Median Tumor Size Research Articles

Succinate dehydrogenase deficient renal cell carcinoma frequently expresses GATA3 and L1CAM.

Succinate dehydrogenase deficient renal cell carcinoma (SDH RCC) is an uncommon, familial RCC that has overlapping morphologic features with other low grade eosinophilic tumors of the kidney. Although the diagnosis of SDH RCC relies on loss of SDHB by immunohistochemistry (IHC), not all laboratories have access to this antibody. GATA3 and L1CAM are increasingly utilized in the diagnosis of eosinophilic renal tumors; however, their expression profile has not been studied in SDH RCC. We evaluated clinical parameters and GATA3 and L1CAM reactivity in a large nephrectomy cohort (n = 40) of patients with SDH RCC. The male-to-female ratio was 3:1 and the median age was 48years (range: 17 to 79years). Specimens included 20 radical resections, 19 partial resections, and 1 unknown procedure. Tumor laterality was nearly equal (right:left = 18:20; one case was bilateral). Tumors in 4 (10%) patients were multifocal. Median tumor size was 2.0cm (range 1 - 14.8cm). Tumor stage distribution was: pT1a (n = 16, 40%), pT1b (n = 7, 18%), pT2a (n = 5, 13%), pT2b (n = 4, 10%), pT3a (n = 6, 15%), and pT4 (n = 1, 3%). Most cases (n = 33, 83%) exhibited classical morphologic features, whereas 2/40 (5%) had sarcomatoid differentiation. GATA3 was positive in 37/39 (95%) tumors, with more than 50% of cells positive in 35/37 (95%), and with moderate-high intensity (2/3 +) in 33/37 (89%). L1CAM was expressed in 13/18 (72%) tumors, with moderate-high intensity (2/3 +) in 10/13 (77%). When both markers were performed, dual GATA3/L1CAM expression was present in 12/17 (71%) tumors. As L1CAM has been postulated to represent a marker of principal cell of the distal nephron, frequent L1CAM expression in SDH RCC suggests that they may originate from the principal cells of the distal nephron.

Predicting pathological tumor volume in prostate cancer lesions: A head-to-head comparison of micro-ultrasound vs. MRI.

Our objective was to evaluate the agreement between micro-ultrasound, MRI and pathological tumor and prostate volume. Retrospective analysis of consecutive prostate cancer patients with MRI and micro-ultrasound diagnostic assessment who subsequently underwent radical prostatectomy. Tumor and prostate volume on micro-ultrasound and MRI imaging calculated by a dedicated software were compared to those of the prostatectomy specimen. Clinical, radiological, and pathological predictors of pathological tumor size were assessed. 65 men with a total of 104 lesions in the final pathology were included. Median micro-ultrasound tumor size was 1.05 ml (IQR 0.35-2.65). On MRI T2WI, DWI and ADC sequences median tumor volume was 0.73 ml (IQR 0.34-1.94), 0.94 ml (IQR 0.38-2.09) and 0.86 ml (IQR 0.42-1.58), respectively. The pathological median tumor size was 1.2 ml (IQR 0.2-3.9). On average, micro-ultrasound underestimated pathological tumor volume by 0.15 ml (P < 0.01) while DWI, the most precise MRI sequence underestimated tumor size by 0.26 ml (P < 0.01). The MRI and micro-ultrasound underestimated the pathological prostate volume by 6 ml (P < 0.01) and 3 ml (P = 0.47), respectively. Both micro-ultrasound and MRI tend to slightly underestimate pathological tumor and prostate volume. Our study shows that both micro-ultrasound and MRI can be useful in the surgical planning although the underestimation of actual tumor size should be considered.

Comparison of Keratinocyte Cancer Tumour and Defect Sizes Treated by Mohs Micrographic Surgery: Sydney Versus Outside Metropolitan Sydney.

