Common Treatment Regimen Research Articles

Epidemiological assessment of clinical poultry cases through the government veterinary hospital-based passive surveillance system in Bangladesh: a case study.

An epidemiological assessment of clinical poultry cases recorded through the existing passive surveillance at Kishoreganj District Veterinary Hospital during February-March 2016 was performed. A total of 200 cases (87 layers, 80 broilers, 21 ducks, and 12 pigeons) were included in this evaluation. The present study attempted to demonstrate the usefulness of passive surveillance data in quantifying the relative burden of poultry cases and their distribution along with drug prescription patterns. The cases were diagnosed based on clinical history, clinical signs, and observable post-mortem lesions by the registered veterinarian or intern veterinarian. The most prevalent diseases in chickens were infectious bursal disease (IBD) (31.7%; CI (confidence interval) 24.7-39.3%), coccidiosis (22.8%; CI 16.6-29.8%), Newcastle disease (ND) (21.6%; CI 15.5-28.5%), and coli-enteritis (8.4%; CI 4.6-13.6%). The most prevalent disease in ducks was duck plague (DP) (76.6%; CI 52.8-91.7%). Newcastle disease was most prevalent (66.7%; CI 34.8-90.0%) in pigeons. Infectious bursal disease, aspergillosis, and colibacillosis respectively were seen in a higher proportion of cases in broiler chickens than in layer chickens (58.7%, 12.5%, and 11.2% vs. 6.9%, 1.1%, and 3.4%; p ≤ 0.05). Contrarily, ND was seen in greater proportion of cases in layer chickens (32.1%) than in broiler chickens (10.0%) (p < 0.001). Infectious bursal disease, ND, coccidiosis, and aspergillosis were higher in older age broilers than in younger broilers (p ≤ 0.05). Antibiotics were often used to treat the poultry diseases such as trimethoprim with sulpha drugs (41%), ciprofloxacin (39%), sulphadiazine (27.5%), and erythromycin (26%). Through the present study, we can see how a passive surveillance system would be an effective tool for delineating disease distributions and common treatment regimens, thus helping to mitigate disease prevalence.

Treatment, HSCT Patterns, and Survival of Elderly Diffuse Large B-Cell Lymphoma Patients in the SEER-Medicare Linked Database

Introduction: Diffuse large B-cell lymphoma (DLBCL) is an aggressive, sometimes fatal hematologic malignancy and is the most common subtype of Non-Hodgkin's Lymphoma. DLBCL has been readily treated with long, durable remissions with the introduction of rituximab to standard chemotherapy in 1997. The most common front line therapy used to treat DLBCL patients is R-CHOP (Rituximab + Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). Since DLBCL is primarily a disease of the elderly, the Surveillance, Epidemiology, and End Results program linked with Medicare (SEER-Medicare) database was queried for adult patients (66 years and older) to describe the characteristics of elderly DLBCL patients, current treatment patterns and regimen changes over time, receipt of any type of hematopoietic stem cell transplantation (HSCT), and overall survival.Methods: This retrospective cohort study included adult patients aged 66 years and older newly-diagnosed with DLBCL from 2001 - 2013 and with continuous enrollment in Medicare parts A and B one year prior to diagnosis. Outcomes of interest included most common treatment regimens, overall survival, and receipt of stem cell transplantation. Descriptive statistics and various subgroup analyses were conducted. Kaplan-Meier overall survival proportions and HSCT proportions were estimated.Results: The cohort included 18,058 patients with a median age of 78 at DLBCL diagnosis. About 19% of patients were 66-70, 22% were 71-75, 23% were 76-80, and 36% were 81 or older. There were slightly more females than males (53% vs. 47%), 88% of patients with non-missing race were Caucasian, 4% Asian, 4% Black, and 2% Hispanic. Among the 69% of patients who received treatment after diagnosis of DLBCL, R-CHOP was the most common front line therapy, followed by rituximab in combination with other chemotherapy agents, and rituximab mono-therapy (Table 1). Approximately 30% of patients survived until the end of follow-up. Overall survival of DLBCL patients improved the more recently they were diagnosed. Median survival of patients diagnosed in the most recent years (2010 - 2013) was nearly twice as long as those diagnosed in the earliest years (2001 - 2003) at approximately 922 days (~2.5 years) compared to 484 days (~1.3 years) (Figure 1). At five years post-diagnosis, estimated survival probabilities by year of diagnosis were 0.32 (2001 - 2003), 0.34 (2004 - 2006), 0.36 (2007 - 2009), and 0.39 (2010 - 2013). Approximately 20% of patients received stem cell transplantation during follow-up. In the first six months following diagnosis, HSCT occurred in <1% diagnosed from 2001 - 2003; 16% of those diagnosed from 2004 - 2006; 26% of those diagnosed from 2007 - 2009; and 31% of those diagnosed from 2010 - 2013. On average, HSCT patients differed from non-HSCT patients significantly (p<0.001) by later year of diagnosis (Figure 2), younger age, and less comorbidity burden.Conclusion: The large sample size and recent data are advantageous in describing temporal changes in treatment strategies and overall survival of DLBCL patients. Over time, the use of CHOP as a front line therapy without rituximab nearly diminished. Overall survival estimates indicate that survival rates have steadily improved in more recent years; however, 5-year survival is still less than 40%, suggesting the need for improved treatment options. Stem cell transplants became increasingly more common for the more recently diagnosed patients, and usually occurred within the first six months after DLBCL diagnosis. HSCT recipients were also more likely to be younger and have less comorbidity burden. These data provide insight into current treatment strategies of DLBCL, the types of patients receiving stem cell transplants, and changes that have occurred over time. [Display omitted] DisclosuresKim:Amgen: Employment, Equity Ownership.

