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Aims: To investigate real-world treatment patterns and outcomes among patients with hormone receptor-positive/human epidermal growth factor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) who initiated first-line palbociclib-fulvestrant., Patients & Methods: Retrospective observational study of iKnowMed electronic health records among patients who initiated first-line palbociclib-fulvestrant between 1 February 2016 and 31 December 2019 and were followed through 30 June 2020. Demographic, clinical, and treatment characteristics were evaluated descriptively. Endpoints including real-world progression-free survival, overall survival, time to chemotherapy, real-world duration of therapy, and time to next treatment were assessed using Kaplan-Meier methods from first-line treatment initiation., Results: 317 patients were included (median age 67.3 years, 90.5% post-menopausal, 36.9% bone-only disease, 15.9 months median follow-up). Among those with prior adjuvant treatment ( n  = 269), 66.2% ( n  = 178) had disease-free intervals less than 12 months. Median real-world progression-free survival was 19.6 months (95% CI 15.2-23.6)., Conclusions: These results suggest favorable real-world clinical outcomes associated with first-line palbociclib-fulvestrant among patients with HR+/HER2- mBC. (clinical trial registration: NCT04498481).

Purpose: Real-world data (RWD) holds promise for ascribing a real-world (rw) outcome to a drug intervention; however, ascertaining rw-response to treatment from RWD can be challenging. Friends of Cancer Research formed a collaboration to assess available data attributes related to rw-response across RWD sources to inform methods for capturing, defining, and evaluating rw-response., Materials and Methods: This retrospective noninterventional (observational) study included seven electronic health record data companies (data providers) providing summary-level deidentified data from 200 patients diagnosed with metastatic non-small cell lung cancer (mNSCLC) and treated with first-line platinum doublet chemotherapy following a common protocol. Data providers reviewed the availability and frequency of data components to assess rw-response (ie, images, radiology imaging reports, and clinician response assessments). A common protocol was used to assess and report rw-response end points, including rw-response rate (rwRR), rw-duration of response (rwDOR), and the association of rw-response with rw-overall survival (rwOS), rw-time to treatment discontinuation (rwTTD), and rw-time to next treatment (rwTTNT)., Results: The availability and timing of clinician assessments was relatively consistent across data sets in contrast to images and image reports. Real-world response was analyzed using clinician response assessments (median proportion of patients evaluable, 77.5%), which had the highest consistency in the timing of assessments. Relative consistency was observed across data sets for rwRR (median 46.5%), as well as the median and directionality of rwOS, rwTTD, and rwTTNT. There was variability in rwDOR across data sets., Conclusion: This collaborative effort demonstrated the feasibility of aligning disparate data sources to evaluate rw-response end points using clinician-documented responses in patients with mNSCLC. Heterogeneity exists in the availability of data components to assess response and related rw-end points, and further work is needed to inform drug effectiveness evaluation within RWD sources.

Background: Limited evidence exists on real-world outcomes with ado-trastuzumab emtansine (T-DM1) treatment and the effectiveness of subsequent therapies., Objective: This study evaluated treatment patterns and outcomes of patients treated with T-DM1 and post-T-DM1 therapy in the United States., Patients and Methods: Adult patients with HER2-positive (HER2+) metastatic breast cancer (mBC) initiating treatment with T-DM1 between 1/1/2013 and 9/30/2018 were included and followed through 12/31/2018. Data were obtained from the iKnowMed electronic health record. Demographic, clinical, and pre- and post-T-DM1 treatment characteristics were described. The Kaplan-Meier method was used to estimate time to treatment discontinuation (TTD) and overall survival (OS)., Results: Of 318 patients treated with T-DM1, 184 (57.9%) had prior treatment with pertuzumab. The median age was 58 years. Most patients had visceral disease (93.4%), and 62.3% had two or more prior treatments for mBC before T-DM1 (range 0-9). The most common subsequent regimens were trastuzumab + vinorelbine (22.5%), HER2-targeted monotherapy (22.5%), and trastuzumab + other chemotherapy (19.6%). Median TTD with T-DM1 was 5.9 months (95% confidence interval [CI] 4.6-6.9); median OS from the start of T-DM1 therapy was 19.2 months (95% CI 16.8-24.5)., Conclusions: Patients treated with T-DM1 in this study appeared to have more advanced disease than patients in clinical trials and were treated in later lines of therapy. Variability was observed across subsequent therapy selections. Treatment patterns and outcomes appeared comparable for patients who received prior pertuzumab. The short treatment durations and survival with T-DM1 therapy in the real-world setting underscore the need for effective post-trastuzumab therapies., (© 2022. The Author(s).)

