Acute Treatment Patterns, Migraine Burden, and Healthcare Resource Use in People With Migraine: Results From the OVERCOME (EU) Observational Study.

INTRODUCTION: The ObserVational survey of the Epidemiology, tReatment and Care Of MigrainE (OVERCOME) European Union (EU) is part of an overarching population-based study program that also includes the United States and Japan. Here, we report data on the migraine/severe headache burden and the use of acute medication and healthcare resources in Spain and Germany. METHODS: OVERCOME (EU) was an online, non-interventional, cross-sectional survey conducted in adults in Spain and Germany between October 2020 and February 2021. A total migraine cohort was established based on health survey participants who reported headache/migraine in the last 12 months AND identified as having migraine based on modified International Classification of Headache Disorders, third edition criteria OR self-reported physician diagnosis. Data were analyzed for the total migraine cohort and the subcohort with moderate to severe headache attacks, with average pain severity ≥ 5 points, pain duration ≥ 4 h, and at least moderate disability due to migraine [Migraine Disability Assessment (MIDAS) score ≥ 11] over the past 3 months. RESULTS: Pain of moderate or severe intensity was the most frequent symptom in the total migraine cohort (n = 19,103/20,756; 92.0%). Proportions of participants reporting severe disability (MIDAS Grade IV), poorer quality of life (QoL; Migraine-Specific QoL Questionnaire), and higher interictal burden (Migraine Interictal Burden Scale-4), generally increased with number of headache days (HDs)/month. Most participants (92.5%) reported current acute migraine/severe headache medication use, although only 39.0% were using triptans. In the moderate to severe attacks subcohort (n = 5547), 48.4% were using triptans, with nonsteroidal anti-inflammatory drugs the most common acute medication. The moderate to severe attacks subcohort also reported poorer QoL and greater pain and disability with increasing HDs/month, although severe interictal burden was reported for ~ 60% of participants regardless of HDs/month. Treatment satisfaction (six-item migraine Treatment Optimization Questionnaire) in those using triptans was generally poor in both total and subcohorts. CONCLUSION: High migraine-related burden levels were reported, despite use of acute medication. Although triptans are recommended for moderate to severe migraine attacks in Spanish and German guidelines, less than half of participants were using triptans; treatment satisfaction in those using triptans was generally poor. New tailored treatment options may help address unmet needs in current acute treatment.

Preventive treatment patterns and treatment satisfaction in migraine: results of the OVERCOME (EU) study.

BACKGROUND: Insights into the burden, needs and treatment of migraine from internet-based surveys in diverse real-world migraine populations are needed, especially at a time when novel preventive migraine medications are becoming part of the therapeutic armamentarium. The objectives of this analysis are to describe traditional preventive (orals and onabotulinum toxin A) treatment patterns in the OVERCOME (EU) study migraine cohort, as well as treatment patterns and patient satisfaction with current treatment in a subgroup of respondents eligible for migraine preventive medication. METHODS: The cross-sectional non-interventional OVERCOME (EU) study was conducted (October 2020-February 2021) via an online survey among adults (aged ≥ 18 years) resident in Germany or Spain. Participants, registered in existing online panels, who were willing to provide consent were considered. The migraine cohort included participants reporting headache/migraine in the past year, identified based on a validated migraine diagnostic questionnaire and/or self-reported physician diagnosis. A subgroup of survey respondents defined as eligible for migraine preventive medication at the point in time the cross-sectional survey was taken was also analysed. Variables assessed included sociodemographic and migraine-related clinical characteristics, preventive (traditional and calcitonin gene-related peptide monoclonal antibodies) treatment patterns and patient satisfaction with current treatment. Results are descriptive only. RESULTS: Of the 20,756 participants in the migraine cohort, 78.5% sought professional medical care, 50.8% received a migraine diagnosis and only 17.7% had ever used preventive medication. Half (53.3%) of participants currently using preventives took their most recent medication for six months or less. Most patients (73.9%) classified as eligible for preventive medication (based on headache frequency and/or at least moderate disability due to migraine) reported not using traditional preventives and many of those who did (66.8%) were not satisfied with their current standard of care. CONCLUSIONS: Our findings highlight the low proportion of people diagnosed with migraine despite a higher rate of consultation and suggest the need for better access to treatment for people with migraine and new preventive therapies with improved efficacy and safety profiles to improve adherence and patient satisfaction.

Burden and Unmet Needs in Migraine Patients: Results from the OVERCOME (Spain) Study.

