the results to come back. If you’re testing a newly diagnosed patient, that three weeks can delay any surgical decision-making.”

Matloff said that the cost of the current test is also a concern for many patients. Without insurance, the test costs approximately $4000 per patient, Matloff said.

, researchers developed a new multiple gene expression profile test that was able to predict whether otherwise healthy women carried harmful 

The researchers found that compared with cells from noncarriers, cells with mutations in one or two copies of 

 had a distinct gene expression profile when exposed to radiation or other causes of DNA damage. The finding could aid researchers in distinguishing healthy mutation carriers from noncarriers.

The researchers collected white blood cells from 9 healthy women with mutated 

 and then exposed them to radiation. After the radiation exposure, the researchers extracted the total RNA from these cells and compared it to RNA that was obtained from white blood cells from 10 healthy noncarrier women that were also exposed to radiation.

The researchers identified approximately 1500 genes that were expressed differently between the 

 carriers and noncarriers. That list was narrowed down to 18 genes that were most significantly differentiated between the two groups. A validation study using 21 of the differentiated genes and 5 control genes to predict the risk for carrying a mutation was also performed. Finally, blood samples from an independent group of 40 women who were 

 carriers and 17 women who were noncarriers were analyzed. The researchers found that their model had a sensitivity of 95% and 88% specificity.

“This novel technology aims to provide a layer of information regarding the cell functionality aspect of 

 mutations that could greatly enhance the doctor’s ability to identify high-risk carriers,” said Asher Y. Salmon, MD, a breast cancer specialist at the Hadassah Hebrew University Medical Center in Jerusalem, Israel, and lead author of the study, in a statement. “The current tool for mutation detection is gene sequencing, which is expensive, time-consuming and, in many cases, lacking clear and decisive clinical decision making information. In many cases, the current sequencing tool identifies a mutation, but we do not know if the mutation is neutral or harmful.”

A large validation study is being developed in Europe and North America to assess whether this method of screening is effective in a much larger and heterogeneous population of patients.

Matloff said that because the test is aimed at healthy carriers and noncarriers, she believes it has the potential to reach a wider population while providing very accurate results, and suggests that it could be used as a screening method.

, researchers from the Catalan Institute of Oncology at the Bellvitge Biomedical Research Institute in Spain developed a comprehensive workflow using next-generation sequencing to improve genetic testing for 

 mutations. The researchers wanted to find a method that was both cost-effective and utilized next-generation sequencing to improve sensitivity and specificity.

Although existing methods of sequencing are effective, the researchers noted a couple of limitations. Both 

 are fairly large genes when it comes to sequencing, and there is a lack of mutation hot spots that are easily identified. They suggested that complementary techniques are required to identify large genomic rearrangements of these genes.

The researchers used the BRCA MASTR kit, a molecular diagnostic assay that identifies mutations in the coding regions of the 

 genes, followed by the small-scale GS Junior, a high-throughput sequencer that is available as a laboratory bench top system. Through a variety of validation analyses, the researchers determined that the algorithm had 100% sensitivity and specificity in the samples that were analyzed. Additionally, the algorithm is designed to eliminate false positives.

“This approach allows [us] to identify all point mutations and small deletions and insertions analyzed, even in regions of high technical difficulty, such as homopolymeric regions,” said Conxi Lázaro, PhD, a researcher at the Catalan Institute of Oncology at the Bellvitge Biomedical Research Institute who headed the study, in a statement.

Matloff said that while the algorithm requires further validation, the results of the study were encouraging.

“I don't know if this would be better than the existing methods, but I hope it will be,” Matloff said.

Currently, Myriad Genetics holds the patents on the 

 genes in the United States and also manufactures the only test currently available to identify the presence of mutations in those genes. These patents were the focus of an intense legal battle. In August, a federal appellate court ruled that Myriad could maintain the patent, stating that the isolated 

 genes are not found that way in nature and could therefore be patented. This may have an impact on the eventual commercial availability of these tests, Matloff said.

