	Dr Massad is a gynecologic oncologist at the Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis. He was a delegate to the consensus conference at the National Institutes of Health, where new cervical cancer screening guidelines were developed.

The release of two sets of guidelines in the past year has changed US clinicians’ approach to cervical cancer prevention by lengthening screening intervals, defining starting and stopping points for screening, and integrating human papillomavirus (HPV) testing into screening and management. The first guidelines covered how clinicians screen for cervical cancer. These were jointly released in March 2012 by the American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology. ASCCP will follow up in April with guidelines on management of screening.

Pap testing has been the foundation of cervical cancer prevention in the United States since Dr George Papanicolaou developed the technique in the 1940s. Once a leading cause of cancer death in US women, cervical cancer is now uncommon, with the ACS projecting only 12,340 cases and 4030 deaths in 2013. This decline is attributable to Pap testing to identify precursor lesions that can be treated prior to the development of cancer. Traditionally, clinicians recommended annual Pap testing and treatment of any grade of cervical intraepithelial neoplasia. However, the discovery of HPV by German virologist Dr Harald zur Hausen in the 1980s has allowed a better understanding of the nature of Pap test abnormalities, the transient nature of most HPV infections that underlie them, and the long lag period between HPV infection and cancer for most women who develop cervical cancer.

The peak age of onset of cervical cancer is around age 50. Cervical cancer is rare in women in their teens and early 20s, and most instances take years to develop after HPV infection. Some 80% of sexually active adults are infected with HPV, but more than 90% of infected individuals will clear their infections and are at low risk for cervical cancer.

Annual Pap tests commonly diagnose these transient HPV infections, including grade 1 CIN, with negligible cancer prevention benefit. Treating these lesions can increase the risk for preterm delivery in subsequent pregnancies. These findings prompted reexamination of past standards for cervical cancer screening and the management of abnormal screening results.

		Once a leading cause of cancer death in US women, cervical cancer is now uncommon. This decline is attributable to Pap testing used to identify precursor lesions, such as the one pictured, that can be treated before cancer develops. Traditionally, clinicians recommended annual Pap testing and treatment of any grade of cervical intraepithelial neoplasia. However, the discovery of the human papillomavirus (HPV) has allowed a better understanding of the nature of Pap test abnormalities, the transient nature of most HPV infections that underlie them, and the long lag period between HPV infection and cancer for most women who develop cervical cancer.

New guidelines were developed by consensus in meetings held on the campus of the National Institutes of Health in Bethesda, Maryland, that included representatives from professional associations, patient advocacy groups and federal agencies, and other stakeholders. All guidelines were based on evidence review. Revision of the screening guidelines was facilitated by randomized trials of Pap and HPV testing in screening. Management guidelines were revised using estimates of the risk of high-grade CIN and cervical cancer from records of nearly 1.4 million women cared for in the Kaiser Permanente Northern California group.

The new screening guidelines recommend delaying Pap testing until age 21, given the low cancer risk among teens and the potential for serious reproductive morbidity from treatment. The guidelines replace annual Pap testing with Pap testing once every 3 years. For women ages 30 to 64, Pap and HPV cotesting is preferred since it has a greater sensitivity for subsequent disease and allows 5-year screening intervals. Screening should cease after hysterectomy for benign disease and at age 65 for women with recent negative screening histories.

The new management guidelines are more complex. Less aggressive evaluation and treatment is recommended for women ages 21 to 24 because their cancer risk is intermediate between that of younger and older women. Women with carcinogenic HPV infections but no Pap abnormality are managed with repeat cotesting in a year, and only those with persistent HPV infection or an abnormal Pap result go on to colposcopy to assess for cervical precancer. Genotyping for the highest risk HPV types (16 and 18) allows earlier triage to colposcopy when Pap tests are negative.

Women with abnormal Pap results but negative HPV tests can be observed if the Pap abnormalities are borderline, but risk remains high for those with high-grade Pap abnormalities, and colposcopy is still indicated. Follow-up after colposcopy and treatment using cotesting combines greater sensitivity for detecting new lesions with longer follow-up intervals.

These guidelines should result in cervical cancer prevention strategies that are less intrusive and more cost-effective, yet also carry lower morbidity. The new screening guidelines allow primary HPV testing as a cervical cancer screen in restricted settings, and future screening strategies may incorporate HPV testing; however, considerable education of patients and providers is needed before US clinicians adopt widespread primary HPV screening.

For more information about the screening guidelines, visit 

Articles

Partner Perspectives

L. Stewart Massad, MD, discusses recent updates to guidelines for cervical cancer screening intended to implement prevention strategies that are less intrusive and reduce morbidity.

Cervical Cancer Screening Guidelines Updated: Changes Mean Less Intrusive Prevention Strategies, Lower Morbidity

	A chronic shortage of the most commonly used taxane for ovarian cancer would add almost $9 million a month to the cost of care if half of newly diagnosed cases were affected, according to a model of transition to an alternative therapy.

