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John D Chester - One of the best experts on this subject based on the ideXlab platform.
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phase iii double blind randomized trial that compared maintenance lapatinib versus placebo after first line chemotherapy in patients with human epidermal growth factor receptor 1 2 positive metastatic bladder cancer
Journal of Clinical Oncology, 2017Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Shahjalal Sarker, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D ChesterAbstract:Purpose To establish whether maintenance lapatinib after first-line chemotherapy is beneficial in human epidermal growth factor receptor (HER) 1/HER2-positive metastatic urothelial bladder cancer (UBC). Methods Patients with metastatic UBC were screened centrally for HER1/HER2 overexpression. Patients who screened positive for HER1/2 and who did not have progressive disease during chemotherapy (four to eight cycles) were randomly assigned one to one to lapatinib or placebo after completion of first-line/initial chemotherapy for metastatic disease. The primary end point was progression-free survival (PFS). Results Between 2007 and 2013, 446 patients with UBC were screened, and 232 with HER1- or HER2-positive disease were randomly assigned. The median PFS for lapatinib and placebo was 4.5 (95% CI, 2.8 to 5.4) and 5.1 (95% CI, 3.0 to 5.8) months, respectively (hazard ratio, 1.07; 95% CI, 0.81 to 1.43; P = .63). The overall survival for lapatinib and placebo was 12.6 (95% CI, 9.0 to 16.2) and 12.0 (95% CI, 10.5 to 14.9) months, respectively (hazard ratio, 0.96; 95% CI, 0.70 to 1.31; P = .80). Discontinuation due to adverse events were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3 to 4 adverse events for lapatinib and placebo was 8.6% versus 8.1% ( P = .82). Preplanned subset analysis of patients strongly positive for HER1/HER2 (3+ on immunohistochemistry; n = 111), patients positive for only HER1 (n = 102), and patients positive for only HER2 (n = 42) showed no significant benefit with lapatinib in terms of PFS and overall survival ( P > .05 for each). Conclusion This trial did not find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
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phase iii double blind randomized trial that compared maintenance lapatinib versus placebo after first line chemotherapy in patients with human epidermal growth factor receptor 1 2 positive metastatic bladder cancer
Journal of Clinical Oncology, 2017Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Shahjalal Sarker, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D ChesterAbstract:Purpose: The purpose of this trial was to establish if maintenance lapatinib after first-line chemotherapy is beneficial in HER1/HER2 positive metastatic urothelial bladder cancer (UBC) patients. Method: Patients with metastatic UBC were screened centrally for HER1/HER2 over expression. HER1/2 positive screened patients, who did not have progressive disease during chemotherapy (4-8 cycles) were randomised (1:1) to lapatinib (L) or placebo (P) after completion of first line/initial chemotherapy for metastatic disease. The primary endpoint was progression free survival (PFS). Results: Between 2007-2013, 446 UBC patients were screened and 232 HER 1 or 2 positive patients were randomised. The median PFS for L and P were 4.5 months (95% CI: 2.8 – 5.4) and 5.1 months (95% CI: 3.0 – 5.8) respectively [HR: 1.07 (95% CI: 0.81 - 1.43) p = 0.63]. The overall survival for L and P were 12.6 months (95% CI: 9.0 – 16.2) and 12.0 months (95% CI: 10.5 – 14.9) respectively [HR = 0.96 (95% CI: 0.7 - 1.31) p = 0.80]. Discontinuation due to AEs were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3-4 AEs for L and P was 8.6% vs. 8.1% (p = 0.82). Pre-planned subset analysis of i) HER1/HER2 strongly positive patients (3+ on immunohistochemistry: n= 111) ii) HER1 only positive patients (n= 102) iii) HER2 only positive patients (n= 42) showed no significant benefit with lapatinib in terms of PFS and OS (p>0.05 for each). Conclusion: This trial failed to find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