			Salmon AY, Salmon-Divon M, Zahavi T, et al. Determination of molecular markers for 

 heterozygosity using gene expression profiling [published online ahead of print January 22, 2013]. 

			Feliubaladó L, Lopez-Doriga A, Castellagué E, et al. Next-generation sequencing meets genetic diagnostics: development of a comprehensive workflow for the analysis of 

 genes [published online ahead of print December 19, 2012]. 

A pair of studies could change the way patients are evaluated for mutations of BRCA1 and BRCA2, two cancer susceptibility genes closely associated with breast and ovarian cancers, as well as other tumor types.

The Future of BRCA1/BRCA2 Testing

Cancer impacts the lives of patients in many different ways, but one way in which adults facing a cancer diagnosis may be affected is the impact that the disease and its subsequent treatment can have on sexual function.

Estimates on just how many cancer patients are impacted vary, depending on the tumor type. However, since general treatment options such as chemotherapy and radiation are similar across tumor types, assessing the sexual needs of a cancer patient may benefit in part from a universal approach, still keeping in mind the individual needs of each patient.

That was the message passed along at NCONN 2012 by Michael Krychman, MD, medical director of sexual medicine at Hoag Hospital and executive director of The Southern California Center for Sexual Health and Survivorship, both in Newport Beach, California.

“There are treatments that we do as healthcare professionals like chemotherapy and radiation that can have far-reaching implications on sexual function, as well as medications that we put our patients on that may be for an extended period of time—that all can have an impact on the sexual response cycle,” Krychman said.

For example, women treated with radiation for their tumors often experience a range of similar side effects that impact sexual function across tumor types, including vaginal changes, erythema and ulcerations, superficial or deep dyspareunia, and local effects due to placement. For patients treated with chemotherapy, sexual side effects can include premature ovarian failure, amenorrhea, menopausal syndrome, and vaginal mucosal erythrodysesthesia.

Some types of cancer have their own impact on sexual healt h beyond these side effects, however. Lung cancer patients of - ten have difficulty breathing, so Krychman recommended that intimacy be scheduled during optimal breathing times and avoided after consuming a heavy meal or alcohol because of the impact that fatigue may have on breathing; in addition, bronchodilators and oxygen therapy should be used prior t o intimacy, if prescribed. Anot her example is Hodgkin’s lymphoma, where intensive treatments such as bone marrow transplants and high-dose chemotherapy can lead to sexual problems and fertility issues.

Krychman said that when it comes to sexual health, patients with cancer may need to establish a “new normal,” which may include the use of various therapies to address sexual complaints. Krychman said that there are more options than ever before when it comes to safely and effectively improving sexual function.

	It’s very important to normalize the experience and create a safe environment where sexuality can be discussed. ”

He reviewed a number of therapies at the conference, including ones that are currently under clinical investigation. One such product is ospemifene, a selective estrogen receptor modulator that is under review by the FDA to treat vulvar and vaginal atrophy in patients who have gone through menopause in order to treat moderate to severe dyspareunia, or painful sexual intercourse. If approved, it would be the first oral alternative to vaginal estrogens. Additionally, intravaginal dehydroepiandrosterone (DHEA) suppositories, which have been shown to restore and revive the vaginal epithelium without affecting estradiol levels, are under clinical investigation as well.

While DHEA suppositories are being studied in cancer survivors, ospemifene is not being explored specifically in cancer patients with sexual health concerns. However, Krychman believes that cancer patients could benefit from these new therapies if studies back up their clinical efficacy.

“We’re waiting to see what will happen in terms of the FDA with ospemifene, and then maybe they would consider further postmarketing studies in the oncologic patient,” Krychman said. “But it’s a very exciting time for sexual medicine in general, particularly when there is some concern for the cancer patient.”

A continually expanding assortment of viable treatment options is available, but Krychman said the only way that a patient is going to benefit from these options is if the channels of communication remain open. Krychman said that the nurse navigator is an essential part of establishing a safe environment for the patient so that he or she feels comfortable enough in discussing sexual health issues, and even then, only when the time is appropriate.

