tbuckley/cabot-search huggingface dataset:
Neoadjuvant atezolizumab + chemotherapy in resectable non-small cell lung cancer (NSCLC).
Authors: Catherine A. Shu, Claud Grigg, Codruta Chiuzan, Robert F. Garofano, Vijeta Patel, Susana Hernandez, Tiffany Negri, Adrian G. Sacher, Stephanie Smith-Marrone, Mark Stoopler, Justin F. Gainor, Mark M. Awad, Frank D'Ovidio, Joshua R. Sonett, Matthew Bacchetta, Anjali Saqi, Naiyer A. Rizvi
Journal: Journal of Clinical Oncology (2018)

8532 Background: Neoadjuvant chemotherapy is an accepted treatment approach for resectable NSCLC. Major pathologic response (mPR) defined as ≥ 90% tumor necrosis is seen in 20% of patients (pts) receiving neoadjuvant chemotherapy and portends a favorable survival. Combination anti-PD-(L)1 therapy and chemotherapy has demonstrated potential synergy in metastatic NSCLC. This ongoing phase II study explores the combination of neoadjuvant atezolizumab + chemotherapy. Methods: Pts with stage IB-IIIA resectable NSCLC receive 4 cycles of atezolizumab, nab-paclitaxel, and carboplatin prior to surgery. Never-smokers are excluded. Planned enrollment is 30 pts with a primary endpoint of mPR. Stage I trial evaluation after enrollment of 18 pts will be performed with pre-defined stoppage criteria for lack of efficacy (mPR in ≤ 4 pts). If ≥ 5/18 pts have mPR, an additional 12 pts will be treated in Stage II. The primary endpoint is met if ≥ 11/30 pts have mPR. Results: From 6/2016 to 1/2018, 14 evaluable pts were treated. Baseline characteristics: median age 71 years (range 49-83), 36% female, 57% adenocarcinoma, 85% stage IIIA, and 54% PD-L1 positive (≥1%, 22C3). The most common toxicity was neutropenia (12/14 Grade 3-4), with 9/14 pts requiring chemotherapy dose reduction. 1 pt experienced G3 transaminase elevation, and another developed Type I diabetes (1 year after completion of treatment). 8/14 (57%) had radiologic PR, and the remainder had SD. 11/14 pts underwent resection successfully; 1 pt had post-operative complications unrelated to study drugs leading to death. The Stage I trial continuation criteria was met with 7/14 (50%) pts with mPR, including 3 with complete pathologic response (21%). mPR was seen in both PD-L1+ and PD-L1- pts. With a median follow-up of 8.6 months (95% CI 3.5, 17.8), there were 4 recurrent events: 2 were brain metastases. Conclusions: The combination of atezolizumab + chemotherapy demonstrated significant activity in the neoadjuvant setting. Treatment response was seen regardless of PD-L1 score. Correlative studies including multiplex IHC and tumor exome sequencing are ongoing. The data exceeded the futility boundary for mPR in Stage I and will proceed to Stage II. Clinical trial information: NCT02716038. Clinical trial information: NCT02716038.
Safety, pharmacokinetics, and efficacy of RC48-ADC in a phase I study in patients with HER2-overexpression advanced solid cancer.