	Using docetaxel instead of paclitaxel would cost $16,107 per six cycles of therapy, or more than three times as much as a typical paclitaxel-carboplatin regimen. The estimate includes the higher cost of the taxane component of the regimen and costs associated with managing higher anticipated rates of adverse events with docetaxel, Laura J. Havrilesky, MD, reported at the 2012 SGO Annual Meeting.

	“Based on the expected 21,990 women in the United States who are diagnosed with ovarian cancer yearly, of whom at least 85% receive platinum-taxane chemotherapy, a drug shortage that affects approximately 50% of women initiating chemotherapy each month is expected to impact 779 women and cost thirdparty payers an additional $8,609,872 per month,” said Havrilesky, associate professor of Obstetrics and Gynecology at Duke University School of Medicine in Durham, North Carolina.

	Last year, paclitaxel joined a list of more than 200 drugs for which supply could not keep up with demand. According to the FDA, the shortage of paclitaxel has resulted from a combination of manufacturing delays and increased demand. As of mid-June, paclitaxel remained on the shortage list posted on the FDA website.

	Most of the drugs on the list are generics, including a substantial number of oncology drugs. In many cases, alternatives—often more expensive alternatives&mdash;are available. The higher price of the alternative only begins to reflect the economic impact of drug shortages. In an effort to quantify the costs more completely, Havrilesky and colleagues examined paclitaxel as an example.

	The investigators developed a modified Markov state transition model to estimate the economic impact of the paclitaxel shortage. They based the analysis on a comparison of two platinum-taxane regimens for newly diagnosed ovarian cancer, which each continued for six cycles:

		175 mg/m2 of paclitaxel plus carboplatin AUC 5 (standard)

		75 mg/m2 of docetaxel plus carboplatin AUC 5 (shortage scenario)

	Survival was assumed to be equivalent with the two regimens. Adverse-event data were derived from the Scottish Randomized Trial of Ovarian Cancer (SCOTROC).

 Costs of chemotherapy, hematopoietic support, and treatment of adverse events were estimated from national databases. Quality-of-life estimates came from utility scores of clinical trials involving women with metastatic breast cancer and ovarian cancer.

	The cost considerations related to adverse events took into account only grade ≥2 neuropathy, febrile neutropenia, and grade 3-4 anemia. The adverse events were assumed not to occur until after the third cycle of therapy.

	Grade ≥2 neuropathy automatically led to a switch from paclitaxel-carboplatin to docetaxelcarboplatin or from docetaxel-carboplatin to carboplatin alone. Investigators assumed that febrile neutropenia resulted in hospitalization in all cases, followed by prophylactic treatment with granulocyte- colony-stimulating factor for the last three cycles of therapy.

	The estimated cost per cycle of therapy averaged $458 for paclitaxel-carboplatin and $2504 for docetaxel-carboplatin. Using the SCOTROC experience, Havrilesky and colleagues assumed that the docetaxel regimen would lead to more febrile neutropenia and grade 3-4 anemia, whereas paclitaxel would be associated with more neurotoxicity. The model yielded an average cost of $4939 for six cycles of paclitaxel-carboplatin versus $16,107 for docetaxel-carboplatin, a difference of $11,168 per patient treated for six cycles.

	“Standard therapy [paclitaxel-carboplatin] was the dominant strategy—less expensive and more effective than the drug-shortage scenario&mdash;based on the lower cost and the more favorable quality-of-life profile of paclitaxel,” said Havrilesky.

	Of nearly 22,000 women with newly diagnosed ovarian cancer each year, about 85% receive the paclitaxel-carboplatin regimen as initial chemotherapy. Assuming that the paclitaxel shortage would affect half of the women who otherwise would receive the standard regimen, the investigators estimated that treatment for 779 women would be affected each month, raising the cost of treatment by $8,699,872 per month (the difference between the $3,847,481 monthly cost of the standard regimen and $12,547,353 monthly for the docetaxel regimen).

	The estimated monthly cost differential between the two regimens would lead to an additional $104,398,464 per year for treatment of newly diagnosed ovarian cancer.

			Havrilesky L, Garfield C, Barnet J, Cohn D. Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer. Presented at the 43rd Annual Meeting of the Society of Gynecologic Oncology; March 24-27, 2012; Austin, TX. 

			Food and Drug Administration. Current Drug Shortages. 

			Vasey PA, Jayson GC, Gordon A, et al. Phase III randomized trial of docetaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. 

Conference Highlights

A chronic shortage of the most commonly used taxane for ovarian cancer would add almost $9 million a month to the cost of care if half of newly diagnosed cases were affected.

Paclitaxel Shortage May Add Millions to Cost of Ovarian Cancer Care

	More than 30,000 oncologists from around the world gathered in Chicago, Illinois, from June 3-7 for the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO). With its “Patients, Pathways, Progress” theme, the conference showcased the latest clinical advances in oncology research. 

 has sifted through the thousands of abstracts presented at ASCO and identified studies to highlight for you. Our abstract selection process focused on research with the potential to change practice, important studies that failed to meet expectations, and topics particularly relevant to oncology nurses. Here is our special ASCO coverage, including personal perspectives from oncology nurses.

