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Multi-object tracking involves maintaining several trajectories of different objects moving in the scene throughout the video. With this objective, in this article, a fully automatic and real-time tracking algorithm to track multiple vehicles in a video is proposed. The proposed method specifically tries to address the challenges of occlusion and fast-motion in traffic surveillance. The algorithm begins with automatic detection of the moving targets by an adaptive GMM-based background subtraction method. The trajectories of these detected targets are then built using a three-level multi-motion modeled particle filter framework which allows to deal with the challenges of occlusion and fast-motions of the target. The likelihood model for targets is based on their color distribution and edge oriented histogram features. It is contended that the color distribution feature, which can represent the target appearance and the edge oriented histogram, which can describe the target structure are sufficient to represent it in an unique feature space. Based on the similarity of target likelihood, the locations of the targets are filtered. These filtered locations are then associated with the most likely detections using the proposed low-cost and fast data association algorithm based on Euclidean distance and prevailing motion vector. The performance evaluation of the proposed scheme is carried out based on the six measures: Multi Object Tracking Accuracy, Multi Object Tracking Precision, Mostly Tracked trajectories, Mostly Lost trajectories, Identity Switches and Frames Per Second. The results evaluated on stationary camera shot sequences from benchmark datasets as well as real-time shot videos indicate that the proposed algorithm ensures robust tracking and can be used effectively for real-time surveillance of highways.

Introduction: ERBB2 or HER2 alterations are found in approximately 2% to 5% of NSCLCs; most are exon 20 insertion mutations. The efficacy and safety of poziotinib, an oral tyrosine kinase inhibitor, were assessed in patients with treatment-naive NSCLC whose tumors harbor HER2 exon 20 insertions. Methods: ZENITH20 is an open-label, multicohort, multicenter, global, phase 2 trial. ZENITH20-C4 enrolled treatment-naive patients with NSCLC with tumors harboring HER2 exon 20 insertions. Poziotinib was administered 16 mg once daily (QD) or 8 mg twice daily (BID). The primary end point was objective response rate (ORR) by independent central review. Secondary and exploratory end points included disease control rate, duration of response, progression-free survival, and safety. Results: A total of 80 patients (16 mg QD, n = 47; 8 mg BID, n = 33) were treated in ZENITH20-C4. ORR was 39% (95% confidence interval [CI]: 28%–50%; 31 of 80), with a disease control rate of 73% (95% CI: 61%–82%; 58 of 80); 80% of the patients experienced tumor reduction. Median duration of response was 5.7 (95% CI: 4.6–11.9) months, and median progression-free survival was 5.6 (95% CI: 5.4–7.3) months. The most common grade 3 treatment-related adverse events were rash (QD, 45%; BID, 39%), stomatitis (QD, 21%; BID, 15%), and diarrhea (QD, 15%; BID, 21%). Among all subtypes of HER2 exon 20 insertions, seven patients (9%) harboring tumors with G778_P780dupGSP had the best clinical outcomes (ORR, 71%). Conclusions: Poziotinib was found to have clinically meaningful efficacy with a manageable toxicity profile for patients with treatment-naive NSCLC harboring HER2 exon 20 mutations.

PURPOSE Insertion mutations in Erb-b2 receptor tyrosine kinase 2 gene ( ERBB2 or HER2) exon 20 occur in 2%-5% of non–small-cell lung cancers (NSCLCs) and function as an oncogenic driver. Poziotinib, a tyrosine kinase inhibitor, was evaluated in previously treated patients with NSCLC with HER2 exon 20 insertions. METHODS ZENITH20, a multicenter, multicohort, open-label phase II study, evaluated poziotinib in patients with advanced or metastatic NSCLC. In cohort 2, patients received poziotinib (16 mg) once daily. The primary end point was objective response rate evaluated by independent review committee (RECIST v1.1); secondary outcome measures were disease control rate, duration of response, progression-free survival, and safety and tolerability. Quality of life was assessed. RESULTS Between October 2017 and March 2021, 90 patients with a median of two prior lines of therapy (range, 1-6) were treated. With a median follow-up of 9.0 months, objective response rate was 27.8% (95% CI, 18.9 to 38.2); 25 of 90 patients achieved a partial response. Disease control rate was 70.0% (95% CI, 59.4 to 79.2). Most patients (74%) had tumor reduction (median reduction 22%). Median progression-free survival was 5.5 months (95% CI, 3.9 to 5.8); median duration of response was 5.1 months (95% CI, 4.2 to 5.5). Clinical benefit was seen regardless of lines and types of prior therapy, presence of central nervous system metastasis, and types of HER2 mutations. Grade 3 or higher treatment-related adverse events included rash (48.9%), diarrhea (25.6%), and stomatitis (24.4%). Most patients had poziotinib dose reductions (76.7%), with median relative dose intensity of 71.5%. Permanent treatment discontinuation because of treatment-related adverse events occurred in 13.3% of patients. CONCLUSION Poziotinib demonstrates antitumor activity in previously treated patients with HER2 exon 20 insertion NSCLC.

The objective of this research was to produce elastomeric nonwovens containing cotton by the combination of appropriate process. Such nonwovens are in demand for use in several healthcare, baby care, and adult care products that require stretchability, comfort, and barrier properties. Meltblown fabrics have very high surface area due to microfibers and have good absorbency, permeability, and barrier properties. Spunbonding is the most economical process to produce nonwovens with good strength and physical properties with relatively larger diameter fibers. Incorporating cotton fibers into elastomeric nonwovens can enhance the performance of products, such as absorbency and comfort. There has not been any study yet to use such novel approaches to produce elastomeric cotton fiber nonwovens. A hydroentangling process was used to integrate cotton fibers into produced elastomeric spunbond and meltblown nonwovens. The laminated web structures produced by various combinations were evaluated for their physical properties such as weight, thickness, air permeability, pore size, tensile strength, and especially the stretch recovery. Incorporating cotton into elastic webs resulted in composite structures with improved moisture absorbency (250%-800%) as well as good breathability and elastic properties. The results also show that incorporating cotton can significantly increase tensile strength with improved spontaneous recovery from stretch even after the 5th cycle. Results from the experiments demonstrate that such composite webs with improved performance properties can be produced by commercially used processes.

