bluuebunny/crossref_metadata_2025 huggingface dataset:
Assessing overall patient satisfaction among cancer patients: A radiotherapy survey.
Authors: Meng JoAnne , Cisa-Pare Elisabeth , Balchin Katelyn , Renaud Julie , Bunch Linda , Wheatley-Price Paul , McNeil Angela , Murray Shelagh , Samant Rajiv
Published: May 2020

e19249

Background: Healthcare providers (HCPs) strive to maximize the experience for cancer patients. Published reports suggest a variety of characteristics that are considered important. We decided to survey our patients undergoing radiotherapy to determine what they considered desirable traits and characteristics. Methods: An ethics approved 35-item patient satisfaction survey evaluating respondent experience was developed by an interdisciplinary team of HCPs working in the radiation medicine program. It was an anonymous, voluntary, paper-based survey for self-completion. It evaluated a variety of domains with respect to the quality of care patients received, and was administered to patients undergoing radiotherapy. Results: A total of 199 patients completed the survey. The median age was 68, with approximately 54% women and 45% men (1% unreported). Most patients (85%) had been diagnosed with their cancer within the previous year, and the commonly reported malignancies (61%) were breast, prostate and lung cancers. Almost all (95%) “agreed" or "strongly agreed" about the importance of physicians being sensitive and compassionate. Over 90% felt they received adequate explanations about their treatment, and had their questions answered. The vast majority (93%) felt included in the decision-making process. They reported the 5 most important qualities among the HCPs as follows (in descending order): knowledge, kindness, honesty (answering questions/giving information), good communicator and cheerful attitude. Most (>70%) reported feeling connected with their HCPs. Although overall satisfaction was high, there were areas for improvement identified. These included patients being offered future appointments to discuss their diagnosis and treatment, receiving information about clinical trials and other treatment options, and being given contact information for psychosocial and community resources. Also, HCPs tended to focus mainly on the physical needs of patients and to a lesser degree on their emotional needs, but spiritual and cultural needs were not routinely addressed (<10%). Conclusions: Reassuringly, cancer patients receiving radiation report high rates of satisfaction across many aspects of their care. The qualities most appreciated serve as a reminder to clinicians that their role is more than just that of a medical expert. These findings also reinforce the different aspects of holistic care that can be improved.
Assess how non-oncology care settings influence the longitudinal journey of cancer patients.
Authors: Carnegie Daniel , Argentinis Elenee , Mazumder Dibyajyoti
Published: May 2020

e19254

Background: Electronic health records (EHRs) are increasingly being accepted by regulators and as real world evidence (RWE). In a recent literature review (published elsewhere in this conference), we identified that many of the commercial databases source data solely from oncology clinics. This analysis aimed to understand the extent to which melanoma skin cancer patients receive cancer care specialties other than oncology. Methods: Newly diagnosed melanoma patients with one or more melanoma encounters (ICD10 CM) from January-Dec 2017 were included from the Optum Electronic Health Record Data Repository. Optum EHR data repository has more than 90 million de-identified patient lives mostly sourced from integrated healthcare delivery network EHRs within the US. Optum data includes the entire care continuum across primary case, across specialties, inpatient and outpatient encounters. Index date was defined as the first date of melanoma diagnosis within the study period. EHR history was assessed for 6 months prior to index and 1 year post index. All pathology, radiology and treatment encounters were identified, and all specialties who participated in the patient’s oncology diagnosis and care were counted. All ICD codes were verified by certified medical professional. Results: A total 7351 patients had one or more melanoma related encounters in 2017. During the 6 months prior to diagnosis, histological tests were ordered mostly by dermatologists (38%), followed by pathologists (19%), while oncologists and surgeons ordered 6% and 5%, respectively. Analysis of surgical excision on or after index indicated that dermatologists performed 47% of procedures followed by plastic surgeons (10%) and oncologists (9%). Oncologists comprised 44% of chemotherapy prescribing, while general medicine accounted for 14%. Conclusions: A large proportion of dermatological cancer care encounters occur outside the oncology setting. Therefore, to understand the factors that affect treatment outcomes, the EHR data used for outcomes research should include the entire care continuum.
Clinicopathological features and prognosis of rare carcinomas of the breast: A comparative analysis from the NCDB.
Authors: Elimimian Elizabeth Blessing , Samuel Thomas A. , Liang Hong , Bilani Nadeem , Elson Leah , Nahleh Zeina A.
Published: May 2020

