Treatment of transfusional iron overload in patients with myelodysplastic syndrome or severe anemia: data from multicenter clinical practices.

BACKGROUND: Patients with myelodysplastic syndrome (MDS) or severe anemia requiring repeated red blood cell (RBC) transfusions risk developing transfusional iron overload, which can reduce survival. Iron chelation therapy (ICT) has been shown to improve survival and quality of life in patients; however, ICT utilization in clinical practices is not well understood. STUDY DESIGN AND METHODS: Medical records of patients diagnosed with MDS or severe anemia at least 6 months before data extraction, aged at least 21 years at diagnosis, and who received at least one RBC transfusion were reviewed. ICT eligibility was defined as at least 20 units of RBCs transfused or at least two serum ferritin levels exceeding 1000 microg/L. Study endpoint was ICT treatment rate among ICT-eligible patients with lower-risk MDS (International Prognostic Scoring System [low or intermediate-1]; World Health Organization [refractory anemia {RA}, refractory anemia with ringed sideroblasts {RARS}, refractory cytopenia with multilineage dysplasia {RCMD}, refractory cytopenia with multilineage dysplasia and ringed sideroblasts, or 5q]; French-American-British [RA/RARS]). RESULTS: Among 78 ICT-eligible patients with lower-risk MDS, 32 (41%) received ICT. At ICT initiation, treated patients received on average 13.3 transfusions (27.6 units) and mean first post-ICT initiation serum ferritin was twice the MDS Foundation recommendation at 1949 microg/L. Median overall survival for all ICT-eligible patients was significantly longer for those ICT-treated patients than untreated patients (8.7 years vs. 4.7 years, log-rank p = 0.02; multivariate hazard ratio 0.372, p = 0.03). CONCLUSION: This study finds only 41% of ICT-eligible patients with lower-risk MDS received ICT in clinical practice, and treatment was initiated later than recommended. Receipt of ICT was associated with significantly longer survival.

Utility of routine nurse assessment of the risk of chemotherapy-induced febrile neutropenia.

Evidence-based guidelines recommend that patients at high risk (> or = 20%) for febrile neutropenia (FN) should receive prophylactic colony-stimulating factors (Aapro et al., 2006; Kouroukis et al., 2008; National Comprehensive Cancer Network [NCCN], 2008; Smith et al., 2006). We studied the utility of having nurses routinely assess FN risk in new patients before the initiation of chemotherapy. Fifteen nurses used a standardized tool to evaluate FN risk in 150 patients. In 94% of patients studied, nurses detected risk factors that prompted interventions to reduce the incidence of FN. On final evaluation, 67% of nurses said the use of a standardized tool helped them to identify patients at risk for FN, and 73% planned to assess FN risk routinely. Thus, it is feasible and valuable for nurses to assess FN risk using a standardized checklist prior to the initiation of chemotherapy.

A retrospective study of quality of life in a community sample of patients with early stage breast cancer.

Few studies have examined the pattern of change in quality of life (QoL) over time among patients with breast cancer, or the impact of disease recurrence on QoL. This retrospective study examined QoL among patients with stage I-IIIB breast cancer. Individual, disease and treatment characteristics were abstracted from the medical record, and linked with QoL data collected as a routine part of patient care. The sample included patients with nonrecurrent (N = 100) and recurrent (N = 19) disease, who completed 1,449 QoL assessments. Linear mixed model analysis showed that disease recurrence significantly and adversely affected QoL across all domains. QoL did not appear to deteriorate before recurrence. The pattern of adjustment after recurrence varied across QoL domains in theoretically consistent ways. Study findings suggest that patients show improvement in some areas after recurrence, but generally do not recover previous levels of QoL.

Health economic analysis of the burden of infusion reactions on patients, caregivers, and providers.

