The Experts below are selected from a list of 66309 Experts worldwide ranked by ideXlab platform
Pallavi Shruti Mishrakalyani - One of the best experts on this subject based on the ideXlab platform.
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analysis of Time to Treatment discontinuation of targeted therapy immunotherapy and chemotherapy in clinical trials of patients with non small cell lung cancer
Annals of Oncology, 2019Co-Authors: Pallavi Shruti Mishrakalyani, Yutao Gong, Gideon M Blumenthal, Kenneth L Kehl, Kirsten B Goldberg, Sean Khozin, Paul G KluetzAbstract:ABSTRACT Background Pragmatic end points, such as Time-to-Treatment discontinuation (TTD), defined as the date of starting a medication to the date of Treatment discontinuation or death has been proposed as a potential efficacy end point for real-world evidence (RWE) trials, where imaging evaluation is less structured and standardized. Patients and methods We studied 18 randomized clinical trials of patients with metastatic non-small-cell lung cancer (mNSCLC), initiated after 2007 and submitted to U.S. Food and Drug Administration. TTD was calculated as date of randomization to date of discontinuation or death and compared to progression-free survival (PFS) and overall survival (OS) across all patients, as well as in Treatment-defined subgroups [EGFR mutation-positive treated with tyrosine kinase inhibitor (TKI), EGFR wild-type treated with TKI, ALK-positive treated with TKI, immune checkpoint inhibitor (ICI), chemotherapy doublet with maintenance, chemotherapy monotherapy]. Results Overall across 8947 patients, TTD was more closely associated with PFS (r = 0.87, 95% CI 0.86–0.87) than with OS (0.68, 95% CI 0.67–0.69). Early TTD (PFS—TTD ≥ 3 months) occurred in 7.7% of patients overall, and was more common with chemo monotherapy (15.0%) while late TTD (TTD—PFS ≥ 3 months) occurred in 6.0% of patients overall, and was more common in EGFR-positive and ALK-positive patients (12.4% and 22.9%). In oncogene-targeted subgroups (EGFR positive and ALK positive), median TTDs (13.4 and 14.1 months) exceeded median PFS (11.4 and 11.3 months). Conclusions At the patient level, TTD is associated with PFS across therapeutic classes. Median TTD exceeds median PFS for biomarker-selected patients receiving oncogene-targeted therapies. TTD should be prospectively studied further as an end point for pragmatic randomized RWE trials only for continuously administered therapies.
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Time to Treatment failure ttf as a potential clinical endpoint in real world evidence rwe studies of melanoma
Journal of Clinical Oncology, 2018Co-Authors: Rajeshwari Sridhara, Marc R Theoret, Jiaxi Zhou, Pallavi Shruti MishrakalyaniAbstract:9578Background: Time to Treatment failure (TTF) has been suggested as a practical clinical endpoint for studies of oncologic agents using real-world evidence (RWE). However, TTF is rarely studied a...
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Time to Treatment discontinuation ttd as a pragmatic endpoint in metastatic non small cell lung cancer mnsclc a pooled analysis of 8 trials
Journal of Clinical Oncology, 2018Co-Authors: Yutao Gong, Pallavi Shruti Mishrakalyani, Kenneth L Kehl, Sean Khozin, Geoffrey R Oxnard, Gideon M BlumenthalAbstract:9064Background: Progression-free survival (PFS) is an important efficacy endpoint in oncology trials. However, clinical trials increasingly allow Treatment beyond objective radiographic progression...
Gideon M Blumenthal - One of the best experts on this subject based on the ideXlab platform.
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analysis of Time to Treatment discontinuation of targeted therapy immunotherapy and chemotherapy in clinical trials of patients with non small cell lung cancer
Annals of Oncology, 2019Co-Authors: Pallavi Shruti Mishrakalyani, Yutao Gong, Gideon M Blumenthal, Kenneth L Kehl, Kirsten B Goldberg, Sean Khozin, Paul G KluetzAbstract:ABSTRACT Background Pragmatic end points, such as Time-to-Treatment discontinuation (TTD), defined as the date of starting a medication to the date of Treatment discontinuation or death has been proposed as a potential efficacy end point for real-world evidence (RWE) trials, where imaging evaluation is less structured and standardized. Patients and methods We studied 18 randomized clinical trials of patients with metastatic non-small-cell lung cancer (mNSCLC), initiated after 2007 and submitted to U.S. Food and Drug Administration. TTD was calculated as date of randomization to date of discontinuation or death and compared to progression-free survival (PFS) and overall survival (OS) across all patients, as well as in Treatment-defined subgroups [EGFR mutation-positive treated with tyrosine kinase inhibitor (TKI), EGFR wild-type treated with TKI, ALK-positive treated with TKI, immune checkpoint inhibitor (ICI), chemotherapy doublet with maintenance, chemotherapy monotherapy]. Results Overall across 8947 patients, TTD was more closely associated with PFS (r = 0.87, 95% CI 0.86–0.87) than with OS (0.68, 95% CI 0.67–0.69). Early TTD (PFS—TTD ≥ 3 months) occurred in 7.7% of patients overall, and was more common with chemo monotherapy (15.0%) while late TTD (TTD—PFS ≥ 3 months) occurred in 6.0% of patients overall, and was more common in EGFR-positive and ALK-positive patients (12.4% and 22.9%). In oncogene-targeted subgroups (EGFR positive and ALK positive), median TTDs (13.4 and 14.1 months) exceeded median PFS (11.4 and 11.3 months). Conclusions At the patient level, TTD is associated with PFS across therapeutic classes. Median TTD exceeds median PFS for biomarker-selected patients receiving oncogene-targeted therapies. TTD should be prospectively studied further as an end point for pragmatic randomized RWE trials only for continuously administered therapies.