Background: Eflapegrastim (Rolontis®, Efla) represents the first novel, long-acting granulocyte-colony stimulating factor (G-CSF) to be introduced in more than 15 years. Efla consists of a recombinant human G-CSF analog conjugated to a human IgG4 Fc fragment via a polyethylene glycol linker. Preclinical, clinical, and pharmacodynamic/pharmacokinetic data have shown increased potency for Efla versus pegfilgrastim (Peg). Both independent, randomized Phase 3 studies comparing Efla and Peg for prophylaxis of chemotherapy-induced neutropenia in patients with early-stage breast cancer (ESBC) met the primary endpoint of non-inferiority in duration of severe neutropenia (SN; ANC75kg. The safety profiles, including AEs and discontinuations, for Efla and Peg were comparable, and >99% of all patients received full dose of TC on schedule. The majority (67%) of patients with SN experienced a 1 day duration, occurring between Days 7 and 8 after TC. Mean duration of SN for Efla was statistically lower than for Peg (0.24 vs. 0.36 days; p=0.029). The above statistical significance was maintained for Efla after adjusting for demographic and baseline characteristics, namely age, weight, enrolling geographical region, and treatment setting in a multivariate model. Similarly, the incidence of SN for Efla was statistically lower than Peg in Cycle 1 (17.5% vs 24%; relative risk reduction [RRR]=27%; p=0.043). Univariate analysis of the incidence of SN showed a significant risk reduction in favor of Efla (8.6% vs 14.1%; p=0.034) for patients weighing >75kg (p=0.034). Multivariate analysis of SN showed significant odds ratio of SN for age ≥65 years and baseline ANC >6 × 109/L in favor of Efla (OR=0.42 and 0.39, respectively). The incidence of SN in Cycles 2-4 was comparable between treatment groups. Also, the incidence of febrile neutropenia and neutropenic complications was similar with 75kg. Eflapegrastim is a novel, long-acting and potent recombinant human G-CSF which may provide an attractive option in supporting patients at risk for SN-related complications. Citation Format: Lee S Schwartzberg, Gajanan Bhat, Alvaro Restrepo, Osama Hlalah, Inderjit Mehmi, Yong Wha Moon, Seungjae Baek, Shanta Chawla, Francois Lebel, Patrick Wayne Cobb. Pooled efficacy analysis from two phase 3 studies in patients receiving eflapegrastim, a novel, long-acting granulocyte-colony stimulating factor, following TC for early-stage breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-59.

Background: Poziotinib is a novel pan-HER inhibitor that irreversibly blocks the EGFR family of tyrosine-kinase receptors and inhibits the proliferation of tumor cells. This study evaluates the safety and clinical activity of poziotinib in patients with HER2-positive metastatic breast cancer (MBC) who received at least 2 therapies (trastuzumab and TDM-1) in dose-schedule ranging study. Methods: Patients were treated with oral poziotinib in 2 dose cohorts: 24mg daily 2 weeks/1 week off and 16mg daily continuously in a 21-day cycle. Dose reduction was allowed if toxicity observed. Patients continued treatment until disease progression, death, intolerable AE, or for a maximum of 24 months. The primary endpoint was the objective response rate (ORR), evaluated using RECIST 1.1. Secondary endpoints included disease control rate (DCR), duration of response (DOR), progression-free survival (PFS) and safety. Results: Sixty-seven patients (33 in 24mg; 34 in 16mg) were enrolled (57 evaluable) in 2 cohorts; all patients either completed or discontinued (36 PD, 5 deaths due to PD, 16 AEs) the study with 1 completed 25 months of treatment. The median (range) age was 57 (29-94) years. Patients were heavily pretreated and the median (range) lines of previous therapy were 7 (2-13) and 4 (2-16) in 2 cohorts respectively [unique drugs 3 (2-5) and 3 (1-9)]; 75% received pertuzumab in addition to trastuzumab and TDM-1 and 37% received at least one tyrosine kinase inhibitor (TKI). The mean relative dose intensity was 57% and 51% with 67% and 47% had dose reductions in 2 cohorts respectively. Common Grade ≥3 treatment-related AEs were similar to other 2nd generation TKIs and include diarrhea (30%), rash (28%) and stomatitis (7%). The ORRs were 27% and 26% with the corresponding median DORs of 5.6 and 13 months respectively. 3 patients in 16mg dose had a CR and another 2 patients had an unconfirmed CR. The DCRs were 50% and 70% in 2 cohorts along with median PFS of 4.1 and 5.8 months respectively. The ORRs were 25% each in 2 cohorts in 24 and 20 heavily pre-treated patients with ≥4 lines of therapy that included trastuzumab, TDM1 and pertuzumab. The ORRs were 23% and 0% in 2 cohorts with 13 and 10 patients received at least one tyrosine kinase inhibitor (TKI) as the sample sizes were small to make any meaningful evaluation. Conclusion: Poziotinib has demonstrated clinical activity in this dose-ranging study with tumor reduction shown in the majority of patients along with durable responses in this heavily pre-treated MBC patients. Safety profile was mechanism related and was similar to other 2nd generation TKIs. Citation Format: Adam Brufsky, Malik Zulfiqar, Julio Peguero, Kate Lathrop, Gajanan Bhat, Francois Lebel. A Phase 2 study of poziotinib in patients with HER2-positive metastatic breast cancer heavily pre-treated with HER2-targeted therapy [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD1-07.