Australia and New Zealand face the world's highest skin cancer rates, with non-metropolitan regions bearing a greater burden. Mohs micrographic surgery (MMS) is the gold-standard treatment for keratinocyte cancers (KCs) due to high cure rates and tissue-sparing benefits. This study evaluates whether Outside Metropolitan Sydney (OMS) patients present with larger tumours and defects than Sydney Metropolitan Area (SMA) patients. This retrospective study examined MMS cases at The Skin Hospital in 2017. Patients were divided into Sydney Metropolitan Area (SMA) and Outside Metropolitan Sydney (OMS), with OMS sub-grouped into Non-Sydney Metropolitan (NSM) and Regional, Rural and Remote (RRR). Tumour and defect sizes were compared between OMS, SMA, and RRR and NSM, with additional exploratory analyses assessing surgical outcomes and tumour characteristics. Of 2073 patients undergoing MMS, 1870 basal cell carcinomas and 203 squamous cell carcinomas were included. Tumours and defects were significantly larger in OMS patients (median tumour size: 0.8 cm2, defect size: 2.1 cm2) compared to SMA patients (median tumour size: 0.7 cm2, defect size: 1.8 cm2). No correlation was found between distance travelled and tumour or defect size. SMA patients also had greater flap and primary closures than OMS. Subgroup analysis of RRR and NSM showed no significant difference in tumour or defect sizes. Patients from OMS presented with larger KCs, suggesting barriers to earlier access to specialised care. This highlights geographic disparities in skin cancer management outside major cities in Australia in the context of MMS, emphasising the need for improved access and dermatological workforce distribution.

Robotic trachelectomy with sentinel lymph node biopsy for cervical cancer: a prospective study investigating minimally invasive radicality.

The importance of minimally invasive fertility-sparing surgery for cervical cancer is gaining increasing interest, both to achieve a cure and for future fertility. Procedures for robotic radical trachelectomy involving uterine reconstruction are not fully established. This study prospectively verified the feasibility and safety of robotic radical trachelectomy between February 2018 and May 2022. The criteria were almost identical to those for our standard abdominal radical trachelectomy. Larger tumors (> 2cm in diameter) were acceptable for surgery, provided a secure ≥ 1cm cancer-free space was identified between the tumor and internal os. Eight patients (median age, 32 y) were registered; the median body mass index was 21.8, and the median tumor size was 11.5mm (range 0-30mm). Robotic radical trachelectomy could be achieved in all patients with hybrid sentinel lymph node navigation surgery, confirming the precise cervical amputation line with a newer small knob ultrasonography probe, adequate cervical cerclage with non-absorbable monofilament stitches, and avoiding looseness between vaginal-uterine anastomosis with uninterrupted barbed U-shaped sutures. None of the cases were converted to laparotomy or radical hysterectomy, and there were no major complications. The median follow-up period was 49.5 mo (range 21-58 mo) and no patient had disease recurrence. Robotic radical trachelectomy is safe and feasible using newer technologies without reducing radicality; it is also less invasive. Procedures are consistently reproducible and have the potential to be generalized to minimally invasive approaches.

90Y-Transarterial Radioembolization Combined with Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: A Systematic Review.

Transarterial radioembolization with yttrium-90 (90Yt-TARE) and immune checkpoint inhibitors (ICIs) are emerging as treatment modalities for intermediate to advanced hepatocellular carcinoma (HCC) based on randomized controlled trials. Herein, we systematically reviewed the published literature on the effects of 90Yt-TARE and ICIs combined on clinical outcomes of HCC. Medical databases of PubMed, Embase, and Cochrane Library were systematically searched for all studies assessing the use of concomitant immunotherapy of ICI with TARE in patients with HCC. Patient characteristics, treatment protocols, treatment outcomes, treatment adverse events, and survival outcomes were extracted after the screening phase. The primary outcomes were overall survival (OS) and patient-free survival (PFS), while the secondary outcomes were imaging objective response (OR) and adverse events. Among 3432 reviewed, ten studies were included in this systematic review, including four randomized controlled trials and six retrospective studies. These consisted of 413 patients with HCC, and seven studies included patients with Child-Pugh A or B7 scores. Most studies allowed advanced or intermediate HCC stages, but only two specified BCLC stages (B and C). Median tumor sizes ranged from 56 to 78.5 mm. Various agents with different administration schedules were used as ICIs for immunotherapy by different studies for the combination of 90Yt-TARE with ICIs. Median OS ranged from 16.2 to 27 months between different studies while the PFS also ranged from 5.6 to 13.3 months. The OR rates according to imaging-based response assessments were reported between 31 and 89%, and the incidence rate of any grade toxicities was between 50 and 80%. Concomitant treatment with 90Yt-TARE and ICIs has shown promising results in the treatment of patients with HCC. Further studies are required to reach a consensus on the optimal treatment protocol and the outcome of these treatments for patients with intermediate to advanced HCC.

Safety of CT-guided percutaneous cryoablation in patients treated for clinical T1 renal cell carcinoma with the need for pre-procedural ureteral stenting: an international cohort study.

