Real-world experience with sipuleucel-T in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) who received prior docetaxel (D): Data from PROCEED.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 30-30 ◽  
Author(s):  
A. Oliver Sartor ◽  
Matthew R. Cooperberg ◽  
Nicholas J. Vogelzang ◽  
Mark Creamer Scholz ◽  
Raoul S. Concepcion ◽  
...  
Keyword(s):  
Real World ◽  
Performance Status ◽  
Phase Iii ◽  
Cellular Immunotherapy ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Disease Characteristics ◽  
Multicenter Phase ◽  
Real World Setting ◽  
Clinical Trial Information

30^ Background: Sipuleucel-T is an autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic mCRPC. The phase III IMPACT trial showed a significant improvement in overall survival with sipuleucel-T treatment (tmt). In IMPACT, D use was prohibited within 3 months prior to registration due to the potential immunosuppressive impact of chemotherapy. PROCEED is an ongoing, multicenter, phase 4 registry enrolling pts receiving sipuleucel-T in the real-world setting. Enrollment has no restrictions on D use; thus, data from PROCEED may help determine whether prior D affects sipuleucel-T manufacture. Here we present preliminary results on baseline demographics and product parameters in PROCEED subjects with and without prior D exposure. Methods: Pts who were treated with sipuleucel-T within the prior 6-months at clinical sites were asked to provide informed consent to participate in PROCEED. Results: By September 2012, 560 pts completed sipuleucel-T tmt; 15% previously received D (median 291 days prior to 1st sipuleucel-T infusion). Patients with prior D had higher PSA levels, and those with recent D use tended to have a lower performance status and higher Gleason scores, but product parameters were generally comparable between the groups (see table). Conclusions: Pts enrolled in PROCEED with and without prior D exposure had different baseline demographics and disease characteristics. However, sipuleucel-T product parameters were comparable regardless of prior D exposure. Clinical trial information: NCT01306890. [Table: see text]

Experience with sipuleucel-T in metastatic castration-resistant prostate cancer (mCRPC) with visceral spread from PROCEED.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 174-174
Author(s):  
Nicholas J. Vogelzang ◽  
Philip W. Kantoff ◽  
Mark C. Scholz ◽  
Jeffrey L. Vacirca ◽  
Shaker R. Dakhil ◽  
...  
Keyword(s):  
Performance Status ◽  
Specific Antigen ◽  
Cellular Immunotherapy ◽  
Castration Resistant Prostate Cancer ◽  
Phase 3 ◽  
Castration Resistant ◽  
Visceral Metastases ◽  
Antigen Presenting ◽  
Post Hoc ◽  
Clinical Trial Information

174 Background: Trials of approved agents in mCRPC have reported shorter overall survival (OS) in men with visceral metastases (mets). The phase 3 IMPACT trial evaluated sipuleucel-T, an autologous cellular immunotherapy, in mCRPC but excluded visceral mets. PROCEED, a registry of mCRPC patients receiving sipuleucel-T, offers the first description of sipuleucel-T in patients with visceral mets. Methods: PROCEED enrolled men with mCRPC treated with sipuleucel-T biweekly x 3. Dose adjustment for organ dysfunction was unnecessary. Men were followed until death, study withdrawal, or a minimum of 3 years. OS is reported in this post-hoc subgroup analysis. Results: 1902 men received ≥1 sipuleucel-T infusion between 2011-2014. Visceral mets (n = 90) included liver (n=21), lung (n=61), and brain (n=2) involvement. Compared to patients without visceral mets (Table), men with visceral mets had poorer performance status (PS) and higher baseline prostate-specific antigen (PSA). Median OS was 20.5 and 31.2 mo in those with and without visceral mets. Patients with liver and lung mets had a median OS of 16.3 and 21.0 mo, respectively. Activation of antigen-presenting cells, a measure of immune activation and product potency, was similar in those with and without visceral mets. Conclusions: Initial observations suggest that patients with mCRPC and visceral spread can activate their immune cells to produce sipuleucel-T, but have a shorter OS than those with bone and/or lymph node spread. (NCT01306890). Clinical trial information: NCT00065442. [Table: see text]

