bluuebunny/crossref_metadata_2025_split huggingface dataset:
Transarterial embolization of uterine arteries in emerging dysfunctional uterine bleeding: a single-center case series study
Authors: El Zaeem Esmaeel Tamer , Fouad AbdelBaki Allam Mohammad , Aboulfotouh Elsayed Mourad Mohamed , Issa Ahmad S. 
Published: June 2024

Abstract
Background
Uterine artery embolization is proven to be an effective treatment for symptomatic uterine fibroids. Yet, its role in the management of dysfunctional uterine bleeding is still debatable. Patients with dysfunctional uterine bleeding have abnormal bleeding from the uterine vascular bed with variable underlying mechanisms. Uterine artery embolization will reduce/prevent bleeding by occlusion of the vascular bed, with subsequent cutoff of the effect of hormones on the endometrium. The aim of this work is to demonstrate the safety, efficacy and possible short-term complications of uterine artery embolization in the treatment of dysfunctional uterine bleeding (DUB) as a first-line treatment modality rather than the current treatment options (hormonal and surgical treatment).

Methods
Thirty patients included in the study were clinically and laboratory diagnosed based on FIGO classification system (PALM-COEIN) as DUB, and the diagnosis was confirmed by MRI imaging. All patients were subjected to transcatheter uterine artery embolization with subsequent clinical and radiological follow-up to assess the treatment outcome.

Results
Uterine artery embolization was able to control bleeding in patients diagnosed as DUB, with subsequent complete cessation of medical treatment; no surgical interference was needed with much less morbidity. We had 93.3% improvement in the frequency, volume of bleeding and 100% improvement of the presenting anemia. No significant change in uterine volume or in endometrial thickness has been noted.

Conclusions
Uterine artery embolization is safe, effective procedure to control dysfunctional uterine bleeding with the preservation of the uterus especially in critical age groups.
Prevalence of musculoskeletal discomfort with associated disability among adult male motorcyclist
Authors: Afridi Zahra Khan , Khan Areeba , Masood Fatima , Rasool Danish , Hashmi Muhammad Ather 
Published: June 2024

Abstract
Background
This study conducted to determine the prevalence and severity of musculoskeletal discomfort among two-wheeler riders; however, musculoskeletal discomfort refers to pain, discomfort, or impairment in the muscles, bones, joints, tendons, ligaments, or other structures that support the body’s movement. It is a common problem experienced by individuals involved in various physical activities, including motorcycle riding.

Methods
This investigation was longitudinal research in which the Nordic muscular questionnaire (NMQ) was used to rule out the possibility of musculoskeletal disorders in motorcyclists. In Karachi, Pakistan, data were collected beginning in September of 2021 and continuing through February of 2022 using the convenience sampling method. Sixty-four individuals made up the sample. Participants were males ranging between the ages of 19 and 50 who rode standard motorcycles for their commute for about 6 to 8 h daily. Participants who had a tumor, an infection, or other comorbid are excluded.

Results
Sixty-four participants were included in this study, out of which 40 (62.5%) reported difficulty and discomfort in their neck, followed by their lower back (48.5%), shoulders (34.4%), and hips (26.6%). Sixteen motorcyclists (25%) complained wrist pain. When asked out their level of discomfort. However, 51.6% of individuals experienced lower back pain at the 12th month, while 46.9% had neck pain. 28.1%, 17.2%, and 14.1% reported shoulder, hip, and upper back discomfort. 51.6% of individuals had not seen a specialist for lower back symptoms. Lower back, neck, shoulders, and hip have been affected the longest, according to participants.

Conclusion
In conclusion, motorcyclists had a substantially greater rate of musculoskeletal problems than other drivers. Regulating musculoskeletal disorders in motorcyclists helps reduce symptoms and clinical indications of disease.
An exploratory randomized controlled trial of virtual reality as a non-pharmacological adjunctive intervention for adults with chronic cancer-related pain
Authors: Garrett Bernie , Tao Gordon , Taverner Tarnia , Gromala Diane , Musoke Richard , Sun Crystal , Shaw Christopher D , Cordingley Elliott 
Published: June 2024

Abstract
Background
The growing popularity and affordability of immersive virtual reality (VR), as adjunctive non-pharmacological interventions (NPIs) for chronic pain, has resulted in increasing research, with mixed results of its effectiveness reported. This randomized controlled superiority trial explored the effects of a home-based adjunctive 3D VR NPI for chronic pain in cancer patients, compared to the same NPI experienced through a two-dimensional (2D) medium.

