Objective: To evaluate the short-term safety and efficacy of total laparoscopic, laparoscopy-assisted, and open total gastrectomy in patients with gastric cancer who have undergone neoadjuvant therapy. Methods: In this retrospective cohort study, relevant clinical data on 243 patients who had undergone radical total gastrectomy after receiving neoadjuvant therapy were collected. These patients had been admitted to the First Affiliated Hospital of Air Force Medical University, Yuncheng Central Hospital of Shanxi Province, and Heji Hospital Affiliated to Changzhi Medical College between January 2020 and April 2024. Among them, 202 were male (83.1%) and 41 were female (16.9%), and their average age was 61.3±8.1 years. The patients were allocated to three groups according to surgical procedure: total laparoscopic (68 cases), laparoscopic- assisted (79 cases), and open surgery (96 cases). We compared relevant baseline characteristics, neoadjuvant treatment, intraoperative and postoperative conditions, postoperative histopathological findings, and related complications between these three groups. Results: There were no statistically significant differences in baseline characteristics or neoadjuvant treatment between the three groups (all P>0.05). The operative time was longer in the total laparoscopic group than in the laparoscopic-assisted and open surgery groups (267.7±37.9 minutes vs. 243.9±38.3 minutes vs. 219.7±41.2 minutes, respectively; F=7,112.278; P<0.001). However, more lymph nodes were harvested in the total laparoscopic group than in the laparoscopic-assisted and open surgery groups (27.8±4.8 vs. 27.4±6.3 vs. 27.2±5.1, respectively; F=6.042;P=0.002). Additionally, the total laparoscopic group had shorter times to first postoperative flatus (2.3±0.7 days vs. 2.4±0.7 days vs. 2.6±0.6 days, respectively; F=5.094;P=0.006] and first postoperative bowel movement (2.9±0.5 days vs. 3.0±0.6 days vs. 3.0±0.6 days, respectively; F=3.929;P=0.020). There were no statistically significant differences in intraoperative blood loss, intraoperative transfusion rates, postoperative intensive care unit admission rates, maximum tumor diameter, number of positive lymph nodes dissected, TNM stage, time to first postoperative oral intake, time to drain removal, or length of hospital stay between the three groups (all P>0.05). Among the 243 patients, 22 developed postoperative complications, making the overall complication rate 9.1%. Six patients (8.8%) in the total laparoscopic group developed complications, comprising two (2.9%) Grade IIIa Clavien-Dindo complications. One of these patients (1.5%) was readmitted within 30 days due to complications. Seven patients (8.9%) in the laparoscopic-assisted group developed complications, comprising two (2.5%) Grade IIIa Clavien-Dindo complications. One of these patients was readmitted within 30 days and another was within 90 days due to complications. Nine patients (9.4%) in the open surgery group developed complications, comprising four (4.2%) Grade IIIa Clavien-Dindo complications. Two patients (2.1%) were readmitted within 30 days and another (1.0%) within 90 days due to complications. There were no statistically significant differences among the three surgical approaches in overall postoperative complication rates, Clavien-Dindo grades, or readmission rates 30 and 90 days postoperatively (all P>0.05). Conclusions: In patients with gastric cancer who have undergone neoadjuvant therapy, there are no significant differences in the overall safety and short-term effectiveness of the three surgical procedures. Although the operative time is longer for total laparoscopic total gastrectomy, this procedure offers the advantages of faster postoperative recovery and earlier resumption of feeding.

