Clinicians who treat patients with multiple myeloma have witnessed a sea change in the past 15 years. Yet another revolution appears right around the corner, with emerging monoclonal antibodies generating promising results in clinical trials and research on risk stratification revealing how to identify which patients should be treated early, according to Jesús F. San Miguel, MD, PhD.

San Miguel delivered the Ham-Wasserman Lecture, “Multiple Myeloma: A Modern Model for Scientific and Clinical Progress,” during the Annual Meeting of the American Society of Hematology (ASH). He is a professor and administrator at the Clinica Universidad De Navarra, Pamplona, Spain.

During his lecture, San Miguel noted the encouraging clinical trial findings about two new agents in development, daratumumab and elotuzumab, presented during the conference. Patient advocates and clinicians who treat individuals with multiple myeloma have been anticipating research data about these agents for some time now, particularly since the FDA has granted breakthrough therapy status to both agents in multiple myeloma settings. In a phase Ib trial reported at ASH, daratumumab combined with standard frontline therapies induced a dramatic improvement in outcomes without additional toxicity for patients with multiple myeloma.

Infusionrelated reactions were the only added toxicity seen with daratumumab when combined with a bortezomib-containing regimen. All infusion reactions were grade 1 and resolved with supportive care, and most other side effects reported in the study were attributed to the backbone therapy.

Findings from another phase Ib/II study presented at ASH showed that treatment with elotuzumab in combination with lenalidomide and dexamethasone demonstrated encouraging efficacy in patients with relapsed/refractory multiple myeloma,

 and this, along with the overall safety and durability of the responses observed, support further phase III clinical development of elotuzumab in the relapsed/ refractory setting, as well as for those newly diagnosed with the disease.

San Miguel said it has become clear that the disease “should not be considered a single entity, but different entities,” and thus, multiple treatment options will exist. For example, he said, many thought there would be no role for melphalan after last year’s ASH meeting in New Orleans, which saw the paradigm-shifting results from Thierry Facon, MD, on lenalidomide and low-dose dexamethasone.

 But San Miguel said that has turned out not to be the case.

An increased understanding of the genetics behind myeloma is building awareness that treatments must be tailored to the individual, said San Miguel. Identifying and measuring key drivers of the disease holds great promise, he noted, since this will give clinicians information to create combination therapies for more patients. While survival has increased from the abysmal rates of 1 to 3 years from previous eras to 5 to 7 years today, more can be done, he said.

San Miguel also reviewed an area where his research team, the Spanish Myeloma Group, made a major contribution in 2013: risk stratification of those patients with precancerous disease who show signs of smoldering myeloma and methods of identifying those at highest risk of progression so that they can receive early treatment. He was the senior investigator on a phase III trial in which patients were randomized to receive lenalidomide and dexamethasone or observation, the latter being the usual standard of care for individuals who have an increase of plasma cells in the bone marrow that produce the monoclonal immunoglobulin (IgG), but do not have any myeloma symptoms.

San Miguel outlined the prognostic factors that allowed the research team to segment out the high-risk group, which included plasma cell bone marrow infiltration, IgG levels, and urinary protein levels.

“You want to give the patient what is needed, and nothing more than is needed,” San Miguel said.

This approach produced improved 3-year survival rates among the high-risk patients identified and treated by the Spanish team during the study; 94% of those who were treated were still alive at 5 years, compared with 80% in the untreated group.

		Moreau P, Mateos M-V, Bladé J, et al. An open-label, multicenter, phase 1b study of daratumumab in combination with backbone regimens in patients with multiple myeloma. Presented at: 2014 ASH Annual Meeting; December 6-9, 2014; San Francisco, CA. Abstract 176.

		Richardson PG, Jagannath S, Moreau P, et al. Final results for the 1703 phase 1b/2 study of elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma. Presented at: 2014 ASH Annual Meeting; December 6-9, 2014; San Francisco, CA. Abstract 302.

		Facon T, Dimopoulos MA, Dispenzieri A, et al. Initial phase 3 results of the First (Frontline Investigation Of Lenalidomide + Dexamethasone Versus Standard Thalidomide) Trial (MM-020/IFM 07 01) in newly diagnosed multiple myeloma patients ineligible for stem cell transplantation. Presented at: The 55th ASH Annual Meeting; December 7-10, 2013; New Orleans, LA. Abstract 2.

