scholarly journals Impact of the M184V/I Mutation on the Efficacy of Abacavir/Lamivudine/Dolutegravir Therapy in HIV Treatment-Experienced Patients

2019 ◽  
Vol 6 (10) ◽  
Author(s):  
Flaminia Olearo ◽  
Huyen Nguyen ◽  
Fabrice Bonnet ◽  
Sabine Yerly ◽  
Gilles Wandeler ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Antiviral Treatment ◽  
Composite Endpoint ◽  
Hiv Treatment ◽  
Hiv Positive ◽  
Prior History ◽  
History Of ◽  
The Impact ◽  
Hiv 1

Abstract Objective The impact of the M184V/I mutation on the virological failure (VF) rate in HIV-positive patients with suppressed viremia switching to an abacavir/lamivudine/dolutegravir regimen has been poorly evaluated. Method This is an observational study from 5 European HIV cohorts among treatment-experienced adults with ≤50 copies/mL of HIV-1 RNA who switched to abacavir/lamivudine/dolutegravir. Primary outcome was the time to first VF (2 consecutive HIV-1 RNA >50 copies/mL or single HIV-1 RNA >50 copies/mL accompanied by change in antiretroviral therapy [ART]). We also analyzed a composite outcome considering the presence of VF and/or virological blips. We report also the results of an inverse probability weighting analysis on a restricted population with a prior history of VF on any ART regimen to calculate statistics standardized to the disparate sampling population. Results We included 1626 patients (median follow-up, 288.5 days; interquartile range, 154–441). Patients with a genotypically documented M184V/I mutation (n = 137) had a lower CD4 nadir and a longer history of antiviral treatment. The incidence of VF was 29.8 cases (11.2–79.4) per 1000 person-years in those with a previously documented M184V/I, and 13.6 cases (8.4–21.8) in patients without documented M184V/I. Propensity score weighting in a restricted population (n = 580) showed that M184V/I was not associated with VF or the composite endpoint (hazard ratio [HR], 1.27; 95% confidence interval [CI], 0.35–4.59 and HR 1.66; 95% CI, 0.81–3.43, respectively). Conclusions In ART-experienced patients switching to an abacavir/lamivudine/dolutegravir treatment, we observed few VFs and found no evidence for an impact of previously-acquired M184V/I mutation on this outcome. Additional analyses are required to demonstrate whether these findings will remain robust during a longer follow-up.

Analysis of Pre-Transplant Therapy with Brentuximab Vedotin for Relapsed/Refractory Hodgkin Lymphoma on Outcomes of Reduced Intensity Conditioned Allogeneic Hematopoietic Cell Transplantation

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4406-4406 ◽  
Author(s):  
Baldeep Wirk ◽  
Barry E. Storer ◽  
David G Maloney ◽  
Ajay K Gopal ◽  
Ryan D Cassaday ◽  
...  
Keyword(s):  
Salvage Therapy ◽  
Research Funding ◽  
Hematopoietic Cell Transplantation ◽  
Brentuximab Vedotin ◽  
Prior History ◽  
Prior Therapy ◽  
History Of ◽  
The Impact ◽  
Refractory Hodgkin Lymphoma

