Treatment patterns, clinical outcomes, health resource utilization, and cost in patients with BRCA-mutated metastatic breast cancer treated in community oncology settings.

PURPOSE: This retrospective study of community oncology patients with breast cancer gene (BRCA)-mutated metastatic breast cancer (MBC) examined treatment outcomes and health resource utilization (HRU) and costs for a sample of patients with human epidermal growth factor receptor 2 (HER2)-negative disease who were either hormone receptor positive (HR+) or triple negative breast cancer (TNBC). METHODS: Evidence from the Vector Oncology Data Warehouse, a repository of electronic medical records/billing data and provider notes, was analyzed. Treatment outcomes were progression-free survival (PFS) and overall survival (OS) from start of first-line therapy in the metastatic setting. HRU and cost measures were collected from the time of MBC diagnosis to end of the record. HRU included hospitalizations, emergency room visits, infused/parenteral supportive care drugs, and outpatient visits. Costs were computed both as total and monthly costs. RESULTS: 57 HR+ and 57 TNBC patients (2013-2015) met inclusion criteria. Eight TNBC patients did not get treatment. HR+ patients had median first line PFS of 12.1 months and TNBC patients had 6.1 months. HR+ patients had median OS from start of first line of 38.4 months, and TNBC patients had 23.4 months. Rate of use of infused/parenteral supportive care drugs was 25.5% overall and 36.7% among TNBC patients with 15.8% among HR+ patients. CONCLUSION: There is an unmet need in BRCA-mutated patients with MBC, including those with HR+ and TNBC disease. The unmet need among TNBC patients was most evident in that 12% were not treated and TNBC patients appeared to have poor treatment outcomes. MICRO ABSTRACT: Reviewed medical records for outcomes, resource utilization, and costs in 114 community patients with BRCA mutated metastatic breast cancer. 57 hormone positive (HP); 57 triple negative (TN). RESULTS: median PFS: 12.1 months HP; 6.1 TN. HP OS was 38.4; TN 23.4. Rate of infused supportive care drugs: 25.5% HP; 36.7% TN. Patients with TN disease need better therapeutic options.

Treatment Patterns and Outcomes in Patients with KRAS Wild-Type Metastatic Colorectal Cancer Treated in First Line with Bevacizumab- or Cetuximab-Containing Regimens.

PURPOSE: Patients with Kirsten rat sarcoma viral oncogene wild-type (KRAS WT) metastatic colorectal cancer (mCRC) treated in first line with bevacizumab (B) or cetuximab (C) plus standard chemo backbones had comparable outcomes in phase III Cancer and Leukemia Group B (CALGB) 80405. We examined comparative effectiveness of B and C regimens in real-world community settings. METHODS: This retrospective study examined progression-free survival (PFS) and OS in a US community sample of KRAS WT mCRC patients treated with first-line B (n = 254) or C (n = 146) regimens. Medical records from the Vector Oncology Data Warehouse were used. Disease progression was determined from patient charts. OS was measured from the start of first-line treatment until death. RESULTS: There were no significant difference in either PFS or OS respectively between B-treated compared to C-treated patients (HR = 1.324, 95% CI 0.901, 1.947; HR = 1.080, 95% CI 0.721, 1.617). More B patients received oxaliplatin backbones (74.8 vs. 36.3%), and more C patients received irinotecan backbones (51.4 vs. 20.1%), ps < 0.001. Multivariate survival analyses showed a significant difference indicating a greater risk for death among C-treated patients with right-sided tumors vs. left-sided tumors (HR = 2.263, 95% CI 1.394, 3.673, p = 0.0009), but not for B-treated patients (HR = 1.209, 95% CI 0.825, 1.771, p = 0.3297). CONCLUSIONS: Consistent with CALGB 80405, median PFS and OS for these community oncology KRAS WT mCRC patients treated with first-line B or C regimens did not differ significantly.

Progression-Free Survival in Patients Receiving Chemotherapy Alone (C) or Chemotherapy with Bevacizumab (CB) for First-Line Treatment of KRAS Mutant Metastatic Colorectal Cancer in Community Oncology Settings.