Synthetic materials used in a wide range of applications are prone to damage in the form of cracking/microcracking. Catastrophic failure of the materials may occur due to the growth and merging of the microcracks, which results in the reduction of the service life of the materials. To avoid these problems and increase the service life, early detection and mending of the microcracks are extremely important. Self-healing materials can be utilized in these cases, which have the capability not only to detect cracks early but also to repair cracks automatically. These materials will also have the potential to improve material reliability, extend the service life, reduce replacement costs, and improve product safety. Due to these attractive features, numerous research studies are conducted every year on the development of self-healing systems. This paper summarizes the latest progress in the design and fabrication techniques of self-healing materials through a wide range of materials, including metals, ceramics, concrete, and polymer composites. Based on recent research, this article provides an overview of different chemistries and approaches involved in preparing self-healing composites. Comparative healing efficiency and related fabrication methods are tabulated. Finally, existing problems, gaps, and challenges, and future research directions and opportunities for commercial applications are highlighted.

Meltblown nonwovens market has been continuing to grow because of the unique characteristics of allowing the production of microfiber webs directly from a thermoplastic polymer in a single step. Whereas a vast majority of meltblown processes have utilized the traditional Exxon die, the Biax-die has also been used in some processes. The aim of this study was to understand the effect of critical process conditions of the Biax process, which has the advantage of lower high pressure hot air consumption compared to the traditional process, on the structure of meltblown webs. As the performance properties of meltblown nonwovens are mainly determined by the fiber diameter and diameter distribution, this study focused on these two characteristics considering various process conditions such as melt temperature, melt throughput, air temperature and air pressure. In conclusion, it was observed that there were three distribution types, the normal distribution, log-normal distribution, and skewed log-normal distribution, for meltblown webs produced by the Biax process. Air pressure and melt throughput were the most effective process conditions on the fiber diameter of meltblown polypropylene webs. It was also observed that fine fiber webs close to one-micron average fiber diameter and relatively narrower fiber diameter distribution can be produced under appropriate processing conditions using the Biax process.

Noise pollution is one of the harmful physical sources in the textile industry, which is among those industries that are faced with noise exposure problems. The results of environmental sound measurements at modern textile mills have shown that the sound pressure level varied from 95 to 130 dB, where the highest sound pressure level was at weaving machines. Textile insulation materials can be fitted in order to decrease sound pollution at a low cost. The objective of this work is to design a sound absorber that can be fixed to the body of the machines, at the point of the noise generation, to reduce noise pollution. Poly(lactic acid) (PLA), which is an environmentally friendly material, was used to produce different samples of meltblown nonwoven absorbers to be used for damping the noise of textile machinery. PLA meltblown nonwoven fabric with the areal density of 16.7 g/m2, average fiber diameter of 1.1 µm, mean pore diameter of 9.8 µm and thickness of 0.27 mm exhibited significant sound absorption. The sample with the smallest average fiber diameter among those investigated had the highest damping effect: 23.95, 41.29 and 29.32 dBA at frequencies of 400, 1000 and 1500 Hz, respectively. Our goal is to have a practical tool that accurately evaluates the absorber sound damping under the actual running conditions of the textile machinery. The design of the absorber from one layer of the PLA meltblown nonwoven over a rigid polyurethane foam sheet had an excellent sound absorption property.

One of the key issues of the 21st century is to reduce the rate of continuously increasing environmental pollution from waste generated by human beings. Use of recycled materials and environmentally friendly approaches to manufacturing can be a good way to deal with these challenges. Similarly, sound pollution has been increasing at an alarming rate due to industrialization and modernization. Use of acoustic insulation materials produced from recycled textile waste can play a vital role in reduction of sound pollution while simultaneously helping reduce municipal solid waste. The goal of this study was to evaluate the recycling of used apparels to produce commercially feasible sustainable products using nonwoven fabrication techniques with a biodegradable thermoplastic binder fiber for possible use as acoustic insulation panels. Recycled denim fibers were used with Sorona® or a PLA binder fiber to successfully produce sound insulation with good performance properties. Maximum transmission loss of about 24 dB and transmission coefficient close to zero at around 1000 Hz were observed. The data indicated that there is a direct correlation between loss of sound transmission with increase in thickness, areal density and decrease in air permeability. When compared with commercially available acoustic insulation material (gypsum board), these products had better insulation properties, indicating that recycled textile products can be used to produce such value-added materials, giving them another useful life before safely disposing in composting environments.

Background Eflapegrastim, a novel, long‐acting recombinant human granulocyte‐colony stimulating factor (rhG‐CSF), consists of a rhG‐CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Preclinical and phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for neutrophil counts for eflapegrastim versus pegfilgrastim. This open‐label phase III trial compared the efficacy and safety of eflapegrastim with pegfilgrastim for reducing the risk of chemotherapy‐induced neutropenia. Materials and Methods Patients with early‐stage breast cancer were randomized 1:1 to fixed‐dose eflapegrastim 13.2 mg (3.6 mg G‐CSF) or standard pegfilgrastim (6 mg G‐CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles. The primary objective was to demonstrate the noninferiority of eflapegrastim compared with pegfilgrastim in mean duration of severe neutropenia (DSN; grade 4) in cycle 1. Results Eligible patients were randomized 1:1 to study arms (eflapegrastim, n = 196; pegfilgrastim, n = 210). The incidence of cycle 1 severe neutropenia was 16% (n = 31) for eflapegrastim versus 24% (n = 51) for pegfilgrastim, reducing the relative risk by 35% (p = .034). The difference in mean cycle 1 DSN (−0.148 day) met the primary endpoint of noninferiority (p < .0001) and also showed statistical superiority for eflapegrastim (p = .013). Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms. Conclusion These results demonstrate noninferiority and comparable safety for eflapegrastim at a lower G‐CSF dose versus pegfilgrastim. The potential for increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study in patients at higher risk for CIN. Implications for Practice Chemotherapy‐induced neutropenia (CIN) remains a significant clinical dilemma for oncology patients who are striving to complete their prescribed chemotherapy regimen. In a randomized, phase III trial comparing eflapegrastim to pegfilgrastim in the prevention of CIN, the efficacy of eflapegrastim was noninferior to pegfilgrastim and had comparable safety. Nevertheless, the risk of CIN remains a great concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations., Myelosuppression, particularly neutropenia, has presented a major challenge in cancer treatment since the introduction of cytotoxic chemotherapy. This article reports the results of a phase III trial that compared the efficacy and safety of eflapegrastim with pegfilgrastim for reducing the risk of chemotherapy‐induced neutropenia.

