Treatment patterns and outcomes associated with sequential and non-sequential use of CDK4 & 6 inhibitors in patients with HR+, HER2- MBC in the real world.

PURPOSE: Cyclin Dependent Kinase 4 & 6 inhibitors (CDK4 & 6i) have transformed the management of HR+, HER2- metastatic breast cancer (MBC); however, the optimal sequence of these treatments and other systemic therapies for MBC remains unclear. METHODS: This study analyzed electronic medical records from the ConcertAI Oncology Dataset. US patients who received abemaciclib and at least one other systemic line of therapy (LOT) for HR+, HER2- MBC were eligible. Treatment sequences were grouped, and data for two pairs of groups are presented herein (N = 397): Group 1 (1L CDK4 & 6i to 2L CDK4 & 6i) vs. Group 2 (1L CDK4 & 6i to 2L non-CDK4 & 6i), and Group 3 (2L CDK4 & 6i to 3L CDK4 & 6i) vs. Group 4 (2L CDK4 & 6i to 3L non-CDK4 & 6i). Time-to-event outcomes (PFS and PFS-2) were analyzed using Kaplan-Meier method and Cox proportional hazard regression. RESULTS: In the total cohort of 690 patients, the most prevalent sequence was 1L CDK4 & 6i to 2L CDK4 & 6i (n = 165). For the 397 patients across Groups 1-4, sequential CDK4 & 6i demonstrated numerically longer PFS and PFS-2 versus non-sequential CDK4 & 6i. Adjusted results demonstrate that patients in Group 1 demonstrated significantly longer PFS (p = 0.05) versus Group 2. CONCLUSIONS: Although retrospective and hypothesis-generating, these data demonstrate numerically longer outcomes in the subsequent LOT associated with sequential CDK4 & 6i treatment.

Unfavorable early-stage Hodgkin lymphoma: assessment of patient characteristics in a real-world setting.

Aim: Unfavorable prognostic factors among classical Hodgkin lymphoma (cHL) patients in the real-world setting have yet to be fully characterized. Methods: In this retrospective study using the ConcertAI Oncology Dataset, patient characteristics, unfavorable prognostic factors and treatment patterns were evaluated among patients diagnosed with cHL. Results: Among 324 adult cHL patients diagnosed 2016-2021, 16.1% were classified as early favorable, 32.7% early unfavorable and 51.2% advanced disease. Early unfavorable patients were younger and had a larger nodal mass. The prognostic factor B symptoms was most frequently documented in early unfavorable patients (59.4%), followed by bulky disease (46.2%), >3 involved lymph node regions (31.1%), and erythrocyte sedimentation rate ≥50 (25.5%). Conclusion: In this analysis of real-world data, we found that nearly a third of newly diagnosed cHL patients had early unfavorable disease. Our analysis also showed differences in the proportion of patients for each unfavorable factor among patients with early-stage unfavorable cHL.

What is this article about? Lymphoma is a type of blood cancer that develops when white blood cells grow out of control. This study looked at a certain type of lymphoma called classical Hodgkin lymphoma (cHL). Patients with cHL are put into groups based on risk factors. Risk factors mean the cancer had certain characteristics that make it more likely to spread to other body parts and more difficult to treat. These can be symptoms like drenching night sweats, unexplained fever, sudden weight loss, or large swellings of the infection fighting glands of the body.What did we do? We studied the risk factors of patients with cHL, using data from electronic medical records. What were the results? About a third of the patients in this study had early stage cHL with unfavorable risk factors, and over half of the patients had advanced stage cHL. The patients who had early stage cHL with unfavorable risk factors were younger and had a larger lump in a lymph node. More than half of the patients experienced drenching night sweats, unexplained fever, or weight loss of more than 10%. What do the results mean? We found that nearly a third of new cHL patients had early-stage cHL with unfavorable risk factors. We also showed differences in the number of patients with each unfavorable risk factor among patients with early-stage unfavorable cHL. This study can help doctors and researchers group patients and determine the best treatment or research study for patients who have cHL.

Comparison of advanced ovarian cancer patients treated with or without bevacizumab in the US Community Oncology Clinics.