The cost and efficiency of medical care is an ongoing issue that has a particular effect on patients and caregivers within the community oncology setting. Monoclonal antibody (MoAb) therapy has proven to be effective in the treatment of cancer patients. Although MoAbs are associated with minimal toxicity, they can cause infusion reactions (IRs) in some patients. Managing these infusion reactions leads to an increased burden on patients, caregivers, and providers. Health economic models can quantify the burden that MoAb-induced IRs have on the patient and can help identify ways to maximize the efficiency of providing quality health care. This review identifies the specific burden, including tasks and associated costs, that IRs have on the patient and caregivers, and discusses the importance of using this information to help manage IRs. Nurses are often the first to respond when an IR occurs and the particular impact IRs have on nurses is reviewed. Patients, caregivers, and providers should be aware of the potential burden that MoAb-induced IRs can have on a patient and use this information to help guide clinical decisions.

The benefits and challenges of using computer-assisted symptom assessments in oncology clinics: results of a qualitative assessment.

Developed for clinical use in oncology settings, the Patient Assessment, Care & Education (PACE) System is a computer technology tool designed to address the under-identification and treatment of chemotherapy-related symptoms. This system includes general core questions together with the Patient Care Monitor (PCM), a validated questionnaire that assesses patient-reported problems, six symptom burden indices, and one global quality of life index. The system automatically scores the PCM and generates a written report. The objective of this study was to assess the manner in which clinicians use this system and identify the benefits and challenges that oncology clinics may face when adopting this system. The study was part of a larger evaluation of the system that included standardized surveys and chart review. Sixteen providers (physicians, nurses, and physician assistants) at 13 community oncology clinics participated in a 30-minute interview. Responses were coded according to common phrases or concepts. Clinicians indicated that they use the system mainly for symptom assessment or review of systems. The most common benefits identified included the improved ability to identify under-reported symptoms, enhanced communication with patients; increased efficiency; and its ability to highlight patients' most bothersome symptoms. Challenges included patient burden from the frequent need to answer the questionnaires, issues with the wording and formatting of the screening questionnaire, and technical difficulties. In sum, these interviews suggest that electronic symptom assessments offer potential advantages in terms improving the integration of routine assessment of patients' symptoms and health-related quality of life into the daily flow of an oncology clinic. The approach should receive additional research and development attention.

The AIM Higher Initiative: new procedures implemented for assessment, information, and management of chemotherapy toxicities in community oncology clinics.

Chemotherapy-related toxicities are common and often undertreated in routine cancer care. Initiatives to improve toxicity management in practices may not always be effective. Quality improvement programs must engage multiple disciplines of the healthcare team and sustain efforts to institute and maintain procedures that address practice needs. The Assessment, Information, and Management (AIM) Higher Initiative, a quality improvement program undertaken at 15 community oncology practices, was initiated to improve the AIM of chemotherapy-related toxicities in patients with cancer. AIM Higher focuses on improving five chemotherapy-related toxicities: neutropenia, anemia, depression and anxiety, diarrhea and constipation, and nausea and vomiting. Led by a nurse champion at each of the clinics, a variety of new procedures, processes, and tools were implemented to improve quality of care. Nurses and practice administrators can use the quality improvement processes to generate changes in procedures and practices.

Unintended Consequences in Cancer Care Delivery Created by the Medicare Part B Proposal: Is the Clinical Rationale for the Experiment Flawed?

PURPOSE: Medicare currently enrolls ≥ 45 million adults, and by 2030 this is projected to increase to ≥ 80 million beneficiaries. With this growth, the Centers for Medicare & Medicaid Services (CMS) issued a proposal, the Medicare Part B Drug Payment Model, to shrink drug expenditures, a major contributor to overall health care costs. For this to not adversely affect patient outcomes, lower-cost alternative medications with equivalent efficacy and no increased toxicity must be available. This is often not true in the treatment of cancer. Herein, we examine the flaws in the rationale of the CMS and the potential unintended consequences of this experiment. METHODS: We identified the top three oncology expenditures (rituximab, bevacizumab, and trastuzumab) and their vetted alternatives (per the National Comprehensive Cancer Network guidelines) to ascertain whether lower-cost equivalent alternatives are available. Drug cost was based on April 2016 average sale price. We explored both efficacy of the agents and, when applicable, toxicity to compare alternatives to these high-dollar medications. RESULTS: For the largest Medicare oncology drug expenditures, there is not a lower-cost option with equal efficacy for their primary indications. Without lower-cost alternatives, the unintended consequence of this CMS experiment may include curtailing access to care or an increase in patient/program costs. CONCLUSION: The CMS proposal, by simply lowering reimbursement for drugs, does not acknowledge the value of these agents and could unintentionally reduce quality of care. Alternative approaches to value-based care, such as the Oncology Care Model and similar frameworks, should be explored.

