The Experts below are selected from a list of 30495 Experts worldwide ranked by ideXlab platform
Hope S Rugo - One of the best experts on this subject based on the ideXlab platform.
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prevention of everolimus related Stomatitis in women with hormone receptor positive her2 negative metastatic breast cancer using dexamethasone mouthwash swish a single arm phase 2 trial
Lancet Oncology, 2017Co-Authors: Hope S Rugo, Thaddeus J Beck, John A Glaspy, Julio Peguero, Timothy J Pluard, Navneet Dhillon, Leon Christopher Hwang, Chaitali Singh Nangia, Lasika Seneviratne, Ingrid A MayerAbstract:Summary Background Stomatitis is a class effect associated with the inhibition of mTOR and is associated with everolimus therapy for breast cancer. Topical steroids might reduce Stomatitis incidence and severity, and the need for dose reductions and interruptions of everolimus. Anecdotal use of topical steroid oral prophylaxis has been reported in patients with breast cancer. We aimed to assess dexamethasone-based mouthwash for prevention of Stomatitis in patients with breast cancer. Methods This US-based, multicentre, single-arm, phase 2 prevention study enrolled women aged 18 years and older with postmenopausal status who had histologically or cytologically confirmed metastatic hormone receptor-positive, HER2-negative breast cancer. Beginning on day 1 of cycle 1, patients received everolimus 10 mg plus exemestane 25 mg daily, with 10 mL of alcohol-free dexamethasone 0·5 mg per 5 mL oral solution (swish for 2 min and spit, four times daily for 8 weeks). After 8 weeks, dexamethasone mouthwash could be continued for up to eight additional weeks at the discretion of the clinician and patient. The primary endpoint was incidence of grade 2 or worse Stomatitis by 8 weeks assessed in the full analysis set (patients who received at least one dose of everolimus and exemestane and at least one confirmed dose of dexamethasone mouthwash) versus historical controls from the BOLERO-2 trial (everolimus and exemestane treatment in patients with hormone receptor-positive advanced breast cancer who were not given dexamethasone mouthwash for prevention of Stomatitis). This trial is registered at ClinicalTrials.gov, number NCT02069093. Findings Between May 28, 2014, and Oct 8, 2015, we enrolled 92 women; 85 were evaluable for efficacy. By 8 weeks, the incidence of grade 2 or worse Stomatitis was two (2%) of 85 patients (95% CI 0·29–8·24), versus 159 (33%) of 482 patients (95% CI 28·8–37·4) for the duration of the BOLERO-2 study. Overall, 83 (90%) of 92 patients had at least one adverse event. The most frequently reported grade 3 and 4 adverse events in the safety set were hyperglycaemia (seven [8%] of 92 patients), rash (four [4%]), and dyspnoea (three [3%]). Serious adverse events were reported in 20 (22%) patients; six (7%) were deemed treatment related, with dyspnoea (three [3%]) and pneumonia (two [2%]) reported most frequently. 12 (13%) of 92 patients had adverse events suspected to be related to treatment that led to discontinuation of everolimus and exemestane (the most common were rash, hyperglycaemia, and Stomatitis, which each affected two [2%] patients). Interpretation Prophylactic use of dexamethasone oral solution substantially reduced the incidence and severity of Stomatitis in patients receiving everolimus and exemestane and could be a new standard of oral care for patients receiving everolimus and exemestane therapy. Funding Novartis Pharmaceuticals Corporation.
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prevention of everolimus exemestane eve exe Stomatitis in postmenopausal pm women with hormone receptor positive hr metastatic breast cancer mbc using a dexamethasone based mouthwash mw results of the swish trial
Journal of Clinical Oncology, 2016Co-Authors: Hope S Rugo, Lasikas Seneviratne, Thaddeus J Beck, John A Glaspy, Julio Peguero, Timothy J Pluard, Navneet Dhillon, Leon Christopher Hwang, Chaitali Singh Nangia, Ingrid A MayerAbstract:189 Background: Stomatitis is a frequent adverse event (AE) associated with mTOR inhibition. In BOLERO-2 patients (pts) receiving EVE/EXE, all grade (Gr) Stomatitis was 67%; 33% had Gr ≥ 2 and 8% Gr 3. Median time to ≥ Gr 2 onset was 15.5 days; incidence of new Stomatitis (Gr ≥ 2) plateaued at 6 wks. In a meta-analysis, 89% of first Stomatitis events occurred within 8 wks. Topical steroids are used to treat aphthous ulcers; anecdotal use as prophylaxis has been reported. Methods: Eligibility included PM women with HR+ MBC prescribed EVE/EXE. Treatment included EVE 10 mg and EXE 25 mg QD, with 10 mL of commercially available 0.5 mg/5 mL dexamethasone oral solution to swish x 2 min and spit QID for 8 wks starting day 1. Pts completed a daily adherence log, including an oral pain (range 0-10) and normalcy of diet score. The primary endpoint was to compare the incidence of Gr ≥ 2 Stomatitis at 8 wks with BOLERO-2 results. Secondary endpoints included MW use by average times/day, EVE/EXE dose intensity, incide...