The BELIEF trial was an international study of belinostat in patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) that led to FDA-approval for the disease. Herein, we present a subset analysis of patients with angioimmunoblastic T-cell lymphoma (AITL). Patients with R/R PTCL received belinostat 1000mg/m(2) intravenously every 21 days. The primary study endpoint was ORR by Cheson 2007 criteria. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Of 129 patients treated, 22 patients were diagnosed with AITL. The ORR for AITL patients was 45.5%, with 18% achieving compete response. After a median follow up of 21.5 months, the median DOR, PFS, and OS were 13.6 months, 4.2 months, and 9.2 months, respectively. Common grade 3/4 adverse events were asthenia, fatigue, cytopenias, and septic shock. Single-agent belinostat induces clinically meaningful duration of response in patients with AITL and warrants further investigation in studies.

In this article, a particle filter based tracking algorithm is proposed to track a target in video with vivid and complex environments. The target is represented in feature space by both color distribution and KAZE features. Color distribution is selected for its robustness to target’s scale variation and partial occlusion. KAZE features are chosen for their ability to represent the target structure and also for their superior performance in feature matching. Fusion of these two features will lead to effective tracking as compared to other features due to their better representational abilities, under challenging conditions. The trajectory of the target is established using the particle filter algorithm based on similarity between the extracted features from the target and the probable candidates in the consecutive frames. For the color distribution model, Bhattacharya coefficient is used as a similarity metric whereas Nearest Neighbor Distance Ratio is used for matching of corresponding feature points in KAZE algorithm. The particle filter update model is based on kinematic motion equations and the weights on particles are governed by an equation fusing both the color and KAZE features. Centre Location Error, Average Tracking Accuracy and Tracking Success Rate are the performance metrics considered in the evaluation process. Also, the overlap success plot and precision plot is considered for performance evaluation. On the basis of these metrics and visual results obtained under different environment conditions: outdoor, occluding and underwater ones, the proposed tracking scheme performs significantly better than the contemporary feature-based iterative object tracking methods and even few of the learning-based algorithms.

Background: Eflapegrastim (E) represents the first myeloid growth factor innovation in more than 15 years. A novel, long-acting recombinant human granulocyte-colony stimulating factor (rhG-CSF), E consists of a rhG-CSF analog conjugated to a human IgG4 Fc fragment via a polyethylene glycol linker. Preclinical and Phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for E versus pegfilgrastim (P). Two independent randomized Phase III trials comparing fixed dose E and P (E 3.6 mg G-CSF and P 6.0 mg G-CSF) for the management of chemotherapy-induced neutropenia (CIN) have recently been completed. Both trials met the primary endpoint of non-inferiority for E vs P in Cycle 1 duration of severe neutropenia (P Patients and Methods: Patients with early-stage breast cancer (ESBC) who were candidates for adjuvant or neoadjuvant chemotherapy were randomized 1:1 in two open-label Phase III trials to E 13.2 mg (3.6 mg G-CSF) or standard P (6 mg G-CSF) administered on Day 2 following TC (docetaxel/cyclophosphamide) chemotherapy on Day 1 of each of 4 cycles. Blood for CBC and serum chemistry was collected in every cycle. Safety assessments began with the first dose of TC and continued for one year after the last dose of study drug. AEs and laboratory values were graded according to NCI CTCAE version 4.03. Immunogenicity was assessed from blood samples collected on Day 1 of each cycle, at the end-of-treatment visit, and at 6- and 12-month follow-up visits. Results: A total of 660 patients who received at least one dose of eflapegrastim (n=334) or pegfilgrastim (n=326) were included in this integrated safety analysis. The two treatment groups were well balanced for demographics and baseline disease characteristics. The mean age was 59y, ~40% were aged >65y, ~54% weighed >75kg, and ~80% were treated in the adjuvant setting. Median relative dose intensity for T and C was >99% for both groups. A similar percentage of patients in both treatment groups discontinued treatment due to AEs (4% E vs 6% P), with 2% in each group discontinuing due to AEs related to E or P. Serious AEs were similar in both groups (15% each). Incidence of AEs irrespective of causality were also similar between groups (74% E vs. 72% P). No notable differences between groups were observed in the types of study-drug-related AEs. The majority of study-drug-related AEs occurred with an incidence ≤10% for both E and P. As expected with myeloid growth factors, study-drug-related AEs occurring in >10% in either group were bone pain (E vs P: 33% vs 34%), arthralgia (15% vs 10%), back pain (14% vs 9%), myalgia (14% vs 9%), and headache (11% vs 8%). Incidence of febrile neutropenia and neutropenic complications were similar and less than 5% in each treatment group. No leukocytosis, splenic rupture, or anaphylaxis was reported in any patient receiving E or P. The overall incidence of immunogenicity was similar in both groups and there was no demonstrable impact on clinical safety or efficacy. Conclusions: Two large, randomized Phase III trials (Total n=660) of E vs P administered once-per-cycle showed E at a lower G-CSF dose to be safe and effective for the prophylaxis of CIN in patients with ESBC receiving TC chemotherapy. E is a novel long-acting rhG-CSF with increased potency and similar toxicity to P and may provide an attractive alternative for growth factor support of patients at high risk for CIN-related complications. Citation Format: Lee S Schwartzberg, Gajanan Bhat, Julio Peguero, Richy Agajanian, Jayaram Bharadwaj, Alvaro Restrepo, Osama Hlalah, Inderjit Mehmi, Shanta Chawla, Francois Lebel, Patrick W Cobb. Eflapegrastim, a novel long-acting granulocyte-colony stimulating factor: Integrated safety results in patients with early-stage breast cancer treated with TC chemotherapy [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-14-12.

