Treatment Patterns and Clinical Outcomes Among Patients With Metastatic Prostate Cancer Harboring Homologous Recombination Repair Mutations.

BACKGROUND: There is currently limited literature assessing the real-world treatment patterns and clinical outcomes of patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) mutations. METHODS: Medical charts were abstracted for mCRPC patients with ≥ 1 of 12 HRR somatic gene alterations treated at US oncology centers participating in the American Association for Cancer Research Project Genomics Evidence Neoplasia Information Exchange. Treatment patterns and clinical outcomes were assessed from the initiation of first-line or later (1L+) mCRPC therapy received on or after July 1, 2014. RESULTS: Among 138 patients included in the study, the most common somatic HRR mutations were CDK12 (47.8%), BRCA2 (22.5%), and ATM (21.0%). Novel hormonal therapy and taxane chemotherapy were most commonly used in 1L; taxane use increased in later lines. Median overall survival (95% confidence interval [CI]) was 36.3 (30.7-47.8) months from initiation of 1L therapy and decreased for subsequent lines. Similarly, there was a trend of decreasing progression-free survival and prostate-specific antigen response from 1L to 4L+ therapy. CONCLUSIONS: Treatment patterns identified in this study were similar to those among patients with mCRPC regardless of tumor HRR mutation status in the literature.

Real-world overall survival with abiraterone acetate versus enzalutamide in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer.

BACKGROUND: There are no large head-to-head phase 3 clinical trials comparing overall survival (OS) for abiraterone and enzalutamide. This study used Medicare claims data to compare OS in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) who initiated abiraterone or enzalutamide. METHODS: This retrospective analysis of the Medicare database (2009-2020) included adult men with ≥1 claim for prostate cancer, metastatic diagnosis, and no prior chemotherapy or novel hormone therapy who initiated first-line (1L) abiraterone or enzalutamide in the index period (September 10, 2014 to May 31, 2017). Cox proportional-hazards models with inverse probability treatment-weighting (IPTW) were used to compare OS between abiraterone- and enzalutamide-treated patients, adjusting for baseline characteristics. Subgroup analyses by baseline characteristics were also conducted. RESULTS: Overall, 5506 patients who received 1L abiraterone (n = 2911) or enzalutamide (n = 2595) were included. Median follow-up was comparable in both cohorts (abiraterone, 19.1 months; enzalutamide, 20.3 months). IPTW-adjusted median OS (95% CI) was 20.6 months (19.7‒21.4) for abiraterone and 22.5 months (21.2‒23.8) for enzalutamide, with an IPTW-adjusted hazard ratio (95% CI) of 1.10 (1.04-1.16). Median OS was significantly shorter for abiraterone versus enzalutamide in patients ≥75 years old; White patients; patients with baseline diabetes, cardiovascular disease, both diabetes and cardiovascular disease, and renal disease; and across all socioeconomic strata. CONCLUSIONS: In the Medicare chemotherapy-naïve mCRPC population, 1L abiraterone was associated with worse OS versus enzalutamide in the overall population and among subgroups with older age and comorbidities, supporting findings from previous real-world studies and demonstrating a disparity in outcomes.

Real-world treatment patterns and overall survival among men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) in the US Medicare population.

BACKGROUND: Real-world treatment patterns and survival in metastatic castration-resistant prostate cancer (mCRPC) have not been characterized for the full fee-for-service Medicare population. METHODS: Men newly diagnosed with mCRPC were identified in Medicare fee-for-service claims during 1/1/2014-6/30/2019. Men had evidence of mCRPC and continuous insurance coverage ≥1 year before and ≥6 months after diagnosis unless patients died. Treatment patterns after diagnosis were described. Survival from mCRPC diagnosis and from start of first-line (1 L) therapy was modeled using Kaplan-Meier analysis. RESULTS: Among 14,780 men with mCRPC, mean age was 76 and median follow-up after mCRPC was 17.0 months. 22% received no life-prolonging therapy after mCRPC, 78% received ≥1 line of therapy (LOT), 42% underwent ≥2 LOTs, and 20% had ≥3 LOTs. Median time from start of 1 L to next LOT or end of follow-up was 13.7 months, 10.9 months from 2 L start, and 8.9 months from 3 L start. The most common 1 L to 2 L treatment sequences among men with ≥2 lines were NHT followed by a different NHT (33%), chemotherapy followed by NHT (14%), and NHT followed by chemotherapy (13%). For those initiating 1 L treatment with NHTs, only 28% received subsequent treatment with a different class of therapy. Median survival was 25.6 months after mCRPC and 23.4 months following treatment initiation. CONCLUSIONS: More than 1 in 5 Medicare patients with mCRPC did not receive any life-prolonging therapy, and less than half received 2 L therapy. NHTs were the most common 1 L and 2 L therapies, with patients treated with NHT as 1 L followed by a different NHT for 2 L as the most common treatment sequence. Median survival from diagnosis for all patients was 25.6 months. These data highlight the dramatic undertreatment that occurs for mCRPC patients, particularly for therapies beyond NHTs as well as the common use of sequential NHTs in real-world data.

