Previous Resection Research Articles

The value of a multimodal approach combining radical surgery and intraoperative radiotherapy in the recurrence treatment of gynecological malignancies - analysis of a large patient cohort in a tertiary care center

BackgroundRecurrent and locally advanced gynecological malignancies have a poor prognosis. In particularly, pelvic local recurrence after previous radiotherapy and/or positive resection margins during surgical treatment for recurrent disease result in low survival rates. Consequently, locoregional control is of utmost importance in this cohort of patients. The aim of this study was to analyze treatment outcomes and determine prognostic factors for patients treated with surgery and intraoperative radiotherapy (IORT) for recurrent and locally advanced gynecological malignancies.Methods40 patients who underwent surgical treatment and IORT between 2010 and 2022 were eligible for inclusion. The median follow-up time was 22 months. The outcomes measured were locoregional control (LRC), overall survival (OS), and survival without distant metastases (DMFS). The Cox proportional hazards model was used for univariate and multivariate analysis to assess the impact of patient variables and treatment factors on the endpoints mentioned. The following variables were analyzed: age at surgical treatment and IORT and initial diagnosis (< 65 vs. ≥65 years, each), disease-free interval (DFI) between initial diagnosis and first recurrence, DFI to surgical treatment and IORT, grading, histology, IORT dose (≤ 13 vs. >13 Gy) and technique (high dose radiotherapy (HDR) vs. IORT using electrons, (IOERT)). Survival curves were generated using the Kaplan-Meier method.ResultsThe mean IORT dose was 13.8 Gy (range 10–18 Gy). Cervical carcinoma was most frequently found in 27.5% of patients followed by endometrial carcinoma and vulvar carcinoma in 25% respectively. The final histopathologic results after surgery with IORT showed no residual tumour in 24 patients (60%), microscopic residual disease in 5 patients (12.5%), resection status could not be evaluated in three patients (7.5%) and the resection status was unknown in eight patients (20%). Subsequently, 27.5% of patients also received adjuvant radiotherapy of the local recurrence bed. However, after IORT, 65% of the women suffered a recurrence. Of these, the recurrences were localized: in-field 32.5%, out-of-field 22.5% and margin-of-field 12.5%. The 3- and 5-year OS was 69% and 55% respectively. The 3- and 5-year LRC was 56% respectively. The 3- and 5-year DMFS was 66% and 49%. Whereas the comparison between groups by IORT dose level (≤ 13 vs. >13 Gy) showed a non-significant trend in favor of the higher dose only for OS (p = 0.094), but not in LRC and DMFS (p > 0.05). OS and DMFS, but not LRC, differed significantly between the HDR-IORT and IOERT groups (p = 0.06 and p = 0.03,) in favor of the HDR-IORT technique. For HDR-IORT technique a trend towards superior OS and LRC was observed in the univariate analysis: HR 3.76, CI 95%: 0.95–14.881, p = 0.059 and HR 2.165 CI 95%: 0.916–5.114, p = 0.078ConclusionsThe survival rate for pelvic recurrence in gynecological malignancies remains poor and comparable with historical data from the last two decades. Particularly HDR-IORT, appears to provide a long-term oncological benefit in carefully selected patients.

Surgical Treatment and Clinical Evaluation of Calvarial Metastases.

The aim of this study is to explore surgical treatment techniques and clinical attributes associated with calvarial metastases, while providing a comprehensive review of the treatment experiences relevant to this particular type of tumor. This study involves a retrospective analysis of clinical data from 12 patients diagnosed with calvarial metastatic tumors who underwent surgical intervention. Among these patients, 5 had a history of previous malignant tumor resections, while 7 presented with calvarial metastatic tumors as their initial symptom. In all cases, the surgical approach consisted of calvarial tumor resection followed by titanium mesh repair. Following the surgical intervention, all patients underwent a comprehensive course of treatment, encompassing both local radiotherapy and systemic chemotherapy. In 1 instance, a patient presented with multiple tumors located in the central area of the frontal bone and the right temporal bone. The larger tumor situated in the middle of the frontal bone was surgically excised, while the tumor in the right temporal bone was treated using radiotherapy. In 2 cases characterized by multiple metastases within the skull, a comprehensive excision of all tumors was accomplished in a single surgical procedure. In the remaining cases featuring a solitary metastatic growth, the respective tumors were surgically removed. There were 10 instances of dura mater invasion and 3 cases involving the invasion of brain tissue. Pathologic examinations revealed 1 case of metastatic lung adenocarcinoma, 1 case of metastatic paraganglioma, 1 case of metastatic hepatocellular carcinoma, 2 cases of metastatic thyroid carcinoma, and 7 cases of metastatic clear cell renal cell carcinoma. Throughout the follow-up period, spanning from 14 to 90 months, various outcomes were noted. These included three occurrences of in situ recurrence. In addition, 1 patient required 3 distinct surgical interventions, while 2 other patients underwent 2 separate surgical procedures each. Notably, 1 of these cases involved the exposure of the titanium mesh on the scalp, necessitating the removal of the titanium mesh. Regrettably, there have been 9 recorded fatalities among the patients, while 3 individuals have survived. Solitary metastasis of calvarium region is rare, and surgical resection is effective. However, it is necessary to extend the resection range and combine with local radiotherapy to avoid local recurrence. Surgical intervention can significantly enhance the quality of life for affected patients. The prognosis of the patients mainly depends on the treatment of the primary disease and the situation of important organ dissemination and treatment.