Aim: To examine and understand patient characteristics, treatment patterns and outcomes for patients with metastatic synovial sarcoma (mSS) treated in a US community setting. Materials & methods: Retrospective observational study in adults with mSS in The US Oncology Network (diagnosed January 2012-December 2018). Results: Of 202 patients diagnosed with synovial sarcoma (SS), 71 had mSS. Of 39 patients with mSS who received first-line (1L) systemic treatment, 25 and 16 continued to 2L and 3L+ treatment, respectively. With each subsequent treatment line, time-to-treatment-discontinuation (1L-3L: 3.9-2.7 months) and time-to-next-treatment (1L-3L: 9.3-4.6 months) decreased. At 1L, median overall survival was 24.5 months. Conclusion: This study highlights the ongoing need for effective therapies for mSS.

Aim: Real-world treatment patterns and clinical outcomes in advanced cutaneous squamous cell carcinoma were evaluated. Methods: Adults receiving their first systemic therapy for unresectable, locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma from 4 September 2014 to 30 June 2017, were evaluated. The primary end point was real-world overall response rate per Response Evaluation Criteria in Solid Tumors or physician assessment. Time-to-event outcomes were assessed using the Kaplan-Meier method. Results: Of 51 eligible patients, the median age was 76 years, 80% were male and 65% had an Eastern Cooperative Oncology Group score of 0-1. The most common regimens were cetuximab (51%) and carboplatin + paclitaxel (22%). Median real-world overall response rate ranged from 9.8% per Response Evaluation Criteria in Solid Tumors to 43.1% when supplemented by physician assessment. Median overall survival was 10.7 months, and median time to next treatment was 7.5 months. Conclusion: Survival in advanced cutaneous squamous cell carcinoma was short. Real-world overall response rate was lower with Response Evaluation Criteria in Solid Tumors than physician assessment.

Objectives: The MYLUNG (Molecularly Informed Lung Cancer Treatment in a Community Cancer Network) consortium pragmatic study assessed real-world biomarker testing rates and turnaround times within a large community-based oncology network., Materials and Methods: This retrospective observational chart review study investigated patients with mNSCLC initiating first-line (1L) systemic therapy between 01-April-2018 and 31-March-2020. Biomarker testing rates and timing relative to 1L therapy for EGFR, ALK, ROS1, BRAF, and PD-L1 were assessed, including use of next-generation sequencing (NGS)., Results: Among 3474 adults: 74% had adenocarcinoma and 76% had a documented ECOG performance status of 0 or 1. Ninety percent had testing for at least one biomarker, and 46% received all 5 biomarker tests. Changes in testing rates from 2018 to 2020 were 71% to 71% for EGFR, 71% to 70% for ALK, 69% to 67% for ROS1, 51% to 59% for BRAF, 82% to 84% for PD-L1, and 42% to 49% for all 5 biomarkers. NGS testing increased from 33% to 45% (p < 0.0001). Median time from mNSCLC diagnosis to 1L therapy was 35 days. Median turnaround times from biomarker testing orders to results ranged from 10 to 15 days for the individual biomarkers and 18 days for NGS., Conclusion: In this real-world study, while most patients received at least one biomarker test prior to 1L, <50% received all 5 tests. NGS testing also occurred in < 50% of patients but appeared to increase over time. The next phase of MYLUNG will evaluate contemporary ordering practices and turnaround times prospectively., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