“We need to individualize and prioritize with our patients who come in,” Krychman said. “Some may not benefit from early discussion. Others may benefit during therapy, and others may benefit in their survivorship phase. There’s really no one hard, fast rule, but I think it’s very important to normalize the experience and create a safe environment where sexuality can be discussed and resources can be accessed as well.”

Dr. Michael Krychman on the Awareness of Sexual Health Concerns 

If a patient is not ready to talk to a nurse navigator or a treating oncologist in person about sexual health concerns, Krychman suggested a number of online resources that could be of some assistance and lend themselves to eventual discussion in person. One website he suggested was the International Society for the Study of Women’s Sexual Health (ISSWSH), where patients can find providers in their region who address sexual health concerns.

“I think it’s important for patients to become educated and mark down their questions so they’re prepared for their visit,” Krychman said.

Sexual Health Considerations in Cancer Treatment and Survivorship

	With approximately 80% to 90% of multiple myeloma patients developing osteolytic bone lesions at some point during the course of their disease, it is important for oncologists to monitor these patients, and to design and administer appropriate bone health treatments at the earliest stages, in an effort to prevent or minimize the effects of skeletal-related events (SREs).

	For many years, the standard method of assessing the extent of bone disease in multiple myeloma patients has been a skeletal survey, which consists of a series of x-rays across the whole skeletal system that can detect “punched out” lesions caused by multiple myeloma. This method detects approximately 80% of cases of myeloma that have metastasized to the bone.

	However, not only does this method not catch every case of bone disease, it only detects them if lytic bone disease has caused at least 30% of the trabecular bone to be lost. Likewise, it is not sensitive enough to assess how patients respond to therapies designed to prevent SREs or maintain bone mass.

	The use of combination PET-CT scans is one method of following a patient after he or she has been prescribed a medication used to mitigate bone disease.

	“A PET-CT can give you a real-time image of whether the disease is progressing,” said David S. Siegel, MD, PhD, Chief of the Division of Multiple Myeloma at John Theurer Cancer Center in Hackensack, New Jersey.

	CT scans utilize a higher level of radiation, so they are not typically used for screening. However, in combination, PET-CT scans are able to detect small lesions that could not have been detected through whole-body x-rays. Because the lesions detected through PET-CT scans are small, there is a higher probability of obtaining false-positive results.

	MRI allows for the assessment of myeloma involvement in bone marrow. It has been shown to have greater sensitivity than radiographs when used to detect asymptomatic bone disease.

	“An MRI is a great way of looking at whether the myeloma is diffuse and has presented itself in other parts of the bone structure,” Siegel said.

	Siegel noted that one method being investigated is the use of PET and MRI scans together. Additionally, PET scans have become much more sensitive as different isotopes, such as (18)F-fluoride, have been utilized, making multiple myeloma lesions easier to identify.

 in August compared the accuracy of (18) F-fluorodeoxyglucose (FDG) PET-CT scans with contrast- enhanced MRI for multiple myeloma. These are the two most sensitive imaging techniques currently available for patients with multiple myeloma. The study was a retrospective analysis of 210 PET-CT and 210 MRI studies of multiple myeloma patients.

	PET-CT scans had a greater impact on downstaging: 11 of 62 patients who received PET-CT scans (17.7%) had their disease down-staged compared with only 1 patient who had an MRI (1.6%). Additionally, in 27 of 40 patients (67.5%) who achieved good or complete clinical response to therapies, the normalization of findings was faster for PET-CT scans than for MRI (

	In 90 patients who received the scans for followup, however, MRI was better at detecting disease recurrence. Of those 90 patients, 10 of the patients presented with clinical recurrence. MRI was able to detect active lesions in 8 of the 10 patients (80.0%) compared with 5 patients by PET-CT scans (50.0%).

	“The skeletal survey is still the standard,” Siegel said. “However, PET and MRI scans are extremely useful and have improved tremendously over time and are a necessary part of following up with these patients.”