Baseline Characteristics of 412 Hodgkin's Lymphoma Patients Diagnosed between July 2015 and May 2018: A Report from China Lymphoma Patient Registry (CLAP)

IntroductionLymphoma is the most common hematologic tumor with about 88000 newly diagnosed cases in China in 2015 (Chen et.al, CA Cancer J Clin 2016). To better understand the epidemiology, treatment and prognosis of lymphoma in China, Beijing Cancer Hospital and other four hospitals jointly launched China Lymphoma Patient Registry (CLAP) study (NCT03313271) in early 2017. By the end of March 2018, a total of 3458 lymphoma patients, including 412 Hodgkin's Lymphoma (HL) cases and 3046 Non-Hodgkin's Lymphoma (NHL) cases, had been prospectively and retrospectively recruited. Here we report the baseline characteristics and initial treatment of HL patients diagnosed between July 2015 and March 2018.MethodThis is an observational bi-directional cohort study based on medical records of hospitalized lymphoma patients. Inclusion criteria of this study include: 1) newly diagnosed as HL after July 2015 in five participating hospitals; 2) age >=18 yrs old at time of disease diagnosed; 3) given informed consent if prospective follow-up is needed. This study has been approved by Institutional Review Board (IRB) of all study sites. Medical records of newly diagnosed adult HL patients in five participating hospitals were systematically reviewed. Study data, including patient demographic information, disease baseline characteristics, treatment options and prognosis were manually entered or directly transferred into a predesigned electronic database with the support of Medbanks Network Technology Co., Ltd. In this study, descriptive analysis was used to understand the distribution of patient demographic information (age, gender, medical history, etc.), disease baseline characteristics (symptom, score, stage, etc.) and initial treatment option (if ABVD) for HL population as a whole as well as by subtype stratification.ResultA total of 412 HL patients were identified between July 2015 and March 2018. Among all HL patients, nodular sclerosis type of classic Hodgkin's lymphoma (NSCHL) was the most common subtype (53.6%) followed by mixed cell type of classic Hodgkin's lymphoma (MCCHL) (23.1%)(Figure1). All classic subtypes accounted for over 93% of all HL patients. Male is more common than female (60.4%vs39.6%), especially for nodular lymphocytes predominant type of HL (NLPHL). However, no statistical significant gender difference was observed across different subtypes. Age of NSCHL patients was relative younger than patients with other subtypes with a median age of 31. The general health status of most HL patients was relative good at first diagnosis, the percentage (excluding missing) of patient with recorded B symptoms and ECOG score >=2 were 42.4% and 2%, respectively. The distribution of clinical staging was 4.9%, 46.1%, 18.2% and 26.5% for I-IV respectively. Doxorubicin, Bleomycin, Vincristine, Dacarbazine (ABVD) contained regimen was the most common initial treatment regimen and was received by 72% of HL patients and no statistical significant difference was observed in term of ABVD use across HL subtypes (Table1). Hypertension was the most common comorbidity and 7% HL patients had reported concomitant hypertension followed by diabetes (4.4%), hepatitis B (1.9%) and tuberculosis (1.0%) (Figure2). Previous personal history of cancer and family history of cancer were reported by 1.7% and 9.2% of study subjects, respectively (Figure3).ConclusionCompared with Non-Hodgkin's Lymphoma, HL is less common, less aggressive and attracts less attention from researchers. In 2013, only about 700 HL newly diagnosed cases were reported, accounting for 5.4% of total lymphoma patients in the country (He, Chen, Chinese Cancer Registry Annual Report 2016). Although some multi-center studies had reported the pathology distribution of HL (Sun et.al, Am J Clin Pathol 2012; Cao et.al, Ann Diagn Pathol. 2018), very few of them have more detailed information on disease characteristics and treatment. As one of the biggest observational studies focus on HL in the country as well as in the region, this registry provides a unique opportunity and platform to understand the whole picture of HL diagnosis, treatment and prognosis in real world. DisclosuresSong:Peking University Cancer Hospital (Beijing Cancer Hospital): Employment. Zhu:Beijing Cancer Hospital: Employment.

Real World Treatment Patterns, Adverse Events and Healthcare Resource Utilization and Costs Among Chronic Lymphocytic Leukemia (CLL) Patients in the United States