Authors: Jifang Gong, Jianmin Fang, Lin Shen
Journal: Journal of Clinical Oncology (2020)

334 Background: HER2 overexpression is common in many malignancies and contributes to tumor growth. Unlike the varied options of anti-HER2 target therapies for breast cancer, there is a huge unmet medical need for HER2 overexpressing non-breast solid tumor (NBST) such as gastric cancer and urothelial cancer. Therefore, we conducted the first study of RC48-ADC, a novel humanized anti-HER2 antibody conjugate, in NBST. Methods: This was an open-label, dose-escalation and expansion study in patients with HER2-overexpression (IHC 2+ and 3+) advanced solid cancers after failure of standard treatment. The dose escalation consisted of accelerated (0.1 and 0.5 mg/kg) and “3+3” titrations (1.0, 2.0, 2.5 and 3.0 mg/kg). In dose expansion stage, patients were given RC48-ADC at 2.0 mg/kg, Q2W. Results: As of Aug 20, 2019, 57 patients (including 47 with gastric cancer and 4 with urothelial cancer) were treated at 0.1 (1 patient), 0.5 (1 patient), 1.0 (3 patients), 2.0 (6 patients in dose escalation and 32 patients in dose expansion), 2.5 (11 patients), and 3.0 mg/kg (3 patients), respectively. Most of them were Stage IV (91.2%) or with metastasis (96.5%). DLT was observed in 1, 2, and 1 patient at 2.0, 2.5, and 3.0 mg/kg, respectively. The MTD was 2.5 mg/kg. Most commonly reported TRAEs were WBC count decreased (66.7%), fatigue (56.1%), neutrophil count decreased (54.4%) and hemoglobin decreased (52.6%). Grade 3/4 TRAEs were reported in 28 patients (49.1%). Confirmed ORR was 21.1% (8/38) for 2.0 mg/kg, and 17.5% (10/57) for all patients. DCR was 52.6% and 49.1%, respectively. PFS was 3.6 months (95% CI: 4.1, 11.3) for 2.0 mg/kg. Subgroup ORR was 20.7% (6/29) at 2.0 mg/kg and 18.2% (2/11) at 2.5 mg/kg for gastric cancer, and 50.0% (2/4) for urothelial cancer. Conclusions: RC48-ADC demonstrated a good safety profile and promising anti-tumor activity in the late stage solid tumor including gastric cancer and urothelial cancer. Response and PFS benefits were clinical meaningful at 2.0 mg/kg and 2.5 mg/kg. Phase 2 pivotal study (NCT03556345) in gastric cancer is ongoing. Clinical trial information: NCT02881190.
Abstract 20819: Hematopoietic Progenitors are Required for Proper Development of Coronary Vasculature
Authors: Gentian Lluri, Vincent Huang, Marlin Touma, Atsushi Nakano
Journal: Circulation (2016)

Introduction: During embryogenesis, hematopoietic cells appear in the myocardium prior to the initiation of coronary formation. However, their role is unknown. Hypothesis: Here we investigate whether pre-existing hematopoietic cells are required for the formation of coronary vasculature. Methods: As a model of for hematopoietic cell deficient animals, we used Runx1 knockout embryos and Vav1-cre; R26-DTA embryos, latter of which genetically ablates 2/3 of CD45+ hematopoietic cells. Results: Both Runx1 knockout embryos and Vav1-cre; R26-DTA embryos revealed disorganized, hypoplastic microvasculature of coronary vessels on section and whole-mount stainings. Furthermore, coronary explant experiments showed that the mouse heart explants from Runx1 and Vav1-cre; R26-DTA embryos exhibited impaired coronary formation ex vivo. Interestingly, in both models it appears that epicardial to mesenchymal transition is adversely affected in the absence of hematopoietic progenitors. Conclusions: Hematopoietic cells are not...