	Side Effects Not Prohibitive to Using Exemestane for Breast Cancer Prevention

	Lisa Schulmeister, RN, MN, APRN-BC, OCN®

	In media reports and interviews, oncologists have expressed excitement about the MAP.3 trial’s findings, and note that exemestane may be an alternative to tamoxifen or bilateral prophylactic mastectomy in reducing breast cancer risk in high-risk postmenopausal women.

	In the trial, side effects that were increased with exemestane use included hot flashes, fatigue, insomnia, gastrointestinal effects, and arthritis. However, the absolute differences in side-effect occurrence between the 2 arms were small, with the exception of hot flashes. Forty percent of the exemestane cohort reported hot flashes versus 32% of the placebo arm.

	The study arms showed no difference in cardiovascular events, clinical skeletal fractures, osteoporosis, and other malignancies. Additionally, exemestane has fewer side effects compared with other agents used to prevent breast cancer, such as tamoxifen.

	One notable limitation of the MAP.3 study was that the median follow-up duration was only 3 years.

Exemestane Is a New Option for Prevention of Breast Cancer in Postmenopausal Women

	Bay Regional Medical Center, Bay City, MI

	Hot flashes affect quality of life in those who have experienced menopause and its aftereffects, as well as those who are undergoing therapy for breast cancer. Flaxseed was seen as a possible relief for hot flashes in a phase III randomized trial at the Mayo Clinic, whose disappointing results were discussed at ASCO by its principal investigator, Sandhya Pruthi, MD, PhD.

	In a pilot study, flaxseed did show an association with decreased number and intensity of hot flashes. However, when compared to a placebo in the phase III trial, the differences were not significant.

	Flaxseed can still be looked at as a healthy component in foods, lending its omega-3 essential fatty acids, its lignans with estrogen and antioxidant qualities, and fiber, both soluble and insoluble.

Flaxseed Ineffective in Controlling Hot Flashes

	Ipilimumab is very unlike chemotherapy in regard to what nurses usually deal with in the infusion room. The drug stimulates the patient’s immune system to go after the cancer, which can also affect other organs. So you can see things as [simple] as a rash when the drug affects the skin cells, or more severe symptoms, such as colitis, which at first people think of as just diarrhea, but it can turn into a very serious, life-threatening situation. Ipilimumab can have similar harmful effects on the liver, as well as the thyroid, adrenal, and pituitary glands.

	Because it is the immune system causing the side effects, it is not just a matter of a drug clearing out of a patient’s system…so nurses have to intervene right away. We developed a patient checklist to monitor patients that goes over things such as number of daily bowel movements, skin integrity, fatigue levels, and more. The goal is to prevent patients receiving ipilimumab from reaching a grade 3 toxicity. There are a lot of times when patients get severe enough grade 3 reactions that we can’t give them any more ipilimumab. With early intervention, however, we can manage the side effects and safely continue the treatment.

Two Studies Herald New Era in Melanoma Therapy

	Genetic Research Is Changing Clinical Practice in Lung Cancer Treatment

	Assistant Director, Senior Medical Liaison

	Although genetic research has made great advances in many other cancer types, the genetic/genomic understanding of lung cancer remains somewhat limited. This appears to be changing, as genetic research results presented at ASCO promise to have a significant impact not only at a level of discovery, but also on the potential to reduce the annual prevalence of lung cancer, as well as have a positive impact on patient quality of life, survivorship, and our society’s economy.

	Preliminary results from the Lung Cancer Mutation Consortium (LCMC) reported at ASCO support pivotal practice changes in lung cancer involving the identification of gene mutations and planning treatment.

	As advancements in targeting cancer behaviors continue, so do the complexities of patient care. These complexities offer the oncology nursing profession complex challenges and unique opportunities. Among the challenges are potential barriers to patient understanding (culture, religion, knowledge, and level of literacy and language) and patient access to timely and appropriate care. Opportunities include expanding professional knowledge, education of peers and patients, nursing research, and advocacy at the patient, physician, payer, and government (local and federal) levels.

	Additional items for oncology nurses to understand as genetic testing changes clinical practice in lung cancer treatment are:

		The genomic mechanism of action aspects of lung cancer and how to interpret medical science language for patient understanding

		The complexities of access to genetic testing and advocating for this important scientific measure

		The importance of a standardized approach for specimen collection processes to ensure efficiencies in testing and reporting

		Important clinical trials and current treatment regimens available to be prepared to answer patient questions

Genetic Testing Delivers Personalized Lung Cancer Therapy

	Otolaryngology Clinical Nurse Specialist

	The Ohio State University Medical Center, Columbus

	With deaths in 2011 resulting from ovarian cancer estimated at more than 15,000, researchers have been working diligently to provide improved outcomes. In the phase III OCEANS trial, not only was there a progression-free survival (PFS) benefit of >4 months in the bevacizumab arm, but those women also had significant tumor shrinkage and a more durable response. In addition, complete response (CR) was seen in 8% more of the women with the addition of bevacizumab.

