Race Differences in Patient-Reported Symptoms during Chemotherapy among Women with Early-Stage Hormone Receptor-Positive Breast Cancer.

BACKGROUND: Symptom burden differences may contribute to racial disparities in breast cancer survival. We compared symptom changes from before to during chemotherapy among women with breast cancer. METHODS: This observational study followed a cohort of Black and White women diagnosed with Stage I-III, hormone receptor-positive breast cancer from a large cancer center in 2007 to 2015, and reported symptoms before and during chemotherapy. We identified patients who experienced a one-standard deviation (SD) increase in symptom burden after starting chemotherapy using four validated composite scores (General Physical Symptoms, Treatment Side Effects, Acute Distress, and Despair). Kitagawa-Blinder-Oaxaca decomposition was used to quantify race differences in symptom changes explained by baseline characteristics (sociodemographic, baseline scores, cancer stage) and first-line chemotherapy regimens. RESULTS: Among 1,273 patients, Black women (n = 405, 31.8%) were more likely to report one-SD increase in General Physical Symptoms (55.6% vs. 48.2%, P = 0.015), Treatment Side Effects (74.0% vs. 63.4%, P < 0.001), and Acute Distress (27.4% vs. 20.0%, P = 0.010) than White women. Baseline characteristics and first-line chemotherapy regimens explained a large and significant proportion of the difference in Acute Distress changes (93.7%, P = 0.001), but not General Physical Symptoms (25.7%, P = 0.25) or Treatment Side Effects (16.4%, P = 0.28). CONCLUSIONS: Black women with early-stage breast cancer were more likely to experience significant increases in physical and psychological symptom burden during chemotherapy. Most of the difference in physical symptom changes remained unexplained by baseline characteristics, which suggests inadequate symptom management among Black women. IMPACT: Future studies should identify strategies to improve symptom management among Black women and reduce differences in symptom burden. See related commentary by Rosenzweig and Mazanec, p. 157.

Racial Differences in Patient-Reported Symptoms and Adherence to Adjuvant Endocrine Therapy Among Women With Early-Stage, Hormone Receptor-Positive Breast Cancer.

Importance: Adjuvant endocrine therapy (AET) reduces breast cancer recurrence, but symptom burden is a key barrier to adherence. Black women have lower AET adherence and worse health outcomes than White women. Objective: To investigate the association between symptom burden and AET adherence differences by race. Design, Setting, and Participants: A retrospective cohort study using electronic health records with patient-reported data from a large cancer center in the US. Patients included Black and White women initiating AET therapy for early-stage breast cancer from August 2007 to December 2015 who were followed for 1 year from AET initiation. Sixty symptoms classified into 7 physical and 2 psychological symptom clusters were evaluated. For each cluster, the number of symptoms with moderate severity at baseline, and symptoms with 3-point or greater increases during AET were counted. Adherence was measured as the proportion of days covered by AET during the first-year follow-up. Multivariable regressions for patients' adherence adjusting for race, symptom measures, sociodemographic characteristics, and clinical characteristics were conducted. Kitagawa-Blinder-Oaxaca decomposition was used to quantify racial differences in adherence explained by symptoms and patient characteristics. Analyses were conducted from July 2021 to January 2022. Exposures: Physical and psychological symptoms at baseline and changes during AET. Results: Among 559 patients (168 [30.1%] Black and 391 [69.9%] White; mean [SD] age 65.5 [12.1] years), Black women received diagnoses younger (mean [SD] age at diagnosis, 58.7 [13.7] vs 68.5 [10.0] years old) than White women, with more advanced stages (30 Black participants [17.9%] vs 31 White participants [7.9%] had stage III disease at diagnosis), and lived in areas with fewer adults attaining high school education (mean [SD], 78.8% [7.8%] vs 84.0% [9.3%]). AET adherence in the first year was 78.8% for Black and 82.3% for White women. Black women reported higher severity in most symptom clusters than White women. Neuropsychological, vasomotor, musculoskeletal, cardiorespiratory, distress, and despair symptoms at baseline and increases during the follow-up were associated with 1.2 to 2.6 percentage points decreases in adherence, which corresponds to 4 to 9 missed days receiving AET in the first year. After adjusting for psychological symptoms, being Black was associated with 6.5 percentage points higher adherence than being White. Conclusions and Relevance: In this cohort study, severe symptoms were associated with lower AET adherence. Black women had lower adherence rates that were explained by their higher symptom burden and baseline characteristics. These findings suggest that better symptom management with a focus on psychological symptoms could improve AET adherence and reduce racial disparities in cancer outcomes.

