The Experts below are selected from a list of 105 Experts worldwide ranked by ideXlab platform
Nicholas J. Vogelzang - One of the best experts on this subject based on the ideXlab platform.
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Radium 223 safety efficacy and concurrent use with abiraterone or enzalutamide first u s experience from an expanded access program
Oncologist, 2018Co-Authors: Oliver Sartor, Daniel Celestino Fernandez, Christopher Sweeney, Andrei Iagaru, Nicholas J. Vogelzang, Fabio Almeida, Manish Agrawal, Matthew R. Smith, Alan Brown, Adam P DickerAbstract:Background In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated Radium-223 survival benefit, and before Radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access Radium-223 allowed life-prolonging therapies in current use. Subjects, materials, and methods This phase II, open-label, single-arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received Radium-223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long-term safety. Additional analyses were done by number of Radium-223 injections, and prior or concomitant abiraterone or enzalutamide use. Results Of 252 patients, 184 received Radium-223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 183 (99%) had prior systemic anticancer therapy. Treatment-related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow-up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow-up due to Radium-223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5-6 Radium-223 injections and unlikely to benefit from Radium-223. Radium-223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. Conclusion Radium-223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. Implications for practice In this phase II U.S. expanded access program, Radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, Radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when Radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.
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Radium‐223 Safety, Efficacy, and Concurrent Use with Abiraterone or Enzalutamide: First U.S. Experience from an Expanded Access Program
Oncologist, 2017Co-Authors: Oliver Sartor, Daniel Celestino Fernandez, Christopher Sweeney, Andrei Iagaru, Nicholas J. Vogelzang, Fabio Almeida, Manish Agrawal, Matthew R. Smith, Alan Brown, Adam P DickerAbstract:BACKGROUND: In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated Radium-223 survival benefit, and before Radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access Radium-223 allowed life-prolonging therapies in current use. SUBJECTS, MATERIALS, AND METHODS: This phase II, open-label, single-arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received Radium-223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long-term safety. Additional analyses were done by number of Radium-223 injections, and prior or concomitant abiraterone or enzalutamide use. RESULTS: Of 252 patients, 184 received Radium-223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 183 (99%) had prior systemic anticancer therapy. Treatment-related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow-up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow-up due to Radium-223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5-6 Radium-223 injections and unlikely to benefit from Radium-223. Radium-223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. CONCLUSION: Radium-223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. IMPLICATIONS FOR PRACTICE: In this phase II U.S. expanded access program, Radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, Radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when Radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.
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chemotherapy following Radium 223 dichloride treatment in alsympca
The Prostate, 2016Co-Authors: Oliver Sartor, Oana Petrenciuc, Kathrin Staudacher, Marcus Thuresson, Nicholas J. Vogelzang, Robert E. Coleman, Sten Nilsson, Peter Hoskin, Chris ParkerAbstract:BACKGROUND. Radium-223 prolongs overall survival in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases, regardless of prior docetaxel. Whether or not chemotherapy can be safely administered following Radium-223 treatment is of clinical importance. An exploratory analysis of prospectively collected data, from the ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) patient subgroup who received chemotherapy after Radium-223 or placebo treatment, was conducted to evaluate the safety and efficacy of chemotherapy following Radium-223. METHODS. In ALSYMPCA, CRPC patients with symptomatic bone metastases and no visceral metastases were randomized 2: 1 to receive six injections of Radium-223 (50 kBq/kg IV) or placebo plus best standard of care, stratified by prior docetaxel, baseline alkaline phosphatase, and current bisphosphonate use. In this exploratory analysis, chemotherapy agents administered following study treatment were identified; timing and duration were calculated. Hematologic safety was reviewed, and overall survival analyzed. RESULTS. Overall, 142 Radium-223 and 64 placebo patients received subsequent chemotherapy; most common were docetaxel (70% Radium-223, 72% placebo) and mitoxantrone (16% Radium-223, 20% placebo). The majority of patients (61% Radium-223, 58% placebo) had received prior docetaxel. Radium-223 patients started subsequent chemotherapy later than placebo patients; chemotherapy duration was similar between groups. In Radium-223 and placebo patients receiving subsequent chemotherapy, median hematologic values (hemoglobin, neutrophils, and platelets) remained nearly constant up to 18 months following start of chemotherapy, regardless of prior docetaxel treatment. A low percentage of patients in both groups had grades 3-4 hematologic values (<10%). Platelet count decline, from last measurement before chemotherapy, was numerically greater in Radium-223 versus placebo patients. Median overall survivals from start of chemotherapy were 16.0 and 15.8 months following Radium-223 and placebo, respectively. CONCLUSIONS. Chemotherapy following Radium-223, regardless of prior docetaxel, is feasible and appears to be well tolerated in patients with CRPC and symptomatic bone metastases. (C) 2016 The Authors. The Prostate published by Wiley Periodicals, Inc.
