bluuebunny/crossref_metadata_2025_split huggingface dataset:
Endoscopic surgery combined chemoradiotherapy and PD-1 blockade in patients with sinonasal mucosal melanoma.
Authors: Yan Li , Song Xiaole , Wang Xiaoshen , Yu Hongmeng 
Published: July 2024

e21552 Background: Primary sinonasal mucosal melanoma (SNMM) is a rare and aggressive disease different from cutaneous melanoma. The best treatment modality including the role of immune checkpoint blockade in SNMM has not been defined. Methods: Between 2021 and 2023, patients with previously untreated sinonasal melanoma were enrolled by three single-center investigator-initiated phase II clinical trials (ChiCTR2100046498 / ChiCTR2100045797/ ChiCTR2100049031). Eligible patients in ChiCTR2100045797 trial received postoperative radical chemoradiotherapy combined with toripalimab (a PD-1 inhibitor) for a year or until the disease progressed. Eligible participants in ChiCTR2100046498 study received surgery combined with radiation without immunotherapy. And for patients in ChiCTR2100049031 study, preoperative radiation was carried out firstly. The locoregional control, distant metastasis-free survival (DMFS), and overall survival (OS) were the main efficacy goals. Results: Fifty-four patients were enrolled (mean age 62 years, 33 males [61.1%] and 21 women [38.9%]) with 2y-OS rate 62.3±7.9%, 2y-RFS rate 67.1±8.2%, and 2y-DMFS rate 63.9±8.1%. Patients with T3 (n = 23), T4a (n = 14), and T4b (n = 17) stages, including12 patients with node-positive disease, were included at baseline. During a median follow-up of 11 months, 19 patients ultimately died, 10 experienced relapses, and 17 developed metastases. Tumor T staging was demonstrated to be an independent prognostic predictor according to the Cox univariate analysis. The primary factor contributing to a poor prognosis and the primary cause of death for 73.7% of patients was distant metastases. Preoperative radiation had an improved long-term survival with 2y-OS rate of 85.7±13.2%, and it can considerably lower the risk of distant metastases (p≤0.05). The overall survival rate for patients receiving postoperative chemoradiotherapy combined with immunotherapy was higher than that for patients not receiving immunotherapy (2y-OS rate 74.1±11.4% vs. 39.3±15.8%), although the difference was not statistically significant due to a small number of patients (p = 0.16). No immune-related adverse effects grade≥3 was recorded. Conclusions: The primary cause of the poor prognostic performance of SNMM is distant metastasis. The risk of distant metastases might be considerably decreased by preoperative radiation treatment. Surgery combined with radiation and immunotherapy could bring promising survival benefit. The way forward may involve investigating the combination of immunotherapy and preoperative radiotherapy. Clinical trial information: NCT04879654 ; NCT05009446 .
Safety and efficacy of PEG-rhG-CSF as primary prophylaxis against neutropenia induced by combination chemotherapy regimens involving oral chemotherapy agents in gastrointestinal cancer patients: A prospective, exploratory, non-randomized controlled study.
Authors: Zhao Jun , Wang Hui , Zhang Gehong , Zhang Xiaoling , Du Yunyi , Ma Ning , Yang Wei , Yang Bo , Gao Yangjun , Wang Mei , Cai Linlin , Feng Tingting , Zhang Na , Yang Suxia , Guo Xiaobo , Wang Ouxiang 
Published: July 2024