Real-world experience with sipuleucel-T in patients (pts) ≥80 years old with metastatic castration-resistant prostate cancer (mCRPC): Data from PROCEED.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 131-131
Author(s):  
Chadi Nabhan ◽  
A. Oliver Sartor ◽  
Matthew R. Cooperberg ◽  
Jeffrey L. Vacirca ◽  
Raoul S. Concepcion ◽  
...  
Keyword(s):  
Phase Iii ◽  
Cellular Immunotherapy ◽  
Castration Resistant Prostate Cancer ◽  
Immune Parameters ◽  
Castration Resistant ◽  
Disease Characteristics ◽  
High Prevalence ◽  
Similar Product ◽  
Antigen Presenting

131^ Background: Sipuleucel-T is an autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic mCRPC based on data from the phase III IMPACT pivotal trial that showed a significant improvement in overall survival (OS) compared to control (HR: 0.78 [95% CI: 0.61, 0.98]; P=0.03; median OS difference 4.1 mos). Analysis of IMPACT demonstrated evidence of a positive sipuleucel-T treatment effect in men above and below the median age of 71. We sought to understand the disease characteristics and product parameters in pts ≥80 years (yrs) given the high prevalence of older men in the mCRPC pt population. Methods: PROCEED is an ongoing, multicenter (>190 sites), phase 4 registry enrolling pts receiving sipuleucel-T. Information on antigen presenting cell (APC) activation and total nucleated cell (TNC) count were obtained during product manufacture. Results: Of 560 subjects who completed sipuleucel-T treatment to date: 110 (20%) pts were ≥80 yrs-old. Disease characteristics in pts ≥80 yrs vs <80 yrs are detailed in the table below. Product parameters were similar between groups. Conclusions: Pts ≥80 exhibit similar product parameters compared with their younger counterparts. Future follow-up will explore OS and correlations with immune parameters in both groups. Clinical trial information: NCT01306890. [Table: see text]

scholarly journals Overall Survival of Black and White Men With Metastatic Castration-Resistant Prostate Cancer Treated With Docetaxel

2019 ◽  
Vol 37 (5) ◽  
pp. 403-410 ◽  
Author(s):  
Susan Halabi ◽  
Sandipan Dutta ◽  
Catherine M. Tangen ◽  
Mark Rosenthal ◽  
Daniel P. Petrylak ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Black Men ◽  
Performance Status ◽  
Specific Antigen ◽  
White Men ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Black And White ◽  
Castration Resistant

Purpose Several studies have reported that among patients with localized prostate cancer, black men have a shorter overall survival (OS) time than white men, but few data exist for men with advanced prostate cancer. The primary goal of this analysis was to compare the OS in black and white men with metastatic castration-resistant prostate cancer (mCRPC) who were treated in phase III clinical trials with docetaxel plus prednisone (DP) or a DP-containing regimen. Methods Individual participant data from 8,820 men with mCRPC randomly assigned in nine phase III trials to DP or a DP-containing regimen were combined. Race was based on self-report. The primary end point was OS. The Cox proportional hazards regression model was used to assess the prognostic importance of race (black v white) adjusted for established risk factors common across the trials (age, prostate-specific antigen, performance status, alkaline phosphatase, hemoglobin, and sites of metastases). Results Of 8,820 men, 7,528 (85%) were white, 500 (6%) were black, 424 (5%) were Asian, and 368 (4%) were of unknown race. Black men were younger and had worse performance status, higher testosterone and prostate-specific antigen, and lower hemoglobin than white men. Despite these differences, the median OS was 21.0 months (95% CI, 19.4 to 22.5 months) versus 21.2 months (95% CI, 20.8 to 21.7 months) in black and white men, respectively. The pooled multivariable hazard ratio of 0.81 (95% CI, 0.72 to 0.91) demonstrates that overall, black men have a statistically significant decreased risk of death compared with white men ( P < .001). Conclusion When adjusted for known prognostic factors, we observed a statistically significant increased OS in black versus white men with mCRPC who were enrolled in these clinical trials. The mechanism for these differences is not known.