The copper-based metal-organic frameworks (Cu-MOFs) was synthesized via the hydrothermal method and modified by 1,2-ethanedithiol. Then the Cu-MOFs/poly (lactic acid) (PLA) composites with ...

Background: Eflapegrastim is a novel investigational biologic comprised of recombinant human G-CSF covalently linked to the human immunoglobulin G4FC fragment using proprietary LAPSCOVERY™ technology with potentially unique distribution to areas rich in FcRn receptors. RECOVER is the second Phase 3 study to investigate the non-inferiority (NI) of eflapegrastim to pegfilgrastim in patients receiving chemotherapy for breast cancer. The first Phase 3 study, ADVANCE, has demonstrated the non-inferiority of eflapegrastim comparing to pegfilgrastim in the duration of severe neutropenia (DSN) in breast cancer patients receiving docetaxel and cyclophosphamide (TC) and was previously published at ASCO 2018 meeting. TrialDesign: Patients with Stage I to Stage IIIA breast cancer from centers in the USA, Canada, Poland, Hungary, South Korea and India were treated on Day 1 of each of four 21-day cycles with adjuvant or neo-adjuvant TC. On Day 2 of each cycle, patients received a single subcutaneous dose of either eflapegrastim 13.2 mg/0.6 mL (equivalent to 3.6 mg G-CSF) or pegfilgrastim (6 mg) in a 1:1 ratio. Patients had CBCs drawn on Day 1 prior to chemotherapy and Days 4-15 daily or until recovery of neutropenia in Cycle 1. CBC was also collected on Days 1, 4, 7, 10 and 15 in Cycles 2-4. The primary endpoint was to demonstrate the non-inferiority of eflapegrastim comparing to pegfilgrastim as measured by the mean DSN in Cycle 1 with NI margin of Results: In a total of 237 intent-to-treat patients (randomized to 118 eflapegrastim; 119 pegfilgrastim), median age was 59 years (range 29 to 88 years); mean (SD) DSN was 0.31 (0.688) days for eflapegrastim and 0.39 (0.949) days for pegfilgrastim, demonstrating the non-inferiority (95% CI of ΔDSN: [-0.292, 0.129]; p Conclusions: Eflapegrastim, a novel long acting G-CSF demonstrated non-inferiority to pegfilgrastim in the reduction of DSN in breast cancer patients treated with TC and has validated the results from the first Phase 3 ADVANCE study. Eflapegrastim was safe and well-tolerated with a similar safety profile to pegfilgrastim. Citation Format: Schwartzberg L, Bhat G, Mezei K, Lang I, Moon YW, Senviratne L, Chawla S, Cobb P, Yang Z. Efficacy and safety of eflapegrastim confirmed in reducing severe neutropenia in breast cancer patients treated with myelosuppressive chemotherapy in the second Phase 3 randomized controlled multinational trial compared to pegfilgrastim (RECOVER trial) [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-13-05.

There are several types of sound absorptive materials, such as natural and synthetic fibers, acoustic mineral wool, acoustic polyester panels, acoustic foam, cotton batts, that reduce the acoustic energy of a sound wave as the wave passes through. In this work, the use of nonwoven materials made of cotton, polyester, and polypropylene fibers for the development of sound absorptive nonwoven materials has been investigated. Samples of different materials (cotton, cotton/polyester blend, polyester fibers needle punched, and polypropylene melt blown nonwoven) and multilayer structures were tested on the designed impedance tube. Acoustic absorption properties of the fiber assemblies were studied in the frequency region of 100–1500 Hz. The values of sound absorption coefficient for different samples indicated that polypropylene microfiber melt blown nonwoven sample displayed a good sound absorption behavior in the entire frequency range. The use of multilayer samples improves the sound absorption coefficient with the condition that one of the layers is a thin melt blown nonwoven layer. The formation of nonwoven absorbent material consisted of hybrid layers, significantly reduces the resultant average sound absorption coefficient, especially when the upper layer is made from finer fibers of melt blown nonwoven of low air permeability value, and in this case the improvement reaches 50%. The use of melt blown layers of fine fibers values of noise reduction coefficient may reach 0.8. The multilayer nonwoven sound absorber design should take into consideration specific noise reduction coefficient values, not the absolute ones, particularly when the weight of the absorber is playing a decisive role.

