Are National Comprehensive Cancer Network Evidence Block Affordability Ratings Representative of Real-World Costs? An Evaluation of Advanced Non-Small-Cell Lung Cancer.

PURPOSE: The National Comprehensive Cancer Network (NCCN) developed the Evidence Blocks framework to assess the value of oncology regimens. This study characterizes the relationship between real-world costs and NCCN affordability ratings (ARs) for advanced non-small-cell lung cancer (aNSCLC) treatments. METHODS: Using the MarketScan and PharMetrics Plus databases, we identified patients treated between 2012 and 2017 with an aNSCLC regimen evaluated by the NCCN Evidence Blocks. We estimated adjusted mean total per-patient-per-month (PPPM) costs and drug costs for each regimen using a log-linked gamma generalized linear model. Weighted regression was used to examine the correlation between adjusted mean PPPM costs per regimen and NCCN AR. RESULTS: A total of 25,162 patients with aNSCLC (mean age, 63 years [standard deviation, 10 years]; 52% male) had identifiable regimens. Mean total PPPM cost by therapeutic class ranged from $16,824 for epidermal growth factor receptors to $41,815 for immunotherapy-based treatment. Epidermal growth factor receptor and anaplastic lymphoma kinase inhibitor treatment had lower ARs compared with generic chemotherapy. No therapy was listed as AR group 5 (least expensive). In pairwise comparisons, AR group 1 had significantly higher PPPM total costs compared with AR groups 2 and 4. There were no significant differences in PPPM total cost among AR groups 2, 3, and 4. CONCLUSION: Real-world aNSCLC treatment costs are often inconsistent with the NCCN ARs. Given that NCCN Evidence Blocks are intended to inform provider-patient discussions and other decision support resources, such as the NCCN Categories of Preference, our results suggest that the NCCN ARs require further refinement and validation.

Characterization and survival of patients with metastatic basal cell carcinoma in the Department of Veterans Affairs: a retrospective electronic health record review.

Available descriptive statistics for patients with metastatic basal cell carcinoma (mBCC) are limited. To describe disease characteristics, treatment patterns, survival outcomes, and prognostic factors of patients with mBCC, we conducted a retrospective review of electronic health records in the Department of Veterans Affairs (VA). The primary outcome was survival. Data were also collected on demographics, comorbidities, medications, and procedures. Median (IQR) age of patients with mBCC (n = 475) was 72.0 (17.0) years; 97.9% of patients were male. Almost two-thirds of patients received no initial therapy for mBCC. Median overall survival was 40.5 months [95% CI (confidence interval) 4.8-140.0], and was shorter in patients with distant metastases (17.1 months; 95% CI 2.8-58.0) than in those with regional metastases (59.4 months; 95% CI 17.6-140.0). Because the VA mBCC population is largely male and elderly, the generalizability of these results in other populations is limited and must be interpreted cautiously. Data from this large cohort add valuable information on a rare and poorly researched disease and refine previously wide estimates of overall survival for mBCC.

Assessment of costs associated with adverse events in patients with cancer.

Adverse event (AE)-related costs represent an important component of economic models for cancer care. However, since previous studies mostly focused on specific AEs, treatments, or cancer types, limited information is currently available. Therefore, this study assessed the incremental healthcare costs associated with a large number of AEs among patients diagnosed with some of the most prevalent types of cancer. Data were obtained from a large US claims database. Adult patients were included if diagnosed with and treated for one of the following cancer types: breast, digestive organs and peritoneum, genitourinary organs (including bladder and ovary and other uterine adnexa), lung, lymphatic and hematopoietic tissue, and skin. Treatment episodes were defined as the period from initiation of the first antineoplastic pharmacologic therapy to discontinuation (i.e., gap of ≥ 45 days), or change in treatment regimen, or end of data availability. A total of 36 AEs were selected from the product inserts of 104 treatments recommended by practice guidelines. A retrospective matched cohort design was used, matching a treatment episode with a certain AE with a treatment episode without that AE. A total of 412,005 patients were selected, for a total of 794,243 treatment episodes, resulting in 1,617,368 matched treatment episodes across all 36 AEs. Incremental healthcare costs associated with AEs of any severity ranged from $546 for cough/upper respiratory infections to $24,633 for gastrointestinal perforation. The three most costly AEs when considering any severity were gastrointestinal perforation ($24,633), central nervous system hemorrhage ($24,322), and sepsis/septicemia ($23,510). Incremental healthcare costs associated with severe AEs ranged from $15,709 for dermatitis and rash to $48,538 for gastrointestinal fistula. The three most costly severe AEs were gastrointestinal fistula ($48,538), gastrointestinal perforation ($41,281), and central nervous system hemorrhage ($38,428). In conclusion, AEs during treatment episodes for cancer were frequent and associated with a substantial economic burden.