Methods
The NPI used four different applications experienced for 30 min for six days a week at home for four weeks using established cognitive distraction and mindfulness meditation techniques. Participants were randomly assigned (N = 110) into two arms: a VR group (n = 57) where the NPI was delivered through a VR system, and a control group (n = 53) which used a computer screen for delivery. Participants were blinded to which arm of the study they were in, and sequence of the NPI applications experienced was randomized. Primary outcomes of daily pre/post/during exposure, and weekly average pain scores were assessed via the Visual Analog Scale (VAS) and the Short Form McGill Pain Questionnaire (SF-MPQ), and secondary outcomes of weekly Quality of Life (SF-12), and sleep quality (Pittsburgh Sleep Quality Index) were measured.

Results
Findings indicate VR applications were not significantly superior to the 2D group, but both VR and control NPIs provided clinically important pain reduction for participants when experiencing significant daily pain of a VAS ≥ 4. No significant adverse effects were encountered, although many of the participants in the VR group reported some cybersickness in certain applications (VR group n = 46 vs 2D group n = 28).

Conclusions
Overall, VR did not provide superiority as an NPI for pain relief compared to 2D computer-based applications. For those experiencing significant pain, cognitive distractive applications appeared superior for VR-based pain reduction during exposure, whilst meditative applications supplied better pain relief post-exposure. Findings from this trial support some clinical efficacy of home-based VR immersive experiences as NPIs for chronic cancer-related pain but in this context the 2D computer-based applications demonstrated similar value.

Trial registration
Clinicaltrials.gov, identifier NCT02995434, registered 2017–07-31.
Palbociclib plus exemestane with GnRH agonist vs capecitabine in premenopausal patients with HR+/HER2- metastatic breast cancer: Updated survival results of the randomized phase 2 study Young-PEARL.
Authors: Park Yeon Hee , Lee Kyung-Hun , Kim Gun Min , Kang Seok Yun , Lee Keun Seok , Kim Jee Hyun , Lee Kyoung Eun , Ahn Hee Kyung , Lee Moon Hee , Kim Hee Jun , Kim Hanjo , Koh Su-Jin , Kim Ji-Yeon , Sohn Joohyuk , Kim Sung-Bae , Ahn Jin Seok , Kim Seonwoo , Cho Hyun , Jung Kyung Hae , Im Seock-Ah 
Published: June 2024