In prior work, Friends of Cancer Research convened multiple data partners to establish standardized definitions for oncology real-world end points derived from electronic health records (EHRs) and claims data. Here, we assessed the performance of real-world overall survival (rwOS) from data sets sourced from EHRs by evaluating the ability of the end point to reflect expected differences from a previous randomized controlled trial across five data sources, after applying inclusion/exclusion criteria. The KEYNOTE-189 clinical trial protocol of platinum doublet chemotherapy (chemotherapy) vs. programmed cell death protein 1 (PD-1) in combination with platinum doublet chemotherapy (PD-1 combination) in first-line nonsquamous metastatic non-small cell lung cancer guided retrospective cohort selection. The Kaplan-Meier product limit estimator was used to calculate 12-month rwOS with 95% confidence intervals (CIs) in each data source. Cox proportional hazards models estimated hazard ratios (HRs) and associated 95% CIs, controlled for prognostic factors. Once the inclusion/exclusion criteria were applied, the five resulting data sets included 155 to 1,501 patients in the chemotherapy cohort and 36 to 405 patients in the PD-1 combination cohort. Twelve-month rwOS ranged from 45% to 58% in the chemotherapy cohort and 44% to 68% in the PD-1 combination cohort. The adjusted HR for death ranged from 0.80 (95% CI: 0.69, 0.93) to 1.15 (95% CI: 0.71, 1.85), controlling for age, gender, performance status, and smoking status. This study yielded insights regarding data capture, including ability of real-world data to precisely identify patient populations and the impact of criteria on end points. Sensitivity analyses could elucidate data set-specific factors that drive results., (© 2021 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

The purpose of this study was to evaluate the potential collective opportunities and challenges of transforming real-world data (RWD) to real-world evidence for clinical effectiveness by focusing on aligning analytic definitions of oncology end points. Patients treated with a qualifying therapy for advanced non-small cell lung cancer in the frontline setting meeting broad eligibility criteria were included to reflect the real-world population. Although a trend toward improved outcomes in patients receiving PD-(L)1 therapy over standard chemotherapy was observed in RWD analyses, the magnitude and consistency of treatment effect was more heterogeneous than previously observed in controlled clinical trials. The study design and analysis process highlighted the identification of pertinent methodological issues and potential innovative approaches that could inform the development of high-quality RWD studies., (© 2021 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Introduction: Although guidelines recommend testing for actionable biomarkers for patients with advanced or metastatic non-small cell lung cancer (NSCLC), testing rates have varied. This study aimed to assess molecular testing patterns in a large network of US community-based oncology practices., Methods: This retrospective observational study examined adult patients with newly diagnosed stage IV NSCLC with ≥ 2 visits in The US Oncology Network from July 1, 2016 to September 30, 2019. Testing patterns were examined using electronic health record structured fields and chart review. Structured data were analyzed for the overall study population (cohort A), and structured and unstructured data were analyzed for a select cohort of 300 patients (cohort B)., Results: In cohort A (n = 3337), programmed death ligand 1 (37%) was the most frequently tested biomarker documented in structured data, followed by epidermal growth factor receptor (36%), anaplastic lymphoma kinase (35%), ROS1 (20%), and BRAF (16%). According to unstructured data in cohort B (n = 300), epidermal growth factor receptor (80%) was the most frequently tested biomarker, followed by anaplastic lymphoma kinase (79%), programmed death ligand 1 (72%), ROS1 (71%), and BRAF (56%). The proportion of tests ordered prior to first-line (1L) treatment increased from 2016 to 2018 for all biomarkers, as did the proportion of test results available prior to 1L treatment. However, some of the test results became available after 1L or later lines of treatment were in progress., Conclusion: Our study found increased testing rates over time and decreases in testing turnaround times. However, rates of testing for all biomarkers still need to improve, as does completion of testing prior to initiation of therapy., (Copyright © 2021 Ontada. Published by Elsevier Inc. All rights reserved.)

Aim: To assess real-world treatment patterns and outcomes among patients with advanced malignant pleural mesothelioma. Patients & methods: Retrospective database analysis. Results: In all, 469 patients received first-line systemic anticancer therapy (SACT) at community centers. Median follow-up from diagnosis was 11.6 months. Pemetrexed + platinum was the most common first-line SACT; similar proportions of patients received cisplatin or carboplatin with pemetrexed. Only a small proportion of patients received second- and third-line therapies. Median overall survival for first-line SACT was 12.0 months (95% CI: 10.7-14.2). Results were similar with pemetrexed + cisplatin and pemetrexed + carboplatin. Median overall survival with second-line SACT was 6.4 months (95% CI: 5.1-7.6). Conclusion: There is a need for more effective SACTs for advanced malignant pleural mesothelioma.

