scholarly journals BBCIC Research Network Analysis of First-Cycle Prophylactic G-CSF Use in Patients Treated With High–Neutropenia Risk Chemotherapy

2021 ◽  
Author(s):  
Pamala A. Pawloski ◽  
Cara L. McDermott ◽  
James H. Marshall ◽  
Vanita Pindolia ◽  
Catherine M. Lockhart ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Comparative Effectiveness ◽  
Scientific Evidence ◽  
Descriptive Analysis ◽  
Safety Data ◽  
The United States ◽  
Research Network ◽  
Comparative Safety ◽  
Effectiveness Studies

Background: Chemotherapy-induced febrile neutropenia (FN) is prevented or minimized with granulocyte colony-stimulating factors (G-CSFs). Several G-CSF biosimilars are approved in the United States. The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is a nonprofit initiative whose objective is to provide scientific evidence on real-world use and comparative safety and effectiveness of biologics and biosimilars using the BBCIC distributed research network (DRN). Patients and Methods: We describe real-world G-CSF use in patients with breast or lung cancer receiving first-cycle chemotherapy associated with high FN risk. We assessed hospitalizations for FN, availability of absolute neutrophil counts, and G-CSF–induced adverse events to inform future observational comparative effectiveness studies of G-CSF reference products and their biosimilars. A descriptive analysis of 5 participating national health insurance plans was conducted within the BBCIC DRN. Results: A total of 57,725 patients who received at least one G-CSF dose were included. Most (92.5%) patients received pegfilgrastim. FN hospitalization rates were evaluated by narrow (<0.5%), intermediate (1.91%), and broad (2.99%) definitions. Anaphylaxis and hyperleukocytosis were identified in 1.15% and 2.28% of patients, respectively. This analysis provides real-world evidence extracted from a large, readily available database of diverse patients, characterizing G-CSF reference product use to inform the feasibility of future observational comparative safety and effectiveness analyses of G-CSF biosimilars. We showed that the rates of FN and adverse events in our research network are consistent with those reported by previous small studies. Conclusions: Readily available BBCIC DRN data can be used to assess G-CSF use with the incidence of FN hospitalizations. Insufficient laboratory result data were available to report absolute neutrophil counts; however, other safety data are available for assessment that provide valuable baseline data regarding the effectiveness and safety of G-CSFs in preparation for comparative effectiveness studies of reference G-CSFs and their biosimilars.

Real-world risk of anosmia with cancer directed systemic therapy: A pharmacovigilance assessment using FDA Adverse Events Reporting System (FAERS) database.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18790-e18790
Author(s):  
Anahat Kaur ◽  
Shuai Wang ◽  
Arlene Yu ◽  
Tarek N. Elrafei ◽  
Lewis Steinberg ◽  
...  
Keyword(s):  
Adverse Events ◽  
Reporting System ◽  
Case Reports ◽  
Descriptive Analysis ◽  
Package Insert ◽  
Case Series ◽  
The United States ◽  
Chemotherapeutic Agents ◽  
United States Food ◽  
Pharmacovigilance Database

e18790 Background: Anosmia is a rare and under-reported adverse event associated with the use of several oncologic drugs. Instances of olfactory disturbances following administration of chemotherapeutic agents have been sporadically documented in case reports and case series. We aimed to conduct a more comprehensive study to generate signal for anosmia as adverse effect of drugs used for oncologic indications. Methods: The United States Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database, a pharmacovigilance database, was used to extract data. All reported cases of anosmia in the database were filtered for an indication of cancer. Descriptive analysis was conducted using SPSS 26. Results: Total 10250 cases of anosmia were extracted from FAERS database. Out of these, cancer as an indication for medication use was noted in 139 cases. Some of the most common suspect medications exclusively associated with more than one case of anosmia were palbociclib (n=16), enzalutamide (13), pazopanib (8), cabozantinib (8), letrozole (6), leuprolide (5), niraparib (5), rucaparib (4), tamoxifen (4), capecitabine (3), everolimus (3), anastrazole (2), exemestane (2), zoledronic acid (2), vandetanib (2) and vismodegib (2). Detailed description of medications with highest number of reported cases is listed in Table. Median age at diagnosis was 66 years (interquartile range 58-71). Anosmia was reported more commonly in females (64% ) as compared to males (33.8%). Reactions were reported to the FDA more commonly by consumers (56.8%) as compared to healthcare professionals (40.3% cases). Out of 139 patients with anosmia, 93 (66.9%) had concomitant ageusia, 8 (5.7 %) had dysgeusia and 6 (4.3%) patients had neuropathy. Conclusions: This study demonstrates a signal for anosmia as side effect in patients receiving select oncologic medications based on the FAERS database. It is worth noting that none of the suspect medications identified in this study have anosmia listed as known adverse reaction on accompanying package insert. Further studies need to be conducted to confirm if causal relationship exists between use of these drugs and olfactory function compromise. [Table: see text]