Sipuleucel-T in metastatic castration-resistant prostate cancer (mCRPC) patients ≥80 years-old: Data from PROCEED.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 64-64 ◽  
Author(s):  
Chadi Nabhan ◽  
A. Oliver Sartor ◽  
Matthew R. Cooperberg ◽  
Andrew J. Armstrong ◽  
Jeffrey L. Vacirca ◽  
...  
Keyword(s):  
Cellular Immunotherapy ◽  
Castration Resistant Prostate Cancer ◽  
Pivotal Phase ◽  
Risk Of Death ◽  
Immune Parameters ◽  
Castration Resistant ◽  
Disease Characteristics ◽  
High Prevalence ◽  
Antigen Presenting

64 Background: Sipuleucel-T is an autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic mCRPC based on data from the pivotal phase 3 IMPACT trial that demonstrated a 22% reduction in the risk of death. Given the high prevalence of older men in the mCRPC patient (pt) population, we sought to understand disease characteristics and sipuleucel-T product parameters in pts ≥80 years (yrs). Methods: PROCEED is an ongoing phase 4 registry enrolling pts treated with sipuleucel-T within ≤6 months. Baseline pt demographics and disease characteristics were collected. Sipuleucel-T product parameters that were assessed included: total nucleated cell (TNC) count, antigen presenting cell (APC) count (large CD54+ cells), and APC activation (upregulation of CD54; a measure of product potency). Results: As of May 2013, 1254 subjects were enrolled and have completed treatment. Of these, 278 (20%) pts were ≥80 yrs-old. Disease and infused product characteristics in pts ≥80 yrs vs. <80 yrs are detailed in the table below. Product parameters appear similar between groups. Conclusions: In this large cohort of elderly pts ≥80 yrs treated prospectively with sipuleucel-T immunotherapy, we demonstrate that product parameters were similar to their younger counterparts (<80 years). This implies adequate immune up-regulation in elderly pts. Additional follow-up is needed to explore correlations between OS and various immune parameters in both groups. Clinical trial information: NCT01306890. [Table: see text]

Impact of prior radiation treatment (tx) on sipuleucel-T (sip-T) product parameters in PROCEED patients (pts).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 183-183
Author(s):  
Steven E. Finkelstein ◽  
Luke T. Nordquist ◽  
Shaker R. Dakhil ◽  
Nathan B. Green ◽  
Elisabeth I. Heath ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Real World ◽  
Radiation Treatment ◽  
Cellular Immunotherapy ◽  
Castration Resistant Prostate Cancer ◽  
The Real ◽  
Risk Of Death ◽  
Real World Setting ◽  
Antigen Presenting

183 Background: Sipuleucel-T (sip-T) is an autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. Approval of sip-T was based primarily on the randomized, controlled, phase 3 study (IMPACT) that demonstrated a 22% reduction in the risk of death. Since radiation tx could suppress bone marrow function and therefore immune function, IMPACT excluded patients (pts) who received radiation more than or equal to 28 days prior to registration. PROCEED is an ongoing phase 4 registry enrolling pts tx with commercial sip-T in the real-world setting. Palliative radiation (PR) tx for bone pain prior to sip-T is not restricted in PROCEED, so the effects of prior radiation on sip-T manufacturing parameters can be evaluated. Methods: Pts treated with sip-T at or before six months were eligible. Baseline pt demographics and disease characteristics were collected. Sip-T product parameters that were assessed included: total nucleated cell (TNC) count, antigen presenting cell (APC) count (large CD54+cells), and APC activation (upregulation of CD54; a measure of product potency). Results: Data were available for 1,244 pts enrolled by May 2013, who completed tx; of those, 112 (9.0%) pts received PR to bone metastases prior to sip-T and 517 (41.6%) pts had no prior radiation of any kind (NRT). To ensure that groups (grp) were homogeneous and to limit the comparison of NRT pts with those who had PR only for bone metastases, pts with radical prostatectomy were isolated from each grp for further study, resulting in 44 pts in the PR grp and 159 pts in the NRT grp. Median cumulative APC counts were similar between grp, however TNC counts (PR: 9.89 vs. NRT: 12.09 x 109; P=0.002) and APC activation (PR: 34.2 vs. NRT: 38.5; P=0.048) were lower in the PR grp. However, the percentage of pts receiving all three infusions in each group was comparable (PR: 93.2% vs NRT: 95.0%; P=0.71). Conclusions: In the real-world setting, there is no evidence that prior radiation inhibits successful production of sip-T. Although TNC counts and APC activation were lower, APC counts were comparable in radiation treated pts. Effects on in vivo post treatment immune measures are being collected prospectively in a companion trial called PRIME. Clinical trial information: NCT01306890.

