Longer Duration Of Therapy Research Articles

Patients\u2019 satisfaction with long-acting injectable somatostatin analog therapy for neuroendocrine tumors

BackgroundLong-acting somatostatin analogs (LA SSAs) are approved and recommended for the treatment of patients with advanced neuroendocrine tumors (NETs). Given the long duration of therapy and differences in administration routes, it is important to understand patients’ experiences with receiving LA SSA injections.MethodsWe conducted a serial survey, informed by qualitative interviews with eight patients treated with LA SSAs and two nurses who administer LA SSA injections, among patients undergoing LA SSA treatment over a 28-day period (administered at baseline and 14 days and 28 days after injection). Eligible patients, recruited by the Carcinoid Cancer Foundation, self-reported having received an LA SSA injection for physician-diagnosed NET within the 5 days before the survey.Results202 patients completed the survey at baseline (82 receiving lanreotide and 120 receiving octreotide), 148 at day 14, and 124 at day 28. Patients reported consistently high satisfaction levels with their most recent LA SSA injection (91.1% at baseline, 85.1% at day 14, and 85.5% at day 28); 68.8% reported that their injection experience differed based on the nursing staff administering the injection.ConclusionsSatisfaction with LA SSA injections is high among patients in this population, and specific experiences with LA SSA injections varied based on the nursing staff administering the injection. Evaluations of patients’ experiences and satisfaction with treatment are increasingly important as patients take more active roles in decision-making for their treatment pathways.

Utilizing oncology biosimilars to minimize the economic burden associated with cancer treatment: managed care considerations.

The high cost of therapies for treatment of cancer places a substantial burden on the United States healthcare system. In recent years, there has been increased attention to the cost-savings benefits associated with clinical uptake of biosimilars and their market availability, with several biosimilars with oncology-related indications currently available. Though the biosimilar development process has contributed to price reductions and increased patient access to care, misconceptions about biosimilar safety and efficacy as well as inconsistent prescribing patterns have emerged as main barriers to their use in clinical practice. However, this hesitation from a clinical standpoint is not necessarily matched by payers or formulary decision makers in the oncology space. Earlier detection of cancer and longer duration of therapy has spurred discussion about initiation of biosimilars for newly diagnosed patients requiring treatment, but incorporation of biosimilars into formularies and institution protocols remain a challenge. There is clear urgency within the healthcare system to initiate the inclusion of biosimilars into treatment pathways for cancer, and pharmacists who care for patients with cancer have an important role in providing consistent messaging to both healthcare professionals and patients about biosimilars.

ASO Author Reflections: Objective Response Rate after Short Duration (< 9 Weeks) Is Not Inferior to Moderate (9-27 Weeks) or Long Duration (> 27 Weeks) of Neoadjuvant Endocrine Therapy (NET)-An NCDB Analysis.

ASO Author Reflections: Objective Response Rate after Short Duration (< 9 Weeks) Is Not Inferior to Moderate (9-27 Weeks) or Long Duration (> 27 Weeks) of Neoadjuvant Endocrine Therapy (NET)-An NCDB Analysis.

Optimal Supportive Care With Selinexor Improves Outcomes in Patients With Relapsed/Refractory Multiple Myeloma

BackgroundSupportive care improves outcomes in many cancers. In the pivotal STORM study selinexor, a first-in-class, oral, selective exportin 1 inhibitor, and low-dose dexamethasone proved to be an effective treatment for patients with triple-class refractory myeloma. We conducted a post-hoc analysis to test the hypothesis that increased utilization of supportive care measures in a sub-cohort of the STORM study prolonged treatment duration with- and improved efficacy of- selinexor. Materials and MethodsThe STORM protocol included specific recommendations for dose modifications and supportive care to mitigate selinexor most common adverse events (AEs) including nausea, fatigue, and thrombocytopenia. The Tisch Cancer Center at Mount Sinai School of Medicine (MSSM) incorporated additional supportive care strategies within the framework of the STORM protocol. ResultsOf 123 patients enrolled in STORM, 28 were enrolled at MSSM. The overall response rate was 26.2% in the overall STORM population and 53.6% in the MSSM cohort. Moreover, duration of response, progression free survival, and overall survival were longer in the MSSM cohort. AEs and dose modification events were similar in the 2 groups. The MSSM cohort had more dose reductions (67.9% vs. 50.5%), and higher use of multiple antiemetic agents (71.4% vs. 50.1%) and romiplostim (32.1% vs. 6.3%), but less discontinuations due to treatment-related AEs (3.6% vs. 25.3%). ConclusionThese results suggests that in addition to more frequent dose reductions, prompter and more aggressive supportive care may have contributed to the low discontinuation rate, longer duration therapy, and greater efficacy rates observed in the MSSM cohort. (ClinicalTrials.gov NCT02336815).

Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension

We evaluated treatment withdrawal, long-term outcomes, and safety of budesonide oral suspension (BOS) 2.0 mg twice daily in patients with eosinophilic esophagitis who completed a 12-week induction study. Induction full responders (≤6 eosinophils per high-power field [eos/hpf] and ≥30% reduction in the Dysphagia Symptom Questionnaire score) to BOS 2.0 mg twice daily (ORBIT1/SHP621-301/NCT02605837) were randomized to continue BOS (BOS-BOS) or withdraw to placebo (BOS-PBO) for 36 weeks (ORBIT2/SHP621-302/NCT02736409). Induction partial responders and nonresponders, and patients who received induction placebo, received BOS for 36 weeks. The primary end point was the proportion of BOS-BOS and BOS-PBO patients who relapsed (≥15 eos/hpf and ≥4 days of dysphagia [Dysphagia Symptom Questionnaire] over 2 weeks) by week 36. The key secondary end point was the proportion of induction partial responders and nonresponders who fully responded after 52 weeks of total BOS therapy. Other secondary end points included the proportion of induction full responders with histologic responses (≤1, ≤6, <15 eos/hpf) at week 12 of the extension study, and safety outcomes. The randomized withdrawal period enrolled 48 patients (BOS-BOS, n= 25; BOS-PBO, n= 23); 106 induction partial responders and nonresponders, and 65 induction placebo patients received BOS. More BOS-PBO than BOS-BOS patients relapsed over 36 weeks (43.5% vs 24.0%; P= .131) and had histologic responses at week 12 of therapy (P < .001). Overall, 13.2% of induction partial responders and nonresponders fully responded at week 36. BOS was well tolerated; therapy duration was not associated with new safety concerns. For induction full responders, continuing BOS numerically improved maintenance of efficacy vs withdrawal. A longer therapy duration did not raise safety concerns. (ClinicalTrials.gov: NCT02736409.).

Comparison of various regimens of itraconazole in treatment of acute vulvovaginal candidiasis

One of the most striking change in the current scenario is the increasing occurrence of non-albicans vulvovaginal candidiasis (VVC), which is considered as the major cause of recurrence, relapse and chronic VVC in India. In the present study we evaluated the effectiveness of three different regimens of itraconazole in the treatment of acute VVC.The present randomised, three arm comparative clinical study involved 123 women aged 18 years or above with symptomatic acute VVC. These patients were randomised (41 patients in each group) to receive either itraconazole 200 mg twice daily for 1 day (group I), 200 mg twice daily for 2 days (group II) or 100 mg twice daily for 3 days (group III). Effectiveness was evaluated on the basis of clinical cure (total symptom score), mycological cure (negative KOH test). All the groups were effective in relieving signs and symptoms (p&amp;#60;0.05), but on comparison between all groups, there was statistical difference between Group II and Group I &amp; III (p&amp;#60;0.05) and Group III &amp; I (p&amp;#60;0.05). Complete cure i.e. disappearance of signs and symptoms and negative KOH test was maximum in group II (44%) as compared to groups I (12%) and III (17% of the patients). Relapse was least in seen in 11 patients (27%) in Group I, 3 patients (7%) in Group II and 7 patients (17%) in Group III. All the 3 regimens were well tolerated.In the present study, 2 day high dose itraconazole therapy was found to have better effectiveness compared to conventional regimens. Longer duration of therapy might be required to attain even better cure rates, especially when the incidence of Non Albicans vulvovaginal candidiasis is rising in all parts of the country.