LBA1002 Background: The Young-PEARL study demonstrated improved progression free survival (PFS) (mPFS: 20.1 vs. 14.4 mo.) of exemestane plus palbociclib with ovarian function suppression (OFS) compared to capecitabine in premenopausal patients with HR+/HER2- metastatic breast cancer (mBC). Here we report updated survival outcomes with median follow-up of 54.8 months (data cutoff, November 30, 2023). Methods: Premenopausal women aged 19 years or older with HR+/HER2- BC who had relapsed or progressed during previous tamoxifen therapy were enrolled. One line of previous chemotherapy for mBC was allowed. The primary endpoint was PFS, which was defined as the time from C1D1 to disease progression or death. The key secondary endpoint was overall survival (OS). Other secondary endpoints included objective response rate (ORR) and toxicities. Results: 184 patients were randomly assigned to exemestane plus palbociclib with OFS (n=92) or capecitabine (n=92). Median age was 44.0 years (range, 28-58). Key efficacy and safety are shown in Table. Final analysis was conducted for 174 patients. The updated mPFS was 19.5 mo. (90% CI, 14.3-22.3) for exemestane + palbociclib + OFS compared with 14.0 mo. (90% CI, 11.7-18.7) for capecitabine (HR 0.75, P=0.04). mOS was 54.8 mo. (95% CI, 48.9-77.1) for palbociclib arm and 57.8 mo. (95% CI, 46.3-N/A) for capecitabine arm (HR 1.06, P=0.77). mPFS2 (from the date of 1st PD to 2nd PD) was significantly shorter in palbociclib arm than those of capecitabine arm (7.5 vs. 11.7 mo. P=0.02). Confirmed ORR based on the investigator assessments was 33.3% (95% CI, 23.6-43.1) for palbociclib and 33.7% (95% CI, 23.6-43.9) for capecitabine. Median treatment duration was 18.9 mo. (range 1.6-88.4) in palbociclib and 13.5 mo. (range 0.1-70.8) in capecitabine. In palbociclib arm, 86 (93.5%) experienced grade 3 or more TEAEs, mainly asymptomatic neutropenia (64.1%), compared to 41 (48.2%) patients with grade ≥3 TEAEs in the capecitabine arm, mainly Hand-Foot syndrome and neutropenia (18.8% for each). Conclusions: Young-PEARL study showed exemestane + palbociclib with OFS improves efficacy compared with capecitabine in terms of PFS, which did not lead to an OS benefit for patients with premenopausal HR+/HER2- mBC (median follow-up duration: 54.8 months). The overall safety profile of palbociclib and capecitabine continues to be manageable with longer follow-up. Clinical trial information: NCT02592746 . [Table: see text]
Results from a randomised, open-label trial of a multimodal intervention (exercise, nutrition and anti-inflammatory medication) plus standard care versus standard care alone to attenuate cachexia in patients with advanced cancer undergoing chemotherapy.
Authors: Solheim Tora S. , Laird Barry J A , Balstad Trude R. , Stene Guro Birgitte , Baracos Vickie , Bye Asta , Dajani Olav , Hendifar Andrew Eugene , Strasser Florian , Chasen Martin Robert , Maddocks Matthew , Simpson Melanie R. , Skovlund Eva , Griffiths Gareth Owen , Hicks Jonathan , Graham Janet Shirley , Kyle Fiona , Bowden Joanna , Fallon Marie T. , Kaasa Stein 
Published: June 2024

LBA12007 Background: Cancer cachexia arises from the interaction between the host and the tumour, triggering an inflammatory response that leads to weight and appetite loss, diminished physical activity, reduced treatment efficacy and survival. Combining interventions to address inflammation, weight loss, and physical activity is proposed as an effective strategy. Building on a promising pilot study, we conducted the MENAC (Multimodal Exercise Nutrition Anti-inflammatory Cachexia) trial to comprehensively evaluate this approach in patients with lung and pancreatic cancer undergoing systemic anti-cancer treatment (SACT). Methods: MENAC was an investigator-initiated, multicentre, open label, randomised phase 3 trial conducted at 17 sites in 4 countries. Patients with stage III or IV lung or pancreatic cancer receiving SACT with non-curative intent were randomly assigned (1:1) to a multimodal intervention consisting of nutritional counselling plus fish oil containing oral nutritional supplements, physical exercise [endurance and strength] and non-steroidal anti-inflammatory drugs [NSAIDs]) versus standard care. Randomisation was stratified by country, cancer type and stage. Primary Objective: To assess differences between arms in change in body weight. Secondary Objectives: To assess differences in muscle mass (measured by CT L3 technique) and physical activity (assessed through step counts using ActivPAL activity meter) between arms. Assessments were conducted at basline (pre-randomisation) and at endpoint (after 6 weeks). Results: From May 2015 to February 2022, 212 patients were enrolled (105 to multimodal treatment, 107 standard care). Over 6 weeks, weight stabilised in patients assigned to multimodal treatment compared with those assigned to standard care (mean weight change [SD] 0.05 kg [3.8] vs – 0.99 kg [3.2], respectively) with a mean difference in weight change of -1.04, 95 % CI -2.02 to -0.06, p=0.04. There was no conclusive difference in muscle mass (mean change [SD] -6.5cm2 [ 10.1] vs -6.3cm2 [11.9], p=0.93) or in mean step counts [SD] (-377.7 [2075] vs -458 [1858], p=0.89). There were 28 and 24 reported SAEs in the intervention and control arm respectively, no SUSARs were reported. Conclusions: A multimodal cachexia intervention stabilised weight compared to standard care at six weeks. There was no difference in physical activity or muscle mass between trial arms. Clinical trial information: NCT02330926 .
Durable complete responses to PD-1 blockade alone in mismatch repair deficient locally advanced rectal cancer.
Authors: Cercek Andrea , Sinopoli Jenna Cohen , Shia Jinru , Weiss Jill A. , Temple Lindsay , Smith Jesse Joshua , Saltz Leonard B. , Widmar Maria , Fumo Gerard , Aparo Santiago , Romesser Paul Bernard , Walch Henry S. , Patel Mitesh , Jayaprakasam Vetri Sudar , Kim Tae-Hyung , Paty Philip , Gonen Mithat , Garcia-Aguilar Julio , Weiser Martin R. , Diaz Luis A 
Published: June 2024

