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Histology

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Histology - Free Register to Access Experts & Abstracts

Frances A Shepherd - One of the best experts on this subject based on the ideXlab platform.

  • treatment by Histology interaction analyses in three phase iii trials show superiority of pemetrexed in nonsquamous non small cell lung cancer
    Journal of Thoracic Oncology, 2011
    Co-Authors: Giorgio V Scagliotti, Thomas Brodowicz, Frances A Shepherd, Christoph Zielinski, Johan Vansteenkiste, C Manegold, Lorinda Simms, Frank V Fossella
    Abstract:

    Introduction: Recently, Histology has emerged as a predictive factor for pemetrexed efficacy in non-small cell lung cancer (NSCLC). These analyses evaluate whether the differential efficacy of pemetrexed by NSCLC Histology is reproducible and consistent across three registration studies of different lines of therapy (first-line/second-line and maintenance settings). Methods: The reported studies for patients with advanced NSCLC were pemetrexed versus docetaxel in previously treated patients ( N = 571), cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemotherapy-naive patients ( N = 1725), and maintenance pemetrexed plus best supportive care versus placebo plus best supportive care ( N = 663). Cox models of overall survival (OS) and progression-free survival (PFS) were used to test for a significant treatment-by-Histology interaction (THI). A significant THI indicates that the efficacy benefit for pemetrexed relative to the control arm is greater in patients with nonsquamous Histology than in those with squamous Histology. Subsequent Cox models were used to estimate hazard ratios for OS and PFS according to Histology. Results: Histology was well balanced between treatment arms in each study. Across all three studies, no clinically relevant differences were observed for the safety profile of pemetrexed among histologic groups. THIs were statistically significant in all three studies for OS ( p = 0.001, 0.002, and 0.033, respectively) and PFS ( p = 0.004, 0.002, and 0.036, respectively). Conclusions: These analyses demonstrate a statistically significant interaction between treatment effect and NSCLC Histology, indicating superior efficacy of pemetrexed in nonsquamous patients compared with other standard treatment options. Thus, Histology is consistently predictive of the improved efficacy of pemetrexed in patients with nonsquamous NSCLC.

  • the differential efficacy of pemetrexed according to nsclc Histology a review of two phase iii studies
    Oncologist, 2009
    Co-Authors: Giorgio V Scagliotti, Lorinda Simms, Frank V Fossella, Nasser H Hanna, Katherine Sugarman, J Blatter, Patrick Peterson, Frances A Shepherd
    Abstract:

    BACKGROUND: Recent studies of pemetrexed have identified a predictive role for non-small cell lung cancer (NSCLC) Histology. We further reviewed the differential efficacy of pemetrexed according to Histology in two large, phase III NSCLC trials. METHODS: One study tested pemetrexed versus docetaxel in previously treated patients (n = 571) and the other tested cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemotherapy-naive patients (n = 1,725) with advanced NSCLC. Cox proportional hazard models were used to test for covariate-adjusted treatment-by-Histology interactions (THIs) for overall survival (OS) and progression-free survival (PFS). For each histologic subgroup, the Kaplan-Meier method was used to estimate unadjusted within-arm medians, and Cox models were used to estimate covariate-adjusted between-arm hazard ratios (HRs). RESULTS: In both studies, treatment arms were well balanced for Histology. THIs were statistically significant (p < .005) for both OS and PFS. Nonsquamous patients treated with pemetrexed-based therapy experienced longer survival than the comparators (HR, 0.78 and 0.84, respectively), whereas squamous patients had shorter survival (HR, 1.56 and 1.23, respectively). Whereas the efficacy of pemetrexed regimens differed according to Histology, it did not differ for docetaxel or for cisplatin plus gemcitabine. Pemetrexed was well tolerated across histologic groups. CONCLUSIONS: The consistency of these results across studies confirms the predictive effect of Histology for pemetrexed and the survival advantage for pemetrexed in patients with nonsquamous Histology. These analyses suggest pemetrexed should not be recommended for the treatment of squamous cell carcinoma, but, because of efficacy and safety advantages, pemetrexed may be preferable to other agents for treatment of patients with nonsquamous NSCLC.

Annie Thompson - One of the best experts on this subject based on the ideXlab platform.

Lorinda Simms - One of the best experts on this subject based on the ideXlab platform.