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a phase ii iii double blind randomized trial comparing maintenance lapatinib versus placebo after first line chemotherapy in her1 2 positive metastatic bladder cancer patients
Journal of Clinical Oncology, 2015Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D Chester, Serena HilmanAbstract:Purpose: The purpose of this trial was to establish if maintenance lapatinib after first-line chemotherapy is beneficial in HER1/HER2 positive metastatic urothelial bladder cancer (UBC) patients. Method: Patients with metastatic UBC were screened centrally for HER1/HER2 over expression. HER1/2 positive screened patients, who did not have progressive disease during chemotherapy (4-8 cycles) were randomised (1:1) to lapatinib (L) or placebo (P) after completion of first line/initial chemotherapy for metastatic disease. The primary endpoint was progression free survival (PFS). Results: Between 2007-2013, 446 UBC patients were screened and 232 HER 1 or 2 positive patients were randomised. The median PFS for L and P were 4.5 months (95% CI: 2.8 – 5.4) and 5.1 months (95% CI: 3.0 – 5.8) respectively [HR: 1.07 (95% CI: 0.81 - 1.43) p = 0.63]. The overall survival for L and P were 12.6 months (95% CI: 9.0 – 16.2) and 12.0 months (95% CI: 10.5 – 14.9) respectively [HR = 0.96 (95% CI: 0.7 - 1.31) p = 0.80]. Discontinuation due to AEs were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3-4 AEs for L and P was 8.6% vs. 8.1% (p = 0.82). Pre-planned subset analysis of i) HER1/HER2 strongly positive patients (3+ on immunohistochemistry: n= 111) ii) HER1 only positive patients (n= 102) iii) HER2 only positive patients (n= 42) showed no significant benefit with lapatinib in terms of PFS and OS (p>0.05 for each). Conclusion: This trial failed to find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
Thomas Powles - One of the best experts on this subject based on the ideXlab platform.
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phase iii double blind randomized trial that compared maintenance lapatinib versus placebo after first line chemotherapy in patients with human epidermal growth factor receptor 1 2 positive metastatic bladder cancer
Journal of Clinical Oncology, 2017Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Shahjalal Sarker, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D ChesterAbstract:Purpose To establish whether maintenance lapatinib after first-line chemotherapy is beneficial in human epidermal growth factor receptor (HER) 1/HER2-positive metastatic urothelial bladder cancer (UBC). Methods Patients with metastatic UBC were screened centrally for HER1/HER2 overexpression. Patients who screened positive for HER1/2 and who did not have progressive disease during chemotherapy (four to eight cycles) were randomly assigned one to one to lapatinib or placebo after completion of first-line/initial chemotherapy for metastatic disease. The primary end point was progression-free survival (PFS). Results Between 2007 and 2013, 446 patients with UBC were screened, and 232 with HER1- or HER2-positive disease were randomly assigned. The median PFS for lapatinib and placebo was 4.5 (95% CI, 2.8 to 5.4) and 5.1 (95% CI, 3.0 to 5.8) months, respectively (hazard ratio, 1.07; 95% CI, 0.81 to 1.43; P = .63). The overall survival for lapatinib and placebo was 12.6 (95% CI, 9.0 to 16.2) and 12.0 (95% CI, 10.5 to 14.9) months, respectively (hazard ratio, 0.96; 95% CI, 0.70 to 1.31; P = .80). Discontinuation due to adverse events were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3 to 4 adverse events for lapatinib and placebo was 8.6% versus 8.1% ( P = .82). Preplanned subset analysis of patients strongly positive for HER1/HER2 (3+ on immunohistochemistry; n = 111), patients positive for only HER1 (n = 102), and patients positive for only HER2 (n = 42) showed no significant benefit with lapatinib in terms of PFS and overall survival ( P > .05 for each). Conclusion This trial did not find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
