bluuebunny/crossref_metadata_2025_split huggingface dataset:
ESTSS—energy system time series suite: a declustered, application-independent, semi-artificial load profile benchmark set
Authors: Günther Sebastian , Brandt Jonathan , Bensmann Astrid , Hanke-Rauschenbach Richard 
Published: January 2024

AbstractThis paper introduces an univariate application-independent set of load profiles or time series derived from real-world energy system data. The generation involved a two-step process: manifolding the initial dataset through signal processors to increase diversity and heterogeneity, followed by a declustering process that removes data redundancy. The study employed common feature engineering and machine learning techniques: the time series are transformed into a normalized feature space, followed by a dimensionality reduction via hierarchical clustering, and optimization. The resulting dataset is uniformly distributed across multiple feature space dimensions while retaining typical time and frequency domain characteristics inherent in energy system time series. This data serves various purposes, including algorithm testing, uncovering functional relationships between time series features and system performance, and training machine learning models. Two case studies demonstrate the claims: one focused on the suitability of hybrid energy storage systems and the other on quantifying the onsite hydrogen supply cost in green hydrogen production sites. The declustering algorithm, although a bys study, shows promise for further scientific exploration. The data and source code are openly accessible, providing a robust platform for future comparative studies. This work also offers smaller subsets for computationally intensive research. Data and source code can be found at https://github.com/s-guenther/estss and https://zenodo.org/records/10213145.
Integral imaging near-eye 3D display using a nanoimprint metalens array
Authors: Fan Zhi-Bin , Cheng Yun-Fan , Chen Ze-Ming , Liu Xia , Lu Wen-Long , Li Shi-Hao , Jiang Shao-Ji , Qin Zong , Dong Jian-Wen 
Published: January 2024

AbstractIntegral imaging (II) display, one of the most critical true-3D display technologies, has received increasing research recently. Significantly, an achromatic metalens array has realized a broadband metalens-array-based II (meta-II). However, the past micro-scale metalens arrays were incompatible with commercial micro-displays; furthermore, the elemental image array (EIA) rendering is always slow. The two hinders in device and algorithm prevent meta-II from being used for practical video-rate near-eye displays (NEDs). This research demonstrates a meta-II NED combining a commercial micro-display and a metalens array. The large-area nanoimprint technology fabricates the metalens array, and a novel real-time rendering algorithm is proposed to generate the EIA. The hardware and software efforts solve the bottlenecks of video-rate meta-II displays. We also build a see-through prototype based on our meta-II NED, demonstrating the feasibility of augmented reality. Our work explores the potential of video-rate meta-II displays, which we expect can be valuable for future virtual and augmented reality.
Neoadjuvant botensilimab plus balstilimab in resectable mismatch repair proficient and deficient colorectal cancer: NEST-1 clinical trial.
Authors: Kasi Pashtoon Murtaza , Jafari Mehraneh D. , Yeo Heather , Lowenfeld Lea , Khan Uqba , Nguyen Alana , Siolas Despina , Swed Brandon , Khan Sahrish , Wood Madeleine , Ocean Allyson J. , Popa Elizabeta C. , Garrett Kelly A. , Golden Encouse , Guniganti Preethi , Zhou Xi K. , Pigazzi Alessio , Shah Manish A. , Hissong Erika , Hidalgo Manuel 
Published: January 2024