Healthcare Costs in Men with Metastatic Castration-Resistant Prostate Cancer: An Analysis of US Medicare Fee-For-Service Claims.

INTRODUCTION: To analyze healthcare resource utilization (HRU) and healthcare costs in men with metastatic castration-resistant prostate cancer (mCRPC) in the US Medicare population. METHODS: A published claims-based algorithm was used to identify men with mCRPC in the fee-for-service Medicare population between January 1, 2014, and December 31, 2019. Unadjusted all-cause HRU (days) and healthcare costs paid by Medicare (medical and pharmacy) per patient per year (PPPY) are described for the periods before mCRPC diagnosis, after diagnosis, and from the start of first-line (1L), second-line (2L), and third-line (3L) therapy with mCRPC life-prolonging treatments to the start of subsequent therapy or end of follow-up/death. RESULTS: A total of 14,780 men with mCRPC were identified. After mCRPC diagnosis, 11,528 men initiated 1L mCRPC therapy, 6275 initiated 2L, and 2945 initiated 3L. All-cause medical HRU (days PPPY) increased after mCRPC diagnosis and from 1L through 3L treatment, particularly for outpatient care (pre-diagnosis, 10.4; 1L, 16.2; 2L, 18.9; 3L, 22.0) and physician/other visits (pre-diagnosis, 30.1; 1L, 46.5; 2L, 50.2; 3L, 56.9). Similarly, mean all-cause healthcare costs PPPY were $27,468 in the year before mCRPC diagnosis and increased over four fold to $124,379 after mCRPC diagnosis and continued to rise from start of 1L ($148,325) to 2L ($160,118) to 3L ($165,186) therapy. CONCLUSION: HRU and healthcare costs increased substantially following mCRPC diagnosis, and continued to increase even further through progression from 1L through 3L mCRPC therapy. These findings help to quantify the economic burden of mCRPC and to contextualize the economic value of treatments that delay disease progression.

Real-World Treatment Trends Among Patients with Metastatic Castration-Sensitive Prostate Cancer: Results from an International Study.

BACKGROUND: Continuous androgen deprivation therapy ± first-generation non-steroidal antiandrogen was previously the standard-of-care for patients with metastatic castration-sensitive prostate cancer (mCSPC). Treatment intensification with novel hormonal therapy (NHT) or taxane chemotherapy is now approved and guideline-recommended for these patients. METHODS: Physician-reported data on adult patients with mCSPC from the Adelphi Prostate Cancer Disease Specific Programme were analyzed descriptively. We evaluated real-world treatment trends for patients with mCSPC in 5 European countries (United Kingdom, France, Germany, Spain, and Italy) and the United States (US), looking at differences between patients initiating treatment in 2016-2018 and in 2019-2020. We also investigated treatment trends by ethnicity and insurance status in the US. RESULTS: This study found that most patients with mCSPC do not receive treatment intensification. However, greater use of treatment intensification with NHT and taxane chemotherapy was observed in 2019-2020 than in 2016-2018 across 5 European countries. In the US, greater use of treatment intensification with NHT in 2019-2020 than in 2016-2018 was observed for all ethnicity groups and those with Medicare and commercial insurance status. CONCLUSIONS: As the number of patients with mCSPC who receive treatment intensification increases, more patients who progress to metastatic castration-resistant prostate cancer (mCRPC) will have been exposed to intensified treatments. Treatment options for patients with mCSPC and mCRPC overlap, suggesting that an unmet need will emerge for new therapies. Further studies are needed to understand optimal treatment sequencing in mCSPC and mCRPC.

Real-World Treatment Patterns Among Patients With Metastatic Castration-Resistant Prostate Cancer: Results From an International Study.