Characterization of Clinical Symptoms by Race Among Women With Early-Stage, Hormone Receptor-Positive Breast Cancer Before Starting Chemotherapy.

Importance: Race disparities persist in breast cancer mortality rates. One factor associated with these disparities may be differences in symptom burden, which may reduce chemotherapy tolerance and increase early treatment discontinuation. Objectives: To compare symptom burden by race among women with early-stage breast cancer before starting chemotherapy and quantify symptom differences explained by baseline characteristics. Design, Setting, and Participants: A cross-sectional analysis of symptom burden differences by race among Black and White women with a diagnosis of stage I to III, hormone receptor-positive breast cancer who had a symptom report collected before chemotherapy initiation in a large cancer center in the southern region of the US from January 1, 2007, through December 31, 2015. Analyses were conducted from November 1, 2019, to March 31, 2021. Blinder-Oaxaca decomposition was used, adjusting for baseline sociodemographic and clinical characteristics. Main Outcomes and Measures: Four symptom composite scores with a mean (SD) of 50 (10) were reported before starting chemotherapy (baseline) and were derived from symptom items: general physical symptoms (11 items), treatment adverse effects (8 items), acute distress (4 items), and despair (7 items). Patients rated the severity of each symptom they experienced in the past week on a scale of 0 to 10 (where 0 indicates not a problem and 10 indicates as bad as possible). Results: A total of 1338 women (mean [SD] age, 54.6 [11.6] years; 420 Black women [31.4%] and 918 White women [68.6%]) were included in the study. Before starting chemotherapy, Black women reported a statistically significantly higher (ie, worse) symptom composite score than White women for adverse effects (44.5 vs 43.8) but a lower acute distress score (48.5 vs 51.0). Decomposition analyses showed that Black patients' characteristics were associated with higher symptom burden across all 4 scores. However, these differences were offset by relatively greater, statistically significant, unexplained physical, distress, and despair symptom reporting by White patients. Conclusions and Relevance: In this study, before starting chemotherapy, Black patients with early-stage breast cancer reported significantly higher burden for symptoms that may be exacerbated with chemotherapy and lower distress symptoms compared with White patients. Future studies should explore how symptoms change before and after treatment and differ by racial/ethnic groups and how they are associated with treatment adherence and mortality disparities.

Identification of Transgender People With Cancer in Electronic Health Records: Recommendations Based on CancerLinQ Observations.

PURPOSE: Cancer prevalence and outcomes data, necessary to understand disparities in transgender populations, are significantly hampered because gender identity data are not routinely collected. A database of clinical data on people with cancer, CancerLinQ, is operated by the ASCO and collected from practices across the United States and multiple electronic health records. METHODS: To attempt to identify transgender people with cancer within CancerLinQ, we used three criteria: (1) International Classification of Diseases 9/10 diagnosis (Dx) code suggestive of transgender identity; (2) male gender and Dx of cervical, endometrial, ovarian, fallopian tube, or other related cancer; and (3) female gender and Dx of prostate, testicular, penile, or other related cancer. Charts were abstracted to confirm transgender identity. RESULTS: Five hundred fifty-seven cases matched inclusion criteria and two hundred and forty-two were abstracted. Seventy-six percent of patients with Dx codes suggestive of transgender identity were transgender. Only 2% and 3% of the people identified by criteria 2 and 3 had evidence of transgender identity, respectively. Extrapolating to nonabstracted data, we would expect to identify an additional four individuals in category 2 and an additional three individuals in category 3, or a total of 44. The total population in CancerLinQ is approximately 1,300,000. Thus, our methods could identify 0.003% of the total population as transgender. CONCLUSION: Given the need for data regarding transgender people with cancer and the deficiencies of current data resources, a national concerted effort is needed to prospectively collect gender identity data. These efforts will require systemic efforts to create safe healthcare environments for transgender people.

Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non-Small Cell Lung Cancer: Real-World Analysis of Select ASCO-Friends Recommendations.