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Time to Treatment discontinuation ttd as a pragmatic endpoint in metastatic non small cell lung cancer mnsclc a pooled analysis of 8 trials
Journal of Clinical Oncology, 2018Co-Authors: Yutao Gong, Pallavi Shruti Mishrakalyani, Kenneth L Kehl, Sean Khozin, Geoffrey R Oxnard, Gideon M BlumenthalAbstract:9064Background: Progression-free survival (PFS) is an important efficacy endpoint in oncology trials. However, clinical trials increasingly allow Treatment beyond objective radiographic progression...
Yutao Gong - One of the best experts on this subject based on the ideXlab platform.
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fda pooled analysis of Time to Treatment discontinuation ttd in frontline advanced renal cell carcinoma trials
Journal of Clinical Oncology, 2020Co-Authors: Elaine Chang, Yutao Gong, Chana Weinstock, Laura L Fernandes, Jessica Hawley, Thomas Gwise, Meredith M Regan, Toni K Choueiri, Brian I Rini, David F McdermottAbstract:5081Background: Time to Treatment discontinuation (TTD) has been proposed as a potential pragmatic real-world data (RWD) endpoint, and was closely correlated with progression-free survival (PFS) in...
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analysis of Time to Treatment discontinuation of targeted therapy immunotherapy and chemotherapy in clinical trials of patients with non small cell lung cancer
Annals of Oncology, 2019Co-Authors: Pallavi Shruti Mishrakalyani, Yutao Gong, Gideon M Blumenthal, Kenneth L Kehl, Kirsten B Goldberg, Sean Khozin, Paul G KluetzAbstract:ABSTRACT Background Pragmatic end points, such as Time-to-Treatment discontinuation (TTD), defined as the date of starting a medication to the date of Treatment discontinuation or death has been proposed as a potential efficacy end point for real-world evidence (RWE) trials, where imaging evaluation is less structured and standardized. Patients and methods We studied 18 randomized clinical trials of patients with metastatic non-small-cell lung cancer (mNSCLC), initiated after 2007 and submitted to U.S. Food and Drug Administration. TTD was calculated as date of randomization to date of discontinuation or death and compared to progression-free survival (PFS) and overall survival (OS) across all patients, as well as in Treatment-defined subgroups [EGFR mutation-positive treated with tyrosine kinase inhibitor (TKI), EGFR wild-type treated with TKI, ALK-positive treated with TKI, immune checkpoint inhibitor (ICI), chemotherapy doublet with maintenance, chemotherapy monotherapy]. Results Overall across 8947 patients, TTD was more closely associated with PFS (r = 0.87, 95% CI 0.86–0.87) than with OS (0.68, 95% CI 0.67–0.69). Early TTD (PFS—TTD ≥ 3 months) occurred in 7.7% of patients overall, and was more common with chemo monotherapy (15.0%) while late TTD (TTD—PFS ≥ 3 months) occurred in 6.0% of patients overall, and was more common in EGFR-positive and ALK-positive patients (12.4% and 22.9%). In oncogene-targeted subgroups (EGFR positive and ALK positive), median TTDs (13.4 and 14.1 months) exceeded median PFS (11.4 and 11.3 months). Conclusions At the patient level, TTD is associated with PFS across therapeutic classes. Median TTD exceeds median PFS for biomarker-selected patients receiving oncogene-targeted therapies. TTD should be prospectively studied further as an end point for pragmatic randomized RWE trials only for continuously administered therapies.
