STATEMENT OF NEED
This CE article is designed to serve as an update on cancer detection and prevention and to facilitate clinical awareness of current and new research regarding state-of-the-art care for those with or at risk for cancer.
Advanced practice nurses, registered nurses, and other healthcare professionals who care for cancer patients may articipate in this CE activity.
Upon completion, participants should be able to:
ACCREDITATION/CREDIT DESIGNATION STATEMENT
Physicians’ Education Resource®, LLC is approved by the California Board of Registered Nursing,Provider #16669 for 1.0 Contact Hour.
DISCLOSURES/RESOLUTION OF COI
It is the policy of Physicians’ Education Resource®, LLC (PER®) to ensure the fair balance, independence, objectivity, and scientific objectivity in all of our CE activities. Everyone who is in a position to control the content of an educational activity is required to disclose all relevant financial relationships with any commercial interest as part of the activity planning process. PER® has implemented mechanisms to identify and resolve all conflicts of interest prior to release of this activity.The planners and authors of this CE activity have disclosed no relevant financial relationships with any commercial interests pertaining to this activity.
METHOD OF PARTICIPATION
This CE activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CE activity is for continuing medical nursing purposes only and is not meant to substitute for the independent medical judgment of a nurse or other healthcare provider relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual authors and do not reflect those of PER®.
Lauren M. Green
A study involving nearly 30,000 patients diagnosed with early-stage breast cancerhas found that up to 60% of these women received imaging tests such as CT, bone, and PET scans that were not medically justified,contrary to national guidelines. The research was presented at the American Society of Clinical Oncology (ASCO) Quality Care Symposium held February 26-27, 2016. Abstract 287
Advanced imaging has been decreasing over time for women with stage 0, I, and IIa breast cancer. The Choosing Wisely initiative of the American Board of Internal Medicine and ASCO in 2012 stated: “Do not perform PET, CT, and radionuclide bone scans in the staging of early breast cancer at low risk for metastasis.” However, this study indicates that the rate of such testing for patients with stage IIb disease has remained high.
The study involved 29,170 women with stage 0-IIb breast cancer receiving care at 1 of 25 hospitals inMichigan. Twenty percent of patients (n = 5954) had at least one imaging test performed within 90days of diagnosis. Average testing rates varied by stage, with the highest rates (53%) occurring in women with stage IIb tumors.
Women who were black or who had HR-negative, HER2-positive, or higher-grade cancer were more likely to undergo advanced imaging. There was significant variability in testing rates among the different practices, with more than two-thirds of women with stage II disease undergoing scans at some hospitals.
“The chance of finding cancer that has spread to other parts of the body on a scan is only about 1% for a woman with stage I or stage II breast cancer,” said lead study author Norah Lynn Henry, MD, an associate professor of internal medicine at the University of Michigan, in a statement. “It’s concerning that so many women are receiving tests that have little benefit to them but may lead to excessive radiation exposure, invasive procedures, anxiety, and financial hardship.”
Henry explained that “the scans we have today are very sensitive, meaning they pick up many small abnormalities, most of which are never going to be clinically important. However, if we find small lung or liver nodules, we often have to keep repeating the scan to make sure those nodules don’t change. At each step of the way, you are increasing anxiety for the patient; while they are waiting for the scan to be performed, waiting for results, it snowballs.”
These study findings align with earlier research in other regions of the country, and the next step for the researchers is to analyze the reasons underpinning the unnecessary testing more closely with an eye toward developing decision tools for practitioners and education for patients.
Andrew J. Roth
A telephone triage service combined with patient education helped to reduce cancer-related emergency department (ED) visits by 60% over 4 months, according to research presented at the American Society of ClinicalOncology’s 2016 Quality Care Symposium. Abstract 51
A review by the study authors showed that 48% of ED visits occurred during office hours of the five public hospitals of the Memorial Healthcare System in south Florida. Patients with breast cancer, hematologic malignancies, and gastrointestinal malignancies were identified as the main users of emergency services. The most common reasons forvisits to EDs were pain, diarrhea, nausea, and fever.
A multidisciplinary physician team worked todevelop a protocol for telephone operators to assesspatient symptoms and determine when a referral to the ED was needed. The team also hired a triagenurse for consultation. Finally, oncology practices reserved time in their daily schedules for walk-in patients.
The other half of the initiative focused on patient education. Patients were taught about chemotherapyside effects and how they can handle them at home. Each patient also received a “chemotherapy passport” with his or her oncologist’s name, off-hours contact information, chemotherapy regimen, date of last treatment, and potential side effects associated with treatment.
Overall, the new system elicited a 60% reduction in the number of patients utilizing ED services, calls to the patient access center increased, and all patients’ treatment, triage, and responsible teammember information were logged.
“By implementing this new system, our goal was to reduce unnecessary patient discomfort, interruptions in treatment, and financial burden,” said Brian Hunis, Medical Director of Quality initiatives and the Head and Neck Cancer Program at Memorial Cancer Institute in Hollywood, Florida. “This triage system is applicable to all patients on active treatment, regardless of the type of therapy they are receiving. We believe that other oncology practices could easily mimic our model.”
