Clinical Insights: July/August 2017

Tuesday, August 01, 2017

Release Date: August 1, 2017
Expiration Date: August 1, 2018


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 0.75 Contact Hours.
 
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/ONN17August
  3. Complete and submit the CE posttest and activity evaluation.
  4. Print your CE Certificate.
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®.
Psychosocial Oncology

Web-Based Therapy Helps Newly Diagnosed Patients Manage Stress

Anita T. Shaffer

Newly diagnosed patients with cancer experienced improvements in quality of life and lower levels of distress by participating in a web-based stress management program, according to results of a study presented at the 2017 ASCO Annual Meeting. Abstract LBA10002

The randomized study demonstrated that most of the participants reported feeling distressed at baseline and that a structured online program guided by psychologists was an effective method of offering them assistance, researchers reported.

“Our online stress management program was feasible with newly diagnosed cancer patients during active treatment,” said lead study author Viviane Hess, MD, a medical oncologist at the University Hospital of Basel in Switzerland. “We were able to reach cancer patients via the internet. At baseline, 3 of 4 patients were highly distressed, so we reached a target population in need of support.”

Hess said most patients who receive a cancer diagnosis experience a “high level of distress,” but do not have access to psychological support. She said studies in patients without cancer have shown that web-based, therapist-guided interventions can be as effective in helping individuals cope with mental disorders such as anxiety and depression.

In order to meet such needs, oncologists and psychologists designed the STREAM program as an intervention that covers 8 weekly topics, such as bodily reaction to stress, cognitive stress reduction, feelings, and social interactions. For each topic, participants receive written and audio information and complete exercises and questionnaires. Psychologists review patients’ feedback on a weekly basis and offer written guidance and support through a secure online portal; patients can then respond in writing.

To test the STREAM program, 129 patients newly diagnosed with cancer were randomized within 12 weeks of starting anticancer treatment to an immediate intervention (n = 64) or to a control group who would have access to the program after a 2-month period (n = 65). The psychologists were based in Basel, but the patients were living in Germany, Switzerland, and Austria.

Overall, the median age of the participants was 52 years (range, 46-58) and 84.5% were female. The cancer diagnoses covered approximately 10 tumor types; more than 70% had breast cancer, whereas 8.5% had lymphoma, 5.4% each had gynecological or gastrointestinal tract cancers, 3.9% had lung cancer, 3.1% had central nervous system or head and neck cancer, 2% had urogenital tract cancer, and 0.8% had skin or soft tissue cancer. Eighty-six percent had localized disease, and 14% had metastatic disease.

To evaluate the program, investigators measured quality of life including fatigue using the Functional Assessment in Cancer Therapy-Fatigue (FACIT-F) scale, psychological distress with Psychological distress on the Distress Thermometer (DT), and anxiety and depression with the Hospital Anxiety and Depression Scale (HADS).

Investigators found that patients who participated in the intervention program experienced significantly improved quality of life with FACIT-F scores that were an average of 8.59 points higher (range, 2.45-14.73; P = .007). Similarly, those who received the intervention had a greater improvement in their distress levels, with an average 0.85 decline on the DT scale (range, -1.60 to -0.10; P = .03). Anxiety and depression as measured by the HADS score also declined for the intervention group by 1.28 points (range, -3.02 to 0.45) but this difference was not statistically significant.

Hess said the findings support the use of remote technologies. “I think online psychological support will be much more important in the years to come, as the digital generation reaches the age when they are at higher risk of cancer. For them, it will be natural to use such online tools and communicate without face-to-face interaction, and so now is the time to standardize and validate the tools.”

Researchers plan to translate the STREAM program, which is currently available only in German, into other languages.

Commenting on the research, ASCO expert Don S. Dizon, MD, FACP, said the study demonstrated the value of psychological support after therapy starts. He said most oncologists assume patients will experience distress when initially diagnosed but that such feelings would abate as they undergo curative therapy.

“Trying to get these patients support can be an issue because they’re at cancer centers quite frequently for medical therapy,” he said. “Trying to squeeze psychological expertise into their treatment plans can become difficult. Utilizing an online system not only has been shown to be feasible, but the promise of being effective as well is quite grounded now in an evidence-based randomized trial.”
 