Introduction: Detection of ctDNA in plasma samples permits temporal assessment of tumor mutation status during treatment. Poziotinib is an oral pan-HER TKI that has been demonstrated to be efficacious in NSCLC patients harboring HER2 exon 20 insertion mutations. We assessed serial plasma samples for changes in tumor genotype in both treatment naive and second line patients to evaluate correlation with clinical response. Methods: For NSCLC patients, HER2 exon 20 insertion mutations identified by tumor tissue based NGS were required for entry into the ZENITH20 study. Plasma samples were collected prior to treatment and at C3D1 (8 weeks post treatment 16mg poziotinib QD). The Guardant360® 74-gene liquid biopsy assay, which assessed changes in ctDNA and, subsequently, mean variant allele fraction (mVAF), was utilized for analysis of samples. The Guardant360 Response™ Molecular Response (MR) algorithm was calculated as a ratio of mVAF of oncogenic alterations at baseline compared to poziotinib treatment at C3D1. Results: 23 patients with tumor tissue confirmed NSCLC harboring HER2 exon 20 insertion mutations were studied. 22 of 23 (96%) had baseline plasma samples with detectable ctDNA. 21 of 22 samples had detectable HER2 exon 20 insertion mutations, resulting in a concordance of 95% versus tissue based NGS. The most prevalent HER2 exon 20 insertion alteration was the A775_G776ins YVMA variant, found in 50% of the baseline blood and tumor samples using both methods (100% concordance). 16 of 17 patients had both baseline and C3D1 samples, permitting assessment of temporal response. 15 of the 16 (94%) patients demonstrated a decrease in mVAF at C3D1 compared to the mVAF at baseline. 12 of 15 patients demonstrated an >50% reduction in mVAF at C3D1, with 7 of the 12 patients showing >95% reduction in mVAF at C3D1 with clinical outcomes of 5 PRs, 1 non-CR/non-PD and 1 SD. Interestingly, 3 of these patients showed complete clearance of ctDNA target HER2 exon 20 insertions at the C3D1 timepoint. Conclusions: Baseline plasma ctDNA genotyping correlated with tumor tissue based NGS in an NSCLC patient population with HER2 mutations. Poziotinib treatment resulted in mVAF reduction, which correlated with clinical response per RECIST1.1. Assessment of longitudinal changes in ctDNA during drug therapy may potentially be used to predict patient response and possibly tumor resistance. Further evaluation in larger cohorts and longer duration of treatment is required to help elucidate the impact of these findings. Citation Format: Arunthi Thiagalingam, Sribalaji Lakshmikanthan, Allysia J. Mak, Scott A. Shell, Sharon Leu, Rocky Washington, Lyndah Dreiling, Gajanan Bhat, Francois Lebel, John A. Barrett. Predictive ability of circulating tumor DNA by Guardant360 in poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 3400.

3051 Background: ctDNA levels in plasma samples permits temporal assessment of tumor mutational status and tumor burden during therapy. Poziotinib is an oral HER2 TKI in development for NSCLC patients harboring HER2 exon 20 insertion mutations. We assessed serial plasma samples for changes in HER2 exon 20 insertion mutations and other driver mutations in first- and second-line patients comparing to clinical response per RECIST1.1. Methods: NSCLC patients harboring HER2 exon 20 insertion mutations were enrolled into the poziotinib ZENITH20 using tumor tissue based NGS. Serial plasma samples were collected at baseline, at C3D1, at Day 1 of every other cycle until disease progression. The Guardant360â 74-gene liquid biopsy assay was used to assess changes in tumor-associated somatic variants including the target variant HER2 exon20 insertion as well as other emergent driver mutations in ctDNA as expressed as percent variant allele frequency (%VAF). Results: 23 first- and second-line NSCLC patients were evaluable with tumor tissue confirmation of HER2 exon 20 insertion mutations. 22 of 23 (96%) had baseline plasma samples with detectable ctDNA. 21 of 22 samples had detectable HER2 exon 20 insertion mutations (mean % VAF 20±5) resulting in a concordance of 95% versus tissue based NGS. 7 patients had serial testing through C7D1 permitting assessment of ctDNA dynamics and comparison to clinical responses. 5 of 7 (71%) serially tested patients treated with poziotinib at 16mg QD had undetectable HER2 exon 20 insertion at C3D1 which was associated with a tumor response PR. Tumor escape (PD) was observed in 2 of the 5 patients which correlated with increases in target HER2 exon 20 insertion VAF in the plasma with the remaining 3 patients ≥PR. Notably, the rise in HER2 exon 20 in ctDNA occurred prior to tumor escape. In one patient treated with poziotinib at 16 mg QD we observed undetectable levels of the HER2 exon 20 insertion in ctDNA at C3D1 which continued through C16. This patient’s responses correlated with patient tumor response of SD at C2 which then became PR through C9 and CR through C17. Conclusions: Poziotinib treatment resulted in reductions in HER2 exon 20 insertion mutations in ctDNA preceded and correlated with the clinical tumor response. Increases in ctDNA HER2 exon 20 insertion mutations were observed prior to confirmation of tumor escape. Serial monitoring of ctDNA is a potential predictive biomarker for treatment response and disease progression. Future evaluation in a larger population is required to confirm the impact of these findings.

Most of the sequential importance resampling tracking algorithms use arbitrarily high number of particles to achieve better performance, with consequently huge computational costs. This article aims to address the problem of occlusion which arises in visual tracking, using fewer number of particles. To this extent, the mean-shift algorithm is incorporated in the probabilistic filtering framework which allows the smaller particle set to maintain multiple modes of the state probability density function. Occlusion is detected based on correlation coefficient between the reference target and the candidate at filtered location. If occlusion is detected, the transition model for particles is switched to a random walk model which enables gradual outward spread of particles in a larger area. This enhances the probability of recapturing the target post-occlusion, even when it has changed its normal course of motion while being occluded. The likelihood model of the target is built using the combination of both color distribution model and edge orientation histogram features, which represent the target appearance and the target structure, respectively. The algorithm is evaluated on three benchmark computer vision datasets: $\textit {OTB}100$ , $\textit {VOT}18$ and $\textit {TrackingNet}$ . The performance is compared with fourteen state-of-the-art tracking algorithms. From the quantitative and qualitative results, it is observed that the proposed scheme works in real-time and also performs significantly better than state-of-the-arts for sequences involving challenges of occlusion and fast motions.