Aim: Real-world data on treatment patterns and outcomes of advanced ovarian cancer (OC) patients since bevacizumab approval in first-line (1L) OC treatment were assessed. Materials & methods: In this descriptive retrospective study using the ConcertAI Oncology Dataset, patient characteristics, treatment patterns and real-world progression-free survival (rwPFS) from start of 1L were evaluated among patients diagnosed with advanced OC between 2011-2020. Treatment data from structured sources were confirmed and/or supplemented by human review of unstructured data. Results: Median rwPFS for bevacizumab and non bevacizumab cohorts was 17.3 months (95% CI: 14.9, 20.4) and 15.7 months (95% CI: 12.3, 29.1), respectively. Patients with ≥10 doses during 1L had higher median rwPFS compared with patients receiving 3-9 doses. Conclusion: This real-world study suggests benefits of bevacizumab treatment in advanced OC were primarily experienced by patients who received ≥10 doses in 1L.

What is this article about? Bevacizumab (Avastin) is a medicine that treats cancer. It makes it harder for the cancer to get nutrients from blood. At first, you could only use it after other cancer medicine did not work. From 2018, bevacizumab could be used with cancer medicine as the first treatment. Experts said it should continue for a year after cancer medicine stopped. This would make it harder for the cancer to come back. What did we do? We checked if more patients got bevacizumab as their first medicine after 2018 approval. We also saw how long it took for the cancer to come back. We did this by looking at electronic medical records between January 2011 and August 2020. We looked for women who had cancer that was staring to spread or had spread. We compared women who got bevacizumab to women who only got other cancer medicines. What were the results? After 2018, more women got bevacizumab early. We saw that the cancer did not take longer to come back. We noticed that half the women took bevacizumab less than ten-times out of up to 22-times. The cancer took longer to come back for women who took bevacizumab ten or more times. What do the result mean? We do not know why so many women stopped treatment early. Other studies in different countries also showed better results for women who got more bevacizumab. This study can help doctors and patients decide how much bevacizumab to give when they might be thinking of stopping treatment.

Treatment patterns and clinical outcomes among patients with relapsed/refractory classical Hodgkin's lymphoma.

Aim: Limited real-world data exist on treatment patterns and clinical outcomes for patients with relapsed/refractory (R/R) classical Hodgkin's lymphoma (cHL). Methods: This study used the ConcertAI Oncology Dataset to assess treatment patterns, real-world progression-free survival (rwPFS), and real-world overall survival (rwOS) in adults with R/R cHL diagnosed from 2000 to 2019. Results: Among 226 (79%) treated patients, there was substantial treatment heterogeneity. Median rwPFS was 21.0 months in the second line (2L) of therapy. Median rwOS was 146.7 months in 2L and decreased to 40.6 months in the fifth line. Conclusion: Patients were exposed to a myriad of treatments in the R/R setting. These data support a relation between rwPFS and rwOS and highlight the need for effective therapeutic options.

Treatment patterns and overall survival in HER2+ metastatic breast cancer at US community oncology practices.

Aim: To describe real-world treatment patterns/outcomes among patients with HER2+ metastatic breast cancer (MBC). Materials & methods: Real-world treatments and overall survival (OS) were evaluated among adult women diagnosed with HER2+ MBC, with and without brain metastases (BMs), between 1 June 2012 and  31 May 2018 using electronic medical records from the Definitive Oncology Dataset. Results: Among 372 patients, 69% initiated first-line trastuzumab plus pertuzumab-based therapy; many therapy combinations were utilized in the second- to fourth-line. During follow-up (median 24.8 months), 18% of patients died (22% with and 16% without BMs). Mean OS was shortest among patients with BMs at MBC diagnosis in the third- and fourth-line. Conclusion: OS was poor, and no clear standard of care was observed among patients with HER2+ MBC progressing on trastuzumab-based therapies.

Real-world patterns on tumor mutation burden testing in a pan-tumor population.

Background: There is limited real-world information on use of tumor mutational burden (TMB) testing and characteristics of patients receiving it. Materials & methods: Patients ≥18 years old and diagnosed with advanced solid tumors between 1 January 2015 and 31 January 2019 with TMB testing (TMB cohort) and without it (non-TMB) were included in this retrospective, observational study. Results: The TMB cohort (n = 202) was younger than non-TMB (n = 212) (mean age: 62.1 vs 65.6 at diagnosis; p = 0.005). There were more Black patients in the TMB cohort (21.3 vs 11.8% in non-TMB; p = 0.004). Clinical characteristics were comparable between the two cohorts; however, systemic anticancer treatment was higher among TMB cohort (91.6 vs 77.8% in non-TMB). Conclusion: Notable differences were observed between patients receiving TMB test and those not receiving it.