BACKGROUND: There is limited real-world evidence on how increasing use of treatment intensification in metastatic castration-sensitive prostate cancer (mCSPC) has influenced treatment decisions in metastatic castration-resistant prostate cancer (mCRPC). The study objective was to evaluate the impact of novel hormonal therapy (NHT) and docetaxel use in mCSPC on first-line treatment patterns among patients with mCRPC in 5 European countries and the United States (US). METHODS: Physician-reported data on patients with mCRPC from the Adelphi Prostate Cancer Disease Specific Program were descriptively analyzed. RESULTS: A total of 215 physicians provided data on 722 patients with mCRPC. Across 5 European countries and the US, 65% and 75% of patients, respectively, received NHT, and 28% and 9% of patients, respectively, received taxane chemotherapy as first-line mCRPC treatment. In Europe, patients who had received NHT in mCSPC (n = 76) mostly received taxane chemotherapy in mCRPC (55%). Patients who had received taxane chemotherapy, or who did not receive taxane chemotherapy or NHT in mCSPC (n = 98 and 434, respectively) mostly received NHT in mCRPC (62% and 73%, respectively). In the US, patients who had received NHT, taxane chemotherapy, or neither in mCSPC (n = 32, 12, and 72, respectively) mostly received NHT in mCRPC (53%, 83%, and 83%, respectively). Two patients in Europe were rechallenged with the same NHT. CONCLUSIONS: These findings suggest that physicians consider mCSPC treatment history when making first-line treatment decisions in mCRPC. Further studies are needed to better understand optimal treatment sequencing, especially as new treatments emerge.

Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer.

BACKGROUND: Talazoparib is a poly (adenosine diphosphate-ribose) polymerase inhibitor approved for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative, locally advanced or metastatic breast cancer (LA/mBC), with approval based on the EMBRACA trial. To date, there are no published data on talazoparib use in the real-world United States (USA) setting. PATIENTS AND METHODS: Characteristics, treatment patterns, and clinical outcomes of real-world US patients with gBRCAm HER2-negative LA/mBC treated with talazoparib monotherapy were collected via retrospective chart review and summarized using descriptive statistics. RESULTS: Among 84 eligible patients, 35.7% had hormone receptor-positive tumors and 64.3% had triple-negative LA/mBC (TNBC). At talazoparib initiation, 29.8% had ECOG PS of ≥2 and 19.0% had brain metastasis. Mutations in gBRCA1 or 2 were detected among 64.3% and 35.7% of patients, respectively. Talazoparib was given as 1st-line therapy in 14.3% of patients, 2nd-line in 40.5%, and 3rd- or 4th-line in 45.2%. Median time to talazoparib treatment failure was 8.5 months (95% CI, 8.0-9.7), median progression-free survival was 8.7 months (95% CI, 8.0-9.9), the median time from initiation to chemotherapy was 12.2 months (95% CI, 10.5-20.1), and the overall response rate was 63.1%. No differences in clinical outcomes were observed between patients with HR-positive/HER2-negative LA/mBC and patients with TNBC by using unadjusted statistical comparisons. Brain metastasis and ECOG PS ≥2 at talazoparib initiation were associated with treatment failure and progression or mortality. CONCLUSION: Overall, talazoparib clinical outcomes in this real-world population are consistent with findings from EMBRACA.

Enzalutamide and Quality of Life in Biochemically Recurrent Prostate Cancer.

BACKGROUND: EMBARK, a controlled trial reported elsewhere, showed enzalutamide plus leuprolide (combination) and enzalutamide monotherapy prolonged metastasis-free survival versus placebo plus leuprolide (alone) in patients with high-risk biochemically recurrent prostate cancer. Health-related quality of life was also analyzed but not reported. METHODS: In EMBARK, patients with biochemical recurrence (prostate-specific antigen doubling time of ≤9 months) were randomly assigned (1:1:1) to combination (n=355), leuprolide-alone (n=358), or enzalutamide monotherapy (n=355). In this article we provide the patient-reported outcomes (PROs) from EMBARK at baseline and every 12 weeks until metastasis or death. The key end point was time to first and confirmed clinically meaningful deterioration (TTFD/TTCD) in pain and health-related quality of life using four PRO measures and predefined thresholds. RESULTS: At baseline, all groups had high health-related quality of life. For worst pain, the median TTFD was 19.35 months with leuprolide alone, 13.93 months with combination (hazard ratio, 1.08; 95% confidence interval [CI], 0.89 to 1.30) and 16.59 months with monotherapy (hazard ratio, 1.09; 95% CI, 0.90 to 1.31). The median TTCD was 66.27 months with leuprolide alone, 80.00 months with combination (hazard ratio, 0.82; 95% CI, 0.65 to 1.04), and 60.91 months with monotherapy (hazard ratio, 1.02; 95% CI, 0.82 to 1.28). For Functional Assessment of Cancer Therapy­Prostate total score, the median TTFD was 11.10 months with leuprolide alone, 8.31 months with combination (hazard ratio, 1.14; 95% CI, 0.95 to 1.36), and 8.38 months with monotherapy (hazard ratio, 1.17; 95% CI, 0.98 to 1.39). The median TTCD was 36.53 months with leuprolide alone, 38.77 months with combination (hazard ratio, 1.04; 95% CI, 0.85 to 1.28), and 30.55 months with monotherapy (hazard ratio, 1.16; 95% CI, 0.95 to 1.41). CONCLUSIONS: The PROs from EMBARK show that both enzalutamide combination and monotherapy versus leuprolide alone, with oncologic benefits noted above, preserved high health-related quality of life in patients with high-risk biochemical recurrence of prostate cancer. (Funded by Pfizer and Astellas Pharma; ClinicalTrials.gov number, NCT02319837.)

