Effect of concomitant proton pump inhibitor (PPI) on effectiveness of tyrosine kinase inhibitor (TKI) in patients with metastatic renal cell carcinoma (mRCC).

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 608-608
Author(s):  
Trang H. Au ◽  
Erin B. Bailey ◽  
Shiven B. Patel ◽  
Srinivas Kiran Tantravahi ◽  
Neeraj Agarwal ◽  
...  
Keyword(s):  
Kinase Inhibitor ◽  
Small Sample Size ◽  
Small Sample ◽  
Kaplan Meier ◽  
Observational Cohort ◽  
Retrospective Study Design ◽  
Tki Treatment ◽  
Lost To Follow Up ◽  
Tki Discontinuation

608 Background: PPIs may reduce TKI bioavailability resulting in reduced efficacy, shortened time on TKI treatment, and disease progression. Axitinib, sorafenib, and pazopanib exhibit pH-dependent solubility. Esomeprazole reduced the AUC and Cmax of pazopanib by 40%, but there was no significant interaction for sorafenib with omeprazole or axitinib with rabeprazole. In real world practice, the effect of PPIs as a class on the efficacy of TKIs as a class in mRCC has not been reported. Methods: This observational cohort study evaluated adult patients treated with a TKI for mRCC. Time on TKI treatment was defined as TKI initiation date to date of discontinuation, change in therapy, lost to follow-up, or death. We performed a treatment line analysis. Time on TKI treatment was compared between patients with and without concurrent PPI (Kaplan-Meier, log-rank). Results: Analysis included 128 treatment lines, including 49 TKI with PPI and 79 TKI with no PPI treatment lines. TKIs included sunitinib, pazopanib, sorafenib, and axitinib. PPIs included omeprazole, lansoprazole, esomeprazole, pantoprazole, and rabeprazole. The three most common TKI/PPI combinations involved omeprazole with sunitinib (26), pazopanib (13), and axitinib (3). No difference in time on TKI treatment with PPI (median 8.7 months) and with no PPI (median 7.0 months, p = 0.41) was observed. In pazopanib treatment lines, no difference in time on treatment was observed in those treated with omeprazole or esomeprazole (n = 14, median 4.8 months) compared to those without PPI (n = 18, median 1.7 months, p = 0.22). Conclusions: Among the TKI/PPI combinations evaluated, there was no difference in time to TKI discontinuation with or without concurrent PPI. This suggests that concurrent PPI does not affect time to discontinuation of TKI. Study limitations include the small sample size, limited number of TKI/PPI combinations, and retrospective study design. A larger study is needed to validate these findings.

Improved Postoperative Survival for Intraductal- Growth Subtype of Intrahepatic Cholangiocarcinoma

2016 ◽  
Vol 82 (11) ◽  
pp. 1133-1139 ◽  
Author(s):  
Laura L. Dover ◽  
Rojymon Jacob ◽  
Thomas N. Wang ◽  
Joseph H. Richardson ◽  
David T. Redden ◽  
...  
Keyword(s):  
Intrahepatic Cholangiocarcinoma ◽  
Small Sample Size ◽  
Tumor Stage ◽  
Small Sample ◽  
Postoperative Survival ◽  
Rank Test ◽  
Intraductal Growth ◽  
Kaplan Meier ◽  
Disease Free

Intrahepatic cholangiocarcinoma (ICC) is classified according to the following subtypes: mass-forming (MF), periductal infiltrating (PI), and intraductal growth (IG). The aim of this study is to measure the association between ICC subtypes and patient survival after surgical resection. Data were abstracted on all patients treated with definitive resections of ICC at a single institution between 2000 and 2011 with at least three years follow-up. Survival estimates were quantified using Kaplan-Meier curves and compared using the log-rank test. There were 37 patients with ICC treated with definitive partial hepatectomies with a median survival of 33.5 months. Tumor stage (P < 0.0001), satellitosis (P < 0.001), lymphovascular space invasion (P = 0.003), and macroscopic subtype (P = 0.003) were predictive of postoperative survival. Disease-free survivals for MF, PI, and IG subtypes, respectively, were 30 per cent, 0 per cent, and 57 per cent (P = 0.017). Overall survivals among ICC macroscopic subtypes were as follows: MF 37 per cent, PI 0 per cent, and IG 71 per cent (P = 0.003). Although limited by the small sample size of this rare cancer, this study demonstrates significant differences among macroscopic subtypes of ICC in both disease-free survivals and overall survivals after definitive partial hepatectomy.