e19256

Background: A comparative analysis of the clinicopathological features, immunohistochemistry, and overall (OS) for rare ( < 10%) of all breast cancers (BCs) has not been widely explored. Methods: The National Cancer Database (NCDB) was reviewed for patients with a confirmed diagnoses of the following rare BC tumors: Mucinous adenocarcinoma (MuC), tubular adenocarcinoma (TuC), intraductal micropapillary (IMP), papillary carcinoma (PaC), and intraductal papillary adenocarcinoma (IPA) between 2010 and 2016. Patients with an unknown stage were excluded. Univariate analyses & multivariable Cox-regression models were performed in SAS v. 9.4. Results: Analysis included 70,341 patients. MuC was the most common histologic type seen among the rare tumors in our cohort n = 30,087 (43%), compared with 9,681 (13.8%) TuC, 12,735 (18.1%) IMP, 435 ( < 1%) PaC, & 17,403 (24.7%) IPA. TuC & IMP both presented earlier in life, with a median age of 60 versus 69 years for MuC patients and 67 years for both PaC & IPA. The majority of carcinomas were ER+/PR+/HER2- (MuC 88.6%, TuC 89.9%, IMP 67.3%, PaC 76.8%, & IPA 79.6%); ER+/PR+/HER2+ were noted in 3.5% of Muc and 13.2 % of IMP, and ER-/PR-/HER2- were seen in PaC 8.7% and IPA 7.3%. Two highly significant factors for inferior outcome were stage (III & IV) and metastasis to the brain. Stage ≥3 at diagnosis conferred a worse prognosis for MuC patients (HR 3.1, p < 0.0001), IPA patients (HR 3.5, p < 0.0001), & IMP patients (HR 4.8; p < .0001) when compared to patients with stage 0 & 1. Brain metastasis was an adverse mortality indicator for MuC patients (HR 2.4, p < .0003), IPA patients (HR 6.8, p < 0.0001), & IMP patients (HR 10.4, p < .0001). For MuC, age ≥60 was also prognostic (HR 2.7; p < .0001). The 5-year OS was 92.2% for patients with MuC, 94.7% for TuC patients, 93.1% for IMP patients, 81% for PaC & 90% for IPA overall (p-values < 0.0001). Conclusions: The rare BC tumors analyzed in this large database confirm that these tumors are typically seen at an older age, are commonly ER+/PR+/HER2 -, and rarely HER2 + or Triple negative. Mucinous adenocarcinoma being the most common type. They have an overall good prognosis, with papillary carcinoma having inferior OS. Other poor prognostic factors include older age, brain metastasis and advanced stages at diagnosis.
Assessing real-world clinical response in patients with multiple myeloma (MM): A survey of the literature.
Authors: Lane Daniel , Norden Andrew D. , Belli Andrew J. , Wang Ching-Kun
Published: May 2020

e19260

Background: A recent study (Foster, Tromanhauser et al. 2019) utilizing Electronic Health Record (EHR) data found that patients with MM rarely have both serum protein electrophoresis (SPEP) and 24-hour urine protein electrophoresis (UPEP) documented in routine clinical practice settings. These elements are necessary to classify response using the International Myeloma Working Group (IMWG) consensus criteria. It could be hypothesized that adding the additional requirements for bone marrow biopsy necessary to confirm a complete response would further reduce the rate of strict adherence to the IMWG criteria in the real world (RW). Clinicians are however assessing response and progression in RW settings and often report these assessments in published literature. In this study, we survey the literature to determine how RW response is being captured and reported outside of the clinical trial setting. Methods: A systematic search was performed using Medline 2010-2019. Using a standardized grading system, English language articles were evaluated that utilized EHR data from routine clinical practice to report RW response in patients with active MM. Registry based and/or pragmatic observational studies were excluded as many had mandatory reporting procedures in place. Studies were then categorized based on methods of assessing response, progression and use of IMWG criteria. Results: The majority of studies grade 1 studies identified (21/25) utilized best response achieved based on treating physician-documented assessment and either did not specify the use of IMWG(10/21) criteria or explicitly stated they did not use conventional criteria (11/21). Progression event capture and reporting varied greatly with many using physician-documented progression, change in regimen, addition of additional agents to existing regimen, stem cell transplant, or an individually created algorithm. Conclusions: Our findings suggest that there is a need for further research on objective techniques for the assessment of RW progression and response in patients with MM. Additionally, validation of an approach that utilizes partial adherence to IMWG criteria would help in the ability to compare findings across clinical trial and RW settings. This validation work is under way, and preliminary results will be reported at the meeting.
Implementation and impact of the first two years of a systemwide molecular tumor board at Henry Ford Health System (HFHS).
Authors: Rybkin Igor I. , Haque Nadia Z , Collins Kristen , Laidlaw Louisa , Mikkelsen Tom
Published: May 2020

e19266

Background: HFHS implemented clinically-oriented Precision Medicine Program (PMP) in 2016. As part of the program, multidisciplinary molecular tumor board (MTB) was created to review complex molecular cases, providing guidance to treating medical oncologist in selecting targeted therapies and clinical trials. In some cases MTB recommended genetic counseling or recommended against/for additional molecular testing. MTB consists of oncologists, molecular pathologists, clinical trial staff, and genetic counselors. MTB was designed as teaching platform engaging hematology-oncology fellows into cases analysis and presentation. Here we present preliminary analysis of the impact of the MTB on the HFHS oncology practice. Methods: From 09/08/2017 to 12/31/2019 MTB reviewed 120 cases, 116 cases were used for this analysis. Data was abstracted using Syapse precision oncology platform, MTB recommendation note, electronic medical record (EMR), and molecular test results. Results: Out of 116 pts 83 (72%) were Caucasian, 25 (22%) African American, 4 (3%) Asian, 1 (1%) American Indian. Fifty-two % (n = 21) had an ECOG performance status of 1. Most common primary disease sites were lung (39%, n = 45) brain (12%, n = 15), and hematologic cancers (9%; n = 10), followed by breast (5%, n = 6), prostate (4%, n = 5), colon (3%, n = 4), and others (28%, n = 31). The most common genetic abnormalities discussed were atypical EGFR (n = 15), non-V600 BRAF (n = 10), KRAS (n = 8), BRCA2 (n = 5), NF2 (n = 4), PTEN (n = 4), CSF3R (n = 3), IDH1 (n = 3), TP53 (n = 3), and 29 less common mutations. Thirty five (30%) pts out of 116 total were recommended clinical trials, although only 3 patients (10% of recommended) were enrolled into trials. 31 pts (27%) were recommended off-label therapy, although trials were preferred. 18% of pts (n = 21) were recommended genetics referral, although only 3 have seen Geneticist, with two undergoing germline testing. One pt was discovered to have a germline RET V804M mutation which was originally detected in the cancer. Conclusions: The first two years of data demonstrate the utility of the MTB and provide a basis for ongoing analysis. Through multidisciplinary approach, MTB encourages care coordination and collaboration. MTB resulted in genetics referrals, clinical trial recommendations, and identification of targeted therapy options, including off label. In many cases, MTB recommendations prevented futile therapies and/or additional molecular testing.
Real-world incidence of grade III/IV side effects, emergency room visits, and hospital admissions after treatment with adjuvant durvalumab in locally advanced non-small cell lung cancer.
Authors: Jafri Syed Imran Mustafa , Lopetegui-Lia Nerea , Reddy Aswanth , Vredenburgh James
Published: May 2020