Dual-action ADHD drug provides both early- and late-onset symptom relief

Dual-action ADHD drug provides both early- and late-onset symptom relief

LGG-08. TREATMENT OUTCOMES AND TOLERABILITY OF TRAMETINIB IN PROGRESSIVE CIRCUMSCRIBED LOW-GRADE GLIOMAS

Circumscribed low-grade gliomas comprise roughly one-third of pediatric CNS tumors. Most of these tumors are caused by activating mutations in the mitogen-activated protein kinase (MAPK) pathway. Drugs targeting the MAPK pathway are effective in other cancers and are being utilized in low-grade gliomas. We describe treatment outcomes and toxicities in a series of thirteen low-grade glioma patients treated with trametinib. We performed a retrospective chart review to evaluate response on T2/FLAIR MRI images per updated RANO criteria, visual outcomes, tolerability, and durability of response in progressive low-grade glioma patients treated with trametinib. Thirteen patients age 22 months to 34 years were included. Best radiographic response on therapy included 2/13 partial response, 3/13 minimal response, 5/13 stable disease, and 3/13 progressive disease. Diagnoses included pilocytic astrocytoma (n=6), desmoplastic infantile ganglioglioma (DIG; n=1), and low-grade glial neoplasms (n=2). Molecular drivers included BRAF:KIAA1549 fusion (n=3), V600E mutation (n=1), and somatic NF1 mutation (n=1). Three patients had germline NF1. In patients with partial or minimal response, best response was seen after longer durations of therapy; 4 of 5 best responses occurred after at least 12 months on therapy. Five patients completed prescribed therapy. Three patients remain stable off therapy at 6, 12, and 21 months; two patients recurred at 1 and 10 months off therapy. Skin manifestations were the predominant form of toxicity. This was more severe in older males, and symptoms improved with intermittent dosing. All patients with optic pathway tumors showed at least stable vision throughout treatment, with some patients having dramatic improvement. Trametinib is effective and well-tolerated in patients with low-grade glioma. Dermatologic toxicity can be mitigated by intermittent dosing. Best responses tended to occur later in therapy, sometimes after relatively stable MRIs. Patients with optic pathway lesions showed stable to improved vision even in the absence of significant radiographic response.

Resolution of large vessel stenosis in giant cell arteritis (GCA) by tocilizumab

Abstract Introduction: Progressive large vessel involvements including stenosis are commonly associated with giant cell arteritis (GCA). Glucocorticoids (GCs) are the mainstay of therapy for GCA stenosis, however, adverse effects including cardiovascular events are frequent. Patients concerns: We describe an 87-years old male patient with a medical history of diabetes mellitus and old cerebral infarction who presented with right temporal headache. Diagnosis: Color duplex sonography revealed the thickening of arterial wall and halo sign in the affected temporal arteries. In laboratory data, the elevated levels of acute phase reactants, including C-reactive protein and serum amyloid A were noted. Temporal artery biopsied specimens showed the lymphocytic infiltration and granulomatous inflammation within the arterial media, which are typical findings associated with GCA. Intervention: The patient was treated with subcutaneous injections of tocilizumab (TCZ, 162 mg) once weekly. Initially, glucocorticoids were withheld since the patient was diabetic and had a history of cerebral infarction. However, low dose prednisolone was combined with the reduced doses of TCZ (162 mg biweekly) injections due to the TCZ-related leukopenia. Outcomes: This treatment strategy resulted in the improvement of the patient's temporal headache and normalized levels of C-reactive protein and serum amyloid A. Follow-up imaging by color duplex sonography revealed the resolution of the temporal artery stenosis after 5 months of TCZ treatment. Conclusions: Patients with GCA often require long duration of steroid therapy and commonly suffer steroid-related complications. TCZ monotherapy, could induce early resolution of progressive vascular inflammation and stenosis in untreated GCA cases.

Managing Anticoagulant Patients Undergoing Dental Extraction by using Hemostatic Agent: Tranexamic Acid Mouthrinse.