		Mateos MV, Hernández MT, Giraldo P, et al. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013;369(5):438-447.

Articles

Feature Story

Clinicians who treat patients with multiple myeloma have witnessed a sea change in the past 15 years.

Big Changes Anticipated in Treatment Paradigms

The year 2014 was distinguished by dramatic progress in cancer care, perhaps nowhere more so than in the treatment of blood cancers. The FDA granted approval to several new agents and indications in this setting, including four for the treatment of chronic lymphocytic leukemia (CLL) alone—a transformation of treatment for the most common form of adult leukemia that earned it the American Society of Clinical Oncology’s inaugural “Cancer Advance of the Year.”

Over the course of the year beginning in late 2013, the antibodies obinutuzumab (Gazyva) and ofatumumab (Arzerra) were approved in the frontline setting, while the small-molecule inhibitors ibrutinib (Imbruvica) and idelalisib (Zydelig) gained approvals for resistant/relapsed CLL.

“These new therapies fill an enormous need for thousands of patients living with CLL,” said Gregory Masters, MD, ASCO expert and coexecutive editor of the report. “For many older patients, especially, these drugs essentially offer the first chance at effective treatment, since the side effects of earlier options were simply too toxic for many to handle.”

“I’ve seen a revolution in how the patient is treated from when I started 20 years ago,” said Michelle Gervino, RN, BSN, OCN. “With biotherapies, with targeted therapies, you’re not seeing the devastation in patients who are very, very sick.”

The side effect profile with many of these newer agents is more tolerable, and Gervino said that once patients get over their fear of the unknown, “They will get up and say that wasn’t that bad.” As an example, noted Linda Casey, BSN, OCN,“ I frequently tell patients when they come in for Rituxan, it’s not like a wildfire burning down the forest to get to one tree. It finds the tree that it needs to take down, and it takes it down.”

In today’s environment, patients come in, get their treatment, and then get on with their lives, Gervino said, adding that one of the benefits of working in this setting is that nurses really get to know their patients, seeing some of them for years. “Cancer is becoming more of a chronic illness, as opposed to a terminal illness,” her colleague, Jenna Forsythe, MSN, RN, OCN, concurred. Now, many patients with these cancers are on maintenance therapies and have the “good” problem of trying to find that balance of working and taking care of their children—no longer having to focus solely on their cancer.

All three of these oncology nurses work in the outpatient setting at the John Theurer Cancer Center (JTCC) in Hackensack, New Jersey, where part of their work includes supporting research nurses and their patients who are participating in clinical trials testing the efficacy and tolerability of new agents for treating hematologic malignancies.

The first of the four CLL agents approved over 2013/2014 was the anti-CD20 agent obinutuzumab.

In November 2013, the FDA approved the drug in combination with chlorambucil as a first-line treatment regimen for patients with CLL based on data from the phase III CLL11 trial. In the study, the obinutuzumab/chlorambucil combination significantly reduced the risk of progression by 84%, compared with chlorambucil alone. The approval came with a Boxed Warning, similar to other monoclonal antibodies in this class, regarding the hepatitis B reactivation and progressive multifocal leukoencephalopathy, a rare disorder affecting the brain. In December 2014, the FDA updated the label for obinutuzumab plus chlorambucil to include data from stage 2 of the CLL11 study, which detailed an unprecedented 11.8-month improvement in progression-free survival (PFS) compared with rituximab (Rituxan) plus chlorambucil as a frontline treatment for patients with CLL (26.7 months vs 14.9 months).

The next new option approved for patients with CLL was the BTK inhibitor ibrutinib in February 2014. The FDA approved the agent for patients with CLL who have received at least one previous therapy. The decision was based on data from 48 patients enrolled in the single-arm phase Ib/II PCYC-1102-CA study. At a median 15.6-month follow-up for this group, singleagent ibrutinib produced an overall response rate (ORR) of 58.3% (all partial responses) with a duration of response of up to 24.2 months.

