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PurposeFor postmenopausal women with hormone receptor-positive breast cancer, long-term use of aromatase inhibitors (AIs) significantly reduces the risk of cancer recurrence and improves survival. Still, many patients are nonadherent due to adverse side effects. We conducted a pilot randomized controlled trial to test the use of a web-based application (app) designed with and without weekly reminders for patients to report real-time symptoms and AI use outside of clinic visits with built-in alerts to patients’ oncology providers. Our goal was to improve symptom burden and medication adherence.MethodsForty-four women with early-stage breast cancer and a new AI prescription were randomized to either an App+Reminder (weekly reminders to use app) or an App (no reminders) group. Pre- and post-assessment data were collected from all participants.ResultsParticipants in the App+Reminder group had higher weekly app usage rate (74 vs. 38%, p < 0.05) during the intervention and reported higher AI adherence at 8 weeks (100 vs. 72%, p < 0.05). Symptom burden increase was higher for the App group compared to the App+Reminder group but did not reach statistical significance.ConclusionsWeekly reminders to use a web-based app to report AI adherence and treatment-related symptoms demonstrated feasibility and improved short-term AI adherence, which may reduce symptom burden for women with breast cancer and a new AI prescription.Implications for Cancer SurvivorsIf short-term gains in adherence persist, this low-cost intervention could improve survival outcomes for women with breast cancer. A larger, long-term study should examine if AI adherence and symptom burden improvements persist for a 5-year treatment period.

Sleep/wake complaints, and specifically insomnia, are some of the more common problems encountered in the outpatient setting. Despite its prevalence, few clinicians are experts at diagnosing and treating this entity. Additionally, diagnosis and treatment of insomnia is a time-intensive process (often the initial interview takes at least 1 h, depending on the complexity of the insomnia). With a conservative estimate of the annual cost of insomnia between $92.5 and $107.5 billion dollars, it is becoming clear that insomnia has significant medical and public health implications. A problem that has hampered insomnia research is the lack of a standard definition of insomnia for use in research, as well as guidelines for assessment. In recent years, there have been important advances in the classification, evaluation, and treatment of insomnia with efforts to establish greater consensus in how to define and measure insomnia. Cognitive behavioral and pharmacologic therapies have been shown to be effective treatment approaches. Insomnia is a complex entity, often multifactorial in its etiology; and as research and clinical guidelines are established and validated (leading to better data interpretation), continued enhancement of our understanding of this disorder is expected.

Background Bevacizumab (B) and cetuximab (C) are both approved for use in the treatment of metastatic colorectal cancer (mCRC) in the second-line. We examined patient reported symptom burden during second-line treatment of mCRC. Methods Adult mCRC patients treated in the second-line setting with a regimen that included B, C, or chemotherapy only (O) and who had completed ≥ 1 Patient Care Monitor (PCM) surveys as part of routine clinical care were drawn from the ACORN Data Warehouse. Primary endpoints were rash, dry skin, itching, nail changes, nausea, vomiting, fatigue, burning in hands/feet, and diarrhea. Linear mixed models examined change in PCM scores across B, C and O (B = reference). Results 182 patients were enrolled (B: n = 106, C: n = 38, O: n = 38). Patients were 51% female, 67% Caucasian, with mean age of 62.0 (SD = 12.6). Groups did not differ on demographic or clinical characteristics. The most common second-line regimens were FOLFIRI ± B or C (23.1%) and FOLFOX ± B or C (22.5%). Results showed baseline scores to be strongly predictive of second-line symptoms across all PCM items (all p’s < .0001 except for Rash, p = .0013). Controlling for baseline, patients on B tended to have more stable and less severe symptoms. Patients on C had more severe rash, dry skin, and itching and had nail change scores that worsened faster than did B patients. Conclusions Patients receiving second-line treatment for mCRC with B report less symptom burden, especially dermatologic, compared to patients treated with C.

Purpose In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD. Methods Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level <11 g/dL while receiving chemotherapy or within 60 days of the last chemotherapy dose. Multivariate analyses were used to calculate the odds of transfusion and to assess the units of blood transfused, controlling for differences in demographics, clinical history, and chemotherapy. Results Eight hundred pre-NCD and 994 post-NCD patients from 49 sites were selected. Of the patients, 56% used ESAs post-NCD vs. 88% pre-NCD ( p  < 0.0001). The duration of ESA use decreased in the post-NCD (32.1 days) vs. pre-NCD (48.4 days, p  < 0.0001) group. The post-NCD group reported significantly lower Hb levels, higher odds of receiving a transfusion (odds ratio: 1.41, 95% CI 1.05–1.89, p  = 0.0238) and increased blood utilization of 53% (units transfused: OR 1.53, 95% CI 1.15–2.04, p  = 0.0034). Conclusions Decreased frequency and duration of ESA administration were reported in the post-NCD vs. pre-NCD period. Findings were accompanied by a modest but statistically significant increase in transfusions and a decrease in Hb values.