The cost-effectiveness of dacomitinib in first-line treatment of advanced/metastatic epidermal growth factor receptor mutation-positive non-small-cell lung cancer (EGFRm NSCLC) in Sweden.

AIMS: Although the benefit of first-line epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) over chemotherapy in EGFR mutation-positive (EGFRm) non-small-cell lung cancer (NSCLC) has been demonstrated in clinical trials, the optimal treatment sequence remains unclear. The objective of our study was to evaluate the cost-effectiveness of dacomitinib in Sweden vs afatinib and osimertinib in first-line treatment of EGFRm NSCLC. MATERIALS AND METHODS: A partitioned survival model was developed with three health states: progression-free, post-progression, and death. Progression-free and overall survival curves were used to inform movements between states. Clinical data were taken from randomized trials, compared via a network meta-analysis (NMA). Utility data were taken from published studies and costs from national Swedish sources. The model used a 15-year time horizon and a Swedish healthcare payer perspective. Sensitivity and scenario analyses were performed. RESULTS: The base-case analysis showed that dacomitinib accrued a total of 2.10 quality-adjusted life-years (QALYs) at a total cost of Swedish krona (SEK) 874,615. The incremental cost-effectiveness ratio (ICER) for dacomitinib vs afatinib was SEK 461,556 per QALY gained. The ICER of osimertinib vs dacomitinib, where the small QALY gains of the former came at a high additional cost, was SEK 11,444,709. Deterministic and probabilistic sensitivity analyses confirmed the robustness of these results; changes to drug and medical resource use costs and overall survival had the greatest impact on ICER estimates. LIMITATIONS: This model is subject to uncertainty associated with extrapolating long-term treatment effects from shorter trial follow-up periods, although this would also be a limitation when using direct comparison or time-dependent hazard ratios. The NMA was limited by the use of indirect comparison, although sensitivity analyses supported the robustness of our findings. CONCLUSIONS: Our model demonstrated that dacomitinib is cost-effective for first-line EGFRm NSCLC treatment in Sweden vs afatinib and osimertinib.

Characterization of individuals with osteoarthritis in the United States and their use of prescription and over-the-counter supplements.

PURPOSE: Osteoarthritis (OA) is a frequently occurring, chronic condition; however, few studies describe the clinical characteristics of individuals with OA and the treatments they use to manage their symptoms. We conducted a study to characterize the OA population in the US and describe the nonsurgical management used by this population based on consumer research data collected through an online survey. METHODS: Data from the 2017 US National Health and Wellness Survey (NHWS) for adults aged ≥35 years were used to evaluate the relationship between OA and certain study participant characteristics and to identify the most commonly used treatment options. NHWS data were collected through a survey of individuals drawn from the internet panel maintained by Lightspeed Research (Bridgewater, New Jersey) and its panel partners. Weighted estimates were generated using data from the 2016 Current Population Survey (Annual Demographics File) of the US Census Bureau. Comparisons between the general and OA populations were made based on body mass index (BMI), exercise frequency, and comorbid diagnoses of hypertension or diabetes. Among the OA population, the use of dietary supplements, prescription or over-the-counter (OTC) treatments with chondroitin with or without glucosamine (Ch ± Gl), prescription treatment by time since OA diagnosis, and utilization of a physical therapist were also recorded. RESULTS: The prevalence of OA in the overall population was 17.6 % and was higher for individuals with a BMI ≥ 25 (21.9 %), patients diagnosed with hypertension or diabetes (36.2 %), and those who did not exercise regularly (19.0 %). Adults without OA were more likely to exercise regularly (12 days per month or more) than adults diagnosed with OA. Ch ± Gl (6.0 %) was the most commonly used OTC dietary supplement in the OA population, followed by omega-3 fatty acids (2.8 %), vitamin D (1.9 %), calcium (1.1 %), and multivitamins (0.7 %). Individuals using Ch ± Gl were more likely to use OTC only products (75.4 % vs 37.3 %) or prescription medications, namely non-steroidal anti-inflammatory drugs (NSAIDs) and/or opioids, and OTC products (24.6 % vs 13.0 %) compared with individuals not using Ch ± Gl, while individuals not using Ch ± Gl were more likely to be untreated (30.3 % vs 0) or to use prescription medications only (19.4 % vs 0). Nearly 32 % of individuals with OA reported using prescription treatments, and the likelihood of using a prescription treatment increased with number of years since OA diagnosis (<3 years: 27.5 %; ≥21 years: 32.5 %). The pharmaceutical products used by this population primarily consisted of nonsteroidal anti-inflammatory drugs, acetaminophen and opioids. Approximately 13 % of patients with OA had visited a physical therapist in the past 6 months. CONCLUSIONS: The prevalence of OA was higher in those with a high BMI, and comorbid diabetes or hypertension. Individuals with OA using Ch ± Gl primarily reported use of OTC products only or used them in combination with prescription products. The likelihood of using prescription products increased with the length of OA history. These data provide valuable new information about demographics, clinical characteristics, and commonly used prescription and OTC treatments and dietary supplements in the OA population.