scholarly journals RADI-40. STEREOTACTIC RADIOSURGERY FOR BRAINSTEM METASTASES: AN ANALYSIS OF SINGLE FRACTION AND MULTI FRACTION TECHNIQUES

2019 ◽  
Vol 1 (Supplement_1) ◽  
pp. i29-i29
Author(s):  
Elana Nack ◽  
Varun Iyengar ◽  
Esther Yu ◽  
Thomas DiPetrillo ◽  
Timothy Kinsella ◽  
...  
Keyword(s):  
Stereotactic Radiosurgery ◽  
Tumor Volume ◽  
Small Sample Size ◽  
Small Sample ◽  
Single Institution ◽  
Single Fraction ◽  
Whole Brain Radiation ◽  
Kaplan Meier ◽  
Brain Radiation

Abstract PURPOSE: Utilization of stereotactic radiosurgery (SRS) for brainstem metastases (BSM) is increasing. Multi-fraction SRS (MF-SRS) is a potential means of obtaining therapeutic gain while limiting toxicity. However, most available data assesses only single-fraction SRS (SF-SRS). This study aims to evaluate the efficacy and safety of SF-SRS and MF-SRS for BSM. METHODS: Data was retrospectively collected for patients with BSM treated with SRS between 2003–2018 at a single institution. Kaplan-Meier method was used to evaluate overall survival (OS) and local control (LC). Independent t-test was used for correlations between groups. RESULTS: 29 patients (31 lesions) were identified; 13 patients (15 lesions) underwent SF-SRS and 16 patients (16 lesions) underwent MF-SRS. Median follow-up was 6.8 months (1–80.8 months). Post-SRS MRI was available for 78% of patients. Median dose was 16Gy (12–18 Gy) for SF-SRS and 24 Gy (18–30 Gy) for MF-SRS. MF-SRS was delivered in a median of 3 fractions (3–5). There was a trend toward larger mean tumor volume with MF-SRS (1.297 vs 0.302mL, p=0.055). OS was 64.8% at 6 months and 49.3% at 12 months. LC was 90.9% at 6 months and 69.9% at 12 months. LC was similar between SF-SRS and MF-SRS at 6 months (100% vs 79.5%, p=0.143) and 12 months (50.0% vs 79.5%, p=0.812). Among the 4 patients who experienced local recurrence, 3 received salvage whole brain radiation and median OS was 8.1 months after LF. Distant CNS failures occurred in 40.3% of patients at 6 months and 72.4% at 12 months. Tumor volume &gt;0.5 mL was associated with worse LC at 6 months (64.3% vs 100%, p=0.022). One patient developed symptomatic radiation necrosis (1/29 lesions, 3.4%) after MF-SRS. CONCLUSION: SRS is a safe and effective treatment for small BSM. Outcomes were not different between SF-SRS and MF-SRS but analysis is limited by small sample size.

Erythema Induratum: Case Series Illustrating the Utility of the Interferon-γ Release Assay in Determining the Association with Tuberculosis

2013 ◽  
Vol 17 (4_suppl) ◽  
pp. S6-S11 ◽  
Author(s):  
Vimal Prajapati ◽  
McKay Steed ◽  
Parbeer Grewal ◽  
Muhammad N. Mahmood ◽  
Geetika Verma ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Case Series ◽  
Complete Response ◽  
Interferon Γ ◽  
Small Sample ◽  
Release Assay ◽  
Novel Method ◽  
Nodular Vasculitis ◽  
Lost To Follow Up