Background: Data are sparse concerning the sequential use of multiple anaplastic lymphoma kinase (ALK) inhibitors for ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)., Objective: This study investigated sequencing and outcomes among patients receiving multiple ALK inhibitors., Patients and Methods: This was a retrospective observational cohort study of adult patients with ALK-positive NSCLC treated with available first- and second-generation ALK inhibitors from 1 September 2011 to 31 December 2017. Duration of therapy (DOT) and overall survival (OS) were assessed with the Kaplan-Meier method. A multivariable linear regression analysis was performed to assess if DOT with a preceding ALK inhibitor was predictive of DOT for subsequent ALK inhibitor treatments., Results: A total of 410 patients were analyzed: 57% received 1 ALK inhibitor; 35%, 2 ALK inhibitors; and 8%, 3-4 ALK inhibitors. Among those receiving > 1 ALK inhibitor (n = 177), 60% received a crizotinib-led sequence and 39% an alectinib-led sequence. Nearly 60% of the overall population received chemotherapy prior to their first ALK inhibitor. Median OS for the study population was 28 months, 15 months in patients who received 1 ALK inhibitor, 42 months in patients who received 2 ALK inhibitors, and 56 months in patients who received 3-4 ALK inhibitors. Longer DOT of the first ALK inhibitor was associated with increased DOT of the second (p < 0.0001), and longer DOT of the second ALK inhibitor was associated with increased DOT of the third (p < 0.0001)., Conclusions: This study provides initial information on real-world treatment patterns following the introduction of new ALK inhibitors, and supports the use of sequential ALK therapies.

Prior studies of conventional chemotherapy or epidermal growth factor receptor inhibitors for advanced (ie, locally advanced cutaneous squamous cell carcinoma [laCSCC] or metastatic [mCSCC]) cutaneous squamous cell cancer enrolled ≤ 40 patients. This retrospective, observational study assessed real-world treatment patterns and clinical outcomes in patients with unresectable laCSCC or mCSCC using electronic health records of patients who initiated first-line (1L) systemic treatment from 1 January 2008 to 31 December 2015, with follow-up to 30 September 2017. The median duration of follow-up from 1L treatment was 10.1 months (range 0.03-67.6 months). Duration of therapy (DOT) and overall survival (OS) were assessed using Kaplan-Meier analysis. Response rate was calculated as the proportion of patients who achieved physician-assessed-response. Eighty-two patients were identified (17 laCSCC and 65 mCSCC). Median age at 1L treatment initiation was 75 years; 85% were male, 88% had an Eastern Cooperative Oncology Group performance status of 1, and 84% had received radiotherapy. The most common 1L regimens were carboplatin + paclitaxel (27%) and cetuximab monotherapy (24%). The median 1L DOT was 4.1 months for laCSCC and 2.3 months for mCSCC. The physician-assessed response rate for 1L therapy was 17.6% for laCSCC, and 18.5% for mCSCC. The median OS from 1L treatment initiation was 16.2 months for laCSCC, and 15.3 months for mCSCC. Only 24 patients (29%) received second-line therapy. This is the largest retrospective data set regarding patients with advanced CSCC treated with anticancer systemic therapy prior to approval of the anti-programmed cell death-1 antibody, cemiplimab. Efficacy was low in both laCSCC and mCSCC. These data provide historic benchmarks for outcomes in patients with advanced CSCC prior to Food and Drug Administration approval of cemiplimab-rwlc., (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Aim: To evaluate the real-world impact of brain metastases (BM) among patients with EGFR mutation-positive ( EGFR m) metastatic non-small-cell lung cancer (NSCLC). Materials & methods: This retrospective, observational matched cohort electronic health record study assessed adults with EGFR m metastatic NSCLC with/without BM. Results: Among 402 patients split equally between both cohorts (±BM), the majority were Caucasian (69%), female (65%) and with adenocarcinoma (92%). Overall symptom burden and ancillary support service use were higher and median overall survival from metastatic diagnosis was significantly shorter in BM patients (11.9 vs 16 months; p = 0.017). Conclusion: BM in EGFR m NSCLC patients can negatively impact clinical outcomes. New targeted therapies that can penetrate the blood-brain barrier should be considered for treating these patients.