To assess the safety of computed tomography-guided percutaneous cryoablation (PCA) in patients who had pre-procedural ureteral stenting, while they were treated for clinical T1 renal cell carcinoma (RCC) with complex location. This retrospective international multicenter cohort study included patients treated between January 2016 and February 2021 at two University Hospitals, X1 and X2. Patients aged more than 18 years with suspected RCC were included. All patients underwent pre-procedural ureteral stenting. The complications were recorded within 30 days and graded according to the Clavien-Dindo classification and the Society of Interventional Radiology classification of adverse events. Major complications were defined as complications≥grade 3 on the Clavien-Dindo classification. The cohort included 61 patients with a median age of 66 years (IQR 55-75 years). The median tumour size was 33 mm (IQR 24-38 mm), with a median R.E.N.A.L score of 8 (IQR 7-10). A complication rate of 36% (n=22) was recorded, and major complications occurred following 10% (n=6) of the procedures. A statistically significant association was found between using more than three cryoprobes and postoperative complications (OR, 4.19; 95% CI: 1.38-12.75; p=0.010). In addition, no associations were found between postoperative complications and prophylactic antibiotics, patient age, tumour complexity, tumour size, histological type, or whether the ice ball was touching the ureter. This multicenter cohort study found a relatively high rate of postoperative complications in patients having a ureteral stent before PCA. However, no complications resulted in a chronic outflow obstruction. The number of high-complexity tumours could explain the high rate of complications.

Natural History of Patients Undergoing Transperineal Fusion Biopsies to Transperineal Fusion Cryoablation: 5-Year Outcomes.

Introduction: Randomized trials comparing radical treatments with surveillance for prostate cancer (PCa) have shown marginal survival benefit with significant detriment in quality of life. MR fusion cryoablation (MRFC) has emerged as a promising approach. We evaluated outcomes of men diagnosed with transperineal fusion biopsies (TPFBx) and treated with MRFC providing intermediate oncological and functional outcomes. Methods: Clinical trial NCT02381990 is a longitudinal registry designed to evaluate outcomes of MRFC for PCa. In this multi-institutional study, we evaluated men with clinically significant PCa (CSPCa) determined by TPFBx, managed with MRFC (<40% of the prostate) in an office setting under local anesthesia. Disease progression (DP), considered a natural history event, was defined as conversion to whole gland treatment, or androgen deprivation or development of metastasis. Univariate and Cox proportional hazards models along with competing risk (CRA) were used against DP. Secondary and functional outcomes are also reported to provide a comprehensive understanding of the therapeutic impact of MRFC. Results: In total, 632 patients met CSPCa criteria managed with MRFC. Median procedure time and pain score were 52 minutes and 2/10, respectively. The 5-year DP rate was 10%. Prostate-specific antigen density was the only independent predictor. Urinary outcomes improved in 3 months and held overtime. Sexual function was affected modestly. A 1-year TPFBx was performed in 439/632 (69%) with PCa and CSPCa found in 144 and 54. IN-field CSPCa and OUT-field CSPCa were present in 19 and 43, respectively. Eight had CSPCa in both fields. Significant reduction in cancer burden at the 1-year biopsy was observed as both IN-field and OUT-field lesions showed a median tumor size under 5 mm. Overall, a second MRFC was conducted in 106/632 men; 17 and 89 were for IN-field and OUT-field tumors, respectively. Conclusions: Office-based MRFC affects the natural progression of PCa while causing minimal impact on functional outcomes. Comprehensive evaluations through randomized controlled trials are necessary to further validate these findings and confirm their effectiveness.

Composite Pheochromocytoma-Paraganglioma With Ganglioneuroma: A Dual-Center Clinical Experience.

Cells derived from neural crest populate several organs. A particular precursor cell, sympathogonia, gives rise to pheochromoblasts and neuroblasts. Due to common origin, tumors originating from pheochromoblasts, such as pheochromocytoma (PHEO) and paraganglioma (PGL), may rarely coexist with ganglioneuroma (GN). We evaluated clinical, biochemical, and radiological characteristics of patients with composite PHEO/PGL and GN (PPGL-GN) and compared them to patients with PHEO. In this retrospective, dual-center, observational, case-control study, we identified patients with PPGL-GN. Similarly, we identified a control group of patients with PHEO who underwent laparoscopic adrenalectomy. All diagnoses were confirmed on histology. Descriptive statistics were used to summarize demographic and clinical data. We identified 19 consecutive patients with PPGL-GN and 86 patients with PHEO. Patients with PPGL-GN, compared to those with PHEO, were younger (aged 46.0 vs 50.8 years; P = .03), had higher rate of underlying genetic disorders (47.4% vs 23.2%; P = .03), and had fewer functioning tumors (89.5% vs 100%; P = .002). There was no difference in the median radiological tumor size or the precontrast computed tomography density. Disease recurrence (at another site) was noted in 15.8% of PPGL-GN patients who had a median follow up of 14.6 months, as opposed to no disease recurrence in patients with PHEO. There was no documented recurrence at the tumor bed and no metastasis in both groups. Patients with PPGL-GN were younger and had a higher occurrence of underlying genetic disorders compared to PHEO. However, PPGL-GN was radiologically indistinguishable from PHEO. The higher observed disease recurrence of PPGL-GN reinforces vigilant postoperative follow-up.