Objective: To evaluate the feasibility and safety of a fascial space priority approach to total pelvic exenteration (TPE) in patients with pelvic malignancy. Methods: This was a descriptive case series. Relevant clinical data of patients who had undergone TPE via a fascial space priority approach at Tianjin Union Medical Center from September 2017 to March 2025 were retrospectively collected. All operations had been performed via a fascial space priority approach, the guiding principle of which is separating the avascular pelvic spaces first and then transecting the vessels and nerves of the pelvic organs. That is, the avascular planes around all the pelvic organs are dissected first, after which the relevant vessels and nerves are fully dissected and transected, followed by en bloc resection of pelvic organs distally or via perineal approach. The variables studied included relevant surgical parameters, postoperative pathological findings, complications (classified according to the Clavien-Dindo criteria); recurrence-free survival (RFS), overall survival, and tumor-specific survival. Results: The study cohort comprised 41 patients, including 30 (73.2%) with primary tumors and 11 (26.8%) with recurrent tumors. Open TPE was performed on five patients (12.2%) and laparoscopic TPE on the remaining 36 (87.8%). All procedures were successfully completed with a fascial space priority approach and there were no intraoperative deaths. R0 resection was achieved in 34 patients (82.9%) and R1 resection in seven (17.1%). The operation time was 500 (265-740) min, and the amount of bleeding 200 (10-3,500) mL. Twelve patients (29.3%) developed postoperative complications, two of which were Clavien-Dindo Grade III complications. One of these patients required re-operation to manage a pelvic hematoma 29 days after the primary TPE. No active bleeding was observed during the re-operation. Another patient underwent interventional angiography for an episode of postoperative bleeding; this showed a pseudoaneurysm of the internal iliac artery that was successfully treated by interventional embolization via the internal iliac artery. Five days after undergoing a primary TPE with bladder preservation, a third patient was found to have a urinary fistula and underwent laparoscopic bladder resection with percutaneous ureterostomy. The median duration of follow-up was 18 (1-90) months. The 5-year RFS and overall survival were 46.7% and 52.2%, respectively, whereas the 5-year tumor-specific survival was 67.8%. Univariate Cox regression analysis identified a positive surgical margin (P < 0.001), lateral pelvic sidewall invasion (P=0.014), and vascular invasion (P=0.004) as significantly associated with RFS, whereas multivariate analysis identified only a positive surgical margin (HR: 21.93, 95% CI: 3.78-127.42, P<0.001) as an independent predictor of RFS. Conclusions: It is safe and feasible to perform TPE with a fascial space priority approach on patients with pelvic malignancy. Positive surgical margins are significantly associated with RFS.

Objective: To explore the feasibility, safety, and short-term efficacy of a total pelvic floor resection procedure as a component of combined resection of pelvic organs for locally advanced or locally recurrent rectal cancer. Methods: This was a descriptive case series. Relevant clinical data of patients with locally advanced or locally recurrent rectal cancer without extrapelvic metastasis or with only oligometastasis who had undergone combined pelvic organ resection with resection of the entire pelvic floor in the Department of Anorectal Surgery of the Second Affiliated Hospital of Naval Medical University from 1 January 2023 to 30 June 2024 were collected from a Chinese database of combined pelvic organ resection for rectal cancer. The study cohort comprised 143 patients, 74 of whom were male (51.7%) and 69 were female (48.3%); their ages averaged 54 (range: 31-75) years; 57 of the patients (39.9%) had locally advanced rectal cancer and 86 (60.1%) locally recurrent rectal cancer. In our institution, the pelvic floor is categorized into two anatomical layers: the levator ani/presacral anterior tissue, and the bone/ligament/pelvic floor soft tissue. The entire pelvic floor was resected en bloc after making incisions on both sides of the pelvic floor, followed by presacral sacral dissection, and abdominoperineal dissection of the anterior side of the pelvic floor. The main factors studied were related to the following: (1) surgical conditions, comprising the scope of surgical resection, operation time, intraoperative blood loss, tissue reconstruction; (2) postoperative recovery, comprising time to recovery of intestinal function, time to removal of drainage tubes, and time to healing of the empty pelvic cavity; and (3) postoperative complications, classified according to the international Clavien-Dindo classification. Results: Combined pelvic organ resection with entire pelvic floor resection was successfully completed in all patients. The operation time was 480 (390 to 1,020) minutes, intraoperative blood loss 800 (50 to 3,500) mL, and volume of blood transfused intraoperatively 1, 000 (400 to 7, 400). R0 resection was achieved in 116 cases (81.1%) and R1 resection in 27 (18.9%). The first layer of the pelvic floor wall (levator ani/sacral anterior tissue) was resected in 79 cases (55.2%) and the second layer of the pelvic floor wall (bone/ligament/pelvic floor soft tissue) in 64 (44.8%). The procedure was completed in the lithotomy position in 114 cases (79.7%) were and in the lithotomy + prone jackknife position in 29 (20.3%). The pelvic floor was reconstructed with mesh in 140 cases (97.7%) and with mesh plus pedicled omental flaps in 92 cases (64.3%). The urinary tract was reconstructed in 92 cases (64.3%). The time to recovery of intestinal function was 3.6 (2.0 to 7.0) days, to removal of drainage tubes 29.4 (24.0 to 54.0) days, and to healing of the empty pelvic cavity 36.2 (27.0 to 56.0) days. Twenty-three patients (16.1%) had Grade I - II complications and 36 (25.2%) Grade IIIa - IV complications. The median duration of follow-up was 15.5 (0.5 to 30.0) months. Six of the patients (4.2%) died, including two (1.4%) who died within 30 days after surgery. Conclusions: Pelvic floor en bloc resection has a high R0 resection rate and is a safe and feasible procedure for pelvic organ resection surgeries in patients with locally advanced or locally recurrent rectal cancer.