Severe adverse events impact overall survival and costs in elderly patients with advanced non-small cell lung cancer on second-line therapy.

OBJECTIVES: Elderly patients with advanced non-small lung cancer (aNSCLC) represent a high-risk patient population due to disease burden, comorbidities, and performance status, particularly after progressing on first-line therapy. Among elderly patients who receive second-line therapy, treatment related toxicities can have substantial impact on both clinical and economic outcomes. This study assessed the impact of severe adverse events (AEs) during second-line therapy on overall survival (OS) and all-cause heathcare costs in elderly with aNSCLC. MATERIALS AND METHODS: Patients with aNSCLC aged ≥65 years who initiated second-line chemotherapy/targeted therapy were identified in the SEER-Medicare database (2007-2011). Fifty-seven AEs were identified by literature review and consultation with two oncologists. Severe AEs were defined as AEs that required a hospitalization and were operationalized based on AE diagnosis(es) recorded during hospitalizations. OS post-second-line initiation and healthcare costs during second-line were compared between patients with and without severe AEs. RESULTS: Among 3967 patients initiating second-line therapy, 1624 (41%) had ≥1 severe AE, where hypertension (26%), anemia (24%), and pneumonia (23%) were most commonly reported. Patients with and without severe AEs had similar demographic and cancer characteristics at diagnosis and similar second-line treatment regimens, but patients with severe AEs had more comorbidities at second-line initiation. Median OS was lower in patients with versus without severe AEs (6 vs. 11 months). After multivariate adjustment, hazard of death was more than twice higher in patients with versus without severe AEs (adjusted hazard ratio [HR] 2.31, 95% CI 2.16-2.47). Healthcare costs were more than twice higher in patients with versus without severe AEs ($16,135 vs. $7559 per-patient-per-month). CONCLUSION: Severe AEs among elderly patients with aNSCLC treated with second-line chemotherapy/targeted therapy were found to be associated with decreased OS and increased healthcare costs. Results suggest a potential link between severe AEs in second-line treated aNSCLC elderly and patient survival and economic burden to the healthcare system.

Assessment of quality of life using Skindex-16 in patients with advanced basal cell carcinoma treated with vismodegib in the STEVIE study.

Health-related quality of life (HRQoL) data are limited in patients with advanced basal cell carcinoma. To report HRQoL outcomes based on STEVIE (NCT01367665), a phase 2 study of vismodegib safety in patients with metastatic BCC or locally advanced BCC that is unsuitable for surgery or radiotherapy. Skindex-16 and MD Anderson Symptom Inventory (MDASI) questionnaires were completed at baseline and at three subsequent visits. Clinically meaningful improvement was defined as a ≥10-point decrease from baseline (Skindex-16) or improvement of at least 3 points from baseline (MDASI). HRQoL-evaluable patients with locally advanced BCC (n = 730) had ≥10-point improvements in Skindex-16 emotion domain scores at all time points. Changes in symptom and function scores in these patients or in any domain scores at any time point in patients with metastatic BCC (n = 10) were not clinically meaningful. Of 10 patients with symptomatic metastatic BCC at baseline, six had ≥3-point improvements in MDASI symptom severity. Skindex-16 and MDASI showed improvement in HRQoL in vismodegib-treated patients with locally advanced or metastatic BCC or BCC.