INTRODUCTION: This analysis aimed to evaluate demographics, migraine-related disability, symptoms, diagnosis and healthcare consultation, work productivity, and treatment patterns according to headache frequency in adults with migraine in the OVERCOME (ObserVational survey of the Epidemiology, tReatment and Care Of MigrainE) (Spain) study. METHODS: Data were obtained from an observational, cross-sectional, web-based survey conducted between October 2020-February 2021 in Spain. Eligible participants were adult members of online survey panels living in Spain who were able to read and write Spanish and fulfilled the International Classification of Headache Disorders, third edition (ICHD-3) criteria for migraine or had a self-reported physician diagnosis. RESULTS: In total, 10,229 patients comprised the Spanish sample. Only 56.2% of respondents had a confirmed healthcare professional (HCP) diagnosis of migraine, despite almost all meeting modified ICHD-3 criteria. Pain severity, migraine-related disability, and interictal burden increased with increasing number of headache days per month. Migraine impacted on respondents' work productivity, with increases in presenteeism, work productivity loss, and daily activity impairment at higher headache frequencies. Over the past year, 66.2% of all HCP visits were specifically due to migraine, most commonly with a general practitioner or pharmacist. A subgroup of 1277 patients (12.5% of the total survey population) met eligibility criteria for migraine preventive medications, of whom only 36.6% were currently taking a preventive. CONCLUSIONS: Results of the OVERCOME (Spain) survey reveal the substantial burden of migraine, which is directly linked to headache frequency. However, most patients experiencing frequent headaches and eligible for migraine preventives are currently not taking them. Findings highlight the importance of addressing unmet needs for people with migraine in Spain.

Treatment Patterns and Health Resource Utilization in Patients With HR+/ HER2- Locally Advanced or Metastatic Breast Cancer in a Real-World Setting in Taiwan.

OBJECTIVES: This study aimed to understand current treatment patterns and healthcare resource utilization (HRU) of women with locally advanced or metastatic breast cancer (advanced breast cancer [ABC]) in Taiwan overall and within the subgroup of patients who were postmenopausal women with no previous systemic therapy in the ABC setting. METHODS: A chart review of anonymized data on patient characteristics, treatment patterns, and HRU was conducted via an online physician survey including 118 patient charts from women ≥ 18 years old with hormone receptor positive/human epidermal growth receptor negative ABC, diagnosed between 2015 and 2017. RESULTS: The mean age of all patients was 56.6 years (range 29-83). Among the 118 patients, the most common first-line systemic therapy group after diagnosis of ABC was endocrine-based therapy (39.0%) or endocrine therapy (ET) plus chemotherapy (ChT) combinations (38.1%). In the postmenopausal subgroup (n = 56), ET-based therapy was the most common (44.6%). Oncologist visits, at annual rate of 9.20 (95% confidence interval 8.81-9.60), and hospitalizations, at annual rate of 1.08 (95% confidence interval 0.96-1.22), were key drivers of HRU. Of the 118 patients, the 72 with at least one ChT agent in their first-line regimen had an annual hospitalization rate of 1.4 versus 0.45 admissions compared with the 46 patients on first-line ET-based therapy. CONCLUSIONS: Current treatment patterns suggest an unmet need for new medications that lead to reduction in high rate of ChT use. Results can inform future evaluations of new ABC treatments that estimate the health economic impact of their adoption in Taiwan.

Real-World Analysis of Clinical Characteristics, Treatment Patterns, and Patient-Reported Outcomes of Insufficient Responders and Responders to Prescribed Acute Migraine Treatment in China.