Breast Cancer

Adding Pertuzumab to Trastuzumab Beneficial as Early-Stage Adjuvant Therapy

Anita T. Shaffer

The addition of pertuzumab (Perjeta) to standard postoperative trastuzumab (Herceptin) therapy for patients with HER2-positive early breast cancer slightly improved the rate of recurrence overall but had a greater benefit for individuals with higher-risk disease, particularly as more time elapsed, according to early results from the phase III APHINITY trial. The findings suggest that the dual HER2 targeting strategy in early-stage adjuvant settings should be stratified by risk level, experts reported at the 2017 ASCO Annual Meeting. Abstract LBA500.

The APHINITY findings demonstrated that patients who received adjuvant pertuzumab along with trastuzumab plus chemotherapy had an invasive disease-free survival (IDFS) rate of 94.1% after 3 years’ follow-up versus 93.2% for those who received trastuzumab plus chemotherapy and placebo. In all, 4805 patients participated in the study.

The benefit was more pronounced among higher-risk subgroups, with the curve widening over time. After a follow-up of 4 years, the IDFS rate for patients with node-positive disease was 89.9% with pertuzumab versus 86.7% with standard therapy. For participants with hormone receptor (HR)–negative disease, the IDFS rate with pertuzumab was 91.0% after 4 years compared with 88.7% in the control group.

“These are very early results, but given that the absolute benefit from adding pertuzumab was modest, we should consider using it primarily in women with the highest risk—those with node-positive and hormone receptor-negative breast cancer,” explained lead study author Gunter von Minckwitz, MD, PhD.

Von Minckwitz said the pertuzumab-containing regimen reduced the risk of developing invasive breast cancer by 19%. After a median follow-up of 45.4 months, 7.1% (n = 171) in the pertuzumab group had developed invasive breast cancer, compared with 8.7% (n = 210) in the standard therapy group.

In translating the potential for the dual HER2 regimen into clinical practice in early breast cancer, ASCO expert Harold J. Burstein, MD, PhD, FASCO, an associate professor at the Dana-Farber Cancer Institute, said the strategy seems most beneficial in the subgroups where it showed more activity, but not for patients with stage I disease where the risk of recurrence is less than 5%.

“In the management of HER2-positive breast cancer, we really are seeing 2 diverging strands,” Burstein said. “For low-risk, particularly stage I, tumors, there’s a lot of talk about de-escalating regimens, finding biologically driven regimens, and sparing patients longer durations of treatment or extra medicines and, on the other extreme for higher-risk cases, demonstrating that additional anti-HER2 therapy will help lower the risk of recurrence.”

The FDA has approved pertuzumab in combination with trastuzumab and docetaxel as neoadjuvant therapy for patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (>2 cm or node positive). The combination also is approved for HER2-positive metastatic disease. The APHINITY trial sought to determine whether the addition of pertuzumab would improve outcomes in the adjuvant setting.

The study recruited patients with T1-3 HER2-positive early breast cancer who had undergone mastectomy or lumpectomy. Overall, 63% of the participants had node-positive disease, and 36% had HR-negative disease.

Participants were randomized to receive adjuvant chemotherapy for 18 weeks and 1 year of either pertuzumab plus trastuzumab (n = 2400) or trastuzumab plus placebo (n = 2405). A choice between several standard anthracycline-taxane sequences or a nonanthracylcine (TCH) regimen was permitted. Additionally, patients could receive radiotherapy and/or endocrine therapy after the end of adjuvant chemotherapy.

Von Minckwitz said the addition of pertuzumab did not significantly increase cardiotoxicity, which can be a worrisome adverse event with anti-HER2 therapy. Heart failure was reported in 17 patients (0.7%) in the pertuzumab-containing arm versus 8 participants in the standard therapy group (0.3%). Approximately half of the patients in each group recovered, and there were 2 cardiac deaths in each arm.

Diarrhea of grade ≥3 severity was more common with the pertuzumab-containing therapy, affecting 9.8% of patients in the safety analysis versus 3.7% of those who received standard therapy.

