BiovaxID Vaccine Therapy of Follicular Lymphoma in First Remission: Phase III Blinded Safety Update.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4500-4500 ◽  
Author(s):  
Angelos M. Stergiou ◽  
Sattva S. Neelapu ◽  
Roman Casciano ◽  
Margo A. Jaffee ◽  
Larry W. Kwak
Keyword(s):  
Chest Pain ◽  
Follicular Lymphoma ◽  
Safety Profile ◽  
Safety Data ◽  
Phase Iii ◽  
Phase 2 ◽  
Phase 3 ◽  
The Impact ◽  
To Receive

Abstract Background: A previous single-arm Phase 2 study (Nature Med5:1171–7,1999), evaluated the ability of tumor-specific idiotype (ID) conjugated to keyhole limpet hemocyanin (KLH) administered with granulocyte-monocyte colony-stimulating factor - GM-CSF (BiovaxID vaccine) to induce complete remission (CR) and molecular remission (MR) in follicular NHL patients in first CR after chemotherapy. We reported (ASH 2005, Abstr 2441) that at 9.2 years follow-up, disease free survival (DFS) and overall survival (OS) were 45% and 95%, respectively; median DFS was 8.0 years. To date, there have been no additional reported mortalities in this cohort. Although these data are promising, improvements in the treatments and increasing survival for patients with follicular lymphoma have necessitated additional rigor in the evaluation of overall safety and overall risk-benefit. The ongoing Phase 3 study that opened in 2000 by the NCI is designed to evaluate the impact of this vaccine on DFS in previously untreated subjects who have attained CR/Cru. As of August 2007, 231 subjects have been enrolled to receive chemotherapy and 176 have been randomized to receive vaccine (ID-KLH or KLH-KLH). Methods: Since Phase 3 trial inception in 2000, SAEs have been reported through a pharmacoviligance group and identified according to time period on the study (i.e. during chemotherapy, during vaccine, after vaccine, or unknown), causality, and relatedness to study agent. Results: As of August 2007, 32 SAEs have been reported in the BV301 trial, 7 of which occurred during the vaccination segment of the study. At a blinded interim analysis of the Phase 3 safety data, of the 7 SAEs reported during the vaccine segment of the study, 3 are considered unlikely to be related to the study agent (chest pain, compression fracture, herpes zoster), 2 possibly related (arrhythmia supraventricular, chest pain), 1 unrelated (vomiting), and 1 unknown (febrile neutropenia). The 1 SAE, cerebral ischaemia, that occurred post vaccine is considered unrelated to the study agent. Conclusions: Additional follow-up on the Phase 2 patients is needed, as well as similar analyses in other cohorts. Blinded Phase 3 safety data shows a positive safety profile for BiovaxID. Unblinded safety data will be needed to determine the final efficacy and safety profile.

Impact of PSMA PET/CT on SRT planning: Preliminary results from the randomized phase III trial NCT03582774.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 30-30
Author(s):  
Jeremie Calais ◽  
Wesley R Armstrong ◽  
Amar Upadhyaya Kishan ◽  
Kiara M Booker ◽  
David Elashoff ◽  
...  
Keyword(s):  
Success Rate ◽  
Phase Iii ◽  
Open Label ◽  
Phase 3 ◽  
Preliminary Results ◽  
Volume Delineation ◽  
Psma Pet ◽  
Pet Ct ◽  
The Impact