Prognostic Impact of Primary Tumor Size in Papillary Thyroid Carcinoma without Lymph Node Metastasis.

We aimed to investigate the prognostic significance of primary tumor size in patients with pT1-T3a N0 M0 papillary thyroid carcinoma (PTC), minimizing the impact of confounding factors. A multicenter retrospective study included 5,759 patients with PTC. Those with lymph node metastasis, gross extrathyroidal extension (ETE), and aggressive variants were excluded. Patients were categorized by primary tumor size (≤1, 1.1-2, 2.1-4, and >4 cm) and subdivided based on the presence of microscopic ETE (mETE). The median age was 48.0 years, and 87.5% were female. The median primary tumor size was 0.7 cm, with mETE identified in 43.7%. The median follow-up was 8.0 years, with an overall recurrent/persistent disease rate of 2.8%. Multivariate analysis identified male sex, larger tumor size, and the presence of mETE as significant prognostic risk factors. The 10-year recurrent/persistent disease rates for tumors ≤1, 1.1-2, 2.1-4, and >4 cm were 2.5%, 4.7%, 11.1%, and 6.0%, respectively. The 2.1-4 cm group had a significantly higher hazard ratio (HR), with the >4 cm group had the highest HR than the ≤1 cm group. Patients with mETE had a higher recurrent/persistent disease rate (4.5%) than those without, with rates by tumor size being 2.6%, 5.6%, 16.7%, and 8.2%. Larger tumor size and the presence of mETE significantly increased the risk of recurrent/persistent disease in PTC. Patients with pT2-T3a N0 M0 PTC (>2 cm) had a recurrent/persistent disease risk exceeding 5%, warranting vigilant management.

Clinical and biological heterogeneity of Grade 2 digestive neuroendocrine neoplasms: prognostic significance of the 10% Ki-67 index cutoff and implications for treatment strategies. A longitudinal study.

Digestive neuroendocrine neoplasms (NENs) encompass a heterogeneous group of tumors with varying prognoses and clinical behaviors. Grade 2 (G2) tumors, defined by a Ki-67 index between 3% and 20%, are particularly challenging to manage due to their intermediate and variable biological behavior. Evidence suggests a distinct prognosis between G2 digestive NENs with a Ki-67 index < 10% and those with a Ki-67 index ≥ 10%. To investigate the clinical and biological heterogeneity between Grade 1 (G1) and G2 digestive NENs, and within G2 tumors, with a focus on the prognostic significance of a 10% Ki-67 index cutoff. This study involved a combined retrospective and prospective analysis of patients with low-grade G1 and G2 digestive NENs managed at IRCCS San Gerardo Hospital in Monza, Italy, between January 2000 and May 2024. Data on patient demographics, tumor characteristics, treatment modalities, and survival outcomes were collected and potential differences were analyzed between G1, G2 with Ki-67 index < 10% and G2 with Ki-67 index ≥ 10%. Out of a total of 113 enrolled patients, 69 (61%) had G1 tumors, and 44 (39%) had G2 tumors. Median tumor size at diagnosis was 19mm (IQR: 12-25mm), with primary lesions mainly localized in the pancreas (57% among G1 and 45% among G2). Most G1 tumors were diagnosed at stage I (29 patients, 42%), while the majority of G2 tumors were metastatic at diagnosis (24 patients, 54.5%). Patients with G1 tumors exhibited a slightly higher 5-year OS rate compared to G2 tumors (98.1% vs. 92.8% respectively, though not statistically significant), and a significantly longer median PFS (141 vs. 22 months, p = 0.0003). Within the G2 group, 31 patients (70%) had a Ki-67 index < 10%, while 13 (30%) had a Ki-67 index ≥ 10%, with comparable baseline characteristics. A Ki-67 index < 10% was associated with a significantly better median PFS (38 vs. 8 months for tumors with Ki-67 index ≥ 10% G2 tumors, p = 0.002). PFS after first-line medical therapy was significantly longer in patients with a Ki-67 index < 10%, compared to those with ≥ 10% (undefined vs. 16 months, p = 0.0085), as well as median post-surgical PFS (84 vs. 10.5 months, p < 0.0001). Multivariate analysis identified higher tumor grade, advanced stage at diagnosis, and absence of PRRT as independent predictors of worse outcomes. The findings highlight the significant clinical heterogeneity within G2 digestive NENs. A Ki-67 index cutoff of 10% within G2 tumors may serve as a critical prognostic marker, with patients with a Ki-67 index < 10% exhibiting significantly better outcomes in terms of PFS. These results suggest that the Ki-67 index could play an essential role in guiding treatment strategies, emphasizing the need for personalized approaches in managing G2 digestive NENs.