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meta analysis of Stomatitis in clinical studies of everolimus incidence and relationship with efficacy
Annals of Oncology, 2016Co-Authors: Hope S Rugo, Gabriel N Hortobagyi, James C Yao, Marianne Pavel, Alain Ravaud, David Neal Franz, Francois Ringeisen, Jorge Gallo, Nicolas Rouyrre, Ozlem AnakAbstract:Background Everolimus, an oral mammalian target of rapamycin (mTOR) inhibitor, is used to treat solid tumors and tuberous sclerosis complex (TSC). Stomatitis, an inflammation of the mucous membranes of the mouth, is a common adverse event associated with mTOR inhibitors, including everolimus. We conducted a meta-analysis of data from seven randomized, double-blind phase 3 clinical trials of everolimus to determine the clinical impact of Stomatitis on efficacy and safety.
Ingrid A Mayer - One of the best experts on this subject based on the ideXlab platform.
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prevention of everolimus related Stomatitis in women with hormone receptor positive her2 negative metastatic breast cancer using dexamethasone mouthwash swish a single arm phase 2 trial
Lancet Oncology, 2017Co-Authors: Hope S Rugo, Thaddeus J Beck, John A Glaspy, Julio Peguero, Timothy J Pluard, Navneet Dhillon, Leon Christopher Hwang, Chaitali Singh Nangia, Lasika Seneviratne, Ingrid A MayerAbstract:Summary Background Stomatitis is a class effect associated with the inhibition of mTOR and is associated with everolimus therapy for breast cancer. Topical steroids might reduce Stomatitis incidence and severity, and the need for dose reductions and interruptions of everolimus. Anecdotal use of topical steroid oral prophylaxis has been reported in patients with breast cancer. We aimed to assess dexamethasone-based mouthwash for prevention of Stomatitis in patients with breast cancer. Methods This US-based, multicentre, single-arm, phase 2 prevention study enrolled women aged 18 years and older with postmenopausal status who had histologically or cytologically confirmed metastatic hormone receptor-positive, HER2-negative breast cancer. Beginning on day 1 of cycle 1, patients received everolimus 10 mg plus exemestane 25 mg daily, with 10 mL of alcohol-free dexamethasone 0·5 mg per 5 mL oral solution (swish for 2 min and spit, four times daily for 8 weeks). After 8 weeks, dexamethasone mouthwash could be continued for up to eight additional weeks at the discretion of the clinician and patient. The primary endpoint was incidence of grade 2 or worse Stomatitis by 8 weeks assessed in the full analysis set (patients who received at least one dose of everolimus and exemestane and at least one confirmed dose of dexamethasone mouthwash) versus historical controls from the BOLERO-2 trial (everolimus and exemestane treatment in patients with hormone receptor-positive advanced breast cancer who were not given dexamethasone mouthwash for prevention of Stomatitis). This trial is registered at ClinicalTrials.gov, number NCT02069093. Findings Between May 28, 2014, and Oct 8, 2015, we enrolled 92 women; 85 were evaluable for efficacy. By 8 weeks, the incidence of grade 2 or worse Stomatitis was two (2%) of 85 patients (95% CI 0·29–8·24), versus 159 (33%) of 482 patients (95% CI 28·8–37·4) for the duration of the BOLERO-2 study. Overall, 83 (90%) of 92 patients had at least one adverse event. The most frequently reported grade 3 and 4 adverse events in the safety set were hyperglycaemia (seven [8%] of 92 patients), rash (four [4%]), and dyspnoea (three [3%]). Serious adverse events were reported in 20 (22%) patients; six (7%) were deemed treatment related, with dyspnoea (three [3%]) and pneumonia (two [2%]) reported most frequently. 12 (13%) of 92 patients had adverse events suspected to be related to treatment that led to discontinuation of everolimus and exemestane (the most common were rash, hyperglycaemia, and Stomatitis, which each affected two [2%] patients). Interpretation Prophylactic use of dexamethasone oral solution substantially reduced the incidence and severity of Stomatitis in patients receiving everolimus and exemestane and could be a new standard of oral care for patients receiving everolimus and exemestane therapy. Funding Novartis Pharmaceuticals Corporation.