Real-world Decision-making Process for Stereotactic Body Radiotherapy Versus Minimally Invasive Surgery in Early-stage Lung Cancer Patients.

To generate a prediction model for selection of treatment modality for early-stage non-small cell lung cancer (NSCLC). Stereotactic body radiotherapy (SBRT) and minimally invasive surgery (MIS) are used in the local treatment of early-stage NSCLC. However, selection of patients for either SBRT or MIS remains challenging, due to the multitude of factors influencing the decision-making process. We analyzed 1291 patients with clinical stage I NSCLC treated with intended MIS or SBRT from January 2020 to July 2023. A prediction model for selection for SBRT was created based on multivariable logistic regression analysis. The receiver operating characteristic curve analysis stratified the cohort into 3 treatment-related risk categories. Post-procedural outcomes, recurrence and overall survival (OS) were investigated to assess the performance of the model. In total, 1116 patients underwent MIS and 175 SBRT. The prediction model included age, performance status, previous pulmonary resection, MSK-Frailty score, FEV1 and DLCO, and demonstrated an area-under-the-curve of 0.908 (95%CI, 0.876-0.938). Based on the probability scores (n=1197), patients were stratified into a low-risk (MIS, n=970 and SBRT, n=28), intermediate-risk (MIS, n=96 and SBRT, n=53) and high-risk category (MIS, n=10 and SBRT, n=40). Treatment modality was not associated with OS (HR of SBRT, 1.67 [95%CI: 0.80-3.48]; P=0.20). Clinical expertise can be translated into a robust predictive model, guiding the selection of stage I NSCLC patients for MIS versus SBRT and effectively categorizing them into three distinct risk groups. Patients in the intermediate category could benefit most from multidisciplinary evaluation.

Grade 1, 2, and 3 Multifocal Type 1 Gastric Neuroendocrine Tumor In The Same Patient, Case Report.

Objective: Gastric neuroendocrine tumors (GNETs) are a rare but increasingly recognized subset of neuroendocrine tumors, primarily due to advancements in diagnostic techniques. These tumors exhibit varied clinical presentations and prognoses, necessitating precise histopathological classification for appropriate management. GNETs are classified into four types, with Type 1 being the most common and often associated with autoimmune atrophic gastritis. Case: This case report presents a 41-year-old male diagnosed with multifocal, grade 2 GNET, initially misclassified as grade 3 at an external facility. Despite the usual indolent nature of Type 1 GNETs, total gastrectomy and D1-D2 lymph node dissection were performed due to the multifocal nature of the tumors and positive margins from previous resections. Immunohistochemical analysis confirmed the diagnosis, with a Ki-67 index of &lt;1%. Despite initial aggressive histological features, the patient showed no recurrence at the 5-month follow-up. Conclusion: This case highlights the challenges in grading and managing GNETs, emphasizing the importance of multidisciplinary approaches and careful pathological examination to guide treatment.