Background: CLL is one of the most common types of leukemia among adults. Treatment options for CLL have expanded in recent years, but few studies provide contemporary real-world data on treatment patterns, treatment-related adverse events (AEs) and the economic burden associated with these agents. This study aimed to evaluate treatment-related AEs and the healthcare resource utilization (HCRU) and cost associated with the current treatment for chronic lymphocytic leukemia (CLL).Methods: This retrospective study used medical and pharmacy claims from the Optum Research Database, a large national US database, to identify adults (≥ 18 years old) commercially insured and Medicare Advantage (MA) enrollees. The study included patients with CLL (≥ 2 medical claims at least 7 days apart between July 1, 2012, through May 30, 2017), at least 1 claim for systemic CLL-directed therapy and continuous enrollment for 12 months prior to (baseline period) and ≥ 1 month after the first observed CLL-directed therapy (index date). Patients with systemic CLL-directed therapy during the baseline period or undergoing stem cell transplantation during the entire study period were excluded from analysis. Up to 3 line of therapy (LOT) periods were captured based on timing and receipt of systemic CLL-directed therapy. Cohorts based on the most common regimens received, regardless of LOT sequence, were created. Potential treatment-related AEs (prevalent and incident conditions) during regimen cohorts were identified by ICD-9 and ICD-10 diagnosis codes in position 1 or 2 on claims. All-cause and AE-related healthcare resource utilization and costs (per patient per month (PPPM)) were examined. All analyses were descriptive.Results: A total of 3292 patients with CLL met all study criteria; 65% were MA enrollees and 35% were commercially insured. Mean age (standard deviation, [SD]) was 71 years (SD 11) with a baseline Charlson comorbidity index score of 3.5 (SD 1.9). During the study period, 31% of patients had ≥ 2 LOTs and 10% had ≥ 3 LOTs. The most common regimens (excluding rituximab maintenance therapy) observed by LOT were; bendamustine + rituximab (23%) during LOT1, ibrutinib (22%) during LOT2 and ibrutinib (17%) during LOT3. Among the study patients, 4,509 LOT periods (LOT1-LOT3) were observed. Of these periods, 3177 accounted for the 5 most common treatment regimens observed: rituximab (excluding maintenance therapy) (30%); bendamustine + rituximab (28%); ibrutinib (20%); obinutuzumab ± chlorambucil (14%); and cyclophosphamide + fludarabine + rituximab (8%). The most common AEs associated with these treatment regimens are reported in the Table.Conclusions: The most common regimen during LOT1 was bendamustine + rituximab, and was ibrutinib during LOT2 and LOT3.This study provides evidence that occurrence of AEs among patients with CLL receiving systemic anti-cancer therapy in the real-world setting is substantial and associated with significant health care cost. The economic burden associated with increased AEs underscores the need for treatments with fewer AEs. DisclosuresKabadi:AstraZeneca: Employment. Le:Optum: Employment; Optum/United Health Group: Equity Ownership. Dacosta Byfield:Optum/United Health Group: Equity Ownership; Optum: Employment. Olufade:AstraZeneca: Employment; AstraZeneca: Equity Ownership.

Long Term Radiographic and Clinical Course in Chest Wall Toxicity following Thoracic Stereotactic Body Radiation Therapy

Stereotactic Body Radiotherapy (SBRT) for malignant lung lesions is known to potentially cause chest wall (CW) toxicity, however the long term course of these side effects is not well described. We hypothesize that radiation-induced rib fractures frequently do not radiographically heal fully and are closely associated with prolonged CW pain in areas of high doses. One-hundred ten lung tumors treated with SBRT in 101 patients (61 female, 40 male) were retrospectively analyzed. Only patients with a minimum follow up of 2 years were included. The most common treatment regimen was 48GY/4fx. The incidence, clinical course, and related dosimetric and clinical factors of CW toxicity are analyzed. In addition, the radiographic appearance of radiation induced rib fractures and their healing process are characterized. Statistical results were obtained using Mann-Whitney U-test and Chi-Square test. Mean follow up was 48 months (range 24-100), mean age at treatment of 68 years (range 47-91). Overall, 29% (32/110) of treatments resulted in rib fractures (cumulative 50 fractured ribs) after on average 23 months (range 1-46). Of the 32 treatments resulting in rib fracture, 66% (20/32) developed CW pain and 56% (18/32) fractured more than one rib, including 10 treatments with 3 or more resulting rib fractures. 31% (34/110) treatments resulted in CW pain occurring at a mean time of 12 months (range 1-50) with mean duration of 22 months (range 2-63); 38% (13/34) had ongoing pain at time of last follow up . Interestingly only 62% (20/34) treatments with CW pain had associated rib fractures. Clinically, women and African Americans were more likely to develop rib fractures (p<0.01 and p=0.01 respectively); while older patients and women were more likely to develop CW pain (p=0.02 and p=0.006 respectively). CW V20Gy, V30Gy, V40Gy, Dmax and D30cc were higher in patients with rib fractures (p<0.05 in all). The PTV was abutting CW in all but 1 patient who developed rib fractures while the mean distance to CW in patients without rib fracture was 1cm (range 0-4.4); p=0.016. Radiographically, only 16% (8/50) ribs were fully healed at last imaging, 76% (38/50) displayed soft tissue fibrosis and 20% (10/50) had commuted fractures. Bone Density was measured but no differences were found between patients with or without rib fracture or CW pain (p>0.05). Thoracic SBRT is associated with a non-negligible risk of rib fracture and CW pain which can occur late after RT. Radiation induced rib fractures are unlikely to fully heal radiographically and can subsequently result in CW pain with long duration. High doses to the CW are most likely to put patients at risk and should be minimized as much as possible, particularly in females.