30 Background: The purpose of this trial is to evaluate the success rate of salvage radiation therapy (SRT) for recurrence of prostate cancer (PCa) after radical prostatectomy with and without planning based on prostate specific membrane antigen (PSMA) positron emission tomography (PET). Methods: This is a multicenter, prospective, randomized, controlled, open-label, Phase 3 clinical imaging trial powered for clinical outcome at 5 years. UCLA is the leading central site in which PSMA PET, clinical follow-up and data management are being done. UCSF was a participating site in which PSMA PET imaging can be done. SRT can be performed anywhere, patients are followed remotely by the UCLA investigators. Patients scheduled for SRT for recurrence after primary prostatectomy and with PSA ≥ 0.1ng/ml at time of enrollment were eligible. Patients were randomized to proceed with standard SRT allowing for any conventional imaging aside from PSMA PET/CT (control arm) or undergo a 68Ga-PSMA-11 PET/CT scan prior to SRT planning (investigational arm). The primary endpoint is the success rate of SRT at 5 years in patients who undergo SRT. We report here the preliminary results of a secondary endpoint: the impact of PSMA PET on SRT planning by comparing the pre-randomization RT plans prospectively obtained on surveys before randomization to the actually delivered RT plans obtained after follow-up. Results: Enrollment of the trial was complete. 193 patients were enrolled from 09.06.2018 to 08.17.2020. 7/90 patients (9%) in the control arm dropped-out the study because they underwent a PSMA PET at another institution, while 1/103 (1%) patients of the intervention arm dropped-out due to COVID-19 related complications. After a median follow-up of 13.3 months (last follow-up date 09/01/2020), delivered RT plans were obtained in 60/83 (72%) and 70/102 (69%) of patients of the control and the PSMA arms, respectively. Median PSA at enrollment was 0.32 ng/ml (IQR 0.17-1.35) and 0.22 ng/ml (IQR 0.14-0.50) in the control and PSMA arms, respectively. There was a change between the intended pre-randomization RT plan and the actually delivered RT plan in 17/60 (28%) and 40/70 (57%) of the patients in the control and PSMA arms, respectively (p = 0.002). SRT was aborted in favor of systemic therapy and/or metastasis directed RT for extra-pelvic M1 disease in 2/60 (3%) and 12/70 (17%) of the control and PSMA arms, respectively (p = 0.17). Dose prescription and/or target volume delineation was changed in 2/60 (3%) and 1/70 (26%) in the control and PSMA arms, respectively (p = 0.001). Conclusions: In this prospective randomized phase 3 study, PSMA PET had an impact on the SRT plan in more than half of the patients. Long-term follow-up will show if the impact of PSMA PET on SRT planning translates into improved outcome or not. Clinical trial information: NCT03582774.

Safety of ipilimumab in patients (pts) with untreated, advanced melanoma alive beyond 2 years: Results from a phase III study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8512-8512 ◽  
Author(s):  
Luc Thomas ◽  
Jedd D. Wolchok ◽  
Claus Garbe ◽  
Celeste Lebbe ◽  
Igor Bondarenko ◽  
...  
Keyword(s):  
Safety Profile ◽  
Human Monoclonal Antibody ◽  
Survival Rates ◽  
Safety Data ◽  
Advanced Melanoma ◽  
T Cell Response ◽  
Phase Iii ◽  
Low Grade ◽  
Grade 3 ◽  
The Impact

8512 Background: Ipilimumab (IPI), a fully human monoclonal antibody, blocks cytotoxic T-lymphocyte antigen-4 to potentiate an antitumor T-cell response. In a phase 3 study (CA184-024) of previously untreated pts with stage III or IV melanoma, IPI + dacarbazine (DTIC) significantly improved overall survival (OS) vs. DTIC alone (Robert et al. NEJM 2011). We now report safety data of IPI in pts from this study alive > 2 yrs from study initiation. Methods: Pts with untreated advanced melanoma, were randomized to IPI (10 mg/kg) + DTIC (850 mg/m2) or placebo + DTIC (850 mg/m2) given at Wks 1, 4, 7, 10 followed by DTIC q 3 wks through Wk 22. Eligible pts (stable disease or better) received IPI or placebo q 12 wks as maintenance. In the population of subjects alive >2 yrs, the appearance of immune-related adverse events (irAEs) occurring after 2 yrs was evaluated. Within this group was a subset of subjects still receiving IPI dosing after 2 yrs; safety for these pts was evaluated to assess the impact of prolonged IPI exposure. Results: In the IPI + DTIC group 68 (28%) pts survived > 2 yrs compared to 44 (18%) in the DTIC alone group; 11 of the 68 continued IPI dosing for ≥ 2 yrs. Safety assessment beyond 2 yrs showed 3 of the 11 pts had any grade irAEs; 1 pt had grade 3/4 rash, pruritus while low grade events included rash, pruritus (n=2) and elevated ALT / AST (n=1). Overall among all 68 pts in the Ipi + DTIC group, there were 5 pts (7.4%) with any grade irAEs including grade 3/4 rash, pruritus (n=1) and low grade rash (n=3), pruritus (n=2), skin hypopigmentation, and elevated ALT / AST (n=1). No gastrointestinal or endocrine events (any grade) were observed. Conclusions: In Study 024, IPI + DTIC treatment improved OS pts with untreated, advanced melanoma with higher survival rates in the IPI + DTIC group at 1 yr (47.3% vs. 36.3%), 2 yrs (28.5% vs. 17.9%), and 3 yrs (20.8% vs. 12.2%) (HR 0.72, p<0.001). The safety profile of pts alive after 2 yrs suggests that treatment with IPI + DTIC is associated with low rates of irAEs in these pts. Furthermore, in pts still receiving active IPI treatment beyond ≥ 2 yrs, the safety profile appears to be consistent and medically manageable using established safety guidelines (Weber, Oncologist 2007).