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phase iii double blind randomized trial that compared maintenance lapatinib versus placebo after first line chemotherapy in patients with human epidermal growth factor receptor 1 2 positive metastatic bladder cancer
Journal of Clinical Oncology, 2017Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Shahjalal Sarker, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D ChesterAbstract:Purpose: The purpose of this trial was to establish if maintenance lapatinib after first-line chemotherapy is beneficial in HER1/HER2 positive metastatic urothelial bladder cancer (UBC) patients. Method: Patients with metastatic UBC were screened centrally for HER1/HER2 over expression. HER1/2 positive screened patients, who did not have progressive disease during chemotherapy (4-8 cycles) were randomised (1:1) to lapatinib (L) or placebo (P) after completion of first line/initial chemotherapy for metastatic disease. The primary endpoint was progression free survival (PFS). Results: Between 2007-2013, 446 UBC patients were screened and 232 HER 1 or 2 positive patients were randomised. The median PFS for L and P were 4.5 months (95% CI: 2.8 – 5.4) and 5.1 months (95% CI: 3.0 – 5.8) respectively [HR: 1.07 (95% CI: 0.81 - 1.43) p = 0.63]. The overall survival for L and P were 12.6 months (95% CI: 9.0 – 16.2) and 12.0 months (95% CI: 10.5 – 14.9) respectively [HR = 0.96 (95% CI: 0.7 - 1.31) p = 0.80]. Discontinuation due to AEs were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3-4 AEs for L and P was 8.6% vs. 8.1% (p = 0.82). Pre-planned subset analysis of i) HER1/HER2 strongly positive patients (3+ on immunohistochemistry: n= 111) ii) HER1 only positive patients (n= 102) iii) HER2 only positive patients (n= 42) showed no significant benefit with lapatinib in terms of PFS and OS (p>0.05 for each). Conclusion: This trial failed to find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
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a phase ii iii double blind randomized trial comparing maintenance lapatinib versus placebo after first line chemotherapy in her1 2 positive metastatic bladder cancer patients
Journal of Clinical Oncology, 2015Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D Chester, Serena HilmanAbstract:Purpose: The purpose of this trial was to establish if maintenance lapatinib after first-line chemotherapy is beneficial in HER1/HER2 positive metastatic urothelial bladder cancer (UBC) patients. Method: Patients with metastatic UBC were screened centrally for HER1/HER2 over expression. HER1/2 positive screened patients, who did not have progressive disease during chemotherapy (4-8 cycles) were randomised (1:1) to lapatinib (L) or placebo (P) after completion of first line/initial chemotherapy for metastatic disease. The primary endpoint was progression free survival (PFS). Results: Between 2007-2013, 446 UBC patients were screened and 232 HER 1 or 2 positive patients were randomised. The median PFS for L and P were 4.5 months (95% CI: 2.8 – 5.4) and 5.1 months (95% CI: 3.0 – 5.8) respectively [HR: 1.07 (95% CI: 0.81 - 1.43) p = 0.63]. The overall survival for L and P were 12.6 months (95% CI: 9.0 – 16.2) and 12.0 months (95% CI: 10.5 – 14.9) respectively [HR = 0.96 (95% CI: 0.7 - 1.31) p = 0.80]. Discontinuation due to AEs were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3-4 AEs for L and P was 8.6% vs. 8.1% (p = 0.82). Pre-planned subset analysis of i) HER1/HER2 strongly positive patients (3+ on immunohistochemistry: n= 111) ii) HER1 only positive patients (n= 102) iii) HER2 only positive patients (n= 42) showed no significant benefit with lapatinib in terms of PFS and OS (p>0.05 for each). Conclusion: This trial failed to find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
Tony Elliott - One of the best experts on this subject based on the ideXlab platform.