Introduction: Epidermal growth factor receptor (EGFR) mutations are observed in approximately 15% of patients with non-small cell lung cancer (NSCLC) in the USA. Little is known about treatment patterns in EGFR mutation-positive NSCLC following progression on or after first-line (1L) treatment with first- or second-generation EGFR tyrosine kinase inhibitors (EGFR-TKIs). Osimertinib, a third-generation EGFR-TKI, is a treatment option for patients with EGFR T790M-positive NSCLC following progression on 1L EGFR-TKIs. This study analyzed real-world treatment sequencing of EGFR-TKIs, EGFR T790M testing rates, and disposition of patients with EGFR mutations after 1L EGFR-TKI post-FDA approval of osimertinib in patients with EGFR mutation-positive NSCLC., Methods: Adult patients with stage IV NSCLC and documented EGFR mutation-positive status were identified between December 1, 2015 and May 31, 2017 from the US Oncology Network iKnowMed™ electronic health record (EHR). Data were abstracted from the EHR database and supplemented by chart review., Results: Of 308 patients, 302 (98%) received an EGFR-TKI overall, and 246 patients (80%) received a 1L EGFR-TKI. The most common 1L EGFR-TKI was erlotinib (66%); the remaining 1L regimens were predominantly combination chemotherapies with or without an EGFR-TKI. Only 80 patients (26%) received any 2L therapy. The most common EGFR-TKIs used as 2L monotherapy in patients who received 1L EGFR-TKI were afatinib and osimertinib (n = 7 for both). Among all patients treated with 1L EGFR-TKI (n = 246), 47 (19%) were tested for EGFR T790M [16 patients (34%) were positive], 48 (20%) remained on 1L EGFR-TKI, 29 (12%) received subsequent therapy, 38 (15%) had died on or after their 1L EGFR-TKI therapy, and 131 (53%) stopped their EGFR-TKI with no recorded evidence of having received subsequent therapy at follow-up end., Conclusion: Following 1L EGFR-TKI treatment, 19% of patients were tested for EGFR T790M, and most (69%) had no record of receiving any subsequent therapy.

Background: The combination chemotherapy regimens of nab-paclitaxel plus gemcitabine (nab-p + G) and FOLFIRINOX (FFX) have each demonstrated improved survival compared with gemcitabine monotherapy in clinical trials for metastatic pancreatic cancer; however, limited comparative data exist., Objective: The objective of this study was to compare patient characteristics and clinical outcomes including time to treatment failure and overall survival in patients with metastatic pancreatic cancer receiving first-line chemotherapy in the community., Methods: We conducted a retrospective, multi-site, observational cohort study of patients with metastatic pancreatic cancer receiving first-line nab-p + G, FFX, or gemcitabine monotherapy between April 2013 and October 2015, using data from the iKnowMed electronic health record database. Patients on clinical trials or with other cancer diagnoses were excluded. Time to treatment failure and overall survival were assessed by Kaplan-Meier methods., Results: Four hundred and eighty-six patients met selection criteria, 255 nab-p + G, 159 FFX, and 72 gemcitabine patients. Median age was 61, 68, and 73 years for FFX, nab-p + G, and gemcitabine patients, respectively (p < 0.01 for nab-p + G vs. FFX). Eastern Cooperative Oncology Group performance status of 0-1 was 91% for FFX, 77% for nab-p + G, and 68% for gemcitabine patients (p < 0.01 for nab-p + G vs. FFX). For the nab-p + G vs. FFX cohorts, respectively, time to treatment failure was 3.7 vs. 4.3 months (log-rank p = 0.25); and OS was 9.8 vs. 11.4 months (log-rank p = 0.38). Among patients with Eastern Cooperative Oncology Group performance status 0-1, time to treatment failure was 4.2 vs. 4.3 months (log-rank p = 0.47); and overall survival was 12.1 vs 11.4 months (log-rank p = 0.68)., Conclusions: The nab-p + G patients were older and had worse performance status than FFX patients. Time to treatment failure and overall survival were not observed to be significantly different in first-line nab-p + G and FFX patients. Results were similar after stratifying by performance status.