117 Background: There is an unmet need to have an effective systemic immunotherapeutic option for patients with mismatch repair proficient/microsatellite stable (pMMR/MSS) colorectal cancer. The neoadjuvant platform presents an ideal setting as a window of opportunity to evaluate new drugs. The NEST-1 trial explored the safety and efficacy of neoadjuvant botensilimab (BOT), an Fc-enhanced next-generation anti–CTLA–4 antibody, alongside balstilimab (BAL; an anti-PD-1 antibody) in patients with colon and rectal cancer who were candidates for surgery. Methods: NEST-1, was a single-arm trial testing the feasibility, safety, and efficacy of the BOT/BAL regimen in neoadjuvant settings for patients with colorectal cancer before resection. All patients received 1 fixed dose of 75 mg of BOT and 2 fixed doses of 240 mg of BAL 2 weeks apart. Patients could proceed to surgery 1 week after completion of the 2nd dose of BAL. Less than 25% of patients were allowed to be mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H). Other inclusion and exclusion criteria were in accordance with ongoing immunotherapy-based clinical trials. Results: The study met its primary endpoints. A total of 12 patients with colon and rectal cancers were safely treated with the BOT/BAL combination without delaying surgery or increasing the risk of any severe adverse events. Significant regression of tumors was noted (Table). Spatial biology analyses on pre-treatment biopsy and post-treatment surgical samples using RareCyte Inc. revealed novel mechanisms of action and patterns of response/regression; most of the viable tumor if present was superficially oriented near the luminal surface. ctDNA reductions correlated with pathological responses. Conclusions: BOT/BAL appears to be a safe and active regimen both in pMMR/MSS and dMMR/MSI-H colon as well as rectal cancers. The downstaging observed may spare surgery and/or adjuvant chemotherapy. Given the findings, the study has now expanded to two additional cohorts that are now enrolling to study further the dosing, and timing and/or need for surgery in these patients. Clinical trial information: NCT05571293 . [Table: see text]
BOLD-100-001 (TRIO039): A phase 2 study of BOLD-100 in combination with FOLFOX in patients with advanced mCRC previously treated with FOLFOX/CAPOX—Efficacy and safety analysis.
Authors: Spratlin Jennifer L. , O'Kane Grainne M. , Oh Do-Youn , Rha Sun Young , McWhirter Elaine , Elimova Elena , Kavan Petr , Choi Moon Ki , Kim Dae Won , Goodwin Rachel Anne , Hecht J. Randolph , Kim Seung Tae , Koo Dong-Hoe , Halani Khalif , McAllister E. Russell , Jones Michelle , Snow Malcolm , Lemmerick Yasmin , Spera Gonzalo , Pankovich Jim 
Published: January 2024

143 Background: BOLD-100 is a first-in-class metallotherapeutic with a unique multimodal mechanism of action currently in phase 2 clinical development for the treatment of advanced gastrointestinal cancers. Standard treatment options for patients (pts) with metastatic colorectal cancer (mCRC) include FOLFOX or CAPOX in first or second line therapy. This study explored the benefit of BOLD-100 + FOLFOX in previously treated mCRC patients. Methods: This prospective, phase 2 study evaluates BOLD-100 + FOLFOX in pts with mCRC. All pts received prior standard treatment, including FOLFOX or CAPOX. Pts received 625 mg/m2 of BOLD-100 + FOLFOX on day 1 of each 14-day cycle and treated until progressive disease or unacceptable toxicity. The primary objective is to evaluate PFS, OS, and ORR in treated patients. Disease Control Rate (DCR) was also determined. Results: As of 31Aug2023, 36 pts with advanced mCRC were treated. Median age was 62 years (range 40-78), 56% were women, all pts were ECOG 0 (25%) or 1 (75%). Enrolled pts had a median of 4 prior systemic therapies, including FOLFOX/CAPOX. All but one patient had stage IV disease. On study, pts received a median of 6 cycles of BOLD-100 + FOLFOX [range 1-17]. Five pts remain on treatment with 19 in follow-up. Median PFS was 3.9 [2.7, 5.7] months, median OS 9.6 [6.0, 17] months, ORR 7% [1,20] and DCR 76% [58, 88] in the 29 evaluable pts. Two pts achieved a partial response, and 2 pts had target tumor lesion decreases between 20-29%. Study treatment was well tolerated. Of the 36 treated pts, 33 had 1 or more treatment-emergent adverse events (AEs), most common neutropenia (n=17, 47%), nausea (n=15, 42%), vomiting (n=8, 22%), fatigue (n=7, 19%), infusion related reaction (n=7, 19%), and pruritus (n=6, 17%). Most related AEs were grade (G) 1-2. 15 pts (42%) had G3/4 neutropenia. Despite previous oxaliplatin treatment, fewer than 6% of pts reported peripheral neuropathy or peripheral sensory neuropathy and all were G1/2. Conclusions: BOLD-100 + FOLFOX is an active and well-tolerated treatment in this heavily pre-treated Stage IV mCRC study population. There were no new safety signals. The mPFS, mOS, ORR and DCR data demonstrate significant clinical benefit and improvement over the currently available therapies, with minimal treatment emergent neuropathy or significant toxicities. This promising treatment combination should be further studied. Clinical trial information: NCT04421820 .
Metachronous remnant gastric cancer after proximal gastrectomy.
Authors: Ishizu Kenichi , Yoshikawa Takaki , Ogawa Rei , Nishino Masahi , Sakon Ryota , Wada Takeyuki , Hayashi Tsutomu , Yamagata Yukinori 
Published: January 2024