e19276

Background: Durvalumab is a selective human IgG1 monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80, allowing T cells to recognize and kill tumor cells. Durvalumab is FDA approved for adjuvant treatment of locally advanced unresectable NSCLC after definitive chemoradiation based on data presented in the PACIFIC trial with benefit in PFS and overall survival. In the PACIFIC trial, discontinuation of the durvalumab because of adverse events occurred in 15.4% of the patients. The most frequent adverse events leading to its discontinuation were pneumonitis (4.8%), radiation pneumonitis (1.3%), and pneumonia (1.1%). The aim of our study is to review real world single institution experience of durvalumab in locally advanced NSCLC. Methods: 23 patient charts with locally advanced NSCLC who had durvalumab ordered for adjuvant treatment were reviewed. 4 patients were excluded given failure to start durvalumab or lack of complete records with treatment at outside institutions. Results: 19 patients were included in the final analysis. 18/19 patients received definitive chemoRT and 1 patient received definitive RT alone given co-morbidities. 8 patients finished durvalumab and 4 are currently on treatment. 8/19 patients (42.1%) had Grade III/IV side effects reported. 7/19 (36.8%) patients had durvalumab discontinued. In 6 patients (31.5%), durvalumab was discontinued due to Grade III/IV toxicity (all with pneumonitis) while 1 patient had sepsis with disease progression. 2 patient had died with one patient death related to pneumonitis/pneumonia along with underlying co-morbidities and the second patient with disease progression. 4 patients (21%) had 7 ER visits and 5 patients (26%) were admitted to the hospital for various reasons 7 times. 2 patients required higher level of care in the step down unit. Treatment was delayed only twice in all 19 patients because of a clinical reason. Conclusions: Durvalumab is an exciting new development in the treatment of locally advanced NSCLC. Our review revealed higher than previously reported incidence of pulmonary toxicity as well as higher discontinuation rate. Other than pulmonary toxicity, durvalumab is very well tolerated with low incidence of ER visits, hospital admissions and treatment delays. Clinicians should monitor patients very closely for pulmonary toxicity during durvalumab treatment. Regular pulmonary function testing may be a reasonable approach to monitor the patients on durvalumab.
Real-world data of a cohort of patients with EGFR mutated metastatic non-small cell lung cancer (NSCLC), follow up of 52 months in Fundación Santa Fe de Bogota.
Authors: Ospina Serrano Aylen Vanessa , Pino Luis , Segovia Javier , Triana Ivan Camilo
Published: May 2020

e19287

Background: In Colombia, clinical information about EGFR mutated metastatic NSCLC is deficient. The goal of this study is to describe the characteristics and outcomes of a cohort of patients as a real-world evidence from a single institution from Colombia. Methods: This is an observational study of a cohort of patients with EGFR mutated metastatic NSCLC. We did follow up for 52 months and analyzed molecular, clinical and epidemiological characteristics, progression free survival (PFS), overall survival (OSm) and treatment related complications. Results: Sixteen patients were included. 81.2% were female and 18.2% male patients. All patients with ECOG 0-2. Previous smoking history was reported in 31.2%. 25% of the patients had brain metastasis and 18.7% had high volume disease (three or more sites of metastasis). The mutations reported were: 62.5% exon 19 deletion, 31.2% L858R mutation, 0.06% exon 19 insertion, 12.5% truncal T790M mutation. The PFS and the OSm for the whole cohort were 14.6 months and 25 months respectively. As a first line of treatment 25% of the patients received erlotinib (PFS 11.7m and OSm 26.6m), 37.5% gefitinib (PFS 12m and OSm 14.6m), 25% afatinib (PFS 16.6m and OSm has not been reached) and 12.5% osimertinib without progression, during 10.5m of follow up. After 52 months, 50% of the patients had progressed. After the progression, rebiopsy was performed in all patients, T790M mutation was detected in 50%, and 50% of these patients died with OSm of 3m with a fast clinical worsening. In relation with grade 3-4 toxicity it was one case of hepatotoxicity with afatinib, with gefitinib 2/6 patients had diarrhea, with erlotinib one case of hematotoxicity and with osimertinib 1/6 patients developed hepatotoxicity. Conclusions: The clinical characteristics of our cohort was similar to previous reports in the literature. Additionally, molecular behavior was concordant with other reports in Latin America, with a higher incidence of exon 19 deletion. Gefitinib was the most frequent treatment used, probably due to non-availability of other therapies such as afatinib or osimertinib in our country until 2018 and 2019 respectively. There were no differences in PFS or OSm according to anti-EGFR treatment and molecular behavior. The OS was lower than reported in clinical trials in gefitinib treatment group, this finding requires validation in bigger cohort of patients, but is real world data that can partially explain these results.
An analysis of trends in prostate cancer treatment from a CMS database.
Authors: Konski Andre A. , Jewell Elizabeth Lin , Havrilesky Laura J , Efstathiou Jason A. , Johnstone Peter A.
Published: May 2020

