Overall Survival Analysis of a Phase II Randomized Controlled Trial of a Poxviral-Based PSA-Targeted Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Therapeutic prostate-specific antigen (PSA) -targeted poxviral vaccines for prostate cancer have been well tolerated. PROSTVAC-VF treatment was evaluated for safety and for prolongation of progression-free survival (PFS) and overall survival (OS) in a randomized, controlled, and blinded phase II stu...
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| Published in | Journal of clinical oncology Vol. 28; no. 7; pp. 1099 - 1105 |
|---|---|
| Main Authors | , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Alexandria, VA
American Society of Clinical Oncology
01.03.2010
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0732-183X 1527-7755 1527-7755 |
| DOI | 10.1200/JCO.2009.25.0597 |
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| Abstract | Therapeutic prostate-specific antigen (PSA) -targeted poxviral vaccines for prostate cancer have been well tolerated. PROSTVAC-VF treatment was evaluated for safety and for prolongation of progression-free survival (PFS) and overall survival (OS) in a randomized, controlled, and blinded phase II study.
In total, 125 patients were randomly assigned in a multicenter trial of vaccination series. Eligible patients had minimally symptomatic castration-resistant metastatic prostate cancer (mCRPC). PROSTVAC-VF comprises two recombinant viral vectors, each encoding transgenes for PSA, and three immune costimulatory molecules (B7.1, ICAM-1, and LFA-3). Vaccinia-based vector was used for priming followed by six planned fowlpox-based vector boosts. Patients were allocated (2:1) to PROSTVAC-VF plus granulocyte-macrophage colony-stimulating factor or to control empty vectors plus saline injections.
Eighty-two patients received PROSTVAC-VF and 40 received control vectors. Patient characteristics were similar in both groups. The primary end point was PFS, which was similar in the two groups (P = .6). However, at 3 years post study, PROSTVAC-VF patients had a better OS with 25 (30%) of 82 alive versus 7 (17%) of 40 controls, longer median survival by 8.5 months (25.1 v 16.6 months for controls), an estimated hazard ratio of 0.56 (95% CI, 0.37 to 0.85), and stratified log-rank P = .0061.
PROSTVAC-VF immunotherapy was well tolerated and associated with a 44% reduction in the death rate and an 8.5-month improvement in median OS in men with mCRPC. These provocative data provide preliminary evidence of clinically meaningful benefit but need to be confirmed in a larger phase III study. |
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| AbstractList | Therapeutic prostate-specific antigen (PSA) -targeted poxviral vaccines for prostate cancer have been well tolerated. PROSTVAC-VF treatment was evaluated for safety and for prolongation of progression-free survival (PFS) and overall survival (OS) in a randomized, controlled, and blinded phase II study.PURPOSETherapeutic prostate-specific antigen (PSA) -targeted poxviral vaccines for prostate cancer have been well tolerated. PROSTVAC-VF treatment was evaluated for safety and for prolongation of progression-free survival (PFS) and overall survival (OS) in a randomized, controlled, and blinded phase II study.In total, 125 patients were randomly assigned in a multicenter trial of vaccination series. Eligible patients had minimally symptomatic castration-resistant metastatic prostate cancer (mCRPC). PROSTVAC-VF comprises two recombinant viral vectors, each encoding transgenes for PSA, and three immune costimulatory molecules (B7.1, ICAM-1, and LFA-3). Vaccinia-based vector was used for priming followed by six planned fowlpox-based vector boosts. Patients were allocated (2:1) to PROSTVAC-VF plus granulocyte-macrophage colony-stimulating factor or to control empty vectors plus saline injections.PATIENTS AND METHODSIn total, 125 patients were randomly assigned in a multicenter trial of vaccination series. Eligible patients had minimally symptomatic castration-resistant metastatic prostate cancer (mCRPC). PROSTVAC-VF comprises two recombinant viral vectors, each encoding transgenes for PSA, and three immune costimulatory molecules (B7.1, ICAM-1, and LFA-3). Vaccinia-based vector was used for priming followed by six planned fowlpox-based vector boosts. Patients were allocated (2:1) to PROSTVAC-VF plus granulocyte-macrophage colony-stimulating factor or to control empty vectors plus saline injections.Eighty-two patients received PROSTVAC-VF and 40 received control vectors. Patient characteristics were similar in both groups. The primary end point was PFS, which was similar in the two groups (P = .6). However, at 3 years post study, PROSTVAC-VF patients had a better OS with 25 (30%) of 82 alive versus 7 (17%) of 40 controls, longer median survival by 8.5 months (25.1 v 16.6 months for controls), an estimated hazard ratio of 0.56 (95% CI, 0.37 to 0.85), and stratified log-rank P = .0061.RESULTSEighty-two patients received PROSTVAC-VF and 40 received control vectors. Patient characteristics were similar in both groups. The primary end point was PFS, which was similar in the two groups (P = .6). However, at 3 years post study, PROSTVAC-VF patients had a better OS with 25 (30%) of 82 alive versus 7 (17%) of 40 