PURPOSE: Cancer clinical trials often accrue slowly or miss enrollment targets. Strict eligibility criteria are a major reason. Restrictive criteria also limit opportunities for patient participation while compromising external validity of trial results. We examined the impact of broadening select eligibility criteria on characteristics and number of patients eligible for trials, using recommendations of the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research. EXPERIMENTAL DESIGN: A retrospective, observational analysis used electronic health record data from ASCO's CancerLinQ Discovery database. Study cohort included patients with advanced non-small cell lung cancer treated from 2011 to 2018. Patients were grouped by traditional criteria [no brain metastases, no other malignancies, and creatinine clearance (CrCl) ≥ 60 mL/minute] and broadened criteria (including brain metastases, other malignancies, and CrCl ≥ 30 mL/minute). RESULTS: The analysis cohort included 10,500 patients. Median age was 68 years, and 73% of patients were White. Most patients had stage IV disease (65%). A total of 5,005 patients (48%) would be excluded from trial participation using the traditional criteria. The broadened criteria, however, would allow 98% of patients (10,346) to be potential participants. Examination of patients included by traditional criteria (5,495) versus those added (4,851) by broadened criteria showed that the number of women, patients aged 75+ years, and those with stage IV cancer was significantly greater using broadened criteria. CONCLUSIONS: This analysis of real-world data demonstrated that broadening three common eligibility criteria has the potential to double the eligible patient population and include trial participants who are more representative of those encountered in practice.See related commentary by Giantonio, p. 2369.

Usefulness of patient-reported outcomes to assess the effectiveness of topical hormonal therapy for gynecologic symptoms after antihormonal treatment for breast cancer.

The aim of this retrospective study was to assess the efficacy of topical hormonal therapy (THT) to relieve vaginal symptoms resulting from antihormonal therapy in women with hormone receptor-positive breast cancer. A total of 74 breast cancer patients who received THT for vaginal complaints were retrospectively identified and statistically matched with 74 control breast cancer patients with vaginal complaints with no documented use of THT. Symptom scores were recorded from the center's proprietary patient-reported outcomes database, Patient Care Monitor (ConcertoHealthAI, Boston). A baseline score was noted at the initiation of antihormonal therapy and was followed at 6 and 12 months. The median differences between baseline, 6-month, and 12-month scores were analyzed. Repeated measures analysis of variance assessed the impact of topical hormonal replacement. There was no statistically significant difference in score change between the two groups at 6 and 12 months. In the active THT group, there were no statistically significant differences in vaginal complaints or sexual problems over time: {F (2, 146) = 0.99, P = 0.369; and F (2, 146) = 1.56, P = 0.217}, respectively. In this study, the use of topical hormonal replacement was not effective in alleviating vaginal symptoms.

Use of a web-based app to improve postoperative outcomes for patients receiving gynecological oncology care: A randomized controlled feasibility trial.

OBJECTIVE: Nearly 1 in 5 patients hospitalized for ovarian cancer surgery are readmitted for complications that may have been prevented with monitoring. We conducted a randomized controlled feasibility trial to evaluate a postoperative web-based app intervention to provide real-time symptom monitoring among patients diagnosed or with suspected gynecological cancer who had open bilateral salpingo-oophorectomy surgery. METHODS: Participants were randomized into two groups: (1) App + Reminder: had access to the app, and use was encouraged with daily and/or weekly reminders; (2) app: had access to the app but received no reminders. The app displayed discharge instructions and queried symptoms. Patients' self-reported health information was integrated into their electronic health records. Outcomes above a predetermined threshold triggered alerts that indicated a patient may need medical intervention. Participants completed a questionnaire at baseline and 30-day follow-up. They were also invited to provide qualitative, post-intervention feedback. RESULTS: We screened 35 patients, with high rates of recruitment (74%, N = 26) and completion (93%, N = 24). Participants in the App + Reminder group had more frequent app use relative to the app group (p = 0.05). Using differences-in-differences (DID) analysis for quality of life, the App + Reminder group had relative increase in the mental health score (DID = 7.51, p = 0.15) but decrease in the physical health score (DID = -7.49, p = 0.13). Participant feedback suggested the relative decrease in physical quality of life was attributable to the app activating patients' focus on physical symptoms, not the intervention. CONCLUSION: The pilot established feasibility, acceptability, and some potential benefits of a new web-based app intervention for gynecological oncology postoperative care.

Use of a web-based app to improve breast cancer symptom management and adherence for aromatase inhibitors: a randomized controlled feasibility trial.