Indirect analysis of first-line therapy for advanced non-small-cell lung cancer with activating mutations in a Japanese population.

Background: Five EGFR-tyrosine kinase inhibitors (EGFR TKIs) are currently available in the first-line setting for non-small-cell lung cancer (NSCLC) in Japan. The aim here was to compare the relative efficacy of EGFR TKIs in the Japanese population. Materials & methods: A systematic review identified randomized controlled trials examining the efficacy of first-line EGFR TKIs. A Bayesian network meta-analysis was used to assess these EGFR TKI comparisons for progression-free survival (PFS). Results: A total of seven randomized controlled trials were identified and considered for network meta-analysis. Dacomitinib showed a trend toward improved PFS versus all comparators. Conclusion: Dacomitinib demonstrated a trend toward improved PFS and therefore, should be considered one of the standard first-line therapies for Japanese patients diagnosed with EGFR+ non-small-cell lung cancer.

Network meta analysis of first-line therapy for advanced EGFR mutation positive non-small-cell lung cancer: updated overall survival.

Aim: To update overall survival (OS) results from a previous network meta analysis comparing the relative clinical efficacy of epidermal growth factor receptor-targeted tyrosine kinase inhibitors (EGFR TKIs) for EGFR mutation positive (EGFR+) advanced non-small-cell lung cancer (NSCLC). Materials & methods: A Bayesian network meta analysis was conducted using updated/mature randomized controlled trial OS results in response to first-line EGFR TKI therapies. Results: Dacomitinib showed a numerical improvement of OS relative to other EGFR TKIs: afatinib (hazard ratio [HR]: 0.87; 95% credible interval [CrI]: 0.61-1.24), erlotinib (HR: 0.79; 95% CrI: 0.44-1.42), gefitinib (HR: 0.75; 95% CrI: 0.59-0.95) and osimertinib (HR: 0.94; 95% CrI: 0.68-1.29). Conclusion: Dacomitinib should be considered as a first-line treatment option for patients diagnosed with advanced EGFR+ NSCLC.

Basal Insulin Initiation and Maintenance in Adults with Type 2 Diabetes Mellitus in the United States.

OBJECTIVE: A survey of US adults with type 2 diabetes mellitus was conducted to better understand patients' insulin initiation experiences and treatment persistence behaviors. RESEARCH DESIGN AND METHODS: Participants were recruited from consumer panels and grouped by basal insulin treatment pattern: continuers (no gap of ≥7 days within 6 months of initiation); interrupters (gap ≥7 days, resumed treatment); discontinuers (stopped for ≥7 days, not resumed). A quota of approximately 50 respondents per persistence category was set. RESULTS: A total of 154 respondents (52 continuers, 52 interrupters, 50 discontinuers) completed the survey. Mean age was 51.4 years; 51.9% male. Continuers were more likely to report their views being considered during initiation, and less likely to report a sense of failure. Concerns included insulin dependence (64.3% agree/strongly agree), frequent blood glucose monitoring (55.2%), costs/ability to pay (53.9%), fears of or mistakes during self-injection (52.6%), and weight gain (52.6%). Continuers were motivated by benefits of insulin therapy; experienced or potential side effects were notable factors for interruption/discontinuation. Healthcare provider instruction was indicated as a reason for continuing, stopping, and restarting therapy. CONCLUSION: Benefits of basal insulin therapy motivated continuers while side effects impacted interruption/discontinuation. Persistence on basal insulin is often influenced by provider actions. Earlier provider intervention upon signs of treatment discontinuation may promote persistence.