Safety of TG-C: 12 years of follow-up safety data from phase 1, phase 2, ongoing phase 3, and long term safety trials

2021 ◽  
Vol 29 ◽  
pp. S253-S254
Author(s):  
D. Hunter ◽  
A. Mobasheri ◽  
S. Mareya ◽  
M. Wang ◽  
H. Choi ◽  
...  
Keyword(s):  
Phase 1 ◽  
Safety Data ◽  
Phase 2 ◽  
Phase 3 ◽  
Ongoing Phase

The impact of prior therapies on outcomes with trifluridine/tipiracil (FTD/TPI) in the phase III TAGS trial.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 247-247
Author(s):  
Kohei Shitara ◽  
Ben George ◽  
Julien Taieb ◽  
Raghav Sundar ◽  
Marwan Fakih ◽  
...  
Keyword(s):  
Safety Profile ◽  
Gastroesophageal Junction ◽  
Progression Free Survival ◽  
Prior Treatment ◽  
Phase Iii ◽  
Phase 3 ◽  
Gastroesophageal Junction Cancer ◽  
Third Line ◽  
Post Hoc ◽  
The Impact

247 Background: It is unclear whether prior treatment with ramucirumab (RAM) or RAM plus paclitaxel (PAC), standard second-line treatments for metastatic gastric or gastroesophageal junction cancer (mGC/GEJC), can influence outcomes with third-line chemotherapy in this patient (pt) population (pop). In the phase 3 TAGS trial, FTD/TPI showed a survival benefit vs placebo (PBO) in pts with mGC/GEJC who had received ≥2 prior chemotherapy regimens. Post hoc analyses were performed to assess the impact of prior RAM, PAC or RAM+PAC treatment on the efficacy and safety of FTD/TPI in TAGS. Methods: Pts in the TAGS trial were categorized into 5 subgroups based on prior treatment received as follows: A) RAM (alone or combined with other agents), B) no RAM, C) PAC (but no RAM), D) RAM+PAC (sequentially or in combination) and E) neither PAC nor RAM. While subgroups A and B were prespecified, all other subgroups were identified post hoc. Efficacy (overall survival [OS] and progression-free survival [PFS]) and safety were assessed in these subgroups. Results: In the overall pop (N=507), 33% had received prior RAM (alone/combined); 30% prior RAM+PAC; 27% prior PAC but no RAM; and 40% had received neither PAC nor RAM. As only 3% of all pts received prior RAM but no PAC, that subgroup was not considered in this analysis. FTD/TPI treatment was consistently associated with benefits in OS and PFS vs placebo across all pt subgroups (Table). Among pts randomized to FTD/TPI, OS benefit was similar between pts who received RAM+PAC vs those who received neither (HR, 1.15; 95% CI, 0.84–1.58) and between pts who received PAC (but no RAM) vs those who received neither (HR, 0.91; 95% CI, 0.66–1.25). The FTD/TPI safety profile was consistent across all subgroups, with similar overall incidences of grade ≥3 adverse events (AEs). Minor variations in hematologic toxicities were noted (Table). Conclusions: In the phase 3 TAGS trial, FTD/TPI treatment in the third or later line provided efficacy benefits vs PBO and demonstrated a consistent safety profile in pts with mGC/GEJC regardless of prior treatments. Clinical trial information: NCT02500043. [Table: see text]