Lauren M. Green
A potential biomarker to guide chemotherapy for metastatic colorectal cancer (mCRC) failed to stratify patients by progresion-free survival (PFS) or responsiveness to bevacizumab, according to a randomized trial reported at the Gastrointestinal Cancers Symposium, held January 21-23, 2016. Abstract 493
Patients with tumors that exhibited high-level expression of excision repair cross-complemetation group 1 (ERCC1) had a median PFS of 9.9 months with modified leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) plus bevacizumab and 11.2 months with leucovorin/5-fluorouracil/irinotecan (FOLFIRI) and bevacizumab. Low baseline tumor expression of ERCC1 was associated with a median PFS of 11.0 months and 12.7 months with the mFOLFOX6 and FOLFIRI regimens, respectively.
However, relatively few patients met the prespecified cutoff for high expression of ERCC1, lead study author Heinz-Josef Lenz, MD, reported during the meeting. For the most part, two combination-therapy strategies demonstrated similar activity. The only notable exception was tumor location, as patients with left-sided tumors had significantly better PFS with FOLFIRI/bevacizumab.
“In the first-line treatment of metastatic colorectalcancer, FOLFIRI/bevacizumab and mFOLFOX6/bevacizumab appeared comparable in this exploratory study with respect to progression-free and overall survival,” said Lenz, director of the Gastrointestinal Oncology Program at the Keck School of Medicine at the University of Southern California in Los Angeles. “The results could be due, in part, to more treatment cycles administered to patients treated with FOLFIRI/bevacizumab, on average, 6 more cycles of irinotecan than oxaliplatin.”
Lenz noted that current standard-of-care options for untreated mCRC include modified mFOLFOX6 and FOLFIRI, plus a biologic agent such as bevacizumab. Whether mFOLFOX6 or FOLFIRI should be preferred for use in combination with anti-VEGF agents has remained unclear.
Some evidence has suggested that ERCC1 is a marker of chemoresistance to platinum-containing chemotherapy. If validated, the marker could have a role in selection of optimal therapy for patients with mCRC.
To compare mFOLFOX6 and FOLFIRI in combination with bevacizumab and evaluate the biomarker potential of ERCC1, investigators in the phase II MAVERICC trial randomized 376 patients 1:1 with previously untreated mCRC.
The trial’s primary objective was to determine whether ERCC1 expression has an association with PFS in patients treated with mFOLFOX6 or FOLFIRI plus bevacizumab.
Overall, the mFOLFOX6 group had a median PFS of 10.1 months compared with 12.6 months for the FOLFIRI group. Median overall survival (OS) was 23.9 months with mFOLFOX6 and bevacizumab versus 27.5 months with FOLFIRI and bevacizumab. Neither finding achieved statistical significance.
Patients with high ERCC1 expression (n = 131) had a median PFS of 9.9 months with the mFOLFOX6 regimen and 11.2 months with the FOLFIRI combination. In patients with lower levels of ERCC1 expression (n = 244), median PFS was 11.0 months with the mFOLFOX6 regimen and 12.7 months with FOLFIRI/bevacizumab.
Analysis of outcomes by tumor location yieldedthe only significant difference. Patients with right-sided tumors had a median PFS of 10 monthswith the mFOLFOX6 regimen and 11.2 months with FOLFIRI. On the other hand, patients with left-side tumor location had a median PFS of 10.2months with mFOLFOX6 and 13.8 months with FOLFIRI, representing a 29% reduction in the hazard ratio in favor of the FOLFIRI regimen.
Adverse event profiles were similar between thetwo treatment groups, Lenz reported. Grade 3/4events included uncontrolled hypertension, venousthromboembolic events, bleeding, proteinuria, left ventricular systolic dysfunction, and wound dehiscence.
Jason M. Broderick
Everolimus reduced the risk of disease progression by at least 40% in patients with either gastrointestinal (GI) neuroendocrine tumors (NETs) or NETs of unknown primary origin, according to a subanalysis of the phase III RADIANT-4 trial.
Findings from RADIANT-4 led to the FDA’s approval of the agent February 26, 2016, for use in adult patients with progressive, well-differentiated, nonfunctional, locally advanced or metastatic GI and lung NETS.
Among patients in this trial with GI NETS, everolimus improved progression-free survival (PFS) by 7.7 months versus placebo. The PFS extension was 6.1 months with the mTOR inhibitor compared with placebo in patients with NETs ofunknown origin. Subgroup data also showed that the PFS benefit with everolimus was maintained regardless of whether patients had midgut or non-midgut NETs, or whether or not they hadreceived prior somatostatin analog (SSA) therapy.
The trial included 302 patients with well-differentiated (G1/G2), advanced, progressive, nonfunctional NETs in the GI tract (n = 175), lung (n = 90), or unknown origin (n = 36). GI NETs were located in the stomach, colon, rectum, appendix, caecum, ileum, duodenum, jejunum, or small intestine.
Patients were randomized 2:1 to receive best supportive care plus either everolimus at 10 mg per day (n = 205) or placebo (n = 97). In a previously reported primary analysis, median PFS was 11 months with everolimus compared with 3.9 monthsfor placebo.