INTRODUCTION: Migraine is a common disabling primary headache disorder characterized by attacks of severe pain, sometimes accompanied by symptoms including nausea and photo-/phono-phobia. Real-world data of patients with migraine who sufficiently (responders) and insufficiently (insufficient responders) respond to acute treatment (AT) are limited in China. This analysis explored whether responders to AT differ from insufficient responders in terms of clinical characteristics, treatment patterns, and patient-reported outcomes in China. METHODS: Data were drawn from the Adelphi Migraine Disease Specific Programme™, a point-in-time survey of internists/neurologists and their consulting patients with migraine, conducted in a real-world setting in China, January-June 2014. Responders and insufficient responders to prescribed AT were patients who typically achieved headache pain freedom within 2 h of AT in ≥ 4 and ≤ 3 of five migraine attacks, respectively. Responders were compared with insufficient responders; logistic regression was used to identify factors associated with insufficient response. RESULTS: Of 777 patients currently receiving AT, 44.0% were insufficient responders. Significantly fewer responders than insufficient responders had migraine with aura (13.1 vs. 23.8%; p = 0.0001). Responders reported a significantly lower mean Migraine Disability Assessment (MIDAS) total score (5.5 vs. 6.6; p = 0.0325). Responders reported a lower mean impairment while working (50.0 vs. 63.9%; p < 0.0001), overall work impairment (52.6 vs. 66.0%; p < 0.0001), and activity impairment (48.9 vs. 59.0%; p < 0.0001). Statistically significant factors associated with insufficient response to AT included diabetes, unilateral pain, vomiting, sensitivity to smell, visual aura/sight disturbance, and an increase in MIDAS total score. However, there were no statistically significant differences in ATs received by responders and insufficient responders at any regimen of therapy. CONCLUSIONS: Many patients with migraine in China are insufficient responders to AT, experiencing worse symptoms that lead to overall poorer quality of life than responders. This unmet need suggests that new effective treatment options are required for migraine.

Real world evidence study on treatment patterns and health resource utilization in patients with HR+/HER2- locally advanced or metastatic breast cancer in Korea.

Objective: To understand current treatment patterns and health care resource utilization (HRU) of women with locally advanced or metastatic breast cancer (advanced breast cancer; ABC) in Korea overall and within patients who had progressed with prior endocrine therapy (as first-line treatment for metastatic disease) and patients with no prior systemic treatment (for advanced disease). Methods: A chart review was conducted in 109 patients (women ≥ 18 years old with HR+/HER2- ABC diagnosed between 2015 and 2017) from 11 hospitals. Anonymized data on patient characteristics, treatment patterns and HRU was abstracted. Results: Mean (range) age of all patients was 57.5 (40-81) years. Overall, the most common first-, second- and third-line systemic therapy after diagnosis of ABC were letrozole ± palbociclib (51%), endocrine therapy (ET)±everolimus (42%) or chemotherapy (ChT) (39%), and ChT (68%), respectively. In patients progressed with ET (n = 33) and those with no prior systemic treatment (n = 52), the most common first-line treatments were letrozole (82%) and letrozole + palbociclib (42%), respectively. The percentage of patients with at least one grade 3 or higher adverse event during first-line therapy was 93.1% vs 39.2% in patients on a ChT based regimen (N = 29) vs. ET (N = 74). Overall, oncologist visits, at an annual rate of 9.27 (95% CI: 8.87, 9.69) visits per month, and hospitalizations, with an annual rate of 0.44 (95% CI: 0.36, 0.54), and mean (SD) length of stay of 14.3 (10.32) days, were the key drivers of HRU. Conclusions: These findings on real world HRU reflected clinical guidelines and severity of ABC. Results can inform future evaluations of new ABC treatments that estimate the health economic impact of their adoption in Korea.

Treatment Patterns and Health Resource Utilization in Patients With Hepatocellular Carcinoma After Failure of Sorafenib in Real-World Setting in Taiwan.

OBJECTIVES: This study aimed to characterize current treatment patterns and healthcare resource utilization (HRU) observed among patients with hepatocellular carcinoma (HCC) after the failure of sorafenib in real-world setting in Taiwan. METHODS: A chart review was conducted in 130 patients; the inclusion criteria were patients with HCC who were aged 20 years or older and had received systemic therapy or best supportive care after failure of first-line systemic treatment with sorafenib between 2016 and 2018. Anonymized data on patient characteristics, treatment pathways, and survival were abstracted. RESULTS: The mean age of patients was 61.7 years (range 27-84); of these 130 patients, 103 (79%) were male, 81 (62%) had high alpha-fetoprotein (AFP) levels (≥400 ng/mL), and 96 (78.0%) were deceased at the time of data abstraction. After sorafenib therapy, 60 patients (46%) received systemic therapy, including nivolumab monotherapy (42%) and chemotherapy (25%). Oncologist visits at a semiannual per-patient rate of 3.7 (95% confidence interval [CI] 3.4-4.0) and hospitalizations at rate of 1.1 (95% CI 1.0-1.3) were the key contributors to HRU. Semiannual per-patient hospitalization rate was 1.3 (95% CI 1.1-1.5) in the high-AFP group. Median survival from discontinuation of sorafenib was 6.9 months (95% CI 5.9-9.0). CONCLUSIONS: This real-world evidence research on treatment patterns reflected substantial HRU consistent with the severity of HCC, particularly in the high-AFP group. Findings highlighted continuing high mortality in HCC, underlying a need for new treatments that can lengthen survival. Results can inform future evaluations of new HCC treatments that estimate the health economic impact of their adoption in Taiwan.