Clinical effectiveness outcomes and healthcare resource utilization of patients diagnosed with small-cell lung cancer.

Background: Real-world data are lacking on patients with small-cell lung cancer (SCLC) with extensive-stage SCLC (eSCLC) and poor performance status (PS). Patients & methods: Eligible patients diagnosed with eSCLC between 1 January 2008 and 31 December 2017 were included in this retrospective, observational study. Results: The study included 406 patients, with 14.3% impaired PS. Progression-free survival and overall survival were not significantly different between impaired (Eastern Cooperative Oncology Group ≥2) and not impaired patients (median, 4.5 vs 5.3 months, and 7.2 vs 8.4 months, respectively). Impaired patients used more supportive care drugs (mean, 3.0 vs 2.0; p = 0.033). Conclusion: Effectiveness outcomes among patients with and without impaired PS did not differ in the real-world setting. Progression-free survival and overall survival were similar to data from clinical trials.

Healthcare resource utilization and cost among patients treated for early-stage triple-negative breast cancer.

Background: This retrospective, observational study examined real-world healthcare resource utilization (HCRU) and costs in 308 patients diagnosed with early-stage (II-IIIB) triple-negative breast cancer between 1 March 2008 and 31 March 2016. Methods: HCRU and costs were evaluated for two time periods: from neoadjuvant treatment start date to surgery (Time 1) and after surgery to recurrence or death (Time 2). Results: The sample included 236 patients who received neoadjuvant treatment without subsequent adjuvant treatment (Neo) and 72 patients who received neoadjuvant treatment followed by adjuvant treatment (Neo + adj). Mean monthly HCRU events and mean monthly costs per patient were higher in Time 1 compared with Time 2 for both groups. Conclusion: These results demonstrate the economic burden of early-stage triple-negative breast cancer especially during neoadjuvant treatment phase.

Lay abstract This study included 308 patients with early-stage triple-negative breast cancer treated in the USA at community oncology practices. Patients were female, 18 years or older and diagnosed with stage II, IIIA or IIIB breast cancer between March 2008 and March 2016, and the breast cancer was determined to be triple negative (i.e., negative for estrogen receptors, progesterone receptors and excess HER2 protein). There were 236 patients who received neoadjuvant treatment without subsequent adjuvant treatment (the Neo group) and 72 patients who received neoadjuvant treatment followed by adjuvant treatment (the Neo + adj group). The study looked at healthcare resource use and costs of care during two time periods: from neoadjuvant treatment start date to surgery (Time 1) and after surgery to recurrence or death (Time 2). Average monthly healthcare resource use and average monthly costs of care per patient were higher in Time 1 compared with Time 2 for both groups. These results demonstrate the economic and resource burden of early-stage triple-negative breast cancer especially in the time from neoadjuvant treatment initiation until surgery.

Real-world treatment patterns and effectiveness outcomes in patients with early-stage triple-negative breast cancer.

Background: This retrospective, observational study examined real-world treatment patterns and effectiveness outcomes in 450 patients with stage II-IIIB early-stage triple-negative breast cancer treated in the community oncology setting. Methods: Kaplan-Meier methods were used to evaluate event-free survival (EFS), time to recurrence and overall survival (OS). Cox regression models were used to evaluate predictors of EFS and OS by pathological complete response (pCR) status. Results: Among patients receiving neoadjuvant systemic therapy only, pCR was a predictor of EFS and OS. Conclusion: These results highlight the unmet need for therapies that improve outcomes for patients with early-stage triple-negative breast cancer including increasing rates of pCR among patients receiving neoadjuvant therapy.

Lay abstract This study included 450 patients with early-stage triple-negative breast cancer treated in the USA at community oncology practices. Patients were female, 18 years or older, diagnosed with stage II, IIIA or IIIB breast cancer between March 2008 and March 2016, and the breast cancer was determined to be triple negative (i.e., negative for estrogen receptors, progesterone receptors and excess HER2 protein). The study looked at the treatments received, whether those treatments worked and the response to treatment at the time of surgery. The study findings align with findings from other studies that complete response in tissue samples is associated with improved clinical outcomes. Triple-negative breast cancer remains challenging to treat, and there is a clear need for innovation in treatment options. Intervening in the early stages of triple-negative breast cancer is critical to improving outcomes.