PURPOSE: Bevacizumab is a standard first-line (L1) treatment for metastatic colorectal cancer (mCRC) patients regardless of RAS status. This retrospective study examined treatment patterns and outcomes in a community oncology sample of KRAS mutant mCRC patients treated with chemotherapy (C) or C plus bevacizumab (CB) in L1. METHODS: This study used medical records from the Vector Oncology Data Warehouse. Eligible patients were confirmed KRAS mutant mCRC and received L1 C or CB. Kaplan-Meier analysis assessed L1 progression-free survival (PFS) and overall survival (OS). Cox regression models examined the interaction of tumor location (R/L) with treatment. RESULTS: CB (n = 264) compared to C (n = 109) patients were younger, less likely performance status (PS) impaired, and more likely with liver metastases. Median unadjusted PFS was 10.41 months (95% CI 9.0-11.3) in CB and 7.66 months (95% CI 6.5-9.1) in C patients (p = 0.174). Median unadjusted OS was 26.91 months (95% CI 24.3-29.3) in CB and 23.33 months (95% CI 19.7-29.2) in C patients (p = 0.571). For patients with right- vs. left-sided tumors, C (but not CB)-treated patients had higher adjusted risk for progression (HR = 1.715, 95% CI 1.108, 2.653; p = 0.015). CONCLUSIONS: CB- vs. C-treated KRAS mutant mCRC patients may have a meaningful PFS benefit. Patients with right-sided tumors treated with C were at higher risk for disease progression than patients with left-sided tumors. Tumor location had no significant effect on outcomes in the CB cohort.

Analysis of the psychological impact of cancer-related symptoms on patients with non-small cell lung cancer.

BACKGROUND: Patients with non-small cell lung cancer (NSCLC) experience adverse physical symptoms because of cancer, cancer treatment, and comorbidities. The relations among Cancer-Related Symptoms, Functional Impairment, and Psychological Symptoms in patients with NSCLC is not well understood. METHODS: Retrospective analysis of patient-reported symptoms with the 38-item Patient Care Monitor survey, collected in routine clinical care for 1138 patients with NSCLC at eight US community oncology practices. Study sample was randomly split, and structural equation models examined the direct and mediated effects of Cancer-Related Symptoms and Functional Impairment on symptoms of acute distress (Distress) and depression (Despair) in the training sample. The training model was cross validated in testing sample. Results are presented for the full model using the entire sample. RESULTS: Patients were 48.3% female, with mean age of 66.0 years. The most common comorbidities were anemia (60.8%) and respiratory disease (24.5%). Severity of Cancer-Related Symptoms was strongly and positively related to Functional Impairment and Psychological Symptoms in both training and testing models. The modeled effect of Functional Impairment on Distress and Despair was significant in the overall model using the total sample, and significant or near-significant in the training and testing models. The mediated effect of Cancer-Related Symptoms by Functional Impairment tended to be weaker than its direct modeled effect on Distress and Despair. CONCLUSIONS: Despite prior research suggesting that Functional Impairment plays a larger role than symptom burden in depression in NSCLC, the independent modeled effects of Functional Impairment were no greater than the direct modeled effects of Cancer-Related Symptoms. Copyright © 2016 John Wiley & Sons, Ltd.

Early treatment discontinuation and switching in first-line metastatic breast cancer: the role of patient-reported symptom burden.

