scholarly journals Antigen Presenting Cell (APC) Activation in Sipuleucel-T: Is Activation Increased in Earlier Prostate Cancer Disease States?

2012 ◽  
Vol 23 ◽  
pp. ix311
Author(s):  
E.J. Small ◽  
J.D. Wesley ◽  
D.I. Quinn ◽  
C. Higano ◽  
D. Lin ◽  
...  
Author(s):  
Joshua Z Drago ◽  
Mithat Gönen ◽  
Gita Thanarajasingam ◽  
Chana A Sacks ◽  
Michael J Morris ◽  
...  

Abstract Background Safety is a central consideration when choosing between multiple medications with similar efficacy. We aimed to evaluate whether adverse event (AE) profiles of 3 such drugs in advanced prostate cancer could be distinguished based on published literature. Methods We assessed consistency in AE reporting, AE risk in placebo arms, and methodology used for risk estimates and quantification of statistical uncertainty in randomized placebo-controlled phase III trials of apalutamide, enzalutamide, and darolutamide in advanced prostate cancer. Results Seven included clinical trials enrolled a total of 9215 participants (range = 1051-1715 per trial) across 3 prostate cancer disease states. Within disease states, baseline patient characteristics appeared similar between trials. Of 54 distinct AE types in total, only 3 (fatigue, hypertension, and seizure) were reported by all 7 trials. Absolute risks of AEs in the placebo arms differed systematically and more than twofold between trials, which was associated with visit frequency and resulted in different degrees of uncertainty in AE profiles between trials. No trial used inferential methodology to quantify statistical uncertainty in AE risks, but 6 of 7 trials drew overall conclusions. Two trials concluded that there was no elevated AE risk because of the intervention, including the trial of darolutamide, which had the greatest statistical uncertainty. Conclusions Rigorous comparison of drug safety was precluded by heterogeneity in AE reporting, variation in AE risks in the placebo arms, and lack of inferential statistical methodology, underscoring considerable opportunities to improve how AE data are collected, analyzed, and interpreted in oncology trials.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 193-193
Author(s):  
R. D. Ennis ◽  
K. J. Clerkin ◽  
S. M. Cohen

193 Background: Androgen deprivation therapy (ADT) is a therapeutic approach for men with various prostate cancer disease states. Treatment related side effects of ADT include rapid bone loss. A large 2005 NEJM study found that the bone loss related to ADT leads to the development of fractures. Methods: This is a retrospective cohort study of patients treated with ADT in a radiation oncology (RDE) and medical oncology (SC) practice at an urban academic medical center from 1998-2010. Patients with evidence of bone metastases responsive to ADT were included. Those with androgen independent prostate cancer were excluded. Results: 130 patients met the criteria for inclusion and had the characteristics listed in the table. Among the 130 only 3 fractures occurred during 373 patient years of follow up, all within 5 months of ADT initiation. The fracture free survival (FFS) rate at 3 years for all was 97.7%. Excluding fractures occurring within 6 months of ADT initiation the FFS rate was 100% at 3 years. No significant difference was demonstrated in those screened with a pretreatment DEXA scan; there was no relationship between the number of AD cycles, recovery of testosterone to normal or total time on AD. Those with any baseline risk factor of osteoporosis had a trend to an increased risk of fractures (p=0.065); older patients, surprisingly, had a lower risk (p=0.054). Patients with normal BMD had a FFS of 93.8% at 3 yrs, osteopenic patients had 94.7%, and patients with osteoporosis and hormone responsive metastases had 100%. Conclusions: The prevalence of fracture among this group is significantly less than what has previously been reported for men receiving ADT, potentially suggesting an overstatement of risk. Further prospective study with a larger sample size is needed. [Table: see text] No significant financial relationships to disclose.


1992 ◽  
Vol 284 (4) ◽  
pp. 189-192 ◽  
Author(s):  
A. Cerny ◽  
S. Izui ◽  
J. -H. Saurat ◽  
F. A. Waldvogel ◽  
H. C. Morse ◽  
...  

2021 ◽  
Author(s):  
Jin Teng, Melody Chung ◽  
Chi Ming Laurence Lau ◽  
Ying Chau

Hydrogel presents as foreign material to the host and participates in immune responses which would skew the biofunctions of immunologic loads (antigen and adjuvants) for in-situ DC priming. This study...


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