Introduction: Multiple therapeutic options now exist for metastatic non-small-cell lung cancer (mNSCLC). In this study we evaluated treatment patterns and outcomes in mNSCLC patients who received first-line (1L), second-line (2L), and third-line (3L) therapy., Patients and Methods: A retrospective, observational cohort study was conducted using an electronic health record database of mNSCLC patients who received initial treatment from January 2012 through April 2016, with follow-up through June 2016. Patient characteristics and treatment patterns were characterized. Overall survival (OS) was assessed using the Kaplan-Meier method., Results: We identified 10,689 1L patients. Median age was 68 years, and 5816 (54%) were male. Most patients (6337; 59%) had a performance status of 1, and 8282 (77%) had nonsquamous histology. 1L treatment was chemotherapy in 9969 (93%) patients, and targeted therapy in 685 (6%). Median OS (mOS) for all patients in 1L was 12.3 months (95% confidence interval [CI], 11.9-12.7), and 24.3 months in 1L patients receiving targeted therapy. Among patients who received 2L therapy (n = 4235), 2790 (66%), 718 (17%), and 727 (17%) received chemotherapy, targeted therapy, and immunotherapy, respectively. mOS from 2L therapy was 9.6 months (95% CI, 9.1-10.1). In patients receiving 3L therapy (n = 1580), 921 (58%), 355 (22%), and 304 (19%) received chemotherapy, targeted therapy, and immunotherapy, respectively. mOS from 3L therapy was 8.2 months (95% CI, 7.3-8.7)., Conclusion: Targeted therapy and immunotherapy was most frequently used in the 2L and 3L setting during the study time frame. Survival differences observed according to treatment types are likely because of biologic differences, and suggest that patients with actionable mutations have a survival advantage., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Around 3⁻5% of non-small cell lung cancers (NSCLC) are ALK-positive. Crizotinib was the first approved ALK inhibitor from clinical trials. However, there are less data on the utilization and patient outcomes associated with crizotinib in real-world clinical practice., Methods: This was a retrospective, observational study of adult crizotinib-treated ALK-positive metastatic NSCLC patients who received treatment between 1 September 2011 and 31 October 2014, with follow up through 31 December 2015. Data were obtained via programmatic queries of the US Oncology Network/McKesson Specialty Health electronic health record database, supplemented with chart abstraction. Overall survival (OS) and time to treatment failure (TTF) were estimated from crizotinib initiation using the Kaplan⁻Meier (KM) method., Results: Of the n = 199 ALK-positive crizotinib-treated patients meeting eligibility criteria, crizotinib was prescribed as first line (1 L) in n = 123 (61.8%). The majority (88.9%) had confirmed adenocarcinoma histology and 32.2% had brain metastases at initial diagnosis. Median age at crizotinib initiation was 60.2 years (range 27.1⁻88.2); 54.8% were never smokers, 33.7% were former smokers. Treatment of 250 mg, twice daily, was most commonly prescribed (89.5%) with the dose unchanged from an initial dose in 79.4% of patients. The primary discontinuation reason was progression ( n = 91, 58.7%). Patients (3.2%) were identified as discontinuing crizotinib as a result of treatment-related toxicity. With median follow-up time of 13.0 months (min⁻max = 0.03⁻46.6), median OS from crizotinib initiation was 33.8 months (95% CI = 24.3⁻38.8). Median TTF was 10.4 months., Conclusions: Crizotinib usage evaluated within the real-world setting is consistent with prior phase III clinical trial data, and illustrates the real-world effectiveness of crizotinib.