Salvage prostatic bed radiotherapy (PBRT) is a standard in case of biochemical recurrence following radical prostatectomy (RP) for prostate cancer (PC). The management of isolated prostatic bed recurrence following RP and PBRT is debated. Reirradiation within stereotactic body radiotherapy (SBRT) guided by metabolic imaging could be a relevant option in this case. In parallel, metformin, an economically viable and well-tolerated oral antidiabetic agent, has demonstrated its radiosensitising properties. This phase I/II clinical trial aims to (i) determine the optimal dose for SBRT reirradiation, (ii) conduct safety assessments and (iii) evaluate the efficacy of the metformin and SBRT combination.

We conducted a prospective, non-randomised, open-label, multicentre, dose escalation, phase I/II study involving a minimum of 44 patients. Eligible patients must have biochemical recurrence (Prostate Specific Antigen (PSA)>0.2 ng/mL and confirmed ascending trend in at least two successive assays), occurring at least 2 years after PBRT and prior RP for PC (including low, intermediate and high risk with a single risk factor) and no Common Terminology Criteria for Adverse Events (CTCAE) grade>=2 toxicity following PBRT. The recurrence should be visible on MRI and/or Positron Emission Tomography (PET) Choline and/or PET PSMA, without evidence of pelvic lymph node recurrence or metastatic disease. The primary objective of phase I is to determine the optimal SBRT dose (5×6, 6×6, or 5×5 Gy) based on dose-limiting toxicity (DLT). The dose will be chosen using a time-to-event continual reassessment method based on DLT, defined as CTCAE grade ≥3 gastrointestinal or genitourinary toxicity, or any other grade 4 adverse event. The primary outcome of the phase II is to estimate the efficacy of SBRT in combination with metformin in terms of biological relapse-free survival (bRFS) rate at 3 years. Secondary outcomes include 5-year bRFS rate, early/late genitourinary and gastrointestinal toxicities, quality of life, biochemical response rate, clinical progression-free survival and overall survival (OS).

Ethical approval has been obtained from the Ethics committee "SUD EST III Bron" Ref.CPP 2020-042B (20.05.07.72735) and the National Agency for the Safety of Medicines (ANSM) Ref. ANSM MEDAECNAT-2020-05-00009. The ethics approval obtained covers all the sites that will take part in this study. The study's findings will be disseminated through publications and conference presentations.

NCT04536805, Registration Date: 2020-08-17.

Real-world effectiveness of a new treatment is relevant information for patients, healthcare professionals and payers, especially when patients encountered in routine clinical care differ significantly from those recruited in the randomised controlled trials (RCTs) that led to approval. However, obtaining effect estimates can be challenging when a new drug has only recently been marketed and real-world data (RWD) are not yet available. For new breast cancer (BC) therapies, we illustrate how RCT inferences can be transported to a target population and how a synthetic population can be generated to mimic a target population for which no RWD is yet available.