Background: The interferon-γ release assay (IGRA) is a novel method for detecting previous sensitization to tuberculosis (TB). Despite having several advantages over the tuberculin skin test (TST), including higher specificity and no influence from past bacille Calmette-Guérin (BCG) exposure, there are a limited number of reports describing its application in patients with erythema induratum (EI)/nodular vasculitis (NV), which is usually but not always related to TB. Objectives: The aim of our case series was to evaluate the usefulness of the IGRA for determining a TB association in patients with EI/NV. Methods: Retrospective chart reviews were conducted on four patients diagnosed with EI/NV at our institution in whom an IGRA had been performed. Results: All four subjects had positive TST results. The IGRA was also positive and therefore supported a link with TB in two cases. One patient responded completely to anti-TB therapy, whereas the second was lost to follow-up. Both cases unrelated to TB, by virtue of negative IGRAs, demonstrated complete response to immunosuppressive therapy (methotrexate), with one individual having failed anti-TB therapy first. Conclusion: Our case series highlights the utility of the IGRA for establishing a TB association in patients with EI/NV. Although limited by a small sample size, we propose adjunctive use of this test at the time of EI/NV diagnosis, especially in the setting of previous BCG exposure, so that management can be tailored according to whether an underlying relationship with TB exists.

Risk of hepatotoxicity with concurrent statin and tyrosine kinase inhibitor (TKI) or mTOR inhibitor (mTORi) in patients with metastatic renal cell carcinoma (mRCC).

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 610-610
Author(s):  
Trang H. Au ◽  
Erin B. Bailey ◽  
Shiven B. Patel ◽  
Srinivas Kiran Tantravahi ◽  
Neeraj Agarwal ◽  
...  
Keyword(s):  
Liver Enzyme ◽  
Kinase Inhibitor ◽  
Competitive Inhibition ◽  
Small Sample Size ◽  
Small Sample ◽  
Exact Test ◽  
Treatment Line ◽  
Concurrent Use ◽  
Additive Risk ◽  
Observational Cohort

610 Background: TKIs and statins alone can cause liver injury. When used together, there is additive risk for hepatotoxicity, as seen with pazopanib and simvastatin, and the potential for discontinuing TKI therapy. Liver enzyme abnormalities are also associated with mTORi. Hepatotoxicity from concurrent use of statins as a class with TKI or mTORi as a class in real world practice in mRCC has not been reported. Methods: This observational cohort study included adult patients treated with a TKI or mTORi for mRCC at the Huntsman Cancer Institute from 2004-2014. We performed a treatment line analysis. For each treatment line, CTCAE criteria were used to categorize maximum AST, ALT, and total bilirubin. Highest grade of any liver enzyme was compared between TKI with and without statin and between mTORi with and without statin (Fisher’s Exact test). Results: A total of 162 treatment lines were included. For TKI and statin, the three most common treatment line combinations were sunitinib and simvastatin (7), sunitinib and atorvastatin (4), and pazopanib and simvastatin (3). For mTORi and statin, the three most common treatment line combinations involved simvastatin with temsirolimus (7) and everolimus (3). Prevalence of hepatotoxicity is shown in the table. Conclusions: Our results show a trend toward significance in the prevalence of hepatotoxicity with concomitant mTORi and statin versus mTORi alone, perhaps explained by mTORi-mediated competitive inhibition of simvastatin (sensitive CYP 3A4 substrate). There was no difference in hepatotoxicity for TKI with or without statin, although there were few pazopanib and simvastatin combinations. Study limitations include the small sample size, limited number of TKI or mTORi and statin combinations, and retrospective study design. A larger study is needed to validate these findings. [Table: see text]

Intralesional Triamcinolone for Fistulous Tracts in Hidradenitis Suppurativa: An Uncontrolled Prospective Trial with Clinical and Ultrasonographic Follow-Up