Heart failure hospitalization risk associated with use of two classes of oral antidiabetic medications: an observational, real-world analysis.

BACKGROUND: Newer oral antidiabetic drug classes are expanding treatment options for type 2 diabetes mellitus (T2DM); however, concerns remain. The objective was to assess relative risk of heart failure hospitalization of sodium-glucose co-transporter-2 (SGLT2) and dipeptidyl peptidase-4 (DPP4) inhibitors in T2DM patients. METHODS: This retrospective observational study used a national commercially insured claims database. Adults (>18 years) with T2DM newly starting SGLT2 or DPP4 medication between April 2013 and December 2014 were included. Depending on their index fill, patients were grouped into either SGLT2 or DPP4 medication class cohorts. The primary outcome was hospitalization for heart failure and the risk was assessed using Cox regression models. Propensity score matching (1:2 ratio) was used to adjust for potential confounders. Analyses were also stratified by the presence of baseline diabetes complication and age (<65 vs 65+). RESULTS: The matched cohort included 4899 SGLT2 and 9798 DPP4 users. The risk of heart failure hospitalization was lower among SGLT2 users in comparison with matched DPP4 users (2.0% SGLT2 vs 3.1% DPP4; adjusted hazard ratio [aHR] 0.68; 95% confidence interval [CI] 0.54-0.86; p = .001). However, the stratified analyses revealed no risk difference among the majority of the analyzed patients, i.e., those aged <65, which comprised 85% of the matched cohort (aHR = 0.78; 95% CI 0.57-1.05; p = .09), and those without prior complication, which comprised 69% of matched cohort (aHR = 0.83; 95% CI 0.54-1.27; p = 0.40). CONCLUSIONS: In this real-life analysis, the rate of hospitalizations for heart failure was significantly lower for patients initiating an SGLT2 compared with a DPP4 medication, specifically among older patients and those with diabetes complication.

Longitudinal Analysis of Opioid Analgesic Dose and Diabetes Quality of Care Measures.

OBJECTIVE: To examine associations of opioid analgesic dose with quality of care for diabetes mellitus. DESIGN: Longitudinal statewide cohort. SUBJECTS: Subjects with diabetes filled one or more prescriptions for Schedule II/III opioids for noncancer pain in Blue Cross Blue Shield of Texas from 2008 through 2012. METHODS: Opioid dose and outcomes were assessed in 6-month intervals after first filled prescription. Two morphine equivalent dose measures were daily dose and quartiles of total dose from all filled prescriptions. In fixed effects models adjusted for clinical and treatment variables, associations of opioid measures were examined for five outcomes: hemoglobin A1c (HbA1c) test, low density lipoprotein cholesterol (LDL) test, any hospitalization, any diabetes-related preventable hospitalization, and any emergency department (ED) visit. RESULTS: All daily and total opioid doses were associated (P < 0.05) with poorer outcomes for all five measures. For HbA1c testing, adjusted odds ratios (AORs) were reduced by 19% for high daily dose (≥100 mg) and highest quartile total dose (>900 mg), respectively, vs no opioids but >900 mg total dose had the lowest AOR for LDL testing (0.74 [CI 0.68, 0.80]). The AORs of any hospitalization or diabetes-related hospitalization were, respectively, 8.19 (CI 7.21, 9.30) and 2.76 (CI 2.19, 3.48) for >900 mg total dose but only 6.22 (CI 4.94, 7.83) and 2.16 (CI 1.34, 3.48) for >100 mg daily dose. Both opioid measures had nonmonotonic associations with ED use. CONCLUSIONS: Daily opioid dose but especially total dose of opioids was strongly associated with poorer diabetes quality of care in a statewide cohort.

Real-world study on the characteristics, post-nephrectomy journey, and outcomes of patients with early-stage renal cell carcinoma based on risk groups.

