Timothy Bell

Impact of palbociclib plus letrozole on pain severity and pain interference with daily activities in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer as first-line treatment

Abstract Background Palbociclib is a recently approved drug for use in combination with letrozole as initial endocrine-based therapy for the treatment of postmenopausal women with advanced estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. This report assesses the impact of palbociclib in combination with letrozole versus letrozole alone on patient-reported outcomes of pain. Methods Palbociclib was evaluated in an open-label, randomized, phase II study (PALOMA-1/TRIO-18) among postmenopausal women with advanced ER+/HER2- breast cancer who had not received prior systemic treatment for their advanced disease. Patients received continuous oral letrozole 2.5 mg daily alone or the same letrozole dose and schedule plus oral palbociclib 125 mg, given once daily for 3 weeks followed by 1 week off over repeated 28-day cycles. The primary study endpoint was investigator-assessed progression-free survival in the intent-to-treat population, and these results have recently been published (Finn et al., Lancet Oncol 2015;16:25-35). One of the key secondary endpoints was the evaluation of pain, as measured using the Brief Pain Inventory (BPI) patient-reported outcome tool. The BPI was administered at baseline and on day 1 of every cycle thereafter until disease progression and/or treatment discontinuation. Clinical trial registration This study is registered with ClinicalTrials.gov (NCT00721409). Results There were no statistically significant differences in Pain Severity or Pain Interference scores of the BPI between the two treatment groups for the overall population or among those with any bone disease at baseline. A limitation of the study is that results were not adjusted for the concomitant use of opioids or other medications used to control pain. Conclusions The addition of palbociclib to letrozole was associated with increased efficacy without negatively impacting pain severity or pain interference with daily activities.

Acute myeloid leukemia: a retrospective claims analysis of resource utilization and expenditures for newly diagnosed patients from first-line induction to remission and relapse

Abstract Objective: The objective of this study was to estimate resource utilization and expenditures for patients with acute myeloid leukemia (AML) in a real-world claims database. Research design and methods: AML patients were identified in MarketScan claims databases between 1 January 2009 and 31 January 2015. Patients had a minimum of two AML diagnosis codes, hospitalization within 14 days after initial diagnosis, and ≥6 months of enrollment before initial diagnosis. Patients were monitored from first-line induction to a record of remission. A subset had a record of a second treatment period, defined as time from relapse to remission. Patient demographics, AML risk factors, and comorbidities were recorded. Descriptive analysis of utilization and expenditures (in 2014

Clinical and economic outcomes by first-line treatment among women with HR+/HER2– metastatic breast cancer in a large US health plan database

US) were reported for each cohort. Results: The inclusion criteria were met in 1597 patients (mean age, 58.4 years; 51.0% male). Ninety percent of patients had ≥1 risk factor for AML. Mean (SD) healthcare expenditures for patients from first-line induction to remission (n = 681) were

Abstract P5-19-19: Impact of adding palbociclib to letrozole on pain severity and pain interference with various activities of daily life in patients with ER+, HER2- metastatic breast cancer as first line treatment

208,857 (

Abstract P3-07-23: Patient characteristics, clinical and economic outcomes of women with first-line therapy for HR+/HER2- metastatic breast cancer in a large US managed care health plan: Chemotherapy first vs. no chemotherapy first

152,090). Of the 157 who had a record of relapse, 70 had a record of a second remission. Expenditures for these patients (n = 70) from relapse to remission were

Abstract P3-07-24: Clinical characteristics and treatment utilization by tumor subtype among metastatic breast cancer patients in a large US managed care health plan

142,569 (

Acute Myeloid Leukemia (AML): A Retrospective Claims Analysis of Resource Utilization and Expenditures

208,307); 60% were admitted to a hospital for a mean of 18.5 hospital days, and 20% had ≥1 emergency room visit. Conclusions: Although this claims-based analysis is limited by a lack of generalizability to noninsured populations and potential underreporting of certain events and diagnoses, we found that treating AML patients poses a significant healthcare burden, during both first-line induction and relapse. With people living longer, the number of cases of AML is expected to increase in the future.

Economic Analysis of Alvimopan—A Clarification and Commentary

Abstract Background: Guidelines recommend that women with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2–) metastatic breast cancer (mBC) initiate hormonal therapy before chemotherapy. This study compared outcomes of women with mBC who received chemotherapy first vs hormonal therapy. Methods: A retrospective cohort study of women with mBC was conducted using a large US commercial health plan database between January 1, 2008–April 30, 2013. Subjects had evidence of a HR+/HER2– tumor sub-type in a cancer registry and use of chemotherapy or hormonal therapy in claims. Subjects were continuously enrolled for ≥6 months after metastasis and assigned to cohorts for receiving chemotherapy only or hormonal therapy only during first-line (CT-1L vs HT-1L). Adjusted incidence rates of clinically significant events were compared using a negative binomial model, and adjusted healthcare costs were compared using a generalized linear model. Results: Three hundred and twenty-four women with HR+/HER2– mBC met the selection criteria; 179 (55%) received CT-1L and 145 (45%) received HT-1L. Mortality rates did not differ between cohorts (unadjusted incidence rate ratio (IRR) = 1.67, 95% CI = 0.82–3.46; adjusted IRR = 0.64, 95% CI = 0.32–1.27). Adjusted average total all-cause healthcare costs were

Phase 3, randomized, placebo-controlled trials evaluating glasdegib in combination with intensive or nonintensive chemotherapy in patients with untreated acute myeloid leukemia.

11 090 for women with CT-1L and

Abstract LB-175: The malignancy associated change hypothesis tested through 3D cellular imaging

6743 for women with HT-1L (cost ratio =1.64, 95% CI =1.36–1.99). Conclusions: Observed use of first-line chemotherapy (>50%) was higher than expected given the HR + molecular profile of the tumors. Chemotherapy use during first-line did not appear to be associated with a survival benefit, but was associated with significantly higher costs compared with the use of hormonal therapy during first-line; however, this comparison is limited by demographic and baseline characteristic differences between the two cohorts. This study contributes to understanding real-world treatment patterns and the associated clinical and economic outcomes of using chemotherapy vs hormonal therapy as a first-line treatment option for the HR+/HER2– mBC population.