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phase iii double blind randomized trial that compared maintenance lapatinib versus placebo after first line chemotherapy in patients with human epidermal growth factor receptor 1 2 positive metastatic bladder cancer
Journal of Clinical Oncology, 2017Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Shahjalal Sarker, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D ChesterAbstract:Purpose To establish whether maintenance lapatinib after first-line chemotherapy is beneficial in human epidermal growth factor receptor (HER) 1/HER2-positive metastatic urothelial bladder cancer (UBC). Methods Patients with metastatic UBC were screened centrally for HER1/HER2 overexpression. Patients who screened positive for HER1/2 and who did not have progressive disease during chemotherapy (four to eight cycles) were randomly assigned one to one to lapatinib or placebo after completion of first-line/initial chemotherapy for metastatic disease. The primary end point was progression-free survival (PFS). Results Between 2007 and 2013, 446 patients with UBC were screened, and 232 with HER1- or HER2-positive disease were randomly assigned. The median PFS for lapatinib and placebo was 4.5 (95% CI, 2.8 to 5.4) and 5.1 (95% CI, 3.0 to 5.8) months, respectively (hazard ratio, 1.07; 95% CI, 0.81 to 1.43; P = .63). The overall survival for lapatinib and placebo was 12.6 (95% CI, 9.0 to 16.2) and 12.0 (95% CI, 10.5 to 14.9) months, respectively (hazard ratio, 0.96; 95% CI, 0.70 to 1.31; P = .80). Discontinuation due to adverse events were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3 to 4 adverse events for lapatinib and placebo was 8.6% versus 8.1% ( P = .82). Preplanned subset analysis of patients strongly positive for HER1/HER2 (3+ on immunohistochemistry; n = 111), patients positive for only HER1 (n = 102), and patients positive for only HER2 (n = 42) showed no significant benefit with lapatinib in terms of PFS and overall survival ( P > .05 for each). Conclusion This trial did not find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
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phase iii double blind randomized trial that compared maintenance lapatinib versus placebo after first line chemotherapy in patients with human epidermal growth factor receptor 1 2 positive metastatic bladder cancer
Journal of Clinical Oncology, 2017Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Shahjalal Sarker, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D ChesterAbstract:Purpose: The purpose of this trial was to establish if maintenance lapatinib after first-line chemotherapy is beneficial in HER1/HER2 positive metastatic urothelial bladder cancer (UBC) patients. Method: Patients with metastatic UBC were screened centrally for HER1/HER2 over expression. HER1/2 positive screened patients, who did not have progressive disease during chemotherapy (4-8 cycles) were randomised (1:1) to lapatinib (L) or placebo (P) after completion of first line/initial chemotherapy for metastatic disease. The primary endpoint was progression free survival (PFS). Results: Between 2007-2013, 446 UBC patients were screened and 232 HER 1 or 2 positive patients were randomised. The median PFS for L and P were 4.5 months (95% CI: 2.8 – 5.4) and 5.1 months (95% CI: 3.0 – 5.8) respectively [HR: 1.07 (95% CI: 0.81 - 1.43) p = 0.63]. The overall survival for L and P were 12.6 months (95% CI: 9.0 – 16.2) and 12.0 months (95% CI: 10.5 – 14.9) respectively [HR = 0.96 (95% CI: 0.7 - 1.31) p = 0.80]. Discontinuation due to AEs were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3-4 AEs for L and P was 8.6% vs. 8.1% (p = 0.82). Pre-planned subset analysis of i) HER1/HER2 strongly positive patients (3+ on immunohistochemistry: n= 111) ii) HER1 only positive patients (n= 102) iii) HER2 only positive patients (n= 42) showed no significant benefit with lapatinib in terms of PFS and OS (p>0.05 for each). Conclusion: This trial failed to find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
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a phase ii iii double blind randomized trial comparing maintenance lapatinib versus placebo after first line chemotherapy in her1 2 positive metastatic bladder cancer patients
Journal of Clinical Oncology, 2015Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D Chester, Serena HilmanAbstract:Purpose: The purpose of this trial was to establish if maintenance lapatinib after first-line chemotherapy is beneficial in HER1/HER2 positive metastatic urothelial bladder cancer (UBC) patients. Method: Patients with metastatic UBC were screened centrally for HER1/HER2 over expression. HER1/2 positive screened patients, who did not have progressive disease during chemotherapy (4-8 cycles) were randomised (1:1) to lapatinib (L) or placebo (P) after completion of first line/initial chemotherapy for metastatic disease. The primary endpoint was progression free survival (PFS). Results: Between 2007-2013, 446 UBC patients were screened and 232 HER 1 or 2 positive patients were randomised. The median PFS for L and P were 4.5 months (95% CI: 2.8 – 5.4) and 5.1 months (95% CI: 3.0 – 5.8) respectively [HR: 1.07 (95% CI: 0.81 - 1.43) p = 0.63]. The overall survival for L and P were 12.6 months (95% CI: 9.0 – 16.2) and 12.0 months (95% CI: 10.5 – 14.9) respectively [HR = 0.96 (95% CI: 0.7 - 1.31) p = 0.80]. Discontinuation due to AEs were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3-4 AEs for L and P was 8.6% vs. 8.1% (p = 0.82). Pre-planned subset analysis of i) HER1/HER2 strongly positive patients (3+ on immunohistochemistry: n= 111) ii) HER1 only positive patients (n= 102) iii) HER2 only positive patients (n= 42) showed no significant benefit with lapatinib in terms of PFS and OS (p>0.05 for each). Conclusion: This trial failed to find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
Charlotte Ackerman - One of the best experts on this subject based on the ideXlab platform.