Real-World Treatment Patterns and Health-Resource Utilization in Patients with Hepatocellular Carcinoma (HCC) Following Failure of Sorafenib: A Retrospective Chart Review of 127 Patients in South Korea.

BACKGROUND: European, US, Asian and Korean treatment guidelines all recommend sorafenib as first-line systemic therapy in patients with hepatocellular carcinoma (HCC). However, due to the emergence of several new treatments, post-sorafenib treatment patterns in real-world clinical practice are less well understood. OBJECTIVE: This study aimed to characterize current treatment patterns and healthcare resource utilization (HRU) in patients with HCC following the failure of first-line sorafenib in a real-world setting in Korea. PATIENTS AND METHODS: A chart review was conducted in 127 HCC patients who received systemic therapy or best supportive care following failure of first-line systemic treatment with sorafenib (2016-2018). Anonymized data on patient characteristics, treatment patterns, and survival were abstracted by 37 physicians in Korea. RESULTS: The mean (range) age of patients was 60 (37-79) years; 63 patients had low alpha-fetoprotein (AFP < 400 ng/mL), 64 patients had high alpha-fetoprotein (AFP ≥ 400 ng/mL). Post-sorafenib, 64 (50%) patients had systemic therapy. Regorafenib, used by 54 (84%) patients in second-line, and nivolumab monotherapy, by ten (56%) patients in third-line, were the most common therapies. Hepatologist visits and hospitalizations, at an average rate of 6.89 (95% CI 6.37-7.45) and 2.24 (95% CI 1.95-2.57) per patient-year, respectively, were the key contributors of HRU. The median overall survival (95% CI) from discontinuation of sorafenib was 13.0 (9.8-20.7), 6.5 (5.0-9.5) and 9.5 (6.7-12.3) months in the low AFP, high AFP and overall group, respectively. CONCLUSION: This real-world evidence research on treatment patterns reflected current clinical guidelines and highlighted fast progressing nature and continuing high mortality in HCC, especially among the high AFP group, underlying a need for new treatments that can lengthen survival. Results from this real-world chart review, together with existing clinical trial data, can inform future evaluations of new HCC treatments that estimate their health economic impact in Korea.

A systematic literature review of prognostic factors in patients with HR+/HER2- advanced breast cancer in Japan.

BACKGROUND: Breast cancer is the most prevalent cancer in women in Japan and the fifth in mortality. This systematic review summarized the evidence for prognostic factors for patients with HR+/HER2- advanced and metastatic breast cancer in Japan. METHODS: MEDLINE and EMBASE were searched with keywords 'breast neoplasms' AND 'Japan' AND 'advanced' or equivalent, and Japan Medical Abstract Society database with 'breast cancer' AND 'advanced/metastatic' for publications from January 2010 to October 2019. ASCO, ESMO, ABC4 abstracts and WHO website were hand searched. The endpoints of interest were overall survival, progression-free survival, tumour response and post-progression survival. Factors were evaluated based on the consistency in direction and the strength (hazard ratios) of association. RESULTS: Searches identified 4530 publications, of which 27 were eligible. All were observational studies. Among the endpoints, overall survival was the most commonly assessed (n = 22) and evaluated further. Ki-67 expression, progesterone receptor expression status, tumour grade and lymph node metastases were consistently associated with poor overall survival in univariate analysis but not in multivariate analysis. Short disease-free interval, the number of metastatic organs and liver metastasis were consistently associated with poor overall survival in both of univariate and multivariate analysis. The association was strong for liver metastasis (hazard ratio ≥2.8 in the majority of studies) and moderate for disease-free interval and the number of metastatic organs (hazard ratio 1.3-2.8 in the majority of studies). CONCLUSIONS: Disease-free interval, the number of metastatic organs and liver metastasis were identified as independent prognostic factors for overall survival. These findings may help clinical decision-making to improve outcomes in patients with HR+/HER2- advanced and metastatic breast cancer.

Treatment Patterns and Costs Associated with Stage IV Non-Small Cell Lung Cancer in a Mexican Population: A Chart Review.

