Changes in the stress markers cortisol and glucose before and during intradermal testing in cats after single administration of pre-appointment gabapentin

2019 ◽  
Vol 22 (2) ◽  
pp. 138-145 ◽  
Author(s):  
Christopher P Hudec ◽  
Craig E Griffin
Keyword(s):  
Blood Sample ◽  
Primary Objective ◽  
Intradermal Test ◽  
Intradermal Testing ◽  
Stress Markers ◽  
Negative Effect ◽  
Mean Glucose ◽  
To Receive ◽  
Privately Owned ◽  
Assessment Of Stress

Objectives Intradermal allergy testing can be difficult to interpret in cats. Studies have shown that intradermal testing leads to elevations in blood cortisol, which may be an explanation for weak wheal reactions in cats. The primary objective of this study was to determine whether utilizing pre-appointment gabapentin will alter stress before and during intradermal testing, as determined by cortisol/glucose concentrations. Methods This was a randomized, single-blinded, crossover clinical trial of 16  privately owned healthy cats. Cats were scheduled two veterinary visits and randomly assigned to receive either gabapentin (25.0–30.5 mg/kg) or no treatment prior to the first visit and the opposite treatment prior to the second visit. Blood samples were obtained to measure cortisol/glucose concentrations at three time points: directly after physical examination; directly after sedation; and 10 mins after the second blood sample. A limited intradermal test was performed after the second blood sample. The primary author also recorded which visit they believed gabapentin was administered with low/high confidence. A non-blinded owner assessment survey documenting stress levels in their cats was also obtained. Results Mean cortisol concentrations were calculated to be 0.30 μg/dl lower in the gabapentin group but this reduction was not significant. Mean glucose concentrations were calculated to be 18 mg/dl higher in the gabapentin group. Gabapentin had no negative effect on intradermal histamine readings. The author was able to correctly identify when 14/16 cats received gabapentin. Non-blinded owners (n = 14/16) believed their cats were less stressed when gabapentin was administered. Conclusions and relevance Gabapentin did not significantly decrease cortisol/glucose concentrations. A sedative effect, rather than suppression of the pituitary–adrenocortical axis, may have led to the lower stress assessment. It is unlikely that pre-appointment gabapentin will alter intradermal testing in a majority of cats. This study supports recent clinical trials demonstrating that administration of gabapentin can lower veterinarian/owner assessment of stress in cats.

Linking fish and crustacean taxonomic composition with seasonal contrasts in the soft-bottom intertidal zone

2020 ◽  
Author(s):  
M. A. Gondal ◽  
S. Iqbal ◽  
U. Atique ◽  
N. U. Saher ◽  
N. A. Qureshi ◽  
...  
Keyword(s):  
Species Richness ◽  
Water Temperature ◽  
Fish Species ◽  
Diversity Index ◽  
Taxonomic Composition ◽  
Primary Objective ◽  
Negative Effect ◽  
Fish Species Composition ◽  
One Year ◽  
Sw Monsoon

Abstract The primary objective of this study was to investigate the seasonal fish and crustacean variations concerning taxonomic composition, species richness, and diversity in sandy beach habitat. For this purpose, we investigated the Sonmiani Hor lagoon area during four distinct seasons, i.e., northeast (NE) monsoon, pre-monsoon, south-west (SW) monsoon, and post-monsoon for one year. During each haul, the net was pulled about 100m along the beach in 0.5m depth. The results showed a strong linear correlation between the diversity index and equitability in fishes (r = 0.978). The diversity index was strong negatively correlated with the abundance and biomass (r = -0.978, -0.972, respectively). The physical attributes like sea surface water temperature and salinity showed a strong negative effect on species assemblages (r = -0.981 and -0.943, respectively). The mean air and water temperature illustrated approximately 3°C difference during NE and pre-monsoon seasons. However, salinity, pH, and electrical conductivity did not show any significant seasonal variabilities. Under the ecological indices, the fish species displayed higher diversity (H’ = 3.19) during SW monsoon, whereas the lowest diversity was observed during pre-monsoon (H’ = 1.58). The equitability and species richness, however, remained more noticeable during SW monsoon (J’ = 0.81). The total number of individuals of fish and crustaceans reached 4799 with 3813 fish individuals and 986 individuals of crustaceans. A total of 27 families of fish while five crustacean families comprising of 30 genera and 38 fish species while ten genera and 17 species of crustaceans were recorded. Liza subviridis displayed the highest abundance among the sampled fish species. In conclusion, fish species constituted a significant part of the coastal fauna in the study area. The seasonal variations displayed distinct variations in fish species composition and diversity.