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Chemotherapy following Radium-223 dichloride treatment in ALSYMPCA
The Prostate, 2016Co-Authors: Oliver Sartor, Oana Petrenciuc, Kathrin Staudacher, Marcus Thuresson, Nicholas J. Vogelzang, Robert E. Coleman, Sten Nilsson, Peter Hoskin, Chris ParkerAbstract:BACKGROUND. Radium-223 prolongs overall survival in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases, regardless of prior docetaxel. Whether or not chemotherapy can be safely administered following Radium-223 treatment is of clinical importance. An exploratory analysis of prospectively collected data, from the ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) patient subgroup who received chemotherapy after Radium-223 or placebo treatment, was conducted to evaluate the safety and efficacy of chemotherapy following Radium-223. METHODS. In ALSYMPCA, CRPC patients with symptomatic bone metastases and no visceral metastases were randomized 2: 1 to receive six injections of Radium-223 (50 kBq/kg IV) or placebo plus best standard of care, stratified by prior docetaxel, baseline alkaline phosphatase, and current bisphosphonate use. In this exploratory analysis, chemotherapy agents administered following study treatment were identified; timing and duration were calculated. Hematologic safety was reviewed, and overall survival analyzed. RESULTS. Overall, 142 Radium-223 and 64 placebo patients received subsequent chemotherapy; most common were docetaxel (70% Radium-223, 72% placebo) and mitoxantrone (16% Radium-223, 20% placebo). The majority of patients (61% Radium-223, 58% placebo) had received prior docetaxel. Radium-223 patients started subsequent chemotherapy later than placebo patients; chemotherapy duration was similar between groups. In Radium-223 and placebo patients receiving subsequent chemotherapy, median hematologic values (hemoglobin, neutrophils, and platelets) remained nearly constant up to 18 months following start of chemotherapy, regardless of prior docetaxel treatment. A low percentage of patients in both groups had grades 3-4 hematologic values (
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Radium-223 vs EBRT for multiple painful bone metastases: the data favor Radium-223.
Oncology, 2014Co-Authors: Nicholas J. VogelzangAbstract:In order to achieve maximum survival of patients with metastatic castration-resistant prostate cancer, the judicious use of all available effective agents and modalities is required. Both EBRT and Radium-223 are effective at relieving pain, but both may decrease bone marrow function.
Oliver Sartor - One of the best experts on this subject based on the ideXlab platform.
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Radium 223 safety efficacy and concurrent use with abiraterone or enzalutamide first u s experience from an expanded access program
Oncologist, 2018Co-Authors: Oliver Sartor, Daniel Celestino Fernandez, Christopher Sweeney, Andrei Iagaru, Nicholas J. Vogelzang, Fabio Almeida, Manish Agrawal, Matthew R. Smith, Alan Brown, Adam P DickerAbstract:Background In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated Radium-223 survival benefit, and before Radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access Radium-223 allowed life-prolonging therapies in current use. Subjects, materials, and methods This phase II, open-label, single-arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received Radium-223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long-term safety. Additional analyses were done by number of Radium-223 injections, and prior or concomitant abiraterone or enzalutamide use. Results Of 252 patients, 184 received Radium-223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 183 (99%) had prior systemic anticancer therapy. Treatment-related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow-up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow-up due to Radium-223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5-6 Radium-223 injections and unlikely to benefit from Radium-223. Radium-223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. Conclusion Radium-223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. Implications for practice In this phase II U.S. expanded access program, Radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, Radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when Radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.
