Evaluation of the palliative benefit and toxicity of Ra-223 treatment of men with hormone refractory prostate cancer in a community setting.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 225-225
Author(s):  
Houman Vaghefi ◽  
Bide Xiong ◽  
Fang Liu ◽  
Elizabeth Garber ◽  
James Wheeler
Keyword(s):  
Prostate Cancer ◽  
Alkaline Phosphatase ◽  
Median Survival ◽  
Phase Iii ◽  
Rank Test ◽  
Hormone Refractory Prostate Cancer ◽  
Cancer Trial ◽  
Pain Scores ◽  
Radium 223 ◽  
Hormone Refractory

225 Background: The ALSYMCA (Alpharadin in Symptomatic Prostate Cancer) trial was a phase III, placebo controlled, randomized trial in which 921 men with bone metastasis from hormone refractory prostate cancer (HRPC) were randomly assigned to receive radium-223 (Ra-223) or placebo. Ra-223 produced a 30% survival benefit, with a median survival of 14.9 months compared to 11.3 months for patients treated with a placebo, which led to FDA approval in 2013. Methods: We identified through the nuclear medicine records 11 patients who started Ra-223 between March 15, 2013 and December 10, 2015. The Wilcoxon signed rank test was used to compare the published results of the ALSYMPCA patients with those from our institution. Results: The Hodges-Lehman estimate of the median survival of our patients from the date of the first Ra-223 infusion was 7.8 months. The 95% confidence interval (CI) was (2.8, 14.7; p = 0.0122) indicating our patients had a significantly shorter survival. Our patients did not have a statistically significant worse rate of anemia, neutropenia, or thrombocytopenia. Only 27.3% (95% CI: 6.0, 61.0%) of our patients completed all 6 planned infusions significantly less than 63% for the ALSYMPCA patients treated with Ra-223 (p = 0.0239), but not statistically different than the placebo patients (p = 0.236). The median survival from the last Ra-223 was 3.53 months. We used 3 measures of treatment effectiveness: (1) reduction in the pain scores, (2) reduction in the serum PSA, and (3) reduction in the alkaline phosphatase. Compared to the pre-treatment values, numerical reductions were seen at the last follow-up evaluation for both the pain scores and the alkaline phosphatase levels, but the reductions were not statistically significant. Conclusions: Not all patients with castration resistant prostate cancer benefit from Ra-223 to the same extent as the ALSYMPCA patients. It is important to identify patients with a sufficient life expectancy to benefit from this treatment.

Vinblastine Versus Vinblastine Plus Oral Estramustine Phosphate for Patients With Hormone-Refractory Prostate Cancer: A Hoosier Oncology Group and Fox Chase Network Phase III Trial

1999 ◽  
Vol 17 (10) ◽  
pp. 3160-3166 ◽  
Author(s):  
Gary Hudes ◽  
Lawrence Einhorn ◽  
Eric Ross ◽  
Andrew Balsham ◽  
Patrick Loehrer ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Specific Antigen ◽  
Phase Iii ◽  
Rank Test ◽  
Hormone Refractory Prostate Cancer ◽  
Estramustine Phosphate ◽  
Time To Progression ◽  
Kaplan Meier ◽  
Hormone Refractory

PURPOSE: To compare vinblastine versus the combination of vinblastine plus estramustine as treatment for patients with hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: A total of 201 patients with metastatic prostate cancer, progressive after hormonal therapy and antiandrogen withdrawal (if prior antiandrogen treatment), were randomized to receive vinblastine (V) 4 mg/m2 by intravenous bolus weekly for 6 weeks followed by 2 weeks off, either alone or together with estramustine phosphate (EM-V) 600 mg/m2 PO days 1 through 42, repeated every 8 weeks. Of 193 eligible patients, 98 received V, and 95 received EM-V. RESULTS: Overall survival trended in favor of EM-V but was not significantly different as determined by Kaplan-Meier analysis (P = .08). Median survival was 11.9 months for EM-V and 9.2 months for V. EM-V was superior to V for secondary end points of time to progression (P < .001, stratified log rank test; median 3.7 v 2.2 months, respectively) and for proportion of patients with ≥ 50% prostate-specific antigen (PSA) decline sustained for at least 3 monthly measurements (25.2% v 3.2%, respectively; P < .0001). Granulocytopenia was significantly less for EM-V compared with V (grade 2, 3, and 4 = 7%, 7%, and 1% v 27%, 18% and 9%, respectively; P < .0001); however, grade 2 or worse nausea (26% v 7%, respectively; P = .0002) and extremity edema (22% v 8%, respectively; P = .005) were more frequent for EM-V. CONCLUSION: Although overall survival was not significantly greater for the combination, EM-V was superior to V for time to progression and PSA improvement. These results encourage further study of estramustine-based antimicrotubule drug combinations in HRPC.

scholarly journals Radium-223 in a Community Setting for Castration Resistant Prostate Cancer

2017 ◽  
Vol 6 (1) ◽  
pp. 44
Author(s):  
Houman Vaghefi ◽  
Sachin Agarwal ◽  
Fang Liu ◽  
Bide Xiong ◽  
Elizabeth Garber ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Median Survival ◽  
Treatment Effectiveness ◽  
Community Setting ◽  
Rank Test ◽  
Castration Resistant Prostate Cancer ◽  
Cancer Trial ◽  
Castration Resistant ◽  
Radium 223 ◽  
Signed Rank Test