Treatment options for metastatic breast cancer (MBC) are complex, and some patients experience early discontinuation or switching of treatment (ETDS). We examined the relationship between ETDS and patient-reported symptom burden among patients receiving first-line treatment of MBC in community oncology settings. This retrospective observational study used the ACORN Data Warehouse, a comprehensive community oncology repository of medical records and patient-reported outcomes. Patients with first-line treatment for MBC who had Patient Care Monitor (PCM) surveys were eligible. ETDS was defined as: record stating ETDS, treatment duration < planned, and planned therapy <6 weeks. Symptom burden was measured by two PCM composite scores [continuous (0-22) and categorical (absent, mild, moderate, and severe)] computed from 22 PCM items with varying cut points to assess symptom burden over time. Cox regression with time-varying covariates was used to assess risk for ETDS controlling for patient characteristics and treatment type: chemo (chemotherapy without targeted therapy (±hormone therapy); targeted (chemotherapy plus targeted therapy (±hormone therapy); and hormone (hormone therapy only). Overall, 197 (24.7 %) of a total sample of 797 patients had an ETDS event, of which 109 (55.3 %) were switches rather than early discontinuation. ETDS rate was nominally lower in the hormone group (11.1 %) versus chemo (27.6 %) or targeted (26.1 %). PCM continuous composite score predicted ETDS, controlling for other variables (HR = 1.132, p < 0.0001). ETDS was predicted by moderate and severe levels of PCM categorical composite score (HR = 4.135, and HR = 5.287 vs. absent, respectively, both p < 0.0001), with the pattern suggesting a threshold effect. Moderate or severe levels of a wide range of patient-reported symptoms and the accumulation of symptoms over time significantly predicted ETDS. Providers may better maintain patients on planned therapy if they attend to overall symptom burden patients experience over time.

Phase II trial of fulvestrant with metronomic capecitabine for postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer.

BACKGROUND: In this phase II study, we explored efficacy and toxicity of combined endocrine and low-dose metronomic chemotherapy therapy consisting of fulvestrant and capecitabine in estrogen and/or progesterone receptor-positive, HER2-negative MBC. PATIENTS AND METHODS: Patients with ≤ 1 previous hormonal treatment in the metastatic setting received an injection fulvestrant loading dose 500 mg on day 1, 250 mg on days 15 and 29 followed by 250 mg every 28 days along with continuous oral capecitabine in divided doses. The total fixed daily dose of capecitabine was either 1500 mg or 2000 mg, depending on the patient's weight (< 80 kg vs. ≥ 80 kg). Primary end points were PFS and TTP. Toxicity was assessed by continuous evaluations of treatment-emergent adverse events (AEs) and changes from baseline in laboratory values. RESULTS: Forty-one women, with a mean age of 64.5 years, were enrolled. Patients completed a median of 11 monthly treatment cycles. Median PFS was 14.98 months (95% confidence interval [CI], 7.26-upper limit [UL] not estimated) and median TTP was 26.94 months (95% CI, 7.26-UL not estimated). Median overall survival was 28.65 months (95% CI, 23.95-UL not estimated). Treatment was well tolerated with < 10% Grade 3 palmar-plantar erythrodysesthesia. Overall, the most frequent AEs were palmar-plantar erythrodysesthesia, fatigue, and nausea. CONCLUSION: Fulvestrant with metronomic capecitabine demonstrates substantial activity in hormone receptor-positive MBC and is well tolerated. Combined chemoendocrine approaches should be further explored considering the low toxicity of the combination with meaningful TTP.

Treatment patterns and clinical effectiveness in metastatic castrate resistant prostate cancer after first-line docetaxel.

BACKGROUND: Treatment for metastatic castrate-resistant prostate cancer in community settings is not well understood. OBJECTIVE: To examine treatment patterns, sequencing, and outcomes in patients receiving second- and third-line treatment after first-line docetaxel. METHODS: We used a community oncology database to identify patients who progressed after line 1 docetaxel (D) and received line 2 cabazitaxel (DC), abiraterone (DA), or other therapy (DO). Progression-free survival (PFS) and overall survival (OS) were assessed using Kaplan- Meier and Cox regression models. Line 3 included subsets DCA and DAC. RESULTS: Line 2 groups (DC = 60 patients, DA = 71, DO = 153) did not differ significantly on demographic and clinical characteristics or median PFS on docetaxel therapy. Cox regression for OS by line 2 groups showed increased risk for DA compared with DC (HR, 1.69; P = .026) when 24 untreated DO patients were excluded. A similar nonsignificant pattern was observed when the 24 untreated patients were included. Of patients receiving DC in line 2, a nominally greater proportion received A in line 3 (57%, 34 of 60 patients) than did patients who received DA in line 2 followed by C in line 3 (25%, 18 of 71). LIMITATIONS: There was a small sample for line 3, and unexamined confounds and selection biases in observational research. Conclusions Treatment patterns in community settings following docetaxel are complex and may involve multiple hormonal agents prior to disease progression. Cabazitaxel may not be optimally used in advanced disease. Although Cox regression showed increased risk of death for DA compared with DC, results need to be validated prospectively. CONCLUSIONS: Treatment patterns in community settings following docetaxel are complex and may involve multiple hormonal agents prior to disease progression. Cabazitaxel may not be optimally used in advanced disease. Although Cox regression showed increased risk of death for DA compared with DC, results need to be validated prospectively.