Frequency, management, and resource use of adverse events (AEs) in nonmetastatic castrate-resistant prostate cancer (nmCRPC) patients receiving apalutamide or enzalutamide: A real-world study.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 217-217
Author(s):  
Shan Jiang ◽  
Della Varghese ◽  
Sreevalsa Appukkuttan ◽  
Shelby Corman ◽  
Nehemiah Kebede ◽  
...  
Keyword(s):  
Resource Use ◽  
Real World ◽  
Descriptive Analysis ◽  
Specific Antigen ◽  
Retrospective Chart Review ◽  
The United States ◽  
Patient Decision Making ◽  
Hot Flush ◽  
Initial Cohort ◽  
Frequency Management

217 Background: Second generation androgen receptor inhibitors (SGARIs), apalutamide (APA) and enzalutamide (ENZ) and darolutamide, are approved in the United States (US) for the treatment of nmCRPC. The objectives of this study were to describe the frequency of AEs and actions taken to manage AEs among nmCRPC patients treated with APA or ENZ and their downstream resource implications. Methods: This is a further descriptive analysis of a retrospective chart review study conducted in 43 US nmCRPC-treating sites. In our sample, the 43 physicians identified 699 nmCRPC patients initiating treatment with APA (N = 368) or ENZ (N = 333) with 2 patients receiving both, between February 1, 2018 and December 31, 2018 and AEs were collected as reported in regular clinical practice. A representative subset of patients, experiencing at least 1 AE for either APA (N = 125) or ENZ (N = 125), were selected randomly from the initial cohort, and their detailed chart data were extracted to understand the actions taken to manage AEs. Results: Of the initial cohort of nmCRPC patients, 72.0% and 78.7% of men receiving APA (N = 368) and ENZ (N = 333) experienced ≥1 AE, respectively. The three most common AEs reported were fatigue/asthenia (APA, 30.2%; ENZ, 38.7%), hot flush (APA, 14.1%; ENZ, 13.5%), and arthralgia (APA, 14.4%; ENZ, 12.9%). Cognitive and mental changes were observed in 5.4% (APA) and 7.8% (ENZA) men. The subset analysis of randomly selected patients experiencing ≥1 AE (APA, 125; ENZ, 125) were mostly Caucasian (APA, 72.8%; ENZ, 71.2%), ECOG score 0-1 (APA, 84%; ENZ, 88%), median prostate specific antigen (PSA) value 13 ng/ml and 11 ng/ml (APA, ENZ; respectively). Actions to address AEs included treatment of AE, SGARI discontinuation, dose reduction and hospitalization (Table). Specifically, treatment discontinuation due to AE was observed in 8.0% (APA) and 12.8 (%) of men. AEs were often not resolved (APA, 43.6%; ENZ, 39.4%), and the median duration of days to resolve AEs were 60.0 for APA and 56.0 for ENZ. Conclusions: This real-world study highlights the clinical and resource use burden of AEs among nmCRPC patients treated with APA and ENZ. The results demonstrate the importance of safety and tolerability as key considerations in shared clinician-patient decision-making regarding SGARI therapy in nmCRPC. [Table: see text]

P963Coronary orbital atherectomy manufacturers and user facility device experience (MAUDE) database: a 5-year analysis of real-world complications

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Saleh ◽  
M J Ahsan ◽  
N Lateef ◽  
M Shokr ◽  
H Badran ◽  
...  
Keyword(s):  
United States ◽  
Real World ◽  
Surgical Intervention ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Current Analysis ◽  
Surgical Interventions ◽  
Orbital Atherectomy ◽  
User Facility