scholarly journals GUIDELINES FOR DESIGNING SAND NOURISHMENT ON LOW TO VERY EXPOSED COASTS

2020 ◽  
pp. 5
Author(s):  
Henrik Vinge Karlsson ◽  
Britt Gadesboll Larsen ◽  
Per Sorensen
Keyword(s):  
Natural Variation ◽  
Primary Objective ◽  
Coastal Protection ◽  
Special Focus ◽  
Protection Scheme ◽  
Coastal Cliff ◽  
Sand Nourishment ◽  
The Impact ◽  
Privately Owned ◽  
Insight Into

Danish law establishes a common right of passage on foot along the Danish shoreline, even though beaches are often privately owned. The law also states that coastal protection must not hinder this. Therefore, sand nourishment should be part of every coastal protection scheme against erosion. Sand nourishments can be designed in numerous ways depending on their objectives. As part of the European Interreg project, Building With Nature (BWN), guidelines will be developed by the Danish Coastal Authority (DCA) in end-2020. This abstract presents these guidelines with special focus on the coasts of Denmark. Special emphasis will be on insight into the natural variation of the coasts, as this is vital both when designing effective coastal protection schemes and when evaluating the impact of the nourishment. In this project, the pathway along which sediment is being transported spans from offshore at the outer bar to the coastal cliff. The aim is to be able to determine the along- and cross-shore paths, along which the nourishment sand is transported, the diffusion velocity of the nourishment and the impact on the surrounding coasts. Based on the results of the multiple analysis, the primary objective is to produce guidelines on how to use sand nourishment to counteract erosion in a sustainable and socioeconomic way.Recorded Presentation from the vICCE (YouTube Link): https://youtu.be/nIrFFmH98V8

Abstract 21: Are Stroke Outcomes Influenced by New Starting Residents? The July Effect: Myth or Reality?

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Tai Hwan Park ◽  
Jitphapa Pongmoragot ◽  
Shudong Li ◽  
Gustavo Saposnik ◽  
Keyword(s):  
Functional Outcome ◽  
Performance Measures ◽  
Stroke Care ◽  
Teaching Hospitals ◽  
Stroke Severity ◽  
Acute Stroke Care ◽  
Stroke Outcomes ◽  
July Effect ◽  
Negative Effect ◽  
To Receive

Background: Acute stroke care provided by comprehensive stroke centers usually follows prespecified protocols. However, there are concerns about lower quality of care and poorer stroke outcomes early after new trainnees (e.g.) residents start in July in academic/teaching hospitals. This has been called ‘the July effect’. Objective: To evaluate access to specialized care and outcomes among patients admitted with an acute ischemic stroke (AIS) in July and other months. Hypothesis: We hypothesized that there were no significant differences in access to stroke care and outcomes for patients admitted in July when new trainees start at academic centers. Methods: Patients presenting with an AIS at 11 stroke centers in Ontario, Canada, between 2003 and 2009 were identified from the Registry of the Canadian Stroke Network. We compared performance measures and functional outcomes (death at 30 days, modified Rankin Scale 3 to 5 at discharge) between AIS patients admitted in July of each studied year and those who admitted during other months. Results: Of 10,319 eligible patients with an AIS, 882 (8.5%) were admitted in July. There was not difference in age, sex, or baseline stroke severity between patients admitted in July or other months. Among the performance measures analyzed, AIS admitted in July were less likely to receive thrombolysis (12.1% vs. 16.0%, p=0.002), swallowing test (64.4% vs. 67.9%, p=0.033), and admission to stroke unit (61.9% vs. 67.6%, <0.001). There was no difference in death at 30-days (16.4% vs. 16.1%, p=0.823) or poor functional outcome (61.0% vs. 63.5%, p=0.14) between two groups (Table). Conclusion: AIS patients admitted in July were less likely to receive thrombolysis and be admitted to stroke units compared to patients admitted on the rest of the year. However, there was no negative effect of “admission on July” on functional outcome or death.