Eflapegrastim (Rolontis®) is a novel, long‐acting hematopoietic growth factor consisting of a recombinant human granulocyte‐colony stimulating factor (rhG‐CSF) analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. We report results from a second pivotal, randomized, open‐label, Phase 3 study comparing the efficacy and safety of eflapegrastim to pegfilgrastim for reducing the risk of chemotherapy‐induced neutropenia. Patients with Stage I to IIIA early‐stage breast cancer (ESBC) were randomized 1:1 to fixed‐dose eflapegrastim 13.2 mg (3.6 mg G‐CSF) or pegfilgrastim (6 mg G‐CSF) administered one day after standard docetaxel/cyclophosphamide (TC) therapy for four cycles. The primary objective was to demonstrate noninferiority (NI) of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN; Grade 4) in Cycle 1. A total of 237 eligible patients were randomized 1:1 to receive either eflapegrastim (n = 118) or pegfilgrastim (n = 119). Cycle 1 severe neutropenia was observed in 20.3% (n = 24) of patients receiving eflapegrastim and 23.5% (n = 28) receiving pegfilgrastim. The DSN of eflapegrastim in Cycle 1 was noninferior to pegfilgrastim with a mean difference of −0.074 days (NI P‐value, This study demonstrates that eflapegrastim has noninferior efficacy to pegfilgrastim, at a lower G‐CSF dose, in all four cycles of TC treatment. Eflapegrastim had comparable safety to pegfilgrastim with no unexpected adverse events.

Flushable wipes have become popular among consumers who worry about environmental problems the world confronts today. However, whether these wipes have a positive effect on environmental protection is contradictory because of the lack of government regulations and legal obligations. Starting from this point, in this study, we characterized commercially available flushable products, which were manufactured from various raw materials by different production methods, in order to understand the relationship between their structure and performance properties. The results showed that production technology had a significant effect on the structural, mechanical, and dispersible properties of nonwovens. The disintegration percentage of nonwovens was inversely related to their wet strength. The findings of this study will be helpful in the design of new flushable nonwovens for improved wet strength and dispersibility performance.

Flushable wipes, which can be completely disintegrated and dispersed into sewage systems, are some of the disposable nonwoven products. Due to its ease of use, hygiene, efficiency, and consumers' environmental perception, flushable wipe market is growing rapidly. A truly flushable wipe should be biodegradable, dispersible, and compatible with water treatment systems. Flushable wipes can be produced by selecting appropriate materials and production technologies. Assessing the flushability performance of these products is quite important with regard to the environmental pollution. This review includes fibers and substrates, web forming and bonding technologies, which are used for making a truly flushable wipe. In addition, the test methods used for measuring flushability performance and standardization studies of the flushability tests are presented in this study, as well as the effect of wet wipes on the environment.

Dyeing wastewaters present high hazards for the environment and human health. Advanced dye removal may be achieved by magnetic metal–organic frameworks (MMOFs) due to their high adsorption and catalyst efficiencies. However, the existing synthesis strategies of frameworks are often cumbersome and time-consuming in the presence of toxic solvents. Hence, a simple and environmentally-friendly synthetic method is desired. Here, a kind of MMOF, Fe3O4/Cu3(BTC)2 (BTC = 1,3,5-benzenetricarboxylate), was synthesized via a novel aqueous solution-phase synthesis. The product Fe3O4/Cu3(BTC)2 has a high specific surface area of 755.15 m2 g−1, and excellent magnetic performance of 31.2 emu g−1. The Fe3O4/Cu3(BTC)2 can effectively remove methylene blue from wastewater in the presence of H2O2. After having been finished the dye removal, it was easily separated and recycled several times by use of the magnetic technology.

This randomized, open‐label, active‐controlled study investigated the safety and efficacy of three doses of Rolontis (eflapegrastim), a novel, long‐acting myeloid growth factor, versus pegfilgrastim in breast cancer patients being treated with docetaxel and cyclophosphamide (TC). The primary efficacy endpoint was duration of severe neutropenia (DSN) during the first cycle of treatment. Patients who were candidates for adjuvant/neoadjuvant TC chemotherapy were eligible for participation. TC was administered on Day 1, followed by 45, 135, or 270 μg/kg Rolontis or 6 mg pegfilgrastim on Day 2. Complete blood counts were monitored daily when the absolute neutrophil count (ANC) fell to

Carbon nanotube (CNT) yarns exhibit low tensile strength compared to conventional high-performance carbon fibers due to the facile sliding of CNTs past one another. Electron beam (e-beam) irradiation was employed for in a single-step surface modification of CNTs to improve the mechanical properties of this material. To this end, CNT yarns were simultaneously functionalized and crosslinked using acrylic acid (AA) and acrylonitrile (AN) in an e-beam irradiation process. The chemical modification of CNT yarns was confirmed by X-ray photoelectron spectroscopy (XPS), Raman spectroscopy and scanning electron microscopy (SEM). The best improvement in mechanical properties was achieved on a sample treated with an aqueous solution of AA and subsequent irradiation. CNT yarn treatment with AA enhanced the strength (444.5 ± 68.4 MPa) by more than 75% and the modulus (21.5 ± 0.6 GPa) by more than 144% as compared to untreated CNT yarn (strength 251 ± 26.5 MPa and modulus 8.8 ± 1.2 GPa).

For the first time, uniform distribution of surface functionalized carbon nanofibers (CNFs) has been achieved in low molecular weight (≈120,000 g/mol) textile grade-polyacrylonitrile (PAN)-based composite filaments. Surface grafting of CNFs with acrylonitrile enhances the dispersion of nanofibers in PAN fiber matrix. XPS study reveals high atomic nitrogen content (7%) on the CNF surface due to the grafting reaction. The solution-spun filaments have been characterized for distribution of CNFs in the PAN matrix by electron microscopy. PAN composite filaments containing 3.2 wt.% CNF and processed at draw ratio of ≈6.3 exhibit enhanced tensile strength and modulus by more than three folds compared to the control PAN filament. Because of chemically compatible surface modification of the nanofibers, better dispersion and improved mechanical properties were accomplished in the reinforced PAN fibers. This should allow the production of CNF reinforced carbon fibers with improved tensile properties. An increase in CNF loading (6.4 wt.%), however, reduced performance due to inefficient alignment of CNF along the fiber axis. Nevertheless, hot stretching (at draw ratio ≈ 10) of the filaments enhanced tensile strength and elastic modulus of PAN composite filaments by 20–30% compared to the control hot stretched PAN filaments.