In our framework, we defined the data-generating process for the RCT population and the real-world (target) population with confounders, effect-modulating covariates and survival times as outcomes. First, we conducted generalisability and transportability (G&T) analyses to transport the RCT results to the simulated target population, applying the inverse probability of sampling weighting and outcome model-based estimator approach. We then used Synthea to generate a synthetic target population based on German BC survival rates and combined both approaches into a coherent strategy.

Effect estimates (HRs with 95% CIs) transported from the RCT to our defined target population closely matched the expected real-world effect (RCT: 0.68 (0.65; 0.71); real-world: 0.75 (0.71; 0.79); transported from RCT: 0.76 (0.71; 0.81)). BC survival rates were very similar between observed and synthetic data (prediction error in absolute survival rates: 1.62%).

Combining G&T with synthetic data may inform decision-making in situations where RWD are not (yet) available.

High-grade squamous intraepithelial lesions are caused by persistent high-risk human papillomavirus (hr-HPV) infections and are subdivided into cervical intraepithelial neoplasia (CIN) lesions: CIN II (moderate) and CIN III (severe). Current treatment options for CIN II include large loop excision of the transformation zone, imiquimod and expectant management. Each treatment option has its drawbacks, and therefore, a non-invasive treatment is desirable. Preliminary evidence shows that medical-grade honey (MGH) has antiviral activity and might be able to modulate the vaginal microbiome, reduce local inflammation or directly influence the intralesional immune response within cervical tissues. Therefore, this study aims to investigate the possible effect of MGH on hr-HPV clearance and to investigate the possible underlying mechanisms contributing to the regression of CIN II lesions.

This study is performed in the Zuyderland Medical Centre and Maastricht University Medical Centre+. A total of 60 eligible women with newly histologically confirmed CIN II will receive MGH (L-Mesitran Soft) for intravaginal use for 6 months. The primary objective is to investigate the effect of MGH on the hr-HPV clearance after 6 months. Secondary aims are the effect of MGH on the regression of CIN II lesions, clearance of hr-HPV at 12 and 24 months and the role of the vaginal microbiome, local immune system and intravaginal inflammatory status in response to MGH. Moreover, data on quality of life, side effects and compliance will be collected.

Ethical approval from the Medical Ethics Review Committee of the Zuyderland Medical Centre Heerlen has been obtained (NL86044.096.24 on 24 April 2024). The results will be presented to researchers and healthcare professionals through conferences, meetings and publications in international journals.

NCT06219018.

To investigate whether positive cognitive emotion regulation (PCER) and sense of coherence (SOC) mediate the relationship between family hardiness (FH) and post-traumatic growth (PTG) in patients with lung cancer undergoing chemotherapy.

Cross-sectional study, convenience sampling method and mediation analyses.

All participants were from two hospitals in Shandong, China.

321 patients with lung cancer who underwent chemotherapy between April and September 2022 at two hospitals in Shandong province, China.

The Family Hardiness Index, Cognitive Emotion Regulation Questionnaire, Sense of Coherence Scale and Post-Traumatic Growth Inventory.

PTG was positively associated with FH (r=0.33, p<0.01), PCER (r=0.31, p<0.01) and SOC (r=0.37, p<0.01). FH was positively associated with PCER (r=0.31, p<0.01) and SOC (r=0.40, p<0.01). PCER was positively associated with SOC (r=0.32, p<0.01). The mediation analysis showed that FH affected PTG (β=0.235, p<0.05) directly and indirectly through PCER and SOC (β=0.097, 0.142, p<0.05). The mediating effects of PCER and SOC accounted for 20.46% and 29.96%, respectively, of the total effect (FH → PTG).

PCER and SOC mediated the relationship between FH and PTG in patients with lung cancer undergoing chemotherapy. Thus, future interventional studies should consider PCER and SOC as targets for developing PTG in patients with lung cancer receiving chemotherapy.