e19288

Background: The Centers for Medicare and Medicaid services (CMS) has announced a new payment model for radiotherapy services, a Radiation Oncology Alternative Payment Model (ROAPM), for 17 malignancies. The data used to calculate the base payments were released with the program announcement. The purpose of this study was to analyze trends in treatment as well as payments for each treatment modality in an attempt to provide a baseline for future comparison once the ROAPM has been completed. Methods: The database, CY2015-2017, contains payment, site of service, anatomic site and limited patient data for 517,988 patients, 91,551 having a diagnosis of prostate cancer. Only CPT codes for radiotherapy were included in the calculation of payment and only codes registered 90 days after a treatment planning charge were included. Stata 15m College Station, Texas, was used to perform all statistical analysis. Chi squared test was used to determine associations between variables. The Kruskal-Wallis H test was used to determine the relationship of total payment to clinical variables. Results: Treatment included IMRT (66,663 patients[pts], conventional therapy[ceb] (8,942 pts), brachy therapy (7,156 pts), stereotactic radiotherapy (srs) (5,120 pts) and proton beam therapy [pbt] (3,661). A slight majority of patients, 51%, were treated in the outpatient setting. Patients treated in a freestanding center were significantly more likely to have more than 41 fractions (54%) as compared to patients treated in an outpatient setting (32%), P < 0.001. Patients receiving pbt were significantly younger when compared to patients receiving other therapies, p < 0.001. Pbt was significantly costlier, mean $45,606.85 when compared to IMRT, $26,33.14, ceb, $10,242.27, srs, $16,514.98, or brachytherapy, $15,615.44, p < 0.001. In addition, patients treated at an outpatient center with IMRT experienced higher cost compared to patients treated at a freestanding setting, $25,448.48 vs $22,934.69 p = 0.001. Conclusions: These data gives baseline treatment practice information prior to the implementation of a ROAPM. These data, however, are limited and do not give any indication as to the outcome, both disease specific metrics, and quality of life metrics. Post ROAPM analysis will be needed to determine the effect of a new payment paradigm on treatment practices of this malignancy.
Development and validation of a novel EHR-based tumor progression outcome to support biomarker discovery.
Authors: Kehl Kenneth L. , Hassett Michael J. , Stafford Katherine A. , Xu Wenxin , Johnson Bruce E. , Schrag Deborah
Published: May 2020

e19297

Background: Obtaining clinical outcomes for analysis has historically been a critical barrier to cancer genomics research. EHRs could constitute an important data source to bridge this gap, but EHRs rarely capture structured outcomes such as cancer progression. Novel, robust methods are needed to capture clinically relevant outcomes from EHRs. Methods: Among patients with lung adenocarcinoma whose tumors were sequenced via the Dana Farber Cancer Institute/Brigham and Women’s PROFILE study from 2013-2018, imaging reports following first palliative-intent systemic therapy were annotated using natural language processing (NLP) models trained to capture cancer progression according to the structured “PRISSMM” framework. NLP-based cancer progression and imaging report frequency were jointly modeled using inverse-intensity weighted generalized estimated equations, censored at six months, to explore associations between alterations in lung cancer biomarkers (ALK, EGFR, ROS1, BRAF, KRAS, SMARCA4) and progression. Among patients with KRAS mutations who received immunotherapy, we also analyzed the association between STK11 mutations and progression. The novel outcome generated by the model – imaging report-based progression (iPROG) – corresponded to the difference in the mean log odds of progression per inverse-intensity weighted report associated with a given biomarker; it was reported as adjusted mean probability and in exponentiated form as an odds ratio (OR). Results: Among 690 patients with lung adenocarcinoma, associations between tumor mutations and the iPROG outcome are listed in the Table. Conclusions: A deep NLP model applied to EHR data can capture a novel cancer progression outcome, which is associated with known prognostic markers in lung cancer. Application of this method to large “real world” datasets, with attention to interactions between treatment and genomics, could speed biomarker discovery. [Table: see text]
Real-world burden of myelosuppression in patients with small cell lung cancer (SCLC): Retrospective, longitudinal data analysis.
Authors: Epstein Robert S. , Krenitsky JoAnn , Weerasinghe Roshanthi K. , Parrish Amy S. , Sanborn Rachel E. , Salimi Tehseen
Published: May 2020