Adverse events, resource use, and economic burden associated with mantle cell lymphoma: a real-world assessment of privately insured patients in the United States

In view of recent therapeutic advances in mantle cell lymphoma (MCL), the aim of this retrospective cohort analysis was to assess treatment patterns, adverse events (AEs), resource utilization, and health care costs in patients with MCL in a US-based commercial claims database. A total of 783 patients with MCL (median age = 65 years) were selected. Among patients receiving systemic therapy (n = 457), the most common treatment regimens were bendamustine/rituximab (BR) (41.1%), rituximab/cyclophosphamide/doxorubicin/vincristine (RCHOP) (26.7%), rituximab monotherapy (20.4%), and ibrutinib monotherapy (14.2%). Mean monthly costs during treatments with BR, RCHOP, rituximab, and ibrutinib were $12,958, $24,719, $13,153, and $21,690, respectively. Mean monthly cost during follow-up was $13,650 among patients with ≥6 AEs versus $5131 among those without AEs. The costs of MCL varied considerably by treatment regimen and care setting. The overall economic burden of managing patients with MCL can be substantially affected by costs associated with managing AEs occurring during treatment.

The Use of β-Blockers for the Treatment of Periocular Hemangiomas in Infants: A Report by the American Academy of Ophthalmology

To review the published literature assessing the efficacy of β-blockers for the treatment of periocular hemangioma in infants. Literature searches were conducted in May 2018 in PubMed with no date restrictions and limited to studies published in English and in the Cochrane Library database without any restrictions. The combined searches yielded 437 citations. Of these,16 articles were deemed appropriate for inclusion in this assessment and assigned a level of evidence rating by the panel methodologist. None of the 16 studies included in this assessment were rated level I, 3 were rated level II, and 13 were rated level III. The most common treatment regimen was 2 mg/kg daily oral propranolol, but intralesional and topical β-blockers were also used. Treatment effect was most often measured in terms of reduction in the size of the lesions, which occurred in the majority of patients. β-Blockers were consistently shown to reduce astigmatism, but this reduction was shown to be statistically significant in only 2 series. The effect of β-blockers on amblyopia was not adequately documented. β-Blockers were generally well tolerated and had mild side effects (fatigue, gastrointestinal upset/diarrhea, restlessness/sleep disturbances, minor wheezing, and cold extremities). Complications severe enough to require cessation of treatment occurred in only 2 patients out of a total of 229 who received β-blockers. There is limited evidence to support the safety and efficacy of both topical and systemic β-blockers to promote regression of periocular hemangiomas. Additional research may confirm the best dosage and route of administration to maximize efficacy in reducing induced astigmatism and amblyopia associated with periocular hemangiomas while minimizing side effects.

Risk and Relevance of Insulin Pump Therapy in the Aetiology of Ketoacidosis in People with Type 1 Diabetes.

The aim of this systematic data analysis was to determine the prevalence of diabetic ketoacidosis (DKA) as well as hypoglycemic and hyperglycemic disorders during insulin pump therapy (CSII) in patients with type 1 diabetes. The main focus was to investigate whether CSII patients have more DKA than the general type 1 diabetes population. This retrospective study with patients who were treated in our treatment center from 2003 to 2016 includes data from 229 patients (52.4% male, 47.6% female, 37.2±16.3 years; DKA: 93, hypoglycemia: 66, hyperglycemia: 70). Intensified insulin therapy was the most common treatment regimen in the study cohort (73.4%), followed by CSII (24%). However, 32.3% of the patients with DKA were on CSII. This number of DKA cases among the insulin pump users in our study cohort was higher than the prevalence reported in a previously published study by Reichel et al. (2013; p<0.05) and in a customer database (p<0.005). Most common causes of DKA in our study cohort were patient errors (43.3%) or insulin resistance induced by an underlying infection (29.8%). Device malfunction caused 13.5% of all DKA cases with an overwhelming majority on insulin pump treatment (93%). Overall, patient errors caused more DKA cases than device malfunctions. Our findings suggest that despite development of more sophisticated insulin pump devices, DKA is still more frequent with CSII than with other kinds of insulin treatment.

Treatment of Helicobacter pylori infection in atrophic gastritis.

Helicobacter pylori (Hp) is a major human pathogen causing chronic, progressive gastric mucosal damage and is linked to gastric atrophy and cancer. Hp-positive individuals constitute the major reservoir for transmission of infection. There is no ideal treatment for Hp. Hp infection is not cured by a single antibiotic, and sometimes, a combined treatment with three or more antibiotics is ineffective. Atrophic gastritis (AG) is a chronic disease whose main features are atrophy and/or intestinal metaplasia of the gastric glands, which arise from long-standing Hp infection. AG is reportedly linked to an increased risk for gastric cancer, particularly when extensive intestinal metaplasia is present. Active or past Hp infection may be detected by conventional methods in about two-thirds of AG patients. By immunoblotting of sera against Hp whole-cell protein lysates, a previous exposure to Hp infection is detected in all AG patients. According to guidelines, AG patients with Hp positivity should receive eradication treatment. The goals of treatment are as follows: (1) Cure of infection, resolution of inflammation and normalization of gastric functions; (2) possible reversal of atrophic and metaplastic changes of the gastric mucosa; and (3) prevention of gastric cancer. An ideal antibiotic regimen for Hp should achieve eradication rates of approximately 90%, and complex multidrug regimens are required to reach this goal. Amongst the factors associated with treatment failure are high bacterial load, high gastric acidity, Hp strain, smoking, low compliance, overweight, and increasing antibiotic resistance. AG, when involving the corporal mucosa, is linked to reduced gastric acid secretion. At a non-acidic intra-gastric pH, the efficacy of the common treatment regimens combining proton pump inhibitors with one or more antibiotics may not be the same as that observed in patients with Hp gastritis in an acid-producing stomach. Although the efficacy of these therapeutic regimens has been thoroughly tested in subjects with Hp infection, there is a paucity of evidence in the subgroup of patients with AG. Bismuth-based therapy may be an attractive treatment in the specific setting of AG, and specific studies on the efficacy of bismuth-based therapies are needed in patients with AG.