The most common grade 3/4 nonhematologic adverse reactions (AEs) were pneumonia (8%), hypertension (8%), dehydration (6.4%), atrial fibrillation (6.3%), and sinusitis (6%). Additionally, ibrutinib-related grade 3/4 cytopenias were reported in 35% of patients.

In July 2014, the FDA expanded the approval of ibrutinib to include the treatment of patients with CLL who harbor a 17p deletion, based on findings from the phase III RESONATE trial.

In RESONATE, ibrutinib lowered the risk of progression by 75% in patients with CLL who harbored a 17p deletion and by 78% in the full population of the study when compared with ofatumumab.

The anti-CD20 agent ofatumumab, which received a new indication in April 2014, marked the third new CLL treatment option made available in the past year. The indication is for ofatumumab plus chlorambucil for previously untreated patients with CLL who are considered inappropriate for treatment with the chemotherapy fludarabine. The FDA first approved ofatumumab in October 2009 for the treatment of patients with CLL who no longer respond to chemotherapy.

The new approval was based on results from the phase III COMPLEMENT 1 trial, in which ofatumumab and chlorambucil demonstrated a 9.3-month improvement in PFS compared with chlorambucil alone. The ORR with the combination was 82% versus 69% with chlorambucil alone.

Grade 3/4 AEs occurred in 50% of patients treated with ofatumumab compared with 43% in the chlorambucil monotherapy arm. The most common grade 3/4 toxicity was neutropenia, which occurred in 26% of patients treated with ofatumumab compared with 14% for chlorambucil alone. Grade 3/4 infusion-related AEs were reported in 10% of patients treated with ofatumumab compared with none for those receiving chlorambucil alone.

Rounding out the impressive 2013/2014 breakthroughs in CLL care was the July 2014 approval of the PI3K-delta inhibitor idelalisib in combination with rituximab for patients with high-risk relapsed or refractory CLL. The approval was based on the phase III Study 116 trial, in which the addition of idelalisib to rituximab improved overall survival by 72% and PFS by 82% versus placebo and rituximab. The approval for idelalisib included a Boxed Warning regarding fatal and serious liver toxicity, diarrhea, colitis, pneumonitis, and intestinal perforation associated with the drug. To address concerns with these side effects, idelalisib was also approved along with a Risk Evaluation and Mitigation Strategy (REMS).

In a phase II study presented at the American Society of Hematology (ASH) Annual Meeting in December, idelalisib as monotherapy yielded high response rates in older patients with CLL and small lymphocytic lymphoma; nearly 90% of patients demonstrated a partial response. (Abstract 1986)

“This has truly been a banner year for CLL and for clinical cancer research as a whole,” ASCO president Peter P. Yu, MD, said. “Advances in cancer prevention and care, especially those in precision medicine, are offering stunning new possibilities for patients.”

These treatment advances, along with promising findings for new targeted agents and combinations for multiple myeloma and other blood cancers reported at ASH, makes supporting patients today with hematologic malignancies an especially rewarding specialty for the nurses who treat them. “I enjoy working with blood cancer patients more than any other types of oncology patients,” said Casey, “because I think it’s a space where there is as much hope as you can get when faced with a cancer diagnosis.”

Louise Eaton, RN, BSN, OCN, works in the inpatient stem cell transplant unit at JTCC. Although not working directly with patients participating in clinical trials, “We do see the benefits,” she said, citing the example of a patient in her unit about to enter hospice who was able to participate in a trial of a research drug. “Now he’s in remission. You hear stories like that, and it’s amazing.”

“These patients have a lot of hope and do very well with many of these new therapies,” said Casey. Yet despite these advances, Gervino acknowledged that not all patients will have a favorable outcome.

“Nurses are on a journey with these patients. Our job is to give them dignity and provide the best care possible, no matter where the path takes them."

Cover Story

The year 2014 was distinguished by dramatic progress in cancer care, perhaps nowhere more so than in the treatment of blood cancers.

Research Strides Change Treatment Landscape for Blood Cancers

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

Oncology Nursing Consultant, Adjunct Assistant Professor of Nursing

		Louisiana State Health Sciences Center in New Orleans, Louisiana

Screening for psychosocial distress is an important component of care, and has even been referred to as the “sixth vital sign.” The goal of distress screening is to facilitate timely and appropriate access to psychosocial services and improve the patient’s quality of life. In reality, though, psychosocial distress screening is not as simple as it appears.