scholarly journals Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer

2016 ◽  
Vol 34 (22) ◽  
pp. 2636-2643 ◽  
Author(s):  
Cora Sternberg ◽  
Andrew Armstrong ◽  
Roberto Pili ◽  
Siobhan Ng ◽  
Robert Huddart ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase Ii ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Double Blind ◽  
End Point ◽  
Castration Resistant ◽  
Phase Iii Study

Purpose Tasquinimod, a novel oral therapy targeting the tumor microenvironment, significantly improved progression-free survival (PFS) in a randomized, placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). This phase III study was conducted to confirm the phase II results and to detect an overall survival (OS) benefit. Patients and Methods Men with chemotherapy-naïve mCRPC and evidence of bone metastases were assigned (2:1) to receive tasquinimod once per day or placebo until progression or toxicity. The primary end point was radiographic PFS (rPFS; time from random assignment to radiologic progression or death) per Prostate Cancer Working Group 2 criteria and RECIST 1.1. The study had 99.9% power to detect an rPFS hazard ratio (HR) of 0.6 with a two-sided alpha error of .05 and 80% power to detect a target HR of 0.8 for OS, the key secondary end point. Results In all, 1,245 patients were randomly assigned to either tasquinimod (n = 832) or placebo (n = 413) between March 2011 and December 2012 at 241 sites in 37 countries. Baseline characteristics were balanced between groups: median age, 71 years; Karnofsky performance status ≥ 90%, 77.3%; and visceral metastases, 21.1%. Estimated median rPFS by central review was 7.0 months (95% CI, 5.8 to 8.2 months) with tasquinimod and 4.4 months (95% CI, 3.5 to 5.5 months) with placebo (HR, 0.64; 95% CI, 0.54 to 0.75; P < .001). Median OS was 21.3 months (95% CI, 19.5 to 23.0 months) with tasquinimod and 24.0 months (95% CI, 21.4 to 26.9 months) with placebo (HR, 1.10; 95% CI, 0.94 to 1.28; P = .25). Grade ≥ 3 adverse events were more frequent with tasquinimod (42.8% v 33.6%), the most common being anemia, fatigue, and cancer pain. Conclusion In chemotherapy-naïve men with mCRPC, tasquinimod significantly improved rPFS compared with placebo. However, no OS benefit was observed.

Analysis of the PROCEED registry by baseline prostate-specific antigen (PSA) quartiles: Preliminary analysis of real-world sipuleucel-T (sip-T) use.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 193-193 ◽  
Author(s):  
Celestia S. Higano ◽  
Andrew J. Armstrong ◽  
Matthew R. Cooperberg ◽  
Raoul S. Concepcion ◽  
Ronald F. Tutrone ◽  
...  
Keyword(s):  
Real World ◽  
African American Men ◽  
Performance Status ◽  
Specific Antigen ◽  
Additional Patient ◽  
Cellular Immunotherapy ◽  
Castration Resistant Prostate Cancer ◽  
Prognostic Features ◽  
Radium 223 ◽  
Baseline Psa