BACKGROUND: The available evidence regarding the clinical characteristics, treatment patterns, adverse events (AEs), and costs of treating patients with stage IV non-small cell lung cancer (NSCLC) in Mexico is scarce. OBJECTIVE: Our objective was to describe the clinical characteristics, treatment patterns, and direct costs associated with Mexican patients diagnosed with stage IV NSCLC who had completed two or more lines of systemic antineoplastic treatment. METHODS: A multicenter retrospective cohort study was designed to collect data from the medical records of patients treated at tertiary-level public hospitals in Mexico (multicenter chart review). We calculated costs from the viewpoint of payers based on data regarding therapy and service utilization. RESULTS: A total of 115 patients were included. Median patient age was 61 years (interquartile range [IQR] 52.4-68.5), and 51.3% were female. The most common NSCLC type was non-squamous (92.2%), and the typical histology was adenocarcinoma (88.7%). All patients received first- and second-line therapy: 54.78% completed a third-line, 27.82% a fourth-line, 7.82% a fifth-line, 2.6% a sixth-line, and 1.7% a seventh-line active therapy. Carboplatin was the most frequently used therapy (28.6%) followed by docetaxel (23.3%), nivolumab (16.7%), and irinotecan (13.3%). AEs occurred in 53% of the patients and none was fatal. In total, 59 patients (51.3%) required hospitalization during the observation period. The median cost per patient was $US7039.40, with a minimum of $US628.30 and a maximum of $US3,557,364.20. Median overall survival of the cohort was 12 months (95% confidence interval 9.8-14.1). CONCLUSIONS: In Mexico, NSCLC is usually diagnosed at stage IV. This study shows considerable variation in chemotherapy regimens, leading to a wide range in treatment cost. The understanding of NSCLC treatment patterns in Mexico will help to identify and address unmet needs.

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.

Retrospective analysis of patients with locally advanced or metastatic gastric cancer in Argentina.

AIM: To assess patient and disease characteristics, treatment patterns and associated costs in patients with locally advanced or metastatic gastric cancer in Argentina, in the public and private sectors. METHODS: A historic cohort of patients who had received first-line chemotherapy treatment (platinum analog and/or a fluoropyrimidine) and were followed-up for at least three months after the last administration of a first-line cytotoxic agent were eligible. Case-report forms were prepared based on medical records from four Argentinian hospitals. Estimates of treatment costs were also calculated using the unit costs of the participating hospitals. RESULTS: Of 101 patients, more than three quarters (79.2%) were male, 41.6% were diagnosed with metastatic stage IV disease (mean age, 57.7years), and 27.7 % had a smoking history. Before locally advanced or metastatic gastric cancer diagnosis, 42.4% of the patients had received total gastrectomy. Ninety-seven percent of the patients received a doublet or triplet therapy, of which epirubicin in combination with oxaliplatin and capecitabine was the most common treatment (38%), followed by capecitabine plus oxaliplatin (29%). Around 36% of the patients responded to first-line treatment (complete and partial response). Out of the 76.2% of the patients who followed a second-line treatment, 37.7% were still administered a platinum analog and/or fluoropyrimidine. During the reported follow-up period, 50% of the patients progressed, and 32.8% had stable disease. The best supportive care consisted mostly of outpatient visits after last-line therapy (16.8%), palliative radiotherapy (16.8%), and surgery (30.7%). We observed significant differences between public and private hospital costs. CONCLUSIONS: Understanding treatment patterns in patients with locally advanced or metastatic gastric cancer may help address unmet medical needs for better patient management and improvement of their clinical outcome in Argentina.