Abstract Background: The impact of prior salvage therapy with brentuximab vedotin (BV) for relapsed/ refractory Hodgkin lymphoma (HL) on long-term outcomes after reduced intensity conditioned (RIC) allogeneic hematopoietic cell transplantation (allo-HCT) is unknown. Early studies (Chen et al Biol Blood Marrow Transplant 2014; 20: 1864-1868) suggested an improved 2-year progression free survival (PFS) with BV salvage given before allo-HCT compared to patients without prior BV treatment. In the current study, we analyzed the impact of prior therapy on the incidence of chronic graft-versus-host disease (cGVHD) and other major outcomes in patients, who received an RIC allo-HCT for relapsed HL. Methods: This is a retrospective study of relapsed/refractory HL patients who had RIC allo-HCT between 2005-2014 at the Fred Hutchison Cancer Research Center. Patients were grouped according to prior history of salvage therapy with or without BV pre allo-HCT. Baseline patient characteristics are shown in the Table. Results: Of the 62 consecutive allo-HCT recipients in this study, 25 had prior therapy with BV (BV group) and 37 received other chemotherapy alone (No BV group) for relapsed HL before allo-HCT. More patients in the BV group were in complete remission at allo-HCT (Table). The 100 day acute GVHD and 5 year cGVHD incidence for the BV vs. no BV group were 58% (95% confidence intervals [CI]: 39%-78%) vs. 65% (95% CI: 50%-80%), p=0.6 and 46% (95% CI: 26%-67%) vs. 51% (95% CI: 35%-68%), p=0.66, respectively. The 5 year non-relapse mortality and relapse/ progression for the BV vs. no BV group were 8% (95% CI: 1%-19%) vs. 25% (95% CI: 11%-38%), p=0.13 and 46% (95% CI: 24%-67%) vs. 38% (95% CI: 22%-53%), p0.98. The 5 year PFS and overall survival for BV vs. no BV group were 46% (95% CI: 25%-68%) vs. 38% (95% CI: 22%-53%), p=0.44 and 78% (95% CI: 60%-95%) vs. 56% (95% CI: 40%-72%), p=0.14. The major cause of death in both groups was relapsed HL. Conclusion: With longer follow-up, similar incidences of cGVHD, PFS and OS were observed in patients who received salvage therapy for relapsed/refractory HL prior to allo-HCT with or without BV. Any potential differences in cGVHD and other major outcomes need to be tested in a larger population. Table 1. Characteristics Prior treatment with Brentuximab vedotin Yes N=25 No N=37 Median age, years (range) 27 (14-47) 32 (17-64) Disease stage at diagnosis, n (%) I II III IV 2 (8)11 (44)7 (28)5 (20) 0 (0)15 (41)12 (32)10 (27) Prior history of local radiation pre allo-HCT 20 (80) 29 (78) No. of prior lines of therapies pre allo-HCT 4 (2 - 10) 3 (2 - 7 ) Prior autologous HCT, n (%) 0 1 2 (tandem auto) 1 (4) 21 (84) 3 (12) 0 (0) 35 (96) 2 (4) Disease status at allo-HCT, n (%) Complete remission Partial remission Progressive disease 9 (36) 13 (52) 3 (12) 7 (19)20 (54)10 (27) Median interval from diagnosis to allo-HCT, months (range) 33 (10.7-222) 30.7 (5-292) Graft type, n (%) Bone Marrow Peripheral blood stem cells 9 (36) 16 (64) 15 (41) 22 (59) Donor type, n (%) Haploidentical Matched related Matched unrelated Mismatch unrelated 16 (64) 5 (20) 4 (16) 0 (0) 17 (46) 14 (38) 5 (14) 1 (2) Conditioning for allo-HCT, n (%) FLU/CY/TBI (2 Gy) FLU/TBI (2 Gy) FLU/TBI (3 Gy) TBI (2 Gy) 16 (64) 6 (24) 1 (4) 2 (8) 17 (46) 15 (40) 0 (0) 5 (14) GVHD prophylaxis, n (%) CNI/MMF/post transplant CY CNI+MMF+/- other 16 (64) 9 (36) 17 (46)20 (54) Median follow-up, months (range) 34 (4 - 99) 84 (34 - 121) Abbrev: FLU fludarabine, CY cyclophosphamide, TBI total body irradiation,CNI calcineurin inhibitor, MMF mycophenolate mofetil Disclosures Maloney: Seattle Genetics: Honoraria; Roche/Genentech: Honoraria; Janssen Scientific Affairs: Honoraria; Juno Therapeutics: Research Funding. Gopal:Gilead, Spectrum, Pfizer, Janssen, Seattle Genetics: Consultancy; Spectrum, Pfizer, BioMarin, Cephalon/Teva, Emergent/Abbott. Gilead, Janssen., Merck, Milennium, Piramal, Seattle Genetics, Giogen Idec, BMS: Research Funding; Millennium, Seattle Genetics, Sanofi-Aventis: Honoraria. Cassaday:Seattle Genetics: Research Funding; Pfizer: Research Funding. Sandmaier:Gilliad: Honoraria; ArevaMed: Honoraria; Jazz Pharmaceutical: Honoraria; Seattle Genetics: Honoraria; Abmit: Research Funding; Bellicum: Research Funding.