Nephrogenic adenoma of the urinary bladder. Clinical features, long-term follow-up and recurrence predictors

ABSTRACT Objectives To review the clinical features of nephrogenic adenoma (NA) of the urinary bladder and assess the long-term recurrence rates. Material and methods A retrospective analysis of all diagnosed NA of the urinary bladder between 2000 and 2023 was done. All patients’ demographics, symptoms, history of previous bladder surgeries, macroscopic and microscopic features of NA and coincidental pathology were reviewed. The long-term recurrence rate including malignant recurrence was assessed. Univariate and multivariate analysis of predictor of recurrence was performed. Results We identified 24 patients diagnosed with NA with a mean (SD, range) age of 56 (16, 15–73) years. Eighteen (75%) patients had previous history of bladder surgeries. Macroscopic appearance on cystoscopy looked polypoidal, flat velvety, papillary and nodular in eight, seven, five, and four patients, respectively. At a median (range) follow-up of 35 (18–145) months, 15 (63%) patients developed one recurrence including NA, non-specific cystitis and urothelial carcinoma (UC) in nine, three and three patients, respectively. Of them, five had a second recurrence, and one patient had a third recurrence. Patients with malignant recurrence had previous history of UC and two of them required radical cystectomy and urinary diversion. Previous TURBT was the only independent predictor for recurrence [OR (95% CI) = 28 (2–37), p = 0.01]. Conclusion Nephrogenic adenoma is a benign disease that mimics malignant lesion clinically. It is associated with high recurrence rate. Previous resection of bladder lesion is the independent predictor of the recurrence.

Causes, management, and prognosis of severe gastrointestinal bleedings in critically ill patients with pancreatic cancer: A retrospective multicenter study

BackgroundGastrointestinal (GI) bleeding is a leading cause of intensive care unit (ICU) admission in pancreatic cancer patients. AimsTo analyze causes, ICU mortality and hemostatic treatment success rates of GI bleeding in pancreatic cancer patients requiring ICU admission. MethodsRetrospective multicenter cohort study between 2009 and 2021. Patients with a recent pancreatic resection surgery were excluded. ResultsNinety-five patients were included (62 % males, 67 years-old). Fifty-one percent presented hemorrhagic shock, 41 % required mechanical ventilation. Main GI bleeding causes were gastroduodenal tumor invasion (32 %), gastroesophageal varices (21 %) and arterial aneurysm (12 %). Arterial aneurysms were more frequent in patients with previous pancreatic resection (36 % vs 2 %, p < 0.001). Hemostatic procedures included gastroduodenal endoscopy in 81 % patients and arterial embolization in 28 % patients. ICU mortality was 19 %. Multivariate analysis identified four variables associated with mortality: performance status >2 (OR 9.34, p = 0.026), mechanical ventilation (OR 14.14, p = 0.003), treatment success (OR 0.09, p = 0.010), hemorrhagic shock (OR 11.24, p = 0.010). Treatment success was 46 % and was associated with aneurysmal bleeding (OR 29.89, p = 0.005), ongoing chemotherapy (OR 0.22, p = 0.016), and prothrombin time ratio (OR 1.05, p = 0.001). ConclusionIn pancreatic cancer patients with severe GI bleeding, early identification of aneurysmal bleeding (particularly in case of previous resection surgery) and coagulopathy management may increase the treatment success and reduce mortality.

Treatment of ventral neurenteric cyst at the cervicothoracic junction with the anterior approach in a pediatric patient: illustrative case.

Neurenteric cysts are rare congenital lesions from heterotopic endodermal tissue, often presenting with radiculopathy or myelopathy in young adults. Gross-total resection is curative; however, the surgical approach remains widely debated for cervicothoracic cases. While the posterior approach is common, the anterior approach has had success in adults. The authors present the first pediatric case of anterior corpectomy with gross-total resection of a cervicothoracic neurenteric cyst alongside an extensive literature review. A 10-year-old male, who had undergone a previous cyst resection via a posterior approach at an outside institution, presented with back pain, paraplegia, and urinary incontinence. Magnetic resonance imaging of the spine revealed a ventral hyperintense cyst at C7-T1 consistent with a neurenteric cyst. An anterior approach involving C7 and T1 corpectomies was performed, including intradural exploration leading to complete cyst resection. This was followed by the placement of an expandable cage and anterior and posterior fixation with arthrodesis for stabilization. The patient's symptoms completely resolved after surgery, and there has been no recurrence. The anterior approach is a viable option for cervicothoracic neurenteric cyst resection in the pediatric population and can aid in gross-total resection by providing better lesion visualization. More studies are needed on long-term outcomes of the anterior approach in pediatric populations. https://thejns.org/doi/10.3171/CASE24120.