Postoperative Sarcopenia and Association with Recurrence in Resected Early-Stage Non-Small Cell Cancer.

We hypothesize that reduction in skeletal muscle volume between the time of surgery and the first postoperative surveillance CT scan is associated with recurrence in resected early-stage NSCLC patients. Patients who underwent lung resection for pT1-2aN0 NSCLC between 2010-2021 were identified. Exclusion criteria included neoadjuvant/adjuvant therapy, missing CT scan data, and steroid use. Volumetric body composition analysis was performed with Data Analysis Facilitation Suite software using preoperative and initial postoperative surveillance CT scans. A Cox proportional hazards model was used to examine the association between body composition changes and recurrence. Overall, 233 patients were examined, including 63% (147/233) females with a median BMI of 27 (IQR 23-30) kg/m2, and median tumor size of 1.6 (IQR 1.3-2.2) cm. Disease recurrence was observed in 14% (33/233), and the median time to recurrence was 15 (IQR 9-25) months. In patients that recurred, median skeletal muscle percent change was -3.6% (IQR -9.26 to 1.23) and 1.99% (IQR -4.6 to 11.4) in non-recurrent patients. On univariable analysis, loss in skeletal muscle volume > 1% was associated with worse disease-free survival (HR 2.93, CI 1.42- 6.04, p=0.004). On multivariable analysis, after controlling for gender, age, race, BMI, pack-years, FEV1, histology, tumor size, number of nodes, procedure type, and co-morbidities, this association persisted (HR 3.16, CI 1.44-6.94, p=0.004). Loss in skeletal muscle volume on first surveillance CT scan is associated with recurrence after resection of early-stage NSCLC.

Pancreatic primitive neuroectodermal tumors: Clinical features, treatment, and influencing factors.

Data on clinical characteristics, treatment outcomes, and prognosis of pancreatic primitive neuroectodermal tumors (PNETs) are limited. To analyze the clinical data of 30 patients with pancreatic PNETs to identify their clinical characteristics and factors associated with prognosis. We used the keywords "primary neuroectodermal tumor," "digestive tract," "pancreas," "pancreatic," and "gastrointestinal," individually or in combination, to collect data from a global database for all patients with pancreatic PNET to date. Univariate and Cox regression analyses were performed to identify prognostic factors for patient survival. A total of 30 cases of pancreatic PNET were included in this study: 15 males and 15 females with a mean age of 24 years. The main symptom was abdominal pain (73.3%), and the median tumor size was 7.85 cm. Twenty-four patients (80.0%) underwent surgery and nineteen patients received adjuvant therapy. Local metastasis was observed in 13 patients (43.3%), lymph node metastasis in 10 patients (33.3%), and distant metastasis in 6 patients (20.0%). Local recurrence was observed in 13 patients (43.3%). The median survival time of all patients was 29.4 months, and the overall estimated 1-year and 3-year survival rates were approximately 66.0% and 36.4%, respectively. Univariate analysis showed that chemotherapy (P = 0.036), local metastasis (P = 0.041), lymph node metastasis (P = 0.003), distant metastasis (P = 0.049), and surgical margins (P = 0.048) were the prognostic factors affecting survival. Multivariate analysis revealed only lymph node metastasis (P = 0.012) as a prognostic factor. Pancreatic PNET is extremely rare, occurs in young adults, has no apparent sex predisposition, has a high rate of metastasis and early recurrence, and has a very poor prognosis. The diagnosis of pancreatic PNET requires a combination of clinical symptoms, pathologic features, immunohistochemistry, and cytogenetic analysis. Univariate analysis suggested that chemotherapy, metastasis, and surgical margins were prognostic factors affecting survival, and multivariate analysis suggested that lymph node metastasis is an important prognostic factor. Therefore, early diagnosis, early and extensive resection, and adjuvant chemoradiotherapy may help improve prognosis.