Impact of NRTI resistance mutations on virological effectiveness of antiretroviral regimens containing elvitegravir: a multi-cohort study

2019 ◽  
Vol 75 (1) ◽  
pp. 194-199
Author(s):  
Sara Modica ◽  
David Redi ◽  
Roberta Gagliardini ◽  
Emanuela Giombini ◽  
Antonia Bezenchek ◽  
...  
Keyword(s):  
Resistance Mutations ◽  
Antiretroviral Drug Resistance ◽  
Antiretroviral Drug ◽  
History Of ◽  
Tenofovir Alafenamide ◽  
The Impact ◽  
Hiv 1 ◽  
Drug Resistant Virus

Abstract Background Antiretroviral drug resistance mutations remain a major cause of treatment failure. Objectives To evaluate the impact of NRTI resistance mutations on virological effectiveness of elvitegravir-containing regimens. Materials and methods We selected treatment-experienced HIV-1-infected patients starting elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), with at least one protease/reverse transcriptase genotype available before switching and at least one HIV-1 RNA viral load (VL) measurement during follow-up. The primary endpoint was virological failure (VF), defined as one VL value of ≥1000 copies/mL or two consecutive VL values of >50 copies/mL. Results We included 264 ART regimens: 75.6% male, median (IQR) age 47 years (39–53), 7 years (3–16) of HIV infection, nadir CD4+ 247 cells/mm3 (105–361), 81.5% with VL ≤50 copies/mL and 11.7% with at least one NRTI mutation at baseline. Eleven (5.2%) VFs occurred in virologically suppressed patients versus eight (15.1%) in viraemic patients. The estimated probability of VF at 48 weeks with versus without any NRTI mutation was 7.4% (95% CI 2.3–12.5) versus 3.8% (2.1–5.5) in virologically suppressed patients and 66.7% (39.5–93.9) versus 11.2% (6.5–15.9) (P<0.001) in viraemic patients. The only predictor of VF was time on therapy (per 1 year more, adjusted HR 1.14, 95% CI 1.02–1.27, P=0.024) in viraemic patients. Conclusions A switch to E/C/F/TDF or E/C/F/TAF is safe for virologically suppressed patients without documented NRTI resistance, but not recommended in viraemic patients with a history of NRTI resistance. Although we did not detect a detrimental effect of past NRTI resistance in virologically suppressed patients, a fully active regimen remains preferred in this setting due to possible rebound of drug-resistant virus in the long term.

The impact of statin therapy after surgical or endovascular treatment of cerebral aneurysms

2020 ◽  
Vol 133 (1) ◽  
pp. 182-189
Author(s):  
Tae-Jin Song ◽  
Seung-Hun Oh ◽  
Jinkwon Kim
Keyword(s):  
Statin Therapy ◽  
Coil Embolization ◽  
Primary Outcome ◽  
Cox Regression ◽  
Cerebral Aneurysms ◽  
Time Dependent ◽  
Lipid Lowering ◽  
Surgical Clipping ◽  
The Impact