e24107 Background: The safety and efficacy of PEGylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) for prevention of chemotherapy-induced neutropenia (CIN) in patients undergoing oral chemotherapy remain unclear. This study investigated the safety and efficacy of PEG-rhG-CSF as primary prophylaxis against CIN in gastrointestinal (GI) cancer patients receiving combination chemotherapy regimens involving oral chemotherapy agents. Methods: This is a prospective, single-center, open-label, exploratory, non-randomized controlled study. GI cancer patients receiving two consecutive cycles of IV oxaliplatin (150mg/m2 on day 1) combined with oral capecitabine 1000mg/m2 or tegafur gimeracil oteracil potassium capsule 40-60mg twice daily on days 1-14 every 3 weeks. PEG-rhG-CSF (6mg) was administered subcutaneously 24 hours post-oxaliplatin treatment in the PEG-rhG-CSF group, while the control group did not receive it. The primary endpoint was safety, and secondary endpoints included CIN incidence and neutropenic complications. The study was registered with the Chinese Clinical Trial Registry (registration number ChiCTR2100054854). Results: Between March 2022 and January 2023, a total of 49 patients was screened, and 43 patients completed the treatment (26 in PEG-rhG-CSF group and 17 in control group). The average age was 61.4 years, with 90.7% males and 83.7% having gastric cancer. Baseline characteristics were similar between the two groups. The overall adverse events (AE) did not differ statistically (88.5% vs. 88.2%, p = 1.000), with grade £2 fatigue and nausea being the most common AEs. Grade 3 platelet reduction showed no significant difference between the two groups (7.69% vs. 17.65%, p = 0.432). Four cases of bone pain (15.4%) and five cases of injection site reactions below grade 3 (19.2%) were observed in the PEG-rhG-CSF group. Grade ≥2 CIN was significantly lower in the PEG-rhG-CSF group (3.84% vs. 58.82%, p < 0.001). One case in the PEG-rhG-CSF group required antibiotic treatment due to febrile neutropenia. Regarding neutropenic complications, the PEG-rhG-CSF group exhibited lower proportion of chemotherapy delay (3.85% vs. 35.29%, p < 0.001) and dose reduction (1.92% vs. 23.53%, p = 0.002). Rescue treatment with rhG-CSF for grade 3/4 CIN was significantly less frequent in the PEG-rhG-CSF group (1.92% vs. 23.53%, p = 0.002). Conclusions: Primary prophylaxis with PEG-rhG-CSF in GI cancer patients undergoing oral capecitabine/tegafur gimeracil oteracil potassium may be safe, without an increased chemotherapy-related AEs, and is associated with a reduced grade ≥2 CIN. Clinical trial information: ChiCTR2100054854.
Understanding discordance in systematic reviews for treating chemotherapy-induced peripheral neuropathy: A focused umbrella review.
Authors: Ye Alice , Butt Ahmed , Geng Yimin , Abdi Salahadin 
Published: July 2024

e24111 Background: Despite the abundance of publications on chemotherapy-induced peripheral neuropathy (CIPN), we are still lacking effective management options. CIPN-focused systematic reviews (SRs) are increasingly encountered but have not aided much in clarifying treatment guidance. Additionally, there is a rising concern that SRs are now over-saturating the clinical literature, leading to redundant and misleading publications. Umbrella reviews (URs) are an attempt to appraise SRs but do not yet have firm methodologic frameworks. The aims of our UR were to appraise the discordance in recently published CIPN SRs and use content analysis as a method for identifying risks of discordance. Methods: This is a focused UR as part of a larger study to characterize the number of efficacy trials for established CIPN. Following PRISMA guidelines, we conducted a systematic literature search of databases MEDLINE, Embase, and Cochrane Library for publications in English from 1/1/2023 to 11/21/2023. Inclusion criteria were published systematic reviews attempting a comprehensive effort to synthesize any treatment outcomes for established CIPN. The AMSTAR 2 framework was used to appraise results for bias. Measures of randomized controlled trial (RCT) overlap are presented using a novel measure of time-adjusted CA, which accounts for RCT publication dates and SR search dates. Grounded theory coding was used for content analysis on efficacy. Results: We identified 18 SRs containing CIPN treatment RCTs published in less than 1 year, resulting in 32 unique CIPN RCTs. Seven SRs assessed exercise interventions, covering 6 exercise RCTs (41% time-adjusted CA). Five SRs assessed acupuncture, with 9 RCTs (50% time-adjusted CA). One SR searched for all CIPN treatments for pain but missed 4 RCTs. One SR was concerning for spurious data. Bias was variable and imperfect across SRs. Contextual analysis identified the themes of SRs combining preventative and treatment RCTs, confusing comparative vs. controlled trials, and frequent use of p-value only reporting to conclude treatment efficacy as major risks of SR discordance. Conclusions: UR was useful in identifying 32 CIPN RCTs that were not comprehensively identified by SRs. We presented a time-adjusted CA measure to indicate concordance percentage. A higher percentage indicates more re-citation of the same RCTs across SRs, with likely better chances of more concordant conclusions. This measure showed that SRs for CIPN treatment are discordant across the topics of exercise and acupuncture interventions. Content analysis revealed multiple potential causes of discordance. However, SR redundancy was helpful for identifying more unique RCTs. CIPN SR content standards should be developed to minimize discordancy and improve clinical applicability. Clinicians should be cautious when applying CIPN SR recommendations given the high discordance.
Retrospective evaluation of drug to drug interactions with paclitaxel use in military health.
Authors: Kigelman Oskar , Luong Thu-Lan T. , Shou Karen J. , Reinhardt Brian J. , Greenfield Kimberly 
Published: July 2024