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Radium‐223 Safety, Efficacy, and Concurrent Use with Abiraterone or Enzalutamide: First U.S. Experience from an Expanded Access Program
Oncologist, 2017Co-Authors: Oliver Sartor, Daniel Celestino Fernandez, Christopher Sweeney, Andrei Iagaru, Nicholas J. Vogelzang, Fabio Almeida, Manish Agrawal, Matthew R. Smith, Alan Brown, Adam P DickerAbstract:BACKGROUND: In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated Radium-223 survival benefit, and before Radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access Radium-223 allowed life-prolonging therapies in current use. SUBJECTS, MATERIALS, AND METHODS: This phase II, open-label, single-arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received Radium-223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long-term safety. Additional analyses were done by number of Radium-223 injections, and prior or concomitant abiraterone or enzalutamide use. RESULTS: Of 252 patients, 184 received Radium-223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 183 (99%) had prior systemic anticancer therapy. Treatment-related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow-up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow-up due to Radium-223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5-6 Radium-223 injections and unlikely to benefit from Radium-223. Radium-223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. CONCLUSION: Radium-223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. IMPLICATIONS FOR PRACTICE: In this phase II U.S. expanded access program, Radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, Radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when Radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.
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chemotherapy following Radium 223 dichloride treatment in alsympca
The Prostate, 2016Co-Authors: Oliver Sartor, Oana Petrenciuc, Kathrin Staudacher, Marcus Thuresson, Nicholas J. Vogelzang, Robert E. Coleman, Sten Nilsson, Peter Hoskin, Chris ParkerAbstract:BACKGROUND. Radium-223 prolongs overall survival in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases, regardless of prior docetaxel. Whether or not chemotherapy can be safely administered following Radium-223 treatment is of clinical importance. An exploratory analysis of prospectively collected data, from the ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) patient subgroup who received chemotherapy after Radium-223 or placebo treatment, was conducted to evaluate the safety and efficacy of chemotherapy following Radium-223. METHODS. In ALSYMPCA, CRPC patients with symptomatic bone metastases and no visceral metastases were randomized 2: 1 to receive six injections of Radium-223 (50 kBq/kg IV) or placebo plus best standard of care, stratified by prior docetaxel, baseline alkaline phosphatase, and current bisphosphonate use. In this exploratory analysis, chemotherapy agents administered following study treatment were identified; timing and duration were calculated. Hematologic safety was reviewed, and overall survival analyzed. RESULTS. Overall, 142 Radium-223 and 64 placebo patients received subsequent chemotherapy; most common were docetaxel (70% Radium-223, 72% placebo) and mitoxantrone (16% Radium-223, 20% placebo). The majority of patients (61% Radium-223, 58% placebo) had received prior docetaxel. Radium-223 patients started subsequent chemotherapy later than placebo patients; chemotherapy duration was similar between groups. In Radium-223 and placebo patients receiving subsequent chemotherapy, median hematologic values (hemoglobin, neutrophils, and platelets) remained nearly constant up to 18 months following start of chemotherapy, regardless of prior docetaxel treatment. A low percentage of patients in both groups had grades 3-4 hematologic values (<10%). Platelet count decline, from last measurement before chemotherapy, was numerically greater in Radium-223 versus placebo patients. Median overall survivals from start of chemotherapy were 16.0 and 15.8 months following Radium-223 and placebo, respectively. CONCLUSIONS. Chemotherapy following Radium-223, regardless of prior docetaxel, is feasible and appears to be well tolerated in patients with CRPC and symptomatic bone metastases. (C) 2016 The Authors. The Prostate published by Wiley Periodicals, Inc.