Heterogeneity of Second-Line Treatment for Patients With Multiple Myeloma in the Connect MM Registry (2010-2016)

BackgroundThe treatment landscape for multiple myeloma (MM) has undergone recent changes with the regulatory approval of several new therapies indicated for second- and later-line disease. Using data from Connect MM, the largest multisite, primarily community-based, prospective, observational registry of MM patients in the United States, selection of second-line treatments was evaluated during a 5-year period from 2010 to 2016. Patients and MethodsEligible patients were aged ≥ 18 years, had newly diagnosed MM ≤ 2 months before study entry, and were followed for up to 8 years. Patients who received ≥ 2 lines of therapy were analyzed. “Tepee” plots of stacked area graphs differentiated treatments by color to allow visualization of second-line treatment trends in MM patients. ResultsAs of February 2017, 855 of 2897 treated patients had progressed to second-line treatment. Treatment selection was heterogeneous; shifting patterns of treatment choices coincided with the approval status of newer agents. The most common treatment regimens in the early part of the decade were lenalidomide and/or bortezomib, with or without dexamethasone, with increasing use of newer agents (carfilzomib, pomalidomide, daratumumab, and elotuzumab) and triplet combinations over time. The influence of the baseline patient characteristics of age, history of diabetes, peripheral neuropathy, and renal function on treatment choice was also examined. ConclusionThese findings indicate that community physicians are current in their MM management practices, with uptake of new drugs and acquaintance with results of randomized clinical trials using combinations almost concurrent with their regulatory approval and publication.

Outcomes of Treatment for Latent Tuberculosis Infection in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy.

Treatment for latent tuberculosis infection (LTBI) is of particular concern in patients with inflammatory bowel disease (IBD) initiating biologic therapies to prevent tuberculosis (TB) reactivation. This study aimed to evaluate the effectiveness of LTBI treatment in IBD patients receiving biologic therapy. There was a retrospective review of all IBD patients diagnosed with LTBI following a tuberculin skin test (TST) and/or interferon gamma release assay (IGRA) and who received biologic therapy between 2002 and 2016. The primary outcome was tuberculosis reactivation after completion of LTBI treatment. Three-hundred twenty-nine IBD patients were identified, and 35 (27 Crohn's disease; 8 ulcerative colitis) met the study inclusion criteria. The mean age was 38.3 years, and 68.6% were male. The most common LTBI treatment regimen was isoniazid (INH) for 9 months (74%). Biologic therapies used were infliximab (40%), adalimumab (29%), vedolizumab (20%), and certolizumab pegol (11%). Combination therapy with an immunomodulator was administered in 57% of cases. The median time from initiation of LTBI treatment to biologics was 43 days. The mean duration of follow-up was 2.9 years. The estimated median annual risk of TB reactivation without treatment was 0.52% by a prediction formula. Only 1 patient taking adalimumab monotherapy developed reactivation of TB several years after completing 6 months of isoniazid therapy. The estimated TB reactivation rate was 0.98 cases per 100 patient-years of follow-up in our cohort. Treatment for LTBI in patients with IBD treated with biologics is effective but does not eliminate the risk of reactivation. 10.1093/ibd/izy133_video1izy133.video15776720675001.

Emergence of Mycobacterium simiae: A retrospective study from a tertiary care center in Lebanon.

ObjectiveThe objective of this study is to describe the clinical significance of Mycobacterium simiae at a major tertiary care center in Lebanon.MethodsThis is a retrospective study of patients with positive cultures for M. simiae isolated between 2004 and 2016 at the American University of Beirut Medical Center.ResultsThis study included 103 M. simiae isolates recovered from 51 patients. Their mean age was 62.7 years. The majority were males and smokers. Specimens were mostly from respiratory sources (97%). Common comorbidities included chronic lung disease (such as chronic obstructive pulmonary disease), solid tumor, systemic disease, and diabetes mellitus. Productive cough and dyspnea were the most common symptoms. Frequent radiographic findings were infiltrates and nodules on chest X-ray and nodules, infiltrates, and bronchiectasis on chest computed tomography scan. Among 18 tested isolates, 5.8% were resistant to clarithromycin, 11.7% to amikacin, and 70–100% to other antimicrobials. Out of 13 patients receiving early treatment, 5 noted improvement, one had recurrence of symptoms, two received alternative diagnosis, and five died. Two of those deaths were related to M. simiae. Common treatment regimens included clarithromycin in different combinations with trimethoprim-sulfamethoxazole, moxifloxacin, and amikacin. Moreover, clofazimine was used in only two patients whose isolates were resistant to all but one agent. Duration of treatment ranged from 6–24 months.ConclusionIn Lebanon, M. simiae is increasingly encountered with true infection rates of at least 47%. Furthermore, the prevalence of multidrug resistance among the Lebanese M. simiae isolates is very high limiting the treatment options.

Rituximab in combination with chemotherapy for the treatment of chronic lymphocytic leukaemia in clinical practice.