e24118 Background: Paclitaxel is an antineoplastic agent used in the management of multiple metastatic and non-resectable tumor types approved for ovarian, breast, AIDS-related Kaposi sarcoma, non-small cell lung, pancreatic, cervical, endometrial, and thymoma or thymic carcinoma cancer by the US Food and Drug Administration. Cytochrome P450 (CYP) 3A4 or 2C8 inducers, inhibitors, or substrates may alter paclitaxel metabolism. Because DDIs can have an effect on clinical outcomes, we aimed to identify drugs that interact with paclitaxel and describe their clinical manifestations. Methods: A retrospective analysis was performed on the health records of patients in the US Department of Defense Cancer Registry (retrieved March 2022), Comprehensive Ambulatory/Professional Encounter Records, and Pharmacy Data Transaction Service database (both retrieved October 2022). Patients’ medical history, diagnoses, and demographics were extracted and analyzed for differences in adverse effects when these agents were used alone vs concomitantly with other prescription drugs. Patients’ diagnoses and prescription drug use were extracted to compare completed vs discontinued treatment groups, identify medications commonly co-administered with paclitaxel, and evaluate DDIs with antidepressants. Results: Of 702 patients using paclitaxel, 338 completed treatments. The P value for paclitaxel discontinuation when used alone vs concomitantly or 1 drug (alone or before or after) vs combination (2 to 4 drugs) was < .001. Patients who took paclitaxel concomitantly with a greater number of prescription drugs had a higher rate of treatment discontinuation than those who received fewer medications. Patients in the completed group received 9 to 56 prescription drugs, and those in the discontinued group were prescribed 6 to 70. Those who discontinued treatment had more diagnosed medical issues than those who completed treatment. Conclusions: This review cannot conclude that concomitant use with prescription drug(s) resulted in paclitaxel discontinuation. There were no significant DDIs determined between paclitaxel and antidepressants.[Table: see text]
Enhancing prostate cancer diagnosis communication: A multicenter study evaluating the impact of animated videos, CartDiag Prostate study.
Authors: Helissey Carole , Pautas Marie , Brureau Laurent , Cessot Anatole , Picchi Hugo , Le Roy Audrey , Audisio Marie-Anne , Barhli Aline , Vanquaethem Hélène , Schernberg Antoine 
Published: July 2024

TPS12148 Background: Prostate cancer is the leading cancer among men. Advances in therapeutic techniques, personalized medicine, and the integration of targeted therapies have significantly improved patient outcomes, resulting in a 5-year overall survival of 93%. However, effective patient care requires a shared decision-making framework and clear communication between healthcare professionals and patients. The initial step in patient care involves disclosing the cancer diagnosis during a dedicated consultation, laying the foundation for the patient-physician trust relationship. Nowadays, less than 50% of patients declared that they understood the information provided during the announcement consultation. The main objective of our study is to assess the effect of the announcement system, reinforced by animated videos, on patients' overall understanding of their diagnosis and treatment. Methods: To enhance the disclosure process, animated videos were developed to outline the patient care journey. This multicenter, controlled before-and-after study aimed to evaluate the impact of the usual disclosure process enhanced by animated videos on patients' understanding of advanced or metastatic prostate cancer. Patients were sequentially assigned to two arms: the standard arm (first 45 patients) received usual written and oral information, while the intervention arm (next 45 patients) received written and oral information supplemented by animated videos. To evaluate the effect of the enhanced disclosure process on patients' overall understanding of their diagnosis and treatment using the EORTC QLQ-INFO25 questionnaire at baseline (Day 0) and after 1 month (Day 30), compared to the standard group without enhanced disclosure. This prospective study is the first to assess the impact of supplementing the standard disclosure process with animated videos positively impacts patients' comprehension of advanced or metastatic prostate cancer. The findings will support the potential value of integrating visual aids into the diagnostic disclosure consultation to enhance patient understanding and promote informed decision-making. Clinical trial information: NCT06117696 .
Randomized, placebo-controlled trial of atorvastatin to prevent hearing loss in patients with head and neck squamous cell carcinoma receiving cisplatin based chemoradiation (CRT).
Authors: Schmitt Nicole C. , Fernandez Katharine , Newlands Shawn , Allen Paul , Kaufman Adam , McMillan Garnett P. , Switchenko Jeffrey M. , Stokes William A. , Mehra Ranee , Mandawat Anant , Shamburek Robert , Saba Nabil F. , Cunningham Lisa L. 
Published: July 2024