193 Background: Sip-T is an FDA-approved, autologous cellular immunotherapy for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Post-hoc analysis of the phase 3 IMPACT study revealed that compared with the highest baseline PSA quartile, patients (pts) in the lowest quartile treated with sip-T had a larger overall survival (OS) benefit, suggesting sip-T is most beneficial if administered earlier in the treatment of mCRPC (Schellhammer et al., Urology. 2013.). This analysis evaluated pt characteristics by PSA quartiles in PROCEED (NCT01306890). Methods: Pts enrolled in PROCEED with baseline PSA and ≥ 1 sip-T infusion were included in this analysis. PSA values were divided into quartiles, and trends in baseline pt characteristics were evaluated as well as time to first anticancer intervention (tACI) with approved mCRPC therapies (docetaxel [D], cabazitaxel, abiraterone [abi], or enzalutamide [enz]) following sip-T treatment. Radium-223 was approved too late in the conduct of PROCEED to be included in the tACI analysis. Results: PSA quartiles from 1880 eligible PROCEED pts were lower than those of IMPACT (Table). Pts in the highest PROCEED quartile were older, more likely to have ECOG performance status ≥ 1, > 10 bone metastases, visceral metastases, and higher ALP and LDH, and lower hemoglobin compared with the lowest PROCEED quartile. More African American men and greater prior systemic therapy use were observed in the highest PSA quartile. Following sip-T, the median tACI (11.0, 8.2, 7.6, and 6.6 mos) was inversely proportional to PSA quartile. Conclusions: Lower baseline PSA values in PROCEED relative to IMPACT suggest that in a real-world setting, clinicians are using sip-T earlier in the treatment of mCRPC. Pts in the lowest PSA quartile had the best prognostic features and longest tACI. Additional patient follow-up is ongoing to evaluate OS and survival by quartile from PROCEED. Clinical trial information: NCT01306890. [Table: see text]

Interpreting survival outcomes for African-American (AA) patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with sipuleucel-T (SIP-T) with number needed to treat to benefit (NNTB).

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 222-222
Author(s):  
Kelvin A. Moses ◽  
Scott C. Flanders ◽  
Matthew Harmon ◽  
Nancy N. Chang ◽  
Walter Rayford ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Absolute Risk ◽  
Performance Status ◽  
Absolute Risk Reduction ◽  
Phase Iii ◽  
Cellular Immunotherapy ◽  
Number Needed To Treat ◽  
Castration Resistant Prostate Cancer ◽  
Kaplan Meier ◽  
Receive Treatment

222 Background: AA men often present with more aggressive prostate cancer and are less likely to receive treatment, negatively affecting quality-of-life and overall survival (OS). Sipuleucel-T is an autologous cellular immunotherapy approved for asymptomatic or minimally symptomatic mCRPC. Data from the PROCEED registry showed that OS for AA pts treated with SIP-T was 9.3 mo longer than OS for Caucasian pts. In a prior subgroup analysis of Phase III data, AA pts realized a 30.7-mo difference in OS with SIP-T vs. placebo (PBO). We calculated the NNTB to further interpret the OS benefit in AA pts. Methods: Data were pooled from 3 Phase III mCRPC SIP-T trials (D9901, D9902A, and IMPACT). The absolute risk reduction (ARR) is calculated from Kaplan-Meier estimates at 12-, 24-, and 36-mo for all SIP-T subjects, and an AA cohort, receiving ≥1 infusion. NNTB, the inverse of the ARR, represents the number of pts needed to be treated with SIP-T to prevent 1 additional death compared to PBO. All NNTB values are rounded up. Results: Of the 737 pooled mCRPC pts enrolled, 488 men were randomized to SIP-T (n=33 AA), and 249 to PBO. Baseline clinical characteristics between the SIP-T and PBO groups were well balanced; however, compared to overall SIP-T and PBO, AA SIP-T pts were more likely to have received prior chemotherapy, lower hemoglobin, and better performance status. The NNTB at 12-mo was the same (13) for both the pooled SIP-T and AA treated cohort. At 24-mo, the NNTB values were 10 for pooled and 5 for AA. At 36-mo, an NNTB of 8 (pooled) and 3 (AA) SIP-T treatments prevented 1 additional death (Table). Conclusions: This NNTB analysis shows a favorable survival benefit for AA men treated with SIP-T and all treated SIP-T subjects. NNTB values declined over 3-years, suggesting durability of clinical benefit with SIP-T, and that it may address a known survival disparity in AA with prostate cancer. Studies with larger sample sizes may confirm if AA pts derive a greater OS benefit from SIP-T. Clinical trial information: NCT00065442. [Table: see text]

scholarly journals Phase II Multicenter Study of Abiraterone Acetate Plus Prednisone Therapy in Patients With Docetaxel-Treated Castration-Resistant Prostate Cancer

2010 ◽  
Vol 28 (9) ◽  
pp. 1496-1501 ◽  
Author(s):  
Daniel C. Danila ◽  
Michael J. Morris ◽  
Johann S. de Bono ◽  
Charles J. Ryan ◽  
Samuel R. Denmeade ◽  
...  
Keyword(s):  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Specific Antigen ◽  
Circulating Tumor Cell ◽  
Abiraterone Acetate ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Ecog Performance Status ◽  
Castration Resistant