260 Background: Proximal gastrectomy is frequently selected for early gastric cancer located at the upper third of the stomach. Annual postoperative endoscopy is considered to be useful for the early detection of metachronous remnant gastric cancer (MRGC). Despite that, we sometimes have also encountered cases that are not suitable for endoscopic resection (ER). The aim of this study is to identify the risk factors for the patients who developed MRGC after proximal gastrectomy, received annual endoscopy, but are not eligible for ER (non-ER). Methods: We retrospectively analyzed 191 patients who had received annual endoscopic surveillance after undergoing PG for cT1 gastric cancer at NCCH between 2006-2015. MRGCs were categorized into two groups: ER group and non-ER group. The remnant stomach was defined as three locations: pseudo-fornix (PF), corpus and antrum. Results: The median observation period was 73 (range 12-168) months. MRGC was observed in 29 cases with 32 lesions. ER was eligible for 20 lesions (ER group, 62.5%), but 12 were not (non-ER group, 37.5%). We compared the characteristics between of ER group and non-ER group in terms of sex, age (>65 years), interval from the initial surgery (>60months), the location (PF vs non-PF), and cross-sectional circumference (posterior wall vs. others). In both univariate and multivariate logistic regression analysis, only the location at PF was identified as a risk factor for non-ER group (OR 25.0, 95% CI: 1.8–339, p = 0.015). Among 12 lesions of the non-ER group, the location of PF was found in 6 (50%) lesions. As compared with MRGC at the non-PF, that at the PF (n = 6) was characterized by younger patients (57.5 (range 37-69) years vs. 69 (56-77) years), larger size (36 (7-57) mm vs. 9 (9-24) mm), deeper depth (MP or deeper; 5/6 vs. 0/6), more frequent undifferentiated-type histology (4/6 vs. 0/6) and frequent nodal metastasis (3/6 vs. 0/6). The interval to detect MRGC appears to be longer in the PF (78 (31-96) months than that of the non-PF (60 (31-96) months), but the difference was not statistically significant (p = 0.86). Then, we examined the visibility and the mucosal normality of the area developing MRGC in the annual follow-up endoscopy one year before the detection of MRGC (n =32). In 25 lesions at the non-PF, the visibility and the mucosal normality was secured in 21 (84%). while 5 PF lesions were difficult to observe (71.4%, p = 0.01) due to food residues in 4 (57%, p = 0.047) and insufficient expansion of the gastric mucosa in 4 (57%, p = 0.001). Conclusions: Detection of the MRGC at the PF at an early stage is crucial and challenging. With annual follow-up endoscopy, complete clearance and adequately extending the gastric mucosa could lead to the early detection of MRGC at the PF.
Safety and short-term efficacy of adjuvant nivolumab after neoadjuvant docetaxel, cisplatin, and fluorouracil for locally advanced esophageal squamous cell carcinoma.
Authors: Okunaka Mashiro , Kotani Daisuke , Sato Kazuma , Fujiwara Naoto , Mishima Saori , Shitara Kohei , Fujita Takeo , Kojima Takashi 
Published: January 2024

271 Background: Efficacy and safety of adjuvant nivolumab has been demonstrated in patients with locally advanced esophageal cancer who received neoadjuvant chemoradiotherapy followed by surgery and had residual pathological disease in the CheckMate-577 trial. Although neoadjuvant docetaxel, cisplatin, and fluorouracil (DCF) is the standard neoadjuvant therapy for patients with locally advanced esophageal squamous cell carcinoma (ESCC) in Japan based on the JCOG1109 study, the safety and efficacy of adjuvant nivolumab in this population remains unclear. Here, we report the short-term safety and efficacy of adjuvant nivolumab after neoadjuvant DCF in patients with locally advanced ESCC. Methods: We retrospectively reviewed medical records of patients who received adjuvant nivolumab after neoadjuvant DCF and surgery for locally advanced ESCC from Nov 2021 to Jun 2023 at National Cancer Center Hospital East. Pathological stage was classified by UICC-TNM 8th edition. Adverse events were assessed according to CTCAE v5.0. Disease-free survival (DFS) was calculated by Kaplan-Meier method. Results: The study included a total of 33 patients with a median age of 67 years (range, 56-77), of which 29 patients were male. All patients had residual pathological disease, with ypStage I/II/III/IV of 5/1/16/11 patients. Median time from surgery to the initiation of adjuvant nivolumab was 10.6 weeks (range, 7.1-16.4 weeks). Treatment-related adverse events (TRAEs) occurred in 27 patients (82%), with pruritus (n = 13, 39%), rash (n = 7, 21%), hypothyroidism (n=7, 21%), xerosis (n = 6, 18%), diarrhea (n = 5, 15%), hypopituitarism (n = 5, 15%), pneumonitis (n = 1, 3%), and hepatic dysfunction (n = 1, 3%). Among these TRAEs, one patient developed grade 3 of hepatic dysfunction, which resolved with corticosteroid. TRAEs which led to discontinuation of nivolumab were hepatic dysfunction (n = 1, 3%), diarrhea (n = 1, 3%), and pneumonitis (n = 1, 3%). No treatment-related death was observed. With a median follow-up of 10.3 months, 1-year DFS rate was 63.3% (95% CI, 39.8-79.7%). Among 9 patients who experienced recurrence (locoregional; n = 3, distant; n = 6), 8 patients received subsequent therapy, including systemic chemotherapy (n = 5) and salvage chemoradiotherapy (n = 3). Conclusions: The safety and short-term efficacy of adjuvant nivolumab after neoadjuvant DCF and surgery was comparable to the results of the CheckMate-577 trial. Our study suggests that adjuvant nivolumab might be a possible treatment option in patients with locally advanced ESCC patients with residual pathological disease after neoadjuvant DCF followed by surgery.
Tumor regression grade after neoadjuvant chemotherapy in patients with locally advanced gastric cancer treated with modern chemotherapy (FLOT): Experience in patients in Guatemala.
Authors: Ramirez Rixci , Rosales-Lopez Daniel Estuardo , Dominguez Jennifer , Camey Carolina , Ovalle Julia 
Published: January 2024