Burden of illness among patients with severe aplastic anemia who have had insufficient response to immunosuppressive therapy: a multicenter retrospective chart review study.

This study assessed treatment patterns and healthcare resource utilization (HRU) of patients with severe aplastic anemia (SAA) with insufficient response to immunosuppressive therapy (IST). A retrospective chart review was conducted at Dana-Farber Cancer Institute (DFCI), United States, and Hôpital Saint-Louis (HSL), France. Eligible patients were ≥ 18 years old, diagnosed with acquired SAA between January 1, 2006, and July 31, 2016, had insufficient response to IST, and had ≥ 12 months of follow-up post-diagnosis. Overall survival (OS) was estimated using the Kaplan-Meier method. Among the 40 patients, mean age at diagnosis was 44 years and 53% were women. Median follow-up time after SAA diagnosis was 48.3 months. Ninety-five percent of patients received antithymocyte globulin (ATG) as primary therapy prior to hematopoietic stem cell transplant (HSCT). Most common secondary SAA therapies prior to HSCT were eltrombopag (28%) and androgens (15%). Seventy-five percent of patients received HSCT. Prior to HSCT, patients received an average of 2.7 red blood cell (RBC) and 3.3 platelet transfusions per month; patients had 0.9 hospitalizations, 0.4 emergency room visits, and 12.8 office visits per year. Five-year OS was 75%, with infection as the primary cause of death. Additionally, this study provides information on the subgroup of patients receiving eltrombopag which was the most common secondary therapy. This study quantified transfusion and HRU burden associated with SAA and demonstrated high 5-year survival in a recently treated cohort.

Basal insulin persistence in Brazilian participants with T2DM.

OBJECTIVE: Real-world effectiveness of basal insulin therapy is affected by poor treatment persistence, often occurring soon after initiation. This analysis is part of an international cross-sectional study conducted in T2DM patients and is intended to describe the reasons behind non-persistence to insulin therapy in Brasil. METHODS: Responders to an online survey in seven countries were classified as continuers (no gap of ≥7 days), interrupters (interrupted therapy for ≥7 days within first 6 months, then restarted), and discontinuers (terminated therapy for ≥7 days within first 6 months, and did not start it again before the survey). We present the results from the Brazilian cohort. RESULTS: Of 942 global respondents, 156 were from Brasil, with a mean age of 34 years and a mean of 5.8 years since T2DM diagnosis. Reasons contributing to insulin continuation (n=50) were improved glycemic control (82%) and improved physical feeling (50%). Common reasons for interruption (n=51) or discontinuation (n=55) were, respectively, weight gain (47.1%, 43.6%), hypoglycemia (45.1%, 38.2%), and pain from injections (39.2%, 49.1%). However, not all patients who reported weight gain and hypoglycemia as a reason for interruption or discontinuation experienced these: 16/24 (66.7%) and 22/24 (91.7%) participants had weight gain, and 13/23 (56.5%) and 15/21 (71.4%) had hypoglycemia, respectively. The most important reason for possible re-initiation for interrupters and discontinuers, respectively, was persuasion by the physician/HCP (80.4%, 72.7%). CONCLUSION: The benefits of basal insulin therapy motivated continuers to persist with the treatment; experienced or anticipated side effects contributed to interruption and discontinuation. Physician and patient training is key in the treatment of diabetes.

Real-world treatment patterns among patients with advanced gastric cancer in Russia: a chart review study.

Objective: Little evidence is available on the management of patients with metastatic and/or unresectable gastric cancer (mGC) after the failure of first-line treatment. This study presents real-world data on characteristics and treatment patterns of patients with mGC in Russia. Methods: Eligible patients were ≥18 years old, diagnosed with mGC ≥ January 1, 2012, received first-line chemotherapy followed by second-line chemotherapy or best supportive care (BSC), had ≥3 months of follow-up after the start of second-line chemotherapy or BSC (except in cases of death), and had not participated in a clinical trial. Data were summarized using descriptive statistics. Results: A total of 88 physicians provided data from 202 charts. Mean age at mGC diagnosis was 53.7 (standard deviation: 11.2) years; 70.8% of patients were male. Reasons for first-line treatment discontinuation included disease progression (50.5%) and adverse events/toxicity (39.1%). There were 52 unique treatment regimens prescribed in second-line; capecitabine (14.5%), paclitaxel (9.3%), and capecitabine + oxaliplatin (8.7%) were the most frequent. Reasons for second-line treatment discontinuation included disease progression (39.8%) and patient refusal to continue (37.5%). During 2nd-line treatment, the most common treatment-related symptoms were nausea/vomiting (75.0%), while pain (73.8%) was the most common disease-related symptom. Antiemetics (63.4%), chemotherapy (61.6%), non-narcotic analgesics (48.3%), endoscopy (45.9%), and nutritional support (35.5%) were most frequently used as supportive care. Conclusions: Second-line treatment patterns for patients with mGC in Russia are heterogeneous. Results of this study indicate the need for more intensive implementation of the most active regimens in second-line treatment of mGC according to international and national guidelines.