Abstract 20232: Haploinsufficiency of MYBPC3 in the Development of Hypertrophic Cardiomyopathy
Authors: David Barefield, Mohit Kumar, Joshua Gorham, Jonathan Seidman, Christine Seidman, Pieter de Tombe, Sakthivel Sadayappan
Journal: Circulation (2014)

Introduction: Mutations in MYBPC3, encoding cardiac myosin binding protein-C (cMyBP-C), account for ~40% of hypertrophic cardiomyopathy (HCM) cases. MYBPC3 mutations are usually encode truncated proteins and are not found in tissue and are typically heterozygous (Het) in humans. Reduced protein levels occur in human HCM patients with these mutations, suggesting haploinsufficiency. However, it is unknown if cMyBP-C reduction causes or results from hypertrophy. Hypothesis: To test whether haploinsufficiency occurs following cardiac stress and if heterozygous MYBPC3 mice had worsened disease progression. Methods &amp; Results: Transverse aortic constriction (TAC) was performed on 3 month old wild type (WT) and Het MYBPC3 truncation mutant mice which were allowed to hypertrophy for 4 or 12 weeks. Het TAC mice showed increased hypertrophy 12 weeks post-TAC compared to WT TAC controls. Het TAC hearts showed reduced ejection fraction compared to WT TAC at 4 and 12 weeks. MYBPC3 transcript levels were significantly reduced in sham and TAC Het hearts. cMyBP-C levels decreased in Het sham and TAC at 4 weeks but returned to baseline levels at 12 weeks. Het TAC myocytes showed higher Ca2+ sensitivity at 4 weeks, and impaired maximal force development. Het sham and TAC skinned cardiomyocytes showed reduced length dependent increases in Ca2+ sensitivity and maximal force development. RNA-Seq shows no alterations in proteasome of RNA-degradation pathways which have been suggested to play a role in the pathology of these mutations. Overexpression of WT cMyBP-C in the presence of truncated MYBPC3 rescued the decline in force observed in Het myocytes in the absence of stress. Conclusions: Heterozygous MYBPC3 truncation mutant carriers develop more profound hypertrophy and dysfunction following stress. Also, increased MYBPC3 expression reverses myocyte deficits in force generation in the presence of truncated alleles.
Absence of indicators of hypercoagulability and antiphospholipid syndrome in bxq-350 first in human study.
Authors: Charles A Cruze, Olivier Rixe, John Charles Morris, Vinay K. Puduvalli, John L. Villano, Trisha Michel Wise-Draper, Angela N. Johnson, Robert Wesolowski
Journal: Journal of Clinical Oncology (2018)

e14533 Background: Saposin C is a lysosomal activator protein that can be combined with a phosphatidylserine lipid to create a nanovesicle that targets cancer cells. Similar lipid nanovesicle preparations are linked to altered coagulation and anti-phospholipid syndrome (APS), thus coagulation parameters and immune markers for APS were explored in the first-in-human (FIH) trial of BXQ-350. Methods: Data from 17 solid tumor/high grade glioma patients (59% M, 24-67 yrs) in the Phase 1a trial of BXQ-350 nanovesicles at IV doses of 0.7-2.4 mg/kg (NCT02859857) were examined for effects on plasma fibrinogen (PF), coagulation factors, prothrombin time (PT), aPPT, INR, and cardiolipins IgG, IgA, and IgM at days 1, 8, 15, 22, 29, 57, 85, 113, 141, and 171 (or off-study date). Mean and change from baseline (Day 0) ±2.0 units are reported. Results: No clinically significant changes in coagulation or baseline PT or INR ±2.0 were observed. For doses 1.1-2.4 mg/kg, subclinical increases occurred at Day 57-171, including PF peak at Day 57 of 1.1 mg/kg (155±142.8 mg/dL) and Day 171 of 2.4 mg/kg (128.8±79.6 