Background:Patient who is on antiplatelet therapy had an impaired fibrin formation which leads to fibrinolysis which is the main reason behind postextraction bleeding.Objectives:The aim of the study is to manage anticoagulated patient who has to undergo dental extraction by using hemostatic agent and the objective is to rule out potential risk factor which may trigger bleeding.Methods:One hundred patients with anticoagulant and antiplatelet therapy and having International Normalized Ratio (INR) in-between 1.9 and 3.5 were selected. Postextraction instruction use 5 ml of 10% tranexamic acid mouthrinse four times a day for next 7 days was suggested. All demographic data, history of anticoagulant and antiplatelet therapy, details of bleeding, and treatment requirement were recorded to identify potential risk factor.Results:Of 100 subjects, 16 were reported postextraction bleeding on days 1 and 2 which was controlled by tranexamic acid pressure pack. Bleeding from extraction socket of 10 patients was stopped by gelatin foam. No life-threatening risk was observed. In patients with age group of 41–60 years whose INR value was ≥2.5, the number of teeth undergoing extraction, whose bleeding time was increased, and were on long duration of antiplatelet and anticoagulation therapy might increase the risk of bleeding.Conclusion:Use of tranexamic acid mouthrinse after extraction is an effective way to control bleeding on patients who are under antiplatelet therapy with at therapeutic INR level is a secure and allowable method of minimizing postextraction oozing.

Outcomes of immune checkpoint inhibitor-mediated colitis: Multicenter cohort study.

2643 Background: Immune checkpoint inhibitor (ICI)-mediated colitis (IMC) is a common and serious adverse event. Although small series have described the clinical presentation of IMC, large multicenter series that integrate clinical, endoscopic, and histologic findings are lacking. Methods: We retrospectively assessed patients who received ICI and had endoscopically confirmed IMC from 2010 to 2019. IMC was graded based on the CTCAE version 5.0 criteria. Multivariate logistic regression analyses were conducted to assess factors associated with recurrence of IMC symptoms and long duration of corticosteroids use (&gt; 70 days). Results: 675 patients were included. 387 patients were males (57%). Median age was 63 years. Melanoma was the most common cancer type (327; 48%). Most (365; 54%) patients received CTLA-4 inhibitor ICI, as monotherapy or in combination with PD-(L)1. Median time from ICI therapy to IMC was 62 days. IMC was grade 2 in 335 (50%) patients, Grade 3 in 181 (27%), and grade 4 in 16 (3%). 155 (23%) patients had mucosal ulceration on endoscopy, 91 of them had severe features (deep, large, or multiple ulcers); 336 (50%) patients had non-ulcerative inflammation. The rest had normal endoscopic findings with histologic inflammation. Most patients were admitted to the hospital for management of IMC (405; 60%) and 16 (3%) needed ICU-level of care. Treatment included corticosteroids in 577 (85%) patients (median duration 52 days), TNF inhibitor in 245 (36%), and vedolizumab in 90 (13%). 202 (32%) patients had recurrent IMC after resolution of symptoms. On multivariate logistic regression, factors associated with IMC recurrence and long (&gt; 70 days) duration of corticosteroid therapy were grade of IMC ( p = 0.049), treatment with infliximab or vedolizumab ( p = 0.044), presence of mucosal ulceration ( p = 0.034 ), or features of active histologic inflammation ( p = 0.076). Of note, patients with mucosal ulceration received infliximab or vedolizumab more frequently ( p &lt; 0.001). For patients with grade 2 IMC, mucosal inflammation on endoscopy and delay in performing endoscopy with time from IMC onset to endoscopy more than a month were associated with IMC recurrence and longer duration of corticosteroid use ( p = 0.029 and p &lt; 0.001, respectively). 16 (3%) patients had colonic perforation, 7 of them underwent surgical resection. No IMC-related death occurred. Conclusions: IMC is a clinically significant adverse event that can lead to premature termination of ICI therapy with high rates of hospital admission. Rarely, it results in colonic perforation requiring surgical intervention and ICU admission. Our data suggest that there is a utility of endoscopic and histologic evaluation in the prediction of worse outcomes from IMC. This finding is particularly important for grade 2 IMC as current guidelines do not recommend endoscopic evaluation for this group.

