1. This study examined the use of aprepitant to treat breakthrough chemotherapy-induced nausea and vomiting (CINV) in patients who were refractory to other antiemetics. The study analyzed retrospective data from 98 metastatic melanoma patients undergoing immunotherapy who received aprepitant after a cyclophosphamide preparative regimen.
2. The primary objective was to compare the number of emetic episodes in the 48 hours before and after aprepitant administration. The secondary objective was to compare use of PRN (as needed) antiemetics in the 48 hours before and after.
3. The results showed that aprepitant significantly reduced both the median number of emetic episodes by 1.5 and the median number
DIA China 2017 Optimizing Clinical Trials with Advanced ToolsE. Dennis Bashaw
This is the companion talk to one I posted yesterday. This is the Third of the talks that I gave in Asia back in May. Both this talk and the "Making Every Patient Count" presentation were part of a larger program at the DIA China Annual meeting.
Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This is the fourth talk that I gave in Asia back in May. It was presented at the Konect (Korea National Enterprise for Clinical Trials) 3rd symposia that was held in Seoul at Seoul National University.
Arjun Balar, MD, and Petros Grivas, MD, PhD, prepared useful practice aids pertaining to bladder cancer management for this CME activity titled "Keeping Pace With Immunotherapy Advances in Bladder Cancer: Tools for Winning the Race and Optimizing Patient Outcomes." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2GpacAq. CME credit will be available until December 30, 2019.
DIA China 2017 Optimizing Clinical Trials with Advanced ToolsE. Dennis Bashaw
This is the companion talk to one I posted yesterday. This is the Third of the talks that I gave in Asia back in May. Both this talk and the "Making Every Patient Count" presentation were part of a larger program at the DIA China Annual meeting.
Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This is the fourth talk that I gave in Asia back in May. It was presented at the Konect (Korea National Enterprise for Clinical Trials) 3rd symposia that was held in Seoul at Seoul National University.
Arjun Balar, MD, and Petros Grivas, MD, PhD, prepared useful practice aids pertaining to bladder cancer management for this CME activity titled "Keeping Pace With Immunotherapy Advances in Bladder Cancer: Tools for Winning the Race and Optimizing Patient Outcomes." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2GpacAq. CME credit will be available until December 30, 2019.
Presentatie van de Connections Roundtable Nederland. Een biojeenkomst voor en door IBM Connections gebruikers in Nederland.
De Roundtable wordt elk kwartaal georganiseerd door e-office en één van de users.
Op Lotus Greenhouse is een Community voor de Roundtable.
Adherence to treatment and quality of life during hepatitis C therapy:a prosp...Michel Rotily
Adherence to treatment and quality of life during hepatitis C therapy:a prospective, real-life, observational study by Patrick Marcellin, Michel Chousterman, Thierry Fontanges, Denis Ouzan, Michel Rotily, Marina Varastet,Jean-Philippe Lang, Pascal Melin and Patrice Cacoub, for the CheObs Study Group published in Liver Int 2011
Poster Presentation Title: A Phase 1 clinical trial of a therapeutic prostate cancer vaccine containing PSA/IL-2/GM-CSF in PSA defined biochemical recurrent prostate cancer patients
Meeting: CRI-CIMT-EATI-AACR: Inaugural International Cancer Immunotherapy Conference: Translating Science Into Survival
Immunotherapy for cancer has had two main approaches that have lead to clinical applications. The first is stimulating immune responses to tumor cells with cytokines or cellular immunotherapy and the second is blocking tumor immune evasion and the associated inhibition of T-cell activation with antibodies to the CTLA-4 receptor, PD-1 receptor or PD-L1. At OncBioMune, we have taken a different approach and have developed therapeutic cancer vaccines that are a combination of tumor antigens (whole cells or proteins) with biological adjuvants (the cytokines IL-2 and GM-CSF). This study is a Phase 1a/1b clinical trial of a PSA/IL-2/GM-CSF vaccine in recurrent prostate cancer in hormone-naïve and hormone-independent patients. Major inclusion criteria include adenocarcinoma of the prostate, rising serum PSA and no measurable disease. Phase 1a examines the rate of dose limiting adverse events (DLAEs) in an initial course of 6 vaccinations (“induction vaccination”). The Phase 1b examines the rate of DLAEs with a continued coarse of an additional 6 vaccinations (“maintenance vaccine”). All patients will receive intradermal injections of the PSA/IL-2/GM-CSF vaccine at weeks 1, 2, 3, 7, 11, and 15. In an additional 28 patients the six maintenance vaccines will alternate IL-2 and the complete vaccine (PSA/IL-2/GM-CSF) at weeks 23, 27, 31, 35, 39 and 43. To date, twelve of twenty patients in the Phase 1a portion of the trial have received at least one vaccine injection and ten patients have received all 6 vaccines. Seven of the ten patients that have received 3 vaccines had increased responses to PSA in a lymphocyte blastogenesis assay and five of the nine patients had an increase in their response after 6 vaccines. None of the patients vaccinated in the Phase 1a portion have had a DLAE and enrollment continues in the Phase 1a.