LBA3512 Background: Early results have demonstrated that locally advanced mismatch repair deficient rectal cancers can become undetectable with PD-1 blockade alone and do not require chemotherapy, radiation, or surgery. Yet, the durability of this approach is unknown. Methods: We enrolled 47 mismatch repair deficient rectal cancers to a phase II study of 6-months of dostarlimab, a PD-1blocking monoclonal antibody. Co-primary endpoints were response rate that was previously met and the sustained clinical complete response rate, which has not yet been reported. A sustained clinical complete response was defined as complete pathologic response at surgery or no evidence of tumor by MRI, endoscopy, and digital rectal exam for at least 12 months following completion of therapy. If 13 or more patients achieved a sustained clinical complete response out of the first 30 patients, the study would be deemed successful. Results: All of the 41 patients who completed treatment achieved a clinical complete response. No patients required any additional therapy, and no patients experienced local or distant disease recurrence. Twenty patients achieved a sustained clinical complete response with a median follow-up of 28.9 months (95% CI 22.9 -37.1) from first treatment, which satisfied the second co-primary endpoint. No serious adverse events greater than grade 2 were observed. Ultrasensitive tumor-informed circulating tumor DNA levels and tumor bed biopsies normalized earlier than endoscopy, MRI or PET/CT. Conclusions: PD-1 blockade for 6-months alone yields durable recurrence-free responses in locally advanced mismatch repair deficient rectal cancer without the need for chemotherapy, radiation, or surgery. Clinical trial information: NCT04165772 .
Effect of chemotherapy/targeted therapy alone vs. chemotherapy/targeted therapy followed by radical surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction: The IKF-575/RENAISSANCE phase III trial.
Authors: Al-Batran Salah-Eddin , Lorenzen Sylvie , Riera Jorge , Caca Karel , Mueller Christian , Stange Daniel E , Zander Thomas , Bolling Claus , Homann Nils , Gaedcke Jochen , Thuss-Patience Peter C. , Michl Patrick , Blau Wolfgang , Wille Kai , Koch Christine , Pauligk Claudia , Mueller Daniel Wilhelm , Bankstahl Ulli Simone , Mönig Stefan Paul , Goetze Thorsten 
Published: June 2024