Mortality and postinterventional complications after ablative treatment of liver malignancies: A cohort study of 4374 patients

PurposeAblative therapies for primary and secondary liver malignancies are increasingly adopted in current guidelines. Nevertheless, surgical resection remains the gold standard in most curative therapy settings.Extensive studies on mortality and morbidity after ablative treatment of the liver are missing. We investigated complications and mortality after ablative treatment in a large, unselected study cohort. Materials and MethodsStandardized patient and treatment data in 4374 percutaneous and angiographic ablative procedures of the liver from the DRG-based hospital reimbursement system (diagnosis-related groups) of an academic hospital in Germany were retrospectively evaluated. We analyzed descriptive patient data, length of stay (LOS), pre-existing medical conditions, previous gastrointestinal surgeries, severe complications, and occurrence of death. ResultsTreatment of secondary liver malignancies constituted over two-thirds of all procedures (71%, n = 3053). The mean LOS was 4.1 ± 3.5 days. Severe complications were documented in 1.4% and in-house death in 0.2% of cases, significantly more often after treatment with chemoembolization of primary liver malignancies (p = 0.003; p = 0.000).Previous partial liver resection, partial bowel resection, and chronic renal failure were independent risk factors for the occurrence of severe complications. ConclusionSevere complications and in-hospital death are rare in the treatment of primary and secondary liver malignancies with percutaneous and angiographic procedures.They are a viable alternative or addition to a surgical approach in treating liver lesions.

The STS 2024 Risk Models for Lung Cancer Resection: Continued Refinement and Improved Outcomes

The Society of Thoracic Surgeons General Thoracic Surgery Database (STS GTSD) has been used to develop risk models for patients undergoing pulmonary resection for cancer. Leveraging a contemporary and more inclusive cohort, we sought to refine these models. The study population consisted of adult patients in the STS GTSD who underwent pulmonary resection for cancer between 2015 and 2022. Unlike previous models, non-elective operations were included. Separate risk models were derived for operative mortality, major morbidity, and composite morbidity or mortality. Logistic regression with backward selection was used with predictors retained in models if p<0.10. All derived models were validated using 9-fold cross validation. Model discrimination and calibration were assessed for the overall cohort and for surgical procedure, demographic, and risk factor subgroups. Data from 140,927 patients at 337 participating centers were included in the study. Overall operative mortality rate was 1.1%, major morbidity 7.3%, and composite morbidity or mortality 7.6%. Novel predictors of short-term outcomes included interstitial lung disease, DLCO, and payor status. Overall discrimination was superior to previous STS pulmonary resection models for operative mortality [C-statistic = 0.80] and for composite morbidity or mortality [C-statistic = 0.70]. Model discrimination was comparable and model calibration was excellent across all procedure- and demographic-specific sub-cohorts. Among STS GTSD participants, major morbidity and operative mortality rates remain low following pulmonary resection. The newly derived pulmonary resection risk models demonstrate superior performance compared to previous models, with broader real-life applicability and clinical face validity.

Pregnancy after advanced ovarian cancer with spontaneous uterine rupture in second trimester: A case report and review of the literature.

Fertility-preserving surgery (FPS) in advanced ovarian cancer (AOC) is extremely rare and consequently, information about the pregnancies of these patients is anecdotal. Therefore, management of the pregnancy after AOC is challenging, especially if an unexpected situation arises. A 31-year-old nulliparous woman was admitted to our tertiary hospital in the 18th week of twin pregnancy with sudden severe abdominal pain. Her medical history included a low-grade AOC stage IIIc diagnosed 2 years before pregnancy and treated by debulking FPS and systemic therapy with carboplatin/paclitaxel and bevacizumab. Clinical examination described normal vital signs and peritoneal irritation without any vaginal discharge. Sonography revealed free fluid in the pouch of Douglas and intact twin pregnancy. Laboratory work showed elevated leukocytes with neutrophilia. To evaluate appendicitis magnetic resonance imaging of the abdomen was indicated. This revealed a uterine rupture with the now extra-cavitary position of the twins. Simultaneously, the patient's symptoms deteriorated, and emergency surgery was necessary where hemoperitoneum with avital fetuses were present. Despite excessive blood loss the uterus could be repaired and preserved. Previous resection of the uterine serosa during her debulking FPS, administration of bevacizumab affecting smooth muscles, and overstretching the uterus in the twin pregnancy were considered as possible risk factors for the presenting uterine rupture. Pregnancy after AOC is possible but should be monitored closely, especially due to the hidden long-term consequences of its therapy. In the differential diagnosis of sudden abdominal pain during pregnancy uterine rupture should be considered even in patients with an unscared uterus.