OBJECTIVES: To examine real-world characteristics, journey, and outcomes among patients with locoregional, nonmetastatic renal cell carcinoma (RCC). METHODS: A retrospective analysis of medical records from the ConcertAI Oncology Dataset was performed on adults in the United States with newly diagnosed nonmetastatic RCC between January 2012-December 2017 who received surgical treatment, and were followed until August 2021. Patients were stratified based on the risk of recurrence after nephrectomy. Recurrence rate and survival outcomes were assessed. RESULTS: The cohort (n = 439) had a median age of 64 years, 66.1% were male, and 76.5% had clear-cell histology. The median follow-up time from nephrectomy was 39.3 months overall, 41.0 months for intermediate-high-risk patients (n = 377; 85.9%) and 24.1 months for high-risk patients (n = 62; 14.1%). For intermediate-high- and high-risk patients, respectively, 68.4% and 56.5% had ≥1 medical oncologist visit after nephrectomy. Of 260 patients with documentation of postoperative imaging assessments, 72% were ordered by medical oncologists, and the median time from initial nephrectomy to the first scan was 110 days (intermediate-high-risk) and 51 days (high-risk). Provider-documented recurrence occurred in 223 (50.8%) patients, of whom 41.7% had ≥1 medical oncologist visit before the recurrence. Three-year disease-free survival (DFS), and overall survival rates were 49.4% and 80.8% (all patients): 27.7% and 64.7% (high-risk); and 52.9% and 83.3% (intermediate-high-risk). CONCLUSIONS: Our study reports low DFS after nephrectomy for patients with intermediate-high- and high-risk RCC. Subsequent approval and use of new and newly approved adjuvant therapeutic options could potentially delay or prevent recurrence.

Comparison of Time to Next Treatment or Death Between Front-Line Daratumumab, Lenalidomide, and Dexamethasone (DRd) Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Among Transplant-Ineligible Patients With Multiple Myeloma.

INTRODUCTION: Daratumumab, lenalidomide, and dexamethasone (DRd) and bortezomib, lenalidomide, and dexamethasone (VRd) are the only preferred treatment regimens for patients with transplant-ineligible (TIE) newly diagnosed multiple myeloma (NDMM). As there are no randomized head-to-head studies of DRd versus VRd, this analysis aimed to compare real-world time-to-next-treatment (TTNT) or death in this population. METHODS: Patients with NDMM who received front-line (FL) DRd or VRd were identified from the Acentrus database (January 1, 2018 to May 31, 2023). Those with a record of a stem cell transplant or aged < 65 years were excluded to limit analysis to the TIE population. Inverse probability of treatment weighting was used to balance baseline patient characteristics. A doubly robust Cox proportional hazards model was used to compare TTNT or death between cohorts. RESULTS: A total of 149 and 494 patients who initiated DRd and VRd, respectively, were identified. After weighting (weighted NDRd = 302, weighted NVRd = 341), cohorts had similar baseline characteristics. Of these, 98 (32.4%) DRd and 175 (51.2%) VRd patients either received a subsequent line of therapy or died, with a median TTNT or death of 37.8 months in the DRd cohort and 18.7 months in the VRd cohort (hazard ratio: 0.58, 95% confidence interval: 0.35, 0.81; p < 0.001). CONCLUSION: Treatment of TIE NDMM patients with DRd led to a significantly longer TTNT or death compared to VRd, evidenced by a 42% risk reduction, supporting the effectiveness of DRd over VRd as FL treatment in this patient population.

Development of aliphatic biodegradable photoluminescent polymers.

None of the current biodegradable polymers can function as both implant materials and fluorescent imaging probes. The objective of this study was to develop aliphatic biodegradable photoluminescent polymers (BPLPs) and their associated cross-linked variants (CBPLPs) for biomedical applications. BPLPs are degradable oligomers synthesized from biocompatible monomers including citric acid, aliphatic diols, and various amino acids via a convenient and cost-effective polycondensation reaction. BPLPs can be further cross-linked into elastomeric cross-linked polymers, CBPLPs. We have shown representatively that BPLP-cysteine (BPLP-Cys) and BPLP-serine (BPLP-Ser) offer advantages over the traditional fluorescent organic dyes and quantum dots because of their preliminarily demonstrated cytocompatibility in vitro, minimal chronic inflammatory responses in vivo, controlled degradability and high quantum yields (up to 62.33%), tunable fluorescence emission (up to 725 nm), and photostability. The tensile strength of CBPLP-Cys film ranged from 3.25 +/- 0.13 MPa to 6.5 +/- 0.8 MPa and the initial Modulus was in a range of 3.34 +/- 0.15 MPa to 7.02 +/- 1.40 MPa. Elastic CBPLP-Cys could be elongated up to 240 +/- 36%. The compressive modulus of BPLP-Cys (0.6) (1:1:0.6 OD:CA:Cys) porous scaffold was 39.60 +/- 5.90 KPa confirming the soft nature of the scaffolds. BPLPs also possess great processability for micro/nano-fabrication. We demonstrate the feasibility of using BPLP-Ser nanoparticles ("biodegradable quantum dots") for in vitro cellular labeling and noninvasive in vivo imaging of tissue engineering scaffolds. The development of BPLPs and CBPLPs represents a new direction in developing fluorescent biomaterials and could impact tissue engineering, drug delivery, bioimaging.