287 Background: Perioperative chemotherapy is the standard of care for locally advanced gastric cancers in Western populations. At this moment perioperative chemotherapy with FLOT (Fluorouracil, leucovorin, oxaliplatin and docetaxel) regimen is recommended in patients who are medically fit with benefit in progression-free survival (PFS) and overall survival (OS). However, the impact of response to this treatment is not well established. The objective of this study is to find the pathological response to FLOT chemotherapy measured by the degree of tumor regression (TRG), the benefit on disease-free survival (DFS) and OS, in patients with gastric cancer locally advanced treated with FLOT chemotherapy. Methods: Patients from the Instituto Guatemalteco de Seguridad Social (IGSS) from Guatemala City, who underwent radical gastrectomy for non-metastatic invasive gastric adenocarcinoma after perioperative chemotherapy (T1-4/N0/N+cM0) from 2019 to 2023 were included. Demographic data, clinical staging, histologic phenotype, surgical factors, tumor regression grade after gastrectomy and survival outcomes were included. The association between ORR and OS were evaluated. OS and DFS were estimated using the Kaplan Meier method with adjustment for covariates using Cox regression. Results: Thirty-eight patients with locally advanced cancer gastric were identified. The median age was 58 years (29-79), most of the patients were men (23, 61%), 35 (92%) patients have primary gastric tumor, 26 (68%) has cT3/T4 tumors and 22 (58%) has intestinal gastric cancer, all patients underwent to surgery. Two patients (6%) had TRG of 1 (complete and almost complete), 8 patients (21%) had an TGR of 2, and 28 patients (74%) had an TGR of 3; 13 patients (38%) developed recurrence, median DFS was 5.2 months (95% CI: 1.0–28). The median OS was 15.3 months (95% CI: 3.0-45). Lack of tumor regression (TRG 3) was significantly associated with lower survival HR 1.42 (1.05-2.24) p= 0.008. Clinical T4 tumors and diffuse histology were associated with poor prognostic (cT4 HR 3.04, p = 0.038, diffuse histology HR 2.08 (p = 0.001) (Table). Conclusions: Since cT4 tumors are an independent risk factor associated with poor prognostic HR 3.04, p = 0.038, it is important to make an adequate clinical staging before deciding to use three-drug treatment regimens of chemotherapy. Other factors in addition to clinical ones should be investigated, such as molecular factors that may be related to this poor response and survival in patients with cT4. This study of molecular factors is currently underway at our institution. [Table: see text]
HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.
Authors: Li Jin , Gao Yong , Li Ning , Qiu Meng , Zhang Yan-Qiao , Yang Mudan , Lu Linzhi , Li Wei , Ma Yuntao , Hou Xiaoming , Sun Guoping , Cai Mingquan , Wang Jingran , Lu Jianwei , Zhong Diansheng , Yang Futang , Li Jing , Wang Qingyu , Zhu Jun ,   HLX22-GC Investigators
Published: January 2024