Abstract Background Coronary Orbital Atherectomy System was approved by the United States FDA (food and Drug Administration) on October 21st, 2013. The initial safety data were published in the ORBIT I trial. Purpose Evaluation of the reported real-life complications related to utilization of orbital coronary atherectomy system since its approval in the United States using the online FDA database. Methods The Manufacturer and User facility Device Experience (MAUDE) database was queried for all complication reports involving the orbital atherectomy (OA) “Diamondback 360 coronary orbital atherectomy system” from 1/1/2013 through 12/31/2018. All reports were searched for complications; mortality, perforation, dissections, device fragmentation, and the need for surgical intervention among reported procedures. Duplicate entries and data with no reporting on final procedure outcome were excluded. Results Over the allocated interval519 reports were identified. Seven reports were excluded (according to exclusion criteria). Over the period of slightly more than five years, coronary perforation was the most commonly reported complication mounting to 44.14% of all the reports (226 reports). Device fragmentation was reported in 18.94% of the reports (97 reports). Surgery was needed to retrieve device fragments in 13 cases (13.4% of all device fragmentation reports). Coronary dissection represented 16.21% of the reports (83 reports) and total surgical interventions were needed in 14.25% of the cases (73 reports). Finally, total reported deaths were 121 cases (23.63% of the total reports). Year 2013 2014 2015 2016 2017 2018 Number of reported complications 4 28 46 81 113 247 Percentage of reported complications Discussion The current analysis, representing data from real world reported complications to the FDA over a period of 5 years, shows that the most common reported complication during coronary orbital atherectomy was coronary perforations, followed by device breakings and fragmentation (which necessitated surgical intervention in almost 13.4% of those device fragmentation cases reported). It is hard to compare these data with published safety trials since the FDA database is involved in reporting complications and not total number of procedures. However the most striking complication involved device fragmentation, which was not seen or reported among the pivotal trials evaluating device safety. The current analysis may shed some light on a non reported complication among patients undergoing orbital atherectomy which might represent a gap between the device performance in real world as opposed to a well-designed study world.

Safety of a trastuzumab biosimilar, used under routine clinical practice conditions in adult HER2+ breast cancer patients in Morocco.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13024-e13024
Author(s):  
Hassan Errihani ◽  
Narjiss Berrada ◽  
Mouna Khouchani ◽  
Abdelkader Acharki ◽  
Kamal Lahbabi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Adverse Events ◽  
Early Breast Cancer ◽  
Real World ◽  
Safety Profile ◽  
Safety Data ◽  
Routine Clinical Practice ◽  
Her2 Breast Cancer

e13024 Background: Hertraz, the first trastuzumab biosimilar was approved in Morocco in 2017. Real world data on trastuzumab biosimilars are very limited or not available. HERLife is a prospective, non-interventional phase IV study program that investigated the experience of using Hertraz, a biosimilar for trastuzumab (Herceptin), under routine clinical practice conditions in Morocco. The primary aim of this study was to confirm the acceptable safety and tolerability of Hertraz. Methods: Ninety-nine patients with HER2-positive breast cancer treated with Hertraz were enrolled from 8 public and private sector hospitals and followed up for 12 months as part of this non-interventional study. Cardiac events (LVEF) and other unexpected or serious adverse events were monitored. The study arms consisted of patients with early breast cancer (Arm 1, n=70) and metastatic breast cancer (Arm 2, n=29) whose median age was 53 years in both groups. Results: Switching from Herceptin to Hertraz was observed in 45% of 29 MBC patients and 27% of 70 EBC patients. Switching was done at a median of 4th cycle. Pertuzumab was used in combination with Hertraz in 69% and 19% of patients in the metastatic and neoadjuvant settings, respectively. Two patients had a decline in LVEF. One patient treated with Hertraz alone and one patient treated with Hertraz and pertuzumab developed a decrease in LVEF requiring a three-week treatment discontinuation of Hertraz. Treatment of Hertraz was continued after 1 skipped cycle without occurrence of new side effects. No other trastuzumab related adverse events was observed. Four patients in the metastatic group and 2 patients in the early breast cancer arm had a relapse in the 12 months of clinical follow-up. Conclusions: The management of HER2+ breast cancer in Morocco follows the international recommendations. This is the first real world safety data of Hertraz from Morocco. The 12-month follow-up treatment with Hertraz showed an acceptable cardiac safety profile. In cases where there was a switch from Herceptin to Hertraz or Hertraz combined with pertuzumab, the safety profile was similar to that previously reported in other studies.