This study was conducted to investigate the real-world effectiveness and tolerability of rituximab-containing chemoimmunotherapies, which have become the standard of care for chronic lymphocytic leukaemia (CLL), particularly for physically fit patients. Furthermore, current treatment patterns in clinical practice were documented, and an unselected real-life population was compared with older, comorbid patients. Prospective, multicentre, observational study with rituximab-containing chemoimmunotherapy in CLL patients. Of 681 patients in total, 485 were enroled in cohort 1 (unselected) and 196 in cohort 2 (comorbid "slow-go" patients). The median patient age was higher than in most randomised controlled trials (cohort 1: 70years and cohort 2: 75years). The most common treatment regimen in both first-line and relapsed patients was rituximab-bendamustine. Two-year progression-free survival rate for first-line therapy was 84.1% for cohort 1 and 69.8% for cohort 2 (with best overall response rate 81.8% for cohort 1 and 76.6% for cohort 2). General and B-symptoms declined during treatment and remained at low level or decreased further until study end. The safety profile observed in randomised clinical trials was confirmed. Chemoimmunotherapy with rituximab is feasible and safe in a wide variety of clinical settings in CLL, including the treatment of older patients with comorbidities (ClinicalTrials.gov NCT01178086).

Effects of Aflibercept for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis of Observational Comparative Studies.

PurposesTo compare the effects of aflibercept and other anti-vascular endothelial growth factor (anti-VEGF) medications on both functional and anatomical outcomes for treatment-naïve neovascular age-related macular degeneration (nAMD) in the real world.MethodsA systematic review and meta-analysis of observational comparative studies.ResultsA total of 18 studies remained after literature selection and quality assessment of 1697 studies. The most common aflibercept treatment regimen was three monthly injections followed by pro re nata (PRN). Aflibercept and ranibizumab had similar effects in 2-year treatment. At 3, 6, 12, and 24 months, the differences in the logarithm of minimum angle of resolution (logMAR) decrease in aflibercept and ranibizumab groups were 0.00 (95% confidence interval [CI]: −0.03 to 0.02); 0.01 (95% CI: −0.02 to 0.05); −0.03 (95% CI: −0.07 to 0.01); and –0.06 (95% CI: −0.30 to 0.17), respectively; the differences in decrease of central retinal thickness (CRT) were 3.25 μm (95% CI: −15.03 to 21.53); 7.89 μm (95% CI: −31.91 to 47.69); 2.89 μm (95% CI: −18.33 to 24.11); and −2.42 μm (95% CI: −77.87 to 73.03), respectively. However, aflibercept was significantly more effective in patients with initial reduced visual acuity (logMAR >0.6 or <55 letters; P = 0.001). In the first year, treatment frequency was not significantly different for aflibercept and ranibizumab, but aflibercept required fewer injections than ranibizumab with PRN regimen (mean −0.90; 95% CI: −1.80 to 0.00).ConclusionsAflibercept has comparable effects with ranibizumab for treatment-naïve nAMD in the real world, and may be more effective for patients with initial lower visual acuity.

Clostridium difficile Infection in Hematopoietic Stem Cell Transplant Patients: A Single-center Experience

BackgroundC. difficile infection (CDI) is the most common cause of nosocomial infections in U.S. and leading cause of gastroenteritis associated death. Incidence of CDI in hematopoietic stem cell transplant (HSCT) patients has been reported between 5.7% to 24.7% during first year after HSCT. Literature review reveals many risk factors i.e., allogenic-HSCT, extremes of age, myeloablative conditioning, prior vancomycin resistance (VRE) colonization, pre-transplant C. difficile colonization, severe mucositis, graft vs. host disease (GVHD), duration and type of antibiotics used, immunosuppression, proton pump inhibitor use and NAP1 C. difficile strain.MethodsTo study incidence and different variables for CDI, we performed a retrospective review of medical records of adult patients who underwent HSCT between 2013 and 2016 at our center. REDCap database was used to record key variables related to each patient’s HSCT and CDI, keeping in mind HIPPA guidelines. Categorical data were summed up as percentages and counts and numeric data as means, medians, standard deviations and ranges.ResultsA total of 181 HSCT recipients were included. Incidence of CDI was 10% (18 Patients). Cohort’s most common underlying malignancy was multiple myeloma (35.4%). 70% had autologous HSCT and 30% had allogenic HSCT. Among allogenic transplants, 53% had matched unrelated donor. Peripheral blood was the most common stem cell source (93%). Most common myeloablative conditioning regimen was melphalan (70%). 27% patients were on PPIs. 4% had PEG/NG tube placed and 12% were on TPN. 10% had diabetes mellitus. 5 patients had previous episodes of CDI. 69% developed mucositis. 5% patients developed acute GVHD. 6% had VRE colonization while 66% had no documentation for VRE. Out of positive CDI cases, 17% were NAP1 positive. No episode of ileus or mega colon was documented. Most common treatment regimen were metronidazole 500 mg per orally every 8 hourly (65%) and vancomycin 125 mg per orally four times a day (58.8%).ConclusionThis single-center study demonstrates that CDI has 10% incidence in patients undergoing HSCT. Risk factors include neutropenia, high dose chemotherapy, mucosal damage and provision of broad spectrum antibiotic prophylaxis. Data on CDI prophylaxis in these patients is emerging and randomized prospective trials are needed.Disclosures All authors: No reported disclosures.