PURPOSE: For 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. METHODS: Forty-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. RESULTS: Participants 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. CONCLUSIONS: Weekly 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 SURVIVORS: If 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.

Results of a prospective phase 2 study of pazopanib in patients with advanced intermediate-grade or high-grade liposarcoma.

BACKGROUND: This phase 2, single-arm, multicenter study was designed to determine the treatment activity and safety of single-agent pazopanib in patients with unresectable or metastatic liposarcoma. METHODS: Eligible patients had high-grade or intermediate-grade liposarcoma with measurable tumors that were unresectable or metastatic, documented disease progression, and had received any number of prior treatments, excluding previous treatment with a vascular endothelial growth factor inhibitor or a tyrosine kinase inhibitor. Patients received oral pazopanib 800 mg once daily for 28-day cycles. Tumor response was evaluated by local radiology assessments every 3 cycles. The primary endpoint was the progression-free rate (PFR) at 12 weeks (PFR12). RESULTS: Forty-one patients were enrolled. The PFR12 was 68.3% (95% confidence interval [CI], 51.9%-81.9%), which was significantly greater than the null hypothesis value of 40% (P = .0002). At 24 weeks, 39% of patients (95% CI, 24.2%-55.5%) remained progression free, and 44% experienced tumor control (partial response or stable disease). The median progression-free survival was 4.4 months (95% CI, 3.2-6.5 months), and the median overall survival was 12.6 months (95% CI, 8.5-16.2 months). The most common adverse events overall were nausea (39%), hypertension (36.6%), diarrhea (34.1%), and fatigue (29.3%), which were typically less than grade 3. There were 5 deaths on study (12.2%), 3 of which were from possible complications of therapy. CONCLUSIONS: The current study provides evidence of potential activity of pazopanib in the liposarcoma subset of patients with soft tissue sarcoma that was specifically excluded from the phase 3 PALETTE trial of other soft tissue sarcoma types. Cancer 2017;123:4640-4647. © 2017 American Cancer Society.

mHealth: Mobile Technologies to Virtually Bring the Patient Into an Oncology Practice.

Accompanied by the change in the traditional medical landscape, advances in wireless technology have led to the development of telehealth or mobile health (mHealth), which offers an unparalleled opportunity for health care providers to continually deliver high-quality care. This revolutionary shift makes the patient the consumer of health care and empowers patients to be the driving force of management of their own health through mobile devices and wearable technology. This article presents an overview of technology as it pertains to clinical practice considerations. Telemedicine is changing the way clinical care is delivered without regard for proximity to the patient, whereas nonclinical telehealth applications affect distance education for consumers or clinicians, meetings, research, continuing medical education, and health care management. Technology has the potential to reduce administrative burdens and improve both efficiency and quality of care delivery in the clinic. Finally, the potential for telehealth approaches as cost-effective ways to improve adherence to treatment is explored. As telehealth advances, health care providers must understand the fundamental framework for applying telehealth strategies to incorporate into successful clinical practice.

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.

Use of "Real-World" data to describe adverse events during the treatment of metastatic renal cell carcinoma in routine clinical practice.

Insights into the experience of metastatic renal cell carcinoma (mRCC) patients are needed to optimize patient care. A retrospective, multicenter registry of mRCC patients treated at academic (Duke) and community (ACORN) practices was developed to fill this need. Treatment data were collected on 466 patients who received first-line therapy from 2007 to 2011. Clinically significant adverse events (AEs) were abstracted from medical records and compared to clinical trials. Two hundred and seventy patients received first-line therapy with sunitinib, 60 temsirolimus, 53 sorafenib, 25 pazopanib, and 58 "other." A total of 85.8 % of all patients experienced at least one AE: fatigue (56.7 %), vomiting (40.1 %), diarrhea (33.7 %), asthenia (32.8 %), and mucosal inflammation (20.8 %). When comparisons were made between patients >65 versus <65 years old, rates of AEs were higher in the younger group. Dosing approaches and timing of AEs during therapy were varied. These data shine light on the patient experience in routine practice versus structured clinical trials. Real-world AE frequency and severity differ from pivotal trials demonstrating the need to monitor patients closely and manage their AEs to optimize outcomes. As the number of treatment options with similar effectiveness grows, it is imperative to understand the real-world patient experience.