354 Background: Gastric/gastroesophageal junction (G/GEJ) cancer represents a global healthcare challenge. With more than 1 million new cases estimated in 2020, it ranked fifth among all cancers. HER2 amplification or overexpression were reported in around 20% of advanced G/GEJ cancer cases. Despite the improved overall survival with trastuzumab plus chemotherapy, the prognosis remains unsatisfactory, and thus more effective treatments are needed. This study aimed to evaluate the combination of HLX22 (a novel anti-HER2 monoclonal antibody), HLX02 (a trastuzumab biosimilar), and chemotherapy for patients with G/GEJ cancer in the first-line setting. Methods: The study was unblinded 3 months after the last patient was enrolled. Patients with locally advanced or metastatic HER2-positive G/GEJ cancer and had not received prior systemic antitumor therapy were enrolled. The study consisted of 2 parts; current report will focus on part 1. In part 1, patients were randomized 1:1:1 to receive HLX22 25 mg/kg + HLX02 + XELOX (group A), HLX22 15 mg/kg + HLX02 + XELOX (group B), or placebo + HLX02 + XELOX (group C) in 3-week cycles. Primary endpoints were PFS and ORR assessed by IRRC per RECIST v1.1. Secondary endpoints included other efficacy measures and safety. Results: As of July 30, 2023 (data cutoff), 53 patients were randomized to group A (n=18), B (n=17), and C (n=18), and were followed up for a median of 14.3 months. 44 (83.0%) patients were male. Main efficacy results are presented in Table. Tumor assessments reported in Table were performed by IRRC. Treatment-related adverse events (TRAEs) occurred in 18 (100.0%), 16 (94.1%), and 17 (94.4%) patients in the respective groups. Serious TRAEs were observed in 5 (27.8%) patients in group A, 1 (5.9%) in group B, and 1 (5.6%) in group C. Only 1 (5.6%) patient in group C had a grade 5 TRAE. Conclusions: Adding HLX22 to HLX02 + XELOX improved survival and antitumor response in patients with HER2-positive G/GEJ cancer in the first-line setting, with a manageable safety profile. Clinical trial information: NCT04908813 . [Table: see text]
Real-world clinical efficacy of epidermal growth factor receptor inhibitors (EGFRi) in patients with early-onset (eo), metastatic colorectal cancer (mCRC).
Authors: Bando Hideaki , Misumi Toshihiro , Pittell Harlan , Ng Dionne , Tajima Eri , Royce Trevor Joseph , Altomare Ivy , Paliwal Prashni , Aoyagi Yoshihiro , Mizuguchi Kazuya , Suzuki Motoko , Takeda Yuriko , Yoshino Takayuki , Ohtsu Atsushi 
Published: January 2024

36 Background: The incidence of eo CRC (age of onset: <50 years) is rising globally, although specific reasons remain unknown. In a prior study using the ARCAD database, the addition of EGFRi to chemotherapy (chemo) significantly improved progression-free survival (PFS) in late-onset (lo) KRAS wild-type (wt) left-sided mCRC patients (pts); however, no such effect was observed in eo mCRC pts (Jin Z et al., 2022). Methods: This retrospective study used the nationwide Flatiron Health electronic health record-derived de-identified database of adult patients diagnosed with mCRC on/after January 1, 2013 with data cut-off on June 30, 2023. The cohort included pts with RAS/BRAF wt and left-sided primary tumors who were treated with first-line (1L) chemo+EGFRi, chemo+bevacizumab (bev), or chemo alone. Associations of disease onset and 1L therapy with real-world overall survival and time to next treatment (rwOS, rwTTNT) were assessed using Kaplan-Meier methods and hazard models adjusted for clinical confounders including year of metastatic diagnosis, group stage at initial diagnosis, site of disease, gender, race/ethnicity, and ECOG performance status. Results: Among 895 left-sided RAS/BRAF wt mCRC pts, 216 and 679 pts had eo and lo mCRC, respectively. In pts treated with chemo+EGFRi vs chemo alone, the adjusted hazard ratio (HR) (95% CI) of rwTTNT was 0.93 (0.56-1.53) and 0.77 (0.58-1.02) for eo and lo pts, respectively; the adjusted HR (95% CI) of rwOS was 0.96 (0.51-1.83) and 0.78 (0.57-1.07) in eo and lo pts, respectively. In pts treated with chemo+bev vs chemo alone, the adjusted HR (95% CI) of rwTTNT was 1.00 (0.62-1.60) and 0.75 (0.58-0.97) for eo and lo pts, respectively; the adjusted HR (95% CI) of rwOS was 0.97 (0.54-1.75) and 0.78 (0.58-1.03) in eo and lo pts, respectively. Conclusions: Adding EGFRi to chemotherapy suggested potential improvements in rwTTNT and rwOS in lo pts but not in eo pts, similar to findings from the prior ARCAD database study. Such differences in outcomes, similarly observed in pts treated with chemo+bev, underscore the need for tailored therapeutic strategies. Given the wide confidence intervals in this study, future research with larger patient cohorts or longer follow-up may yield more precise estimates of these differences. [Table: see text]