Basal insulin persistence in Brazilian participants with T2DM

SUMMARY OBJECTIVE Real-world effectiveness of basal insulin therapy is affected by poor treatment persistence, often occurring soon after initiation. This analysis is part of an international cross-sectional study conducted in T2DM patients and is intended to describe the reasons behind non-persistence to insulin therapy in Brasil. METHODS Responders to an online survey in seven countries were classified as continuers (no gap of ≥7 days), interrupters (interrupted therapy for ≥7 days within first 6 months, then restarted), and discontinuers (terminated therapy for ≥7 days within first 6 months, and did not start it again before the survey). We present the results from the Brazilian cohort. RESULTS Of 942 global respondents, 156 were from Brasil, with a mean age of 34 years and a mean of 5.8 years since T2DM diagnosis. Reasons contributing to insulin continuation (n=50) were improved glycemic control (82%) and improved physical feeling (50%). Common reasons for interruption (n=51) or discontinuation (n=55) were, respectively, weight gain (47.1%, 43.6%), hypoglycemia (45.1%, 38.2%), and pain from injections (39.2%, 49.1%). However, not all patients who reported weight gain and hypoglycemia as a reason for interruption or discontinuation experienced these: 16/24 (66.7%) and 22/24 (91.7%) participants had weight gain, and 13/23 (56.5%) and 15/21 (71.4%) had hypoglycemia, respectively. The most important reason for possible re-initiation for interrupters and discontinuers, respectively, was persuasion by the physician/HCP (80.4%, 72.7%). CONCLUSION The benefits of basal insulin therapy motivated continuers to persist with the treatment; experienced or anticipated side effects contributed to interruption and discontinuation. Physician and patient training is key in the treatment of diabetes.

RESUMO OBJETIVO Dados de vida real sobre como a eficácia da terapia com insulina é afetada pela baixa persistência ao tratamento que ocorre logo após o início da terapia. Esta análise é a parte brasileira de um estudo transversal internacional conduzido em pacientes com DM2 que teve como objetivo descrever as razões relacionadas à não persistência ao tratamento com insulina. METODOLOGIA O estudo realizado em sete países por meio de questionários on-line classificou como pacientes continuadores (aqueles que não apresentaram intervalo ≥7 dias sem uso da insulina), interrompedores (interromperam a terapia por ≥7 dias nos primeiros seis meses de uso, depois recomeçaram) e descontinuadores (interromperam a terapia por ≥7 dias nos primeiros seis meses de uso e não retornaram). Nesta análise descrevemos os dados da coorte brasileira. RESULTADOS Dos 942 pacientes incluídos, 156 eram do Brasil, com idade média de 34 anos e média de seis anos desde o diagnóstico de DM2. Razões que contribuíram para o uso contínuo da insulina (n=50) foram a melhora do controle glicêmico (82%) e a melhora no estado geral (50%). Razões para a interrupção (n=51) ou para a descontinuação (n=55) foram, respectivamente, ganho de peso (41,7%, 43,6%), hipoglicemia (45,1%, 38,2%) e dor à aplicação (39,2%, 49,1%). Entretanto, nem todos os pacientes que reportaram ganho de peso e hipoglicemia como possível razão para interrupção ou descontinuação realmente apresentaram esses eventos: 16/24 (66,7%) e 22/24 (91,4%) dos participantes apresentaram ganho de peso e 13/23 (56,6%) e 15/21 (71,4%) apresentaram hipoglicemia, respectivamente. A razão mais importante para o possível recomeço entre os interrompedores e descontinuadores foi a persuasão de médicos/profissionais de saúde (80,4% e 72,7%, respectivamente). CONCLUSÕES Os benefícios do tratamento com insulina basal motivaram continuadores a persistir com a terapia; a experiência ou a antecipação de eventos adversos contribuíram para a interrupção e descontinuação. O treinamento de médicos e pacientes é um dos pilares fundamentais do tratamento do diabetes.