mg/dL). Subclinical aPTT peak was also observed Day 171 of 2.4 mg/dL (13.7±20.3 s), but not at other doses. No DLTs or severe adverse events related to BXQ-350 were reported. Conclusions: Therapeutic BXQ-350 nanovesicle dosages did not cause APS or clinically significant hypercoagulability in humans. Further, AEs related to BXQ-350 were not due to hypercoagulability. Clinical trial information: NCT02859857.Table. Δ Coagulability Factors mg/kg Day PF aPTT IgG IgM IgA 1.1 1 - - - 11.4±0 8 35±132.5 - - - - 15 20.3±35.7 - - - - 22 22.3±111.3 11.5±16 3±0 - 9.8±0 29 42.5±7.8 2.7±1.8 - - - 57 155±142.8 - - - - 171 47.5±193 - - 3.6±4 1±0.7 1.4 1 - - - - 9.8±0 8 82±195.1 - 975±0 18±0 241±0 15 58.7±99.1 - - - - 22 42.7±64.1 - - 9±0 - 29 75.5±30.4 7.6±11.9 - - - 57 15.5±50.2 - - - - 171 36.7±54.6 8.7±15.9 - - - 1.8 1 - - 6±0 6.1±5.9 - 8 14.3±47 - 5±0 - 9.8±0 15 25±84.2 4.4±8.3 - - - 22 5.7±96 1.2±2.4 4±0 - - 29 14±92.5 6.4±6 - - - 57 47.5±57.3 - - - - 113 0 - 4±0 6±0 - 171 38.7±27.8 - 8±0 3.3±2.9 - 2.4 1 - 0 7.4±8.7 7±0 8 13.2±35.7 - 8.9±6.5 - 11.2±0 15 14.2±34.8 6±11.3 - - - 22 13±32.2 - 3.6±3 7±0 - 85 55±51.5 2.6±3.8 - - - 171 128.8±79.6 13.7±20.3 10±5.7 6±1.4 -
Abstract 12807: Characteristics of Patients With Left Atrial Thrombi/spontaneous Echocardiographic Contrast in the Acute Phase After Cardiogenic Cerebral Infarction
Authors: Hideyuki Kishima, Takanao Mine, Satoshi Takahashi, Kenki Ashida, Masaharu Ishihara, Tohru Masuyama
Journal: Circulation (2016)

Background: Some patients have been reported to have a re-infarction in the acute phase after the onset of cardiogenic cerebral infarction (CI) due to remaining or newly formed left atrial thrombus (LAT). Those patients need strict and rapid treatment with anticoagulants. However, identification of cardiogenic CI patients at risk for re-infarction still remains unclear. We investigated the risk stratification in patients with LAT after the onset of CI. Methods: We retrospectively studied 97 consecutive patients (55 men, age 69±15) who had suffered acute cardiogenic CI. Neurological score (NIHSS score) and clinical factors were evaluated on admission. A standard 12-lead ECG, transthoracic echocardiography (TTE), transesophageal echocardiography (TEE) and a blood sample for brain natriuretic peptide (BNP) were obtained within 24 hours after the onset of cardiogenic CI. Left atrial thrombi (LAT) and spontaneous echocardiography contrast (SEC) were assessed using TEE. Results: Fifteen LAT (15%) and 28 SEC (21%) were detected in 97 patients using TEE. All LAT were found in the left atrial appendage. Sixty patients showed atrial fibrillation (AF) in on admission. Patients with LAT/SEC (n = 29) had a higher prevalence of left ventricular hypertrophy (LVH, 52% vs. 13%, P &lt;0.0001), higher NIHSS score (11.3 ± 7.7 vs. 5.9 ± 7.7, P = 0.0021), higher rate of hypertension (72% vs. 47%, P = 0.0217), higher prevalence of persistent AF (89% vs. 47%, P=0.0217), larger left atrial diameter (47 ± 9 mm vs. 39 ± 7 mm, P &lt;0.0001), and higher hemoglobin levels (13.4 ± 2.3 g/dl vs. 12.4 ± 2.3 g/dl, P = 0.0402) compared with patients without LAT/SEC, while BNP levels were not significantly associated. On multivariate analysis, only LVH (P = 0.0241, OR 5.779, 95%CI 1.249-33.236) was independently associated with LAT/SEC. Conclusion: Detection of left ventricular hypertrophy in the acute phase of patients with cardiogenic cerebral infarction may provide additional risk stratification for re-infarction.
Association of nutritional parameters and survival in parenteral nutrition-supported (PN) gastrointestinal cancer patients.