Treatment patterns and outcomes among patients with metastatic melanoma treated in community practice.

BACKGROUND: The primary systemic treatments for advanced melanoma have been chemotherapy and immunotherapy. New agents are currently in development. OBJECTIVES: This study aimed to characterize treatment patterns and outcomes across several lines of therapy and to illustrate the treatment landscape prior to the approval of new therapies. The study endpoints were progression-free survival (PFS), overall survival (OS), and best overall response within line of therapy. METHODS: A retrospective chart analysis was conducted at 11 community oncology practices in the USA. Data for patients aged ≥18 years and diagnosed with stage IV and/or metastatic melanoma during 2006-2010 were analyzed. Primary endpoints were PFS within line of therapy and OS from the diagnosis of metastasis. RESULTS: Data on a total of 202 patients were collected. The sample was mostly male (60%) and Caucasian (88%), with a mean age of 61.3 years. Of the 202 patients, 56 (28%) never received any systemic therapy. In the remaining 146 patients, systemic therapies included temozolomide-based regimens (n = 68), platinum-based regimens without temozolomide (n = 16), other regimens (n = 23), and research regimens (n = 39). Of the 146 patients who received systemic therapy, not all did so immediately after the diagnosis of metastasis: 102 (51%) patients did so shortly after diagnosis and before first disease progression, and 44 (22%) did so after first disease progression. Response rates were very low (≤5%) and did not differ across treatment groups. Progressive disease was the most frequent best overall response category identified, with rates of 83, 78, and 89% in the first to third lines of treatment, respectively. In 146 patients receiving first-line systemic therapy, median PFS was 3.25 months. Median OS in the entire sample was 7.66 months. CONCLUSIONS: Findings provided little evidence for any beneficial effects of the treatments available in the timeframe referred to in this study. Few patients (≤5%) responded to treatment, PFS among treated patients was short (3.25 months in first-line treatments, less in later lines), and there was no evidence of a differential effect of treatment regimens on PFS. There was no evidence of shorter survival in patients who never received systemic therapy. The high proportion of patients who did not receive any systemic therapy highlights the lack of effective therapies and underscores the unmet medical need in this patient population.

Real-world outcomes in metastatic renal cell carcinoma: insights from a Joint Community-Academic Registry.

INTRODUCTION: As new therapeutics for metastatic renal cell carcinoma (mRCC) are quickly introduced to market, comparative randomized trial evidence guiding treatment decisions is lacking, especially in the second treatment exposure and beyond. As a demonstration case, we studied mRCC in real-world clinical settings by creating a joint community-academic retrospective mRCC registry to assess outcomes. MATERIALS AND METHODS: For this overall survival (OS) analysis, the analytic cohort included all patients in the registry diagnosed between January 1, 2007, to May 31, 2011 (N = 384). Patients were grouped by up to three treatment exposures according to each drug's mechanism of action: vascular endothelial growth factor tyrosine kinase inhibitor (VEGFR TKI), mammalian target of rapamycin inhibitor (mTOR), or no systemic treatment (NSTx, which could include radiation or surgery). OS by exposure sequence was evaluated using Kaplan-Meier, pairwise comparison, and Cox regression analyses. RESULTS: Median OS was 17.2 months. OS (months) for one exposure was: mTOR 5.4, TKI 18.2, NSTx 18.4; for two exposures: mTOR/TKI 9.3, TKI/mTOR 13.9, TKI/TKI 35.2; and for three exposures: TKI/mTOR/TKI 20.9, TKI/TKI/mTOR 33.1. By pairwise comparison, OS for TKI, mTOR/TKI, TKI/mTOR, TKI/TKI, TKI/mTOR/TKI and TKI/TKI/mTOR sequences was greater than mTOR (all P < .04); demographics confirmed that individuals treated with early mTOR inhibition more commonly had adverse prognostic features. In Cox regression analysis, compared with the referent (TKI), TKI/TKI (hazard ratio = 0.53; P = .03) had a lower risk of death, and mTOR (hazard ratio = 2.16; P = .002) had a higher risk of death. CONCLUSIONS: mRCC survival outcomes are different by pattern, with general findings consistent with trial-based expectations in similar patient populations. Real-world data can provide context around patterns of care and impact when experimental trial data are lacking.

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.

Willingness to pay to prevent chemotherapy induced nausea and vomiting among patients with breast, lung, or colorectal cancer.