OBJETIVO: Describir las características clínicas, los patrones de tratamiento y los costos asociados en pacientes con cáncer gástrico localmente avanzado o metastásico en Argentina, en los sectores público y privado. MÉTODOS: Una cohorte histórica de pacientes que recibieron tratamiento de quimioterapia de primera línea (análogo de platino y/o una fluoropirimidina) y fueron seguidos durante al menos tres meses después de la última administración de un agente citotóxico de primera línea fueron elegibles. Se extrajeron los datos a través de un cuestionario estructurado a partir de los registros médicos de cuatro hospitales argentinos. Las estimaciones de los costos de tratamiento también se calcularon utilizando los costos unitarios de los hospitales participantes. RESULTADOS: Entre los 101 pacientes, más de tres cuartas partes (79,2%) eran hombres, 41,6% fueron diagnosticados con enfermedad metastásica en estadio IV, la edad media fue de 57,7 años y el 27,7% tenían antecedentes de tabaquismo. Antes del diagnóstico de cáncer gástrico metastásico, el 42,4% de los pacientes habían recibido gastrectomía total. El 97% de los pacientes recibió una terapia doble o triplete, de los cuales el tratamiento más frecuente fue la epirubicina en combinación con oxaliplatino y capecitabina (38%), seguida de capecitabina + oxaliplatino (29%). Alrededor del 36% de los pacientes respondieron al tratamiento de primera línea (respuesta completa y parcial). Del 76,2% de los pacientes que siguieron un tratamiento de segunda línea, al 37,7% todavía se les administró un análogo de platino y/o fluoropirimidina. Durante el período de seguimiento, el 50% de los pacientes progresó y el 32,8% tenía enfermedad estable. La terapia de apoyo consistió principalmente en visitas ambulatorias después de la última línea de quimioterapia (16,8%), radioterapia paliativa (16,8%) y cirugía (30,7%). Se observaron diferencias significativas entre los costos de los hospitales públicos y privado. CONCLUSIONES: Comprender los patrones de tratamiento en pacientes con cáncer gástrico localmente avanzado o metastásico puede ayudar a abordar las necesidades médicas no satisfechas para un mejor manejo del paciente y la mejora de sus resultados clínicos en Argentina.

Retrospective analysis of patients with advanced or metastatic gastric cancer in Colombia.

Aims: To assess patient and disease characteristics, treatment patterns, and associated costs in patients with advanced or metastatic gastric cancer (A/MGC) in Colombia, in both the public and private hospitals. Materials and methods: A total of 145 patients who had received first-line chemotherapy treatment (platinum analog and/or a fluoropyrimidine) and were followed for at least 3 months after the last administration of a first-line cytotoxic agent were eligible for inclusion. Case-report forms were elaborated based on the patients' medical records from three Colombian hospitals. Estimates of treatment costs were calculated using unit costs from the participating hospitals. Results: Of the 145 patients, more than half (64.83%) were male, 79.56% were diagnosed with metastatic stage IV disease (mean age = 58.14 years). Prior to MGC diagnosis, 31.71% of the patients being operated on received a total gastrectomy; 66.9% of the patients received a doublet therapy, of which 5-fluorouracil (5-FU) in combination with cisplatin was the standard treatment (14%), followed by combination with leucovorin (12%). Only around 10% of the patients responded to first-line treatment. Out of 41.38% of the patients who received a second-line treatment, 71.67% were still administered a platinum analog and/or fluoropyrimidine. During the follow-up period, 52% of the patients progressed and 20% achieved stable disease. Best supportive care mostly consisted of outpatient visits after last line-therapy (72.41%), palliative radiotherapy (18.6%), and surgery (37.2%). Limitations and conclusions: Gastric cancer is one of the main causes of cancer-related death in Colombia, as most of the patients are diagnosed at an advanced stage, when prognosis is poor. Treatment patterns are highly heterogeneous. Second-line treatments were mostly initiated with paclitaxel, capecitabine, irinotecan, or cisplatin.

Characteristics and Treatment Patterns of Patients with Advanced Soft Tissue Sarcoma in Korea.

PURPOSE: A soft tissue sarcoma (STS) is a rare type of cancer, accounting for 1% of adult solid cancers. The aim of the present study is to determine the incidence of localized and advanced STS in Korean patients, their treatment patterns, and the survival of patients by disease status. MATERIALS AND METHODS: The STS patient cohort was defined using National Health Insurance Service medical data from 2002 to 2015. Incidence, distribution, anatomical location of tumors, survival rates (Kaplan-Meyer survival function) and treatment patterns were analyzed by applying different algorithms to the STS cohort containing localized and advanced STS cases. RESULTS: A total of 7,813 patients were diagnosed with STS from 2007 to 2014, 4,307 were localized STS and 3,506 advanced STS cases. The total incidence of STS was 2.49 per 100,000 person- years: 1.37 per 100,000 person-years for localized STS and 1.12 per 100,000 person-years for advanced STS. The 5-year survival rate after diagnosis was 56.4% for all STS, 82.4% for localized, and 27.2% for advanced STS. Half of the advanced STS patients (49.98%) received anthracycline-containing chemotherapy as initial treatment after diagnosis. CONCLUSION: This study provides insights into localized and advanced STS epidemiology, treatment patterns and outcomes in Korea, which could be used as fundamental data in improving clinical outcomes of STS patients in the future.