Differences in Health Care Use and Costs Among Patients With Cancer Receiving Intravenous Chemotherapy in Physician Offices Versus in Hospital Outpatient Settings.

PURPOSE: The current shift in site of care from community oncology practices to the hospital outpatient department to deliver oncology services may have significant implications for the economic and clinical outcomes of cancer care. Therefore, this study compares health care use and costs among patients with cancer receiving intravenous (IV) chemotherapy in physician offices (PO) versus in hospital outpatient settings (HOP). METHODS: This retrospective study, which was based on medical and pharmacy claims data, included patients (age, 18 to 64 years) initiating IV chemotherapy/biologic treatment between January 1, 2006, and August 31, 2012, who were diagnosed with early or metastatic breast cancer, metastatic lung cancer, metastatic colorectal cancer, or non-Hodgkin lymphoma or chronic lymphocytic leukemia. Patients were assigned to PO or HOP groups on the basis of where they received > 95% of their IV cancer therapy. RESULTS: The study sample included 18,740 patients (12,899 PO; 5,841 HOP) who had a mean age of 51.6 years and a Deyo-Charlson Comorbidity Index score of 5.37. Overall office visits (21.8 ± 13.8 PO v 21.2 ± 12.9, P < .005) and outpatient services (50.8 ± 35.5 PO v 48.5 ± 33.6, P < .001) were higher in the PO group than in the HOP group. Cancer-related inpatient hospitalizations (0.6 ± 1.2 PO v 0.7 ± 1.4 HOP, P = .002) were lower in the PO group than in the HOP group. Although quality-of-care metrics were similar between the HOP and PO groups, follow-up all-cause costs ($82,773 PO v $122,473 HOP) and cancer-related health care costs ($69,037 PO v $108,177 HOP) were higher in the HOP group than in the PO group. CONCLUSION: Despite similar resource use, all-cause and cancer-related health care costs in HOP were significantly higher compared with those in PO settings.

Treatment patterns and outcomes in BRAF V600E-mutant melanoma patients with brain metastases receiving vemurafenib in the real-world setting.

Brain metastases are a common and serious complication among patients with metastatic melanoma. The selective BRAF inhibitor vemurafenib has demonstrated clinical efficacy in patients with BRAF V600E-mutant melanoma brain metastases (MBM). We examined the real-world application and clinical outcomes of vemurafenib in this patient population. Demographic, treatment patterns, response, and survival data were collected from medical charts. Clinical data on 283 patients with active BRAF V600E-mutant MBM treated with vemurafenib were provided by 70 US oncologists. Mean age was 57.2 years, 60.8% were male, 67.5% had ECOG performance status of 0-1, and 43.1% used corticosteroids at vemurafenib initiation. Median follow-up was 5.7 months. Following vemurafenib initiation, 48.1% of patients experienced intracranial response and 45.6% experienced extracranial response. The Kaplan-Meier estimate for overall survival was 59% at 12 months. Multivariate analyses showed associations between intracranial response and both corticosteroid use and vemurafenib as initial therapy after MBM diagnosis. Larger size (5-10 mm vs. < 5 mm) and number of brain metastases (≥ 5 vs. < 2) and progressive extracranial disease at treatment initiation were associated with decreased intracranial response and increased risk of disease progression. Multiple extracranial sites (2 vs. < 2) and the absence of local treatments were also associated with increased risk of progression. Increased risk of death was associated with ≥ 2 extracranial disease sites, progressive extracranial disease, and ≥ 5 brain metastases. Subgroups of MBM patients may derive more benefit with vemurafenib, warranting prospective investigation.

Comparative healthcare costs in patients with metastatic melanoma in the USA.