The pattern of alpha-fetoprotein, CD4+ count, albumin, AST, ALT and ALP in HIV subjects on long term antiretroviral therapy in Nauth Nnewi, Anambra State, Nigeria

This study determined the pattern of alpha-fetoprotein, CD4 count, albumin, AST, ALT and ALP in HIV positive subjects on long term antiretroviral therapy in NAUTH Nnewi, Anambra State, Nigeria. A total of ninety six (96) participants who were aged between 18 and 60 years attending the voluntary counseling and testing unit (VCT) and antiretroviral therapy unit (ART) of NnamdiAzikiwe University Teaching Hospital (NAUTH), Nnewi were randomly recruited for the study and grouped based on WHO criteria for HIV staging. Six millilitres (6mls) of blood sample were collected from each of the participants in each group and dispensed into EDTA and plain containers in appropriate volumes for the determination of the alpha fetoprotein (AFP), albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and CD4+ count using standard laboratory methods. Results revealed no statistically significant differences in mean AFP levels, AST and ALP activities when compared between HIV positive participants on long term ART, short term ART, and HIV positive subjects not on ART and control groups respectively (p&amp;#62;0.05). Serum albumin concentration and ALT was not significantly different in HIV positive participants on long term ART than in those on short term ART (p&amp;#62;0.05) although serum albumin levels were significantly higher in HIV participants on long term ART and short term ART than in HIV positive subjects not on ART in each case (p&amp;#60;0.05) but was significantly lower in HIV positive participants not on ART compared to control subjects (p&amp;#60;0.05). CD4 count was significantly higher in HIV positive participants on long term ART when compared with those o short term ART and HIV positive participants not on ART respectively (p&amp;#60;0.05). Therefore, this study has shown improved immune recovery with no hepatotoxicity in HIV positive persons on long term duration of antiretroviral therapy. Importantly, hypoalbuminemia existed among HIV positive subjects not on ART which is suggestive of further progression of the disease.

Therapeutic Drug Monitoring in Non-Tuberculosis Mycobacteria Infections.

Nontuberculous mycobacteria can cause minimally symptomatic self-limiting infections to progressive and life-threatening disease of multiple organs. Several factors such as increased testing and prevalence have made this an emerging infectious disease. Multiple guidelines have been published to guide therapy, which remains difficult owing to the complexity of therapy, the potential for acquired resistance, the toxicity of treatment, and a high treatment failure rate. Given the long duration of therapy, complex multi-drug treatment regimens, and the risk of drug toxicity, therapeutic drug monitoring is an excellent method to optimize treatment. However, currently, there is little available guidance on therapeutic drug monitoring for this condition. The aim of this review is to provide information on the pharmacokinetic/pharmacodynamic targets for individual drugs used in the treatment of nontuberculous mycobacteria disease. Lacking data from randomized controlled trials, in vitro, in vivo, and clinical data were aggregated to facilitate recommendations for therapeutic drug monitoring to improve efficacy and reduce toxicity.

Abstract SS2-05: Emerging from COVID-19 pandemic: Provider perspective on use of neoadjuvant endocrine therapy (NET) in early stage hormone receptor positive breast cancer