	The response was not without difficulty. Although both groups had some adverse events, the bevacizumab group had a higher rate of serious adverse events, including 8% higher rates of grade 3-5 adverse events. These more serious events were typical of known adverse events with bevacizumab, namely hypertension, proteinuria, and bleeding/thrombotic events. However, one of the most harmful side effects of bevacizumab, gastrointestinal perforation, was not seen at all in the women receiving bevacizumab in this trial.

	Given the improved PFS, CR, and duration of response with OCEANS, the bevacizumab combination should be considered as a viable option for women with recurrent platinum-sensitive ovarian cancer. Oncology nurses should be aware of the risks associated with bevacizumab therapy and be diligent in their assessments and education regarding adverse events. Preventative measures for bleeding/thrombosis should be initiated with treatment and education regarding symptoms and precautions for bleeding/thrombosis, hypertension, and proteinuria are imperative for better patient outcomes.

Bevacizumab Added to Chemotherapy Provides Meaningful Benefit in Recurrent Ovarian Cancer

Personal perspectives from oncology nurses of abstracts presented at ASCO on research with the potential to change practice, important studies that failed to meet expectations, and topics particularly relevant to oncology nurses.

ASCO 2011: What Nurses Need to Know

In postmenopausal diabetic women, metformin use was associated with lower estrogen receptor—positive (ER ) and progesterone receptor–positive (PR ) breast cancer incidence, according to data presented at ASCO.

	“Metformin is a biaguanide used in management of type 2 diabetes, in which it improves insulin resistance and may improve clinical outcomes,” said Rowan T. Chlebowski, MD, PhD, chief of Medical Oncology/Hematology at the David Geffen School of Medicine, University of California, Los Angeles, and lead author of the study. “Preliminary evidence suggests that metformin may decrease breast cancer risk by decreasing insulin levels and reducing cell proliferation.”

	Metformin helps reduce low-density lipoprotein cholesterol and triglyceride levels, and is not associated with weight gain. As such, the drug is commonly used as a first-line treatment for type 2 diabetes, particularly among overweight and obese patients with normal kidney function.

	Chlebowski and his fellow researchers measured associations between metformin use and breast cancer incidence by hormone receptor status in diabetic patients in the Women’s Health Initiative (WHI). The WHI is a multicomponent study designed to address determinants of major chronic disease in women.

	The researchers’ cohort consisted of 156,229 postmenopausal women aged 50-79 years. A total of 9277 medication-treated cases of diabetes were identified in the cohort and followed for an average of 11.1 years (SD, 3.5 years). Information on drugs taken for diabetes was collected at baseline and after 3 years of follow-up. A subgroup of 2963 women were identified as being treated with metformin.

Positive Metformin Effects Not Surprising

	Metformin, an affordable diabetes medication with a low risk of side effects, is now being considered for treatment in ER /PR breast cancer. The evidence that ER /PR breast cancer patients with lower insulin levels have improved outcomes arrives from a study presented at ASCO. The population group consisted of 156,229 postmenopausal women, of whom 2963 were women with diabetes treated with metformin.

	Metformin works by decreasing the insulin level in the body. Another way to decrease insulin levels is with healthy eating, exercising, and maintaining a healthy weight, which also reduces the risk for breast cancer and recurrence. So it’s not totally surprising that metformin use is linked with decreased ER /PR breast cancer occurrence. Continued research is needed to determine when to potentially prescribe metformin, along with specific dosage details.

	According to Chlebowski, there were major imbalances between the populations with and without diabetes.

	“The diabetics were significantly older and were more likely to be African American, certainly less likely to be physically active than the cohort as a whole, and had a tremendous difference in body mass index [BMI]: 58.6% had a BMI greater than 30,” he said.

	Among the entire study population, 8572 women had breast cancer, with 6994 cases of invasive breast cancer. Among women with diabetes, 502 had breast cancer, with 422 cases of invasive breast cancer. In the metformin subgroup, there were 174 patients with breast cancer.

	On the basis of hormone receptor status, postmenopausal women with diabetes had a 15% lower incidence (hazard ratio [HR] = 0.85; 95% confidence interval [CI], 0.72-1.00; 

 =.04) of ER /PR breast cancer compared with women without diabetes. Additionally, women with diabetes taking metformin had a 38% lower risk for ER /PR breast cancer compared with diabetic women on other regimens (HR = 0.62; 95% CI, 0.44- 0.87; 

	However, this relationship did not hold true for women with invasive breast cancer or for women with ER-/PR , ER-/PR- breast cancer. Breast cancer incidence was also not observed to be lower with triple-negative status, HER2 status, and tumor size and stage, according to Chlebowski.

	In discussing these data, Pamela J. Goodwin, MD, of Mount Sinai Hospital and Princess Margaret Hospital in Toronto, Canada, noted that there have been a number of observational studies of metformin and breast cancer risk, although none have reported details of breast cancer characteristics.