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prevention of everolimus exemestane eve exe Stomatitis in postmenopausal pm women with hormone receptor positive hr metastatic breast cancer mbc using a dexamethasone based mouthwash mw results of the swish trial
Journal of Clinical Oncology, 2016Co-Authors: Hope S Rugo, Lasikas Seneviratne, Thaddeus J Beck, John A Glaspy, Julio Peguero, Timothy J Pluard, Navneet Dhillon, Leon Christopher Hwang, Chaitali Singh Nangia, Ingrid A MayerAbstract:189 Background: Stomatitis is a frequent adverse event (AE) associated with mTOR inhibition. In BOLERO-2 patients (pts) receiving EVE/EXE, all grade (Gr) Stomatitis was 67%; 33% had Gr ≥ 2 and 8% Gr 3. Median time to ≥ Gr 2 onset was 15.5 days; incidence of new Stomatitis (Gr ≥ 2) plateaued at 6 wks. In a meta-analysis, 89% of first Stomatitis events occurred within 8 wks. Topical steroids are used to treat aphthous ulcers; anecdotal use as prophylaxis has been reported. Methods: Eligibility included PM women with HR+ MBC prescribed EVE/EXE. Treatment included EVE 10 mg and EXE 25 mg QD, with 10 mL of commercially available 0.5 mg/5 mL dexamethasone oral solution to swish x 2 min and spit QID for 8 wks starting day 1. Pts completed a daily adherence log, including an oral pain (range 0-10) and normalcy of diet score. The primary endpoint was to compare the incidence of Gr ≥ 2 Stomatitis at 8 wks with BOLERO-2 results. Secondary endpoints included MW use by average times/day, EVE/EXE dose intensity, incide...
David E Stallknecht - One of the best experts on this subject based on the ideXlab platform.
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Biological Transmission of Vesicular Stomatitis Virus (New Jersey Serotype) by Simulium vittatum (Diptera: Simuliidae) to Domestic Swine (Sus scrofa)
Journal of Medical Entomology, 2004Co-Authors: Daniel G Mead, Molly D. Murphy, Elizabeth W Howerth, Elmer W Gray, Raymond Noblet, David E StallknechtAbstract:Abstract The role of hematophagous arthropods in vesicular Stomatitis virus (New Jersey serotype; VSV-NJ) transmission during epizootics has remained unclear for decades in part because it has never been shown that clinical or subclinical disease in a livestock host results from the bite of an infected insect. In this study, we investigated the ability of VSV-NJ–infected black flies (Simulium vittatum Zetterstedt) to transmit the virus to domestic swine, Sus scrofa L. Experimental evidence presented here clearly demonstrates that VSV-NJ was transmitted from black flies to the swine. Transmission was confirmed by seroconversion or by the presence of clinical vesicular Stomatitis followed by seroconversion. Our results represent the first report of clinical vesicular Stomatitis in a livestock host after virus transmission by an insect.
Thaddeus J Beck - One of the best experts on this subject based on the ideXlab platform.