OBJECTIVECerebral aneurysms represent the most common cause of spontaneous subarachnoid hemorrhage. Statins are lipid-lowering agents that may expert multiple pleiotropic vascular protective effects. The authors hypothesized that statin therapy after coil embolization or surgical clipping of cerebral aneurysms might improve clinical outcomes.METHODSThis was a retrospective cohort study using the National Health Insurance Service–National Sample Cohort Database in Korea. Patients who underwent coil embolization or surgical clipping for cerebral aneurysm between 2002 and 2013 were included. Based on prescription claims, the authors calculated the proportion of days covered (PDC) by statins during follow-up as a marker of statin therapy. The primary outcome was a composite of the development of stroke, myocardial infarction, and all-cause death. Multivariate time-dependent Cox regression analyses were performed.RESULTSA total of 1381 patients who underwent coil embolization (n = 542) or surgical clipping (n = 839) of cerebral aneurysms were included in this study. During the mean (± SD) follow-up period of 3.83 ± 3.35 years, 335 (24.3%) patients experienced the primary outcome. Adjustments were performed for sex, age (as a continuous variable), treatment modality, aneurysm rupture status (ruptured or unruptured aneurysm), hypertension, diabetes mellitus, household income level, and prior history of ischemic stroke or intracerebral hemorrhage as time-independent variables and statin therapy during follow-up as a time-dependent variable. Consistent statin therapy (PDC > 80%) was significantly associated with a lower risk of the primary outcome (adjusted hazard ratio 0.34, 95% CI 0.14–0.85).CONCLUSIONSConsistent statin therapy was significantly associated with better prognosis after coil embolization or surgical clipping of cerebral aneurysms.

scholarly journals Rare Etiology of Odynophagia in a Female Adolescent

2021 ◽  
pp. 352-358
Author(s):  
Anastasios Koutsoumourakis ◽  
Asterios Gagalis ◽  
Maria Fotoulaki ◽  
Maria Stafylidou
Keyword(s):  
Antiviral Treatment ◽  
Healing Process ◽  
Rare Condition ◽  
Female Adolescent ◽  
Mucosal Barrier ◽  
Esophageal Mucosa ◽  
Intact Immune System ◽  
History Of ◽  
Orolabial Herpes

Herpes esophagitis (HE) is a rare condition in immunocompetent adolescents. However, it commonly occurs as a primary infection in younger individuals. Herein, we report a 16-year-old female patient who had a history of fever for 5 days, odynophagia, and orolabial herpes infection for 7 days. Clusters of painful vesicles on an erythematous base on the lips, gingiva, and palate were observed on physical examination. Further, esophagogastroduodenoscopy revealed diffuse linear ulcerations in the distal esophagus. The patient then received the following treatment: intravenous (I.V.) acyclovir 5 mg/kg three times a day, I.V. omeprazole 40 mg two times a day, and acyclovir 5% cream four times a day. After 8 days of admission, the patient was discharged. A follow-up esophagogastroduodenoscopy was performed 7 weeks after discharge, and the results revealed that the esophageal mucosa had a normal appearance. The effect of antiviral treatment against HE remains unknown in these patients. Nevertheless, it is believed to accelerate the healing process in individuals with esophageal mucosal barrier damage. To the best of our knowledge, this case of a female adolescent with an intact immune system is the sixth case of herpes simplex esophagitis to be reported in the literature.

scholarly journals S19 The impact of clotting abnormalities on the natural history of idiopathic pulmonary fibrosis: an extended follow up of a population based cohort

Thorax ◽  
2016 ◽  
Vol 71 (Suppl 3) ◽  
pp. A13.1-A13
Author(s):  
V Navaratnam ◽  
AW Fogarty ◽  
T McKeever ◽  
N Thompson ◽  
G Jenkins ◽  
...  
Keyword(s):  
Natural History ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Population Based ◽  
History Of ◽  
The Impact

scholarly journals Coronary risk of patients with valvular heart disease: prospective validation of CT-Valve Score

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001380
Author(s):  
Rasmus Bo Hasselbalch ◽  
Mia Marie Pries-Heje ◽  
Sarah Louise Kjølhede Holle ◽  
Thomas Engstrøm ◽  
Merete Heitmann ◽  
...  
Keyword(s):  
Heart Disease ◽  
Valvular Heart Disease ◽  
Primary Outcome ◽  
Multislice Ct ◽  
Cost Effective ◽  
University Hospital ◽  
Before And After ◽  
History Of ◽  
Artery Disease