	“Energy balance, as reflected by obesity, diabetes, and its treatment are important endogenous ‘host’ factors that may influence cancer risk and progression,” she stated. “I think as we study these associations, it’s important to be aware of a time course of hyperinsulinemia, hypoglycemia, and diabetes. The potential reversibility of these factors suggests key approaches to cancer prevention.” 

In postmenopausal diabetic women, metformin use was associated with lower ER  and PR  breast cancer incidence.

Metformin May Decrease Diabetics' Breast Cancer Risk

Patients with breast cancer who undertook yoga following radiotherapy derived physical and emotional benefits from the ancient Indian practice, according to research presented at ASCO.

	The study randomized 163 stage 0-III breast cancer patients to either yoga (n = 53), stretching (n = 56), or a wait-listed control group (n = 54). The yoga and stretching groups met 3 times a week for 6 weeks during radiotherapy.

	Patients self-reported changes in fatigue, physical function, depression, benefit finding, and spirituality. The authors also assessed cortisol slope and heart rate variability (HRV) with saliva tests and 10-minute electrocardiograms that were collected at baseline, end of treatment, and 1, 3, and 6 months’ follow-up.

	By the end of radiotherapy, the yoga and stretching groups showed marked improvements in various study endpoints compared with the control group. The results were calculated as change scores:

		Changes in fatigue: yoga (-0.23, for a reduction), stretching (-0.45, for a reduction), wait-list control (0.52, for an increase), 

		Increase in physical function: yoga (5.8 at 1 month, 6.5 at 3 months, 6.1 at 6 months), stretching (2.0, 3.4, 3.4), wait-list control (0.8, -0.2, 1.1); 

		Increase in benefit finding: yoga (3.1 at 3 months and 1.1 at 6 months), stretching (-2.5 and -3.9), wait-list control (-2.5 and -4.7); 

Yoga Facilitates Healthy Living for Patients and Survivors

	It is not surprising that yoga, as compared with stretching and usual practice (control group), improved outcomes such as decreasing fatigue, improving physical functioning, and improving cortisol levels in women with breast cancer undergoing radiation treatment. The results also demonstrated a positive, linear relationship between yoga attendance and beneficial outcomes. Additionally, no injuries or adverse events occurred.

	More researchers are turning to yoga practice as a noninvasive method to help women with breast cancer during and after their treatment. Such research allows for the development of evidence-based protocols for conducting yoga sessions in this population.

	Oncology nurses can investigate yoga classes for cancer patients and survivors that are offered in their community and recommend reputable instructors to their patients. While 3 times a week for yoga practice may seem prohibitive in terms of time and money, yoga is truly a practice for living a healthy life. Yoga transcends the physical poses, breathing practices, and respect for self in the classroom and becomes a daily practice. One’s choices for selecting food to eat, responding to a stressful situation, and taking care of oneself are practiced every day.

	You can learn more about yoga for people with cancer in the Yoga for Cancer Care blog at 

	There were no differences in scores for spirituality and depression.

	The authors also found that the cortisol slope at the end of radiotherapy was steepest for the yoga group compared with the stretching and wait-list control arms (-0.12, -0.08, -0.08, respectively; 

	Yoga has been credited with acting as a stress buffer during radiotherapy, and “what we see by the end of radiotherapy is a split, where the yoga group had the steepest cortisol slope. Blunting of the cortisol slope is actually a predictor of mortality in stage IV disease,” said Lorenzo Cohen, PhD, director of the Integrative Medicine Program in the General Oncology Department at the MD Anderson Cancer Center in Houston, Texas.

	Finally, there were significant increases in HRV from baseline to post-therapy for the yoga group (64.3 ms; 

 < .05) but not for the stretching group (5.8 ms) or the wait-list control arm (-8.1 ms).

	His group is now recruiting 600 patients for a phase III trial in which patients will be blinded to the opposite study arm (yoga vs another type of stress management). This will address criticism from the cancer community that yoga offers little more than a placebo effect, Cohen said. The followup for this study will be 1 year, and the authors also will assess economic outcomes, he added. 

Patients with breast cancer who undertook yoga following radiotherapy derived physical and emotional benefi ts from the ancient Indian practice, according to research presented at ASCO.

Yoga Benefits Patients With Breast Cancer

Breast cancer survivors who stop working during chemotherapy may face the loss of long-term employment for several years after their diagnosis, according to the preliminary findings of a Surveillance Epidemiology and End Results (SEER) registry survey presented at ASCO.

	The researchers found that missed paid work during breast cancer treatment is common. They reported that 24% of patients from a population-based sample in Los Angeles missed more than 1 month of work and 32% stopped working altogether after their diagnosis.

	The team surveyed a diverse, population-based sample of 2245 women with nonmetastatic breast cancer reported to the Detroit and Los Angeles SEER registries over a 19-month period (7/05-2/07) and merged these data to SEER.