Diagnostic value of pleural cholesterol in differentiating exudative and transudative pleural effusion.

Background: Pleural effusions are most commonly classified as transudative or exudative based on Light's criteria which has shown misclassification in 10%-20% of cases. Studies have demonstrated lesser misclassification with pleural fluid cholesterol criteria. Thus, this study aimed to find the diagnostic properties of pleural fluid cholesterol in differentiating the type of effusion. Materials and methods: This cross-sectional study involving 72 patients was undertaken in a tertiary center in Nepal for a duration of 2 years. On the basis of Light's, Heffner's, etiological, and pleural fluid cholesterol criteria, pleural effusion was classified as exudative or transudative. The findings were then evaluated to determine the diagnostic value of each approach in identifying the effusion type and comparing them on the basis of sensitivity, specificity, positive predictive value and negative predictive value. Result: Pleural fluid cholesterol detected effusion as exudative with sensitivity of 91.94% and specificity of 80.00% against Light's criteria; with a sensitivity of 98.28% and specificity of 85.71% against the etiological diagnosis. Additionally, against the etiological diagnosis, sensitivity of both Light's and Heffner's criteria was 100%; however, specificity was 71.43% and 64.29% respectively, which is far less than that of pleural fluid cholesterol (85.71%). Furthermore, pleural fluid cholesterol was also found to have better results than protein ratio, LDH ratio and pleural fluid protein ratio in determining the type of effusion. Conclusion: When considering the avoidance of confusing outcomes in equivocal instances and cost effectiveness in developing nations, pleural fluid cholesterol can be one of the most useful alternative diagnostic methods for differentiating between exudative or transudative effusions.

Clinical and utilization outcomes associated with tumor mutational burden in a real-world pan-tumor population.

Aim & methods: This real-world study examined the association of tumor mutational burden (TMB) with clinical and healthcare utilization in adults diagnosed with advanced solid tumor 1 January 2015- 31 January 2019. Results: There were 170 patients in low-TMB group (TMB<10 mut/Mb) and 32 in high-TMB group (TMB ≥10 mut/Mb). Median overall survival was 18.8 (95% CI: 17.3-28.8) and 15.9 months (95% CI: 11.3-18.0) whereas median progression-free survival was 9.9 (95% CI: 8.6-11.4) and 7.8 months (95% CI: 3.8-12.5) for the low- and high-TMB groups, respectively. Hospitalization (49.4 vs 37.5%), emergency visit (25.3 vs 21.9%), and median overall cost of care (US$135,403 vs 87,570) were all lower in low-TMB group. Conclusion: Despite the limited sample, these data provide a historical perspective for examining real-world outcomes associated with TMB.

Lay abstract Tumor mutational burden (TMB) is the total number of mutations found in the DNA of cancer cells. Knowing the TMB may help plan the best treatment. The goal of this study was to examine whether higher TMB is directly associated with clinical outcomes or healthcare use and costs in patients who have not received immuno-oncology treatment. This study included 202 adult patients who were diagnosed with advanced solid tumors between January 2015 and January 2019. Patients were divided into two groups based on their TMB level. The study results indicate some relationship between TMB level and real-world outcomes. Future studies with a larger sample size are needed to confirm these results.

Mean Platelet Volume and Platelet Count in Patients with Type 2 Diabetes Mellitus and Impaired Fasting Glucose.