ObjectiveTo prospectively validate the CT-Valve score, a new risk score designed to identify patients with valvular heart disease at a low risk of coronary artery disease (CAD) who could benefit from multislice CT (MSCT) first instead of coronary angiography (CAG).MethodsThis was a prospective cohort study of patients referred for valve surgery in the Capital Region of Denmark and Odense University Hospital from the 1 February 2015 to the 1 February 2017. MSCT was implemented for patients with a CT-Valve score ≤7 at the referring physician’s discretion. Patients with a history of CAD or chronic kidney disease were excluded. The primary outcome was the proportion of patients needing reevaluation with CAG after MSCT and risk of CAD among the patients determined to be low to intermediate risk.ResultsIn total, 1149 patients were included. The median score was 9 (IQR 3) and 339 (30%) had a score ≤7. MSCT was used for 117 patients. Of these 29 (25%) were reevaluated and 9 (7.7%) had CAD. Of the 222 patients with a score ≤7 that did not receive an MSCT, 14 (6%) had significant CAD. The estimated total cost of evaluation among patients with a score ≤7 before implementation was €132 093 compared with €79 073 after, a 40% reduction. Similarly, estimated total radiation before and after was 608 mSv and 362 mSv, a 41% reduction. Follow-up at a median of 32 months (18–48) showed no ischaemic events for patients receiving only MSCT.ConclusionThe CT-Valve score is a valid method for determining risk of CAD among patients with valvular heart disease. Using a score ≤7 as a cut-off for the use of MSCT is safe and cost-effective.

scholarly journals Surgically resected skull base meningiomas demonstrate a divergent postoperative recurrence pattern compared with non–skull base meningiomas

2016 ◽  
Vol 125 (2) ◽  
pp. 431-440 ◽  
Author(s):  
Alireza Mansouri ◽  
George Klironomos ◽  
Shervin Taslimi ◽  
Alex Kilian ◽  
Fred Gentili ◽  
...  
Keyword(s):  
Skull Base ◽  
Recurrence Rate ◽  
Postoperative Recurrence ◽  
Prior History ◽  
Skull Base Tumors ◽  
Who Grade ◽  
Predictors Of Recurrence ◽  
History Of ◽  
Skull Base Meningiomas

OBJECTIVE The objective of this study was to identify the natural history and clinical predictors of postoperative recurrence of skull base and non–skull base meningiomas. METHODS The authors performed a retrospective hospital-based study of all patients with meningioma referred to their institution from September 1993 to January 2014. The cohort constituted both patients with a first-time presentation and those with evidence of recurrence. Kaplan-Meier curves were constructed for analysis of recurrence and differences were assessed using the log-rank test. Cox proportional hazard regression was used to identify potential predictors of recurrence. RESULTS Overall, 398 intracranial meningiomas were reviewed, including 269 (68%) non–skull base and 129 (32%) skull base meningiomas (median follow-up 30.2 months, interquartile range [IQR] 8.5–76 months). The 10-year recurrence-free survival rates for patients with gross-total resection (GTR) and subtotal resection (STR) were 90% and 43%, respectively. Skull base tumors were associated with a lower proliferation index (0.041 vs 0.062, p = 0.001), higher likelihood of WHO Grade I (85.3% vs 69.1%, p = 0.003), and younger patient age (55.2 vs 58.3 years, p = 0.01). Meningiomas in all locations demonstrated an average recurrence rate of 30% at 100 months of follow-up. Subsequently, the recurrence of skull base meningiomas plateaued whereas non–skull base lesions had an 80% recurrence rate at 230 months follow-up (p = 0.02). On univariate analysis, a prior history of recurrence (p < 0.001), initial WHO grade following resection (p < 0.001), and the inability to obtain GTR (p < 0.001) were predictors of future recurrence. On multivariate analysis a prior history of recurrence (p = 0.02) and an STR (p < 0.01) were independent predictors of a recurrence. Assessing only patients with primary presentations, STR and WHO Grades II and III were independent predictors of recurrence (p < 0.001 for both). CONCLUSIONS Patients with skull base meningiomas present at a younger age and have less aggressive lesions overall. Extent of resection is a key predictor of recurrence and long-term follow-up of meningiomas is necessary, especially for non–skull base tumors. In skull base meningiomas, recurrence risk plateaus approximately 100 months after surgery, suggesting that for this specific cohort, follow-up after 100 months can be less frequent.