Purpose Persistence of ligand-mediated androgen receptor signaling has been documented in castration-resistant prostate cancers (CRPCs). Abiraterone acetate (AA) is a potent and selective inhibitor of CYP17, which is required for androgen biosynthesis in the testes, adrenal glands, and prostate tissue. This trial evaluated the efficacy and safety of AA in combination with prednisone to reduce the symptoms of secondary hyperaldosteronism that can occur with AA monotherapy. Patients and Methods Fifty-eight men with progressive metastatic CRPC who experienced treatment failure with docetaxel-based chemotherapy received AA (1,000 mg daily) with prednisone (5 mg twice daily). Twenty-seven (47%) patients had received prior ketoconazole. The primary outcome was ≥ 50% prostate-specific antigen (PSA) decline, with objective response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and changes in Eastern Cooperative Oncology Group (ECOG) performance status (PS) and circulating tumor cell (CTC) numbers. Safety was also evaluated. Results A ≥ 50% decline in PSA was confirmed in 22 (36%) patients, including 14 (45%) of 31 ketoconazole-naïve and seven (26%) of 27 ketoconazole-pretreated patients. Partial responses were seen in four (18%) of 22 patients with RECIST-evaluable target lesions. Improved ECOG PS was seen in 28% of patients. Median time to PSA progression was 169 days (95% CI, 82 to 200 days). CTC conversions with treatment from ≥ 5 to < 5 were noted in 10 (34%) of 29 patients. The majority of AA-related adverse events were grade 1 to 2, and no AA-related grade 4 events were seen. Conclusion AA plus prednisone was well tolerated, with encouraging antitumor activity in heavily pretreated CRPC patients. The incidence of mineralocorticoid-related toxicities (hypertension or hypokalemia) was reduced by adding low-dose prednisone. The combination of AA plus prednisone is recommended for phase III investigations.

Effect of prior abiraterone (ABI) or enzalutamide (ENZ) on sipuleucel-T (sip-T) manufacture in PROCEED patients (pts).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 185-185 ◽  
Author(s):  
Nicholas J. Vogelzang ◽  
Jeffrey L. Vacirca ◽  
Philip W. Kantoff ◽  
Mark C. Scholz ◽  
Shaker R. Dakhil ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Advanced Disease ◽  
Immune Monitoring ◽  
Cellular Immunotherapy ◽  
Castration Resistant Prostate Cancer ◽  
Cancer Treatments ◽  
Castration Resistant ◽  
Prostate Cancer Treatments ◽  
Ongoing Phase ◽  
Clinical Trial Information

185 Background: Sip-T is an autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). PROCEED is an ongoing phase 4 registry, enrolling pts receiving commercial sip-T. There are no exclusions based on prior prostate cancer treatments, so sip-T product parameters can be evaluated in pts receiving prior hormonal agents such as ABI or ENZ. Methods: Pts treated with sip-T within ≤6 mo were eligible to provide informed consent. Prior anticancer interventions were recorded at baseline. Sip-T product parameters were assessed. Results: Of 1,376 pts (as of May 2013), 108 (7.8%) received prior ABI and 58 (4.2%) received ENZ. Patients with ABI or ENZ generally had more advanced disease vs. pts without prior ABI or ENZ (WPT) and a greater proportion of the ABI and ENZ pts received prior docetaxel. There were slight differences in some sip-T product parameters in the ABI and ENZ groups, but neither manufacture nor receipt of sip-T were inhibited, as indicated by the percentage of pts with 3 successful infusions. All groups showed evidence of immune prime boost (Table). Conclusions: A subset of patients in PROCEED have received ABI or ENZ prior to sip-T. We observed no impact of prior ABI/ENZ on sip-t manufacturing or delivery, despite these men having more advanced disease. These results are consistent with prior analyses demonstrating a positive sip-T treatment immune effect in patients who have received prior therapies, including chemotherapy. Further immune monitoring and outcome studies are currently ongoing in the pre-docetaxel mCRPC setting where these agents will likely be used clinically. Clinical trial information: NCT01306890. [Table: see text]

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