The first issue is that distress screening is everyone’s job, which often ends up meaning that it’s nobody’s job. In practice settings in which “we all” need to screen for distress, chart documentation often reveals that distress is documented using standardized language (eg, patients have “no anxiety, no depression”), is inconsistently documented on some but not all dates, or noted differently by one or more clinicians.  

There also is confusion about what we’re doing, or supposed to do. Depending on the practice setting, we generally are 

 for it. Screening is the rapid identification of a patient’s key concerns, whereas assessment is conducted after the screening and involves a more comprehensive and focused exploration of the patient and family’s situation.

The scope of psychosocial distress screening extends beyond the patient to encompass family members and clinicians; however, in practice, the patient is often the only one who is screened for distress. The stress of caregiving can have a negative impact on the well-being of the family caregiver, which in turn, can negatively impact the caregiver's ability to provide care and support. When the caregiver/patient dyad is recognized as the unit of care, actions can be taken to promote the well-being of both the patient and caregiver.

No one will argue that all patients should be screened for distress. The conundrum is when to screen, how to screen, and what to screen. In terms of frequency, it’s common for distress screening to occur at the time of cancer diagnosis and continue at specified intervals (eg, monthly, bimonthly), at subsequent critical time points (eg, end of treatment, when disease progression occurs), or as needed when distress is either self-identified by the patient or recognized by the clinician.

Perhaps the easiest process is to screen for distress at every clinical or treatment visit, which is the frequency stated in the ASCO/ONS Chemotherapy Administration Safety Standards. When screening is conducted every time instead of some of the time, it’s less likely that it will be overlooked.

You’re probably thinking you don’t have the staff, time, expertise, and tools to screen for distress every time a patient comes in. And you may be right, because distress screening does take time, depending on how you do it. The widely used NCCN Distress Thermometer for Patients (available at NCCN.org) includes yes/no checkboxes for noting practical problems (eg, housing, work/school, transportation, etc.), spiritual concerns, and family, emotional, and physical problems. It’s a comprehensive tool, and when fully completed by patients, provides a great deal of information.

One problem with the tool, however, is that it has 41 items and does not prioritize concerns. Consequently, some patients find the tool burdensome to complete (especially if they are being seen frequently), and clinicians often don’t know where to start when patients check several items on the list. In some facilities, the NCCN tool is electronic, with patients or clinicians entering the patient’s responses. However, many facilities still rely on paper/pencil completion of the tool, and the tool is either scanned into the electronic medical record or the responses are manually entered. To reduce the paper burden, the tool can be laminated, which allows the patient to check the boxes using a wipe-away marker and enables the tool to be cleaned, sanitized, and used with subsequent patients.

To reduce the time burden to both patient and clinician, an abbreviated distress screening process is an option. Ask the patient to rate either distress or emotional well-being on a 0-10 scale, and ask if the patient has housing, transportation, work/school, family, spiritual, or physical concerns. Measuring distress using a thermometer or other rating scale makes it possible to assess distress over time, and having specified distress scores that trigger action standardizes the intervention and referral process.

While some tools, such as the Edmonton Symptom Assessment System, have a rating scale, which assists in identifying problems that are more concerning to the patient than others, several tools (including the NCCN Distress Thermometer) contain yes/no checkboxes. When multiple items are checked, follow-up is required to explore each one to determine how to prioritize the patient’s needs.

Regardless of the distress screening tool used, a helpful question to ask is, “What is of most concern to you right now?” Not only does this question help prioritize care, it’s also broader and may elicit concerns that are not stated on any tool. For instance, a woman recently responded to the question by saying that she was very worried about how her son was doing in school. It’s possible, but unlikely, that a tool would have identified her concern.

Psychosocial distress has many dimensions, and simply asking if the patient is anxious or depressed is not enough. By standardizing the screening process, involving the patient’s caregiver, and addressing the multidimensional aspects of distress, optimal psychosocial care can be provided.

Nurse's Notes

Screening for psychosocial distress is an important component of care, and has even been referred to as the "sixth vital sign."