TPS12153 Background: Cisplatin chemotherapy is associated with several adverse effects, including a permanent, high-frequency, sensorineural hearing loss in about 50% of patients. Preclinical studies suggest that statin drugs can mitigate cisplatin ototoxicity (Fernandez et al., Hearing Research 2020). In our prior combined retrospective/prospective dataset of patients with head and neck squamous cell carcinoma (HNSCC) treated with cisplatin-based CRT, the incidence of CTCAE grade ≥ 2 hearing loss was 29.4% in statin non-users, versus 9.7% in atorvastatin users (Fernandez et al., J Clin Invest 2021). An adjusted odds ratio analysis indicated that atorvastatin users are significantly less likely to develop hearing loss versus statin non-users (odds ratio 0.47), providing the rationale for a randomized, controlled, prospective study. Methods: This multi-center, randomized, placebo-controlled study is enrolling patients with previously-untreated, locally advanced head and neck squamous cell carcinoma (HNSCC) for which cisplatin-based chemoradiation is indicated, either in the definitive or adjuvant setting. Patients who will be treated with cisplatin (at 75-100 mg/m2 bolus every three weeks or 40 mg/m2 weekly) are eligible. Patients currently taking a statin or those without measurable hearing in at least one ear are excluded. A baseline audiogram is performed, and patients are randomized to atorvastatin (40 mg/day) or placebo, which is started 2-7 days before CRT and taken daily until 3 months after completion of CRT. Post-treatment audiometry is repeated at 3 months and 2 years after CRT, along with collection of patient-reported outcomes on hearing, tinnitus, and peripheral neuropathy. Patients are monitored for liver and muscle toxicity, with dose de-escalation or cessation of atorvastatin as needed. The primary endpoint is the incidence of CTCAE grade ≥2 hearing loss at 3 months after CRT. Secondary endpoints include other treatment related grade 3-4 adverse events, overall survival, and disease-free survival. Up to 214 subjects will be enrolled at 4 U.S. sites (NIH Clinical Center, Emory University, University of Maryland, University of Rochester). Funding: NIH/NIDCD, U01 DC020452 and intramural project ZIA DC000079. Clinical trial information: NCT04915183 .
Acupuncture for preventing progression of taxane-induced peripheral neuropathy (ATP): A phase II randomized, placebo-controlled trial.
Authors: Zhi Iris , Han Katherine , Kim Danne , Piluson Lauren , Weitzman Matthew , Baser Raymond E , Li Qing Susan , Bao Ting , Mao Jun J. 
Published: July 2024

TPS12154 Background: Chemotherapy-induced peripheral neuropathy (CIPN) from chemotherapy drugs such as taxanes can be detrimental to cancer survival, increasing the risk of falls and worsening physical functions. The current management of worsening and persistent CIPN during chemotherapy is dose reduction or discontinuation of chemotherapy. There is no effective treatment or preventative measure for CIPN. Methods: Trial design: The ATP trial is a two-arm, parallel, randomized controlled trial comparing weekly real acupuncture (RA) versus sham acupuncture (SA) during preplanned curative intent taxane containing regimens in patients with breast cancer. Eligibility criteria: English or Spanish-proficient; aged ≥18 years; histological diagnoses of invasive carcinoma of the breast; and plan to receive curative intent chemotherapy regimen containing paclitaxel or nab-paclitaxel weekly or biweekly as standard of care, developed CIPN grade ≥1 based on the NCI-CTCAE version 5.0, while receiving taxane; ≥ four weeks of paclitaxel or nab-paclitaxel weekly or biweekly planned, as standard of care and at treating physician’s discretion; willing to adhere to requirement that no new pain medication or dose changes be taken throughout the first 12 weeks of the study period; and willing to adhere to all study-related procedures. Specific aims: The primary aim is to evaluate the effectiveness of RA versus SA in preventing taxane-induced peripheral neuropathy progression as measured by Neuropathic Pain Scale (NPS) in patients with early-stage breast cancer who are receiving curative intent neurotoxic chemotherapy. The secondary aim is to evaluate the effectiveness of RA versus SA on chemotherapy relative dose intensity (RDI) and CIPN-related chemotherapy discontinuation. Statistical methods: We will randomize 80 patients, 40 to each arm. All randomized patients will be evaluable in the Intent to Treat (ITT) analyses because all will have completed the baseline assessment before randomization. We will use a linear mixed model (LMM) to compare the change in NPS between the arms from baseline to week 4. Based on our pilot data, a difference in CIPN grade from 1 to 2 corresponded to a difference in NPS from 12 to 22, a difference of ten points in 27 patients. The NPS standard deviation (SD) in patients with grade 1 CIPN was 17. With 80 patients we will have 80% power to detect a difference between arms as small as 10 points on the NPS, assuming a one-sided test, type I error of 5%, correlation between baseline and follow-up measurements of 0.5, SD of 17, and 15% attrition at week 4. Present accrual and target accrual: We accrued 43 participants in the intervention phase by the end of January 2024; the target accrual is 80 participants. Clinical trial information: NCT05458284 .
Inherited Germline Variants in Urinary Tract Cancer: A Multicenter Whole-Exome Sequencing Analysis and Correlation With Clinical Features and Tumor Genomics
Authors: Kohlmann Wendy , Nix David A. , Pauley Kristen , Greenberg Samantha , Atkinson Aaron , Boucher Kenneth M. , Kolesar Jill , Singer Eric A. , Edge Stephen B. , Churchman Michelle L. , Graham Laura , Salhia Bodour , Sanchez Alejandro , Zakharia Yousef , Nepple Kenneth G. , Schneider Bryan P. , Byrne Lindsey , Jain Rohit K. , Chahoud Jad , Feng Bing-Jian , Gupta Sumati 
Published: July 2024