Wilms tumour is the second most common extracranial solid tumour in paediatric patients. It is frequently associated with hypertension due to renal artery compression and activation of the renin-angiotensin-aldosterone system. This study aimed to identify predictors of hypertension, assess therapeutic factors and evaluate its impact on renal function.

We retrospectively analysed 67 patients treated for Wilms tumour following International Society of Paediatric Oncology (SIOP) guidelines at our institution between 2005 and 2024. Clinical records, radiological reports and laboratory data were collected. Statistical analyses were performed to assess the relationship between hypertension, tumour characteristics, treatment and renal function.

Hypertension was strongly associated with central tumour localisation (p=0.0003) and younger patient age (p=0.024). Prolonged postoperative antihypertensive therapy correlated with the need for combination therapy before surgery (p=0.01136). Younger age (p=0.02994) and higher hypertension grade (p=0.03884) were linked to the requirement for multidrug antihypertensive therapy. Hypertension at presentation did not affect renal function at the end of follow-up.

Central tumour localisation and younger age are significant predictors of hypertension in children with Wilms tumour. The need for combination antihypertensive therapy before surgery predicts prolonged postoperative treatment. These findings underline the importance of early identification and management of hypertension in affected patients.

In humans and cats, pancreatic carcinoma (PC) arising from the exocrine pancreas is considered an aggressive cancer associated with a poor prognosis due to its high metastatic rate. The aim of this retrospective multi-institutional study was to investigate tissue expression of biomarkers of tumour invasiveness, metastasis and immune escape in cats with PC. A secondary aim was to correlate the overall immunohistochemical scores (OISs) with histological characteristics, presence of metastasis and survival. Immunohistochemistry for COX-2, E-cadherin, CD44, c-KIT and PD-L1 was performed on 40 PC tissue samples. CD44 was expressed in all PCs with 27 (67 %) having a moderate to high OIS. PD-L1, E-cadherin, COX-2 and c-KIT expression was seen in 20 (50 %), 21 (52 %), 18 (45 %) and 14 (35 %) cases, respectively, with predominantly low OISs. Metastasis was present in 43 % of cats with a median survival time (MST) of 7 days (95 % CI 0-20; range, 1-1,094) and a 1-year survival rate of 13.8 %. When excluding cats that died or were euthanized at diagnosis, the MST was 19 days (95 % CI 0-99; range, 2-1,094). No statistical associations were found between COX-2, E-cadherin, PD-L1, CD44 or c-KIT OIS and histological subtype, necrosis, vascular invasion, mitotic count, presence of metastasis or survival. Positive E-cadherin expression was significantly associated with the presence of perineural invasion (P = 0.009; OR 1.50 [95 % CI 1.11-2.03]).

Acute lymphoid leukaemia (ALL) is a significant cause of morbidity and mortality globally, with increasing incidence rates observed in Saudi Arabia. Despite advances in treatment, there is a lack of localized, sex-specific forecasts to guide public health interventions.

This study aims to forecast the future incidence of acute lymphoid leukaemia in males and females using ARIMA models.

Saudi national cancer registries data from 1990 to 2019 were used. The dataset was divided into training (80%) and testing (20%) sets. ARIMA models were developed for male and female incidence, with model parameters determined using ACF and PACF plots. Stationarity was assessed using the Augmented Dickey-Fuller test, and model accuracy was validated using MAE, MSE, and MAPE. Forecasts included point estimates and 95% confidence intervals.

For males, the ARIMA (3, 3, 3) model forecasted an increase in ALL incidences from 957 cases in 2020 to 2181 cases in 2029. For females, the ARIMA (4, 3, 0) model projected an increase from 1019 cases in 2020 to 2159 cases in 2029. The models demonstrated high accuracy, with MAE of 1.19895 and 2.749188, MSE of 62.33 and 31.83, and MAPE of 0.6805807 and 1.443453 for males and females, respectively.

Forecasts indicate a substantial rise in ALL incidence among both sexes, highlighting the urgent need for improved surveillance, early detection, and healthcare capacity planning. Incorporating ARIMA modelling into routine monitoring could support proactive resource allocation. Further studies should integrate additional predictive variables to enhance model precision.