OBJECTIVE: Understanding the value patients place on avoiding various aspects of chemotherapy induced nausea and vomiting (CINV) can help medical professionals assess whether current and emerging treatments are acceptable based on their costs and expected effects. Little is known, however, about the value patients place on avoiding various aspects of CINV. The current study helps fill this gap in the literature. METHODS: 301 patients completed a discrete-choice conjoint survey. Patients viewed 25 conjoint tasks, each containing two descriptions of CINV, and indicated which they preferred. The descriptions combined levels from eight CINV attributes (likelihood of nausea, duration of nausea, severity of nausea, likelihood of vomiting, duration of vomiting, severity of vomiting, need to seek treatment for dehydration, and out-of-pocket treatment costs). RESULTS: Cost contributed more to patient choices than any other single attribute. The combined effect of the likelihood, duration, and severity attributes for nausea, however, was a stronger driver of patient choices than cost, as was the combined effect of the likelihood, duration, and severity attributes for vomiting. The nausea attributes also were a stronger driver of patient choices than the vomiting attributes. Patients were willing to pay to avoid increases in all attributes, except likelihood of vomiting, where the result was not statistically different from zero. Willingness-to-pay varied by income, disease stage, Eastern Cooperative Oncology Group performance status, chemotherapy status, and whether patients worked while on chemotherapy. LIMITATIONS: Although the study used a convenience sample, data were collected from several geographically dispersed U.S. oncology clinics. CONCLUSIONS: Several antiemetics are now available at different price points. This study assesses the value patients place on their benefits and may be used to inform decisions about the management of CINV.

Prospective observational comparison of clinical outcomes between african-american and caucasian patients receiving second-line treatment with pemetrexed for advanced non-small-cell lung cancer.

INTRODUCTION: This prospective observational study evaluated the effect of race on disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in patients with NSCLC treated with second-line pemetrexed. PATIENTS AND METHODS: Eligibility criteria included stage IIIB or IV NSCLC patients receiving single-agent pemetrexed for second-line therapy in routine clinical practice. Noninferiority was evaluated using logistic regression analysis of DCR, controlling for predefined covariates. Noninferiority was considered if the upper 95% confidence bound on the adjusted odds ratio (OR) for Caucasian vs. African-American individuals was less than 1.78, corresponding to a difference in proportion of 14% assuming Caucasian individuals to have a DCR of approximately 50%. The bound was chosen to be half of the anticipated difference between treatment and no second-line treatment. PFS and OS were estimated using the Kaplan-Meier method. Tools were used to measure functional status and symptom burden. RESULTS: The unadjusted DCR was 43.7% (117/268) for Caucasian and 45.0% (27/60) for African-American individuals (unadjusted OR, 0.95; 95% confidence interval [CI], 0.54-1.66). The adjusted OR in the final logistic regression model was 0.82 (95% CI, 0.43-1.58). This upper 95% confidence bound was within the prespecified acceptable bound of 1.78. Median PFS times (months) were 2.7 (95% CI, 2.4-3.4) for Caucasian and 3.0 (95% CI, 2.3-4.7) for African-American individuals (P = .91). Median OS times (months) were 6.7 (95% CI, 5.7-7.9) for Caucasian and 6.9 (95% CI, 4.5-8.9) for African-American individuals (P = .92). Baseline and functional status after baseline assessment and mean symptom burden did not differ substantially among races. CONCLUSION: African-American race was not considered to be a significant predictor of disease control after second-line treatment with pemetrexed.

"Real world" treatment of metastatic renal cell carcinoma in a joint community-academic cohort: progression-free survival over three lines of therapy.