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Chemotherapy following Radium-223 dichloride treatment in ALSYMPCA
The Prostate, 2016Co-Authors: Oliver Sartor, Oana Petrenciuc, Kathrin Staudacher, Marcus Thuresson, Nicholas J. Vogelzang, Robert E. Coleman, Sten Nilsson, Peter Hoskin, Chris ParkerAbstract:BACKGROUND. Radium-223 prolongs overall survival in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases, regardless of prior docetaxel. Whether or not chemotherapy can be safely administered following Radium-223 treatment is of clinical importance. An exploratory analysis of prospectively collected data, from the ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) patient subgroup who received chemotherapy after Radium-223 or placebo treatment, was conducted to evaluate the safety and efficacy of chemotherapy following Radium-223. METHODS. In ALSYMPCA, CRPC patients with symptomatic bone metastases and no visceral metastases were randomized 2: 1 to receive six injections of Radium-223 (50 kBq/kg IV) or placebo plus best standard of care, stratified by prior docetaxel, baseline alkaline phosphatase, and current bisphosphonate use. In this exploratory analysis, chemotherapy agents administered following study treatment were identified; timing and duration were calculated. Hematologic safety was reviewed, and overall survival analyzed. RESULTS. Overall, 142 Radium-223 and 64 placebo patients received subsequent chemotherapy; most common were docetaxel (70% Radium-223, 72% placebo) and mitoxantrone (16% Radium-223, 20% placebo). The majority of patients (61% Radium-223, 58% placebo) had received prior docetaxel. Radium-223 patients started subsequent chemotherapy later than placebo patients; chemotherapy duration was similar between groups. In Radium-223 and placebo patients receiving subsequent chemotherapy, median hematologic values (hemoglobin, neutrophils, and platelets) remained nearly constant up to 18 months following start of chemotherapy, regardless of prior docetaxel treatment. A low percentage of patients in both groups had grades 3-4 hematologic values (
Adam P Dicker - One of the best experts on this subject based on the ideXlab platform.
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Radium 223 safety efficacy and concurrent use with abiraterone or enzalutamide first u s experience from an expanded access program
Oncologist, 2018Co-Authors: Oliver Sartor, Daniel Celestino Fernandez, Christopher Sweeney, Andrei Iagaru, Nicholas J. Vogelzang, Fabio Almeida, Manish Agrawal, Matthew R. Smith, Alan Brown, Adam P DickerAbstract:Background In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated Radium-223 survival benefit, and before Radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access Radium-223 allowed life-prolonging therapies in current use. Subjects, materials, and methods This phase II, open-label, single-arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received Radium-223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long-term safety. Additional analyses were done by number of Radium-223 injections, and prior or concomitant abiraterone or enzalutamide use. Results Of 252 patients, 184 received Radium-223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 183 (99%) had prior systemic anticancer therapy. Treatment-related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow-up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow-up due to Radium-223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5-6 Radium-223 injections and unlikely to benefit from Radium-223. Radium-223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. Conclusion Radium-223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. Implications for practice In this phase II U.S. expanded access program, Radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, Radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when Radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.
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Radium‐223 Safety, Efficacy, and Concurrent Use with Abiraterone or Enzalutamide: First U.S. Experience from an Expanded Access Program
Oncologist, 2017Co-Authors: Oliver Sartor, Daniel Celestino Fernandez, Christopher Sweeney, Andrei Iagaru, Nicholas J. Vogelzang, Fabio Almeida, Manish Agrawal, Matthew R. Smith, Alan Brown, Adam P DickerAbstract:BACKGROUND: In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated Radium-223 survival benefit, and before Radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access Radium-223 allowed life-prolonging therapies in current use. SUBJECTS, MATERIALS, AND METHODS: This phase II, open-label, single-arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received Radium-223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long-term safety. Additional analyses were done by number of Radium-223 injections, and prior or concomitant abiraterone or enzalutamide use. RESULTS: Of 252 patients, 184 received Radium-223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 183 (99%) had prior systemic anticancer therapy. Treatment-related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow-up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow-up due to Radium-223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5-6 Radium-223 injections and unlikely to benefit from Radium-223. Radium-223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. CONCLUSION: Radium-223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. IMPLICATIONS FOR PRACTICE: In this phase II U.S. expanded access program, Radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, Radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when Radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.
Alan Brown - One of the best experts on this subject based on the ideXlab platform.
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Radium 223 safety efficacy and concurrent use with abiraterone or enzalutamide first u s experience from an expanded access program
Oncologist, 2018Co-Authors: Oliver Sartor, Daniel Celestino Fernandez, Christopher Sweeney, Andrei Iagaru, Nicholas J. Vogelzang, Fabio Almeida, Manish Agrawal, Matthew R. Smith, Alan Brown, Adam P DickerAbstract:Background In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated Radium-223 survival benefit, and before Radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access Radium-223 allowed life-prolonging therapies in current use. Subjects, materials, and methods This phase II, open-label, single-arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received Radium-223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long-term safety. Additional analyses were done by number of Radium-223 injections, and prior or concomitant abiraterone or enzalutamide use. Results Of 252 patients, 184 received Radium-223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 183 (99%) had prior systemic anticancer therapy. Treatment-related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow-up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow-up due to Radium-223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5-6 Radium-223 injections and unlikely to benefit from Radium-223. Radium-223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. Conclusion Radium-223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. Implications for practice In this phase II U.S. expanded access program, Radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, Radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when Radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.