Validation of the Cancer Care Monitor items for physical symptoms and treatment side effects using expert oncology nurse evaluation.

The Cancer Care Monitor (CCM) is a tablet computer-based multidimensional measure of symptom burden and quality of life. This study examined individual item validity for 42 items measuring general physical symptoms and treatment side effects. Patients (40 females and 20 males) completed the CCM and a blinded nurse interview. In general, patient self-reported symptoms on the CCM corresponded well to nurse-verified evaluations. There was excellent agreement between the patient-reported CCM items and nurses' ratings on whether the symptom was present or absent and on the severity of a given symptom. Additionally, the results suggested that the majority of items had high sensitivity, specificity, positive predictive value, negative predictive value, and Youden's Index score. Taken together, the results suggest that the CCM can provide an efficient method for collecting information about symptom presence and symptom burden at the point of care.

Impact of less frequent injections on patients, caregivers, and practices.

Many factors can affect decisions about chemotherapy and supportive care, including disease outcome, patient quality of life, and drug toxicities. Chemotherapy and supportive therapy may require numerous medical visits that may significantly affect patients and their caregivers. It has recently been shown that practice resources should also be considered in evaluating the full impact of medical visits. To this end, increasing the efficiency of a practice may help ensure the viability of delivering quality care. Greater efficiency can lead to improvements in the quality of life of patients and their caregivers, lower practice operating expenditures, and increase practice capacity and productivity. Chemotherapy-induced anemia is common in patients with cancer, and erythropoiesis-stimulating proteins (ESPs) can lessen its incidence and severity but may require many additional medical visits. This article discusses the importance of establishing efficiency in the oncology practice and considers the role of coordinating tests and procedures, specifically the role of available scheduling options for growth factors. Synchronizing treatments with ESPs and chemotherapy may increase patient convenience and improve practice efficiencies.

A prospective investigation of chemotherapy-induced neutropenia and quality of life.

This prospective study of chemotherapy-induced neutropenia (CIN) explored the association between the relative grade of neutropenia and symptom burden and quality of life (QOL). Eighty-four adult cancer patients from nine community oncology centers receiving 1 of 13 myelosuppressive chemotherapies were evaluated at days 0, 4, 7, 9, 11, 14, and 21 of their respective first cycle. Neutropenia grade (grade 3/4 vs grades 0 to 2) was determined by serial absolute neutrophil count (ANC) measures. Measures of patient-reported outcomes included the Rotterdam Symptom Checklist (RSCL), Hospital Anxiety and Depression Scale (HADS), Cancer Care Monitor-Medical Isolation Scale (CCM-MIS), and SF-36. Changes in outcomes from baseline to highest grade of neutropenia were evaluated using mixed model-repeated measures for each of 15 outcomes. Compared with grades 0-2, grade 3/4 neutropenia was associated with greater symptom burden and worse QOL for six measures (P < 0.05). The pattern of differences suggested that measures of symptom distress and social functioning were sensitive to patient changes associated with grade 3/4 neutropenia. Worsening of symptom burden and QOL appears to be associated with severe afebrile neutropenia. A causal relationship between neutropenia and worse symptoms and QOL remains difficult to establish due to the confounding of the effects of neutropenia with other adverse effects of chemotherapy.

Experiencing neutropenia: quality of life interviews with adult cancer patients.