Objective: To understand the relationship between primary platinum-free interval (PFI), BRCA mutation status, and overall survival (OS) in patients with recurrent ovarian cancer receiving multiple lines of therapy in a multicenter, community-based, retrospective observational cohort study of adult patients with stage III-IV high-grade ovarian cancer., Methods: Data were retrospectively obtained from the electronic health record (EHR) of a US community oncology network, including patient characteristics, subsequent treatments, primary PFI, and BRCA status. OS was analyzed by the Kaplan-Meier method, stratified by primary PFI and BRCA status., Results: 750 patient charts were reviewed. BRCA testing status was known in 267 patients (16% BRCA mutation). Among patients with identified recurrent disease, 41% had a primary PFI <6months and 59% had a primary PFI ≥6months. Of second-line patients, 59% received third-line therapy, and 60% of third-line patients received fourth-line therapy within the period of observation. Median OS from the start of primary treatment for the entire population was 41.4months (95% CI, 39.0-48.3months). Median OS was significantly increased in patients with primary PFI ≥6months at second-line and third-line (P<0.0001 and P=0.002, respectively). Survival was observed to be increased among patients with BRCA mutations across multiple treatment lines, although this was not statistically significant., Conclusions: Patients with a primary PFI ≥6months demonstrated improved outcomes over multiple lines of therapy. BRCA status was known in 36% of patients, and those patients with a BRCA mutation demonstrated a trend toward delayed primary recurrence and improved clinical outcomes., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: To compare the costs of: 1) chemotherapy treatment across clinical, demographic, and geographic variables; and 2) various cancer care-related cost categories between patients receiving chemotherapy in a community oncology versus a hospital outpatient setting., Study Design: Data from the calendar years 2008 to 2010 from the Truven Health Analytics MarketScan Commercial Claims and Encounters Database were analyzed. During 2010, the data set contained approximately 45 million unique commercially insured patients with 70,984 cancer patients receiving chemotherapy. These patients were assigned to cohorts depending on whether they received chemotherapy at a community oncology or hospital outpatient setting., Methods: Cost data for 9 common cancer types were extracted from the database and analyzed on a per member per month basis to normalize costs; costs included amounts paid by the payer and patient payment. Community oncology and hospital outpatient setting chemotherapy treatment costs were categorized and examined according to cancer diagnosis, patient demographics, and geographic location., Results: Patients receiving chemotherapy treatment in the community oncology clinic had a 20% to 39% lower mean per member per month cost of care, depending on diagnosis, compared with those receiving chemotherapy in the hospital outpatient setting. This cost differential was consistent across cancer type, geographic location, patient age, and number of chemotherapy sessions. Various cost categories examined were also higher for those treated in the hospital outpatient setting., Conclusions: The cost of care for patients receiving chemotherapy was consistently lower in the community oncology clinic compared with the hospital outpatient setting, controlling for the clinical, demographic, and geographic variables analyzed.

Purpose: Report descriptive outcome measures related to the quality of pharmacist-managed anticoagulation care with warfarin in patients with breast cancer since the formation of the anticoagulation management service (AMS)., Methods: Retrospective review of 145 patients with breast cancer (median age 54 years) receiving warfarin therapy for venous thromboembolism (VTE) managed by the pharmacist-run AMS between 1998 and 2005., Results: The median time followed by the AMS was 151 days. Fifty three percent (n = 1651) of total lab draws (n = 3129) were within the target therapeutic INR range 2-3. Recurrent thrombosis occurred in 4.1% of patients. Minor bleeding occurred in 18.6% of patients and major bleeding occurred in three patients (2.1%, gastrointestinal, intra-abdominal, and subdural hematoma)., Conclusion: To date, this is the largest known published database of cancer patients receiving anticoagulation in a pharmacist-managed anticoagulation service. Recurrent VTE rates, major and minor bleeding rates, and percentage of time spent within the therapeutic range are slightly different in our patient population compared to an oncology population receiving warfarin and a non-oncology population with warfarin managed by AMS. Oral anticoagulation with warfarin is an effective, albeit complicated, treatment for venous thromboembolism in the oncology population. Although low-molecular weight heparin (LMWH) therapy is now the preferred treatment for thrombosis in malignancy, warfarin is still relevant in patients who are unable to receive treatment with LMWH. This report provides valuable information supporting coordinated anticoagulation therapy with a pharmacist-managed service in a breast cancer-specific population, and contributes to the growing data supporting the challenging nature of maintaining warfarin anticoagulation in patients with cancer.

Purpose: The goal of this study was to use two separate databases to evaluate the clinical outcomes and the economic impact of adherence to Level I Pathways, an evidence-based oncology treatment program in the treatment of colon cancer., Patients and Methods: The first study used clinical records from an electronic health record (EHR) database to evaluate survival according to pathway status in patients with colon cancer. Disease-free survival in patients receiving adjuvant treatment and overall survival in patients receiving first-line therapy for metastatic disease was calculated. The second study used claims data from a national administrative claims database to examine direct medical costs and use, including the cost of chemotherapy and of chemotherapy-related hospitalizations according to pathway status., Results: Overall costs from the national claims database-including total cost per case and chemotherapy costs-were lower for patients treated according to Level I Pathways (on-Pathway) compared with patients not treated according to Level I Pathways. Use of pathways was also associated with a shorter duration of therapy and lower rate of chemotherapy-related hospital admissions. Survival for patients on-Pathway in the EHR database was comparable with those in the published literature., Conclusion: Results from two distinct databases suggest that treatment of patients with colon cancer on-Pathway costs less; use of these pathways demonstrates clinical outcomes consistent with published evidence.