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phase iii double blind randomized trial that compared maintenance lapatinib versus placebo after first line chemotherapy in patients with human epidermal growth factor receptor 1 2 positive metastatic bladder cancer
Journal of Clinical Oncology, 2017Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Shahjalal Sarker, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D ChesterAbstract:Purpose To establish whether maintenance lapatinib after first-line chemotherapy is beneficial in human epidermal growth factor receptor (HER) 1/HER2-positive metastatic urothelial bladder cancer (UBC). Methods Patients with metastatic UBC were screened centrally for HER1/HER2 overexpression. Patients who screened positive for HER1/2 and who did not have progressive disease during chemotherapy (four to eight cycles) were randomly assigned one to one to lapatinib or placebo after completion of first-line/initial chemotherapy for metastatic disease. The primary end point was progression-free survival (PFS). Results Between 2007 and 2013, 446 patients with UBC were screened, and 232 with HER1- or HER2-positive disease were randomly assigned. The median PFS for lapatinib and placebo was 4.5 (95% CI, 2.8 to 5.4) and 5.1 (95% CI, 3.0 to 5.8) months, respectively (hazard ratio, 1.07; 95% CI, 0.81 to 1.43; P = .63). The overall survival for lapatinib and placebo was 12.6 (95% CI, 9.0 to 16.2) and 12.0 (95% CI, 10.5 to 14.9) months, respectively (hazard ratio, 0.96; 95% CI, 0.70 to 1.31; P = .80). Discontinuation due to adverse events were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3 to 4 adverse events for lapatinib and placebo was 8.6% versus 8.1% ( P = .82). Preplanned subset analysis of patients strongly positive for HER1/HER2 (3+ on immunohistochemistry; n = 111), patients positive for only HER1 (n = 102), and patients positive for only HER2 (n = 42) showed no significant benefit with lapatinib in terms of PFS and overall survival ( P > .05 for each). Conclusion This trial did not find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
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phase iii double blind randomized trial that compared maintenance lapatinib versus placebo after first line chemotherapy in patients with human epidermal growth factor receptor 1 2 positive metastatic bladder cancer
Journal of Clinical Oncology, 2017Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Shahjalal Sarker, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D ChesterAbstract:Purpose: The purpose of this trial was to establish if maintenance lapatinib after first-line chemotherapy is beneficial in HER1/HER2 positive metastatic urothelial bladder cancer (UBC) patients. Method: Patients with metastatic UBC were screened centrally for HER1/HER2 over expression. HER1/2 positive screened patients, who did not have progressive disease during chemotherapy (4-8 cycles) were randomised (1:1) to lapatinib (L) or placebo (P) after completion of first line/initial chemotherapy for metastatic disease. The primary endpoint was progression free survival (PFS). Results: Between 2007-2013, 446 UBC patients were screened and 232 HER 1 or 2 positive patients were randomised. The median PFS for L and P were 4.5 months (95% CI: 2.8 – 5.4) and 5.1 months (95% CI: 3.0 – 5.8) respectively [HR: 1.07 (95% CI: 0.81 - 1.43) p = 0.63]. The overall survival for L and P were 12.6 months (95% CI: 9.0 – 16.2) and 12.0 months (95% CI: 10.5 – 14.9) respectively [HR = 0.96 (95% CI: 0.7 - 1.31) p = 0.80]. Discontinuation due to AEs were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3-4 AEs for L and P was 8.6% vs. 8.1% (p = 0.82). Pre-planned subset analysis of i) HER1/HER2 strongly positive patients (3+ on immunohistochemistry: n= 111) ii) HER1 only positive patients (n= 102) iii) HER2 only positive patients (n= 42) showed no significant benefit with lapatinib in terms of PFS and OS (p>0.05 for each). Conclusion: This trial failed to find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