Critical Illness Corticosteroid Insufficiency after Blunt Abdominal Trauma: A Case Report

A 60-year-old man with a history of a previous colon resection presented after a motor vehicle collision. He was hypotensive in the field. A systolic pressure of 58 was noted on admission to the trauma bay. The remaining vital signs revealed a pulse of 99 and respirations 18. The temperature was 98 degrees. The patient was alert with a GCS of 15. He was given 2 liters of crystalloids and his systolic pressure increased to 100. His initial hemoglobin was 12.3 with hematocrit of 37. The initial base deficit was -12 and a venous lactate was 3.3. Work up revealed a left femur fracture, a right tibial plateau fracture and right radius and ulna fractures. An abdominal CT revealed a possible small bowel injury and the patient was taken to the operating room for exploration. The operative findings included small bowel injury and blunt colon injuries requiring jejunal resection and a primary anastomosis along with a segmental colon resection and end-colostomy. The left femur fracture was fixed along with the radius and ulna fractures at a separate operative intervention.

217 Outcomes of Reoperation for Residual or Recurrent Obstruction After Previous Myectomy in Patients with Hypertrophic Cardiomyopathy

Abstract Aim Describe the mechanism(s) of residual or recurrent obstruction in patients who have previously undergone septal myectomy for hypertrophic cardiomyopathy and assess early outcomes of reoperation. Method From January 1989 to March 2022, we performed 73 repeat myectomies at our institution. Patients’ demographics, operative details, echocardiographic parameters, and postoperative complications were retrieved from a prospectively maintained surgical database and electronic healthrecords. Results Median age at reoperation was 48.3 years (IQR 38.6-58.6); 51 patients were women (69.9%). 90.4% presented with NYHA class III/IV symptoms. Median interval between previous myectomy and reoperation was 2.7 years (IQR 1.2-4.5). Mechanism of obstruction was an inadequate length of previous septectomy in 41 patients (56.2%), a combination of inadequate length and midventricular obstruction in 30 (41.1%), and isolated midventricular obstruction in 2 patients (2.7%). There were no instances of recurrent LVOT obstruction due to muscle regrowth at the site of previous resection. All patients had an extended transaortic septal myectomy; 14 patients (19.2%) had concomitant transapical myectomy. Preoperatively, the median LVOT gradient was 83 mmHg (IQR 60-122), which reduced to 2 mmHg (IQR 0-7) following repeat myectomy. There were no perioperative deaths. Postoperatively, 4 patients (5.5%) developed a new CHB, necessitating PPM implantation. The 5-,10-, and 20-year survival after reoperation were 100%, 91%, and 76%, respectively. Conclusions Inadequate resection at the time of primary septal myectomy is the commonest cause of residual or recurrent obstruction in oHCM patients. However, repeat myectomy, including a combined transaortic and transapical approach has minimal risk with excellent hemodynamic and long-term survival outcomes.

Does previous transurethral resection of the prostate affect the outcomes in robotic assisted radical prostatectomy?

Transurethral resection of the prostate (TURP) is one of the surgical options for treating enlarged prostates with lower urinary symptoms (LUTS). In this older group of patients, concomitant prostate cancer is not uncommon. However, the fibrosis and distortion of the prostate anatomy by prior TURP can potentially hinder surgical efficacy at robotic-assisted radical prostatectomy (RARP). We aim to evaluate functional, and oncologic outcomes of RARP in patients with and without previous TURP. 231 men with previous TURP underwent RARP (TURP group). These men were propensity score matched using clinicopathological characteristics to men without previous TURP who underwent RARP (Control group). Perioperative and postoperative variables were analysed for significant differences in outcomes between groups. Variables analysed included estimated blood loss (EBL), operative time, catheter time, hospitalization time, postoperative complications, positive surgical margins (PSM) rates, cancer status, biochemical recurrence (BCR), potency, and continence rates. Patients in the TURP group showed no statistically significant differences in operative safety measures including median EBL, operative time, catheter time, hospitalization time or postoperative complications. No significant difference between the groups in terms of potency rates and continence rates. Furthermore, there were no statistically significant differences in oncological outcomes, including PSM rates (15% vs 18%, P = 0.3) and BCR. In RARP after TURP there is often noticeable distortion of the surgical anatomy. For an experienced team the procedure is safe and provides similar oncologic control and functional outcomes to RARP in patients without previous TURP.