	The patients were initially surveyed 9 months after diagnosis and again 4 years later. The survey data were then merged with SEER. The team examined patterns and correlates of paid work for a preliminary sample of 760 patients aged <65 years whose cancer did not recur using chi-squared tests and logistic regression.

	“Our principal dependent variable was long-term work loss, which we defined as working prior to diagnosis but not working four years later,” noted the study’s lead author, Reshma Jagsi, MD, DPhil, associate professor in the Department of Radiation Oncology at the University of Michigan in Ann Arbor.

Increased Survivorship Introduces Challenges

		Mercy Suburban Hospital, Norristown, PA

	Breast care management and breast cancer detection have undergone dramatic changes over the last 20 to 30 years. Survivorship has increased because women are increasingly diagnosed with early-stage disease. Treatment is focused on curing the disease and preventing relapse due to metastatic disease. According to the American Cancer Society, the overall 5-year survival rate for local/regional disease is now >80%. Additionally, women are taking better care of themselves overall through improved nutrition, exercise, and rehabilitation. All of this and the increase in technology have led to the treatment of women who are more likely to be part of the workforce.

	For some women, the diagnosis of breast cancer may impose an economic hardship because they often need to take a leave of absence from work, especially during chemotherapy treatment. This will affect not only the cancer survivor, but her entire family as well. Return to work after breast cancer is important, not only from a societal point of view, but also for the rehabilitation of the cancer survivor. Moreover, returning to or maintaining employment after a cancer diagnosis is important for survivors’ quality of life, including physical, spiritual, and emotional. It seems clear from the study presented at ASCO that further development and evaluation is needed to support women with breast cancer returning to work and the obstacles they will encounter.

	A total of 539 patients (71%) reported working prior to diagnosis. Of this group, 172 (33%) were not working 4 years later.

	The researchers univariate analysis uncovered that long-term work loss was significantly associated with chemotherapy during initial treatment (40% with chemotherapy vs 26% without), as well as those who were older, Latina, less educated, had comorbidities, or received mastectomy. Jagsi reported that tumor behavior (in situ vs invasive), marital status, and radiation receipt were not associated with work loss.

	The researchers’ multivariate analysis— controlling for age, marital status, tumor behavior, comorbidity, race, mastectomy receipt, and radiation receipt&mdash;found that chemotherapy receipt at the time of diagnosis was independently associated with work loss (odds ratio, 2.4; 

 = .004). The excess long-term work loss observed for women who received chemotherapy began soon after diagnosis: Compared with women who did not get chemotherapy, women who did were much more likely to report stopping work 2 years ago or more (34% vs 16%).

	Jagsi said that breast cancer survivors were more likely to experience long-term work loss if they were older, had 2 or more comorbidities, lacked employment support, received chemotherapy at the time of diagnosis, and they lived in Detroit as opposed to Los Angeles. She noted that most women who were not working at the time of re-interview wanted to work: 59% (97/165) reported that it was important for them to work and 27% (46/168) were actively looking for work.

	“The oncology community may wish to explore targeted employment support interventions for patients who plan to receive chemotherapy and whose jobs do not include sick leave or flexible scheduling,” said Jagsi. 

Breast cancer survivors who stop working during chemotherapy may face the loss of long-term employment for several years after their diagnosis.

Breast Cancer Survivors Vulnerable to Long-Term Work Loss

A randomized trial comparing survivorship care plans with standard oncologist discharge visits in patients with breast cancer found no differences in outcomes among the groups, according to data presented at ASCO.

	A research team led by Eva Grunfeld, MD, DPhil, Giblon Professor and director of Family Medicine Research in the Department of Family and Community Medicine at the University of Toronto, examined Recommendation 2 from the Institute of Medicine handbook 

From Cancer Patient to Cancer Survivor: Lost in Transition

, which states, “Patients completing primary treatment should be provided with a comprehensive care summary and follow-up plan that is clearly and effectively explained. This ‘Survivorship Care Plan’ should be written by the principal provider who coordinated oncology treatment.”

	Grunfeld noted that the recommendation was made for all patients because it was considered to have face validity, although there had never been a rigorous evaluation of the hypothesis.

	The multicenter study enrolled 408 patients with early-stage breast cancer who completed primary treatment at least 3 months previously (except for continued use of hormonal therapy) and without recurrent or new primary cancer. All the patients were transferred to their family practitioner (FP) for follow-up care.

Survivorship Care Study Contradicts Expectations

		The University of Kansas Cancer Center, Kansas City

	The results about survivorship care plan outcomes presented by Grunfeld et al at ASCO seem contradictory to what we hear in daily interactions with patients. Repeatedly, nurse navigators hear stories from patients lost in the shuffle and seeking to answer, “What is my roadmap once treatment ends?”

	Survivorship care plans have been sought by survivors and are intended to improve care coordination. Given this report, should we ask, “Are we communicating long-term needs in a way meaningful to the survivor?”

	Nurse navigators are key players in the successful integration of survivorship as a distinct phase in cancer care. Key to that role is preparing patients for a transition from the safety net of their oncology care providers and for achieving a lifetime of good health.