scholarly journals Three-dimensional analysis of the physiologic drift of adjacent teeth following maxillary first premolar extractions

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Fei Teng ◽  
Fei-Yu Du ◽  
Hui-Zhong Chen ◽  
Ruo-Ping Jiang ◽  
Tian-Min Xu
Keyword(s):  
Three Dimensional ◽  
Posterior Teeth ◽  
Fixed Appliance ◽  
Premolar Extraction ◽  
Negative Effect ◽  
Vertical Changes ◽  
Anchorage Loss ◽  
Drift Models ◽  
To Receive ◽  
Positive Effect

Abstract We assessed the three-dimensional (3D) pattern of the physiologic drift of the remaining adjacent teeth after premolar extraction due to orthodontic reasons and the associated factors. Data were collected from 45 patients aged 17.04 ± 5.14 years who were scheduled to receive a fixed appliance after maxillary premolar extraction. Seventy-five drift models were obtained and digitalized via 3D scanning. The average physiologic drift duration was 81.66 ± 70.03 days. Angular and linear changes in the first molars, second premolars, and canines were measured using the 3D method. All the examined teeth had tipped and moved towards the extraction space, leading to space decreases. Posterior teeth primarily exhibited significant mesial tipping and displacement, without rotation or vertical changes. All canine variables changed, including distal inward rotation and extrusion. The physiologic drift tended to slow over time. Age had a limited negative effect on the mesial drift of posterior teeth, whereas crowding had a limited positive effect on canine drift. Thus, the mesial drift of molars after premolar extraction may lead to molar anchorage loss, particularly among younger patients. The pattern of the physiologic drift of maxillary canines can help relieve crowding and facilitate labially ectopic canine alignment, whereas canine drift is accelerated by more severe crowding.

Retrospective Analysis of Clinical Outcomes Associated With the Use of Pegfilgrastim On-body Injector in Patients Receiving Chemotherapy Requiring Granulocyte Colony-Stimulating Factor Support

2019 ◽  
pp. 001857871986765 ◽  
Author(s):  
Jolly Patel ◽  
Rebecca Ann Rainess ◽  
Miranda J. Benfield ◽  
Kate M. L. Rogers ◽  
Donald C. Moore ◽  
...  
Keyword(s):  
Failure Rate ◽  
Primary Prophylaxis ◽  
Primary Objective ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Device Failure ◽  
Patients With Cancer ◽  
Electronic Chart ◽  
To Receive ◽  
Stimulating Factor

Objectives: Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) used as primary prophylaxis in patients receiving myelosuppressive chemotherapy regimens that have greater than 20% risk of developing febrile neutropenia (FN). Historically, pegfilgrastim has been administered 24 to 72 hours after chemotherapy, necessitating a return to clinic to receive the provider-administered injection. An alternative option is the pegfilgrastim on-body injector (OBI). With the OBI device, patients have their pegfilgrastim administered 27 hours after receiving chemotherapy while remaining at home, avoiding an additional clinic appointment. Concerns with pegfilgrastim OBI include lack of experience with the device in both the patient and provider, device-related failures, and the success of delivery. This study evaluates pegfilgrastim OBI failure rates through associated patient outcomes among cancer patients receiving chemotherapy requiring G-CSF. Methods: A retrospective electronic chart review was conducted of adult patients with cancer who received chemotherapy and pegfilgrastim OBI from July 1, 2016, to July 31, 2018. The primary objective of this study was the incidence of FN in patients receiving pegfilgrastim OBI. Results: There were no reported cases of hospitalization due to FN in patients who received pegfilgrastim OBI. Dose delays and dosage modifications were not observed in our review. The OBI device failure rate was found to be low (1.92%). Conclusion: The low device failure rate from this study suggests that the OBI is a viable option for administration of pegfilgrastim in patients receiving chemotherapy requiring G-CSF.

scholarly journals Sexual Function during Bupropion or Paroxetine Treatment of Major Depressive Disorder

2006 ◽  
Vol 51 (4) ◽  
pp. 234-242 ◽  
Author(s):  
Sidney H Kennedy ◽  
Kari A Fulton ◽  
R Michael Bagby ◽  
Andrea L Greene ◽  
Nicole L Cohen ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Sexual Function ◽  
Rating Scale ◽  
Primary Objective ◽  
Major Depressive ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive ◽  
Over Time