Recent advances have increased treatment options for, and improved clinical outcomes in, metastatic melanoma (mM). Using a large claims database, this retrospective study compared healthcare and adverse event (AE) costs in a US managed care population of mM patients initiating vemurafenib (VEM), ipilimumab (IPI), dacarbazine (DTIC), paclitaxel (PAC), or temozolomide (TMZ) from July 2009 to September 2012. Treatment episodes were identified from the start of study drugs (index date) to a switch to a different study drug, or a gap greater than 45 days (>112 days for IPI). Grade 3/4 adverse events occurring ≥5% from study drug package inserts were selected for this analysis. All-cause costs for treatment episodes and AEs were normalized as monthly costs. Generalized estimating equation models with log link and gamma distribution provided adjusted monthly treatment episode and AE costs. A total of 809 treatment episodes were identified in 541 mM patients, with a mean (SD) age of 57.5 (11.5) years. The total mean (SD) all-cause cost per treatment episode for VEM was $77 687 ($60 329), for IPI was $153 062 ($134 048), for DTIC was $35 243 ($33 641), for TMZ was $42 870 ($41 384), and for PAC was $58 991 ($81 306). The adjusted mean monthly treatment episode cost for VEM was significantly lower than that for IPI and comparable to that for other drugs. VEM had a significantly lower monthly AE cost than IPI, DTIC, and PAC. In combination with safety and efficacy findings, these results may assist clinicians, patients, policy makers, and payers in the treatment of mM.

Impact of symptom burden on work-related abilities in patients with locally recurrent or metastatic breast cancer: Results from a substudy of the VIRGO observational cohort study.

Limited data exist on the association of symptom burden, daily activity impairment, and work productivity (WP) in patients with advanced breast cancer. This cross-sectional analysis evaluated baseline patient-reported outcomes (PROs) in patients with locally recurrent or metastatic breast cancer (MBC) receiving first-line hormonal therapy or chemotherapy and/or targeted therapy in the VIRGO observational study. The primary PRO study endpoint, symptom severity and interference score, was measured using the MD Anderson Symptom Inventory (MDASI). Secondary endpoints included Activity Level Scale (ALS), health-related quality of life (HRQOL), and Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) scores. Overall, 152 patients (chemotherapy cohort, 104; hormonal therapy cohort, 48) answered questionnaires. Fatigue, decreased sexual interest, disturbed sleep, emotional distress, and drowsiness were the most common severe symptoms, and were of moderate-to-severe intensity in 38.8%-52.0% of patients. Mean percent daily activity impairment was 30% for study patients, and WP impairment ranged from 20% to 40% across indices in employed patients (n, 58). Significant positive correlations existed for MDASI severity and interference scores with activity impairment and WP indices (Pearson correlation coefficients [R] = 0.47-0.82; p < 0.0001). ALS and overall HRQOL correlated negatively with these indices (R = -0.41 to -0.60; p ≤ 0.001). After adjustment for potential confounders, MDASI symptom interference and ALS were significant predictors of activity and WP impairment. Our results indicate patients receiving treatment for MBC are symptomatic with significant daily activity and/or WP impairment. Symptom severity and interference, functional status, and overall HRQOL were moderately correlated with perceived work-related ability.

Assessing health-related quality of life for advanced basal cell carcinoma and basal cell carcinoma nevus syndrome: development of the first disease-specific patient-reported outcome questionnaires.

IMPORTANCE Little is known about patients' experiences of advanced basal cell carcinoma (aBCC) and basal cell carcinoma nevus syndrome (BCCNS), a rare genetic disorder that greatly increases the number of BCCs. OBJECTIVE To develop a questionnaire to measure patient-reported outcomes (PROs) in these populations. DESIGN, SETTING, AND PARTICIPANTS Concept elicitation interviews were conducted with patients with aBCC and BCCNS from 5 US clinical sites and the BCCNS Life Support Network and 4 physicians. The PRO questionnaires were drafted based on results from a literature review and findings from these interviews. Questionnaires were finalized after cognitive debriefing interviews were conducted with patients. Concept elicitation interviews were conducted with 30 patients (14 with aBCC, 16 with BCCNS) and 4 physicians (2 dermatologists, 1 Mohs surgeon, and 1 oncologist) in the United States. A subset of 10 of these patients (5 with aBCC, 5 with BCCNS) took part in cognitive debriefing interviews. MAIN OUTCOMES AND MEASURES Development of 2 questionnaires to allow clinicians to assess the emotional, social, and physical impacts of the disease on patients with aBCC and BCCNS. RESULTS Most concept elicitation interview patients were male (63%) and white (93%); their mean age was 57 years. There were impacts on emotional, social, and physical functioning in both conditions. Patients were unable to do many activities and avoided other activities. Seventy-nine percent of patients with aBCC and all patients with BCCNS reported scarring. Physician interviews revealed similar findings. During cognitive debriefing interviews, the questionnaires were found to be relevant, clear, and comprehensive. CONCLUSIONS AND RELEVANCE Advanced BCC and BCCNS affect patients in unique and substantial ways. These PRO questionnaires were developed with patient and clinician input and measure the key areas that have an impact on patients with these conditions.