Safety Profile of Bortezomib Impacts Survival in Light Chain Amyloidosis

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5664-5664
Author(s):  
Zoé Van de Wyngaert ◽  
Greg Vanoutryve ◽  
Guillemette Fouquet ◽  
Stéphanie Guidez ◽  
Charles Herbaux ◽  
...  
Keyword(s):  
Overall Survival ◽  
Dose Reduction ◽  
Safety Profile ◽  
Cardiac Involvement ◽  
Hematological Toxicity ◽  
Al Amyloidosis ◽  
Kidney Involvement ◽  
The Impact ◽  
To Receive

Abstract Background. Bortezomib has improved overall survival (OS) in light chain (AL) amyloidosis; however, data on its activity in severe cardiac AL are sparse. Furthermore, the impact of the safety profile of Bortezomib on overall survival in severe cardiac AL amyloidosis remains unknown given the fragile population. We sought to outline the activity and safety profile of Bortezomib in severe cardiac AL amyloidosis. Methods. Twenty-seven patients diagnosed with AL amyloidosis and treated with Bortezomib were included, mean age was 63 years (36-85), with a sex ratio of 18/9. Eighteen patients had cardiac involvement, among which all had Mayo-Clinic stage III staging but 3, and 9 had kidney involvement only. Seventy percent of patients received Bortezomib as a 1st-line therapy, once (19%) or twice weekly (81%), given IV at the starting dose of 1.3g/m2 in combination to Dexamethasone. Thirteen (48%) patients also received an alkylating agent. Results. Overall hematological response rate was 75% in patients who received at least 1 cycle of Bortezomib, and 83% and 62.5% in patients with and without cardiac involvement, respectively. Complete response was obtained in 45%, and 42% and 50% in the 2 groups, respectively. 44% patients with cardiac involvement had an organ response. An hematological toxicity occurred in 26% of patients, similarly in the 2 groups, consisting mainly of thrombocytopenia with no need for treatment modification. Non-hematological toxicity (grade ≥2) rate was 62% in patients with cardiac involvement and 38% in patients with kidney involvement (p=ns), consisting mostly of fatigue, peripheral neuropathy, infection and gastro-intestinal adverse effects, and leading to 25% of dose reduction, and 33% of Bortezomib interruption before cycle 4, similarly in both groups. The median follow-up was 41 months from start of Bortezomib. Seven patients died during the first cycle of treatment, all of them but one had severe stage III cardiac involvement with LVEF <40%. Importantly, the patients with cardiac involvement who were treated past the first cycle had an estimated 3-year OS similar to those with kidney involvement only (50 vs. 62%, p=ns). All patients with cardiac AL who completed at least 3 cycles of treatment and survived beyond 3 months remained alive at follow-up date. In univariate analysis for the cohort as a whole, occurrence of non-hematological toxicity grade ≥2 was associated with a lower OS (20% if present vs. 67% when absent; p=0.001), as for the consequence of Bortezomib dose reduction (54% vs. 71%, respectively; p=0.036), and decrease of the total dose received to less than 50% of the initial dose (12% vs. 92% respectively, p=0.009). Bortezomib interruption (36% vs. 78%, respectively; p=0.004), or inability to receive at least 3 cycles of Bortezomib also impacted OS (36% vs. 78%, respectively; p=0,004). The impact on OS appeared even more dramatic in patients with cardiac involvement. In multivariate analysis, independent variables that were associated with poor OS were the number of Bortezomib cycles (inability to receive at least 3 cycles) (OR=34.7; p=0.001), occurrence of a non-hematological toxicity (OR=5.1; p=0.011), and absence of hematological response (OR=3.6; p=0.05). Conclusion. Bortezomib is an effective treatment of AL amyloidosis, and significantly improves the most adverse patients characterized with severe cardiac presentation. However, the safety profile is of particular concern in severe cardiac AL, particularly the non hematological ≥grade 2 incidence rate; patients often characterized with dose reduction or interruption, inability to receive sufficient dose concentration or number of cycles. This study confirms that alteration of the safety profile of Bortezomib may hamper the benefits seen particularly in severe cardiac AL, questioning on the use of weekly and sub-cutaneous Bortezomib for very fragile AL, as optimized in fragile patients with Myeloma. Disclosures No relevant conflicts of interest to declare.

scholarly journals Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies

2020 ◽  
Author(s):  
William J Sandborn ◽  
Brian G Feagan ◽  
Silvio Danese ◽  
Christopher D O’Brien ◽  
Elyssa Ott ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
Safety Profile ◽  
Phase 2 ◽  
Phase 3 ◽  
Number Of Patients ◽  
Serious Infections ◽  
Inflammatory Bowel