Dermatology ◽  
2019 ◽  
Vol 236 (1) ◽  
pp. 46-51 ◽  
Author(s):  
Pedro Álvarez ◽  
F. Javier García-Martínez ◽  
Ines Poveda ◽  
José Carlos Pascual
Keyword(s):  
Hidradenitis Suppurativa ◽  
Single Injection ◽  
Small Sample Size ◽  
Prospective Trial ◽  
Small Sample ◽  
Control Group ◽  
Open Label ◽  
Open Label Study ◽  
Lost To Follow Up

Background: There is little evidence on the use of intralesional triamcinolone (ILT) for managing fistulous tracts in hidradenitis suppurativa (HS). Objective: To assess the clinical and ultrasound response to ILT for single fistulous lesions in HS patients. Methods: A prospective open-label study was conducted to assess response to ILT (40 mg/mL) for fistulous tracts in HS. Consecutive patients (Hurley II stage exclusively) presenting to our department were recruited from August 2016 to August 2018. They received a single injection of ILT as the sole treatment. Lesions were assessed clinically and by ultrasound at baseline and 90 days. Results: Of the 53 included HS patients with fistulous tracts, 36 (67.9%) were women, 30 (56.6%) were smokers, and 36 (67.9%) were obese or overweight (body mass index ≥25). Median Sartorius score was 9.0 (IQR 9.0–36.0), and median duration of the lesion treated was 6 months (IQR 3.0–12.0). Fistulous tracts were injected with 0.5 mL triamcinolone 40 mg/mL. Seven patients were lost to follow-up. At 90 days, 20 (43.5%) lesions showed clinical and ultrasound resolution, 13 (28.3%) showed only clinical resolution while persisting on ultrasound, and 13 (28.3%) persisted both clinically and on ultrasound. Mean clinical size decreased from 17.0 to 5.1 mm (p < 0.0001), while mean length on ultrasound decreased from 16.0 to 8.6 mm (p < 0.0001). Limitations: Small sample size and no control group. Conclusions: Our study suggests that ILT is beneficial for small fistulous tracts in HS.

scholarly journals Assessing Biomarkers of Breast Cancer Risk in Underserved Women in a Midwestern County

2021 ◽  
Vol 12 ◽  
pp. 215013272110177
Author(s):  
Marla A. DeWitt ◽  
Ivana T. Croghan ◽  
Celine M. Vachon ◽  
Thomas D. Thacher ◽  
Marcia R. Venegas Pont ◽  
...  
Keyword(s):  
Vitamin D ◽  
Mammographic Density ◽  
Small Sample Size ◽  
Vitamin D Insufficiency ◽  
Screening Mammography ◽  
Small Sample ◽  
Vitamin D Status ◽  
Small Pilot Study ◽  
Unexpected Findings

Objective: The primary aim of this study was to evaluate the feasibility of collecting risk factor information and accessing digitized mammographic data in a medically marginalized population. A secondary aim was to examine the association between vitamin D status and mammographic density. Methods: Breast-screening examinations were provided for age-appropriate patients, and a referral for no-cost screening mammography was offered. Study participants were asked to undergo 25-hydroxyvitamin D testing at mammography and 1-year follow-up. Results: Of 62 women approached, 35 (56%) consented to participate. Of 32 participants who had baseline mammography, the median mammographic density measured by VolparaDensity (Volpara Solutions Limited) was 5.7%. After 1 year, 9 women obtained follow-up mammograms, with a median density of 5.7%. Vitamin D status was measured for 31 participants at baseline and 13 participants in the following year. Insufficient vitamin D status (<30 ng/mL) was noted in 77% at each time point. Mammographic density was not significantly correlated with vitamin D status ( P = .06). Conclusions: On the basis of this small pilot study, vitamin D insufficiency is common in this study population. Owing to the small sample size, an association between vitamin D insufficiency and breast density was not clear. Additional unexpected findings included substantial barriers in initial access to care and longitudinal follow-up in this population. Further study of these issues is needed.