Introduction During the coronavirus 2019 (COVID-19) pandemic in USA, NET use has been recommended to allowsafe deferral of surgical treatment in early stage, estrogen receptor positive breast cancer (ER+BC) In suchcircumstances, after NET use there is limited guidance on locoregional treatment, especially with management of the axilla We aimed to evaluate patterns of care in early stage ER+BC during the first several months of theCOVID-19 pandemic Method A cross-sectional, 30-item survey was developed using a standardized surveydevelopment framework The survey was administered May 8 - June 12, 2020 to a convenience sample of medicaloncologists (MO), radiation oncologists (RO), and surgeons (SO) - breast committee members of two nationalcooperative groups (Alliance and SWOG) with additional participation through chain referrals Providers were presented with general questions on NET use before and during the pandemic They were asked their propensity foromitting axillary lymph node dissection (ALND) after NET if 1 micrometastatic node is found on sentinel lymph nodebiopsy, based on duration of NET Results 114 providers from 29 US states completed the survey - 42 (37%) MO, 14(12%) RO, and 58 (51%) SO, the majority (N=73/96, 76%) with practices dedicated ≥ 75% to BC, at NCI designatedcomprehensive cancer centers 52% (N=48/94) and in large cities (N=49/94, 52%) Prior to COVID-19, most rarely(N=49/107, 46%) or sometimes (N=36, 33%) used NET for early stage ER+BC Nearly half were willing to delay surgery up to 2 months (46%) and 3 months (21%) without use of NET (Table 1, p<0 05) Most providers wouldperform a genomic assay on the biopsy specimen on all or select patients prior to NET initiation, more frequently byMO compared to RO and SO (90% vs 75% and 60%, p<0 05) The most preferred regimen was tamoxifen (withoutovarian suppression) for premenopausal patients and aromatase inhibitor for postmenopausal patients Mostplanned to use NET for as little time as possible until surgery could proceed When stratified by specialty, more MOstated they would vary the duration of therapy based on patient's risk of cancer progression Most providersrecommended omitting ALND after 1, 2, or 3 months of NET (1 month N=56/93, 60%;2 months N=54/92, 59%;3months N=48/90, 53%) With longer duration of therapy, the propensity for omitting ALND decreased (definitely omitafter 6 months N=25/91, 27%;probably omit after 6 months N=38/91, 42%;definitely omit after 1 year N=26/92,28%;probably omit after 1 year N=29/92, 32%) Omitting ALND was not associated with provider's years in practice,percent of practice dedicated to BC, practice type or setting, participation in multidisciplinary tumor board, or numberof COVID-19 cases in the provider's practicing state ConclusionMost providers changed their management of early stage ER+BC during the COVID-19 pandemic by utilizing NET until surgery could proceed As the duration of NET extended, more providers favored ALND in low volume axillary metastatic disease in early stage ER+BC Additional data to inform the care on post-NET locoregional management is needed

Study Protocol: Seven vs. 14 days treatment for afebrile men with urinary tract infection

The optimal treatment duration for men with urinary tract infection (UTI) is poorly defined. Observational data suggests that shorter-duration therapy may perform as well as longer-duration therapy, but trial data are lacking. We present the protocol and methods for a Department of Veterans Affairs-funded trial of seven vs. 14 days of antimicrobial therapy for afebrile men with UTI, with the primary outcome of symptom resolution 14 days after completing active antimicrobial treatment. An optional sub-study will investigate the effect of treatment duration on the intestinal carriage of antimicrobial-resistant microorganisms. Subjects are enrolled after their UTI is diagnosed and treatment initiated, using a combination of in-person and mail enrollment to maximize participation and minimize resource utilization. This trial will provide high-quality evidence to guide the management of a common infectious disease and potentially limit unnecessary antimicrobial use.

Effects of Duration of Diabetes and Diabetes Therapy (Metformin) on Fbxw7 Levels in Iraqi Type II Diabetic Patients

Background: This study concentrated on evaluation the FBXW7 levels and other markers in T2DM patients related to the duration of metformin monotherapy and duration of T2DM. Method: The current study includes 60 diabetic patients type II and30 control subjects. The groups of patients were subdivided in to two groups: (group I) (30) Newly diagnosed T2DM which also subdivided to two groups(&gt; 1 year, and &lt;1 year). Group II(30) T2DM (who were treated with metformin monotherapy) which also subdivided into two group (&gt; 1 year and &lt;1 year). In the present study FBXW7, FetuinA, pentraxin3, Nitric oxide and insulin were determined bythe enzyme linked immune sorbent assay (ELISA). Biochemical markers, fasting serum glucose, and lipide profile were determined through spectrophotometere technique in patients and control groups. Result: The levelsof glucose, HbA1c and IR significantly affected byincrease the duration of diseaseWhile each of fbxw7, pentraxin 3,NO, and fetuin A not influenced by increase duration of disease. There was nonsignificant effect of metformin therapy duration on levels of Fbxw7,fetuinA, pentraxin3 and lipid profile. While IR showed significant decrease when the duration of treatment increase. Conclusion: Fbxw7, fetuinA, pentraxin3 and NO arenot affected by long duration of therapy or by duration of disease while glucose, HbA1c, and IR are affected by increase duration of diseaseonly. Whereas insulin and IR are affected by both; duration of disease and therapy.