Liver Transplantation for Adenomatosis: A Single-Center Experience

Liver adenomatosis is characterized by multiple adenomas diffusely distributed throughout the liver parenchyma. Studies addressing liver transplantation for those cases are scarce, and the criteria used to indicate transplantation are still debatable. To report a single-center experience of liver transplantation for diffuse adenomatosis. Single-center retrospective study involving all adult patients who underwent liver transplantation due to adenomatosis from January/2010 to June/2023. A total of 13 patients were identified, corresponding to 0.89% of liver transplants performed during the study period. The mean age was 33 ± 6.55 years, and most of them were female (n = 9, 69.23%). There were 12 transplants with deceased donors and 1 with a right lobe from a living donor. The most frequent reason to preclude liver resection was multiple and large unresectable adenomas in patients without previous liver disease (n = 8, 61.58%), followed by underlying liver disease (Abernethy Malformation, n = 3, 23.07%) and recurrence after liver resection (n = 2, 15.38%). The indications for liver transplantation were high risk of malignant transformation (n = 7, 53.84%), increasing size and number of nodules (n = 3, 23.07%), confirmed malignant transformation (n = 2, 15.38%), and hemorrhage (n = 2, 15.38%). There was 1 perioperative death due to primary non-function. Another patient died during follow-up because of COVID-19. Liver adenomatosis is a rare indication for liver transplantation, with acceptable post-transplant outcomes. Unresectable adenomas with high-risk or confirmed malignant transformation are the main indications for transplant. Reasons for unresectability involve underlying liver disease, multiple and large high-risk nodules, and recurrence after previous resection.

A DNA plasmid melanoma cancer vaccine, SCIB1, combined with nivolumab + ipilimumab in patients with advanced unresectable melanoma: Efficacy and safety results from the open-label phase 2 SCOPE trial.

9535 Background: Targeting melanoma by T cells drives anti-tumor responses. We previously showed that SCIB1, a DNA vaccine incorporating T cell epitopes from TRP-2/gp100 into an antibody framework to allow Fc targeting of activated dendritic cells, was successful as monotherapy in a Phase 1/2 trial in Stage III/IV melanoma patients. Disease control was achieved in 60% of cases of unresectable melanoma. In addition, 88% of 20 Stage III/IV patients treated with SCIB1 who had had a previous successful tumor resection, were disease free for 5 years. 1st line combination treatment with nivolumab and ipilimumab in advanced melanoma has a reported ORR of 50%. The current SCOPE trial tests the hypothesis that patients with unresectable melanoma may improve response rate when SCIB1 is given with checkpoint inhibitors (CPI). Methods: Previously untreated patients with unresectable Stage III/IV melanoma were treated with nivolumab with ipilimumab and SCIB1 (8 mg) i.m. using needle-free injections at a fixed dosing schedule for a total of 10 doses over 24 months. The CPI therapy was administered in accordance with respective SmPC. ORR, as measured by RECIST 1.1 in the intention-to-treat population, is the primary endpoint. The study is designed using Simon's two stage methodology with 80% power when the ORR of no interest is 50% and the true ORR is 70% with an overall type I error of 5%. In the 1st stage, 15 patients have been enrolled and as there were more than 8 clinical responses (ORR [CR or PR]) within 25 weeks of the 1st SCIB1 dose. Having passed Simon Stage 1, further recruitment continues. The null hypothesis will be rejected if 27 or more responses are observed in 43 patients. Results: To date, 23 patients have received the combination of SCIB1 with nivolumab and ipilimumab. At study entry, all patients were Stage IV. 13 patients have reached the first imaging timepoint at 13 weeks, the objective response rate is 11/13 (85%). 11/11 responses were confirmed in a subsequent scan (1 CR and 10 PRs); DCR 12/13 (92%) and 1 PD. Patients showed a 40-100% reduction in tumor volume at 13 and/or 25 weeks. Most of the SCIB1 adverse reactions were Grade 1/2 injection site related or headaches. 3 patients reported Grade 3 events (rash, neutropenia and raised GGT) all related to the CPIs. Observed toxicity frequency and intensity was in line with reported figures from ipilimumab/nivolumab therapy. Serious adverse reactions to date have all been related only to the CPIs. Conclusions: SCIB1 given with nivolumab and ipilimumab, as 1st line treatment in unresectable melanoma, improved the ORR to 85% without an increase in clinically meaningful adverse events. These results, if confirmed in the larger ongoing patient cohort, provide confidence in initiating a randomized registration program in unresectable melanoma patients with this novel DNA plasmid technology. Clinical trial information: NCT04079166 .