 Nurse Perspective

Janice Famorca Tran, RN,MS, AOCNP, CBCN, ANP-C Janice Famorca Tran, PhD, RN, AOCNP, CBCN, ANP-C
Texas Oncology
Houston, TX


Approximately 15% to 25% of patients with breast cancer have overexpression of the human epidermal growth factor receptor 2 (HER2). Treatment for this subset of breast cancers has significantly evolved since the inception of the monoclonal antibody trastuzumab. Pertuzumab, another HER2 monoclonal antibody, ultimately gained approval in 2012 in combination with trastuzumab for the treatment of metastatic breast cancer, and in 2013, in the neoadjuvant setting. This eventually led to the examination of pertuzumab in the adjuvant setting, in the phase III APHINITY trial. The results revealed a 19% reduction in the risk of developing invasive breast cancer for those who received the combination of pertuzumab, trastuzumab, and chemotherapy versus those who received trastuzumab and chemotherapy alone. The benefit of treatment with pertuzumab favored those with higher risk disease.

The two main reported side effects in the pertuzumab arm were cardiac toxicity and diarrhea. A thorough patient history with a focus on any cardiac and gastrointestinal problems is important for nurses to obtain when caring for these patients. Consultation with specialists (ie, gastroenterologist or cardiologist) to ensure the safety of treatment may be necessary depending on the individual’s medical history.

A baseline cardiac evaluation with assessment of left ventricular ejection fraction should always be performed prior to treatment and at regular intervals during the course of treatment.  Because of the known diarrhea effect of pertuzumab, prophylactic diarrhea treatment is a prudent measure that should be implemented due to the potential risk of dehydration.

Patients should be educated before and during treatment about maintaining optimal hydration status and to report symptoms of diarrhea not controlled with antidiarrheal medications.  Keeping an open line of communication between the nurse and patient, built upon trust, is vital in the care of these patients. 
Colorectal Cancer

Study Backs 50% Chemotherapy Cutback After Surgery for Low-Risk Colon Cancer

Anita T. Shaffer

Most patients with low-risk advanced colon cancer would benefit from a 50% reduction in the oxaliplatin-containing chemotherapy they typically receive after surgery without notably increasing their risk of recurrence and while markedly decreasing the likelihood that they will develop neuropathy, according to an analysis that challenges the current standard of care and paves the way for a more personalized approach. Findings were presented at the 2017 ASCO Annual Meeting. Abstract LBA1

The results of the IDEA international collaboration, which involved more than 12,800 patients, demonstrated that a 3-month course of adjuvant chemotherapy is nearly as effective as the standard 6-month course for patients with stage IIIC, lymph-node positive, colon cancer who have undergone surgery.

Overall, the 3-month regimen was associated with a less than 1% lower risk of recurrence compared with a 6-month course as measured by the 3-year disease-free survival (DFS) rate (74.6% vs. 75.5%, respectively). In a subset of patients categorized as low risk of cancer recurrence, defined as cancer spread to 1 to 3 lymph nodes and not completely through the bowel wall, there was almost no DFS difference between a 3-month versus 6-month course of therapy (83.1% vs 83.3%).

Additionally, the rates of grade ≥2 neurotoxicity were approximately 30% less with the shorter duration of chemotherapy.
The findings will change the standard of care for 60% of patients with low-risk colon cancer, which accounts for about 20,000 patients annually in the United States and approximately 400,000 individuals worldwide, said senior study author Axel Grothey, MD, an oncologist at the Mayo Clinic Cancer Center in Rochester, Minnesota.

For higher risk patients, the analysis provides a framework for clinicians to discuss balancing risks versus benefits, Grothey said. “We come into clinical judgment,” he said. “How much are we willing to push patients into 6 months of therapy for a very small minimal difference in disease-free survival?”

Since 2004, adjuvant therapy for this population has consisted of oxaliplatin-containing chemotherapy administered over 6 months. In the study, investigators examined pooled results for patients who had received either FOLFOX (leucovorin, fluorouracil, oxaliplatin) or CAPOX (capecitabine, oxaliplatin), which also is known as XELOX.