e19300

Background: Myelosuppression is a common side effect of chemotherapy (CT) that can compromise patient (pt) and economic outcomes. To evaluate the overall burden of myelosuppression, a longitudinal, patterns of care analysis was conducted among pts with SCLC treated with CT in routine clinical practice. Methods: Data were obtained from Providence St. Joseph Health electronic medical records between Jan 2016 and Dec 2019. Hematologic adverse events, treatment patterns, and hospital-based healthcare resource utilization and costs were assessed during the 12 months from first diagnosis of SCLC in pts who had CT-induced grade 3/4 myelosuppression in 1st or 1st/2nd/3rd-line (1/2/3L) treatment settings. Descriptive statistics were utilized to summarize key findings. Costs of care were calculated from actual treatment costs for inpatient, outpatient, and emergency room services after first diagnosis and treatment with CT. Professional billing was not included due to variability in physician employment by the system. Results: 347 pts were eligible for analysis; mean age (SD) was 66 (9.0) years, 49% were female, and 89% were Caucasian. Prominent comorbidities included chronic obstructive pulmonary disease (52%), diabetes (23%), and peripheral vascular disease (20%). 264 pts (76%) received 1L treatment only, while an additional 83 pts (24%) had both 1L and 2/3L treatment. Of 339 evaluable pts with longitudinal laboratory data, grade 3/4 cytopenias were reported as follows: 45%, neutropenia; 41%, anemia; and 25%, thrombocytopenia. 43% and 15% of pts received red blood cell or platelet transfusions, respectively. 49% of pts received prophylaxis (6%) or treatment (43%) with G-CSF, and 4% of pts were treated with erythropoiesis-stimulating agents. Average total costs of care (post initial-diagnosis and treatment) for pts without grade 3/4 hematologic events (n = 110) were $67,802 per pt throughout the 12 months’ follow-up. On average, annual per pt costs for those with grade 3/4 hematologic events were $131,047 for neutropenia, $95,954 for anemia, and $90,053 for thrombocytopenia. Conclusions: A large and meaningful proportion of pts had grade 3/4 myelosuppression with annual incremental associated costs per pt ranging from $22,251 for pts with thrombocytopenia to $63,245 for pts with neutropenia. Despite the availability of protocols of care and various rescue treatments, CT-induced myelosuppression places a significant real-world burden on pts and the healthcare system.
Real-world treatment attrition rates in advanced esophagogastric cancer.
Authors: Tsang Erica S , Lim Howard John , Renouf Daniel John , Davies Janine Marie , Loree Jonathan M. , Gill Sharlene
Published: May 2020

e19301

Background: Over the last decade, multiple agents have demonstrated efficacy for advanced esophagogastric cancer (EGC). Despite the availability of later lines of therapy, there remains limited real-world data about the treatment attrition rates between lines of therapy. We sought to characterize the use and attrition rates between lines of therapy for patients with advanced EGC. Methods: We identified patients who received at least one cycle of chemotherapy for advanced EGC between July 1, 2017 and July 31, 2018 across 6 regional centers in British Columbia (BC), Canada. Clinicopathologic, treatment, and outcomes data were extracted by chart review. Patients who continued on treatment were censored at the date of last contact. Results: Of 245 patients who received at least one line of therapy, median age was 65.7 years (IQR 58.2-72.3) and 186 (76%) were male, ECOG PS 0/1 (80%), gastric vs. GEJ (36% vs. 64%). Histologies included adenocarcinoma (78%), squamous cell carcinoma (8%), and signet ring (14%), with 31% HER2 positive. 72% presented with de novo disease, and 25% had received previous chemoradiation. There was a high level of treatment attrition, with patients receiving only one line of therapy (n = 122, 50%), two lines (n = 83, 34%), three lines (n = 34, 14%), and four lines (n = 6, 2%). Kaplan-Meier survival analysis demonstrated improved survival with increasing lines of therapy (median overall survival 7.7 vs. 16.6 vs. 22.8 vs. 40.4 months, p< 0.05). On multivariable Cox regression, improved survival was associated with better baseline ECOG and increased lines of therapy ( p< 0.05). Conclusions: The steep attrition rates between therapies highlight the unmet need for more efficacious earlier-line treatment options for patients with advanced EGC. [Table: see text]
The impact of home hospice care on patients with hematologic disorder in Taiwana population-based cohort study.
Authors: Chang Yuehshih , Lai Chien-Hong , Wang Cheng-Hsu
Published: May 2020

e19304

Background: The aim of the study is to examine the effect of home hospice care on quality of end-of-life (EOL) care for patients with hematologic malignancies in Taiwan between 2002 and 2011 by using the Taiwanese National Health Insurance Research Database. Methods: We enrolled patients with hematologic malignancies and lung cancer from the Longitudinal Cohort of Diabetes Patients database. For realizing the impact of home hospice care, those patients were divided into two groups, inpatient hospice care and home hospice care. Results: In Taiwan, 18.44 % patients with hematologic malignancies received hospice care and the ratio was similar with patients with lung cancer. Among those patients, 28.64% patient were able to receive home hospice care. The mean probability of survival was longer in the home-hospice group. Considering those indicators for the quality of hospice, blood transfusion and antibiotic use were significantly more frequent in the home hospice group. But the total cost for the last month for home hospice group was cheaper than inpatient hospice group. Conclusions: Hospice care for patients with hematologic disorder still need improvement. Receiving home hospice care in Taiwan did not decrease the survival life so to enroll the suitable patients for home hospice care are reasonable.
Study on deep vein thrombosis (DVT) risk factors at the time of cancer diagnosis in patients from the multicenter, prospective Cancer-Venous Thromboembolism (VTE) Registry.
Authors: Ohashi Yasuo , Ikeda Masataka , Kunitoh Hideo , Sasako Mitsuru , Okusaka Takuji , Mukai Hirofumi , Fujiwara Keiichi , Nakamura Mashio , Saito-Oba Mari , Kimura Tetsuya , Ibusuki Kei , Sakon Masato
Published: May 2020