BACKGROUND: Neutropenia is a common toxicity in chemotherapy but detailed information about how neutropenia is associated with changes in patients' quality of life is not readily available. This prospective study interviewed patients with grade 4 neutropenia to provide qualitative information on patients' experience of developing and coping with grade 4 neutropenia during a cycle of chemotherapy. METHODS: A sample of 34 patients who developed grade 4 neutropenia during the first cycle of chemotherapy completed a total of 100 structured clinical interviews. Interviews were transcribed, and 2 raters inductively developed 5 broad categories comprising 80 specific complaint domains nominated by patients. Thirty-five patient-nominated problems were mentioned in 5% or more of the interviews. RESULTS: Fatigue was the most common physical symptom. Interference in daily routine, negative self-evaluation, negative emotion, and social isolation were other common complaints associated with neutropenia. CONCLUSION: Neutropenia is associated with a number of negative experiences among cancer patients undergoing chemotherapy, and these negative experiences have an adverse effect on the patient's quality of life. Oncology nurses can play a key role in helping patients manage adverse effects to maintain their quality of life.

Medical visits for chemotherapy and chemotherapy-induced neutropenia: a survey of the impact on patient time and activities.

BACKGROUND: Patients with cancer must make frequent visits to the clinic not only for chemotherapy but also for the management of treatment-related adverse effects. Neutropenia, the most common dose-limiting toxicity of myelosuppressive chemotherapy, has substantial clinical and economic consequences. Colony-stimulating factors such as filgrastim and pegfilgrastim can reduce the incidence of neutropenia, but the clinic visits for these treatments can disrupt patients' routines and activities. METHODS: We surveyed patients to assess how clinic visits for treatment with chemotherapy and the management of neutropenia affect their time and activities. RESULTS: The mean amounts of time affected by these visits ranged from approximately 109 hours (hospitalization for neutropenia) and 8 hours (physician and chemotherapy) to less than 3 hours (laboratory and treatment with filgrastim or pegfilgrastim). The visits for filgrastim or pegfilgrastim were comparable in length, but treatment with filgrastim requires several visits per chemotherapy cycle and treatment with pegfilgrastim requires only 1 visit. CONCLUSIONS: This study provides useful information for future modelling of additional factors such as disease status and chemotherapy schedule and provides information that should be considered in managing chemotherapy-induced neutropenia.

A survey of pain-related hospitalizations, emergency department visits, and physician office visits reported by cancer patients with and without history of breakthrough pain.

Pain is a common problem for cancer patients and can result in substantial medical costs, but little is known about the characteristics of pain that may predict these costs. This study applied telephone survey methodology to investigate the relationship between breakthrough pain (BTP) and the use of medical resources in a cancer population with pain. A nonrandom sample of 1,000 cancer patients was contacted by using standard telephone survey techniques. Eligible patients were questioned about the occurrence of BTP and pain-related hospitalizations, emergency department visits, and physician office visits. Patients who indicated that they had experienced BTP were compared with similar patients who had not experienced BTP by using cost estimations derived from patient reports of health care use. The analysis indicated that BTP patients were more likely to have experienced pain-related hospitalizations and physician office visits. When statistical control was made for patient ratings of the effectiveness of scheduled analgesics, BTP had higher costs associated with pain-related hospitalizations and physician office visits. The total cost of pain-related hospitalizations, emergency visits, and physician office visits was 12,000 US dollars/yr per BTP patient and 2,400 US dollars/yr per non-BTP patient. Cancer patients with BTP may sustain higher direct medical costs than patients without BTP. Implications and limitations of the study are discussed, and studies that will further clarify the relationship between BTP and medical costs are encouraged.

The Cancer Care Monitor: psychometric content evaluation and pilot testing of a computer administered system for symptom screening and quality of life in adult cancer patients.