"The Sixth Vital Sign": Screening for Psychosocial Distress

	Barbara A. Leone, RN, BSN, CCM, is Team Leader, Department of Clinical Resource Management at the Hospital of the University of Pennsylvania.

A new diagnosis of acute leukemia can pose an immediate threat to life given the substantial morbidity and mortality associated with the disease. According to the American Cancer Society, there will be approximately 27,000 cases of acute leukemia in 2015, with the number of deaths estimated at nearly 12,000.

Median survival for those choosing no treatment is only 6 weeks,

 with overall 5-year survival rates ranging from 24% for adults diagnosed with acute myeloid leukemia to 65% for those with acute lymphoblastic leukemia.

 Given these data points, it is quite understandable that the disease trajectory can be punctuated by considerable psychological distress which can disrupt the treatment course at various points along the clinical care continuum. Distress can, in a sense, quietly and surreptitiously sabotage what could be a successful treatment outcome.

Distress is described by the NCCN as a “multifactorial unpleasant emotional experience of psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment.”

 Multiple studies cite a rising incidence of psychological morbidity among patients with a variety of malignancies at various stages of disease progression.

 At diagnosis and beyond, patients diagnosed with acute leukemia report a decreased quality of life and an increase in depressive symptomatology.

 There is also a significant impact on patient adherence to the plan of care, medication compliance, and follow-through with provider appointments which can lead to increases in emergent oncology clinic visits, emergency department encounters, and hospital readmissions, all of which could have implications for survival.

In January 2014, the American College of Surgeons (ACoS) Commission on Cancer (CoC) released its

 Cancer Program Standards 2012 Version 1.2.1: Ensuring Patient-Centered Care, 

which establishes a 2015 requirement that all cancer centers implement programs designed to screen for psychosocial distress.

 This mandate creates a new standard for accreditation and follows closely the call to action in 2007 published by the Institute of Medicine which introduced specific recommendations for the management of distress in cancer populations in its document “Cancer Care for the Whole Patient.”

Embedded in the new 2015 CoC mandate is the understanding that psychosocial distress surrounding the clinical picture of acute leukemia has historically gone unrecognized and hence untreated.

 Distress has been found to occur in more than 45% of patients diagnosed with acute leukemia.

 Yet, there currently exist low rates of distress recognition in the clinical setting with distress undetected by clinicians who are not trained to accurately recognize patients with distress.

Evidence-Based Guidelines for Distress Management 

In 2014, the NCCN published its Distress Management Guideline (the Guideline) addressing the acute need for psychosocial distress screening. The Guideline establishes standards of care for distress management, recommending routine screening of all cancer patients for distress followed by referral to treatment providers according to multiple algorithms. 

Multiple self-report inventories exist for the purpose of identifying patients with threshold levels of distress. The Guideline endorses use of the Distress Thermometer which offers a sliding scale measurement of self-perceived levels of distress with additional identifiers offering the patient the opportunity to identify specific sources of distress.

 The Distress Thermometer is to be administered during critical checkpoints along the clinical care continuum such as with initiation of treatment, at discharge from the hospital setting, at relapse, and upon entering the survivorship phase. A score of 4 or greater on the Distress Thermometer signals the treatment team to initiate referrals to mental health professionals for the initiation of appropriate treatment.

There are numerous potential barriers to implementation of the 2015 CoC mandate.  Programmatic time constraints within the clinic setting divert attention from issues of emotional distress to more immediate issues of acute symptom management

Clinicians’ comfort level with matters surrounding psychosocial distress can be lacking, and hence the issue is never broached with the patient. The burden of additional duties and responsibilities related to screening for distress can add significant strain to an already taxed outpatient clinic setting workflow. Patients themselves may be reticent to discuss matters concerning emotional health given the stigma attached to psychological issues.

Additional barriers to implementation can include lack of staff confidence in the process, a paucity of staff training and support for programmatic initiatives, low acceptance rates of the process, and failure to link treatment to the results of the screening process.

 Lack of familiarity with the Guideline has also been cited as a barrier to effective implementation.

As systems are developed to meet compliance standards of the CoC mandate, nurses are critically positioned to identify distress and to facilitate communication between patients and care providers. Educational programs introducing the Guideline to clinical staff as well as patients and family members would support compliance with the CoC mandate.