	Early Interviews, Follow-up Scans Crucial

	Bone disease is so prevalent in multiple myeloma patients that the time to begin examining a myeloma patient’s bones is right at baseline, according to Elizabeth Bilotti, MSN, BSN, APN-C, who works in the myeloma division at John Theurer Cancer Center in Hackensack, New Jersey. She said that it is important to interview the patient at baseline to see if he or she reports being symptomatic, complains of bone pain, or exhibits any other signs that might indicate bone disease, in addition to a skeletal survey. “All of that needs to be part of the work-up when trying to provide a diagnosis.”

	While early diagnostic tests are important, Bilotti said that follow-up tests utilizing PET-CT scans or MRI scans are crucial when it comes to following the course of disease.

	“A PET-CT can be a great way of determining whether a patient is developing plasmacytoma,” Bilotti said, indicating that plasmacytoma denotes a lesion that appears to be an isolated form of myeloma, and therefore has not yet spread throughout the bone.

	Bilotti cautioned that a combination PET-CT scan is not perfect. Even when a head-to-toe PET scan is performed, there is a high probability of obtaining a false-positive.

	This is why Bilotti recommends employing multiple imaging methods in every patient when available. In Bilotti’s experience, a MRI scan is not as good a method for looking at the bone, but it’s a better method of looking at the marrow and soft tissue in general. For example, a MRI scan is better for looking at the spinal cord and determining whether the disease has caused any cord compression.

	“If a patient is experiencing cord compression fractures, MRIs are a good way of identifying and following those fractures,” Bilotti said.

	Drugs like zoledronic acid are recommended by several treatment guidelines as a method of addressing these bone issues, but Bilotti said that nothing on the market as of yet reverses the bone damage caused by multiple myeloma.

	“When looking at these images, we’re not expecting to see a reversal of the lesions or the fractures,” Bilotti said. “We’re looking to compare these lesions to baseline and make sure that their progression is being kept to a minimum.”

	Spinnato P, Bazzocchi A, Brioli A, et al. Contrast enhanced MRI and (18)F-FDG PET-CT in the assessment of multiple myeloma: a comparison of results in different phases of the disease. [published online ahead of print August 23, 2012]. 

It is important for oncologists to monitor, design, and administer appropriate bone health treatments at the earliest stages for the 80% to 90% of patients with multiple myeloma who develop osteolytic bone lesions.

Detecting Bone Disease in Multiple Myeloma Patients

	Oncologists are focused on treating a patient’s cancer. They want to eliminate tumors, minimize the side effects of chemotherapy and radiation therapy, prevent the disease from spreading, and focus on patient survival. While this treatment addresses a patient’s physical health, the mental state of the patient is something that might need more than an oncologist’s expertise.

	“We have wonderful medical technicians and clinicians who will treat the cancer itself,” said Wayne A. Bardwell, PhD, MBA, director, Patient and Family Support Service and the Doris A. Howell Palliative Care Service at the University of California, San Diego Moores Cancer Center. “But we need to be aware of the individual and the family support system that’s affected by the cancer as well.”

	Bardwell spoke at NCONN 2011 about psychosocial considerations in cancer patients, noting that gathering concrete data in this population can be quite difficult. The data that are available reveal that the most common mood disorder among cancer patients is depression, which can be triggered by everything from the initial diagnosis, to treatment, to changes in physiology. In breast cancer, Bardwell said it is estimated that as many as 55% of patients deal with depressive disorders, with 17% to 30% of patients experiencing depression well into survivorship.

		Factors associated with depressive symptoms in patients with early-stage breast cancer.

	Bardwell discussed a study he published in the 

 in 2006 that reported the unexpected finding that cancer-related variables such as treatment and diagnosis were not associated with breast cancer patients’ depressive symptoms (

). Rather, those depressive symptoms were more closely linked to psychosocial variables beyond cancer.

	“The quality of the individual’s social support network, whether or not they had insomnia, whether or not they felt comfortable expressing their feelings, these were factors that we understand are important risk factors for depression in the general population, and they turned out also to be the important factors in this breast cancer population,” Bardwell said. “The surprise was that these very specific cancer variables such as cancer severity or type of treatment were unimportant in understanding who might get depressed.”