BACKGROUND: Diabetes mellitus is a chronic metabolic disorder characterized by hyperglycemia and associated with long term macrovascular and microvascular complications. Platelet parameters such as mean platelet volume and platelet count are indicators of thrombotic potential. These parameters have been reported to be increased in diabetic patients, leading to increased risk of vascular complications. The objective of this study was to determine mean platelet volume and platelet count in patients with Type 2 Diabetes mellitus, impaired fasting glucose and non -diabetic controls, and compare mean platelet volume and platelet count between the three groups. METHODS: A hospital based cross-sectional observational study was conducted at KIST Medical College Teaching Hospital from February to May 2018. A total of 300 participants were included in the study which were grouped into Group 1,2 and 3 based on fasting blood glucose level as non -diabetic controls, impaired fasting glucose and Type 2 Diabetes mellitus respectively with 100 subjects each. Platelet count and mean platelet volume were compared between the three groups. Analysis of variance with post hoc Tukey test and Pearson correlation coefficient were used for statistical evaluation. Data were expressed as mean ± standard deviation. A p value <0.05 was considered as statistically significant. RESULTS: Mean platelet volume was significantly higher in diabetic and impaired fasting glucose group (7.40 ± 0.77 fl and 6.62 ± 0.58 fl), respectively as compared to non diabetic group (6.06 ± 0.41 fl) (p<0.001). There was no significant difference in the platelet count between the three groups (p=0.869). Significant correlation was seen between rising fasting blood sugar and mean platelet volume (r =0.559; p<0.001), while no correlation existed between platelet count and fasting blood sugar level (r =0.037; p =0.526). CONCLUSIONS: Mean platelet volume is increased in patients with type 2 diabetes mellitus and impaired fasting glucose. This is a simple and cost effective test to predict vascular complications in type 2 diabetes mellitus.

Using claims data to attribute patients with breast, lung, or colorectal cancer to prescribing oncologists.

BACKGROUND: Alternative payment models frequently require attribution of patients to individual physicians to assign cost and quality outcomes. Our objective was to examine the performance of three methods for attributing a patient with cancer to the likeliest physician prescriber of anticancer drugs for that patient using administrative claims data. METHODS: We used the HealthCore Integrated Research Environment to identify patients who had claims for anticancer medication along with diagnosis codes for breast, lung, or colorectal lung cancer between July 2013 and September 2017. The index date was the first date with a record for anticancer medication and cancer diagnosis code. Included patients had continuous medical coverage from 6 months before index to at least 7 days after index. Patients who received anticancer drugs during the 6 months prior to index were excluded. The three methods attributed each patient to the physician with whom the patient had the most evaluation and management (E&M) visits within a 90-day window around the index date (Method 1); the most E&M visits with no time window (Method 2); or the E&M visit nearest in time to the index date (Method 3). We assessed the performance of the methods using the percentage of the study cohort successfully attributed to a physician, and the positive predictive value (PPV) relative to available physician-reported data on patient(s) they treat. RESULTS: In total, 70,641 patients were available for attribution to physicians. Percentages of the study cohort attributed to a physician were: Method 1, 92.6%; Method 2, 96.9%; and Method 3, 96.9%. PPVs for each method were 84.4%, 80.6%, and 75.8%, respectively. CONCLUSION: We found that a claims-based algorithm - specifically, a plurality method with a 90-day time window - correctly attributed nearly 85% of patients to a prescribing physician. Claims data can reliably identify prescribing physicians in oncology.

Comparison of Specialty Medication Use for Common Chronic Inflammatory Diseases Among Health Exchange and Other Commercially Insured Members.