In the GI subgroup, according to data reportedby lead study author Simron Singh, MD, at the GICancers Symposium held January 21-23, 2016,the median PFS was 13.1 months with everolimus versus 5.4 months with placebo. Median PFS was 13.6 versus 7.5 months, respectively, in the unknown origin cohort.
Singh, who is a medical oncologist at Sunnybrook’s Odette Cancer Centre in Toronto, Canada, also reported safety data for the GI NETs and unknown primary NETs subgroups. “These [data] showed the typical type of side effects that we seewith everolimus and that we’re comfortable with managing.”
The most common all-grade adverse events(AEs) in the GI NETs everolimus arm included stomatitis (71.9%), infections (59.0%), diarrhea (44.4%), peripheral edema (40.2%), and fatigue (36.8%). The most frequently reported grade 3/4 AEs with everolimus versus placebo were infections (12.8% vs 3.4%), diarrhea (11.1% vs 3.4%), stomatitis (7.7% vs 0), anemia (6.8% vs 1.7%) and fatigue (5.1% vs 1.7%).
In patients with NETs of unknown primary origin, the most frequently-occurring all-grade AEs in the everolimus arm were stomatitis (63.6%), infections (45.5%), fatigue (40.9%), and diarrhea (36.4%). The most common grade 3/4 AEs with everolimus versus placebo were stomatitis (13.6% vs 0), abdominal pain (13.6% vs 0), fatigue (4.5% vs 0), diarrhea (4.5% vs 0), and peripheral edema (4.5% vs 0).
Singh S, Carnaghi C, Buzzoni R, et al. Efficacy and safety of everolimus in advanced, progressive, nonfunctional neuroendocrine tumors (NET) of the gastrointestinal (GI) tract and unknown primary: A subgroup analysis of the phase III RADIANT-4 trial. J Clin Oncol 34, 2016 (suppl 4S; abstr 315).
Anne Marie Shaftic, RN, NP-C, AOCNP
Patients with locally advanced head and neck cancer (LAHNC) should be screened for social isolation and financial hardship, as these factors play a role in their ability to stay on medication, minimize hospital stays, and achieve optimal health outcomes, according to a study presented at the 2016 Multidisciplinary Head and Neck Cancer Symposium, sponsored by the American Society for Radiation Oncology (ASTRO). Abstract 323
Researchers also concluded that a majority of study patients with LAHNC—which is characterized by high morbidity and high medical costs—resorted to life-altering strategies to cope with the financial burden of their treatment.
The study followed 73 patients with LAHNC by doing monthly surveys over a 6-month period. Most patients in the study were male (78%),Caucasian (74%) and covered by private health insurance (54.8%).
The strategies included drawing down savings (62%), borrowing money or using credit (42%),selling possessions (25%), and relying on family members to work longer hours (23%), in order to compensate for the patient’s lower earnings capability. More than two-thirds of study participants (69%) said they resorted to one or more of these strategies.
“Patients with high perceived social isolation have more days in which they take less medication. They have suboptimal medication adherence, they have a higher number of missed appointments, and they also have longer stays in the hospital compared to their peers,” said Sunny Kung, lead author on the study and a second-year student at the University of Chicago’s Pritzker School of Medicine.Increased loneliness caused by isolation should also be considered a risk factor, she said.
Approximately 60,000 new cases of head and neck cancer are diagnosed each year. Despite a high cure rate (80% at 5 years), physical morbidity and financial toxicity take a heavy and alasting toll, Kung said.
“Those with higher out-of-pocket costs were more likely to use [cost-coping] strategies,” Kung said. Patients had average out-of-pocket costs of $1589, of which $1287 was attributable to direct medical costs that included deductibles, hospital bills, and doctor’s visits; the remainder, $303, was for insurance premiums.
“What was surprising to us, however, was that patients who have perceived social isolation have an odds ratio of 11.5 (95% CI, 1.8-73.8) of using more of these lifestyle altering coping strategies, compared with their peers who have low or moderate perceived social isolation,” Kung said.
The study also examined the prevalence of perceived social isolation among LAHNC patients and its association with socioeconomic factors perceived isolation in 7 of the 73 patients (9.5%) prior to treatment. Patients who reported high perceived social isolation were more likely to be unemployed and divorced or widowed.
Among all patients enrolled in the study, the average number of days taking less medication was 6.99.For those with low/moderate perceived social isolation the average was 5.45 days, and for those with high perceived social isolation the average was 21.4 days. The number of days for missed appointments for all participants, low/moderate perceived isolation, and high perceived isolation were 3.4, 3.02, and 7, respectively. Length of inpatient hospital stays also trended higher for the high perceived social isolation patients.
Based on their findings, study authors concluded the following:
“Physical side effects are not the only ones our patients endure,” said Kung. ”Our findings indicate that the majority of our patients have adopted or will adopt strategies to cope with the financial side effects of their care. Social interventions can be introduced for patients who feel isolated in order to minimize financial burden while maximizing effective healthcare utilization. For example, providers can work with patient navigators to improve adherence to medical care among vulnerable populations.”
Colleen M. O’Leary, RN, MSN, AOCNS