Abstract P011: Heart Failure and the Obesity Paradox Among Participants in the in the REasons for Geographic and Racial Differences in Stroke (REGARDS) Study

Circulation ◽  
2013 ◽  
Vol 127 (suppl_12) ◽  
Author(s):  
Raegan W Durant ◽  
Todd M Brown ◽  
Emily B Levitan ◽  
Joshua S Richman ◽  
Nicole Redmond ◽  
...  
Keyword(s):  
Heart Failure ◽  
Health Behaviors ◽  
Normal Weight ◽  
Community Dwelling ◽  
Prior History ◽  
Central Adiposity ◽  
All Cause Mortality ◽  
History Of ◽  
Regards Study

Background: Overweight and obese adults living with heart failure (HF) have lower mortality compared to those of normal weight. However, the specific relationships of overall weight status and central adiposity with mortality among those with HF are less well-defined. We examined the relationships among body mass index (BMI), waist circumference (WC) and mortality among patients hospitalized for HF in the REGARDS Study. Methods: REGARDS is a national cohort of US community-dwelling adults aged >45 recruited from 2003 to 2007. We measured all-cause mortality rates among 565 participants hospitalized with HF who were normal weight (BMI 18.5-24.9 kg/m 2 ), overweight (BMI 25.0-29.9 kg/m 2 ), or obese (BMI > 30.0 kg/m 2 ) at baseline. Underweight participants (BMI < 18.5 kg/m 2 ) were excluded. Baseline WC, weight, and height were measured during an in-home exam. Index HF hospitalizations during follow-up were adjudicated by a panel of experts. Vital status was determined using the Social Security Death Index or the National Death Index. Cox proportional models estimated hazard ratios for all-cause mortality following the index HF hospitalization. Models were sequentially adjusted for WC, sociodemographics, HF severity (EF and BNP during HF hospitalization, prior history of HF, prior history of diastolic dysfunction), comorbidities, and health behaviors. Results: Among 565 participants hospitalized for HF, 116 (21%) were normal weight, 209 (37%) overweight, and 240 (42%) obese at baseline. Over a mean follow-up of 2.5 years, 253 deaths occurred. In multivariable analyses, overweight was associated with lower all-cause mortality in all models (Table). Each 1-cm increase in WC was associated with higher risk of all-cause mortality, but the relationship was not statistically significant after health behaviors were added in the final model. . Conclusions: Among adults hospitalized for HF, overweight as assessed by BMI may be associated with lower risk for mortality. However, central adiposity may confer higher risk of mortality.

scholarly journals Attendance at an outpatient follow-up clinic by HIV-positive psychiatric patients initiated on ART as inpatients

2015 ◽  
Vol 21 (3) ◽  
pp. 5
Author(s):  
Yvette M Nel ◽  
Gregory Jonsson
Keyword(s):  
Psychiatric Patients ◽  
Mental Healthcare ◽  
Limited Resource ◽  
Primary Objective ◽  
Hiv Treatment ◽  
Hiv Positive ◽  
Hiv Status ◽  
Post Discharge ◽  
Resource Setting