Authors: Wenli Liu, Aiham Qdaisat, Eric Lee, Jason Yeung, Khanh Vu, Junzhong Lin, Todd Canada, Juhee Song, Lorenzo Cohen, Eduardo Bruera, Sai-ching J. Yeung
Journal: Journal of Clinical Oncology (2017)

10078 Background: PN is a major tool in managing nutritional challenges in cancer patients. However, a clear set of clinical and biochemical indices to determine PN application in cancer patients has not been developed. We assessed the association between PN related nutritional parameters and survival in a large group of gastrointestinal (GI) cancer patients. Methods: 1197 consecutive GI cancer patients who received PN support between 08/01/08 – 08/01/13 were reviewed. Height, weight, plasma glucose (baseline and within 48 hours after PN initiation), surgical history, and pharmacy data including PN contents (dextrose, amino acids, and fat) and non-PN dextrose or fat in drug administration were recorded. Body mass index (BMI), Ideal body weight (IBW), PN and non-PN Calorie, and nitrogen were calculated for analysis. Data were entered into a multivariate analysis controlling for age, gender, cancer site, and medical comorbidities. Results: Median BMI was 25.4. 70% of the patients had unsteady weight ( &gt; 2.5% change) before PN initiation. The magnitude of weight change was inversely related to survival (HR 1.02), P &lt; 0.001). Patients with BMI &gt; 25 and &lt; 7.5% weight change prior to PN initiation had the most favorable survival. Glycemic instability (maximum plasma glucose variation &gt; 100mg/dL) was independently related to shorter survival (HR 1.53, P &lt; 0.001). Total calorie by IBW (kcal/kg/day) (HR 0.97, P &lt; 0.001), non-PN calorie % (HR 1.04, P &lt; 0.001), and calorie to nitrogen ratio (kcal:g) (HR 1.02, P &lt; 0.001) were all independently associated with overall survival. Conclusions: Lower BMI, weight instability, and glycemic instability were adversely associated with survival. Higher total PN calorie and amino acid support were associated with better survival. Higher non-PN calorie % was adversely related to survival. Future studies must focus on developing a set of indices incorporating independent prognostic clinical and biochemical factors in determining PN application and monitoring in cancer patients. Optimum calorie and amino acids in PN support for cancer patients also require further investigation.
TCT-73 Treatment of Severe TRIcuspid Regurgitation in Patients with Advanced Heart Failure with CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL): a controlled prospective randomized trial
Authors: Michael Laule, Isabel Mattig, Bernd Hewing, Christoph Schöbel, Fabian Knebel, Alexander Lauten, Alexander Lembcke, Martin Thoenes, Verena Stangl, Ulf Landmesser, Karl Stangl, Henryk Dreger
Journal: Journal of the American College of Cardiology (2018)
Adverse events as a cause of unscheduled hospitalizations for solid tumor oncology patients receiving chemotherapy.
Authors: Chris I. Wong, Jessica A. Zerillo, Sherri Oliver Stuver, Jocelyn Siegel, Joseph O. Jacobson, Kristen K. McNiff
Journal: Journal of Clinical Oncology (2018)

e18815 Background: Developing strategies to prevent or minimize cancer treatment-related adverse events (AEs) is a priority for value and patient safety. To develop a strategy for easier identification and mitigation of AEs, we sought to understand the frequency and severity of those resulting in hospitalizations. Methods: A single institution retrospective analysis was conducted to characterize hospitalizations of ambulatory adult solid tumor cancer patients within 30 days of chemotherapy administration (including immune checkpoint inhibitors). Demographics, treatment, and hospitalization details were abstracted from the medical record by trained clinical abstractors and used to categorize the reason for hospitalization as related to: cancer and cancer symptoms; a non-cancer medical condition; or treatment-related AE. A second review of the hospitalization and independent assessment of the reason for hospitalization was triggered if the first reviewer was not “virtually certain” of the categorization. Discrepancies triggered a third independent review as the final determination of the reason for hospitalization. Severity of the treatment-related AE hospitalization was rated using the National Patient Safety Agency (NPSA) risk assessment matrix scale. Results: Between May-October 2016, 116 patients experienced 197 hospitalizations within 30 days of chemotherapy (mean 1.7 hospitalizations per patient; range 1-7). Sixty-six percent of hospitalizations were related to complications of cancer, while 19% (n = 38) were considered treatment-related AE hospitalizations. The median length of stay of hospitalizations resulting from an AE was 6 days (interquartile range 3-9), with 19% of hospitalizations having > 1 AE described. Gastrointestinal symptoms accounted for 48% of AEs and neutropenic fever for 11%. The highest proportion of treatment-related AE hospitalizations resulted in moderate severity based on the NPSA scale (hospitalization of 4–15 days). Conclusions: These findings argue persuasively for novel approaches such as automated trigger tools to identify and manage chemotherapy toxicity before hospitalization is needed.