Purpose: To evaluate the toxicity, palliative benefit, and survival benefit of Radium-223 (Ra-223) in a community setting.Introduction: The ALSYMCA (Alpharadin in Symptomatic Prostate Cancer) trial demonstrated improved survival for men with painful bone metastasis from castration resistant prostate cancer who were treated with Ra-223. The median survival was 14.9 months for the Ra-223 patients compared to 11.3 months for patients treated with a placebo.Methods: We identified through the nuclear medicine records 11 patients who started Ra-223 between March 15, 2013 and December 10, 2015. The Wilcoxon signed rank test was used to compare the published results of the ALSYMPCA patients with those from our institution.Results: The Hodges-Lehman estimate of the median survival of our patients from the date of the first Ra-223 infusion was 7.8 months. The 95% confidence interval (CI) was (2.8, 14.7; p=0.0122) indicating our patients had a significantly shorter survival than the Ra-223 ALSYMPCA patients.Our patients did not have a statistically significant worse rate of anemia, neutropenia, or thrombocytopenia. We used 3 measures of treatment effectiveness: 1) reduction in the pain scores, 2) reduction in the serum PSA, and 3) reduction in the alkaline phosphatase from baseline, but the reductions were not statistically significant.Conclusions: This small study is not meant to challenge the results of the ALSYMPCA international trial. It is intended only as a caution that prior lines of therapy, especially with newer agents such as abiraterone and enzalutamide, may attenuate the benefit from this treatment, particularly in elderly patients.Radium-223 in a Community Setting for Castration Resistant Prostate Cancer

Prostate-specific antigen as a measure of disease outcome in metastatic hormone-refractory prostate cancer.

1993 ◽  
Vol 11 (4) ◽  
pp. 607-615 ◽  
Author(s):  
W K Kelly ◽  
H I Scher ◽  
M Mazumdar ◽  
V Vlamis ◽  
M Schwartz ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Univariate Analysis ◽  
Prognostic Significance ◽  
Specific Antigen ◽  
Phase Iii ◽  
Cancer Center ◽  
Hormone Refractory Prostate Cancer ◽  
Data Set ◽  
Hormone Refractory

PURPOSE To evaluate the prognostic significance of pretreatment parameters and posttherapy declines in prostate-specific antigen (PSA) in relation to the survival of patients with hormone-refractory prostate cancer. PATIENTS AND METHODS One hundred ten assessable patients treated on seven sequential protocols at Memorial Sloan-Kettering Cancer Center (MSKCC) for hormone-refractory prostate cancer were evaluated for 29 different pretherapy and posttherapy parameters, including a posttherapy decline in PSA of 50% and 80% from baseline. RESULTS In the univariate analysis, initial Karnofsky performance status (KPS) > or = 80% was associated with a favorable outcome (P = .005), while age, extent of disease on bone scan, and individual sites of metastatic disease were not significant. No difference in survival was observed between patients with measurable or assessable (bone only) disease. Initial hemoglobin (HGB; P = .0012), alkaline phosphatase (ALK; P = .0015), and lactate dehydrogenase (LDH; P = .0002) levels were significant discriminators, while the initial PSA was not. Using a landmark analysis, a significantly longer median survival rate was observed for patients with a > or = 50% decline in PSA (median not reached) versus patients with a less than 50% decline in PSA (median, 8.6 months; P = .0001). Multivariate analysis using the Cox proportional hazards model showed that a > or = 50% decline in PSA (P = .0004) and the natural log of LDH (P = .0001) were the two most significant variables predicting survival. The model was confirmed on an independent data set from the Norwegian Radium Hospital (NRH) in Oslo, Norway. CONCLUSION The results suggest that posttherapy PSA declines can be used as a surrogate end point to evaluate new agents in hormone-refractory prostate cancer. The criteria for response need prospective validation in phase III trials.

Hormone Refractory Prostate Cancer: Focus on Sipuleucel-T

2009 ◽  
Vol 1 ◽  
pp. CMT.S1084
Author(s):  
Christian Doehn ◽  
Martin Sommerauer ◽  
Xiyuan Guo ◽  
Ingo Kausch ◽  
Dieter Jocham
Keyword(s):  
Prostate Cancer ◽  
Prostatic Acid Phosphatase ◽  
The United States ◽  
Phase Iii ◽  
Fusion Product ◽  
Hormone Refractory Prostate Cancer ◽  
Clinical Responses ◽  
Hormone Refractory ◽  
Macrophage Colony ◽  
Antigen Presenting

Sipuleucel-T is a vaccine based on autologous antigen presenting cells that are loaded with an antigen-cytokine (prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor) fusion product. Sipuleucel-T is given intravenous in weeks 0, 2, and 4. Within phase I–III trials, patients with metastatic hormone-refractory prostate cancer have been treated. In these trials an activation of the immune system could be demonstrated. Also, some clinical responses could be documented. Moreover, in a placebo-controlled phase III trial including 127 patients a statistical significantly prolongation of survival was achieved. Side effects from the vaccine are rather mild and included fever, myalgia, fatigue and others. The Food and Drug Administration in the United States requested further data before possible approval of sipuleucel-T.

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