Nursing leadership may also wish to consider incorporating the distress screening tool into the initial nursing assessment typically embedded in the Electronic Medical Record. This would facilitate an automatic pathway for the nurse to evaluate for psychosocial distress with each patient contact. 

Recognizing psychological distress in patients newly diagnosed with acute leukemia is critical to successful treatment outcomes for these patients. The nurse is well positioned to identify signs of distress, implement distress screening, and work to reduce the burden of fear which may be inexorably linked to survival of these patients.

		American Cancer Society.  Cancer facts & figures: 2014.  

http://www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-042151.pdf

		Nissim R, Zimmerman C, Minden M, et al. Abducted by the illness: a qualitative study of traumatic stress in individuals with acute leukemia.  

		Howlander N, Noone AM, Neyman N, et al. SEER Cancer Statistics Review, 1975—2009 (Updated August 20, 2012). 

http://seer.cancer.gov/csr/1975_2009_pops09/

		National Comprehensive Cancer Network, Inc. NCCN Clinical Practice Guidelines in Oncology: Distress Management. Version 2.2014. 

http://www.nccn.org/professionals/physician_gls/pdf/distress.pdf

		Mosher CE, Duhamel KN. An examination of distress, sleep, and fatigue in metastatic breast cancer patients. 

		Suzuki N, Ninomiya M, Maruta S, et al. Psychological characteristics of Japanese gynecologic cancer patients after learning the diagnosis according to the hospital anxiety and depression scale. 

		Ugalde A, Aranda S, Krishnasamy M, et al. Unmet needs and distress in people with inoperable lung cancer at the commencement of treatment. 

		Tavernier SS, Beck SL, Dudley WN. Diffusion of a distress management guideline into practice. 

		Commission on Cancer, American Cancer Society. Collaborative Action Plan Guide. 

https://www.facs.org/~/media/files/quality%20programs/cancer/clp/collaborative%20action%20plan%20guide.ashx

		Institute of Medicine of the National Academies. Cancer Care For The Whole Patient: Meeting Psychosocial Health Needs.  

http://www.iom.edu/Reports/2007/Cancer-Care-for-the-Whole-patient-Meeting-Psychosocial-Health-Needs.aspx

		Mitchell AJ, Vahabzadeh A, Magruder K. Screening for distress and depression in cancer settings: 10 lessons from 40 years of primary-care research. 

		Albrecht TA, Rosenzweig M. (2013). Distress in patients with acute leukemia: a concept analysis.  

		Danhauer SC, Tooze JA, Holder P, et al. Healing touch as a supportive intervention for adult acute leukemia patients: A pilot investigation of effects on distress and symptoms. 

		Ma X, Zhang J, Zhong W, et al. The diagnostic role of a short screening tool —the distress thermometer: a meta-analysis. 

Partner Perspectives

A new diagnosis of acute leukemia can pose an immediate threat to life given the substantial morbidity and mortality associated with the disease.

Recognizing Distress in Patients with Acute Leukemia

	Howard Cohen RPh, MS, FASHP, is Interim Associate Director, Oncology Pharmacy at the Smilow Cancer Hospital at Yale-New Haven.

The Smilow Cancer Hospital at Yale-New Haven is an NCCN- and NCI-designated cancer center. Over the past several years, process improvements in the care of our oncology patients have been implemented that focus on the provision of safe and high quality clinical care and employee safety. These process improvements included implementation of Epic EMR, development of standardized oncology treatment protocols, and a standardized multidisciplinary approach to patient care. 

While tremendous work has been accomplished within our clinics, care centers and inpatient units, little has been done with regard to the oral chemotherapy drugs that are prescribed for home administration by our ambulatory patients. It is widely recognized that these oral drugs are considered hazardous medications that carry with them potential safety and quality of care issues. Patients prescribed oral chemotherapy and targeted therapies should be supported, educated, and monitored with the same vigilance as those receiving chemotherapy in our clinics and inpatient units.