		Cancer patients’ psychosocial needs have only recently begun to be addressed as part of comprehensive cancer care by nationally recognized organizations, such as the American College of Surgeons, ASCO, and NCCN. Wayne Bardwell, PhD, MBA, spoke to the NCONN attendees specifically about the complexity of these patients’ psychosocial needs.

		Bardwell emphasized the importance of early and ongoing assessment. Though a cancer diagnosis is not predictive of depressive symptoms, early and ongoing intervention is important for quality of life. This can also have an impact on overall survival, though further studies are needed to determine the significance and relevance of this theory.

		ASCO Standards for Psychosocial Care were implemented in 2008. While participating practices saw an increase in the assessment of newly diagnosed patients, rates for taking action did not change.

		Bardwell reviewed active listening skills, which are helpful for developing a therapeutic relationship with cancer patients and their families. Having a healthy therapeutic relationship with patients is a crucial aspect of patient navigation, particularly when action is needed in a timely fashion. He also discussed common emotional needs that patients may have during the continuum from diagnosis to survivorship. He closed by remarking on healthy coping habits and skills, and left us with some inspirational quotes.

	At the NCONN conference, Bardwell suggested a number of actions that nurses can take to minimize depressive episodes in cancer patients. Active listening, providing valuable feedback, and responding to the patient’s questions and concerns appropriately are among the ways nurses can ensure that patients’ mental health concerns are properly addressed.

	Bardwell said that physicians often tell patients that they have nothing to fear after being given a cancer diagnosis, yet even though the practitioner might have the best of intentions, saying that might leave the patient feeling ashamed or misunderstood. Letting patients speak and offering them help might be a better approach to allaying patients’ concerns.

	“We have a tendency to want to help people solve their problems,” Bardwell said, “but there’s a power in just listening to an individual describe what’s going on with them.”

	The overall accessibility of psychosocial care for cancer patients will receive a tremendous boost next year from an update to the Cancer Program Standards of the American College of Surgeons Commission on Cancer (CoC). Starting in 2012, all cancer programs seeking accreditation from the CoC will be required to screen and evaluate patients to identify psychosocial issues impeding patient progress during treatment and survivorship. The new standard will additionally require that all CoC-accredited oncology programs either have psychosocial services onsite or be equipped to link patients to the proper resources.

	Bardwell WA, Natarajan L, Dimsdale JE, et al. Objective cancer-related variables are not associated with depressive symptoms in women treated for early-stage breast cancer. 

Cancer treatment addresses a patient's physical health but the mental state of the patient is something that might need more than an oncologist's expertise.

Psychosocial Considerations in Cancer Care

	Awareness and treatment of oncofertility have been given a tremendous boost over the past 5 years by the Oncofertility Consortium, a national interdisciplinary research network dedicated to fertility preservation and sparing for patients with cancer. Teresa K. Woodruff, PhD, the director of the Oncofertility Consortium, discussed oncofertility at NCONN 2011.

	Approximately 800,000 young women in the United States face reproductive issues related to cancer treatment, and 40,000 new cancer patients join this list every year, according to Woodruff, a Thomas J. Watkins Professor of Obstetrics & Gynecology at the Northwestern University Feinberg School of Medicine and professor of Biochemistry, Molecular Biology and Cell Biology in the Weinberg College of Arts and Sciences. Studies report that survivors with fertility issues experience increased depression, anxiety, and stress.

	To help these patients, Woodruff said the Oncofertility Consortium seeks to increase overall awareness of reproductive issues related to cancer treatment, gather data to determine the risk of sterility and early menopause for young women, and facilitate the delivery of existing and emerging reproductive treatment technologies to the patients who need them. The Consortium, which is headquartered at Northwestern University, provides >2700 oncofertility consultations each year.

	Oncofertility intervention should take place at diagnosis, or even earlier if genetic screening reveals patients are at risk for certain cancers, Woodruff said. Early intervention is crucial because fertility preservation often involves procedures that take place before cancer treatment begins.

		The Oncofertility presentation brought forth a mission and message of hope in helping some of our current cancer patients and survivors achieve their lifetime goal of having a family. The message was powerful and encouraging for those of us who are caregivers of adolescents and young adults who seek guidance about their fertility options.