Technology is making the routine screening of symptoms and the measurement of quality of life (QoL) more feasible at the point of care. However, most existing symptom screening scales and QoL measures were not developed for clinical use and were not formatted and validated for administration through computerized mediums. The Cancer Care Monitor (CCM) is a symptom-based scale developed for administration on pen-based computers. This study is an initial evaluation of the reliability and validity of the CCM. Three samples of adult outpatients provided ratings on 38 physical, psychological, and functional oriented items of the CCM that comprise six symptom scales and one global QoL index. All additive scales are converted to normalized T scores. Reliability was examined through internal consistency and confirmatory factor analysis. Convergent and divergent validity were examined by comparing CMM scores to established measures of corresponding constructs and physician judgments. Alternative forms reliability was established by comparing paper and pencil administration with computer administration. Internal consistency reliability and factor analyses confirmed the structure of the CCM as comprising six primary symptom scales and one global QoL index. Internal consistency reliabilities ranged from 0.80 to 0.89. The pattern of correlations between CCM scales and established measures supported the convergent and divergent validity of the CCM scales. Alternate forms reliability based on paper and computer forms of the CCM scales was high. Patients indicated a preference for the computer-administered version. Results suggest that CCM items can be scored as a reliable and valid measure of constructs related to physical, psychological, and functional status, and global health-related QoL in adult cancer patients. Future studies should replicate and further evaluate the properties of the CCM, especially in relation to clinical utility.

Description and predictors of direct and indirect costs of pain reported by cancer patients.

The purpose of this study was to describe direct and indirect costs associated with pain in cancer patients and to examine potential predictors of these costs. The study surveyed cancer outpatients about direct costs resulting from pain-related hospitalizations, emergency department visits, physician office visits, and use of analgesic medications and indirect costs related to money spent on pain-related transportation, complementary methods to improve pain management, educational materials, over-the counter medication, domestic support, and childcare. Furthermore, the study examined age, marital status, race, income level, pain severity, pain interference, and presence of breakthrough pain as predictors of direct and indirect costs. Three hundred and seventy-three cancer outpatients were sampled. One hundred and forty-four cancer patients (39%) reported experiencing cancer-related pain and completed the study questionnaires. Seventy-six percent (76%) of the patients had experienced at least one pain-related cost, resulting in an average monthly direct cost of US$ 891/month per patient. Sixty-nine percent (69%) of patients had experienced some type of direct medical cost due to pain, resulting in an average total direct pain-related cost of US$ 825/month per patient. Fifty-seven percent (57%) of patients reported incurring at least one indirect pain-related expense for an average indirect cost of US$ 61/month per patient. Higher pain intensity, greater pain interference, and presence of breakthrough pain predicted higher direct and indirect medical expenses. Younger age and lower income level also predicted higher direct medical expenses.

Sleep and quality of life in breast cancer patients.

This study described sleep in a heterogeneous sample of breast cancer patients using the Pittsburgh Sleep Quality Index (PSQI) and examined the relation between sleep disturbance and health-related quality of life as measured by the Rand 36-Item Health Survey. Chemotherapy and radiation therapy were explored as predictors of sleep disturbance in breast cancer patients, and the sleep characteristics of breast cancer patients were compared to the sleep characteristics of a sample of medical patients with general medical conditions. Results showed that 61% of breast cancer patients had significant sleep problems. Sleep was characterized by reduced total sleep time with sleep frequently being disturbed by pain, nocturia, feeling too hot, and coughing or snoring loudly. Despite the frequency of significant sleep disturbance, pharmacological and cognitive-behavioral treatments of sleep problems were observed to be inadequate. Limited evidence was found for the role of chemotherapy and radiation therapy in the sleep disturbance of breast cancer patients, and the general pattern of sleep disturbance in breast cancer patients was not significantly different than that observed in medical patients with general medical conditions. Breast cancer patients having significant sleep problems had greater deficits in many areas of health-related quality of life. The implications of the findings and study limitations are discussed.

The Zero Acceptance of Pain (ZAP) Quality Improvement Project: evaluation of pain severity, pain interference, global quality of life, and pain-related costs.