We need to ensure patients have access to the oral chemotherapy drugs and adhere to the oral chemotherapy regimens. We need to educate our patients about potential toxicities and serious side effects. We need to understand that when we prescribe an oral chemotherapy agent, we shift much of the responsibilities of managing the treatment regimen including the monitoring and potential toxicities from the oncology care team to the patient. In 2013, our ASCO QOPI (Quality Oncology Practice Initiative) certification visit identified oral chemotherapy as an area that needed attention. A standardized program for oral chemotherapy was needed to effectively monitor and improve patient outcomes.

In an effort to address the management of oral chemotherapy medications, we first conducted a survey of all clinical staff to determine satisfaction with the current processes, and to identify gaps within our system. Many issues were identified and included the following:

		Lack of feedback from specialty pharmacies

		Variable documentation and inconsistent oral chemotherapy tracking

		Delays with patients obtaining their medications

		An overall lack of a coordinated patient communication and education plan

A chartered multidisciplinary task force met over the course of 4 months to reach the goal of developing a specific program for patients prescribed oral chemotherapy that would: (1) help to identify all patients prescribed oral chemotherapy; (2) standardize the process of the oral chemotherapy prescription, including patient consent; (3) ensure patient access to oral chemotherapy drugs; (4) ensure clinical support, including patient education and counseling and ongoing monitoring.

	The Epic oral chemotherapy treatment plan development included a clinical review by oncology trained pharmacists and nurses.	

			All patients prescribed oral chemotherapy receive pretreatment evaluation and patient consent.

			A plan for staff and patient caregiver education

			A work plan that would decrease delays in patient access to oral chemotherapy medications, including the development of a specialty pharmacy that would serve as a hub for all discharged oral chemotherapy prescriptions

			Only one cycle of treatment would be dispensed at first cycle of treatment, and all prescriptions would be dispensed in blister packaging to avoid contact with the hazardous medications.

			All prior authorizations will be completed, and patients would be given a choice to have their prescriptions filled by our specialty pharmacy or at a specialty pharmacy of their choice. Additionally, we included our Medication Assistance Program (MAP) to assist indigent patients with access and reimbursement issues regarding oral chemotherapy.

			A plan to provide ongoing patient education and counseling

			An ongoing process for the monitoring of the patient for regimen specific adherence and compliance with flow sheet documentation and follow up

			A process to ensure ongoing toxicity assessment and early identification of side effects

			An ongoing evaluation process, including quality assurance, and patient and staff satisfaction

We also wanted to ensure patient safety and compliance by establishing an ongoing and regimen-specific adherence and toxicity assessment program that would include early identification of side effects.

Recognizing high patient copayments, limited access to medications, and several other patient barriers, we decided to include the development and implementation of a specialty pharmacy in our improvement plan. The specialty pharmacy would serve as the hub to identify all patients prescribed oral chemotherapy and triage all prescriptions.

Given the oral chemotherapy team acknowledged that oral chemotherapy medications are classified as hazardous medications that bring about concern for patient safety, we first created a current state process map, identified potential risk points through a gap analysis process using a cause-and-effect diagram, and then mapped our ideal approach to ensure both safety and quality.

A final oral chemotherapy process map was developed that detailed our care model to support patients receiving oral chemotherapy (

Implementation of the new oral chemotherapy care model will include a pilot in several adult ambulatory Cancer Care Centers and one oncology disease team. The success of the pilot would allow for hospital-wide expansion.We believe that the care model that has been developed will improve care for our patients who are prescribed oral chemotherapy. We recommend the ongoing review and adjustment of our workflow and the development of programs that address approaches for safe administration of oral chemotherapy.

Over the past several years, process improvements in the care of our oncology patients have been implemented that focus on the provision of safe and high quality clinical care and employee safety. 

Improving Safety and Quality with Oral Chemotherapy

She found me on our website, just doing a general search for prostate cancer resources in the area. Her father had just received the news that he had prostate cancer, and it sounded like late-stage disease. He was diagnosed by a local urologist, but not one from whom I routinely get referrals for prostate cancer navigation. On that first call, we spent at least half an hour addressing all of her questions and concerns, among them:

The patient’s daughter had not been at the initial consult and thus had only secondhand information from her father and mother. She did know that her father’s Gleason score was 9, and his PSA was a little over 10. Given that her father was already in his late 70s, with other comorbidities including cardiac and renal disease, surgery was not a good option. In reviewing the NCCN guidelines, another option to consider would be radiation, with or without hormone treatment. His urologist had initiated the hormone treatment, but no radiation oncology consult was ordered yet.