		As medical professionals in the oncology field, we aspire to guide our patients and their families through these difficult conversations with a sense of hope and accuracy.

		Teresa K. Woodruff, PhD, offered insight into cutting-edge research and basic science breakthroughs in follicle growth and egg preservation.

		The conversations surrounding reimbursement of these procedures were very helpful in guiding our patients with concerns of the cost of such technology and provided potential financial resources for their oncofertility options.

		We also gained insight into multiple websites and an iPhone application that are excellent resources for our patients and their families in guiding them through the process and gaining up-to-date information about current practices and research.

		This presentation will undoubtedly impact our current practice and ignite a sense of urgency in supporting programs and research by the Oncofertility Consortium and other related fertility preservation initiatives.

	Woodruff also noted the importance of informing patients that fertility issues can develop long after treatment ends. Some women are not immediately sterile following treatment, and can even experience the return of a somewhat normal menstrual cycle. However, cancer treatments can cause menopause to start 5 to 10 years earlier than in the average healthy woman. Survivors who think they are in the clear after treatment could eventually become sterile.

	At NCONN 2011, Woodruff highlighted several oncofertility options:

	Embryo banking involves the freezing of fertilized eggs for future use. Prior to cancer treatment, a woman receives hormone injections to increase egg production. Through in vitro fertilization, the eggs are then removed and combined with the partner’s or donor’s sperm in a laboratory dish. After fertilization, the embryos are frozen until they are used to impregnate the woman.

	With egg banking, the eggs are extracted and frozen instead of fertilized. They are then thawed and fertilized at a later date. Success rates for pregnancy are lower with egg banking than with embryo banking.

	Ovarian tissue cryopreservation provides an option for patients who are too young or who are not candidates for embryo or egg banking, or do not want to receive the hormone treatments required for the banking process. The procedure involves removal of a woman’s ovary prior to receiving chemotherapy and/or radiation. Ovarian tissue is then frozen and can later be implanted back into the patient through an ovarian tissue transplant. Pregnancies have resulted from this method.

	The Oncofertility Consortium is also working on isolating follicles and enclosed eggs from the ovarian tissue, and fertilizing the eggs in vitro. The procedure has been used to impregnate mice but has not yet been successful in humans.

Exclusive Interview With Teresa K. Woodruff, PhD

	Woodruff said insurers are often hesitant to reimburse women for oncofertility care because of a lack of clinical data. The Oncofertility Consortium is working to produce the data, and in the meantime is advocating for patients. “We are sending the information to these insurers, and hopefully we’ll get reimbursed for many of these costs,” Woodruff said.

	The Oncofertility Consortium offers a patient website at MyOncofertility.org. Its main website (oncofertility. northwestern.edu) has resources for both oncology patients and oncology professionals. Other resources include the National Fertility Hotline at (866) 708-3378 and the iSaveFertility iPhone app, which provides a quick reference guide to fertility preservation.

Awareness and treatment of oncofertility have been given a tremendous boost over the past 5 years by the Oncofertility Consortium.

Oncofertility: Updates on Fertility Preservation Related to Cancer Care

	From initial screening and diagnosis to reconstructive surgery and survivorship, breast cancer patients have many options when it comes to their care. However, navigating the system can be complex, and as a result, patients may not be receiving the best possible care available to them. For example, in a recent study by Alderman et al,

 70% of general surgeons did not discuss reconstructive surgery options with breast cancer patients.

	“I think we need to raise the bar,” said Beth Baughman DuPree, MD, FACS, medical director of the breast health program at Holy Redeemer Hospital in Pennsylvania.

	At NCONN 2011, DuPree spoke to oncology nurses about prevention, detection, diagnosis, treatment, and survivorship pertaining to breast cancer patients and how much the field has changed based on clinical trials and an increased knowledge base. “I want our nurses who are in the forefront of this cancer process to be able to help educate their patients on what their choices are all along the way,” said DuPree.