The association of rash severity with overall survival: findings from patients receiving erlotinib for pancreatic cancer in the community setting.

OBJECTIVES: This retrospective study examined pancreatic cancer patients who received combination gemcitabine and erlotinib to determine if the association between rash and outcomes observed in clinical trials would be observed in 'real-world' community oncology settings. METHODS: Medical records from 10 community oncology practices were used to identify eligible patients. Rash severity was classified as High (moderate/severe) versus Low (absent/mild) based on medical record review. Kaplan-Meier analysis assessed progression-free survival (PFS) and overall survival (OS) by rash status from a landmark of 42 days after treatment initiation. Cox regression with time-varying covariates tested whether high-severity rash predicted longer OS and PFS. RESULTS: The High Severity group (n = 34) had longer median OS from the landmark than the Low Severity group (n = 134; 7.58 months vs 5.03 months, P = 0.0339). Cox regression analysis (n = 174) confirmed a reduced risk of death with High Rash Severity (hazard ratio [HR] = 0.67, P = 0.0389). Progression-free survival results showed a similar pattern (median PFS 2.37 months from landmark vs 2.04 months for High vs Low Severity groups, P = 0.0485). CONCLUSIONS: Results from this community sample were consistent with findings from randomized clinical trials, showing that longer OS is predicted by high-severity rash in erlotinib-treated pancreatic cancer patients.

Relationship between incidence of fracture and health-related quality-of-life in metastatic breast cancer patients with bone metastases.

OBJECTIVE: This retrospective observational study describes treatment patterns and longitudinal health-related quality-of-life (HRQoL) among metastatic breast cancer patients with bone metastasis from nine community oncology clinics. METHODS: For description of treatment patterns, patients were classified as treated if they started zoledronic acid within 60 days of diagnosis of bone metastasis, were considered untreated if they had not, and were considered unclassified if they died or experienced fracture before 60 days had elapsed. Medical record review provided demographic and disease characteristics as well as history of treatment. Patients completed Patient Care Monitor (PCM) assessments of patient reported outcomes during routine care for up to 2 years from the date of bone metastasis diagnosis. RESULTS: The overall rate of fracture in the sample was 17.4%. Of the 321 patients enrolled, 160 were treated as of 60 days after diagnosis of bone metastasis, 147 were untreated, and 14 were unclassified. Of the 147 untreated as of 60 days, 82 did eventually receive zoledronic acid. More than half of all patients treated with zoledronic acid delayed the start of treatment by more than 30 days after diagnosis of bone metastasis. Patients who had a fracture showed decreased mobility and increased pain and anxiety at fracture, with recovery taking ~16 months. LIMITATIONS: Key limitations included: convenience sample with information limited to medical record content, low rate of observed fractures possibly due to limited 2-year follow-up, and exclusion of non-zoledronic acid bisphosphonate use. CONCLUSIONS: Whereas the proportion of patients experiencing a fracture was small, the impact of fracture on HRQoL was significant and was more prominently seen to impact specific dimensions of HRQoL.

Small N designs for rehabilitation research.

Rehabilitation research presents unique and challenging problems to investigators during both the design and analysis periods. Statistical issues regarding sample size requirements for an adequately powered study may be in direct conflict with realistic recruitment and subject retention goals. Issues of underpowered studies, sample size requirements, and recruitment goals plague rehabilitation research. Randomized clinical trials (RCTs) are typically narrow in scope and thus lack generalizability to everyday, yet specific, clinical problems; they are also costly and time-consuming and require large numbers of participants for randomization to have optimal, desired effects. Further, the RCT design may not be applicable to assistive technologies and environmental modifications-vital components of disability and rehabilitation research-nor is it appropriate in situations in which theoretical models of change are lacking or premature. Single-case designs are better suited for studies in which understanding and changing patient behavior and functional status are primary goals and the targeted sample sizes are less than 30 and frequently less than 10. Theoretical, methodological, and clinical reasons for using experimental and quasi-experimental single-case designs are presented. Recommendations for designing and conducting single-case studies that contribute to the evidence base are also discussed.

