Clinical Insights: March 2016

Wednesday, March 23, 2016

Release Date: March 24, 2016
Expiration Date: March 24, 2017


This activity is provided free of charge.

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.

TARGET AUDIENCE

Advanced practice nurses, registered nurses, and other healthcare professionals who care for cancer patients may articipate in this CE activity.
 

EDUCATIONAL OBJECTIVES

Upon completion, participants should be able to:

  • Describe new preventive options and treatments for patients with cancer
  • Identify options for individualizing the treatment for patients with  cancer
  • Assess new evidence to facilitate survivorship and supportive care for patientswith cancer

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

  1. Read the articles in this section in its entirety.
  2. Go to www.gotoper.com/go/ONN16Mar
  3. Complete and submit the CE posttest and activity evaluation.
  4. Print your Certificate of Credit.

OFF-LABEL DISCLOSURE/DISCLAIMER

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®.

Oncology Practice

Unnecessary Imaging in Early-Stage Breast Cancer

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.
 

Project Reduces Emergency Department Visits

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.”

Colorectal Cancer

PFS in Metastatic Colorectal Cancer Similar With Two Chemotherapy Backbones

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.


 Nurse Perspective  

Laura Metcalfe, MSN, RN, APN-C, AOCNS 
Laura Metcalfe, MSN, RN, APN-C, AOCNS
John Theurer Cancer Center
Hackensack, NJ
 
Even though this study failed to find a significant difference in response rates to either FOLFOX/bevacizumab or FOLFIRI/bevacizumab among patients with high ERCC1 levels, I still found it intriguing. When I first became an oncology nurse in 1990, treatment for colorectal cancer consisted of 5 FU and leucovorin.

Essentially, that was the treatment for all comers, adjuvant as well as metastatic. With the addition of irinotecan and then oxaliplatin to the 5 FU and leucovorin, in around 2000, outcomes improved significantly for our patients withcolorectal cancer. It was still essentially “one size fits all,” however. With the advent of the targeted therapies this began to change to more “personalized” treatments, which is the ultimate goal in oncology. Specifically,with the anti-EGFR therapies (cetuximab, panitumumab), this is especially true.

Those of us who have been in oncology for a few (okay, maybe more than a few) years will remember that initially we looked at EGFR over-expression as a potential indicator of response to anti-EGFR agents. Certainly this seemedlogical. However, clinical outcomes did not bear this out.

We later identified KRAS mutations, and it was learned that if patients had a KRAS mutation (despite EGFR overexpression), not only would they not respond to anti-EGFR therapy, but said therapy could actually worsen their cancer. Thus, KRAS status became the marker for whether or not a patient could receive anti-EGFR therapy. Even then, however, we only saw about a 40% response rate. Obviously, there were other factors at play. Of course, now we know about BRAF and NRAS mutations and it is NOT only KRAS status which can predict response to anti-EGFR therapy. The standard now is to do “Pan RAS” testing prior to giving any patient anti-EGFR therapy.

I think it is possible that ERCC1 overexpression may be analogous to EGFR overexpression, meaning there are likely some other factor(s) or mutation(s) involved, not just ERCC1 overexpression.

However, with the goal being to become smarter about therapies for specific cancers with specific genotypes, I think all research will help us in our quest. Each discovery is a stepping stone to build upon and ultimately improve the treatment of colorectal cancer. Therefore, although this study did not prove ERCC1 overexpression to be an indicator as to which therapy might be better for a given patient, it may move us one step closer to identifying such a marker.

Gastrointestinal Cancer

Everolimus Emerges as New Standard of Care for GI Neuroendocrine Tumors

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).
__________________________________________________________________________________
Reference

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).
 

 Nurse Perspective  

Anne Marie Shaftic, RN, NP-C, AOCNP

Anne Marie Shaftic, RN, NP-C, AOCNP
Nurse Practitioner, Oncology
Holy Name Hospital
Teaneck, NJ


Many of us deal with a number of different cancer types, but one category of cancers not commonly seen on a daily basis are the neuroendocrine tumors or carcinoid tumors. This type of tumor arises from glandular endocrine hormone tissue such as lung, pancreas, appendix and small intestines. Characteristically, these tumors are slow growing and patients tend to lead normal lives with little interruption from their cancer or cancer treatments. 