Treatment Patterns Among Patients with Metastatic and/or Unresectable Gastric Cancer in Brazil.

PURPOSE: In Brazil, patients with gastric cancer have not been systematically followed-up and evaluated, thus data regarding patterns of care and outcomes are scarce or missing. The objective of this study was to evaluate patterns of care of advanced gastric cancer in standard practice in Brazil. METHODS: This was an observational, multicenter, retrospective study, which included patients with metastatic and/or unresectable gastric cancer (MGC) who underwent at least one line of treatment. RESULTS: We analyzed data on 155 patients diagnosed with MGC, most are men (57.4%), with mean age of 61.9 years at diagnosis, with 99 (63.9%) from the public healthcare system and 56 (36.1%) from the private setting. Platinum- and/or fluoropyrimidine-containing regimens prevailed as first-line therapy, while irinotecan was the most used regimen in the second and in the third lines. More than 40% of patients underwent only one line of systemic therapy, of which around 40% either died during the treatment or went on to best supportive care (BSC) only. The remaining patients received further treatment lines. A fifth of the patients in the study died within two months after discontinuation of the first-line treatment. Adverse events, use of concomitant medications, support procedures, outpatient visits, and hospitalizations were reported for most patients, especially in the first and second lines of treatment and during exclusive BSC. CONCLUSIONS: Survival during or after the first-line chemotherapy remains poor among patients with MGC. Adverse events and health resource use were common in the first and second lines of treatment and in exclusive BSC. These results suggest that there is space for improvement in the treatment of MGC in Brazil.

Clinical outcomes of patients with major depressive disorder treated with either duloxetine, escitalopram, fluoxetine, paroxetine, or sertraline.

PURPOSE: To compare treatment outcomes in patients with major depressive disorder treated with duloxetine, escitalopram, fluoxetine, paroxetine, or sertraline for up to 6 months. PATIENTS AND METHODS: Data were taken from a 6-month prospective, observational study that included 1,549 major depressive disorder patients without sexual dysfunction in 12 countries. We report the overall results and those from Asian countries. Depression severity was measured using the Clinical Global Impression and the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16). Clinical and functional remissions were defined as having a QIDS-SR16 <6, and as having a rating of <3 on all three Sheehan Disability Scale items and no reduced productivity, respectively. Mixed effects modeling with repeated measures analysis and generalized estimating equation models were used. Propensity scores were included in the models. RESULTS: The mixed effects modeling with repeated measures regression models showed that the Clinical Global Impression rating during follow-up was significantly lower in those patients treated with duloxetine compared with escitalopram (0.40, 95% CI 0.25 to 0.56); fluoxetine (0.22, 95% CI 0.05 to 0.38); paroxetine (0.38, 95% CI 0.23 to 0.54); and sertraline (0.32, 95% CI 0.16 to 0.49). The QIDS-SR16 of duloxetine-treated patients was significantly lower than those treated with escitalopram (1.58, 95% CI 1.03 to 2.12); fluoxetine (1.48, 95% CI 0.90 to 2.06); paroxetine (1.53, 95% CI 1.00 to 2.07); and sertraline (1.19, 95% CI 0.61 to 1.78). The probability of clinical remission of the patients treated with escitalopram, fluoxetine, paroxetine, and sertraline was lower than those treated with duloxetine (OR 0.46, 95% CI 0.33 to 0.64; OR 0.42, 95% CI 0.29 to 0.61; OR 0.40, 95% CI 0.29 to 0.56; OR 0.50, 95% CI 0.35 to 0.71; respectively). The regression analysis of functional remission also showed more favorable results for duloxetine, with OR ranging from 0.43, 95% CI 0.31 to 0.60 for paroxetine to 0.49, 95% CI 0.35 to 0.70 for sertraline. The results for the Asian countries were generally consistent. CONCLUSION: Duloxetine-treated patients had better 6-month outcomes in terms of depression severity and clinical and functional remission, compared with selective serotonin reuptake inhibitor-treated patients.

Resources and Costs Associated with the Treatment of Advanced and Metastatic Gastric Cancer in the Mexican Public Sector: A Patient Chart Review.