The Patient Care Monitor-Neutropenia Index: development, reliability, and validity of a measure for chemotherapy-induced neutropenia.

PURPOSE/OBJECTIVES: To provide an initial evaluation of the psychometric properties of the Patient Care Monitor 1.0 Revised-Neutropenia Index (PCM-N), a symptom-based assessment tool designed to measure health-related quality-of-life (HRQOL) changes associated with chemotherapy-induced neutropenia. DESIGN: Known-groups methodology and self-report instrument validation. SETTING: A large community oncology practice in Memphis, TN. SAMPLE: 424 patients with cancer in four samples. METHODS: All patients in the first three samples were assessed at baseline of chemotherapy administration and at a point analogous to midcycle. The fourth sample underwent a cross-sectional evaluation of the ability of the PCM-N to distinguish patients with febrile neutropenia, severe afebrile neutropenia, and no neutropenia. MAIN RESEARCH VARIABLES: PCM-N score, grade of neutropenia, and febrile status. FINDINGS: Internal consistency reliability and factor analysis supported the single additive scale structure of the 13 items of the PCM-N. The PCM-N demonstrated good known-groups validity and was able to distinguish patients with grades 3-4 neutropenia from those with grades 0-2. The tool also was able to distinguish patients with febrile neutropenia, severe afebrile neutropenia, and no neutropenia. Receiver operating characteristic analyses provided a psychometrically based threshold score. CONCLUSIONS: The PCM-N is a reliable and valid instrument sensitive to changes in HRQOL associated with moderate-to-severe chemotherapy-induced neutropenia. IMPLICATIONS FOR NURSING: Nurses can use the PCM-N as a rapid and cost-effective tool for monitoring symptoms of neutropenia in patients with cancer.

Symptom Burden and Quality of Life in Patients with Follicular Lymphoma undergoing Maintenance Treatment with Rituximab Compared with Observation.

BACKGROUND: The impact on health related quality of life (HRQoL) of rituximab maintenance (R-M) versus observation (OBS) after induction for treatment of follicular lymphoma (FL) is unclear. METHODS: We reviewed the charts of 137 patients (53% female, 87% White, age 61.0 ± 12.4 years) who received either R-M (n = 53) or OBS (n = 84) after chemotherapy induction for newly diagnosed FL at community oncology practices within the US. Patients (65% with advanced disease; 48% with a high FLIPI score [3-5]) had completed ≥1 Patient Care Monitor HRQoL survey in the period following front-line therapy, and were excluded if they had progressed during front-line therapy. RESULTS: Linear mixed models showed that postinduction, most symptoms were stable, with patients on R-M reporting HRQoL that was equal to that reported by OBS patients. CONCLUSIONS: Among R-M patients, receipt of rituximab was associated with improved psychological symptoms.

Use of the Patient Care Monitor to screen for depression in adult cancer patients interviewed with the structured clinical interview for DSM-IV.

OBJECTIVE: To evaluate the Patient Care Monitor (PCM1.0) Acute Distress and Despair normalized T scores as indicators of a diagnosis of Major Depression according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID). METHODS: Subjects were 21 adult cancer patients identified by treating community oncologists as having significant emotional distress matched on age, cancer type, treatment history, and sex to 21 patients not having significant distress. All completed e/tablet PCM 1.0 and SCID administered by trained interviewers. Unweighted kappa and receiver operating characteristics (ROC) analyses were used to assess scale properties. RESULTS: Agreement between SCID Major Depression and Acute Distress and Despair (T> or =65) were kappa=0.751 and 0.755, respectively. ROC area under the curve values for these two scales were 0.967 (SE+/-0.03) and 0.942 (SE+/-0.03), respectively, with optimal cut points of T=61 and 63, respectively. CONCLUSIONS: Under conditions of preselected extreme groups, PCM 1.0 Acute Distress and Despair T scores are reasonable screening indicators of clinical depression in cancer patients. PCM 1.0 provides an efficient method for point-of-care screening of depression in community oncology clinics.