e19323

Background: Although the incidence of VTE is known to be high in cancer patients, many details of the frequency, risk factors, and management of VTE in patients with cancer remain unclear, especially in Asian populations. Methods: The multicenter, prospective, Cancer-VTE Registry study (UMIN000024942) aimed to clarify the actual status of VTE in cancer patients. The study enrolled patients diagnosed with colorectal, lung, stomach, breast, gynecological, or pancreatic cancer in Japan. Patients underwent VTE screening before initiating cancer treatment and were observed for 1 year. Registry objectives included the assessment of VTE prevalence and risk factors for VTE before initiating cancer treatment, real-world treatment of VTE, and frequency of new-onset events during the observation period. DVT screening was waived for those with a normal D-dimer level. Using a multivariate logistic regression model, we examined risk factors for DVT in cancer patients prior to initiating cancer treatment. Results: Of the 9726 patients enrolled, 3661 patients underwent DVT screening and 549 subjects were diagnosed with DVT. The risk factors for DVT among patients who underwent DVT screening (n=3661) are shown in the Table. Conclusions: The risk of DVT before initiating cancer treatment was clarified, and the factors strongly influencing DVT risk included age, sex, VTE history, D-dimer concentration, and hemoglobin concentration. [Table: see text]
Regorafinib outcomes from the population-based South Australian mCRC registry (SAmCRCR).
Authors: Price Timothy Jay , Piantadosi Cynthia , Townsend Amanda Rose , Padbury Rob , Roy Amitesh Chandra , Maddern Guy , Moore James , Karapetis Christos Stelios
Published: May 2020

e19344

Background: Regorafinib has been shown to improve survival over BSC alone in large randomized trials. The median survival in the CORRECT study was 6.4 months and 12 month survival 24.3%. In Australia regulators have limited the use of regorafenib and patients are required to self-fund. Understanding the potential benefit of regorafenib in a real world non trial setting would be informative for consumers when considering self funding. Methods: The SAmCRCR collects all mCRC patients prospectively. The Registry was analysed for patients who had received regorafinib between February 2006 and December 2018. Survival was analysed using Kaplan Meier method. Results: Only 53 patients have received regorafenib therapy since February 2006. The median age was 66 (range 34-82). 66% were male, 66% had stage IV at diagnosis, 53% had liver only, 13% liver and lung and 6% lung only involvement. 75% were left sided. K/RAS was available in 35/53 patients, 49% WT. BRAF in 8/53, 25% MT. MSI measured in 14, and MSI-H 21%. Prior lines of treatment received: one 4%, two 9%, three 23%, four 26%, > four 37%. Prior biological use: bevacizumab 72%, anti-EGFR 100% (for RAS WT). Median survival from diagnosis was 3.3 years (95% CI 2.8-3.8 years). From start of regorafinib median survival was 7.1 months (95% CI 4.8-9.4 months) and12 month survival 28%. Conclusions: The outcome for those patients who do access regorafinib is in keeping with that reported from large randomized trials and thus clinicians can quote these outcomes when discussing access to regorafinib in the community.
Real-world outcomes among patients with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer treated with EGFR tyrosine kinase inhibitors versus immunotherapy or chemotherapy in first-line setting.
Authors: Simmons Daniel , DerSarkissian Maral , Shenolikar Rahul , Wang Min-Jung , Lax Angela , Muthukumar Aruna , Laliberté François , Duh Mei Sheng
Published: May 2020