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Time to Treatment discontinuation ttd as a pragmatic endpoint in metastatic non small cell lung cancer mnsclc a pooled analysis of 8 trials
Journal of Clinical Oncology, 2018Co-Authors: Yutao Gong, Pallavi Shruti Mishrakalyani, Kenneth L Kehl, Sean Khozin, Geoffrey R Oxnard, Gideon M BlumenthalAbstract:9064Background: Progression-free survival (PFS) is an important efficacy endpoint in oncology trials. However, clinical trials increasingly allow Treatment beyond objective radiographic progression...
Natasha B Leighl - One of the best experts on this subject based on the ideXlab platform.
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biomarker testing and Time to Treatment decision in patients with advanced nonsmall cell lung cancer
Annals of Oncology, 2015Co-Authors: Ming-sound Tsao, R Burkes, Gilda Da Cunha Santos, Suzanne Kamelreid, David M Hwang, Ronald Feld, Jean-françois Tanguay, Frances A Shepherd, Lisa W. Le, Natasha B LeighlAbstract:ABSTRACT Background Testing for EGFR mutations and ALK rearrangement has become standard in managing advanced nonsmall-cell lung cancer (NSCLC). However, many institutions in Europe, North America and other world regions continue to face a common challenge of facilitating Timely molecular testing with rapid result turnaround Time. We assessed the prevalence of biomarker testing for advanced NSCLC patients and whether testing affected the Timeliness of Treatment decisions. Methods We conducted a retrospective chart review of a random sample of one-quarter of all patients with advanced NSCLC referred to the Princess Margaret Cancer Centre from 1 April 2010 to 31 March 2013. Results Of 300 patients reviewed, 175 seen by medical oncology had nonsquamous NSCLC, 72% of whom had biomarker testing carried out. Patients tested for biomarkers were more likely to be female (47% versus 21%, P = 0.002), Asian (27% versus 6%, P = 0.005) and never smokers (42% versus 8%, P Conclusions Awaiting biomarker testing results can delay Treatment decisions and Treatment initiation for patients with advanced NSCLC. This may be avoided by incorporating reflex biomarker testing into diagnostic algorithms for NSCLC at the level of the pathologist, and further education of specialists involved in obtaining diagnostic cancer specimens to ensure they are sufficient for molecular testing.
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biomarker testing and Time to Treatment decision in patients with advanced nonsmall cell lung cancer
Annals of Oncology, 2015Co-Authors: Ming-sound Tsao, R Burkes, Gilda Da Cunha Santos, Suzanne Kamelreid, David M Hwang, Ronald Feld, Jean-françois Tanguay, Frances A Shepherd, Lisa W. Le, Natasha B LeighlAbstract:BACKGROUND: Testing for EGFR mutations and ALK rearrangement has become standard in managing advanced nonsmall-cell lung cancer (NSCLC). However, many institutions in Europe, North America and other world regions continue to face a common challenge of facilitating Timely molecular testing with rapid result turnaround Time. We assessed the prevalence of biomarker testing for advanced NSCLC patients and whether testing affected the Timeliness of Treatment decisions. METHODS: We conducted a retrospective chart review of a random sample of one-quarter of all patients with advanced NSCLC referred to the Princess Margaret Cancer Centre from 1 April 2010 to 31 March 2013. RESULTS: Of 300 patients reviewed, 175 seen by medical oncology had nonsquamous NSCLC, 72% of whom had biomarker testing carried out. Patients tested for biomarkers were more likely to be female (47% versus 21%, P = 0.002), Asian (27% versus 6%, P = 0.005) and never smokers (42% versus 8%, P < 0.0001). Only 21% of patients with biomarker testing had results available at their initial oncology consultation. This group had a shorter median Time from consultation to Treatment decision (0 versus 22 days, P = 0.0008) and Time to Treatment start (16 versus 29, P = 0.004). Thirteen percent underwent repeat biopsy for molecular testing after the initial consultation. Of those with positive EGFR or ALK results, 19% started chemotherapy before biomarker results became available. CONCLUSIONS: Awaiting biomarker testing results can delay Treatment decisions and Treatment initiation for patients with advanced NSCLC. This may be avoided by incorporating reflex biomarker testing into diagnostic algorithms for NSCLC at the level of the pathologist, and further education of specialists involved in obtaining diagnostic cancer specimens to ensure they are sufficient for molecular testing.
David F Mcdermott - One of the best experts on this subject based on the ideXlab platform.
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fda pooled analysis of Time to Treatment discontinuation ttd in frontline advanced renal cell carcinoma trials
Journal of Clinical Oncology, 2020Co-Authors: Elaine Chang, Yutao Gong, Chana Weinstock, Laura L Fernandes, Jessica Hawley, Thomas Gwise, Meredith M Regan, Toni K Choueiri, Brian I Rini, David F McdermottAbstract:5081Background: Time to Treatment discontinuation (TTD) has been proposed as a potential pragmatic real-world data (RWD) endpoint, and was closely correlated with progression-free survival (PFS) in...