scholarly journals 2719. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered in Adults 18–55 Years of Age

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S957-S957
Author(s):  
James Peterson ◽  
James Hedrick ◽  
Judy Pan ◽  
David Neveu ◽  
Emilia Jordanov ◽  
...  
Keyword(s):  
Single Dose ◽  
Adverse Events ◽  
Conjugate Vaccine ◽  
Geometric Mean ◽  
Safety Data ◽  
The United States ◽  
Phase Iii ◽  
Meningococcal Vaccine ◽  
Post Vaccination ◽  
Quadrivalent Meningococcal Conjugate Vaccine

Abstract Background The MenACYW-TT conjugate vaccine is a quadrivalent meningococcal vaccine that contains tetanus toxoid as carrier protein. The vaccine is intended for global use in all age groups (i.e., individuals 6 weeks of age and older). This Phase III study evaluated the immune lot consistency, and safety and immunogenicity of the vaccine when compared with a licensed quadrivalent meningococcal conjugate vaccine in individuals 10–55 years of age. Methods A randomized, modified double-blind, multi-center study (NCT02842853) was conducted in the United States. The study evaluated 3344 meningococcal vaccine naïve adolescents and adults, who were randomly assigned to receive either a single dose of one of the three lots of MenACYW-TT conjugate vaccine or single dose of Menactra® [MenACWY-D]. Serum bactericidal assay with human complement (hSBA) and rabbit complement (rSBA) was used to measure antibodies against serogroups A, C, W, and Y at baseline before vaccination (Day 0) and 30 days post-vaccination. Safety data were collected up to 6 months post-vaccination. Herein we report the performance of MenACYW-TT in adults 18 through 55 years of age (n = 1,807). Results Immune equivalence was demonstrated across all 3 lots of MenACYW-TT conjugate vaccine based on geometric mean titers (GMTs) for all serogroups. Non-inferiority of immune responses, based on percentages of participants achieving hSBA vaccine seroresponse, was demonstrated between MenACYW-TT and MenACWY-D for all four serogroups at Day 30 compared with baseline. The proportions of individuals (18–55 years) with hSBA ≥ 1:8 following MenACYW-TT administration were higher than those after MenACWY-D administration for all four serogroups (A: 93.5% vs. 88.1%; C: 93.5% vs. 77.8%; W: 94.5% vs. 80.2%; Y: 98.6% vs. 81.2%). A similar trend was observed for post vaccination GMTs in adult participants. Reactogenicity profiles were comparable across study groups. Most unsolicited adverse events were of grade 1 or grade 2 intensity. No vaccine-related serious adverse events were reported. Conclusion MenACYW-TT vaccine was well tolerated and demonstrated a non-inferior immune response compared with the licensed MenACWY-D vaccine when administered as a single dose to meningococcal vaccine naïve adults. Disclosures All authors: No reported disclosures.

Trastuzumab biosimilar (Kanjinti) in breast cancer patients: One-center retrospective observational study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13015-e13015
Author(s):  
Agnieszka I. Jagiello-Gruszfeld ◽  
Izabela Lemanska ◽  
Elzbieta Brewczynska ◽  
Katarzyna Pogoda ◽  
Roman Dubianski ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Real World ◽  
Safety Profile ◽  
Safety Data ◽  
Her2 Positive ◽  
Reference Drug ◽  
Her2 Positive Breast Cancer ◽  
Metastatic Setting ◽  
Positive Breast Cancer