<p><strong>Background.</strong> Evidence suggests that the presence of mental illness may be associated with poorer adherence to antiretroviral therapy (ART). There is also a general understanding that patients initiated on ART as inpatients have poorer outcomes than those initiated as outpatients. Negative perceptions regarding future adherence may affect the clinical decision to initiate ART in hospitalised psychiatric patients. Attendance at clinic appointments is an indicator of medication adherence, and is easily measurable in a limited-resource setting. </p><p><strong>Objectives.</strong> The primary objective of this study was to examine the rate of attendance at the first clinic appointment post discharge from a period of psychiatric hospitalisation in HIV-positive psychiatric patients initiated on ART as inpatients. A secondary objective was to determine which factors, if any, were associated with clinic attendance. </p><p><strong>Methods.</strong> This study was a retrospective record review, conducted at the Luthando Neuropsychiatric HIV Clinic in Soweto, which is an integrated mental healthcare and ART clinic. Patients who were initiated on ART as psychiatric inpatients from 1 July 2009 to 31 December 2010, and subsequently discharged for outpatient follow-up at Luthando Clinic were included in the sample.  </p><p><strong>Results.</strong> There were 98 patients included in the analysis. The sample was predominantly female. The rate of attendance was 80%. The attendant and non-attendant groups were similar in terms of demographic and clinical data.  Significantly fewer non-attendant patients had disclosed their HIV status to their treatment supporter (<em>p</em>=0.01). </p><p><strong>Conclusion.</strong> Non-disclosure of HIV status needs to be further addressed in integrated psychiatric HIV treatment facilities in order to improve attendance. Female predominance in this setting should also be further investigated.</p>

Real world treatment patterns in chronic myeloid leukemia patients newly initiated on tyrosine kinase inhibitors in an U.S. integrated healthcare system

2017 ◽  
Vol 24 (4) ◽  
pp. 253-263
Author(s):  
Nazia Rashid ◽  
Han A Koh ◽  
Kathy J Lin ◽  
Brian Stwalley ◽  
Eugene Felber
Keyword(s):  
Chronic Myelogenous Leukemia ◽  
Index Date ◽  
Stem Cell Transplant ◽  
Study Time ◽  
Myelogenous Leukemia ◽  
Prior History ◽  
Cell Transplant ◽  
Time Period ◽  
History Of

Purpose To evaluate treatment patterns in patients diagnosed with incident chronic myelogenous leukemia (CML) newly initiating therapy with imatinib, dasatinib, or nilotinib. Patients were followed to determine switching and discontinuation rates. Factors associated with switching or discontinuation from index TKI therapy, reasons for discontinuation based on electronic chart notes, and frequency of laboratory monitoring were assessed during the follow-up period. Methods A retrospective cohort study was conducted in chronic myelogenous leukemia patients aged ≥ 18 years who were identified from the Kaiser Permanente Southern California (KPSC) Cancer Registry database during the study time period of 1 January 2007 to 12 December 2013. The index date was defined as the date of the first TKI prescription (imatinib, dasatinib, or nilotinib) identified during the study time period with no prior history of TKI use within 12 months. Patients had to have continuous membership with drug benefit eligibility and no prior history of stem cell transplant (SCT) or other cancers during the 12 months prior to the index date. Baseline characteristics were identified during 12 months prior to the index date and outcomes were identified during the follow-up period after the index date. All patients were followed from index TKI therapy until end of study time period (12 December 2014), death, stem cell transplant, or disenrollment from the health plan unless one of the following occurred first: a patient switched their index therapy, or a patient discontinued their index therapy. Forward stepwise selection multivariable logistic regression models were used to evaluate factors associated with patients who continued therapy compared to those who switched or discontinued therapy with the index TKI. Chart notes were reviewed 30 days prior and 30 days post index TKI discontinuation to evaluate reasons for discontinuation. Molecular and cytogenetic testing frequency was also assessed during the follow-up period among the different patient groups. Results Two hundred sixteen patients were identified with incident chronic myelogenous leukemia and use of TKI therapy: 189 (87.5%) received imatinib, 19 (8.8%) received dasatinib, and 8 (3.7%) received nilotinib. The mean age on index date was 53 years and 63% were male; 103 patients (48%) continued on their index therapy, while 62 patients (28%) switched, and 51 patients (24%) discontinued.

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