	The field of survivorship has matured in part due to the growing voice of survivors who seek patient-centered care throughout their lifetime. Rightfully so. Given the shortage of cancer specialists and increasing complexity of cancer treatments, oncologists will not be able to follow their patients long-term. The movement toward survivorship wellness will continue and be further refined not only by the medical field, but most importantly, by patients and customer demand.

	An intervention group of 200 patients received a survivorship care plan consisting of a treatment summary, a patient version of follow-up guidelines, and brochures and information about local relevant supportive care resources. These were compiled and reviewed with the patient in a 30-minute educational session with a nurse.

	The FPs of intervention patients received a copy of all documents plus the full guideline and a reminder table of recommended follow-up visits and tests.

	In the control group, 208 patients received a discharge visit and FPs received a discharge letter, according to usual practice.

	“The primary outcome was breast cancer— related psychological adjustment at 12 months post-intervention,” said Grunfeld. She added that secondary outcomes included continuity of care, health-related quality of life (SF-36), patient satisfaction, and adherence to guidelines.

	According to the researchers, there were no differences among the groups on psychosocial adjustment, or on any of the secondary outcomes studied.

	“The results of this trial do not support the hypothesis that survivorship care plans are beneficial to improve patient-reported outcomes,” Grunfeld noted. “A standard discharge visit with the oncologist achieved similar results as a comprehensive care plan and educational session.”

	Lynne I. Wagner, PhD, director of Supportive Oncology at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago and co-chair of the session in which the data were presented, said that she was surprised by Grunfeld’s findings because a survivorship care plan “seems like the right thing” to do.

	Wagner did, however, note one positive result from the study.

	“The finding in both arms of the study that the primary care physician is the correct point of contact is significant given the anticipated gap in the oncology workforce in the United States,” Wagner said. “It will become increasingly important for survivors to know who their ‘go-to’ medical provider is.” 

A randomized trial comparing survivorship care plans with standard oncologist discharge visits in patients with breast cancer found no differences in outcomes among the groups.

Survivorship Care Plans Do Not Improve Outcomes for Patients With Breast Cancer

Breast cancer and its treatment present many personal and physical challenges. Much like the variations in their individual diagnoses, each individual patient will likely have vastly different recovery goals after treatment, with varying physical, psychological, social, and spiritual objectives. Additionally, for each person, the transition from active treatment to survivorship occurs; however, the pace is often much slower than individuals are prepared to handle.

	Whether it is oral or intravenous chemotherapy, radiation, or surgical intervention, treatment involves actively fighting the cancer. This offers a level of comfort, as patients are constantly checking in with physicians and nurses. The interactions provide reassurance that either the treatment is progressing or the cancer is gone.

	When the treatment phase ends, the emotional ramifications of what one has been through may cause a flood of emotions in the newly “cancer-free” individual. Questions arise such as, “Will the cancer return?” and “How will I know if the cancer returns?” Patients eagerly anticipate the completion of treatment; however, the end of treatment does not always bring them comfort. Transitioning from active treatment to one’s “old” life leaves many patients feeling lost and in a constant state of waiting for “what’s next.”

	The Breast or Oncology Nurse Navigator (ONN) can be instrumental to ensuring that a patient transitions from active treatment to becoming a “survivor thriver.” From the time of engagement, the navigator is “hand in hand” with the patient, identifying obstacles and barriers that may derail a successful completion of treatment and transition to survivorship. This is the navigator’s role and area of expertise.

	As with any relationship, communication is essential to a successful navigator-patient relationship. Navigators can be instrumental in educating patients and helping them develop a survivorship care plan. These individualized survivorship blueprints should start as soon as a patient is diagnosed with cancer.

		Complete history of cancer treatment from time of diagnosis to end of active care. This background should include type of surgery, chemotherapy and radiation regimens, as well as names of healthcare providers and treatment facilities.

		Prevention and screening schedule for recurrent and new cancers

		Education guidelines for the patient on how to recognize latent physical and psychosocial effects of cancer treatment

		Surveillance schedule frequency (follow-up visit schedule), including coordination between the patient’s primary care providers and specialists

		Intervention care plan for cancer recurrence

		Resources and support services available to the patient and family/caregiver in her community

	Survivorship care plans consider the patient’s life before cancer, the treatment prescribed and completed, and how to integrate this plan into the patient’s “new” life. Being a survivor is a continuum of cancer care.

Facing Forward: Life After Cancer Treatment

National Coalition for Cancer Survivorship

	Recently, patient navigation has become a focus in healthcare. The reason for the surge in patient navigation is the increased fragmentation of how healthcare is delivered. The complexity of navigating healthcare facilities, increase in available treatment options, decrease in participating specialty providers, and struggling economy have further complicated the process of completing treatment and entering survivorship.