Although these regimens have improved survival for patients, oxaliplatin is associated with cumulative dose–dependent nerve damage, such as numbness, tingling, and pain that many patients find debilitating and that can persist long after therapy ends, sometimes permanently. Grothey said dose reductions and early discontinuation due to neurotoxicity are common.

The IDEA investigators reached a consensus on a risk-based approach to adjuvant chemotherapy for patients with stage III colon cancer: for patients with T1-3 N1 disease, they recommended 3 months of chemotherapy; for patients with T4 and/or N2 or other high-risk factors, they advise determining the duration of therapy by tolerability, patient preference, assessment of risk recurrence factors, and choice of regimen.

“This is a great day for patients throughout the world,” said Nancy Baxter, MD, FRCSC, PhD, chief of the General Surgery Department at St. Michael’s Hospital in Toronto, Canada. “What we’ve heard today is practice-changing work that shows for most people with stage III colon cancer, 3 months of treatment provides all the benefits of 6 months of treatment with fewer risks. Less is more.”

The study synthesized data from 6 phase III trials concurrently conducted in 12 countries in North America, Europe, and Asia through IDEA, the International Duration Evaluation of Adjuvant therapy collaboration. “It’s by far the largest prospective study conducted in the history of colorectal cancer research,” said Grothey.

Patients were randomized according to duration of therapy (3 months vs 6 months); regimens were not compared with each other. Only FOLFOX was administered in the United States, where patients participated through the Alliance/SWOG 80702 trial. Sixty-percent of the participants received FOLFOX, and 40% received CAPOX.

Of the participants in the trials with stage IIIC T1-4 colon cancer, 13% had T1-2 disease, 66% had T3, and 21% had T4. Approximately 60% had low-risk disease (T-1 N1) and 40% had high-risk (T4 or N2). The median follow-up was 39 months.

The goal of the study was to determine whether 3 months of adjuvant chemotherapy would be as effective as 6 months. Grothey said patients and oncologists agreed in the planning of the studies that a shorter duration of therapy, “should not sacrifice more than 12% of the benefit of adjuvant therapy.” In statistical terms, that meant that the upper limit of the 95% confidence interval (CI) for the DFS hazard ratio (HR) should not exceed 1.12.

Under that definition, the DFS findings for the overall patient population favored the 3-month regimen but did not meet the threshold for statistically significant noninferiority (HR, 1.07; 95% CI, 1.00-1.15). When analyzed by the type of regimen, the findings in favor of a 3-month duration were statistically significant for CAPOX (HR, 0.95; 95% CI, 0.85-1.06), but not for FOLFOX (HR, 1.16; 95% CI, 1.06-1.26).

In terms of risk groups, the DFS was 0.2% lower with a 3-month versus 6-month regimen among low-risk patients (83.1% vs 83.3%) but 1.7% lower among high-risk patients (62.7% vs 64.4%). When analyzed by regimen, the DFS was 2.4% lower when FOLFOX was administered in a shorter versus longer regimen (73.6% vs 76.0%) but 1.1% higher with CAPOX (75.9% vs 74.8%).

However, the rates of grade ≥2 neurotoxicity were statistically significantly lower (P <.0001) for patients who received 3 months rather than 6 months of chemotherapy, regardless of the regimen: 17% versus 48% for FOLFOX and 15% versus 45% for CAPOX.

Nurse Perspective

Laura Metcalfe, MSN, RN, APN-C, AOCNS
Laura Metcalfe, MSN, RN, APN-C, AOCNS
John Theurer Cancer Center
Hackensack, NJ

Tumor resection is the cornerstone of treatment for colon cancer that has not spread to other parts of the body. For early-stage disease, surgery alone may be sufficient to eradicate the cancer, but for more advanced stage III colon cancer, adjuvant chemotherapy may help prevent or delay the return of the cancer and prolong the lives of patients.