Objective: The primary objective was to evaluate sexual function (SF) separately in men and women with major depressive disorder (MDD) before and during treatment with bupropion sustained release (SR) or paroxetine. The secondary objectives involved a comparative evaluation of the Sex Effects Scale (Sex FX) and the Investigator-Rated Sexual Desire and Functioning Scale (IRSD-F), as well as a comparison of antidepressant outcomes and an examination of the relation between level of depression and SF over time. Method: There were 141 patients (68 women and 73 men) who met DSM-IV criteria for a current major depressive episode. They were randomly assigned to receive bupropion SR (150 to 300 mg daily) or paroxetine (20 to 40 mg daily) under double-blind trial conditions. Patients were assessed at baseline and at 2, 4, 6, and 8 weeks with the 17-item Hamilton Depression Rating Scale (HDRS17), Sex FX, and IRSD-F. Results: Prior to treatment, women reported significantly lower SF on both the Sex FX and IRSD-F scales, compared with men. During treatment, there were no significant drug differences on measures of SF over time for women; however, men who were treated with paroxetine reported a worsening of SF, whereas bupropion SR did not significantly alter SF. Both bupropion SR and paroxetine produced clinically and statistically significant reductions in HDRS17 scores as well as comparable rates of response and remission. There was a statistically significant correlation between the 2 measures of SF at all visits. There was also a significant inverse relation between depression and SF in women, but not in men, irrespective of drug. Conclusion: According to the Sex FX scale, a significant difference in antidepressant-related sexual dysfunction was detected in men, but not women, during treatment with bupropion SR or paroxetine.

Vandetanib plus mFOLFOX6 in patients with advanced colorectal cancer (CRC): A randomized, double-blind, placebo-controlled phase II study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4084-4084
Author(s):  
T. S. Yang ◽  
D. Y. Oh ◽  
R. Guimbaud ◽  
J. Szanto ◽  
T. Salek ◽  
...  
Keyword(s):  
Tyrosine Kinases ◽  
Day Treatment ◽  
Sensory Neuropathy ◽  
Primary Objective ◽  
Double Blind ◽  
Once Daily ◽  
Assessment Visit ◽  
Number Of Patients ◽  
Peripheral Sensory ◽  
To Receive

4084 Background: Vandetanib is a once-daily oral agent that selectively targets key signaling pathways in cancer by inhibiting VEGF, EGF and RET receptor tyrosine kinases. Methods: Eligible patients with advanced CRC and who had previously progressed after an irinotecan- and fluoropyrimidine-containing regimen were randomized 1:1:1 to receive once-daily oral vandetanib (100 or 300 mg) + modified FOLFOX6 (mFOLFOX6) or placebo + mFOLFOX6; mFOLFOX6 was given as standard 14-day treatment cycles (oxaliplatin 85 mg/m2 2-hr and leucovorin 400 mg/m2 2-hr i.v. infusions, followed by 5- fluorouracil [5-FU] 400 mg/mg2 i.v. bolus and 5-FU 2400 mg/m2 46-hr i.v. infusion). The primary objective was to compare the number of patients with a progression event on or before a mandatory tumor assessment visit at data cut-off (∼4 months after last patient randomized). A progression event was defined as the earliest of objective and/or clinical disease progression, or death from any cause. Results: Between March and November 2007, 104 patients (aged 32–81 years) were randomized to receive study treatment ( Table ). At data cut-off on 8 March 2008, there was a greater % of progression events in the vandetanib 100 mg arm compared with placebo (72% [n=23] versus 65% [n=24]; HR=1.21, 2-sided 80% CI 0.82–1.80; 2-sided P=0.53), and also in the vandetanib 300 mg arm compared with placebo (77% [n=27] versus 65% [n=24]; HR=1.41, 2-sided 80% CI 0.96–2.07; 2-sided P=0.25). All except one patient in each group experienced an adverse event (AE) during the study with diarrhea, nausea, thrombocytopenia, and peripheral sensory neuropathy the most commonly reported AEs ( Table ). Neutropenia was the only CTC grade 4 AE to occur in >1 patient in any group (n=2, vandetanib 100 mg arm; n=0, vandetanib 300 mg arm; n=3, placebo arm). Conclusions: In this study of patients with advanced, previously treated CRC, there was no efficacy benefit for vandetanib (100 or 300 mg) + mFOLFOX6 versus placebo + mFOLFOX6. [Table: see text] [Table: see text]