Abstract Background Ustekinumab is currently approved globally in Crohn’s disease (CD) and psoriatic diseases. Recent phase 3 data demonstrate safety/efficacy in ulcerative colitis (UC). Crohn’s disease and UC phase 3 programs had similar study designs, facilitating integrated safety analyses. Methods Data from 6 ustekinumab phase 2/3 CD and UC studies were pooled, and safety was evaluated through 1 year. Patients received 1 placebo or ustekinumab (generally 130 mg or ~6 mg/kg) intravenous induction, then subcutaneous (90 mg) maintenance every 8/12 weeks. Analyses incorporated all patients who received ≥1 ustekinumab dose. Safety outcomes are presented as percentages of patients (induction) and as number of patients with events per 100 patient-years of follow-up (through 1 year). For key safety events, 95% confidence intervals (CIs) are provided, as appropriate. Hazard ratios with 95% CIs from time-to-event analyses for serious adverse events and serious infections were also performed. Results Through 1 year, 2574 patients received ustekinumab (1733 patient-years of follow-up). The number of patients with adverse events per 100 patient-years (placebo 165.99 [95% CI, 155.81–176.67] vs ustekinumab 118.32 [95% CI, 113.25–123.55]), serious AEs (27.50 [95% CI, 23.45–32.04] vs 21.23 [95% CI, 19.12–23.51]), infections (80.31 [95% CI, 73.28–87.84] vs 64.32 [95% CI, 60.60–68.21]), serious infections (5.53 [95% CI, 3.81–7.77] vs 5.02 [95% CI, 4.02–6.19]), and malignancies excluding nonmelanoma skin cancer (0.17 [95% CI, 0.00–0.93] vs 0.40 [95% CI, 0.16–0.83]) were similar between placebo and ustekinumab. Conclusions The safety profile of ustekinumab across the pooled inflammatory bowel disease population through 1 year was favorable and generally comparable to placebo. These data are consistent with the established safety profile of ustekinumab across indications. ClinicalTrials.gov numbers NCT00265122; NCT00771667; NCT01369329; NCT01369342; NCT01369355; NCT02407236.

scholarly journals Safety, Efficacy, and Patient Acceptability of Everolimus in the Treatment of Breast Cancer

2016 ◽  
Vol 10 ◽  
pp. BCBCR.S12443 ◽  
Author(s):  
Laurence Lousberg ◽  
Guy Jerusalem
Keyword(s):  
Breast Cancer ◽  
Treatment Option ◽  
Safety Profile ◽  
Combined Therapy ◽  
Safety Data ◽  
Phase Iii ◽  
Patient Acceptance ◽  
Patient Acceptability ◽  
Optimal Sequence ◽  
The Impact

Everolimus combined with exemestane is an important treatment option for patients suffering from estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer (ABC) who have been previously treated with a nonsteroidal aromatase inhibitor (NSAI). After presentation of phase III registration trial BOLERO-2, several phase IIIb trials have been started to evaluate this regimen in a more real-world setting. Here, we review the efficacy and safety data published or presented at selected international meetings. These studies confirmed the outcome observed in the BOLERO-2 trial. Patient acceptance rate is also discussed by focusing on the permanent everolimus discontinuation rate in these trials. Factors influencing the safety profile are also reported, including the impact of age. The optimal sequence of combined therapy approaches associating targeted and endocrine therapy (ET) has yet to be determined as new treatment options such as cyclin-dependent kinase inhibitors become available. However, everolimus–exemestane remains an important treatment option with a major impact on progression-free survival (PFS) and an acceptable safety profile.