Background This retrospective study evaluated the impact of disease progression and of specific sites of metastasis on patient reported outcomes (PROs) that assess symptom burden and health related quality of life (HRQoL) in women with metastatic breast cancer (mBC). Methods HER-2 negative mBC patients (n = 102) were enrolled from 7 U.S. community oncology practices. Demographic, disease and treatment characteristics were abstracted from electronic medical records and linked to archived Patient Care Monitor (PCM) assessments. The PCM is a self-report measure of symptom burden and HRQoL administered as part of routine care in participating practices. Linear mixed models were used to examine change in PCM scores over time. Results Mean age was 57 years, with 72% of patients Caucasian, and 25% African American. Median time from mBC diagnosis to first disease progression was 8.8 months. Metastasis to bone (60%), lung (28%) and liver (26%) predominated at initial metastatic diagnosis. Results showed that PCM items assessing fatigue, physical pain and trouble sleeping were sensitive to either general effects of disease progression or to effects associated with specific sites of metastasis. Progression of disease was also associated with modest but significant worsening of General Physical Symptoms, Treatment Side Effects, Acute Distress and Impaired Performance index scores. In addition, there were marked detrimental effects of liver metastasis on Treatment Side Effects, and of brain metastasis on Acute Distress. Conclusions Disease progression has a detrimental impact on cancer-related symptoms. Delaying disease progression may have a positive impact on patients' HRQoL.

Goals of work Monoclonal antibody (MoAb) treatments can result in severe infusion reactions. Managing infusion reactions in the outpatient setting introduces clinical and resource challenges for patients and providers, but there is little information regarding prevention, management, or outcomes of severe infusion reactions. This study represents one of the first attempts to describe the clinical consequences of severe infusion reactions associated with MoAb treatment. Materials and methods Clinic staff identified adults treated with rituximab, cetuximab, or bevacizumab who experienced a grade 3 or higher (severe) infusion reaction. Chart reviews from 19 oncology practice sites across the USA captured patient demographics, infusion reaction management procedures, and clinical outcomes. Main results With an average age of 62 years, the sample comprised of 76 patients who experienced a severe infusion reaction while receiving rituximab ( n  = 47), cetuximab ( n  = 24), and bevacizumab ( n  = 5). The most common pretreatment medications were acetaminophen and antihistamine in the rituximab group and corticosteroids (42%) in the cetuximab group. All cetuximab and the majority of rituximab severe infusion reactions occurred during the first cycle of therapy. Postinfusion reaction management typically included corticosteroids, oxygen, and intravenous fluids. Overall, 22% were hospitalized for a mean of 4 days (range = 2.0 to 6.0 days). Permanent discontinuation of MoAb therapy occurred after the majority of cetuximab (79 to 100%) related severe infusion reactions. Conclusions Severe infusion reactions are intensive events that present a serious challenge to patients and oncology practices. Efforts to prevent or reduce such reactions could be of great benefit.

Goals of work Targeted monoclonal antibodies (MoAbs) have become a promising treatment option for patients with cancer. However, there is a risk of developing infusion reactions (IRs) with MoAbs. This study was conducted to evaluate the impact of IRs on staff time and costs among patients receiving an initial infusion of cetuximab (Erbitux®) and rituximab (Rituxan®). Patients and methods A prospective multicenter study involving time and motion and activity sampling methods was conducted among patients with cancer receiving their first outpatient infusion of cetuximab or rituximab. Patients were observed from initiation of MoAb infusion to the end of the clinic visit. IRs were classified as absent, mild/moderate, and severe/life threatening. Staff time and costs were estimated for preparation and administration of MoAb, other chemotherapy agents, and for management of IRs. Resource costs were compared across IR groups within each MoAb. Main results Among 161 patients enrolled, 32% of 71 patients on cetuximab and 39% of 90 patients on rituximab experienced IRs. Treatment of patients who experienced IRs required more staff time (31–80% more time) and resulted in higher human resource costs (increase of 17–65 US dollars) than patients who did not experience IRs. Conclusions IRs following cetuximab and rituximab administration are common and are associated with measurably increased costs of care. The frequency of IRs suggests the importance of identifying clinical guidelines for intervention and management.

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.

Background Oral chemotherapy regimens have emerged as comparably effective to intravenous regimens with the potential for less resource utilization, fewer treatment side effects and a better quality-of-life outcome. The objective of this retrospective chart review was to examine these issues among patients who received single-agent taxane therapy vs. single-agent capecitabine for first- or second-line treatment of metastatic breast cancer (MBC) Methods Data from the medical charts of 61 patients who received single-agent capecitabine, docetaxel, or paclitaxel therapy were supplemented with data from the 38-item Patient Care Monitor (PCM) survey of symptom burden and quality of life, prospectively collected during chemotherapy. The endpoints were PCM index scores, hospitalization during treatment, and the number of clinic visits during treatment. Results The sample was 75% Caucasian, 16% African–American, with a mean age of 59.4 years. Taxane-treated patients had more clinic visits than capecitabine patients, were more likely to have been hospitalized during treatment, and had worse treatment side effects. Controlling for depression, infusion-treated patients reported greater acute distress at the start of therapy than those on oral medication. Conclusion Capecitabine for MBC was associated with a more favorable outcome regarding treatment side effects and quality of life, with reduced resource burden to patients and providers. Physicians may have differentially selected patients with greater depressive symptoms for capecitabine therapy.

Oral adjuvant endocrine therapy (AET) improves survival in hormone receptor-positive breast cancer, but younger, premenopausal women often struggle with adherence. In a post hoc analysis of a randomized trial (N = 304), app-based remote symptom monitoring improved 12-month AET adherence among premenopausal women (App-only: 53.9% vs. EUC: 25.0%), with no benefit for postmenopausal women. Findings suggest remote monitoring may help close adherence gaps in younger patients. Prospectively registered on ClinicalTrials.gov: NCT03592771.