Vandetanib versus erlotinib in patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior cytotoxic chemotherapy: A randomized, double-blind phase III trial (ZEST)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 8009-8009
Author(s):  
R. B. Natale ◽  
S. Thongprasert ◽  
F. A. Greco ◽  
M. Thomas ◽  
C. M. Tsai ◽  
...  
Keyword(s):  
Objective Response ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Phase Iii ◽  
Double Blind ◽  
Equivalent Efficacy ◽  
Secondary Endpoints ◽  
Previously Treated ◽  
Grade 3 ◽  
To Receive

8009 Background: Vandetanib is a once-daily oral inhibitor of VEGFR, EGFR and RET signaling. This phase III study compared the efficacy of vandetanib vs erlotinib in patients (pts) with advanced, previously treated NSCLC. Methods: Eligible pts (stage IIIB/IV NSCLC, PS 0–2, 1–2 prior chemotherapies; all histologies permitted) were randomized 1:1 to receive vandetanib 300 mg/day or erlotinib 150 mg/day until progression/toxicity. The primary objective was to show superiority in progression-free survival (PFS) for vandetanib vs erlotinib. Secondary endpoints included overall survival (OS), objective response rate (ORR), time to deterioration of symptoms (TDS; EORTC QoL Questionnaire) and safety. Results: Between Oct 06-Nov 07, 1240 pts (mean age 61 yrs; 38% female; 22% squamous) were randomized to receive vandetanib (n=623) or erlotinib (n=617). Baseline characteristics were similar in both arms. Median duration of follow-up was 14 months, with 88% pts progressed and 67% dead. There was no difference in PFS for pts treated with vandetanib vs erlotinib (hazard ratio [HR] 0.98, 95.22% CI 0.87–1.10; P=0.721), and no difference in the secondary endpoints of OS (HR 1.01, 95.08% CI 0.89–1.16; P=0.830), ORR (both 12%) and TDS (pain: HR 0.92, P=0.289; dyspnea: HR 1.07, P=0.407; cough: HR 0.94, P=0.455). A preplanned non-inferiority analysis for PFS and OS demonstrated equivalent efficacy for vandetanib and erlotinib. The adverse events (AEs) observed for vandetanib were generally consistent with previous NSCLC studies with vandetanib 300 mg. There was a higher incidence of some AEs (any grade) with vandetanib vs erlotinib, including diarrhea (50% vs 38%) and hypertension (16% vs 2%); rash was more frequent with erlotinib (38% vs 28%). The overall incidence of CTCAE grade ≥3 AEs was also higher with vandetanib (50% vs 40%). The incidence of protocol-defined QTc prolongation in the vandetanib arm was 5%. Conclusions: The study did not meet its primary objective of demonstrating PFS prolongation with vandetanib vs erlotinib in pts with previously treated advanced NSCLC. However, vandetanib and erlotinib showed equivalent efficacy for PFS and OS in a preplanned non-inferiority analysis. [Table: see text]

TARIBO trial: Cytoreductive nephrectomy in metastatic renal cell carcinoma patients treated with targeted agents.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS4601-TPS4601
Author(s):  
Paolo Grassi ◽  
Elena Verzoni ◽  
Alessandra Bearz ◽  
Sergio Bracarda ◽  
Marco Bregni ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Clinical Benefit ◽  
Renal Cell ◽  
Primary Objective ◽  
Phase Iii ◽  
Rank Test ◽  
Cytoreductive Nephrectomy ◽  
To Receive