Bendamustine Versus Chlorambucil in Treatment-Naive Patients with B-Cell Chronic Lymphocytic Leukemia (B-CLL): Results of an International Phase III Study.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2043-2043 ◽  
Author(s):  
Wolfgang Ulrich Knauf ◽  
Toshko Lissichkov ◽  
Ali Aldaoud ◽  
Raoul Herbrecht ◽  
Anna Marina Liberati ◽  
...  
Keyword(s):  
Partial Response ◽  
Remission Rate ◽  
Safety Data ◽  
Data Monitoring Committee ◽  
Lymphocytic Leukemia ◽  
Phase Iii ◽  
Binet Stage ◽  
Hodgkin's Lymphomas ◽  
To Receive

Abstract Introduction: Bendamustine (BEN) is a purine analog / alkylator hybrid agent with a particular mechanisms of action that provides effective treatment for a number of hematologic and non-hematologic malignancies. It is used primarily for chemo-naïve, relapsed or refractory B-CLL as well as for other types of non-Hodgkin’s lymphomas. The aim of this randomized phase III, open-label, multicenter study was to compare the efficacy and safety of BEN versus chlorambucil (CLB) in treatment-naïve patients (pts) with B-CLL Binet stage B/C. Patients and Methods: Pts with untreated B-CLL were randomized to receive BEN (100 mg/m2 on days 1+2) or CLB (0.8 mg/kg on days 1+15) for up to 6 treatment cycles. Primary endpoints were overall remission rate (ORR), defined as complete response (CR), nodular partial response (nPR) and partial response (PR), confirmed after 8 weeks, and progression-free survival (PFS). Secondary endpoints were duration of remission, overall survival (OS), safety, and quality of life (QoL). Follow-up was for ≥12 months after completion of treatment of the last patient, or until progression for pts with CR, nPR or PR and stable disease, or until death or lost to follow-up. A 5-stage, adaptive-group, sequential procedure was used with planned interim analyses to adjust the number of pts. Safety and efficacy were assessed by an Independent Data Monitoring Committee. Results: 305 pts were randomized to receive BEN (n=156) or CLB (n=149). As 7 pts did not receive study medication, 298 pts were included in the safety analysis. At the time of this analysis, 264 pts (139 BEN; 125 CLB) were available for the efficacy analysis. For both treatment groups: median age was 64 years; 70% had Binet stage B and 30% Binet stage C disease; median number of cycles/patient was 6; median follow-up was 18.5 months. ORR was significantly higher with BEN than with CLB (68% vs 39%; p&lt;0.0001), with a CR of 30% vs 2%, respectively. Among the subgroups with Binet stage B and C disease, ORR was 70% and 61%, respectively, with BEN, vs 47% and 22%, respectively, with CLB. Median PFS (Kaplan-Meier estimate) was 21.7 months with BEN and 9.3 months with CLB (p&lt;0.0001), and median duration of remission was 18.9 months with BEN and 6.1 months with CLB (p&lt;0.0001). No difference in OS was seen between groups. Toxicity of BEN was manageable and did not impair QoL when compared with CLB. Infection rates (common toxicity criteria grades III+IV) were low in both groups (5.8% BEN; 3.5% CLB). Conclusions: BEN was significantly more effective than CLB in achieving remissions in treatment-naïve pts with B-CLL Binet stage B/C; median PFS and duration of remission were also significantly longer. Furthermore, safety data indicate that BEN toxicities are manageable and the drug is well tolerated. On the basis of these results, BEN should be considered as first-line chemotherapy for patients with B-CLL Binet stage B or C.

scholarly journals P095: Preparing emergency patients and providers study: Clinician and patient satisfaction with communication tool

CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S98
Author(s):  
J. Nunn ◽  
D. Chiasson ◽  
C. Cassidy ◽  
S. MacPhee ◽  
B. Rose-Davis ◽  
...  
Keyword(s):  
Nova Scotia ◽  
Response Rate ◽  
Phase 1 ◽  
Descriptive Statistics ◽  
Phase 2 ◽  
Phase 3 ◽  
Item Questionnaire ◽  
Ed Visits ◽  
The Impact