LBA4001 Background: The IKF-575 trial investigates the long-standing question about the role of surgical intervention in limited-metastatic gastric / esophagogastric junction cancer after systemic induction therapy. Methods: Previously untreated patients (pts) with limited metastatic disease (retroperitoneal lymph node (RPLN) metastases only or a maximum of one incurable organ site that is potentially resectable or locally controllable with or without retroperitoneal lymph nodes) received 4 cycles of FLOT, + trastuzumab if Her2+ or + nivolumab if PD-L1 positive. Pts without progression after 4 cycles were randomized to receive additional FLOT (Arm B) or radical complete surgical resection of primary and metastases followed by the same treatment (Arm A). It was planned to randomize 176 pts for which 271 pts had to enrolled. The primary endpoint was overall survival in the ITT population using Kaplan-Meier estimates. Recruitment was stopped after enrollment of 183 patients (141 patients randomized) with minimal impact on statistical power, due to a slow enrollment rate. Results: The ITT comprised 139 pts (A, 67; B, 72): 20% had RPLN metastases only, 58% organ metastases only, and 22% had both. Surgery in Arm A (ITT) was performed in 91% of pts and R0-resection rate (primary) was 82%. 30-d and 90-d mortalities in the surgery population were 3% and 8%. At least 4 additional cycles of post-op or post-randomization chemotherapy were achieved in 42% of pts in Arm A vs. 71% of pts in Arm B. The primary endpoint ovrall survival was not met due to increased early mortality in the surgery Arm leading to crossing survival curves with OS 25%- and 75%-Quantiles being 10 vs. 14 months and 65 vs. 41 months for Arms A vs. B, respectively. Pts with RPLN metastases only seemed to benefit most from the surgical approach (mOS, 30 vs. 17 months; 5y OS 38% vs. 19%; still having increased early mortality), while pts showing no response to chemo (mOS, 13 vs. 22 months) or pts with peritoneal disease (mOS, 12 vs. 19 months) derived a detrimental effect. Conclusions: The IKF-575/RENAISSANCE trial is negative but informs future research. Future protocols should focus on pts with RPLN only disease and exclude non-responding pts or those with peritoneal disease. There is a need for strategies against the early mortality caused by chemotherapy interruption. Clinical trial information: NCT02578368 .
AXLerate-OC/GOG-3059/ENGOT OV-66: Results of a phase 3, randomized, double-blind, placebo/paclitaxel-controlled study of batiraxcept (AVB-S6-500) in combination with paclitaxel in patients with platinum-resistant recurrent ovarian cancer.
Authors: Fuh Katherine Cynthia , Tsitsishvili Zaza , Reid Thomas J. , De Giorgi Ugo , Hand Lauren , Bowen Rebecca , Miller Devin , Vulsteke Christof , Sharma Sudarshan K. , Chudecka-Głaz Anita M. , Liu Joyce F. , Eberst Lauriane , Neff Robert , Lim Peter C , Iglesias David A. , Jenkins Vogel Tilley , Myers Tashanna K. N. , González-Martín Antonio , Gonzalez Martin Antonio 
Published: June 2024

LBA5515 Background: Batiraxcept is an Fc-fusion protein engineered to have a 200-fold higher affinity than wild-type AXL for its activating ligand GAS6. Batiraxcept sequesters GAS6 and inhibits its interaction with AXL. The Phase 1b study demonstrated safety with batiraxcept in combination with paclitaxel. Methods: This was a global, placebo-controlled, double-blind, phase III trial (ClinicalTrials.gov identifier: NCT04729608). Patients with PROC were randomly assigned 1:1 to receive intravenous batiraxcept every 2 weeks (D1, 15 every 28 days) with once-a-week IV paclitaxel (D1, 8, 15 every 28 days) or placebo with paclitaxel until disease progression. The primary endpoint was progression-free survival as assessed by investigator-assessed progression-free survival and secondary endpoint was overall survival. The randomization was stratified by platinum-free interval (< 3 months, 3 to 6 months), prior lines (1 to 2, 3 to 4), and prior bevacizumab status (yes, no). Exploratory endpoints include objective response rate, duration of response, quality of life, clinical benefit rate, and pharmacokinetic and pharmacodynamic profile. Results: A total of 366 participants were randomly assigned, and analysis was performed based on intent-to-treat. There were 183 participants who had prior bevacizumab and 177 with no prior bevacizumab. Median PFS (mPFS) was 5.13 months in the batiraxcept + paclitaxel arm and 5.49 months in the control paclitaxel arm, hazard ratio (HR) 1.29 (CI, 1.01 to 1.64; p=0.98). Median OS with batiraxcept + paclitaxel was 14.29 months versus 14.39 months, HR 1.06 (CI 0.77 to 1.46; p=0.64). Objective response rates (ORRs) per RECIST 1.1 were similar in both arms: 25.1% with batiraxcept + paclitaxel versus 26.2% with control paclitaxel arm. An exploratory analysis of the 304 evaluable tumors found that 61 (20%) of tumors had high AXL expression by immunohistochemistry (IHC). In participants with high tumor AXL expression, median PFS was 5.78 months in the batiraxcept + paclitaxel arm and 3.71 months in the control paclitaxel arm, HR 0.55 (CI, 0.31 to 0.98; p=0.042). For high AXL expressing tumors, median OS was 17.8 months in the batiraxcept + paclitaxel cohort and 8.11 months in the paclitaxel cohort, HR 0.32 (CI, 0.14 to 0.73; p=0.006). Conclusions: The addition of batiraxcept to paclitaxel did not improve PFS or OS. However, in AXL high tumors, the PFS and OS were higher in participants who received batiraxcept with paclitaxel compared to paclitaxel alone. Clinical trial information: NCT04729608 .