Trends in glassy cell cervical cancer in the United States from 1973-2015: Analysis based on SEER database.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17502-e17502
Author(s):  
Anahat Kaur ◽  
Shuai Wang ◽  
Tarek N. Elrafei ◽  
Lewis Steinberg ◽  
Abhishek Kumar
Keyword(s):  
United States ◽  
Cervical Cancer ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Small Sample Size ◽  
Black Population ◽  
The United States ◽  
Small Sample ◽  
Cervix Uteri ◽  
Kaplan Meier

e17502 Background: Glassy cell carcinoma of cervix (GCCC) is a rare histological subtype of cervical cancer which has historically been associated with rapidly progressive disease, early development of metastases and overall poor prognosis. We attempt to define real-world trends in GCCC in the United States based on data from SEER (Surveillance, Epidemiology and End Results) database. Methods: We extracted data from the US National Cancer Institute's SEER 2018 dataset using ICD-O code for ‘Cervix Uteri Glassy Cell Carcinoma’. All patients who were diagnosed between 1973-2015 were included. Statistical analysis was done using SPSS 26. Kaplan Meier curve was used for survival analysis. Results: Data for a total of 57 patients with GCCC was available from 1975 to 2017. Median age at diagnosis was 38 years (range 30.5-44.5). Increased frequency of cases was noted in white females (77.2%) as compared to black population (22.2%). Most cases initially presented with localized or regional spread (47.4% and 40.4% respectively) with distant metastasis seen in only 10.5% patients. Data analysis revealed that 63.2% patients had Grade III poorly differentiated carcinoma, 66.7% received radiation therapy, 57.9% underwent chemotherapy and 59.6% had cancer direceted surgery performed. Calculated mean overall survival was 121.9 months. We were unable to calculate 5 year and 10 year median overall survival due to small sample size and censored data. Conclusions: GCCC is a rare histologic type of cervical cancer that presents at a younger age, is more frequently seen in white females and is commonly associated with localized or regional spread at time of initial presentation.[Table: see text]

Role of multiparametric MRI in long-term surveillance following focal laser ablation of prostate cancer

2021 ◽  
pp. 20210414
Author(s):  
Mark Paxton ◽  
Eitan Barbalat ◽  
Nathan Perlis ◽  
Ravi J Menezes ◽  
Mark Gertner ◽  
...  
Keyword(s):  
Laser Ablation ◽  
Recurrent Disease ◽  
Small Sample Size ◽  
Focal Therapy ◽  
Outcome Data ◽  
Small Sample ◽  
Restricted Diffusion ◽  
Treatment Site ◽  
Imaging Characteristics

Objective: Determine the multiparametric magnetic resonance imaging (mpMRI) appearance of the prostate following focal laser ablation (FLA) for PCa and to identify imaging characteristics associated with recurrent disease. Methods: Retrospective analysis of patients who underwent FLA for low-intermediate risk PCa between 2010 and 2014 was performed. Early (median 4 months) and late mpMRI (median 49 months) follow-up were qualitatively assessed for T2-weighted, dynamic contrast enhanced (DCE) and diffusion weighted imaging (DWI) appearances and also compared to corresponding PSA values and biopsy results. Results: 55 cancers were treated in 54 men (mean age 61.0 years). Early mpMRI was performed in 30 (54.5%) patients while late follow-up mpMRI in 42 (84%). Ill-defined scarring with and without atrophy at the treatment site were the most common appearances. In patients with paired MRI and biopsy, one of four patients with clinically significant PCa on biopsy (≥GG2 or≥6 mm GG1) showed hyperenhancement or restricted diffusion at early follow-up. At late follow-up, positive biopsies were seen in 5/8 (63%) cases with hyperenhancement and 5/6 (83%) cases with restricted diffusion at the treatment site. PSA change was not associated with biopsy results at either time point. Conclusion: mpMRI is able to document the morphological and temporal changes following focal therapy. It has limited ability to detect recurrent disease in early months following treatment. Late-term mpMRI is sensitive at identifying patients with recurrent disease. Small sample size is, however, a limitation of the study. Advances in knowledge: Implementing MRI in follow-up after FT may be useful in predicting residual or recurrent PCa and therefore provide reliable outcome data.