Age distribution of patients with advanced non-melanoma skin cancer in the United States.

The epidemiology of non-melanoma skin cancer (NMSC) is not well understood due to exclusion from most US cancer registries. Patients with at least two claims with a NMSC diagnosis (ICD-9-CM 173.xx) at least 60 days apart, or at least one claim for a NMSC-specific treatment from 1/2010 to 12/2010, were identified from a large US commercial insurance claims database and grouped into one of three cohorts: metastatic (MET), locally advanced (LA), or "all other". MET patients had at least two claims with a metastasis code at least 30 days apart. LA patients had at least two visits to a medical oncologist, one diagnostic imaging service, two radiation therapy services, or one visit to two or more physician specialties. Remaining patients were "all other". Incidence and prevalence of NMSC were calculated from among the total number of persons continuously enrolled in the plan during the study period and standardized to the 2010 US population. From among 6,610,256 patients, there were 47,451 incident cases of NMSC (MET n=16, LA n=387, all other n=47,048). The age-adjusted incidence rate of 693 per 100,000 persons (2010 population) approximates to 2,139,535 total NMSC cases in the US (0.7% of population). 671 prevalent cases had advanced disease (MET n=43, LA n=628); an age-adjusted rate of 0.6 and 10 per 100,000 US persons equivalent to 1,993 and 29,841 MET and LA cases, respectively. Although NMSCs rarely progress, the number of patients with advanced disease is significant. Further studies to determine proportions of advanced NMSC by subtype are needed.

Adverse events associated with bevacizumab and chemotherapy in older patients with metastatic colorectal cancer.

BACKGROUND: The safety of bevacizumab in older mCRC patients is poorly understood. The purpose of this analysis was to determine the prevalence, incidence, and risk factors for treatment-related AEs in older bevacizumab recipients. PATIENTS AND METHODS: Patients age ≥65 were identified from SEER-Medicare and categorized by mCRC diagnosis pre and post bevacizumab approval (2001-2003 vs. 2005-2007). Preexisting conditions known to increase bevacizumab-related AE risk were identified in the year before diagnosis. Factors associated with bevacizumab receipt were identified using logistic regression. Incidence rates for all AEs and specific serious AEs were determined. Risk factors for first AE were determined by competing risks regression. RESULTS: Of 6821 patients, 3282 (48%) were diagnosed in 2005-2007 of whom 19% received first-line bevacizumab. Likelihood of bevacizumab receipt was lower in patients age ≥ 75 (odds ratio [OR], 0.41; 95% confidence interval [CI], 0.36-0.47), nonwhite patients (OR, 0.67; 95% CI, 0.55-0.81), patients with higher comorbidity index (OR, 0.52; 95% CI, 0.43-0.62), and patients with preexisting cerebrovascular disease (OR, 0.49; 95% CI, 0.33-0.73). AE incidence rate was not increased among first-line bevacizumab recipients relative to first-line chemotherapy recipients. In a competing risk regression adjusting for potential confounders, bevacizumab receipt (2005-2007) was not associated with an increased risk of first AE compared with chemotherapy alone (2001-2007) (hazard ratio, 0.97; 95% CI, 0.87-1.08). CONCLUSION: In an older mCRC population, bevacizumab receipt was less likely in older (age ≥ 75) nonwhite patients with preexisting cerebrovascular comorbidities. First-line bevacizumab was not associated with increased AE incidence or risk of first AE compared with chemotherapy alone.