Currently, a 6-month course of adjuvant FOLFOX (fluorouracil /leucovorin/ oxaliplatin) is considered standard treatment for resected stage III colon cancer. Clinical trials have demonstrated that this combination extends disease-free survival and overall survival better than adjuvant fluorouracil and leucovorin alone. Unfortunately, one of the most common and serious side effects associated with oxaliplatin is peripheral neuropathy.

The likelihood of developing peripheral neuropathy increases with each dose of FOLFOX. We have seen people opt to not complete the prescribed 6 months of therapy due to neuropathy as well as other side effects. We have, therefore, been anxiously awaiting the results of the IDEA trial which compared 3 months versus 6 months of FOLFOX.

As reported, although the results of this study favored the 3-month regimen, it did not meet the threshold for statistically significant inferiority. Not surprisingly, however, neuropathy was decreased by approximately 30% for the shorter course. As acknowledged in this article, clinical judgment is always used when deciding on the appropriate treatment for any 1 patient.

We have always discussed the rationale for treatment, including benefits relative to the risks of side effects. We have often opted to give only 8 doses, or 4 months, of oxaliplatin to those patients at greater risk of neuropathy (ie, diabetics) or have stopped oxaliplatin prior to completion of adjuvant therapy if the patient is experiencing increasing neuropathy. In other words, while therapy is always evidence-based, it is also individualized to maximize benefit but reduce risk.

Therefore, while the results of this study will be included in the discussion and decision making for select patients (ie, node-negative or only 1 positive node), 6 months of FOLFOX will likely still be the recommendation for the majority of the patients we see in our practice.
Prostate Cancer

Abiraterone Lowers Risk of Death From Prostate Cancer in Two Clinical Trials

Anita T. Shaffer

Earlier intervention with abiraterone acetate (Zytiga) lowered the risk of death by nearly 40% for men with high-risk advanced or metastatic prostate cancer who were newly diagnosed or had not yet received hormone therapy in findings from 2 clinical trials presented at the 2017 ASCO Annual Meeting.

Experts said results from the LATITUDE and STAMPEDE trials would immediately change clinical practice.

Results from the phase III LATITUDE trial demonstrated that the addition of abiraterone plus prednisone to androgen deprivation therapy (ADT) lowered the risk of death by 38%. The combination more than doubled median progression-free survival (PFS) to 33 months compared with 14.8 months for ADT plus placebo in men with newly diagnosed, high-risk metastatic disease. Abstract LBA3

In the STAMPEDE trial, which consisted of a broader population of high-risk hormone-naïve patients including some participants with nonmetastatic disease, results showed that the addition of abiraterone to standard initial therapy lowered the relative risk of death by 37% and improved the PFS by 71%. The 3-year survival rate was 83% with abiraterone plus standard therapy compared with 76% for standard therapy alone. Abstract LBA5003

“It is remarkable to see the similarity in survival benefit across the 2 studies in the metastatic population,” said Sumanta Kumar Pal, MD, a medical oncologist at City of Hope in Duarte, California.

He said the LATITUDE data “should immediately reshape our treatment algorithms for prostate cancer, and abiraterone with conventional hormone therapy should become a new standard of care for men with high-risk metastatic prostate cancer.” He said the STAMPEDE data confirm that approach for metastatic patients but that more study is needed to move abiraterone forward for individuals with nonmetastatic disease.

However, Nicholas James, BSc, MBBS, PhD, lead investigator on the STAMPEDE trial, said abiraterone plus prednisone improves the standard of care for men with hormone-naïve prostate cancer regardless of metastatic disease status: “Based on the magnitude of clinical benefit, we believe that the upfront care for patients newly diagnosed with advanced prostate cancer should change.”

LATITUDE Study Findings
The multinational LATITUDE trial enrolled men who had not previously received ADT therapy and had at least 2 of 3 risk factors: Gleason score greater than or equal to 8, measurable visceral metastases, or 3 or more bone lesions. Results presented at the conference were from the first interim analysis involving 1199 patients: 597 in the abiraterone arm and 602 in the control group.

Patients with newly diagnosed metastatic disease live less than 5 years on average, Fizazi said. He said this category includes 3% to 5% of patients in the United States and other Western countries, and rises as high as approximately 60% of newly diagnosed patients in some Asian countries.