Objective: The goal of this study was to use 2 separate databases to evaluate the clinical outcomes and the economic impact of adherence to Level I Pathways, an evidence-based oncology treatment program in the treatment of colon cancer., Patients and Methods: The first study used clinical records from an electronic health record (EHR) database to evaluate survival according to pathway status in patients with colon cancer. Disease-free survival in patients receiving adjuvant treatment and overall survival in patients receiving first-line therapy for metastatic disease was calculated. The second study used claims data from a national administrative claims database to examine direct medical costs and use, including the cost of chemotherapy and of chemotherapy-related hospitalizations according to pathway status., Results: Overall costs from the national claims database-including total cost per case and chemotherapy costs-were lower for patients treated according to Level I Pathways (on- Pathway) compared with patients not treated according to Level I Pathways. Use of pathways was also associated with a shorter duration of therapy and lower rate of chemotherapy-related hospital admissions. Survival for patients on- Pathways in the EHR database was comparable with that in the published literature., Conclusion: Results from 2 distinct databases suggest that treatment of patients with colon cancer on-Pathways costs less; use of these pathways demonstrates clinical outcomes consistent with published evidence.

Purpose: A case of paclitaxel-induced painful crisis in a patient with breast cancer and hemoglobin sickle cell disease (SCD) is reported., Summary: A 55-year-old postmenopausal African-American woman had stage IIB invasive ductal carcinoma of the left breast. She was not taking any medications and did not report a history of cancer or other diseases. She had mild microcytic anemia, but the rest of her blood counts and liver function test values were normal. Bone scans and computed tomography scans of her chest and abdomen did not reveal any metastatic disease. She underwent a routine left segmental mastectomy and axillary lymph node dissection that revealed a 4-cm invasive cancer with 1 of 10 axillary lymph nodes positive for metastatic disease. Her treatment plan included chemotherapy with weekly paclitaxel, followed by fluorouracil, epirubicin, and cyclophosphamide and radiation. The first cycle of paclitaxel was well tolerated until one week after initiation when the patient woke up in the middle of the night with a sudden onset of excruciating back pain and muscle spasms. Other symptoms that developed included fatigue, left-sided rib pain, and shortness of breath. The patient recalled being told that she had sickle cell trait but said that she never had a sickle cell crisis. Laboratory tests during her 13-day hospitalization revealed hemolysis. The patient was diagnosed with hemoglobin SCD and later discharged with as-needed, low-dose oxycodone and baclofen, antibiotics, and folic acid., Conclusion: A patient with breast cancer and SCD had a painful crisis after receiving paclitaxel as part of her chemotherapy regimen.

Unlabelled: Premenopausal women who develop ovarian failure after receiving chemotherapy are at a higher risk of rapid bone loss. Pharmacists have successfully implemented osteoporosis screening programmes in the general population and thus, assessment of breast cancer survivors for ovarian failure and osteopenia could represent a novel focus for oncology pharmacists. Therefore, we conducted a retrospective chart review to determine the adequacy of ovarian failure and osteoporosis assessment and management in premenopausal breast cancer survivors., Methods and Results: The charts of 20 women diagnosed with early stage breast cancer treated with cyclophosphamide over a 4.5-year timespan were included. Their median age was 36.7 years (range 29.8-41). The median cyclophosphamide cumulative dose was 9 g/m(2) (range 2.4-14.45), with a median duration of follow-up being 4.62 years. The assessment of ovarian failure mainly occurred by documenting menstrual periods, which has been questioned as a reliable method for assessing ovarian failure. Menses stopped while or shortly after receiving chemotherapy in 11 women. Prior to and during cyclophosphamide administration, osteoporosis screening or counselling was not documented for any patient. After completion of chemotherapy administration, eight patients were counselled regarding osteoporosis and seven women were screened for osteoporosis with a dual X-ray absorptimetry (DXA) scan. Five women had DXA scans indicative of osteopenia according to World Health Organization guidelines., Conclusions: Improvements are needed in the documentation and potentially also the management of ovarian failure and osteoporosis in premenopausal breast cancer survivors receiving cyclophosphamide-based regimens. This represents a potential opportunity for pharmacists to manage long-term chemotherapy toxicity.