PURPOSE This study investigates a real-world multicenter cohort of patients with urinary tract cancer (UTC), with primary disease sites including the bladder, urethra, and upper tract, who enrolled for research molecular testing of their germline and tumor. The purpose of this study was to evaluate factors that could affect the likelihood of identifying a clinically actionable germline pathogenic variant (PV). METHODS Patients with UTC were identified from 10 cancer institutes of the Oncology Research Information Exchange Network consortium. The data set comprised abstracted clinical data with germline and tumor genomic data, and comparative analyses were conducted. RESULTS Clinically actionable germline PVs in cancer predisposition genes were identified in 16 (4.5%) of 354 patients. A higher proportion of patients with the urethra and the upper tract as the primary sites of disease had PVs with a prevalence of 11% (5/45), compared with only 3.6% (11/308) in those with the bladder as the primary site of disease ( P = .04). There were no significant differences in markers of genomic instability (such as tumor mutational burden, microsatellite instability [MSI], and loss of heterozygosity, copy number, and chromosomal instability) between those with PVs and those without ( P > .05). Of the PVs identified, 10 (62%) were in homologous recombination repair (HRR) genes, three (19%) in mismatch repair (MMR) genes, and three (19%) in genes associated with other pathways. CONCLUSION Tissue-based assessment of genomic instability, such as MSI, does not reliably indicate germline PV. A comprehensive clinical germline testing approach that includes HRR genes in addition to MMR genes is likely to yield PVs in approximately one of 10 patients with nonbladder primary disease sites such as the upper tract and the urethra.
An comprehensive examination of the therapeutic and dietary attributes of Stevia
Authors: Kotowicz Zuzanna , Kwaśniak Ksenia , Magierska Agata , Kmiotek Weronika , Foryś Angelika , Miłek Magdalena , Banach Mariola , Ślusarczyk Monika , Stawska Weronika , Niemczyk Anna 
Published: July 2024

Introduction
Stevia rebaudiana, an indigenous plant of South America, is becoming increasingly popular because of its potent sweetness obtained from steviol glycosides, which are considerably sweeter than sucrose. Due to its low calorie content and this characteristic, Stevia is considered a favoured sugar alternative in a wide range of food products. In addition to being a substitute for sugar, Stevia provides a range of metabolic benefits. Studies have shown that extracts from this plant have antihypertensive and antihyperlipidemic qualities, can control blood glucose and insulin levels, enhance kidney function, and may have potential anticancer effects. The wide range of advantageous characteristics linked to Stevia highlights its promise as a subject for further exploration of its health-promoting effects. This article offers an analysis of scientific research and reliable sources, presenting the metabolic advantages and health impacts of steviol glycosides obtained from Stevia in the human body.

Aim of the study
This review aims to identify the metabolic benefits of Stevia rebaudiana on the human body. The main objective is to present its action as a component in the fight against obesity, diabetes, hypertension, dyslipidaemia and cancer cells.
Material and method
This article presents the current state of knowledge about the range of metabolic benefits of Stevia rebaudiana. Publications describing the effects of Stevia rebaudiana use on the metabolism and health of the human body were reviewed using the PubMed platform. The search included the keywords 'stevia', 'artificial sweetener', 'sugar substitute', 'obesity'.