The relation of trouble sleeping, depressed mood, pain, and fatigue in patients with cancer.

STUDY OBJECTIVES: To evaluate the relation among several symptoms that occur commonly in cancer patients: trouble sleeping, fatigue/sleepiness, depressed mood, and pain in a large cohort of cancer patients undergoing treatment in a community oncology practice. METHODS: Demographic, clinical, and patient reported outcomes data from 11,445 cancer patients undergoing treatment in a large community oncology practice were analyzed using structural equation modeling. The data were split so that a model was constructed using half of the patients; this model was then cross-validated on the remaining patients. RESULTS: Fatigue was best represented as a latent variable, and significant direct effects were found for trouble sleeping, depressed mood, and pain. Also, there were significant indirect effects of these variables on fatigue. The effect of depressed mood on fatigue and pain was mediated by trouble sleeping, and the effect of trouble sleeping on fatigue was mediated by pain. CONCLUSIONS: These results predict that interventions aimed at treatment of trouble sleeping, depressed mood, and pain will improve fatigue in patients with cancer. Further, these data predict that treatment of trouble sleeping will improve pain management in this population.

Second- and third-line treatment of patients with non-small-cell lung cancer with erlotinib in the community setting: retrospective study of patient healthcare utilization and symptom burden.

INTRODUCTION: The purpose of this study was to describe treatment use patterns and outcomes with single-agent erlotinib among patients with advanced non-small-cell lung cancer (NSCLC) in the community oncology setting. PATIENTS AND METHODS: Retrospective chart review identified patients treated with single-agent erlotinib as either second- or third-line therapy from 4 community oncology clinics. Medical records were extracted for medical outcomes and resource utilization. Patients reported outcome measures of symptom burden and functioning. RESULTS: A total of 45 patients with stage IIIB/IV disease in second- (n = 27) or third-line (n = 18) therapy were 44% female and 84% white (16% black), with mean age of 66.7 years (SD, 9.2). Over 93% of the patients had previous platinum-based chemotherapy. Patients were treated with erlotinib for an average of 24 weeks. Dose reductions (24%) and treatment delays (29%) were due to skin reactions, diarrhea, and fatigue. The most common reasons for stopping erlotinib therapy were disease progression (53%), death (22%), and toxicities (11%). Patients' physical functioning improved during the first 3 months of erlotinib therapy. Hospitalizations (22%) were not due to erlotinib complications, and unplanned medical visits to the clinics were rare. CONCLUSION: Data from this community sample were generally in agreement with the major clinical trial of erlotinib. Erlotinib is well tolerated by second- and third-line patients with advanced NSCLC in the community setting.

Initial treatment and changes in adjuvant endocrine therapy for early stage breast cancer.

Clinical trials have shown that aromatase inhibitors (AIs) are an important advance in the treatment of early stage breast cancer (ESBC), but practice patterns and the impact of treatment side effects of endocrine therapy in the community setting have not been extensively explored. This retrospective chart review describes practice patterns among patients receiving adjuvant endocrine therapy for ESBC. Charts of 200 patients with confirmed stage I-IIIA breast cancer were reviewed. Patients received first-line treatment with tamoxifen (n=96) or AIs (n=104). Fifty-one patients completed a structured interview regarding symptom burden during therapy. Time to discontinuation or switching from first-line therapy did not vary by drug class (tamoxifen vs. AI). Musculoskeletal symptoms predicted time to switching among AI patients. Tamoxifen patients who switched to AIs tended to do so following clinical guidelines for use of AIs. Interview results showed that more anastrozole than tamoxifen patients cited side effects as the reason for switching.

Patient and practice impact of capecitabine compared to taxanes in first-/second-line chemotherapy for metastatic breast cancer.

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.

Implications of IV monoclonal antibody infusion reaction for the patient, caregiver, and practice: results of a multicenter study.

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.

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.

Retrospective chart review of severe infusion reactions with rituximab, cetuximab, and bevacizumab in community oncology practices: assessment of clinical consequences.

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.