Association between timing and duration of adjuvant chemotherapy and survival for colorectal cancer in korea, 2011-2014: A nationwide study based on the database of quality assessment and the health insurance.
Authors: In Gyu Hwang, Ji Sung Lee, Sang-Cheol Lee, Sun Kyung Baek, Jong Gwang Kim, Tae Won Kim
Journal: Journal of Clinical Oncology (2017)

3605 Background: Few population-based analyses on treatment outcomes of colorectal cancer (CRC) have been conducted in Asian countries. We conducted a nationwide study to assess relationship between timing and duration of adjuvant chemotherapy (AC) and survival for patients with CRC in South Korea. Methods: Data from the Health Insurance Review and Assessment Service Database (HIRA) were analyzed for demographics, tumor characteristics, adjuvant chemotherapy, and survival of patients who underwent curative-intent surgical resection for CRC from 2011 to 2014. Results: From the HIRA data, a total of 61315 patients were identified: 15620 (25.5%) in stage I, 20525 (33.5%) in Stage II, and 25170 (41.0%) in stage III. Chemotherapy regimens were consisted: 11332 (18.5%) in 5-fluorouracil and leucovorin/capecitabine (FL/CAP), 13183 (21.5%) in FL/CAP plus oxaliplatin (FOLFOX/CAPOX), 357 (0.6%) in uracil and tegafur/doxifluridine (UFT/D) and 36443 (59.4%) in surgery alone. For patients with stage II and III CRC, the initiation of AC ≥ 8 weeks after surgery was associated with a significant decrease in overall survival (OS) (FL/CAP: HR, 1.82; 95% CI, 1.53 to 2.17, and FOLFOX/CAPOX: HR, 2.92; 2.47 to 3.45, respectively), however UFT/D regimens were not statistically significant. For patients with stage II and III colon cancer, receiving AC &lt; 3 months had lower OS (FL/CAP: HR, 3.72; 95% CI, 2.80 to 4.94, FOLFOX/CAPOX: HR, 2.15; 1.87 to 2.47, and UFT/D: HR, 1.74; 0.56 to 5.41, respectively). For patients with stage II and III rectal cancer, receiving AC &lt; 3 months regardless of chemotherapy regimens had a significant lower survival (FL/CAP: HR, 1.91; 1.66 to 2.20, FOLFOX/CAPOX: HR, 2.20; 1.75 to 2.77, and UFT/D: HR, 3.71; 1.45 to 9.44, respectively). Conclusions: Time to initiation and duration of AC after surgery were associated with survival. Based on our results, starting within 8 weeks and receiving more than 3 months of AC are needed to have an overall survival benefit.
Daratumumab plus bortezomib-melphalan-prednisone (VMP) in elderly (≥75 y) patients (Pts) with newly diagnosed multiple myeloma (NDMM) ineligible for transplantation (ALCYONE).