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prevention of everolimus related Stomatitis in women with hormone receptor positive her2 negative metastatic breast cancer using dexamethasone mouthwash swish a single arm phase 2 trial
Lancet Oncology, 2017Co-Authors: Hope S Rugo, Thaddeus J Beck, John A Glaspy, Julio Peguero, Timothy J Pluard, Navneet Dhillon, Leon Christopher Hwang, Chaitali Singh Nangia, Lasika Seneviratne, Ingrid A MayerAbstract:Summary Background Stomatitis is a class effect associated with the inhibition of mTOR and is associated with everolimus therapy for breast cancer. Topical steroids might reduce Stomatitis incidence and severity, and the need for dose reductions and interruptions of everolimus. Anecdotal use of topical steroid oral prophylaxis has been reported in patients with breast cancer. We aimed to assess dexamethasone-based mouthwash for prevention of Stomatitis in patients with breast cancer. Methods This US-based, multicentre, single-arm, phase 2 prevention study enrolled women aged 18 years and older with postmenopausal status who had histologically or cytologically confirmed metastatic hormone receptor-positive, HER2-negative breast cancer. Beginning on day 1 of cycle 1, patients received everolimus 10 mg plus exemestane 25 mg daily, with 10 mL of alcohol-free dexamethasone 0·5 mg per 5 mL oral solution (swish for 2 min and spit, four times daily for 8 weeks). After 8 weeks, dexamethasone mouthwash could be continued for up to eight additional weeks at the discretion of the clinician and patient. The primary endpoint was incidence of grade 2 or worse Stomatitis by 8 weeks assessed in the full analysis set (patients who received at least one dose of everolimus and exemestane and at least one confirmed dose of dexamethasone mouthwash) versus historical controls from the BOLERO-2 trial (everolimus and exemestane treatment in patients with hormone receptor-positive advanced breast cancer who were not given dexamethasone mouthwash for prevention of Stomatitis). This trial is registered at ClinicalTrials.gov, number NCT02069093. Findings Between May 28, 2014, and Oct 8, 2015, we enrolled 92 women; 85 were evaluable for efficacy. By 8 weeks, the incidence of grade 2 or worse Stomatitis was two (2%) of 85 patients (95% CI 0·29–8·24), versus 159 (33%) of 482 patients (95% CI 28·8–37·4) for the duration of the BOLERO-2 study. Overall, 83 (90%) of 92 patients had at least one adverse event. The most frequently reported grade 3 and 4 adverse events in the safety set were hyperglycaemia (seven [8%] of 92 patients), rash (four [4%]), and dyspnoea (three [3%]). Serious adverse events were reported in 20 (22%) patients; six (7%) were deemed treatment related, with dyspnoea (three [3%]) and pneumonia (two [2%]) reported most frequently. 12 (13%) of 92 patients had adverse events suspected to be related to treatment that led to discontinuation of everolimus and exemestane (the most common were rash, hyperglycaemia, and Stomatitis, which each affected two [2%] patients). Interpretation Prophylactic use of dexamethasone oral solution substantially reduced the incidence and severity of Stomatitis in patients receiving everolimus and exemestane and could be a new standard of oral care for patients receiving everolimus and exemestane therapy. Funding Novartis Pharmaceuticals Corporation.
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prevention of everolimus exemestane eve exe Stomatitis in postmenopausal pm women with hormone receptor positive hr metastatic breast cancer mbc using a dexamethasone based mouthwash mw results of the swish trial
Journal of Clinical Oncology, 2016Co-Authors: Hope S Rugo, Lasikas Seneviratne, Thaddeus J Beck, John A Glaspy, Julio Peguero, Timothy J Pluard, Navneet Dhillon, Leon Christopher Hwang, Chaitali Singh Nangia, Ingrid A MayerAbstract:189 Background: Stomatitis is a frequent adverse event (AE) associated with mTOR inhibition. In BOLERO-2 patients (pts) receiving EVE/EXE, all grade (Gr) Stomatitis was 67%; 33% had Gr ≥ 2 and 8% Gr 3. Median time to ≥ Gr 2 onset was 15.5 days; incidence of new Stomatitis (Gr ≥ 2) plateaued at 6 wks. In a meta-analysis, 89% of first Stomatitis events occurred within 8 wks. Topical steroids are used to treat aphthous ulcers; anecdotal use as prophylaxis has been reported. Methods: Eligibility included PM women with HR+ MBC prescribed EVE/EXE. Treatment included EVE 10 mg and EXE 25 mg QD, with 10 mL of commercially available 0.5 mg/5 mL dexamethasone oral solution to swish x 2 min and spit QID for 8 wks starting day 1. Pts completed a daily adherence log, including an oral pain (range 0-10) and normalcy of diet score. The primary endpoint was to compare the incidence of Gr ≥ 2 Stomatitis at 8 wks with BOLERO-2 results. Secondary endpoints included MW use by average times/day, EVE/EXE dose intensity, incide...
John A Glaspy - One of the best experts on this subject based on the ideXlab platform.