The co-primary endpoints for the study were overall survival (OS) and radiographic PFS. Based on results thus far, the International Data Monitoring Committee has unanimously recommended unblinding the study and allowing patients to cross over to the abiraterone arm.
After a median follow-up of 30.4 months, the median OS had not yet been reached (NR) in the abiraterone arm; the median OS in the control group was 34. The OS rate at 3 years was 66% in the abiraterone group versus 49% with placebo.

The abiraterone-containing regimen also has been shown to significantly improve secondary endpoints compared with the control group in the time to pain progression (NR vs 16.6 months), prostate-specific antigen (PSA) progression (33.2 vs 7.4 months), chemotherapy (NR vs 38.9 months), and subsequent prostate cancer therapy (NR vs 21.6 months).

In terms of toxicities, the abiraterone-containing regimen resulted in higher rates of grade 3/4 adverse events compared with the control arm including hypertension (20.3% vs 10.0%); hypokalemia (10.4% vs 1.3%); elevated alanine aminotransferase (5.5% vs 1.3%), and elevated aspartate aminotransferase (4.4% vs 1.5%). “We need to be cautious when using abiraterone in men who have an increased risk for heart problems, such as those with diabetes,” said Fizazi.

STAMPEDE Trial Results
The STAMPEDE trial is the largest study of first-line abiraterone ever conducted in patients with locally advanced or metastatic prostate cancer. In all, 1917 patients were randomized 1:1 to receive either abiraterone at 1000 mg daily plus prednisone at 5 mg daily plus standard of care (SOC) versus SOC alone. SOC consisted of ADT for at least 2 years with radiotherapy required for participants with N0M0 disease and encouraged for those with stage N+M0.

Treatment duration depended on stage and intent to administer radiotherapy: patients not receiving radiotherapy or with M1 disease were eligible to continue treatment until radiological, clinical, or prostate-specific antigen (PSA) progression. Other patients continued therapy at least 2 years or until progression.

The median age of participants was 67 years (range, 39-85 years); 52% had prostate cancer that had spread, of whom 88% had disease that spread to the bone; and 95% were newly diagnosed.

At a median follow up of 40 months, 184 deaths had occurred in the abiraterone group and 262 deaths in the standard therapy arm. The median adjusted HR for the median OS was 0.63. Abiraterone-containing therapy also markedly improved skeletal-related outcomes with a 55% reduction in the time for such problems to develop.

Although most adverse events (AEs) were similar between the 2 groups, researchers reported that serious AEs occurred more frequently among participants who received abiraterone, with 41% of patients reporting grade 3/4 AEs compared with 29% in the standard therapy group.
As with the LATITUDE trial, the main AEs occurring more frequently with abiraterone were cardiovascular problems such as high blood pressure; there were also more liver problems. There were 2 treatment-related deaths in the abiraterone group and in the standard therapy group, researchers reported.

Supportive Care

Survival Benefit With Online, Real-Time Symptom Reporting

Lauren M. Green

Patients receiving treatment for metastatic cancer who used a web-based tool to report their symptoms either while at home or during clinic visits lived 5 months longer than their counterparts who had standard symptom monitoring, according to findings of a randomized trial reported at the 2017 ASCO Annual Meeting and published simultaneously online June 4 in the Journal of the American Medical Association. Abstract LBA2

Those who used the tool also stayed on their chemotherapy longer, had fewer visits to the emergency department (ED), and experienced better quality of life and physical function, reported lead author Ethan M. Basch, MD, MSc, FASCO.

“Compared to standard care, patients who self-reported symptoms experienced multiple, statistically significant, clinical benefits,” said Basch, MD, MSc, FASCO, professor of medicine at the Lineberger Comprehensive Cancer Center of the University of North Carolina, who was practicing at Memorial Sloan Kettering Cancer Center (MSK) when the study was conducted.