scholarly journals Adherence Over Time: The Course of Adherence to Customized Diabetic Insoles as Objectively Assessed by a Temperature Sensor

2017 ◽  
Vol 12 (3) ◽  
pp. 695-700 ◽  
Author(s):  
Dominic Ehrmann ◽  
Monika Spengler ◽  
Michael Jahn ◽  
Dea Niebuhr ◽  
Thomas Haak ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Temperature Sensor ◽  
Small Sample Size ◽  
Temperature Sensors ◽  
Small Sample ◽  
Gender Effects ◽  
Kaplan Meier ◽  
Foot Problems ◽  
Mean Time

Background: Temperature sensors are an objective way to assess adherence to diabetic footwear. Good adherence is essential for the prevention of diabetic foot problems. Little is known about the long-term course of adherence in patients at risk for diabetic foot problems. Method: A temperature sensor was incorporated into the specialized footwear of patients with type 2 diabetes after their first plantar ulceration. Kaplan-Meier curve was used to analyze when patients started to become nonadherent (not wearing the footwear for two straight weeks). Gender effects on adherence were also analyzed. Results: 26 patients with a mean observation time of 133.5 days could be analyzed. Mean wearing time of diabetic footwear was 4.2 ± 3.6 h/day (Mdn = 3.4 h/day; interquartile range = 0.5-7.0 h/day) and on 51% of the days patients did not wear their footwear at all. Kaplan-Meier curve revealed that the mean time of adherence was 27.5 weeks. Men achieved a mean time of adherence of 30.5 weeks, while women only achieved 14 weeks. However, due to the small sample size, this difference was not statistically significant. Conclusions: Temperature sensors revealed a low long-term adherence to diabetic footwear. Women seemed to be at a higher risk for earlier nonadherent behavior. Adherence to diabetic footwear should be closely monitored and tailored intervention strategies should be developed.

scholarly journals QTc interval in patients with schizophrenia receiving antipsychotic treatment as monotherapy or polypharmacy

CNS Spectrums ◽  
2017 ◽  
Vol 23 (4) ◽  
pp. 278-283 ◽  
Author(s):  
Anja Elliott ◽  
Thibault Johan Mørk ◽  
Mikkel Højlund ◽  
Thomas Christensen ◽  
Rasmus Jeppesen ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Torsades De Pointes ◽  
Small Sample ◽  
Polymorphic Ventricular Tachycardia ◽  
Antipsychotic Treatment ◽  
Qtc Interval ◽  
Qtc Prolongation ◽  
Worst Case ◽  
Clinical Interviews ◽  
Observational Cohort

ObjectiveAntipsychotics are associated with a polymorphic ventricular tachycardia, torsades de pointes, which, in the worst case, can lead to sudden cardiac death. The QT interval corrected for heart rate (QTc) is used as a clinical proxy for torsades de pointes. The QTc interval can be prolonged by antipsychotic monotherapy, but it is unknown if the QTc interval is prolonged further with antipsychotic polypharmaceutical treatment. Therefore, this study investigated the associations between QTc interval and antipsychotic monotherapy and antipsychotic polypharmaceutical treatment in schizophrenia, and measured the frequency of QTc prolongation among patients.MethodsWe carried out an observational cohort study of unselected patients with schizophrenia visiting outpatient facilities in the region of Central Jutland, Denmark. Patients were enrolled from January of 2013 to June of 2015, with follow-up until June of 2015. Data were collected from clinical interviews and clinical case records.ResultsElectrocardiograms were available for 65 patients, and 6% had QTc prolongation. We observed no difference in average QTc interval for the whole sample of patients receiving no antipsychotics, antipsychotic monotherapy, or antipsychotic polypharmaceutical treatment (p=0.29). However, women presented with a longer QTc interval when receiving polypharmacy than when receiving monotherapy (p=0.01). A limitation of this study was its small sample size.ConclusionsWe recommend an increased focus on monitoring the QTc interval in women with schizophrenia receiving antipsychotics as polypharmacy.

Sign in / Sign up

Export Citation Format

Share Document