e13015 Background: The switch of anti-HER2 therapy from the reference drug Herceptin to a biosimilar has presented challenges to the clinics. Real world data on trastuzumab biosimilars are very limited or not available. In our clinic we perform observational retrospective study to confirm safety and efficacy Kanjinti. Methods: 195 patients (pts) with HER2-positive breast cancer were treated with Kanjinti from Jul.18. 2018 to Jan.29.2020. Cardiac events (↓LVEF) and other unexpected or serious adverse events were monitored in all pts. 34 pts received carboplatin, docetaxel pertuzumab and trastuzumab biosimilar in neoadjuvant setting, 99 received trastuzumab biosymilar in monotherapy or with other cytostatic drugs in neoadjuvant or adjuvant setting, and 62 received docetaxel, pertuzumab and Kanjinti in metastatic setting. Results: Pertuzumab was used in combination with Kanjinti in 49% of pts (32% in the 1st. line of palliative tretment and 17% in the neoadjuvant settings, respectively).Switching from Herceptin to Kanjinti was observed in 65% of MBC patients and 37% of EBC patients. Switching was done at a median of 4th cycle. 6 patients had a decline in LVEF. No other trastuzumab related adverse events was observed. Conclusions: The management of HER2 positive breast cancer in our clinic follows the international recommendations. This is the first real world safety data of Kanjinti from Poland. The 12-month follow-up treatment with Kanjinti an acceptable cardiac safety profile. In cases where there was a switch from Herceptin to Kanjinti or Kanjinti combined with pertuzumab, the safety profile was similar to that previously reported in other studies.

Real-world safety data and differentiation of second-line (2L) 5-fluorouracil (5-FU) based regimens among patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 390-390
Author(s):  
George P. Kim ◽  
Paul Cockrum ◽  
Aleksander Chudnovsky ◽  
Andy Surinach ◽  
Zev A. Wainberg ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Safety Data ◽  
Ductal Adenocarcinoma ◽  
Icd 10 ◽  
Health Database ◽  
Liposomal Irinotecan ◽  
Grade 3 ◽  
Cost Implications

390 Background: Chemotherapy related adverse events (AEs) can impact the treatment of patients, reducing quality of life and leading to dose delays and treatment discontinuation. This study examined the proportion of patients (pts) with mPDAC treated with 5-FU-based regimens in the 2L setting who experienced AEs during treatment. Methods: Data were extracted for pts diagnosed with mPDAC who initiated 2L treatment between January 2016 and July 2020 from the Flatiron Health electronic health database. Pts included in the study were treated with FOLFIRINOX (FFX), FOLFOX, FOLFIRI, or a regimen containing liposomal irinotecan. The occurrence of grade 3 (G3) and grade 4 (G4) neutropenia, G3/G4 elevated alanine transaminase (ALT) and anemia where transfusion was indicated were determined using lab results and the grading criteria from the Common Terminology Criteria for Adverse Events v4.03. The occurrence of diarrhea, fatigue, nausea and vomiting (N/V), and neuropathy were identified from structured diagnosis records through ICD-10-CM codes. Duration of therapy (DOT) was assessed for each regimen. Descriptive statistics for AEs and DOT were reported. Results: Of the 804 pts included in the study, 28.4% (n=228) received FFX, 39.8% (n=320) received regimens containing liposomal irinotecan, 24.8% (n=199) received FOLFOX, and 7.1% (n=57) received FOLFIRI. The median DOT (IQR) was 86 days (d) (43 – 206), 79d (41 – 169), 72d (43 – 166), and 84d (46 – 148) for pts who received FFX, liposomal irinotecan, FOLFOX, and FOLFIRI, respectively. G3/G4 neutropenia (<1000/mm3) presented in 28.1% (n=64) of pts treated with FFX, 11.9% (n=38) of pts treated with liposomal irinotecan, 17.1% (n=34) of pts treated with FOLFOX, and 36.8% (n=21) of pts treated with FOLFIRI. NV occurred in 14.9% (n=34), 13.1% (n=42), 12.6% (n=25), and 10.5% (n=6), respectively. The full AE results are summarized in the table. Conclusions: In this assessment of often dose-limiting AEs among pts with mPDAC treated in 2L, pts who received liposomal irinotecan had the lowest proportion of neutropenia. No clear pattern was noted for N/V, neuropathy, fatigue, anemia, and elevated ALT. Further research is necessary to determine the real-world cost implications of AEs in this patient population. [Table: see text]

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