The Zero Acceptance of Pain (ZAP) Quality Improvement Project was a multi-site effort to improve the lives of outpatients with cancer pain by enhancing the clinical practice of pain assessment and management. Independent samples of patients completed self-report measures of severity of pain, pain interference, global quality of life, pain treatment satisfaction, general medical treatment satisfaction, pain attitudes, and pain-related medical costs before and after the implementation of ZAP. Results suggested that ZAP decreased the severity of recent pain, decreased interference of pain on daily functioning, and improved satisfaction with pain treatment and attitudes about addiction to opioid medication. Direct medical costs consisting of pain-related hospitalizations, emergency department visits, and physician office visits were greatly reduced. In summary, the findings of this study support the idea that clinic-based efforts to improve the practice of pain management are effective in improving the lives of cancer patients who are experiencing pain.

Safety and treatment patterns of angiogenesis inhibitors in patients with metastatic renal cell carcinoma: evidence from US community oncology clinics.

Safety and treatment patterns of sunitinib and sorafenib in metastatic renal cell carcinoma (mRCC) had been previously reported using retrospective chart review of patients treated in US tertiary centers. Because practice patterns may vary between hospital- and office-based settings, this study examined safety and treatment patterns of these agents in US community oncology clinics. Medical records were retrospectively reviewed for 250 patients with mRCC treated at 18 community oncology clinics. Eligible patients were ≥18 years old and received ≥1 prescription for sunitinib (n = 131) or sorafenib (n = 119) as first-line anti-angiogenic treatment. Rates of adverse events (AEs) and treatment modifications were analyzed; reasons for treatment modifications were examined. Median duration of first-line sunitinib and sorafenib treatment was 5.9 and 5.5 months, respectively. Among patients treated with sunitinib and sorafenib, 86% (30%) and 87% (28%), respectively, experienced ≥1 all-grade (grade 3/4) AE. The most common AEs were fatigue/weakness in sunitinib (all-grade: 42%; grade 3/4: 5%) and skin rash in sorafenib (all-grade: 35%; grade 3/4: 6%). Sixty-two and 64% of patients treated with sunitinib and sorafenib, respectively, had ≥1 treatment modification due to AEs. Recorded AE rates in patients with mRCC treated with angiogenesis inhibitors in community practice tended to be lower than in tertiary centers, possibly due to shorter treatment duration. Rates of treatment modifications due to AEs tended to be higher in community practice. This study provides evidence from an office-based setting of unmet need for agents that may provide improved tolerability in mRCC.

Predictors of response to sequential sunitinib and the impact of prior VEGF-targeted drug washout in patients with metastatic clear-cell renal cell carcinoma.

OBJECTIVE: To identify factors that can be used to identify metastatic clear cell RCC patients more likely to benefit from sequential sunitinib. PATIENTS AND METHODS: We identified patients who failed sorafenib or bevacizumab and subsequently received sunitinib. We looked at objective response rates (ORR), progression-free survival (PFS), and overall survival (OS) to sunitinib in relation to baseline clinical variables. RESULTS: Seventy-one patients received sunitinib sequential therapy. Median duration of follow-up after starting sunitinib was 9.3 months. Median PFS was 5.8 months; median OS was not reached. Significantly higher ORR was seen in patients with normal hemoglobin (25.6%) [defined as >12 gm/dl for female; >13 gm/dl for male]. In addition, a shorter PFS for patients with low hemoglobin, and patients with time from diagnosis to first treatment ≤ 1 year was found. There was a shorter OS for patients ≥ 60 years old, with brain metastasis, low hemoglobin, and time from diagnosis to treatment ≤ 1 year. There was no difference in ORR, PFS, or OS in patients who started sunitinib after or within a 30-day period. CONCLUSIONS: Metastatic clear-cell RCC patients with anemia have less clinical benefit from sequential sunitinib after failure of bevacizumab or sorafenib. Other factors associated with poor outcome include brain metastases, older age, and <1 year between diagnosis and first treatment. Importantly, no difference in outcomes was observed if sequential therapy was initiated within or after 30 days. External validation and prospective evaluation are needed to confirm these findings.