Laser interstitial thermal therapy (LITT) for pediatric low-grade glioma—case presentations and lessons learned

BackgroundThe surgical treatment of brain tumors has developed over time, offering customized strategies for patients and their specific lesions. One of the most recent advances in pediatric neuro-oncological surgery is laser interstitial thermal therapy (LITT). However, its effectiveness and indications are still being evaluated. The aim of this work is to review the current literature on LITT for pediatric low-grade gliomas (pLGG) and evaluate our initial results in this context.MethodsWe retrospectively reviewed our pediatric neurosurgery database for patients who received LITT treatment between November 2019 and December 2023. We collected data on the indications for LITT, technical issues during the procedure, and clinical and radiological follow-up.ResultsThree patients underwent 5 LITT procedures for pLGG. The lesion was thalamo-peduncular in one patient, cingulate in one, and deep parietal in one patient. Two patients had a previous open resection done and were diagnosed with pLGG. One patient underwent a stereotaxic biopsy during the LITT procedure that was non-diagnostic. The same patient underwent a later open resection of the tumor in the cingulate gyrus. There were no surgical complications and all patients were discharged home on the first post-operative day. The follow-up period was between 20 and 40 months. Radiological follow-up showed a progressive reduction of the tumor in patients with LGG.ConclusionLaser interstitial thermal therapy is a minimally invasive treatment that shows promise in treating deep-seated pLGG in children. The treatment has demonstrated a reduction in tumor volume, and the positive results continue over time. LITT can be used as an alternative treatment for tumors located in areas that are difficult to access surgically or in cases where other standard treatment options have failed.

Long-term Outcome of Risankizumab in Crohn’s Disease: a Real-world GETAID Study

IntroductionThe aim of this study was to assess the long-term effectiveness and safety of risankizumab maintenance treatment in a large real-world cohort of patients with CD. Patients and MethodsFrom May 2021 to August 2023, all consecutive CD patients treated with risankizumab in 25 GETAID centers have been retrospectively included. The primary endpoint was steroid-free clinical remission (Harvey Bradshaw Index (HBI) <5) at 52 weeks. ResultsOf the 174 patients included, 99%, 93%, and 96% had been previously exposed to anti-TNF, vedolizumab, and ustekinumab, respectively. All patients had received ≥3 biologics and 108 (62%) had previous intestinal resection. Median follow-up was 13.7 (10.0-18.1) months. The rates of steroid-free clinical remission and clinical remission at week 26 were 47% (72/152) and 52% (79/152), and 46% (58/125), and 48% (60/125) at week 52, respectively. Risankizumab persistence rates were 94%, 89%, and 79% at weeks 12, 26, and 52, respectively. At the end of follow-up, 45 (45/174, 26%) patients had discontinued risankizumab (loss of response, 42%; primary failure, 37%; intolerance, 13%). Thirty-six patients (36/174, 20.9%) were hospitalized and 22 (22/174, 12.6%) required intestinal resection. Fifty-one (29%) patients had an adverse event including 26 (15%) serious adverse events (CD flare, n=17). One death (myocardial infarction) and one cancer (papillary thyroid carcinoma) were observed. ConclusionThis is the first real-life study to report long-term outcomes in patients with refractory CD treated with risankizumab. Half of the patients achieved steroid-free clinical remission after one year, and the safety profile was consistent with the literature.

Predictive factors associated with technical difficulty in colorectal endoscopic submucosal dissection: A Honam Association for the Study of Intestinal Disease (HASID) multicenter study.