	The good news is breast cancer care has had a patient navigation standard since 2009, when the National Accreditation Programs for Breast Centers (NAPBC) instituted this mandate. The American College of Surgeons Commission on Cancer will soon be adding a new standard on patient navigation so that all patients, regardless of their cancer diagnosis, will have the benefit of a navigator throughout cancer treatment. The Institute of Medicine’s 

 report stressed that all cancer care should provide and ensure appropriate psychosocial health services, facilitate effective communication, identify each patient’s psychosocial needs, design and implement a plan that links the patient with needed psychosocial care, coordinate biomedical and psychosocial care, engage and support patients in managing illness, and systematically follow up on evaluating and adjusting this plan.

	Individuals may benefit from a navigator at any stage of cancer treatment. Patients with breast cancer who have not been connected to a navigator may locate one by contacting their oncologist or cancer center and asking if they have a Breast Cancer Navigator, Patient Navigator, or ONN on staff. Patients can also locate an ONN by visiting the Patient page at 

 and seeing if there is a navigator located near them.

	Sharon Francz, LPN, BHA, is an oncology nurse navigator and the president and co-founder of the National Coalition of Oncology Nurse Navigators (NCONN).

	Institute of Medicine. Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs. Washington, DC: National Academies Press; 2007.

Nurse Navigators

The Breast or Oncology Nurse Navigator (ONN) can be instrumental to ensuring that a patient transitions from active treatment to becoming a 'survivor thriver.'

Navigating Transition: Treatment to "Survivor Thriver"

Am I just noticing the ads, billboards, and TV commercials more often, or have cancer centers increased their advertising? And is it the messages, rather than the number of them, that have caught my eye?

	Not all cancer centers and oncology providers advertise, and there are some that provide straightforward, objective information in their ads. However, there are more than a few that have messages and patient testimonials that, in my opinion, are misleading. I’m not alone in this observation. Back in December 2009, Natasha Singer wrote a piece in The New York Times titled, “Cancer Center Ads Use Emotion More Than Fact” (

). She reviewed multimedia ads from prestigious cancer centers and found that they “often use superlatives, promote the latest technologies, promise unique care, or recount miraculous patient recoveries.” Not much has changed in the 2 years since that article was published, except that I’m noticing that more and more local and regional cancer providers are doing the same thing in their ads.

	Patient testimonials always get my attention, and as Singer noted, it’s the patients who have been cured or have far outlived their projected life expectancies that appear in these ads. I’ve never seen an ad featuring a person with advanced cancer or one who is visibly affected by the disease. In fact, in the ads I’ve seen, patients are smiling and appear to be vibrant and active, with some even holding tennis rackets or golf clubs. Both the stated and implied message is that cancer treatment at the featured facility will fully restore health and well-being. And sometimes, the treatments do, in fact, result in what many would call, “miraculous outcomes.” However, the ads do not note that these results are atypical, and patients are led to believe that they too will respond this well to treatment. Even weight loss ads include the disclaimer that the results are not typical, yet cancer treatment ads are not required to state this.

	Some of the patient testimonial ads link a new treatment modality with a desirable treatment outcome, such as “freedom from cancer” or “life without cancer.” The problem with these ads is that they are only partly correct; it may be true that no other facility provides the new treatment, but it’s misleading to so visibly link the new treatment with curing the patient.

	Other ads focus on the facility itself and use adjectives such as “the first,” “the best,” and “the only” to describe some facet of the services it offers. Some ads are more specific and claim that the facility has “the highest” or “unsurpassed” cure rates. Because this is advertising, these claims don’t need to be substantiated.

	It’s not surprising that patients are asking about a facility’s cure rate, complication rate, death rate, and so on. However, even these numbers can be misleading. Selection bias can occur and skew the data. For instance, the cure rates are higher for a community oncology practice that only treats patients with early-stage cancers than for a cancer center that is administering investigational agents to patients with metastatic disease. And conversely, outcomes for patients who require complex treatment are better in facilities in which specialized services are routinely provided (eg, cancer centers) than in facilities that rarely provide this type of cancer treatment.

	Choosing an oncology provider is a big decision when a person is diagnosed with cancer. There are many things that influence this decision, including a physician’s recommendation, health insurance stipulations, recommendations from relatives and friends, and, of course, advertising. It’s unclear to what extent advertising influences this decision, but since advertising of cancer care is so prevalent these days, it’s worth examining.

	Take a look at the advertising being done by your practice or facility. Is the information accurate? Is there anything that could be misconstrued by a patient or is potentially misleading? Are claims based on solid evidence and data? If you see something disturbing, take action and make your concerns known. Nurses are patients’ advocates, and patients deserve fair and balanced information about cancer treatment care and outcomes.

Lisa Schulmeister, RN, MN, APRN-BC, OCN®, FAAN, is an oncology nursing consultant and adjunct assistant professor of nursing at Louisiana State Health Sciences Center in New Orleans, LA, and the editor-in-chief of

Nurse's Notes

There are many things that influence this decision, including a physician's recommendation, health insurance stipulations, recommendations from relatives and friends, and, of course, advertising.

August 2011