Identifying solutions to psychological insulin resistance: An international study.

AIMS: To identify actions of healthcare professionals (HCPs) that facilitate the transition to insulin therapy (IT) in type 2 diabetes (T2D) adults. METHODS: Included were T2Ds in seven countries (n = 594) who reported initial IT reluctance but eventually began IT. An online survey included 38 possible HCP actions: T2Ds indicated which may have occurred and their helpfulness. Also reported were delays in IT start after initial recommendation and any period of IT discontinuation. RESULTS: Exploratory factor analysis of HCP actions yielded five factors: "Explained Insulin Benefits" (EIB), "Dispelled Insulin Myths" (DIM), "Demonstrated the Injection Process" (DIP), "Collaborative Style" (CS) and "Authoritarian Style" (AS). Highest levels of helpfulness occurred for DIP, EIB and CS; lowest for AS. Participants who rated DIP as helpful were less likely to delay IT than those who rated DIP as less helpful (OR = 0.75, p = 0.01); participants who rated CS and EIB as helpful were less likely to interrupt IT than those who rated these as less helpful (OR = 0.55, p < 0.01; OR = 0.51, p = 0.01, respectively). CONCLUSIONS: Three key HCP actions to facilitate IT initiation were identified as helpful and were associated with more successful initiation and persistence. These findings may aid the development of interventions to address reluctance to initiating IT.

Patient and Oncologist Preferences for the Treatment of Adults with Advanced Soft Tissue Sarcoma: A Discrete Choice Experiment.

BACKGROUND: There has been no single standard-of-care treatment of patients with advanced/metastatic soft tissue sarcoma (STS). This study was designed to understand patient and oncologist preferences in the advanced/metastatic setting. METHODS: Adult patients diagnosed with STS and oncologists treating patients with STS completed discrete choice experiment surveys. Study participants chose between pairs of hypothetical treatment profiles for advanced STS characterized by varying levels of overall survival (14, 20, or 26 months), progression-free survival (3, 5, or 7 months), objective tumor response rate (12, 18, or 26%), risk of hospitalization due to side effects (12, 30, or 46%), and days/month to administer treatment (1, 2, or 4 days). A hierarchical Bayes model was used to estimate preferences and relative importance of attributes. RESULTS: Seventy-six patients (23.7% male, mean age 52.8 years) and 160 oncologists (73.8% male, mean 16.9 years in practice) completed the surveys. Among patients, overall survival had the highest relative importance (39.5%, standard deviation [SD] 18.2%), followed by response rate (21.2%, SD 10.4%), and hospitalization (19.8%, SD 12.5%). Among oncologists, overall survival had the highest relative importance (44.6%, SD 16.0%), followed by hospitalization (18.4%, SD 8.3%). CONCLUSIONS: Both patients with STS and oncologists preferred a treatment that maximizes the life of patients while avoiding hospitalizations.

Key factors for overcoming psychological insulin resistance: an examination of patient perspectives through content analysis.

Objective: To understand participant perceptions about insulin and identify key behaviors of healthcare professionals (HCPs) that motivated initially reluctant adults from seven countries (n=40) who had type 2 diabetes (T2D) to start insulin treatment. Research design and methods: Telephone interviews were conducted with a subset of participants from an international investigation of adults with T2D who were reluctant to start insulin (EMOTION). Questions related to: (a) participants' thoughts about insulin before and after initiation; (b) reasons behind responses on the survey that were either 'not helpful at all' or 'helped a lot'; (c) actions their HCP may have taken to help start insulin treatment; and (d) advice they would give to others in a similar situation of starting insulin. Responses were coded by two independent reviewers (kappa 0.992). Results: Starting insulin treatment was perceived as a negative experience that would be painful and would lead down a 'slippery slope' to complications. HCPs engaged in four primary behaviors that helped with insulin acceptance: (1) showed the insulin pen/needle and demonstrated the injection process; (2) explained how insulin could help with diabetes control and reduce risk of complications; (3) used collaborative communication style; and (4) offered support and willingness to answer questions so that participants would not be 'on their own'. Following initiation, most participants noted that insulin was not 'as bad as they thought' and recommended insulin to other adults with T2D. Conclusions: Based on these themes, two actionable strategies are suggested for HCPs to help people with psychological insulin resistance: (1) demonstrate the injection process and discuss negative perceptions of insulin as well as potential benefits; (2) offer autonomy in a person-centred collaborative approach, but provide support and accessibility to address concerns. These findings help HCPs to better understand ways in which they can engage reluctant people with T2D with specific strategies.