With multiple questions and too many unknowns, I invited the family to come in to visit with me. In the meantime, I would reach out to the patient’s urologist and primary care provider to gather more information to support the family in making their treatment decisions.

Mr M, his wife, and daughter all came in to meet with me. Since that first call with his daughter, I was able to connect with his urologist and primary care provider to get a better sense of the situation.  Without any symptoms, the plan was to reserve radiation until needed, which was reasonable given his clinical picture (T2a, Gleason 4+5, PSA 10.2), and no reported back pain.

At this point, Mr M was not having any problems with the regimen of bicalutamide and leuprolide acetate that had started about 1 month earlier; however, there was obviously still a lot of worry in the room. Mr M and his wife are clearly from an “old school” generation who obeyed doctor’s orders and didn’t want to disappoint the esteemed professionals providing his care.

Mr M’s daughter was a bit more inquisitive but was having difficulties with the role reversal of caring for someone who basically cared for her all her life. On top of all this, Mr M is a stoic man, not inclined to disclose many symptoms anyway—hoping to power through treatment on his own as a lone warrior&mdash;not wanting to burden his family.

Many more questions later, I gathered that Mr M and family were a bit more comfortable (although understandably not totally happy) with the plan at hand for an advanced prostate cancer—though not truly curable, definitely treatable for a long period of time. So they could hear it directly from the specialists, I offered visits with medical and radiation oncology. During these detailed consultations, I knew that there would be an even more thorough review of the pros and cons of treatments beyond the scope of my practice. Nevertheless, I reinforced with the patient and his family that they should reach out to me anytime, because as their nurse navigator, I could serve as their “inside man” and advocate within the system to get the answers and assistance they might need during this tough time.

The radiation oncologist met with the family and concurred with the urologist, aiming to reserve treatment until needed. Mr M and his family were grateful to meet him, so that when the time comes, they would already have a relationship with the specialist.

The medical oncologist also concurred with the urologist, reinforcing the plan for hormone therapy alone. She also was able to advise them on potential clinical trials for the near future.  The family was grateful to meet her and have a connection for managing the myriad options down the line, ranging from hormones to chemotherapies to clinical trials. The medical oncologist also began to see them on a regular basis; having yet another physician monitoring gave the family even more reassurance.

Over the following weeks, I connected frequently with Mr M, his wife, or his daughter by phone and e-mail, answering questions about the tests and visits he was completing. Unfortunately, Mr M developed some nagging moderate back pain, matching with the lesions in the thoracic spine already identified by MRI and bone scan, so treatment planning is underway.  

As of today, it is odd not to get frequent calls from Mr M and his family. He is getting plenty of great care, having multiple visits with both medical and radiation oncology, even exploring some clinical trials.

In working with a different urologist for a change, it was nice to know that our advice to the patient was on the same page, with little to no conflict overall. Even without meeting with the urologist in person myself, I was able to reinforce his teaching and advice through my interactions with Mr M and his family. Some physicians may not understand the role of the oncology nurse navigator (ONN), perceiving that it will take away from their practice; yet patients, families, and providers soon come to realize that the ONN is there to support them and collaborate in their care.

Sometimes I wonder what would have happened if Mr M’s daughter had not found me online.  I would hope future patients and their caregivers will just expect to have a navigator when met with a cancer diagnosis. I left messages with Mr M and his daughter just to check.  I haven’t heard back yet . . . could be a good thing. really. I hope they’re getting everything they need at this point.

Frank delaRama is a clinical nurse specialist, oncology/genomics, and a prostate cancer nurse navigator at the Palo Alto Medical Foundation (PAMF) in California.

Nurse Perspectives

The patient's daughter had not been at the initial consult and thus had only secondhand information from her father and mother.

January/February 2015

Big Changes Anticipated in Treatment Paradigms

Research Strides Change Treatment Landscape for Blood Cancers

"The Sixth Vital Sign": Screening for Psychosocial Distress

Recognizing Distress in Patients with Acute Leukemia

Improving Safety and Quality with Oral Chemotherapy

Reaching Out, Getting Answers, to Understand Treatment Options