TPS4601 Background: In the cytokine era cytoreductive nephrectomy (CN) has been shown to increase survival in patients (pts) with metastatic renal cell carcinoma (mRCC). Efficacy of tyrosine kinase inhibitors (TKIs), including first-line sunitinib and pazopanib has been demonstrated. It is unclear if similar survival benefit could be achieved without CN with TKIs since most of pts enrolled into phase III trials had undergone CN. Methods: A total of 270 mRCC pts will be randomized to receiveCN followed by TKIs vs upfront TKIs without CN. Patients will receive pazopanib 800 mg orally daily or sunitinib 50 mg daily, 4 weeks on/ 2 weeks off. The choice of TKI will be done according to investigator’s clinical practice. Primary objective: to compare clinical benefit, as measured by overall survival (OS), provided by CN followed by TKIs vs upfront TKIs in pts with mRCC. Secondary objectives: i) to compare clinical benefit, as measured by progression-free survival (PFS) and response rate (RR) provided by CN followed by TKIs vs upfront TKIs; ii) Safety; iii) Exploratory analyses: evaluation of the predictive role of circulating tumor cells count and circulating tumor DNA at baseline, before and after surgery (in pts undergoing CN), 24 weeks after randomization and at the time of disease progression. Key inclusion criteria: Favorable or intermediate MSKCC or Heng prognostic risk group; histological diagnosis of RCC with a clear-cell component; resectable asymptomatic mRCC with primary tumor in place; up to three different metastatic sites; ≥ 3 metastatic lesions. Key exclusion criteria: Widespread disease ( > or = 4 metastatic organ sites); disease suitable of metastasectomy ( < 3 lesions confined at one organ site). Statistical plan: The sample size was calculated in order to compare 5-year OS between subjects randomized to receive CN followed by TKIs and those randomized to receive upfront TKIs. A total of 191 deaths will yield 80% power to detect a hazard ratio of 1.5 of upfront TKIs vs CN followed by TKIs with an overall type 1 error of 0.05 (two-sided log-rank test). Such a HR corresponds to an increase in the 5-year OS, from an anticipated value of 10% for TKIs to 21.5% for CN followed by TKIs. To date 10/270 pts have been enrolled. Clinical trial information: NCT02535351.

Results from a phase 2b, randomized, multicenter study of GVAX pancreas and CRS-207 compared to chemotherapy in adults with previously-treated metastatic pancreatic adenocarcinoma (ECLIPSE Study).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 345-345 ◽  
Author(s):  
Dung T. Le ◽  
Andrew H. Ko ◽  
Zev A. Wainberg ◽  
Vincent J. Picozzi ◽  
Hedy L. Kindler ◽  
...  
Keyword(s):  
Single Agent ◽  
Dropout Rate ◽  
Primary Objective ◽  
Gm Csf ◽  
Pancreatic Cancer Cells ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Phase 2 Study ◽  
High Dropout Rate ◽  
Previously Treated ◽  
To Receive

345 Background: GVAX is composed of irradiated, allogeneic pancreatic cancer cells modified to express GM-CSF and induce broad tumor antigen responses. Low-dose cyclophosphamide (CY) is administered with GVAX to inhibit regulatory T cells. CRS-207 is live, attenuated, double-deleted Listeria monocytogenes(LADD) engineered to express mesothelin. CRS-207 boosts T cell responses against mesothelin and stimulates innate and adaptive immunity. In an earlier Phase 2 study in patients with mPDA, CY/GVAX + CRS-207 resulted in a significant improvement in overall survival (OS) compared to CY/GVAX alone. Methods: Patients with previously-treated mPDA were randomized 1:1:1 to receive 2 doses of CY/GVAX + 4 doses of CRS-207 (Arm A), 6 doses of CRS-207 alone (Arm B), or physician’s choice of single-agent chemotherapy (Arm C). Two cohorts were included based on number of prior lines of therapy; the primary cohort (PC) represented those with ≥ 2 prior lines. The primary objective was to compare OS between Arms A and C in the PC. Additional objectives include OS analyses between all treatment arms, safety, tumor responses and immune analyses. Results: 303 patients were enrolled: 213 in the PC and 90 in an exploratory 2nd-line cohort (SC). Common AEs associated with CRS-207 treatment included transient fevers, chills, and nausea. High dropout rates were observed in Arm C prior to treatment (40% in PC, 63% in SC). Clinical trial information: NCT02004262 . Subset and immune analyses, as well as OS data from SC, will be presented at the meeting. Conclusions: The combination of CY/GVAX + CRS-207 did not show a survival benefit over chemotherapy in patients with previously-treated mPDA, although survival of patients receiving CRS-207 alone appeared similar to chemotherapy. The regimens were well tolerated with no new significant safety findings. The high dropout rate in the chemotherapy arm demonstrates a potential challenge for conventional controls in immunotherapy trials. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document