Authors: Michele Cavo, Shinsuke Iida, Joan Blade, Maria-Victoria Mateos, Je-Jung Lee, Mamta Garg, Vania Hungria, Meral Beksac, Ivan Spicka, Stefan Knop, Ludek Pour, Philip Campbell, Andrzej J. Jakubowiak, Jianping Wang, Susan Wroblewski, Rachel Kobos, Ming Qi, Jesus San-Miguel
Journal: Journal of Clinical Oncology (2018)

8031 Background: Daratumumab (D) plus VMP (D-VMP) prolonged progression-free survival (PFS) compared with VMP and was well-tolerated in the phase 3 ALCYONE study (NCT02195479). We examined the efficacy and safety profiles of D-VMP vs VMP in elderly (≥75 y) and non-elderly ( < 75 y) NDMM pts in ALCYONE. Methods: Pts were ineligible for high-dose chemotherapy with ASCT. Pts received up to nine 6-week VMP cycles (V: 1.3 mg/m2 SC Days 1, 4, 8, 11, 22, 25, 29, 32 [Cycle 1] and Days 1, 8, 22, 29 [Cycles 2-9]; M: 9 mg/m2 PO and P: 60 mg/m2 PO Days 1-4 [Cycles 1-9]) ± D (16 mg/kg IV QW for Cycle 1, Q3W for Cycles 2-9, and Q4W for Cycles 10+ [post VMP-treatment phase] until progression). Minimal residual disease (MRD) was assessed by clonoSEQ assay (Adaptive Biotechnologies). Results: 706 (350 D-VMP; 356 VMP) pts were randomized, including 211 ≥75 y (104 D-VMP; 107 VMP) and 495 < 75 y (246 D-VMP; 249 VMP) pts. For D-VMP vs VMP, the median duration of study treatment was 14.5 mo vs 12.0 mo for ≥75 y pts and 15.0 mo vs 12.0 mo for < 75 y pts, respectively. After median follow-up of 16.5 months, PFS was prolonged with D-VMP vs VMP in both the ≥75 y (median not reached [NR] vs 20.4 mo; HR 0.53; 95% CI 0.32-0.85) and < 75 y (median NR vs 17.9 mo; HR 0.49; 95% CI 0.36-0.68) pts. ORR and ≥complete response (CR) rates were consistently higher for D-VMP vs VMP in ≥75 y (ORR: 88% vs 70%; ≥CR: 41% vs 24%) and < 75 y (ORR: 92% vs 76%; ≥CR: 43% vs 25%) pts. MRD-negative rates (10–5 threshold) also increased with D-VMP vs VMP in ≥75 y (24% vs 8%) and < 75 y (22% vs 6%) pts. Rates of most common grade 3/4 (≥10%) treatment-emergent adverse events, peripheral sensory neuropathy, and infections are in Table. D-associated infusion-related reactions were 36% (9% grade 3/4) in ≥75 y and 24% (3% grade 3/4) in < 75 y pts. Conclusions: Efficacy and safety of D-VMP vs VMP in pts ≥75 y of age were consistent with the overall study population. Clinical trial information: NCT02195479.Grade 3/4, % ≥75 y < 75 y D-VMP VMP D-VMP VMP Most common TEAEs Neutropenia 52 42 35 38 Thrombocytopenia 51 43 28 35 Anemia 24 23 13 19 Leukopenia 13 9 6 9 Lymphopenia 10 10 7 4 Pneumonia 18 9 9 2 Peripheral sensory neuropathy 0 6 2 3 Infections 28 20 21 13
TCT-7 Predictors and Outcomes of Aborted Procedures During Elective Transcatheter Aortic Valve Replacement
Authors: Jennifer Rymer, Katelyn Xiang, Alice Wang, David Cohen, Nimesh Desai, Ajay Jayant Kirtane, G. Chad Hughes, J. Kevin Harrison, Sreekanth Vemulapalli
Journal: Journal of the American College of Cardiology (2018)