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prevention of everolimus related Stomatitis in women with hormone receptor positive her2 negative metastatic breast cancer using dexamethasone mouthwash swish a single arm phase 2 trial
Lancet Oncology, 2017Co-Authors: Hope S Rugo, Thaddeus J Beck, John A Glaspy, Julio Peguero, Timothy J Pluard, Navneet Dhillon, Leon Christopher Hwang, Chaitali Singh Nangia, Lasika Seneviratne, Ingrid A MayerAbstract:Summary Background Stomatitis is a class effect associated with the inhibition of mTOR and is associated with everolimus therapy for breast cancer. Topical steroids might reduce Stomatitis incidence and severity, and the need for dose reductions and interruptions of everolimus. Anecdotal use of topical steroid oral prophylaxis has been reported in patients with breast cancer. We aimed to assess dexamethasone-based mouthwash for prevention of Stomatitis in patients with breast cancer. Methods This US-based, multicentre, single-arm, phase 2 prevention study enrolled women aged 18 years and older with postmenopausal status who had histologically or cytologically confirmed metastatic hormone receptor-positive, HER2-negative breast cancer. Beginning on day 1 of cycle 1, patients received everolimus 10 mg plus exemestane 25 mg daily, with 10 mL of alcohol-free dexamethasone 0·5 mg per 5 mL oral solution (swish for 2 min and spit, four times daily for 8 weeks). After 8 weeks, dexamethasone mouthwash could be continued for up to eight additional weeks at the discretion of the clinician and patient. The primary endpoint was incidence of grade 2 or worse Stomatitis by 8 weeks assessed in the full analysis set (patients who received at least one dose of everolimus and exemestane and at least one confirmed dose of dexamethasone mouthwash) versus historical controls from the BOLERO-2 trial (everolimus and exemestane treatment in patients with hormone receptor-positive advanced breast cancer who were not given dexamethasone mouthwash for prevention of Stomatitis). This trial is registered at ClinicalTrials.gov, number NCT02069093. Findings Between May 28, 2014, and Oct 8, 2015, we enrolled 92 women; 85 were evaluable for efficacy. By 8 weeks, the incidence of grade 2 or worse Stomatitis was two (2%) of 85 patients (95% CI 0·29–8·24), versus 159 (33%) of 482 patients (95% CI 28·8–37·4) for the duration of the BOLERO-2 study. Overall, 83 (90%) of 92 patients had at least one adverse event. The most frequently reported grade 3 and 4 adverse events in the safety set were hyperglycaemia (seven [8%] of 92 patients), rash (four [4%]), and dyspnoea (three [3%]). Serious adverse events were reported in 20 (22%) patients; six (7%) were deemed treatment related, with dyspnoea (three [3%]) and pneumonia (two [2%]) reported most frequently. 12 (13%) of 92 patients had adverse events suspected to be related to treatment that led to discontinuation of everolimus and exemestane (the most common were rash, hyperglycaemia, and Stomatitis, which each affected two [2%] patients). Interpretation Prophylactic use of dexamethasone oral solution substantially reduced the incidence and severity of Stomatitis in patients receiving everolimus and exemestane and could be a new standard of oral care for patients receiving everolimus and exemestane therapy. Funding Novartis Pharmaceuticals Corporation.
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prevention of everolimus exemestane eve exe Stomatitis in postmenopausal pm women with hormone receptor positive hr metastatic breast cancer mbc using a dexamethasone based mouthwash mw results of the swish trial
Journal of Clinical Oncology, 2016Co-Authors: Hope S Rugo, Lasikas Seneviratne, Thaddeus J Beck, John A Glaspy, Julio Peguero, Timothy J Pluard, Navneet Dhillon, Leon Christopher Hwang, Chaitali Singh Nangia, Ingrid A MayerAbstract:189 Background: Stomatitis is a frequent adverse event (AE) associated with mTOR inhibition. In BOLERO-2 patients (pts) receiving EVE/EXE, all grade (Gr) Stomatitis was 67%; 33% had Gr ≥ 2 and 8% Gr 3. Median time to ≥ Gr 2 onset was 15.5 days; incidence of new Stomatitis (Gr ≥ 2) plateaued at 6 wks. In a meta-analysis, 89% of first Stomatitis events occurred within 8 wks. Topical steroids are used to treat aphthous ulcers; anecdotal use as prophylaxis has been reported. Methods: Eligibility included PM women with HR+ MBC prescribed EVE/EXE. Treatment included EVE 10 mg and EXE 25 mg QD, with 10 mL of commercially available 0.5 mg/5 mL dexamethasone oral solution to swish x 2 min and spit QID for 8 wks starting day 1. Pts completed a daily adherence log, including an oral pain (range 0-10) and normalcy of diet score. The primary endpoint was to compare the incidence of Gr ≥ 2 Stomatitis at 8 wks with BOLERO-2 results. Secondary endpoints included MW use by average times/day, EVE/EXE dose intensity, incide...