Factors for Sustaining Molecular Remission after Discontinuation of Tyrosine Kinase Inhibitors Therapy in Chronic Myeloid Leukemia: Results of Non-Randomized Prospective Clinical Trial

Aim. To study the impact of different clinical and biological factors on sustaining molecular remission after discontinuation of tyrosine kinase inhibitors (TKI) therapy in chronic myeloid leukemia (CML) patients with a stable deep molecular response (MR). Materials &amp; Methods. The prospective multi-center trial on molecular remission sustainability after TKIs withdrawal, held from 2015 to 2019, enrolled 98 CML patients. The trial included patients with chronic phase CML treated with TKIs at least during 3 years and having a stable deep MR (&lt; МО4; BCR-ABL &lt; 0.01 %) during at least 2 years. Molecular monitoring was carried out every month during first 6 months after TKIs withdrawal, every 2 months during 0.5-1 year, and every 3 months after 1-year follow-up. In case of the loss of major MR (BCR-ABL &gt; 0.1 %) therapy was reinitiated. Results. Three-year molecular relapse-free survival was 51 % (95% confidence interval 41-61 %) in all patients, 25 % in patients with the failure of prior treatment discontinuation, and 53 % in patients who discontinued TKI therapy for the first time. According to univariate analysis, the following factors proved to be significant: persistance of deep MR, duration of therapy, and depth of MR. It was shown that TKI therapy duration, but not deep MR persistance, has independent prognostic value for the Russian population of CML patients. No significant differences were identified in 3-year molecular relapse-free survival in the groups of patients treated only with imatinib (55 %) compared with patients who received 2nd generation TKI (TKI2) as first-line (70 %; p = 0.26) and second-line (39 %; p = 0.09) therapy. However, duration of therapy in patients treated with TKI2 as first-line therapy was more than twice as short as in patients treated with imatinib as first-line therapy (median 41.5 vs. 96.4 months, respectively; p &lt; 0.0001). Conclusion. Longer therapy duration and MR depth (&lt; M04.5) before TKI withdrawal raise the probability of sustaining off-treatment remission. The study showed that molecular relapse-free survival does not significantly increase with the use of TKI2 as first-line treatment compared to imatinib. Nevertheless, TKI2 as first-line treatment enables to halve the duration of therapy needed to achieve comparable molecular relapse-free survival, as compared with imatinib.

Epidemiological and Microbiological Study of Onychomycosis

Introduction: Onychomycosis is a common fungal infection of nail. It may be caused by dermatophytes, non-dermatophytic moulds or yeasts involving nail bed, nail plate or matrix of nail. As the fungi show variable susceptibility to antifungal drugs and treatment requires long duration of antifungal therapy, so it’s prevalence as well as proper laboratory diagnosis and antifungal susceptibility testing is essential for effective therapy. Aim: To find the prevalence of onychomycosis with demography along with various aetiology and the suitable antifungal drugs used for treatment. Materials and Methods: For this prospective study, over a period of two years a total of 300 nail samples were processed in the Department of Microbiology at IMS and SUM Hospital, Bhubaneswar, Odisha, India. The wet mount for microscopic examination was prepared using 20% Potassium Hydroxide (KOH) and examined after overnight incubation. Culture was done in duplicate in Sabouraud’s Dextrose Agar (SDA) tubes; one with actidione and another without it and both were incubated at 25°C in Biological Oxygen Demand (BOD) incubator. Culture tubes growing yeasts were further subjected to speciation by germ tube test, culture on Chromogenic (CHROM) agar and on cornmeal agar. In-vitro antifungal susceptibility testing was performed against Candida species using disc diffusion method on Muller Hinton agar. Chi-square test was used for statistical analysis of the results. Results: Onychomycosis can affect a wide age group though seen commonly at 31-40 years equally in both male and females. Fingernail infection was observed mostly in female cases. It was caused by Candida species (66%), moulds (24%) and dermatophytes (10%) and out of Candida sp. C.albicans was the main culprit. Although all the Candida strains were susceptible to amphotericin B, still some of them showed resistance to the commonly used antifungals like fluconazole and itraconazole. Conclusion:Candida albicans was the most common aetiological agent which contributed for onychomycosis and showed a variable resistance pattern to the commonly used antifungals. Proper laboratory diagnosis and selection of antifungal drug is essential prior to institution of therapy for successful treatment of this disease.