To develop degradable and magnetic PLA-based melt-blown (MB) nonwoven materials for air filtration applications, poly (lactic acid) (PLA)/magnetic Fe3O4 (PLA/Fe3O4) MB nonwovens were obtained by melt blowing using the PLA/Fe3O4 composites with different components prepared by melt-mixing as the masterbatch. The crystallization and melting behavior of the composites were examined with differential scanning calorimetry (DSC). Although the results showed that the Fe3O4 particles obviously hindered the cold crystallization process of PLA and the relative crystallinity degree of the composites decreased due to the addition of Fe3O4; there was no overall change in the crystal structure of PLA according to the wide-angle X-ray diffraction (XRD). Thermogravimetric analysis (TGA) and dynamic rheological measurements demonstrated that the introduction of Fe3O4 reduced the thermal stability of PLA. The effect of Fe3O4 particles on the morphology of the PLA/Fe3O4 composites and MB nonwovens was characterized by scanning electron microscopy (SEM). It revealed that the Fe3O4 particles were dispersed in a PLA mixture with the “sea-island” structure, and the addition of Fe3O4 particles also made the fiber surface rough and the nonwoven web turned fluffy to some extent. The magnetic properties and filtration performance of the MB nonwovens were also investigated in detail.

Background: Eflapegrastim (Rolontis®, Efla) is a long-acting granulocyte-colony stimulating factor (G-CSF), consisting of a recombinant human G-CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Efla is not a biosimilar and represents the first myeloid growth factor innovation in more than 15 years. In preclinical studies with chemotherapy-induced neutropenic rats, Efla showed ~3-fold higher exposure in serum and higher exposure in bone marrow at similar doses compared to pegfilgrastim (Peg). The duration of neutropenia (DN) was shown to be significantly shorter with Efla vs Peg when administered on the same day or 24-hours post-chemotherapy. Additionally, the DN after Efla administered on the same day as chemotherapy was similar to the DN 24 hours post-chemotherapy. Moreover, in two Phase 3 studies that randomized a total of 643 patients with early-stage breast cancer (ESBC) to either Efla (3.6 mg G-CSF n=314) or Peg (6 mg G-CSF n=329) given ~ 24 hours after docetaxel and cyclophosphamide (TC), the duration of severe neutropenia (DSN) was statistically noninferior in patients treated with Efla compared to Peg. As a standard of practice, G-CSF products require administration 24 hours after chemotherapy. Since Efla preclinical and clinical results suggest that the increased activity of Efla may provide effective prophylaxis against chemotherapy-induced neutropenia when administered on the same day as chemotherapy, the purpose of this study is to assess the feasibility of giving Efla same-day (at 3 different dosing timepoints) in patients receiving TC for the treatment of ESBC. Study Design and Methods : This is a randomized, schedule finding, multicenter, Phase 1, open-label study evaluating the same-day administration of 13.2 mg/0.6 mL Efla following IV infusion of docetaxel (75 mg/m2) and cyclophosphamide (600 mg/m2) in patients with ESBC. Treatment: On Cycle 1, Day 1, patients will be randomized 1:1:1 to Efla dose administration schedules of 0.5, 3, and 5 hours after TC. In Cycles 2-4, Efla will be administered ~ 24 hours following the administration of TC for all treatment arms. Clinical Endpoints: The primary endpoint is DSN (ANC Inclusion Criteria: This study is enrolling histologically confirmed (operable stage I-IIIA) patients with ESBC, who are >18 years of age, are candidates for neoadjuvant or adjuvant TC, have an ECOG of Exclusion Criteria: Patients will be excluded if they have an active or concurrent malignancy, or locally recurrent/metastatic or bilateral breast cancer, a life-threatening disease, a known sensitivity or previous reaction to E. coli derived products, exposure to a G-CSF agent within 3 months, history of bone marrow or hematopoietic stem cell transplant, radiotherapy or surgery within 30 days, are pregnant or are breast-feeding. Statistical Methods: A sample size of 15 patients per dosing schedule arm was determined to provide adequate precision for the 95% CI of the DSN and secondary endpoints, including PK parameters, assuming a standard deviation of 1.0 days based on the prior studies. A safety evaluation will be performed once the first three patients in each arm have completed Cycle 1. Target Accrual: 45 patients (15 subjects/arm). Enrollment began in April 2020. Disclosures Schwartzberg: Spectrum Pharmaceuticals, Inc.: Consultancy, Other: clinical investigator for trial. Francis:Spectrum Pharmaceuticals, Inc.: Other: clinical investigator for trial. Osama:Spectrum Pharmaceuticals, Inc.: Other: clinical investigator for trial. Modiano:Spectrum Pharmaceuticals, Inc.: Other: clinical investigator for trial. Bharadwaj:Spectrum Pharmaceuticals, Inc.: Other: clinical investigator for trial. Chawla:Spectrum Pharmaceuticals, Inc.: Current Employment, Current equity holder in publicly-traded company. Bhat:Spectrum Pharmaceuticals, Inc.: Current Employment, Current equity holder in publicly-traded company. Lebel:Spectrum Pharmaceuticals, Inc.: Current Employment, Current equity holder in publicly-traded company. Tchekmedyian:Spectrum Pharmaceuticals, Inc.: Other: clinical investigator for trial.