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a phase ii iii double blind randomized trial comparing maintenance lapatinib versus placebo after first line chemotherapy in her1 2 positive metastatic bladder cancer patients
Journal of Clinical Oncology, 2015Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D Chester, Serena HilmanAbstract:Purpose: The purpose of this trial was to establish if maintenance lapatinib after first-line chemotherapy is beneficial in HER1/HER2 positive metastatic urothelial bladder cancer (UBC) patients. Method: Patients with metastatic UBC were screened centrally for HER1/HER2 over expression. HER1/2 positive screened patients, who did not have progressive disease during chemotherapy (4-8 cycles) were randomised (1:1) to lapatinib (L) or placebo (P) after completion of first line/initial chemotherapy for metastatic disease. The primary endpoint was progression free survival (PFS). Results: Between 2007-2013, 446 UBC patients were screened and 232 HER 1 or 2 positive patients were randomised. The median PFS for L and P were 4.5 months (95% CI: 2.8 – 5.4) and 5.1 months (95% CI: 3.0 – 5.8) respectively [HR: 1.07 (95% CI: 0.81 - 1.43) p = 0.63]. The overall survival for L and P were 12.6 months (95% CI: 9.0 – 16.2) and 12.0 months (95% CI: 10.5 – 14.9) respectively [HR = 0.96 (95% CI: 0.7 - 1.31) p = 0.80]. Discontinuation due to AEs were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3-4 AEs for L and P was 8.6% vs. 8.1% (p = 0.82). Pre-planned subset analysis of i) HER1/HER2 strongly positive patients (3+ on immunohistochemistry: n= 111) ii) HER1 only positive patients (n= 102) iii) HER2 only positive patients (n= 42) showed no significant benefit with lapatinib in terms of PFS and OS (p>0.05 for each). Conclusion: This trial failed to find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
Robert Jones - One of the best experts on this subject based on the ideXlab platform.
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phase iii double blind randomized trial that compared maintenance lapatinib versus placebo after first line chemotherapy in patients with human epidermal growth factor receptor 1 2 positive metastatic bladder cancer
Journal of Clinical Oncology, 2017Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Shahjalal Sarker, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D ChesterAbstract:Purpose To establish whether maintenance lapatinib after first-line chemotherapy is beneficial in human epidermal growth factor receptor (HER) 1/HER2-positive metastatic urothelial bladder cancer (UBC). Methods Patients with metastatic UBC were screened centrally for HER1/HER2 overexpression. Patients who screened positive for HER1/2 and who did not have progressive disease during chemotherapy (four to eight cycles) were randomly assigned one to one to lapatinib or placebo after completion of first-line/initial chemotherapy for metastatic disease. The primary end point was progression-free survival (PFS). Results Between 2007 and 2013, 446 patients with UBC were screened, and 232 with HER1- or HER2-positive disease were randomly assigned. The median PFS for lapatinib and placebo was 4.5 (95% CI, 2.8 to 5.4) and 5.1 (95% CI, 3.0 to 5.8) months, respectively (hazard ratio, 1.07; 95% CI, 0.81 to 1.43; P = .63). The overall survival for lapatinib and placebo was 12.6 (95% CI, 9.0 to 16.2) and 12.0 (95% CI, 10.5 to 14.9) months, respectively (hazard ratio, 0.96; 95% CI, 0.70 to 1.31; P = .80). Discontinuation due to adverse events were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3 to 4 adverse events for lapatinib and placebo was 8.6% versus 8.1% ( P = .82). Preplanned subset analysis of patients strongly positive for HER1/HER2 (3+ on immunohistochemistry; n = 111), patients positive for only HER1 (n = 102), and patients positive for only HER2 (n = 42) showed no significant benefit with lapatinib in terms of PFS and overall survival ( P > .05 for each). Conclusion This trial did not find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