e19345

Background: While epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the NCCN-recommended first-line (1L) therapy for non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutation (EGFRm), many pts initiate immunotherapy (IO) + chemotherapy (chemo) prior to receiving EGFRm test results. This study assessed clinical outcomes associated with initiating EGFR-TKI vs other therapies in stage IV EGFRm NSCLC. Methods: A retrospective study was conducted in adult pts with stage IV EGFRm NSCLC who initiated 1L EGFR-TKI, IO (+ chemo), or chemo alone from 5/2017-12/2018, using data from Flatiron Health. Treatment patterns were characterized with respect to timing of EGFRm test results. Kaplan-Meier analysis was used to assess the median duration of therapy (mDoT) and time to next therapy (mTTNT), as proxies for progression-free survival. Adjusted hazards ratios (HR) and 95% confidence intervals (CI) representing the effect of 1L therapy on the risk of discontinuing treatment or death (DoT) and risk of initiating second-line therapy or death (TTNT) were reported from multivariable Cox proportional hazards models controlling for differences in demographics, smoking history, histology, cancer stage, ECOG score, NCI index, and year of and time from diagnosis to 1L initiation, across treatment arms. Results: Among 593 study pts, mean age was 67.5 years and 65.4% were female. EGFR-TKI was used as 1L therapy for 77.2% of pts (n=458), IO in 13.3% (n=79) and chemo alone in 9.4% (n=56). 7.2% of EGFR-TKI pts, 54.4% of IO pts, and 57.1% of chemo pts initiated 1L before receiving EGFRm test results. Compared to pts on IO and chemo alone, pts on EGFR-TKI had longer mDoT (EGFR-TKI: 8.7 months [mo]; IO: 4.8 mo; chemo alone: 3.0 mo, p<0.01) and mTTNT (EGFR-TKI: 12.3 mo; IO: 6.5 mo; chemo alone: 4.0 mo, p<0.01). After adjustment, pts on EGFR-TKI vs pts on IO or chemo alone had significantly lower risk of discontinuing therapy or death (DoT) and initiating second-line therapy or death (TTNT) (see Table). Conclusions: A substantial number of stage IV EGFRm NSCLC pts initiated IO or chemo alone in 1L and EGFR-TKI was associated with better clinical outcomes than IO or chemo alone, highlighting the importance of adhering to NCCN-recommended therapy for these pts. [Table: see text]
Characterization of first-line use of cyclin dependent kinase 4/6 (CDK4/6) inhibitors in metastatic breast cancer among Florida health care systems.
Authors: Mahtani Reshma L. , Raez Luis E. , Unzaga Jessica , García Jorge J , Paranjpe Krupa , Arias Irene , Castrellon Aurelio Bartolome
Published: May 2020

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Background: First-line treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor for HR+/HER2- postmenopausal metastatic breast cancer (mBC) is considered standard of care based on the compelling data across all landmark trials. Commission on Cancer (CoC) as well as the Quality Oncology Practice Initiative (QOPI) describe standards for cancer care; some of which include utilizing data for continuous quality improvement as well as using nationally recognized guidelines to drive treatment selection. Reducing unwarranted variations in care through tracking and reporting adherence to nationally-recognized guidelines can be one way to focus on improving quality metrics. We evaluate first-line real-world treatment patterns of HR+/HER2- mBC patients in three health care systems in south Florida and compare with national standards. Methods: A retrospective analysis utilizing pharmacy and medical claims data (commercial and governmental payers) was performed. The data source was the IQVIA anonymized patient longitudinal open claims data for patients treated at the south Florida health systems. Patients age ≥18 years with HR+/HER2- mBC were included. First-line treatment was defined as the first claim for a medication after the mBC diagnosis. Results: Characterization of treatment patterns in three cancer centers in south Florida showed an increased utilization of CDK4/6 inhibitors as compared to the national average across all groups (see table). Conclusions: These data provide a baseline assessment of the utilization of CDK4/6 inhibitors in the first-line treatment of HR+/HER2- mBC. These data are reassuring with respect to the appropriate treatment in south Florida patients. However, we anticipate that treatment patterns may vary in other geographic areas given the national data trends. We would recommend this data be evaluated in other systems to identify potential areas of improvement. Limitations of this evaluation are consistent with any methodology using claims data which include possible coding errors and missing data which may or may not be systematic. [Table: see text]
Naloxegol for patients with cancer pain diagnosed with opioid induced constipation (OIC): NACASY observational study.
Authors: Davies Andrew , Tack Jan , Fernandez Ana , Chambers Jonathan , Sanz Juan Luis ,   on behalf of NACASY Study Group
Published: May 2020

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Background: Opioids have been the cornerstone of analgesic treatment for severe chronic pain. OIC is the most commonly reported adverse effect associated with opioids, and compromises patient satisfaction and adherence to analgesic treatment and also quality of life. Naloxegol is a PEGylated derivative of the µ-opioid receptor antagonist naloxone indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives. This real-world (RW) study (NCT03638440) aims to evaluate safety and efficacy of Naloxegol in patients with cancer pain diagnosed with OIC. Methods: This is a single-arm, multinational, prospective, RW observational study in adult subjects receiving treatment with opioids for at least 4 weeks, diagnosed with OIC that receive naloxegol in routine clinical practice. This study will recruit patients from 25 European hospitals. Data for efficacy are collected through the patient's diary during a 4-week period. Results: One hundred fifty-two patients, median age 66 years, 54% women, have been included in this analysis. Main cancer locations were lung (26%), breast (21%), prostate (10%), pancreas (9%) and head and neck (9%), and 67% had metastasis, mainly in bone (37%). Most frequent opioid treatments were fentanyl (29%), oxycodone (22%), and morphine (15%). Most frequent previous laxatives were osmotic (61%) and stimulant (27%) laxatives. Over 109 patients with at least one BFI score available after baseline, change in BFI score was ≥12 points in 61% of patients and 33% had BFI score <30 points after 4 weeks of treatment. There were statistically significant differences between baseline and final visit in BFI overall score as well as in the score of each of the three questions. Most common adverse reactions to naloxegol were abdominal pain (7.9%), diarrhea (2.6%), flatulence (1.3%) and nausea (1.3%), most of them grade 1-2. Eight patients had adverse reactions leading to study discontinuation: abdominal pain (5), diarrhea (2), intestinal perforation (1) and fatigue (1). Only one patient died due to an adverse reaction: intestinal perforation. Conclusions: Preliminary results show a promising efficacy of naloxegol in this RW treatment study. Toxicity profile was as expected. RW evidence seems to be a useful methodology to assess the real-life use of naloxegol and its efficacy in cancer patients.
Factors related to drug pipeline success for oncology companies using stock performance as a surrogate.
Authors: Ferris Matthew J. , Sun Kai , Savard Corey , Suresh Tejas , Mishra Mark Vikas
Published: May 2020