Frequently patients will complain of flushing mainly of the face and frequent episodes of diarrhea throughout the day, which can often be overlooked. Even when these symptoms are present, the diagnosis is not always considered because these tumors are so rare. One way to confirm the diagnosis in a relatedly rapid fashion is to obtain urine 5 HIAA, which measures 5-hydroxyindoleacetic acid and the breakdown of serotonin, as patients with neuroendocrine tumors (NETs) will express elevated levels.

For years, the mainstay of treatment has been octreotide acetate (Sandostatin LAR) to control symptoms associated with carcinoid syndrome, as well as potentially inhibiting the growth of the tumors. Chemotherapy such as doxorubicin, cisplatin, and cyclophosphamide, have been used for many years, but often can be associated with multiple side effects. As with many cancers, advances in treatment for neuroendocrine tumors have also been made.

In 2011, the RADIANT-2 trial provided patients with pancreatic NETs a well- tolerated treatment option: everolimus (Afinitor). Everolimus is an mTOR inhibitor, which inhibits targets of signaling pathways resulting in cell death. 

More recently, findings from the RADIANT-4 trial facilitated expansion of the FDA’s everolimus approval, thereby offering patients with GI and lung NETs better access to this drug. Results from this trial show a 7.7 month improvement in progression-free survival, and this is excellent news, since there have been limited treatments available up to this time.

In our practice, we see a large number of patients who are being treated with everolimus for a variety of different neuroendocrine tumors. The average starting dose is 10 mg per day, given daily without planned breaks. The most common side effects associated with everolimus are stomatitis, diarrhea, and fatigue for all grades. Despite these toxicities, patients tend to do very well with treatment.

As we learn more about neuroendocrine tumors and how they respond to different treatments, we will be able to offer our patients more advanced therapies.

Head and Neck Cancer

Social Isolation, Cost Burdens High in Advanced Head and Neck Cancer

Tony Hagen

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:

  • A majority of patients rely on lifestyle-altering cost-coping strategies to manage the financial side effects of head and neck cancer care.
  • Lack of social support coupled with increased loneliness is a risk factor for suboptimal medication adherence, missed appointments, and longer length of hospital stay.
  • Assessing for factors such as financial burden, loneliness, and social support is imperative to provide optimal care for patients.

“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.” 
 

 Nurse Perspective  

Nicole Spray

Colleen M. O’Leary, RN, MSN, AOCNS
Associate Director Nursing Education
James Cancer Hospital and Solve Research Institute
Associate Director  Evidence-Based Practice
Ohio State University Wexner Medical Center
Columbus, OH
Since 2009 when the initial ASCO/ONS Chemotherapy Administration Safety Standards were released, physicians and nurses had to really think about areas where they had previously not treaded. Although I believe this has always been something that needed to be addressed, these standards spelled it out in black and white.

Specifically, they state that there should be “assessment regarding psychosocial concerns and need for support, with action taken when indicated.” The standards further clarify that, “this standard applies to all clinical encounters including each inpatient day, practitioner visits, and chemotherapyadministration visits…”

Nurses are in a perfect position to assess this on an ongoing basis. It is notenough to be concerned only with a patient’s physical health but their psychosocialwell-being as well. Often patients won’t bring up issues like the financial toxicity of cancer, so it is up to us to broach the topic.

In locally advanced head and neck cancer (LAHNC), many patients comefrom a lower socioeconomic status to begin with, so their cancer treatment costs compete with other financial struggles. Deciding whether to skip a treatment to make it go further, or to pay their mortgage or rentso they have some place to live, is reality for many patients.

The social isolation in patients with LAHNC comes froma variety of sources as well. Not only do they already feel socially isolated because of the cancer itself, but treatment for LAHNC often leaves a person looking different, sounding different, and feeling different. Because many patients with LAHNC often don’t have the best coping abilities, it’s easy to hide away when they are faced with the additional struggles.

As nurses, we see our patients more often than most other healthcare professionals.We need to build relationships with them so that they feel comfortable enough to talk about their struggles, and we need to be comfortable enough to bring psychosocial issues up in order to help them in the right direction.

The ASCO/ONS standards also state that it is important for “the practice/institution to maintain referral resources for psychosocial and other supportive care services.”

Often it is the nurse or social worker who is trying to help the patient with their financial issues, and it would be ideal to have trained financial counselors available to help the patient discover ways to decrease the financial toxicity of their cancer treatment.