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phase iii double blind randomized trial that compared maintenance lapatinib versus placebo after first line chemotherapy in patients with human epidermal growth factor receptor 1 2 positive metastatic bladder cancer
Journal of Clinical Oncology, 2017Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Shahjalal Sarker, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D ChesterAbstract:Purpose: The purpose of this trial was to establish if maintenance lapatinib after first-line chemotherapy is beneficial in HER1/HER2 positive metastatic urothelial bladder cancer (UBC) patients. Method: Patients with metastatic UBC were screened centrally for HER1/HER2 over expression. HER1/2 positive screened patients, who did not have progressive disease during chemotherapy (4-8 cycles) were randomised (1:1) to lapatinib (L) or placebo (P) after completion of first line/initial chemotherapy for metastatic disease. The primary endpoint was progression free survival (PFS). Results: Between 2007-2013, 446 UBC patients were screened and 232 HER 1 or 2 positive patients were randomised. The median PFS for L and P were 4.5 months (95% CI: 2.8 – 5.4) and 5.1 months (95% CI: 3.0 – 5.8) respectively [HR: 1.07 (95% CI: 0.81 - 1.43) p = 0.63]. The overall survival for L and P were 12.6 months (95% CI: 9.0 – 16.2) and 12.0 months (95% CI: 10.5 – 14.9) respectively [HR = 0.96 (95% CI: 0.7 - 1.31) p = 0.80]. Discontinuation due to AEs were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3-4 AEs for L and P was 8.6% vs. 8.1% (p = 0.82). Pre-planned subset analysis of i) HER1/HER2 strongly positive patients (3+ on immunohistochemistry: n= 111) ii) HER1 only positive patients (n= 102) iii) HER2 only positive patients (n= 42) showed no significant benefit with lapatinib in terms of PFS and OS (p>0.05 for each). Conclusion: This trial failed to find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
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a phase ii iii double blind randomized trial comparing maintenance lapatinib versus placebo after first line chemotherapy in her1 2 positive metastatic bladder cancer patients
Journal of Clinical Oncology, 2015Co-Authors: Thomas Powles, R A Huddart, Tony Elliott, Charlotte Ackerman, Robert Jones, Syed A Hussain, Simon J Crabb, Satinder Jagdev, John D Chester, Serena HilmanAbstract:Purpose: The purpose of this trial was to establish if maintenance lapatinib after first-line chemotherapy is beneficial in HER1/HER2 positive metastatic urothelial bladder cancer (UBC) patients. Method: Patients with metastatic UBC were screened centrally for HER1/HER2 over expression. HER1/2 positive screened patients, who did not have progressive disease during chemotherapy (4-8 cycles) were randomised (1:1) to lapatinib (L) or placebo (P) after completion of first line/initial chemotherapy for metastatic disease. The primary endpoint was progression free survival (PFS). Results: Between 2007-2013, 446 UBC patients were screened and 232 HER 1 or 2 positive patients were randomised. The median PFS for L and P were 4.5 months (95% CI: 2.8 – 5.4) and 5.1 months (95% CI: 3.0 – 5.8) respectively [HR: 1.07 (95% CI: 0.81 - 1.43) p = 0.63]. The overall survival for L and P were 12.6 months (95% CI: 9.0 – 16.2) and 12.0 months (95% CI: 10.5 – 14.9) respectively [HR = 0.96 (95% CI: 0.7 - 1.31) p = 0.80]. Discontinuation due to AEs were similar in both arms (6% lapatinib and 5% placebo). The rate of grade 3-4 AEs for L and P was 8.6% vs. 8.1% (p = 0.82). Pre-planned subset analysis of i) HER1/HER2 strongly positive patients (3+ on immunohistochemistry: n= 111) ii) HER1 only positive patients (n= 102) iii) HER2 only positive patients (n= 42) showed no significant benefit with lapatinib in terms of PFS and OS (p>0.05 for each). Conclusion: This trial failed to find significant improvements in outcome by the addition of maintenance lapatinib to standard of care.