controls, longer median survival by 8.5 months (25.1 v 16.6 months for controls), an estimated hazard ratio of 0.56 (95% CI, 0.37 to 0.85), and stratified log-rank P = .0061.PROSTVAC-VF immunotherapy was well tolerated and associated with a 44% reduction in the death rate and an 8.5-month improvement in median OS in men with mCRPC. These provocative data provide preliminary evidence of clinically meaningful benefit but need to be confirmed in a larger phase III study.CONCLUSIONPROSTVAC-VF immunotherapy was well tolerated and associated with a 44% reduction in the death rate and an 8.5-month improvement in median OS in men with mCRPC. These provocative data provide preliminary evidence of clinically meaningful benefit but need to be confirmed in a larger phase III study. Therapeutic prostate-specific antigen (PSA) -targeted poxviral vaccines for prostate cancer have been well tolerated. PROSTVAC-VF treatment was evaluated for safety and for prolongation of progression-free survival (PFS) and overall survival (OS) in a randomized, controlled, and blinded phase II study. In total, 125 patients were randomly assigned in a multicenter trial of vaccination series. Eligible patients had minimally symptomatic castration-resistant metastatic prostate cancer (mCRPC). PROSTVAC-VF comprises two recombinant viral vectors, each encoding transgenes for PSA, and three immune costimulatory molecules (B7.1, ICAM-1, and LFA-3). Vaccinia-based vector was used for priming followed by six planned fowlpox-based vector boosts. Patients were allocated (2:1) to PROSTVAC-VF plus granulocyte-macrophage colony-stimulating factor or to control empty vectors plus saline injections. Eighty-two patients received PROSTVAC-VF and 40 received control vectors. Patient characteristics were similar in both groups. The primary end point was PFS, which was similar in the two groups (P = .6). However, at 3 years post study, PROSTVAC-VF patients had a better OS with 25 (30%) of 82 alive versus 7 (17%) of 40 controls, longer median survival by 8.5 months (25.1 v 16.6 months for controls), an estimated hazard ratio of 0.56 (95% CI, 0.37 to 0.85), and stratified log-rank P = .0061. PROSTVAC-VF immunotherapy was well tolerated and associated with a 44% reduction in the death rate and an 8.5-month improvement in median OS in men with mCRPC. These provocative data provide preliminary evidence of clinically meaningful benefit but need to be confirmed in a larger phase III study. |
| Author | Wayne R. Godfrey Jeffrey Schlom Thomas J. Schuetz L. Michael Glode Kelledy Manson Michael Wyand Philip W. Kantoff William L. Dahut Philip M. Arlen Brent A. Blumenstein David L. Bilhartz Dennis L. Panicali Reiner Laus James L. Gulley |
| Author_xml | – sequence: 1 givenname: Philip W. surname: Kantoff fullname: Kantoff, Philip W. organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 2 givenname: Thomas J. surname: Schuetz fullname: Schuetz, Thomas J. organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 3 givenname: Brent A. surname: Blumenstein fullname: Blumenstein, Brent A. organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 4 givenname: L. Michael surname: Glode fullname: Glode, L. Michael organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 5 givenname: David L. surname: Bilhartz fullname: Bilhartz, David L. organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 6 givenname: Michael surname: Wyand fullname: Wyand, Michael organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 7 givenname: Kelledy surname: Manson fullname: Manson, Kelledy organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 8 givenname: Dennis L. surname: Panicali fullname: Panicali, Dennis L. organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 9 givenname: Reiner surname: Laus fullname: Laus, Reiner organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 10 givenname: Jeffrey surname: Schlom fullname: Schlom, Jeffrey organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 11 givenname: William L. surname: Dahut fullname: Dahut, William L. organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 12 givenname: Philip M. surname: Arlen fullname: Arlen, Philip M. organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 13 givenname: James L. surname: Gulley fullname: Gulley, James L. organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA – sequence: 14 givenname: Wayne R. surname: Godfrey fullname: Godfrey, Wayne R. organization: From the Dana-Farber Cancer Institute, Harvard Medical School, Boston; Therion Biologics, Cambridge, MA; Trial Architecture Consulting, Washington, DC; University of Colorado, Aurora, CO; Urology Associates, Nashville, TN; Medical Oncology Branch and the Laboratory of Tumor Immunology and Biology, National Cancer Institute, National Institutes of Health, Bethesda, MD; and BN ImmunoTherapeutics, Mountain View, CA |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22447126$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/20100959$$D View this record in MEDLINE/PubMed |
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| Title | Overall Survival Analysis of a Phase II Randomized Controlled Trial of a Poxviral-Based PSA-Targeted Immunotherapy in Metastatic Castration-Resistant Prostate Cancer |
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