BACKGROUND: The Affordable Care Act of 2010 allows the purchase of health insurance through special marketplaces called "health exchanges." The majority of individuals enrolling in the exchanges were previously uninsured, older, and sicker than other commercially insured members. Early evidence also suggests that exchange plan members use more costly specialty drugs compared with other commercially insured members. OBJECTIVES: To (a) examine patient characteristics and specialty drug use for common chronic inflammatory diseases (CIDs) among exchange plan members compared with other commercially insured members and (b) explore variations in specialty drug use within exchange plans by metal tiers (bronze, silver, gold, and platinum), as well as across local markets. METHODS: This analysis included adults aged ≥ 18 years who were enrolled in exchange plans (exchange population) and other commercial health plans (nonexchange population). The primary outcome was the likelihood of using specialty drugs prescribed to treat common CIDs, such as rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and psoriasis. The adjusted likelihood of using CID specialty drugs was calculated from logistic regression controlling for prevalence of CIDs and other health risk factors. RESULTS: A total of 931,384 exchange plan members and 2,682,855 nonexchange plan members were included in the analysis. Compared with the nonexchange population, the exchange population was older, more likely to be female, had more comorbid conditions, but filled fewer prescriptions. The 2 groups were similar in terms of CID prevalence. The observed likelihood of CID specialty drug use was 20.0% lower in the exchange versus the nonexchange populations (341 users per 100,000 exchange members vs. 427 users per 100,000 nonexchange members; P < 0.001). Within the exchange population, the observed likelihood of CID specialty drug use was 132 per 100,000 bronze plan members (69.1% lower than nonexchange); 326 per 100,000 silver plan members (23.5% lower than nonexchange); 579 per 100,000 gold plan members (35.6% higher than nonexchange); and 672 per 100,000 platinum plan members (57.5% higher than nonexchange). All differences were statistically significant at P < 0.001. There were also large differences by local market, ranging from 49.1% lower to 75.8% higher CID use in the exchange population than in the nonexchange population. After adjustment, the exchange population was 16.6% less likely to use CID specialty drugs than the nonexchange population (P < 0.001). Large variation in specialty drug use within the exchange plan metal tiers was reduced. After adjustment, the higher use of CID specialty drugs among the exchange population in certain local plans was no longer statistically significant. CONCLUSIONS: Members insured through exchange plans were older and sicker than those with nonexchange plans, but they did not use more CID specialty drugs compared with the nonexchange population. Large variations were seen among the exchange plan metal tiers and by local markets, which were often related to the risk profiles of exchange plan enrollees. DISCLOSURES: Funding for this study was provided by Anthem. Anthem had no role in study design, data interpretation, manuscript development, or the decision to publish. Chen, Gautam, DeVries, and Sylwestrzak are employees of HealthCore, a wholly owned subsidiary of Anthem. Richards is an employee of Anthem. Ruggieri is a former employee of Anthem and a current employee of MedImpact Healthcare Systems. Study concept and design were contributed by Ruggieri, Richards, DeVries, and Sylwestrzak. Chen took the lead in data collection, along with Gautam. Data interpretation was performed by Chen, along with the other authors. The manuscript was written by Chen, Gautam, Sylwestrzak, and DeVries and revised by Chen, Gautam, and Sylwestrzak, along with the other authors.

Results From a Health Insurer's Clinical Pathway Program in Breast Cancer.

PURPOSE:: Pathway regimens are value-driven, evidence-based therapies that aim at high-quality, affordable cancer care. There are few real-world data to support the value of such regimens, especially for patients with breast cancer. MATERIALS AND METHODS:: Using nationally representative claims data from Anthem, together with clinical data from its Cancer Care Quality Program, we identified patients with breast cancer for whom chemotherapy was initiated between January 2015 and October 2016. On the basis of demographic and clinical characteristics, patients receiving a pathway regimen (on-pathway cohort) were matched to those who did not (off-pathway cohort) using 1:1 propensity score matching. We compared post-6-month quality-of-care outcomes including hospitalization, emergency department visits, need for supportive drugs such as granulocyte colony-stimulating factor, and cost outcomes between the cohorts. RESULTS:: There were 959 patients in each cohort after matching. Patients in both cohorts had a similar age distribution (median age, 52 years in the off-pathway cohort v 53 years in the on-pathway cohort), and most presented with stage II disease (49.4% in the off-pathway cohort v 49.8% in the on-pathway cohort); nearly two thirds of each cohort had hormone receptor positive cancer (67.3% in the off-pathway cohort v 64.9% in the on-pathway cohort). The two cohorts had similar rates of hospitalization and emergency department visits; however, the rate of granulocyte colony-stimulating factor use was significantly lower in the on-pathway cohort (72.5% in the on-pathway cohort v 82.8% in the off-pathway cohort; odds ratio, 0.55; P ≤ .0001). The average post-6-month cost of care was $16,176 lower (95% CI, -$24,291 to -$8,061; P ≤ .0001) in the on-pathway cohort. CONCLUSION:: Pathway regimens for breast cancer demonstrate an example of high-value care. They are associated with a reduced cost of care without compromising quality of care.