BACKGROUND: New targeted therapeutics approved for metastatic renal cell carcinoma (mRCC) offer multiple options in each line of therapy; however, there are few prospective data beyond the first-line settings, and overall comparative effectiveness data are limited. In the targeted therapy era, progression-free survival (PFS) has been the most common regulatory end point for demonstrating the benefit of new therapies. PATIENTS AND METHODS: Drawing on a joint community-academic retrospective mRCC registry, we analyzed all patients who had undergone at least 1 line of systemic therapy (N = 325) for PFS. Patients were grouped according to treatment choice (sorafenib, sunitinib, temsirolimus, everolimus, and "other") for up to 3 lines of therapy. PFS by treatment choice and line of therapy was evaluated using Kaplan-Meier and Cox regression analyses. RESULTS: PFS was longest in patients treated with sunitinib in the first and second lines of therapy. First-line PFS for sorafenib, sunitinib, temsirolimus, everolimus, and "other" was 6.9, 8.9, 4.2, not analyzed (too few patients), and 10.8 months, respectively. Second-line PFS was 4.6, 7.0, 3.2, 3.8, and 4.1 months, respectively. Third-line PFS was 4.5, 4.6, 9.9, 4.2, and 2.9, months, respectively. The risk of progression in patients treated with temsirolimus was about twice that of patients treated with sunitinib in the first and second lines of therapy. CONCLUSION: Patients treated with sunitinib had the longest PFS in the first and second lines of therapy. PFS from practice-based data appear consistent with trial-based expectations; however, practice variation was still evident.

Sorafenib or placebo with either gemcitabine or capecitabine in patients with HER-2-negative advanced breast cancer that progressed during or after bevacizumab.

PURPOSE: We assessed adding the multikinase inhibitor sorafenib to gemcitabine or capecitabine in patients with advanced breast cancer whose disease progressed during/after bevacizumab. EXPERIMENTAL DESIGN: This double-blind, randomized, placebo-controlled phase IIb study (ClinicalTrials.gov NCT00493636) enrolled patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer and prior bevacizumab treatment. Patients were randomized to chemotherapy with sorafenib (400 mg, twice daily) or matching placebo. Initially, chemotherapy was gemcitabine (1,000 mg/m(2) i.v., days 1, 8/21), but later, capecitabine (1,000 mg/m(2) orally twice daily, days 1-14/21) was allowed as an alternative. The primary endpoint was progression-free survival (PFS). RESULTS: One hundred and sixty patients were randomized. More patients received gemcitabine (82.5%) than capecitabine (17.5%). Sorafenib plus gemcitabine/capecitabine was associated with a statistically significant prolongation in PFS versus placebo plus gemcitabine/capecitabine [3.4 vs. 2.7 months; HR = 0.65; 95% confidence interval (CI): 0.45-0.95; P = 0.02], time to progression was increased (median, 3.6 vs. 2.7 months; HR = 0.64; 95% CI: 0.44-0.93; P = 0.02), and overall response rate was 19.8% versus 12.7% (P = 0.23). Median survival was 13.4 versus 11.4 months for sorafenib versus placebo (HR = 1.01; 95% CI: 0.71-1.44; P = 0.95). Addition of sorafenib versus placebo increased grade 3/4 hand-foot skin reaction (39% vs. 5%), stomatitis (10% vs. 0%), fatigue (18% vs. 9%), and dose reductions that were more frequent (51.9% vs. 7.8%). CONCLUSION: The addition of sorafenib to gemcitabine/capecitabine provided a clinically small but statistically significant PFS benefit in HER2-negative advanced breast cancer patients whose disease progressed during/after bevacizumab. Combination treatment was associated with manageable toxicities but frequently required dose reductions.

The discrepancy between subjective and objective measures of sleep in older adults receiving CBT for comorbid insomnia.

OBJECTIVE: To examine the effect of cognitive-behavioral therapy for insomnia (CBT-I) on the underreporting of sleep relative to objective measurement, a common occurrence among individuals with insomnia. METHOD: Pre-treatment and post-treatment self-report measures of sleep were compared with those obtained from home-based polysomnography (PSG) in 60 adults (mean age = 69.17; 42 women) with comorbid insomnia. The self-report data were published previously in a randomized controlled trial demonstrating the efficacy of CBT-I compared with a placebo treatment. RESULTS: Self-report measures significantly underestimated sleep at pre-treatment and CBT-I led to a correction in this discrepancy. There were no significant changes in PSG after CBT-I. Path analysis showed that an increase in an objective proxy measure of sleep quality (i.e., decreased stage N1 sleep) after CBT-I was significantly related to improvements in self-report of sleep, with full mediation by reductions in discrepancy. CONCLUSIONS: This is the first CBT-I outcome study to analyze discrepancy changes and demonstrate that these changes account for a significant portion of self-report outcome. In addition, improved sleep quality as measured by a decrease in percentage of stage N1 sleep following treatment may be one mechanism that explains why sleep estimation is more accurate following CBT-I.