The trial enrolled 766 patients between September 2007 and January 2011 who were being treated with chemotherapy for metastatic solid tumors (breast, lung, genitourinary, or gynecologic) at MSK. Patients in the intervention arm used online questionnaires to report on 12 common symptoms, including appetite loss, dyspnea, fatigue, hot flashes, nausea, and pain, and were asked to grade each on a 5-point grading scale based on the Common Terminology Criteria for Adverse Events. Each symptom could be reported either as “none,” or graded from 1 (mild) to 4 (disabling). Short descriptions were included alongside each of the choices to help patients accurately rate their symptoms.

Participants in the self-report intervention arm (n = 441) either completed the questionnaire at home between visits, which generated an automated email alert to nurses any time a severe or worsening symptom was reported by the patient, or they could complete the symptom survey at terminals in the waiting room before their clinic visit for immediate dispatch to their oncology team prior to the appointment.

Usual care control participants (n = 325) discussed symptoms during clinic visits and were encouraged to telephone the office between visits if any worrying symptoms arose.

Median overall survival for patients in the self-reporting arm was 31.2 months versus 26.0 months in the standard care cohort, which, Basch said, equated to an almost 20% increase in survival time for these patients. Looking at this finding in the context of 5-year survival, he added, “At 5 years, 8% more patients were alive in the self-reporting group,” (41% vs 33%, respectively).

Basch said that 1 obvious benefit is that the system enables better management of chemotherapy side effects, which allows patients to stay on their treatment longer. The system also yielded more responsive care, he said, “by alerting clinicians in real time about symptoms as they emerged, prompting them to take early action and manage problems before they became complications.”

Finally, “By controlling symptoms better, this system kept patients more physically functional and kept them from becoming deconditioned or immobile, which we know from multiple prior studies has a strong association with better survival.”

Findings are being confirmed in a larger clinical trial being conducted in community practices across the US. Basch said the focus now is on how best to integrate these tools into oncology practice.

Nurse Perspective

Darcy Burbage, RN, MSN, AOCN, CBCN
Darcy Burbage, RN, MSN, AOCN, CBCN
Supportive and Palliative Care Nurse Navigator

Helen F. Graham Cancer Center and Research Institute
Newark, DE


Effectively managing symptoms is an essential role of oncology nurses across all practice settings. Although oncology nurses provide a great deal of patient education regarding symptoms to expect along with evidence-based side effect management strategies, it is just as important to emphasize reportable symptoms to help minimize the impact and intervene prior to a visit to the emergency department becomes necessary. Empowering patients to advocate for themselves can be a challenge as some patients express a concern in calling their oncologists stating, “I don’t want to bother them.”

Results from this study by Basch et al may provide another mechanism for our patients to communicate with their treatment team by utilizing an electronic platform to self-report common symptoms of cancer treatment.

Harnessing technology is an exciting as well as challenging opportunity for oncology nurses at the frontlines providing symptom management counseling and referrals for our patients. Although results from this study conducted at 1 large academic cancer center appear promising, many questions remain regarding how to adapt this technology for use in other clinical settings, such as smaller rural or community cancer centers, where the resources available in large academic settings aren’t as accessible.

Additionally, how will this technology work with patients who don’t speak English, who are elderly, or are at otherwise high risk based on their cognitive function or social situation? For individuals who don’t own the technology, will they be given an electronic device? If the devices aren’t provided to each individual patient, but, as the article states, can be utilized in the waiting rooms, how many will need to be purchased and maintained?

Other concerns include: Who is receiving the automated messages? Is there a specific nurse assigned to check the e-mails, or is this an additional responsibility? Will practices need to hire additional staff to provide 24/7 resource accountability to check these messages? Although this study specifically looked at individuals with advanced cancer, is there an opportunity for all patients to participate, regardless of stage or treatment? And, finally, what about our cancer survivors who express feeling disconnected from their treatment team between appointments and are living with long-term and late effects of treatment: will they be included if this type of electronic reporting system becomes more available?

Additional research is needed to determine what other patient populations would benefit from this type of reporting system and if adjustments can be made to tailor this online tool to interface with the EHR. To provide high quality, high value care, oncology nurses play an important role in advocating for interventions that can improve the quality of life for our patients and potentially impact survival. I look forward to hearing more about additional research with this online tool and hope that our patients, regardless of where they live or receive care, will have access to this technology.

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