  • treatment by Histology interaction analyses in three phase iii trials show superiority of pemetrexed in nonsquamous non small cell lung cancer
    Journal of Thoracic Oncology, 2011
    Co-Authors: Giorgio V Scagliotti, Thomas Brodowicz, Frances A Shepherd, Christoph Zielinski, Johan Vansteenkiste, C Manegold, Lorinda Simms, Frank V Fossella
    Abstract:

    Introduction: Recently, Histology has emerged as a predictive factor for pemetrexed efficacy in non-small cell lung cancer (NSCLC). These analyses evaluate whether the differential efficacy of pemetrexed by NSCLC Histology is reproducible and consistent across three registration studies of different lines of therapy (first-line/second-line and maintenance settings). Methods: The reported studies for patients with advanced NSCLC were pemetrexed versus docetaxel in previously treated patients ( N = 571), cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemotherapy-naive patients ( N = 1725), and maintenance pemetrexed plus best supportive care versus placebo plus best supportive care ( N = 663). Cox models of overall survival (OS) and progression-free survival (PFS) were used to test for a significant treatment-by-Histology interaction (THI). A significant THI indicates that the efficacy benefit for pemetrexed relative to the control arm is greater in patients with nonsquamous Histology than in those with squamous Histology. Subsequent Cox models were used to estimate hazard ratios for OS and PFS according to Histology. Results: Histology was well balanced between treatment arms in each study. Across all three studies, no clinically relevant differences were observed for the safety profile of pemetrexed among histologic groups. THIs were statistically significant in all three studies for OS ( p = 0.001, 0.002, and 0.033, respectively) and PFS ( p = 0.004, 0.002, and 0.036, respectively). Conclusions: These analyses demonstrate a statistically significant interaction between treatment effect and NSCLC Histology, indicating superior efficacy of pemetrexed in nonsquamous patients compared with other standard treatment options. Thus, Histology is consistently predictive of the improved efficacy of pemetrexed in patients with nonsquamous NSCLC.

  • the differential efficacy of pemetrexed according to nsclc Histology a review of two phase iii studies
    Oncologist, 2009
    Co-Authors: Giorgio V Scagliotti, Lorinda Simms, Frank V Fossella, Nasser H Hanna, Katherine Sugarman, J Blatter, Patrick Peterson, Frances A Shepherd
    Abstract:

    BACKGROUND: Recent studies of pemetrexed have identified a predictive role for non-small cell lung cancer (NSCLC) Histology. We further reviewed the differential efficacy of pemetrexed according to Histology in two large, phase III NSCLC trials. METHODS: One study tested pemetrexed versus docetaxel in previously treated patients (n = 571) and the other tested cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemotherapy-naive patients (n = 1,725) with advanced NSCLC. Cox proportional hazard models were used to test for covariate-adjusted treatment-by-Histology interactions (THIs) for overall survival (OS) and progression-free survival (PFS). For each histologic subgroup, the Kaplan-Meier method was used to estimate unadjusted within-arm medians, and Cox models were used to estimate covariate-adjusted between-arm hazard ratios (HRs). RESULTS: In both studies, treatment arms were well balanced for Histology. THIs were statistically significant (p < .005) for both OS and PFS. Nonsquamous patients treated with pemetrexed-based therapy experienced longer survival than the comparators (HR, 0.78 and 0.84, respectively), whereas squamous patients had shorter survival (HR, 1.56 and 1.23, respectively). Whereas the efficacy of pemetrexed regimens differed according to Histology, it did not differ for docetaxel or for cisplatin plus gemcitabine. Pemetrexed was well tolerated across histologic groups. CONCLUSIONS: The consistency of these results across studies confirms the predictive effect of Histology for pemetrexed and the survival advantage for pemetrexed in patients with nonsquamous Histology. These analyses suggest pemetrexed should not be recommended for the treatment of squamous cell carcinoma, but, because of efficacy and safety advantages, pemetrexed may be preferable to other agents for treatment of patients with nonsquamous NSCLC.

  • the prognostic and predictive role of Histology in advanced non small cell lung cancer a literature review
    Journal of Thoracic Oncology, 2008
    Co-Authors: Fred R Hirsch, Lorinda Simms, Anna Spreafico, Silvia Novello, Mary Dugan Wood, Mauro Papotti
    Abstract:

    Introduction The importance of non-small cell lung cancer (NSCLC) histologic subtype has increased during the last few decades because of an unprecedented shift in epidemiology and an increasing number of target-specific chemotherapeutic agents. This review examined Histology as a potential prognostic and/or predictive factor of clinical outcomes in advanced NSCLC. Methods Literature searches of articles from 1982 to 2007 were conducted. We identified publications detailing phase II or III studies, retrospective analyses, and meta-analyses that reported a statistically significant prognostic or predictive role for Histology. Results Of 408 publications identified, 11 reported a prognostic association between Histology and clinical outcomes, and 7 suggested that histologic subtype was predictive of outcomes in patients with advanced NSCLC treated with specific cytotoxic chemotherapy regimens. Fourteen publications reported Histology was prognostic and/or predictive in patients treated with epidermal growth factor receptor inhibitors. Inadequate data collection, test methodology, or study design—including insufficient sample size, misclassified samples, and grouping of histologic subtypes for analysis—may have obscured the interpretation of the role of Histology in many of the studies. Conclusions Although differences in study design and analyses make definitive conclusions difficult, evidence suggests that Histology may be prognostic or predictive of clinical efficacy outcomes. To determine which patients would benefit from specific treatments and to further understand the role of Histology, future studies should focus on establishing a definitive histologic diagnosis, and should include an analysis of histologic subtypes and efficacy outcomes.

Frank V Fossella - One of the best experts on this subject based on the ideXlab platform.

  • treatment by Histology interaction analyses in three phase iii trials show superiority of pemetrexed in nonsquamous non small cell lung cancer
    Journal of Thoracic Oncology, 2011
    Co-Authors: Giorgio V Scagliotti, Thomas Brodowicz, Frances A Shepherd, Christoph Zielinski, Johan Vansteenkiste, C Manegold, Lorinda Simms, Frank V Fossella
    Abstract:

    Introduction: Recently, Histology has emerged as a predictive factor for pemetrexed efficacy in non-small cell lung cancer (NSCLC). These analyses evaluate whether the differential efficacy of pemetrexed by NSCLC Histology is reproducible and consistent across three registration studies of different lines of therapy (first-line/second-line and maintenance settings). Methods: The reported studies for patients with advanced NSCLC were pemetrexed versus docetaxel in previously treated patients ( N = 571), cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemotherapy-naive patients ( N = 1725), and maintenance pemetrexed plus best supportive care versus placebo plus best supportive care ( N = 663). Cox models of overall survival (OS) and progression-free survival (PFS) were used to test for a significant treatment-by-Histology interaction (THI). A significant THI indicates that the efficacy benefit for pemetrexed relative to the control arm is greater in patients with nonsquamous Histology than in those with squamous Histology. Subsequent Cox models were used to estimate hazard ratios for OS and PFS according to Histology. Results: Histology was well balanced between treatment arms in each study. Across all three studies, no clinically relevant differences were observed for the safety profile of pemetrexed among histologic groups. THIs were statistically significant in all three studies for OS ( p = 0.001, 0.002, and 0.033, respectively) and PFS ( p = 0.004, 0.002, and 0.036, respectively). Conclusions: These analyses demonstrate a statistically significant interaction between treatment effect and NSCLC Histology, indicating superior efficacy of pemetrexed in nonsquamous patients compared with other standard treatment options. Thus, Histology is consistently predictive of the improved efficacy of pemetrexed in patients with nonsquamous NSCLC.

  • the differential efficacy of pemetrexed according to nsclc Histology a review of two phase iii studies
    Oncologist, 2009
    Co-Authors: Giorgio V Scagliotti, Lorinda Simms, Frank V Fossella, Nasser H Hanna, Katherine Sugarman, J Blatter, Patrick Peterson, Frances A Shepherd
    Abstract:

    BACKGROUND: Recent studies of pemetrexed have identified a predictive role for non-small cell lung cancer (NSCLC) Histology. We further reviewed the differential efficacy of pemetrexed according to Histology in two large, phase III NSCLC trials. METHODS: One study tested pemetrexed versus docetaxel in previously treated patients (n = 571) and the other tested cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemotherapy-naive patients (n = 1,725) with advanced NSCLC. Cox proportional hazard models were used to test for covariate-adjusted treatment-by-Histology interactions (THIs) for overall survival (OS) and progression-free survival (PFS). For each histologic subgroup, the Kaplan-Meier method was used to estimate unadjusted within-arm medians, and Cox models were used to estimate covariate-adjusted between-arm hazard ratios (HRs). RESULTS: In both studies, treatment arms were well balanced for Histology. THIs were statistically significant (p < .005) for both OS and PFS. Nonsquamous patients treated with pemetrexed-based therapy experienced longer survival than the comparators (HR, 0.78 and 0.84, respectively), whereas squamous patients had shorter survival (HR, 1.56 and 1.23, respectively). Whereas the efficacy of pemetrexed regimens differed according to Histology, it did not differ for docetaxel or for cisplatin plus gemcitabine. Pemetrexed was well tolerated across histologic groups. CONCLUSIONS: The consistency of these results across studies confirms the predictive effect of Histology for pemetrexed and the survival advantage for pemetrexed in patients with nonsquamous Histology. These analyses suggest pemetrexed should not be recommended for the treatment of squamous cell carcinoma, but, because of efficacy and safety advantages, pemetrexed may be preferable to other agents for treatment of patients with nonsquamous NSCLC.