Colorectal endoscopic submucosal dissection (ESD) is a promising but challenging procedure. It is not widely performed due to its technical difficulty. We aimed to find the predictive factors associated with technical difficulty in colorectal ESD before the procedure. Clinical data from patients who underwent ESD for colorectal tumors in 5 hospitals in Honam province of South Korea between 2015 and 2020 were reviewed retrospectively. Technically difficult colorectal ESD procedure was defined in 3 points. Long procedure time (longer than 60 minutes), occurrence of perforation, and failure of en bloc resection. Factors associated with technically difficult ESD were included as main outcome measure. 1446 patients were identified and their data were analyzed. Median procedure time was 30.0 minutes and median long axis of the tumor was 20.1 mm. Technically difficult procedures including long procedure time were 231 cases (16.0%), perforation occurred in 34 cases (2.3%), and en bloc resection was done in 1292 cases (89.3%). Tumor size larger than 35 mm (odd ratio [OR]: 1.474, P = .047), central depression or ulceration in the lesion (OR: 1.474, P = .013), previous endoscopic mucosal resection (EMR) or polypectomy procedure (OR: 2.428, P = .020) were associated with technically difficult ESD. Descending colon-located tumor (OR: 5.355, P < .001), and use of IT knife (OR: 4.157, P = .003) were associated with perforation. Recognizing factors associated with technically difficult ESD can help in planning the ESD procedure beforehand.

Clinical Outcome of Patients with Gastric, Duodenal, or Rectal Neuroendocrine Tumors after Incomplete Endoscopic Resection.

Objectives: Our aim was to investigate the clinical outcome of patients with well-differentiated gastric, duodenal, and rectal neuroendocrine tumors after treatment with incomplete endoscopic resection due to the finding of microscopic positive resection margins (R1). Methods: This is a retrospective analysis of consecutive patients with type 1 gastric, non-ampullary non-functioning duodenal, or rectal neuroendocrine neoplasms with positive R1 margins after endoscopic resection. The rate of tumor recurrence and progression-free survival were considered to be the study's main endpoints. Statistical analysis was performed using MedCalc® v.17 software and a p-value of <0.05 was considered significant. A Cox proportional-hazard regression was performed to identify risk factors for disease recurrence/progression. Results: After evaluating 110 patients, a total of 58 patients were included in the final analysis (15 gastric NENs, 12 duodenal NENs, and 31 rectal NENs). After evidence of endoscopic R1 resection had been gathered, 26 patients (44.8%) underwent an endoscopic/surgical extension of the previous resection. Tumor progression (all local recurrences) occurred in five out of fifty-eight patients (8.6%) with a median PFS of 36 months. There were no tumor-related deaths. G2 grading and the gastric primary tumor site were the only features significantly associated with the risk of recurrence of the disease (HR: 11.97 [95% CI: 1.22-116.99], HR: 12.54 [95% CI: 1.28-122.24], respectively). Conclusions: Tumor progression rarely occurs in patients with microscopic positive margin excision (R1) after endoscopic resection and does not seem to affect patients' clinical outcomes.

Pamiparib as consolidation treatment after concurrent chemoradiotherapy of limited-stage small cell lung cancer: a single-arm, open-label phase 2 trial

BackgroundSmall cell lung cancer (SCLC) is highly invasive with poor prognosis, and its treatment has historically been hindered due to the absence of targetable driver genomic alterations. However, the high genomic instability and replication stress in SCLC have made poly(ADP-ribose) polymerases (PARPs) inhibitors a focus of research. Pamiparib is an orally available PARP1/2 inhibitor with high selectivity, strong PARP trapping activity, and excellent brain penetration. Utilizing pamiparib as consolidation maintenance therapy in limited-stage SCLC holds promise for improving survival outcomes and offering a viable therapeutic approach.MethodsThis single-arm, open-label phase II trial will enroll patients aged 18–75 years with histologically/cytologically confirmed, limited-stage SCLC who have not progressed following definitive platinum-based cCRT and have an ECOG PS of 0 or 1. Patients will be excluded if they have histologically confirmed mixed SCLC or NSCLC, or have undergone previous tumor resection, or can be treated with surgery or stereotactic body radiation therapy/stereotactic ablative radiation therapy. Participants will receive pamiparib 40 mg twice daily every 3 weeks within 2 to 6 weeks after cCRT for up to 1 year or until disease progression according to RECIST v1.1. The primary endpoint is the 1-year progression-free survival (PFS) rate assessed by investigators per RECIST v1.1. Secondary endpoints include PFS, objective response rate, and duration of response assessed by investigators per RECIST 1.1, overall survival, time to distant metastasis, and safety.DiscussionThe study will provide valuable data on the feasibility, safety, and effectiveness of pamiparib as a consolidation therapy after cCRT in patients with LS-SCLC. The correlation between molecular typing or gene expression profile of the disease and curative response will be further explored.Trial registrationNCT05483543 at clinicaltrials.gov.