BACKGROUND: Little evidence is available on the management and cost of treating patients with advanced or metastatic gastric cancer (GC). This study evaluates patient characteristics, treatment patterns, and resource utilization for these patients in Mexico. METHODS: Data were collected from three centers of investigation (tertiary level). Patients were ≥18 years of age, diagnosed between 1 January 2009 and 1 January 2015, had advanced or metastatic GC, received first-line fluoropyrimidine/platinum, and had ≥3 months follow-up after discontinuing first-line treatment. Data were summarized using descriptive statistics. RESULTS: The study sample totaled 180. Patients' mean age was 57.2 years (±12.4) and 57.0% were male; 151 (83.9%) patients received second-line chemotherapy. A total of 16 and 19 regimens were identified in first- and second-line therapy. Of the sample, 51 (28.3%) received third-line therapy, and <10% received more than three lines of active chemotherapy. Supportive care received in first- and second-line chemotherapy, included pain interventions (12.2 and 7.9%), nutritional support (3.3 and 1.3%), radiotherapy (6.1 and 16.6%), and transfusions (13.3 and 10.6%), respectively. Using Mexican Institute of Social Security (IMSS) tariffs, the average total cost per patient-month in first- and second-line therapy was US$1230 [95% confidence interval (CI) 1034-1425] and US$1192 (95% CI 913-1471), respectively. Administration and acquisition of chemotherapy comprised the majority of costs. CONCLUSIONS: This study shows considerable variation in first- and second-line chemotherapy regimens of patients with advanced or metastatic GC. Understanding GC treatment patterns in Mexico will help address unmet needs.

Impact of pain and remission in the functioning of patients with depression in Mainland China, Taiwan, and Hong Kong.

INTRODUCTION: The present study analyzes functioning during the course of treatment of a major depressive disorder in Mainland China, Taiwan, and Hong Kong. METHODS: Data in this post hoc analysis were taken from a 24-week prospective, observational study in 12 countries worldwide. Of these, 422 patients were included from Mainland China (N = 205; 48.6%), Taiwan (N = 199; 47.2%), and Hong Kong (N = 18; 4.2%). Functioning was measured with the Sheehan Disability Scale, pain with the Somatic Symptom Inventory, and depression severity with the Quick Inventory of Depressive Symptomatology Self Report 16. Patients were classified as having no pain, persistent pain, or remitted pain. A mixed model with repeated measures was fitted to analyze the relationship between pain and functioning, adjusting for severity and other factors. RESULTS: At baseline, 40% of the patients had painful physical symptoms. At 24 weeks, 6% of the patients had persistent pain. Sixty percent of the patients achieved remission. Patients with pain had a higher severity of depression score and lower functioning (P < .05) at baseline. At 24 weeks, patients with persistent pain had lower functioning (P < .05). The regression model found that clinical remission was associated with higher functioning at endpoint and that patients with persistent pain had lower functioning at endpoint when compared with the no-pain group. CONCLUSIONS: Patients presenting with pain had lower functioning at baseline. At 24 weeks, pain persistence was associated with significantly lower functioning as measured by the Sheehan Disability Scale. Clinical remission was associated with better functional outcomes. The course of pain was related to achieving remission.

Functional Impairment and Painful Physical Symptoms in Patients with Major Depressive Disorder Treated with Antidepressants: Real-World Evidence from the Middle East.

BACKGROUND: The Global Burden of Disease 2010 study reported the relative size of major depressive disorder (MDD) burden to be greater in the Middle East and North Africa than anywhere else. However, little research has been carried out to examine the comparative effectiveness of antidepressants in this region. OBJECTIVE: To assess and compare functioning levels in Middle Eastern patients with MDD treated with either duloxetine or a selective serotonin reuptake inhibitor (SSRI), and to examine the impacts of depression-related pain on functioning by the type of treatment. METHOD: This post-hoc analysis, which focused on Middle Eastern patients, used data from a 6-month prospective observational study that included 1,549 MDD patients without sexual dysfunction. Levels of functional impairment and depression-related pain were assessed using the Sheehan Disability Scale (SDS) and the modified Somatic Symptom Inventory, respectively. A mixed model with repeated measures (MMRM) was employed. RESULTS: The mean age of the patients was 37.3 (SD=8.4) years, and 34.6% were female. Patient functioning was, on average, moderately impaired at baseline, but improved substantially during follow-up in both the duloxetine (n=152) and the SSRI (n=123) cohorts. The MMRM results showed a lower level of functional impairment at 24 weeks in the duloxetine cohort than in the SSRI cohort (p<0.001). Pain severity at baseline was positively associated with functional impairment during follow-up only in the SSRI cohort (p=0.003). CONCLUSION: Duloxetine-treated MDD patients achieved better functioning than SSRI-treated patients. This treatment difference was partly driven by depression-related pain.