Giorgio V Scagliotti - One of the best experts on this subject based on the ideXlab platform.

  • treatment by Histology interaction analyses in three phase iii trials show superiority of pemetrexed in nonsquamous non small cell lung cancer
    Journal of Thoracic Oncology, 2011
    Co-Authors: Giorgio V Scagliotti, Thomas Brodowicz, Frances A Shepherd, Christoph Zielinski, Johan Vansteenkiste, C Manegold, Lorinda Simms, Frank V Fossella
    Abstract:

    Introduction: Recently, Histology has emerged as a predictive factor for pemetrexed efficacy in non-small cell lung cancer (NSCLC). These analyses evaluate whether the differential efficacy of pemetrexed by NSCLC Histology is reproducible and consistent across three registration studies of different lines of therapy (first-line/second-line and maintenance settings). Methods: The reported studies for patients with advanced NSCLC were pemetrexed versus docetaxel in previously treated patients ( N = 571), cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemotherapy-naive patients ( N = 1725), and maintenance pemetrexed plus best supportive care versus placebo plus best supportive care ( N = 663). Cox models of overall survival (OS) and progression-free survival (PFS) were used to test for a significant treatment-by-Histology interaction (THI). A significant THI indicates that the efficacy benefit for pemetrexed relative to the control arm is greater in patients with nonsquamous Histology than in those with squamous Histology. Subsequent Cox models were used to estimate hazard ratios for OS and PFS according to Histology. Results: Histology was well balanced between treatment arms in each study. Across all three studies, no clinically relevant differences were observed for the safety profile of pemetrexed among histologic groups. THIs were statistically significant in all three studies for OS ( p = 0.001, 0.002, and 0.033, respectively) and PFS ( p = 0.004, 0.002, and 0.036, respectively). Conclusions: These analyses demonstrate a statistically significant interaction between treatment effect and NSCLC Histology, indicating superior efficacy of pemetrexed in nonsquamous patients compared with other standard treatment options. Thus, Histology is consistently predictive of the improved efficacy of pemetrexed in patients with nonsquamous NSCLC.

  • the differential efficacy of pemetrexed according to nsclc Histology a review of two phase iii studies
    Oncologist, 2009
    Co-Authors: Giorgio V Scagliotti, Lorinda Simms, Frank V Fossella, Nasser H Hanna, Katherine Sugarman, J Blatter, Patrick Peterson, Frances A Shepherd
    Abstract:

    BACKGROUND: Recent studies of pemetrexed have identified a predictive role for non-small cell lung cancer (NSCLC) Histology. We further reviewed the differential efficacy of pemetrexed according to Histology in two large, phase III NSCLC trials. METHODS: One study tested pemetrexed versus docetaxel in previously treated patients (n = 571) and the other tested cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemotherapy-naive patients (n = 1,725) with advanced NSCLC. Cox proportional hazard models were used to test for covariate-adjusted treatment-by-Histology interactions (THIs) for overall survival (OS) and progression-free survival (PFS). For each histologic subgroup, the Kaplan-Meier method was used to estimate unadjusted within-arm medians, and Cox models were used to estimate covariate-adjusted between-arm hazard ratios (HRs). RESULTS: In both studies, treatment arms were well balanced for Histology. THIs were statistically significant (p < .005) for both OS and PFS. Nonsquamous patients treated with pemetrexed-based therapy experienced longer survival than the comparators (HR, 0.78 and 0.84, respectively), whereas squamous patients had shorter survival (HR, 1.56 and 1.23, respectively). Whereas the efficacy of pemetrexed regimens differed according to Histology, it did not differ for docetaxel or for cisplatin plus gemcitabine. Pemetrexed was well tolerated across histologic groups. CONCLUSIONS: The consistency of these results across studies confirms the predictive effect of Histology for pemetrexed and the survival advantage for pemetrexed in patients with nonsquamous Histology. These analyses suggest pemetrexed should not be recommended for the treatment of squamous cell carcinoma, but, because of efficacy and safety advantages, pemetrexed may be preferable to other agents for treatment of patients with nonsquamous NSCLC.