291. Impact of Surveillance and Offered Infectious Diseases Consults for Staphylococcus aureus Bacteremia on Quality of Care Indicators

Background Staphylococcus aureus bacteremia (SAB) remains the leading cause of bloodstream infections and is associated with 20–40% mortality. Past studies demonstrated that Infectious Diseases (ID) consultation is associated with better adherence to quality of care indicators (QCIs), including follow-up blood cultures, echocardiography, early source control, and appropriate choice and duration of antibiotics. A 2014 quality improvement project at Medstar Washington Hospital Center (MWHC) by Narsana et al. showed significantly better adherence to SAB QCIs among patients with ID consults and a non-significant trend towards lower mortality. In 2015, MWHC instituted a policy advocating ID consultation for all SAB patients, and active surveillance was performed by the ID Section to offer prompt consults prospectively. Our study aimed to assess the impact of this policy and the proactively offered ID consults on adherence to SAB QCIs and mortality rates amongst patients with SAB with and without ID consults.MethodsWe retrospectively reviewed 557 patients diagnosed with SAB between July 1st, 2015 - June 30th, 2018. Data included follow-up blood cultures, echocardiography, presence of a focal source of infection, use of appropriate antibiotics, measurement of vancomycin levels, duration of therapy, death during hospitalization, and presence of an ID consultation. Chi-Square and Fisher exact tests, and t-test and Wilcoxon rank sum test were used to analyze categorical and continuous variables, respectively.ResultsA total of 513 patients were included in the analysis, 88% (n=453) of whom had ID consultations. Patients with ID consultations were more likely to have a focal source of infection (84% vs. 50%, p < 0.0001), echocardiography (97% vs. 56%, p < 0.0001), use of a beta-lactam antibiotic for methicillin-susceptible S. aureus (90% vs 65%, p < 0.0001), and a longer duration of therapy (33 vs 9 days, p< 0.0001). Mortality was lower among patients with ID consults (16% vs. 23%, p=0.1495), but the difference was not statistically significant.Table 1 ConclusionOur study demonstrates that ID consultation is associated with better adherence to SAB QCIs, with a trend towards lower mortality. Hospital systems should support mandatory ID consultation for patients with Staphylococcus aureus bacteremia.Disclosures All Authors: No reported disclosures

1147. Short Course of Voriconazole Therapy as a Risk Factor for Relapse of Invasive Pulmonary Aspergillosis

BackgroundInvasive pulmonary aspergillosis (IPA) is a life-threatening opportunistic infection which usually occurs in immunocompromised patients. Recommended duration of voriconazole therapy is a minimum of 6-12 weeks for IPA, despite the lack of any firm evidence. In addition, risk factors for relapse of IPA are still unclear. Here, we explored risk factors for IPA relapse after initial treatment.MethodsAll patients with proven or probable IPA who had finished voriconazole treatment between 2005 and 2019 in a tertiary-care hospital were reviewed. IPA relapse was defined as re-diagnosis of proven or probable IPA at the same site within 1 year after treatment termination. Short course of voriconazole treatment was defined as a treatment less than 9 weeks, which is a median of the recommended minimum duration of therapy from the Infectious Disease Society of America. The radiological response was defined as a reduction in IPA burden by more than 50% on chest computed tomography (CT).ResultsOf 87 patients who had completed voriconazole treatment, 14 (16.1%) experienced IPA relapse. Multivariable Cox regression identified that short voriconazole treatment duration (adjusted hazard ratio [aHR], 3.7; 95% confidence interval [CI], 1.1–12.3; P=0.033) and radiological non-response (aHR, 4.6; 95% CI, 1.2–17.5; P=0.026) were independently associated with relapse of IPA after adjusting for several clinical risk factors.ConclusionLess improvement in CT, and short duration of voriconazole therapy were the independent risk factors for relapse after treatment of IPA. Longer duration of therapy should be considered for those at higher risk of relapse.Disclosures All Authors: No reported disclosures