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Radium‐223 Safety, Efficacy, and Concurrent Use with Abiraterone or Enzalutamide: First U.S. Experience from an Expanded Access Program
Oncologist, 2017Co-Authors: Oliver Sartor, Daniel Celestino Fernandez, Christopher Sweeney, Andrei Iagaru, Nicholas J. Vogelzang, Fabio Almeida, Manish Agrawal, Matthew R. Smith, Alan Brown, Adam P DickerAbstract:BACKGROUND: In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated Radium-223 survival benefit, and before Radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access Radium-223 allowed life-prolonging therapies in current use. SUBJECTS, MATERIALS, AND METHODS: This phase II, open-label, single-arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received Radium-223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long-term safety. Additional analyses were done by number of Radium-223 injections, and prior or concomitant abiraterone or enzalutamide use. RESULTS: Of 252 patients, 184 received Radium-223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 183 (99%) had prior systemic anticancer therapy. Treatment-related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow-up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow-up due to Radium-223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5-6 Radium-223 injections and unlikely to benefit from Radium-223. Radium-223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. CONCLUSION: Radium-223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. IMPLICATIONS FOR PRACTICE: In this phase II U.S. expanded access program, Radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, Radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when Radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.
Matthew R. Smith - One of the best experts on this subject based on the ideXlab platform.
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Radium 223 safety efficacy and concurrent use with abiraterone or enzalutamide first u s experience from an expanded access program
Oncologist, 2018Co-Authors: Oliver Sartor, Daniel Celestino Fernandez, Christopher Sweeney, Andrei Iagaru, Nicholas J. Vogelzang, Fabio Almeida, Manish Agrawal, Matthew R. Smith, Alan Brown, Adam P DickerAbstract:Background In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated Radium-223 survival benefit, and before Radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access Radium-223 allowed life-prolonging therapies in current use. Subjects, materials, and methods This phase II, open-label, single-arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received Radium-223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long-term safety. Additional analyses were done by number of Radium-223 injections, and prior or concomitant abiraterone or enzalutamide use. Results Of 252 patients, 184 received Radium-223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 183 (99%) had prior systemic anticancer therapy. Treatment-related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow-up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow-up due to Radium-223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5-6 Radium-223 injections and unlikely to benefit from Radium-223. Radium-223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. Conclusion Radium-223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. Implications for practice In this phase II U.S. expanded access program, Radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, Radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when Radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.
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Radium‐223 Safety, Efficacy, and Concurrent Use with Abiraterone or Enzalutamide: First U.S. Experience from an Expanded Access Program
Oncologist, 2017Co-Authors: Oliver Sartor, Daniel Celestino Fernandez, Christopher Sweeney, Andrei Iagaru, Nicholas J. Vogelzang, Fabio Almeida, Manish Agrawal, Matthew R. Smith, Alan Brown, Adam P DickerAbstract:BACKGROUND: In the phase III ALSYMPCA trial, metastatic castration-resistant prostate cancer (mCRPC) patients had few prior life-prolonging therapies. Following ALSYMPCA, which demonstrated Radium-223 survival benefit, and before Radium-223 U.S. commercial availability, an expanded access program (EAP) providing early-access Radium-223 allowed life-prolonging therapies in current use. SUBJECTS, MATERIALS, AND METHODS: This phase II, open-label, single-arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received Radium-223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long-term safety. Additional analyses were done by number of Radium-223 injections, and prior or concomitant abiraterone or enzalutamide use. RESULTS: Of 252 patients, 184 received Radium-223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 183 (99%) had prior systemic anticancer therapy. Treatment-related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow-up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow-up due to Radium-223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5-6 Radium-223 injections and unlikely to benefit from Radium-223. Radium-223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. CONCLUSION: Radium-223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. IMPLICATIONS FOR PRACTICE: In this phase II U.S. expanded access program, Radium-223 was well tolerated, with a median overall survival of 17 months in metastatic castration-resistant prostate cancer patients. In post hoc analyses, Radium-223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when Radium-223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from Radium-223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients.