	To emphasize her point, DuPree noted that many surgeons nationwide still use radical breast surgeries similar to those developed by William Stewart Halsted in the late nineteenth century, physically disfiguring patients for life while not guaranteeing a complete disease remission. She said that surgeries have become far less invasive and reconstructive surgeries—from nipple-sparing mastectomies to silicone implants&mdash; have drastically improved a patient’s self-image after treatment.

		TABLE 1. Survival Outcomes of the Z11 Study

	ALND indicates axillary lymph node dissection; DFS, disease-free survival; HR, hazard ratio; OS, overall survival; SLND, sentinel lymph node dissection. [Adapted from Giuliano et al. 

	Z11 Trial: Some Patients Need Less Surgery

	DuPree said that performing more surgery might not always be the best option for the patient, as clinical trials are starting to reveal. She pointed to the Z11 study,

 in which the survival of patients with 1 or 2 cancerous sentinel lymph nodes was not affected by whether or not they had a sentinel lymph node dissection alone or axillary lymph node dissection (

	In the Zll trial, “Less surgery did not cause less survival,” DuPree said. However, DuPree added that this only applied to patients who had been tested mammographically, ultrasonographically, and had palpably negative axilla. “We really need to make sure we are putting the appropriate patients into that subgroup [of patients who do not require axillary lymph node dissection].”

		One of the highlights of the NCONN conference was Dr DuPree’s breast care update. She covered topics from the history of breast care, to where we are today and important studies/trials that have influenced today’s breast care. She then went into specifics on prevention, screening, genetic risk assessment, and surgical intervention. She wrapped up her talk by explaining the recent paradigm shift in breast care and outlining how that shift allows for early detection, better screening tools, and minimally invasive diagnostic biopsies, just to name a few of her points.

		I am not a specific breast care nurse navigator, but I am a general oncology nurse navigator so I do work with breast patients as part of my practice. It was very beneficial to have Dr DuPree present such a thorough and comprehensive update on breast care. For me it was an opportunity to learn a lot at once and not have to go back and put different pieces of the puzzle together—very valuable for a navigator who navigates many different disease types.

	DuPree also provided an update on diagnostic techniques. After the United States Preventive Services Task Force made a controversial recommendation that women aged 40 to 49 years not receive regular mammograms, additional studies have actually confirmed the effectiveness of screening at these early ages. DuPree said that women should consider getting an annual mammogram performed starting at age 40.

	MRIs offer an additional screening option for women who are BRCA1 or BRCA2 positive, have a history of atypical ductal hyperplasia or lobular carcinoma in situ, have a personal history with breast cancer, or have a family history of breast cancer with >20% risk of developing the disease.

	DuPree also explained newer diagnostic techniques that utilize advances in stereotactic imaging, including MRI-assisted and ultrasoundguided biopsies. The ultrasound-guided biopsies provide images in real time and are minimally invasive without exposing the patient to radiation. MRI-guided biopsies are able to rule out multifocal disease, as well as evaluate the extent of the disease. Positron emission mammography is also being explored as a highly sensitive test that may eventually be used for breast cancer screening.

	DuPree also discussed the benefits of an integrative approach for both cancer prevention and an improved quality of life during survivorship. She described several studies that have suggested the anti-cancer benefits of a high-fiber, low-fat diet; anti-cancer foods, such as certain spices, mushrooms, vegetables, and chocolate; and omega-3 fatty acids.

	Regarding survivorship, DuPree said services such as massages and spiritual counseling can help turn “survivors” into “thrivers.” She described “thrivorship” as “When cancer’s not the first and last thing you think about every morning and when you find positives in your life after the cancer, and you’re living your life, and you’re living in the moment, that’s when you’re thriving, because you’re no longer defined by your cancer experience.”

			Alderman AK, Hawley ST, Waljee J, et al. Understanding the impact of breast reconstruction on the surgical decision-making process for breast cancer. 

			Giuliano AE, Hunt KK, Ballman KV, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. 

Beth Baughman DuPree, MD, FACS, discussed the latest in breast cancer care at the 3rd Annual NCONN Conference.

Ben Leach