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Background: Developing oncology drugs demands substantial investment despite high uncertainty of success and ultimate market value. High drug costs have become subject to recent controversy. We sought to analyze factors influencing success in bringing new drugs to market using stock performance as a surrogate. Methods: Stock screeners and lists of initial public offerings (IPOs) captured small and mid-cap drug companies with share price ≥ $1.00 on major US indices. Share price was obtained from IPO to 03/09/2019. Company websites provided: headquarters (HQ) location, number/nature of drug programs (oncology vs. not, immunotherapy, gene editing, RNA-targeted, CAR-T). Funding to physicians and teaching hospitals (CMS funding) was acquired via CMS.gov Open Payments, and categorized into contributions < or ≥ $100,000. Stock performance was considered good (+ ≥25%), average (+/- 25%), or poor (- ≥25%). Univariate and multivariate associations were assessed for all companies; a subset analysis included only oncology-focused companies. Results: 420 companies were included. 101 companies (24%) had good, 76 average (18%), and 243 poor (58%) performance. Associated with performance in univariate analysis: IPO price ( P < 0.001), time from IPO ( P < 0.001), number of drug programs ( P = 0.019), and CMS funding ( P = 0.00013), with a strong trend for diverse pipelines that included both oncology and non-oncology programs ( P = 0.069). On multivariable analysis, IPO price was inversely associated ( P < 0.0001), while CMS funding ( P < 0.0001) and greater number of drug programs ( P = 0.0025) were positively associated with performance. Within the sub-analysis of oncology companies, 178 were included. 44 (24.7%) had good, 30 (16.9%) average, and 104 (58.4%) poor performance. The following were associated with performance on univariate analysis: IPO price ( P < 0.001), time from IPO ( P < 0.001), HQ location ( P = 0.009), diverse pipelines (P = 0.016), and CMS funding ( P < 0.001). On multivariable analysis, IPO price was inversely associated ( P < 0.0001), while California HQ location ( P < 0.01), diverse pipelines ( P = 0.028), and CMS funding ( P = 0.0002) were positively associated with performance. Conclusions: The majority of included companies had lackluster stock performance suggestive of low potential for drug success and high probability of financial disaster during development. Diverse pipelines and academic collaboration seem to be strongly related to success. This is the first study to demonstrate association between CMS funding and pharmaceutical stock performance.
Superior therapy response predictions for patients with acute myeloid leukemia (AML) using Cellworks Singula: MyCare-009-01.
Authors: Marcucci Guido , Watson Drew , Kapoor Shweta , Rajagopalan Swaminathan , Parashar Rajan , Alam Aktar , Sahu Diwyanshu , Lala Deepak Anil , Singh Divya , Basu Kabya , Grover Himanshu , G Poornachandra , Tyagi Anuj , Macpherson Michele , Narvekar Yugandhara , Agrawal Ashish , Mitra Upasana , Sauban Mohammed , Mandal Rema , Stein Anthony Selwyn
Published: May 2020

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Background: Despite using cytogenetic and molecular-risk stratification and precision medicine, the current overall outcome of AML patients remains relatively poor. Therapy selection is often based on information considering only cytogenetics and single molecular aberrations and ignoring other patient-specific omics data that could potentially enable more effective treatments. The Cellworks Singula™ report predicts response for physician prescribed therapies (PPT) using the novel Cellworks Omics Biology Model (CBM) to simulate downstream molecular effects of cell signaling, drugs, and radiation on patient-specific in silico diseased cells. We test the hypothesis that Singula is a more accurate predictor of patient-specific therapy response than PPT. Methods: Singula’s ability to predict response was evaluated in an independent, randomly selected, retrospective cohort of 494 AML patients aged 2 to 85 years (median 54) treated with PPT. Patient omics data was available from PubMed. The accuracy of Singula was compared to that of PPT using McNemar’s test to account for the correlation between Singula and PPT. Multivariate logistic regression modeled complete response (CR) as a function of patient age, PPT, and Singula against any non-response (NR). Likelihood ratio tests were performed to further validate if Singula provides predictive information beyond PPT or patient age. Similar analyses were performed for overall survival (OS) using proportional hazards regression. Results: Singula was a better predictor for CR than PPT (McNemar’s χ2 = 72.0, p-value < 0.0001), with an overall accuracy of 88.5% (95% CI: 85.3%, 91.1%) compared to 70.2% (95% CI: 66.0%, 74.2%) for PPT. Singula exhibited a sensitivity and specificity of 97.1% and 68.0%, respectively. In multivariate regression analysis, Singula (p < 0.0001) remained an independent predictor for CR after adjusting for patient age (p = 0.0329) while PPT became not significant (p = 0.75). Singula was also an independent predictor for OS (p < 0.0001) after adjusting for patient age (p = 0.0018) and PPT (p = 0.0011). For all 100 true negatives, Singula generated alternative standard of care therapy selections with predicted clinical response. Conclusions: Singula is a superior independent predictor for CR and OS compared to PPT in AML patients. The Singula report can also validate therapy selection, correctly identify non-responders to PPT and further provide alternative therapy selections.