Symptom burden & quality of life among patients receiving second-line treatment of metastatic colorectal cancer.

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.

Survival outcomes of bevacizumab beyond progression in metastatic colorectal cancer patients treated in US community oncology.

BACKGROUND: Bevacizumab prolongs OS when added to first- or second-line chemotherapy for mCRC. This retrospective analysis evaluated the association between the continued use of BBP and survival outcomes in mCRC patients treated in a community oncology setting. PATIENTS AND METHODS: Data were derived from the US Oncology iKnowMed electronic medical record system. Patients with mCRC who received first-line bevacizumab-containing therapy between July 1, 2006 and June 30, 2009, were dichotomized into 2 second-line treatment cohorts: those receiving BBP and No-BBP. Clinical outcomes, including OS and postprogression OS (ppOS; time from start of second-line therapy to any-cause death), were calculated using Kaplan-Meier methods. A Cox proportional hazards model was used to assess the effects of patient and treatment characteristics on survival outcomes, adjusting for covariates. RESULTS: Overall, 573 patients met the inclusion criteria for analysis-BBP (n = 267) and No-BBP (n = 306). Median OS and ppOS were longer in the BBP cohort (27.9 and 14.6 months, respectively) compared with the No-BBP cohort (21.4 and 10.1 months). According to multivariate analyses, BBP was associated with longer OS (HR, 0.76; 95% CI, 0.61-0.95) and ppOS (HR, 0.74; 95% CI, 0.60-0.93) after adjusting for potential confounders. CONCLUSIONS: In the community oncology setting, BBP treatment was correlated with prolonged OS and ppOS in patients with mCRC. These results provide insight into real-world patterns of care and resultant bevacizumab use in this patient population.

Healthcare costs associated with bevacizumab and cetuximab in second-line treatment of metastatic colorectal cancer.

OBJECTIVE: To compare the health care costs of patients with metastatic colorectal cancer (mCRC) who received second-line treatment with Avastin (bevacizumab) versus Erbitux (cetuximab), from the third-party payer's perspective. METHODS: Patients with mCRC were selected from the PharMetrics claims database if they received second-line therapy containing either bevacizumab (second-line bevacizumab cohort) or cetuximab (second-line cetuximab cohort). Six-month costs following second-line therapy start date and average monthly healthcare costs while on second-line therapy (in 2009 US$) were calculated and compared between the two groups. RESULTS: A total of 2188 patients with mCRC who met the eligibility criteria were included in the analysis, including 1808 patients receiving bevacizumab and 380 patients receiving cetuximab in second-line treatment. Demographic and baseline characteristics were similar between the two groups. Patients' mean age was 61 years and 56% were males. In second-line treatment, bevacizumab was commonly used with oxaliplatin (43.5%) and irinotecan-based regimens (40.4%), whereas cetuximab was commonly used with irinotecan-based regimens (68.2%). Bevacizumab patients had significantly lower total all-cause healthcare costs than cetuximab patients (adjusted difference: -$10,231, p = 0.020), and lower medical costs (-$10,796, p = 0.012) during the 6 months following second-line therapy initiation. Approximately half of the difference in total all-cause healthcare costs was attributable to the lower chemotherapy and targeted therapy costs (-$5635, p = 0.032) of bevacizumab patients than those of cetuximab patients. While on second-line therapy, bevacizumab patients also had lower average monthly all-cause healthcare costs than cetuximab patients. LIMITATIONS: Second-line treatment in the current study was defined based on changes in mCRC medications, not based on disease progression due to the limited clinical information available in claims. CONCLUSION: The use of bevacizumab in second-line therapy was associated with significantly lower healthcare costs in mCRC patients, compared to the use of cetuximab.

Retrospective study of the effect of disease progression on patient reported outcomes in HER-2 negative metastatic breast cancer patients.

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.