But until that happens, nurses should study and learn some ways of dealing with this toxicity just as they study and learn how to help patients with other toxicities of cancer care. These burdens are real, and as shown in the article, do indeed affect patient outcomes.
 

Chemoradiation Improves Overall Survival for Elderly Patients With Head and Neck Cancers

Silas Inman

Concurrent chemoradiation significantly improved overall survival (OS) compared with radiation therapy alone for elderly patients with locally advanced head and neck cancers, according to a large analysis of the National Cancer Data Base (NCDB) presented at the 2016 Multidisciplinary Head and Neck Cancer Symposium. Abstract 100

In the study, the 5-year OS rate was 30.3% with chemoradiation versus 15.2% with radiation alone for patients >70 years. In a propensity score matching analysis, the 5-year OS rate was 26.4% for chemoradiation versus 18.1% with radiation. “The addition of chemotherapy can improve survival dramatically, even for those who are elderly,” senior study author Sana Karam, MD, PhD, an assistant professor of radiation oncology at the University of Colorado School of Medicine in Aurora, said during a presentation of the data. “Our results clearly show that there is a significant overall survival benefit with the addition of concurrent chemoradiation.”

In the study, data were examined from 5265 patients treated with definitive radiation therapyalone (n = 3604) or in combination with chemotherapy (n = 1661). Radiation was delivered in 1.2 to 2.0 Gy fractions, for a total of 66 to 81.6 Gy. Patients were eligible for the chemoradiation arm if they had started chemotherapy within 14 days of receiving radiation. The NCDB did not specify the type of chemotherapy administered.

All patients examined in the study had stage III and IV tumors of the oropharynx, larynx, and hypopharynx. All tumors were either node positive T1-2 or T3-4, N0-3. The median age in the chemoradiation arm was 75 years (range, 71-90). In the radiation-alone arm, the median age was 77 years (range, 71-90).

OS was assessed using univariate and multivariate Cox regression analysis. Additionally, propensity score matching and recursive partitioning analyses were conducted on the data to rule out any confounding factors, such as age, Charlson comorbidity score, T-stage, and N-stage. In the recursive partitioning analyses, improvement in OS was associated with patient age of ≤81 years, a low comorbidity (CD) score, and either T1-2/N2-3 or T3-4/N0-3 disease.

“The patients who benefit the most are those younger than age 80 with early T stage but advanced nodal or advanced T stage and any nodal, and they have to be healthy,” said Karam. 

In a multivariate subgroup analysis, those aged <79 years experienced a 20% reduction in the risk of death with chemoradiation versus radiation alone, according to the study abstract. Those younger than age 79 with a CD score of 0-1 had a 16% reduction in risk, and those with stage III/IV disease had a 23% reduction in the risk of death with chemoradiation.

OS was not improved with the addition of chemotherapy for those over the age of 81. Additionally, OS was not improved in patients aged 71 to 80 with T1-2/N1 tumors and a CD score of 0-1 and those aged 71 to 80 with T3-4/N1+ tumors with a CD score of more than CD1. Patients aged ≥79 years with a CD score of ≥2 experienced a trend toward worse OS when treated with chemoradiation versus radiation alone. Outside of patient characteristics, those treated with intensity-modulated radiation therapy experienced an improvement in OS; however, three-dimensional radiation was not associated with an OS benefit.

The addition of chemotherapy to radiation is associated with increased toxicity; however, as radiation, chemotherapy, and supportive care echniques have improved, these adverse events have become more manageable. Unfortunately, this aspect could not be analyzed, as the NCDB does not provide clear-cut data for toxicity, Karam said.

“We found that patients who did get concurrent chemoradiation had a longer time to completion of radiation therapy, suggesting more treatment breaks. We couldn’t look at aspiration pneumonia,” she said. “Despite treatment breaks, even after controlling for that, we found an overall survival advantage across subsites.”

Prior to the database analysis, studies had suggested that patients >70 years of age had worse survival outcomes with chemoradiation. In general, however, this elderly population represented just 4% of patients analyzed, which underpowered the data. 

Findings from the database study could beinstrumental in changing the standard of care for elderly patients, specifically outside of the United States. “The main takeaway is that you should not just look at the age of the patient,” said Karam. “In this day and age, when patients are healthier and living longer, give them the benefit of curative intent with the chemo.”

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