Nik Nuradlina N.A,Mohd Syamir M. S. ,Noor Nashreen M.S.,Rozita M.
Pharmacy Department, National Cancer Institute, Putrajaya.
1st Clinical Audit Pharmacy Department
Acp guidelines for pharmacists ordering lab tests and using laboratory data ...
Aprepitantposter_final
1. Matthew Cummings1, Daniel Zlott, PharmD, BCOP2
National Institutes of Health Clinical Center Pharmacy Department, Bethesda, MD
1University of California San Francisco; 2National Institutes of Health
Purpose
1. To determine, using retrospective data in the NIH Clinical Center
database, whether patients who are refractory to other antiemetics
receive clinical benefit from off-label administration of aprepitant for
breakthrough chemotherapy-induced nausea and vomiting (CINV).
2. To determine the extent of nausea before and after aprepitant
administration by using surrogate markers such as number of
emetic episodes and use of other PRN (as needed) breakthrough
medications.
3. To determine if a more robust prospective study of aprepitant
treatment for breakthrough CINV is warranted.
Methods
Retrospective data was collected from the NIH Clinical Center CRIS
database on metastatic melanoma patients undergoing experimental
immunotherapy in trials between August 2007 and May 2015.
Primary Objective
Compare the difference in emetic episodes 48 hours before and 48
hours after aprepitant administration.
Secondary Objective
Compare the difference in PRN (as needed) antiemetic use 48 hours
before and 48 hours after aprepitant administration.
Inclusion Criteria
1. Received a preparative regimen with cyclophosphamide
60mg/kg/day x2 days
2. Aprepitant given >24 hours after the end of last
cyclophosphamide dose
3. Enrolled in an Adoptive Cell Transfer (ACT) protocol at the
National Cancer Institute
Exclusion Criteria
1. Scheduled anti-emetics given within 12 hours prior to aprepitant
dosing
2. Patients for whom data was incomplete
Conclusions
1. Aprepitant is effective at reducing emetic episodes following a
highly emetogenic preparative regimen with cyclophosphamide in
patients with metastatic melanoma.
2. Administering aprepitant reduced patient reliance on other PRN
antiemetics for at least 48 hours after cylcophosphamide.
3. These results strongly support the need for a prospective
randomized controlled trial to determine the efficacy of aprepitant in
this setting.
Disclosures: The authors have no disclosures to report.
Aprepitant as treatment for delayed-onset chemotherapy-induced nausea and
vomiting following a preparative cyclophosphamide regimen
Figure 3 Aprepitant Administration. Chemotherapy schedule and
administration frequency of aprepitant throughout study period.
Statistics
A Wilcoxon Signed-Rank test was used to analyze the primary and secondary
objectives. Non-responders were defined as patients who received scheduled
anti-emetics beginning within 48 hours after aprepitant dosing, or patients who
did not meet a predefined response of 50% reduction in emetic episodes.
Table 1 Response to aprepitant treatment. Total patients administered
aprepitant in the study period, patients excluded, “non-responders” , and
response percentage.
Total
patients
Exclusions Non-
responders
Responders Response %
98 18 20 60 66.6%
2-045
Emetic Episodes PostEmetic Episodes Pre
2.0
1.5
1.0
0.5
0.0
NumberofEpisodes
Number of Emetic Episodes Pre- and Post-Aprepitant Administration
95% CI for the Mean
Grey bars = Median
Blue brackets = 95% CI
PRN Administrations PostPRN Administrations Pre
7
6
5
4
3
2
1
0
NumberofPRNAdministrations
Number of PRN Antiemetics Pre- and Post-Aprepitant Administration
95% CI for the Mean
Grey bars = Median
Blue brackets = 95% CI
Results
Secondary Outcome
The median reduction in PRN
antiemetic use was 2.5
administrations per patient
(95% CI 1.5-3.0; P<0.001).
Primary Outcome
The median reduction in emetic
episodes was 1.5 episodes per
patient (95% CI 1.00-1.5; P
<0.001).
Figure 1 Primary Outcome. Median number of emetic episodes (grey bar) pre- and
post-aprepitant administration with 95% confidence interval (blue bracket).
Figure 2 Secondary Outcome. Median number of PRN antiemetic administrations (grey
bar) pre- and post aprepitant administration with 95% confidence interval (blue bracket).