Daily Opioid Use Fluctuates as a Function of Pain, Catastrophizing, and Affect in Patients With Sickle Cell Disease: An Electronic Daily Diary Analysis

Chronic opioid therapy is a common treatment regimen for patients with sickle cell disease (SCD), a chronically painful recessive hemoglobinopathy. The collective risk profile of chronic opioid therapy necessitates an understanding of which pain-related factors, such as affect and pain catastrophizing, are associated with the ebbs and flows of opioid use in daily life, a topic that has received very little attention among patients with any type of chronically painful condition, including SCD. We therefore investigated the variability of day-to-day patterns of short- and long-acting opioid use and their associations with pain and pain-related cognitive and affective processes in daily life among patients with SCD using a nightly electronic diary (N = 45). Opioid use was self-reported and converted into oral morphine equivalents for analysis, which was conducted with mixed effects modeling. Results indicated that greater pain and pain catastrophizing were associated with greater use of short-acting opioids, and negative affect was associated with greater use of long-acting opioids. Additionally, the association of pain and short-acting opioid use was moderated by pain catastrophizing, showing that opioid use was elevated when patients catastrophized about their pain, even if they reported low levels of pain. These findings suggest that monitoring pain-related cognitive and affective variables may be a useful approach to understanding risk for problematic opioid use in patients with daily pain. PerspectiveThe present study shows that pain and pain-related cognitive and affective variables are associated with daily variation in prescription opioid use in SCD. The findings may have broad implications for tracking and defining risk for prescription opioid misuse in patients with daily pain.

Chinese acute ischemic stroke treatment outcome registry (CASTOR): protocol for a prospective registry study on patterns of real-world treatment of acute ischemic stroke in China

RationaleStroke presents a serious health problem in China. Despite progresses made in recent years, there is still a lack of effective treatments for acute ischemic stroke (AIS) in clinical practices.AimsThe Chinese Acute Ischemic Stroke Treatment Outcome Registry (CASTOR) is designed to evaluate the patterns and cost-effectiveness of current treatments for AIS in real-world settings in China.DesignCASTOR is a prospective, multi-center study registered with ClinicalTrials.gov (NCT02470624) with a target sample size of 10,000 patients who are experiencing AIS. The patients are treated for AIS following the Chinese stroke guideline and local practice. Real-world data on treatment regimens, outcomes and costs are collected at baseline (Visit 1) and during subsequent visits (Visit 2 to Visit 5) after medication treatments.OutcomeThe primary objective of the present study is to analyze the current treatment status of AIS in real world settings. The secondary objectives include: 1) to compare the effectiveness of common treatment regimens, 2) to analyze the cost-effectiveness of different treatment regimens for AIS, 3) to analyze the incidence of adverse events and complications in enrolled patients with AIS, 4) to analyze the effect of Trial of Org 10,172 in Acute Stroke Treatment (TOAST) classification on the specific therapies during acute phase treatment period.DiscussionIn face of changing treatment patterns and increasing demand from medical insurers for cost-effectiveness data in China, a large-scale registry study examining the real-world patterns of AIS in hospitals is needed. The CASTOR study will help to find favorable cost-utility treatment regimens for AIS and improve the overall treatment outcome of Chinese patients with AIS.

A multicenter survey of first-line treatment patterns and gene aberration test status of patients with unresectable Stage IIIB/IV nonsquamous non-small cell lung cancer in China (CTONG 1506)

BackgroundIn recent years, systemic chemotherapy and molecular targeted therapy have become standard first-line treatments for locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). The objective of this survey was to investigate first-line anticancer treatment patterns and gene aberration test status of patients with advanced nonsquamous NSCLC in China.MethodsPatients included in this study had unresectable Stage IIIB/IV nonsquamous NSCLC and were admitted during August 2015 to March 2016 into one of 12 tertiary hospitals throughout China for first-line anticancer treatment. Patient data (demographics, NSCLC histologic type, Eastern Cooperative Oncology Group [ECOG] Performance Status [PS], gene aberration test and results [if performed], and first-line anticancer treatment regimen) were extracted from medical charts and entered into Medical Record ion Forms (MERAFs), which were collated for analysis.ResultsOverall, 1041 MERAFs were collected and data from 932 MERAFs were included for analysis. Patients with unresectable Stage IIIB/IV nonsquamous NSCLC had a median age of 59 years, 56.4% were male, 58.2% were never smokers, 95.0% had adenocarcinoma, and 92.9% had an ECOG PS ≤1. A total of 665 (71.4%) patients had gene aberration tests; 46.5% (309/665) had epidermal growth factor receptor (EGFR) gene mutations, 11.5% (48/416) had anaplastic lymphoma kinase (ALK) gene fusions, and 0.8% (1/128) had a c-ros oncogene 1 gene fusion. The most common first-line treatment regimen for unresectable Stage IIIB/IV nonsquamous NSCLC was chemotherapy (72.5%, 676/932), followed by tyrosine kinase inhibitors (TKIs; 26.1%, 243/932), and TKIs plus chemotherapy (1.4%, 13/932). Most chemotherapy regimens were platinum-doublet regimens (93.5%, 631/676) and pemetrexed was the most common nonplatinum chemotherapy-backbone agent (70.2%, 443/631) in platinum-doublet regimens. Most EGFR mutation-positive patients (66.3%, 205/309) were treated with EGFR-TKIs.ConclusionsFindings from our survey of 12 tertiary hospitals throughout China showed an increased rate of gene aberration testing, compared with those rates reported in previous surveys, for patients with advanced nonsquamous NSCLC. In addition, pemetrexed/platinum-doublet chemotherapy was the predominant first-line chemotherapy regimen for this population. Most patients were treated based on their gene aberration test status and results.