Introduction: Effective communication to develop a shared understanding of patient/caregiver (P/C) expectations is critical during emergency department (ED) encounters. However, there is limited research examining the use of communication tools of P/C expectations to improve communication in the ED. The objective of this study was to examine satisfaction with a patient expectations questionnaire, known as the PrEPP tool, and its impact on communication and management of patients in the ED. Methods: The PrEPP tool collected P/C expectations over 3 phases of the study. In phase1, the PrEPP tool was distributed to all P/Cs (CTAS score of 2 to 5) in four EDs in Nova Scotia. In phase 2 the PrEPP tool was refined to a 5-item questionnaire. In phase 3 the PrEPP tool was re-implemented over a six-month period. Follow-up surveys were distributed to P/Cs via email (phase 1, 3) and HCPs on iPads in the ED (phase 3) to determine the impact of the tool on communication and management of patients. Entries were compiled on a REDCap database and descriptive statistics were used to analyze responses related to satisfaction.The PrEPP tool collected P/C expectations over 3 phases of the study. In phase1, the PrEPP tool was distributed to all P/Cs (CTAS score of 2 to 5) in four EDs in Nova Scotia. In phase 2 the PrEPP tool was refined to a 5-item questionnaire. In phase 3 the PrEPP tool was re-implemented over a six-month period. Follow-up surveys were distributed to P/Cs via email (phase 1, 3) and HCPs on iPads in the ED (phase 3) to determine the impact of the tool on communication and management of patients. Entries were compiled on a REDCap database and descriptive statistics were used to analyze responses related to satisfaction. Results: In Phase 1, 11418 PrEPP tools and 147 surveys (29% response rate) were collected from January-June 2016. The majority of P/Cs found the PrEPP questionnaire easy to complete (95.9%) and felt HCPs met their expectations (87.1%). In Phase 3, 951 P/C (31.1% response rate) and 128 HCP surveys were collected. Of P/C respondents 45.9% felt PrEPP helped to communicate expectations, while 49.7% said that they would like to use it on future ED visits. The majority of P/C respondents (75.4%) indicated their expectations were met during their visit to the ED. Of those whose expectations were not met, 69% felt their expectations were not discussed. The majority of HCP respondents (90.4%) indicated they used the PrEPP tool at least sometimes. Also, 78.4% said it influenced patient communication and 42% indicated the tool influenced management of patients at least sometimes. Conclusion: Obtaining expectations early in the patient encounter may provide opportunities for improved communication in the ED. P/Cs found the PrEPP tool easy to use to communicate their expectations and HCPs felt it influenced communication and management of patients in the ED. Further qualitative thematic analysis is needed to explore how the PrEPP tool impacted ED visits.

Double-blind, randomized phase 3 study to compare efficacy and safety of the biosimilar CT-P10 to rituximab combined with CVP therapy in patients with previously untreated advanced-stage follicular lymphoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 7532-7532 ◽  
Author(s):  
Won Seog Kim ◽  
Wojciech Jurczak ◽  
Juan-Manuel Sancho ◽  
Edvard Javrid ◽  
Jin Seok Kim ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Safety Profile ◽  
Overall Response Rate ◽  
Virus Reactivation ◽  
Phase 3 ◽  
Double Blind ◽  
B Virus ◽  
Independent Review ◽  
To Receive ◽  
Clinical Trial Information

7532 Background: CT-P10 is a biosimilar candidate to the innovator rituximab (RTX). In patients with rheumatoid arthritis, CT-P10 has demonstrated equivalence in pharmacokinetics (PK) and efficacy (Yoo, ACR 2016). This study aimed to demonstrate non-inferiority of efficacy and PK equivalence between CT-P10 and RTX in patients with newly diagnosed advanced follicular lymphoma (AFL) (NCT02162771). PK equivalence was confirmed (Coiffier, ASH 2016). Methods: A total of 140 patients were randomized in a 1:1 ratio to receive CT-P10 or RTX (375 mg/m2 i.v) plus CVP (cyclophosphamide, vincristine, and prednisone) every 3 weeks over 8 cycles. Overall response rate (ORR) according to the 1999 IWG criteria over 24 weeks was assessed by the independent review committee. Results: Noninferiority of CT-P10 to RTX was shown for the primary efficacy endpoint of ORR. The ORR difference was 4.3% (Table) and the lower bound of the 95% confidence interval was -4.25%. B-cell depleted after the 1st infusion and remained as depleted over 8 cycles in both groups. Overall safety profile of CT-P10 was consistent with that of RTX and the proportion of patients with positive anti-drug antibody was similar in both groups (4.3% and 2.9%) for 24 weeks. Neither progressive multifocal leukoencephalopathy nor Hepatitis B virus reactivation was reported in each group. Conclusions: This study demonstrates noninferiority of efficacy of CT-P10 to RTX combined with CVP in previously untreated AFL. CT-P10 was well-tolerated and the safety profile including immunogenicity of CT-P10 was comparable to that of RTX over 8 cycles of induction period. Clinical trial information: NCT02162771. [Table: see text]

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