Presentations, treatment complications and outcomes in HCV‐infected B‐cell lymphoma patients treated with immunochemotherapy: A single institute retrospective study

Numerous epidemiologic studies show an association between hepatitis C virus (HCV) and B-cell lymphomas. However, limited studies focused on hepatic consequences after immunochemotherapy, and the prognostic role of HCV is still a matter of debate. We retrospectively analyzed the clinical presentations, hepatic complications, and outcome of B-cell lymphoma patients who were HCV-infected and not HCV-infected. During 2008 to 2013, there were 230 newly diagnosed lymphoma patients who were negative for HBsAg received rituximab-containing chemotherapy as their first-line therapy in our institute. Thirty-six patients (15.7%) were positive for anti-HCV and 194 patients were negative. Most common lymphoma subtypes were DLBCL (73.5%) and follicular lymphoma (19.1%). DLBCL patients had a higher anti-HCV positive rate than FL (18.3% vs 5.6%, P = 0.015). Anti-HCV-positive patients had higher baseline AST and ALT levels (AST, 57.7 ± 46.5 U/L vs 31.1 ± 25.9 U/L, P < 0.001; ALT, 51.6 ± 51.0 U/L vs 25.6 ± 30.6 U/L, P < 0.001), and more liver cirrhosis before treatment (19.4% vs 2.2%, P < 0.001). However, spleen involvement (30.6% vs 21.2%, P = 0.227), extranodal involvements more than one site (27.8% vs 29.4%, P = 0.706), and other parameters are similar in both groups. The most common treatment regimens were R-CHOP like (65.7%) and R-COP (24.8%). After chemotherapy, the patients who were positive for anti-HCV developed more hepatitis (defined as ALT >40 U/L) (80.6% vs 59.8%, P = 0.018) and severe hepatitis (defined as ALT >200 U/L) (30.6% vs 7.7%, P < 0.001). One HCV-positive patient died of hepatic failure after salvage therapy (ESHAP), which was administered at 3 months after last cycle of R-CHOP. The reduction rate of chemotherapy dose (<90% of standard dose) due to hepatotoxicity occurred more often in HCV-infected patients (19.4% vs 2.4%, P = 0.001). Chemotherapy early stop is defined as patients received less cycles of chemotherapy than initial planning or guideline. Chemotherapy early stop rate for all causes was similar in both groups (38.9% vs 26.7%, P = 0.143), but early stop specifically due to hepatotoxicity was slightly higher in patients with HCV infection (3/36 (8.3%) vs 3/165 (1.8%), P = 0.072). The median follow-up time was 21.6 months (range, 1.3-92.8 months) for patients who were HCV-positive and 30.7 months (range, 0.7-78.1 months) for those who were HCV-negative. Complete remission rates were 58.3% and 55.2% in HCV-positive and HCV-negative patients, respectively. Partial response rates were 25.0% and 23.7% in HCV-positive and HCV-negative, respectively. No significant difference was observed in event free survival according to HCV infection (3-year EFS, 41.0% vs 42.8%, P = 0.989). The overall survival tended to be worse in patients who were positive for anti-HCV than those negative for anti-HCV (3-year OS, 47.6% vs 63.2%, P = 0.058). Keywords: B-cell lymphoma; hepatitis C; rituximab

Concurrent preoperative chemotherapy and three-dimensional conformal radiotherapy followed by surgery for oral squamous cell carcinoma: a retrospective analysis of 104 cases.

ObjectivesThe objectives of this study were to assess the clinical effects of an integrated program consisting of concurrent preoperative combined paclitaxel and nedaplatin chemotherapy and three-dimensional conformal radiotherapy followed by surgery intended to cure oral squamous cell carcinoma and to determine whether this integrated program is feasible and effective with respect to the treatment of oral squamous cell carcinoma.MethodsA total of 104 biopsy-confirmed patients who presented with oral squamous cell carcinoma for the first time were included in this study. Concurrent preoperative combined paclitaxel and nedaplatin chemotherapy and three-dimensional conformal radiotherapy were administered to these patients. The most common treatment regimen consisted of infusions of paclitaxel (135-175 mg/m2/day), infusions of nedaplatin (150 mg; 80-100 mg/m2/day), and irradiation at doses ranging from 1.5 Gy twice daily to 30-40 Gy over 3-4 weeks. The clinical variables evaluated herein included the local recurrence rate, distant metastasis rate, postoperative survival rate, and degree of mouth opening restriction.ResultsThe median follow-up time for surviving patients was 60 months, and the median time to progression for all patients was 57.69 months (95% confidence interval, 56.09 to 59.29 months, and the 3-year disease-free survival probability was 97.11%). The effectiveness rate of the integrated program was 98.08%, and the surgery resection rate was 100%. Only a few postoperative adverse reactions were observed. The local recurrence and distant metastasis rates were 1.92% (2 patients) and 2.88% (3 patients), respectively. The titanium rejection and infection reaction rate that led to restriction of mouth opening was only 2.88% (3 patients). Finally, the 5-year post-surgery survival rate was 91.35% (95 patients).ConclusionPreoperative combined paclitaxel and nedaplatin chemotherapy and three-dimensional conformal radiotherapy have significant clinical effects leading to positive anti-tumor results in patients with oral squamous cell carcinoma. These treatments also increase the likelihood that patients will undergo successful surgical treatment. The integrated program described herein can increase long-term survival and surgery resection rates and is associated with only a limited number of adverse reactions.