Impact of upstaging from cT2a–b to pT3a on overall survival (OS) among patients with renal cell carcinoma.

601 Background: Identifying patients with renal cell carcinoma (RCC) who may benefit from adjuvant systemic therapy has proven difficult. Approximately 40% of patients with cT2a-b tumors will be upstaged to pT3a disease following surgery. These patients, given their large tumor size, may represent a higher risk cohort compared to patients with concordant T3a staging. We assessed OS among cT2a-b patients who were upstaged to pT3a compared to their cT3a counterparts with concordant pathologic staging. Methods: Using the National Cancer Database, we identified N0M0 adult patients with cT2a, cT2b, and cT3a RCC who underwent partial or radical nephrectomy and had pT3a disease on final pathology. We categorized patients into three groups: (1) cT2a to pT3a, (2) cT2b to pT3a, and (3) cT3a to pT3a. We compared OS between the groups using Kaplan Meier estimates and multivariable analysis using Cox proportional hazards models. Subgroup analysis of overall survival was performed for histology (clear cell vs non–clear cell). Results: 11,241 patients met inclusion criteria (3,067 cT2a, 1,893 cT2b, and 6,281 cT3a). Median pathological tumor size was 8.0, 11.2, and 7.5 cm for cT2a, cT2b and cT3a tumors, respectively. Mean 5-year OS was 37% for both cT2a and cT2b disease upstaged to pT3a and 48% for cT3a disease with concordant pathological staging (log rank p &lt; 0.0001). This finding persisted on multivariable analysis (cT3a HR 0.81 [0.77–0.85], p &lt; 0.001). Conclusions: Patients who were pathologically upstaged from cT2 to pT3a disease had worse OS compared to patients with concordant staging, a finding likely related to differences in median tumor size. Our findings imply that it is reasonable to include well-selected cT2 tumors in the next iteration of perioperative trials. However, those designing and conducting clinical trials must power their studies to adjust for heterogeneity in pathologic restaging.

PUNCH01: Interim results from a phase II study of intra-arterial chemotherapy (IAC) combined with tislelizumab and bacillus Calmette-Guerin (BCG) in high-risk non-muscle-invasive bladder cancer (HR NMIBC).

767 Background: Our study was established to evaluate the efficacy and safety of IAC combined with tislelizumab and BCG as a bladder-preserving treatment for HR NMIBC pts. Methods: This open-label, single arm phase II study enrolled BCG-naïve HR NMIBC pts with papillary tumors (high-grade Ta or T1 tumors). Firstly, the papillary tumors should be removed all visible lesions by TURBT. Secondly, angiographic catheter was placed into the internal iliac arteries with Seldinger’s percutaneous technique, cisplatin (60 mg/m 2 ) and epirubicin (50 mg/m 2 ) were administered arterially in day 1 (D1), every 3 weeks for 2-4 cycles. And pts received tislelizumab 200 mg ivgtt in D1, every 3 weeks for 2-4 cycles. Finally, pts received 18 instillations of BCG plus at least 8 cycles of tislelizumab (200 mg ivgtt, every 3 weeks). Specifically, pts were started on an induction course of BCG with 6 instillations every week, followed by maintenance with 3 instillations every 2 weeks and 9 instillations every 4 weeks. The primary end point was disease-free survival(DFS) rate at 12 months. Secondary end points were bladder-preservation rate, OS and safety. Our study estimated a DFS rate at 12 months was no less than 55% and the study would enroll 29 pts. Results: By Jul. 2024, 23 eligible pts were enrolled. Twenty-two pts were analyzed (male 90.9%; median age 61 years(37-80); pure TCC 80.0%; median tumor size 3.0 cm (0.4-8.0); multiple papillary tumours=72.7%; high-gradeTa=54.5%, T1=45.5%). Median follow-up was 11.4 months (6.0-40.3), the mean number of IAC cycles was 2.7, mean number of tislelizumab cycles was 8.3, and the median BCG instillations was 10 (6-18). The DFS rate at 12month was 100.0% (95%CI, 63.8%-100%). The bladder-preservation rate at 12 months was 100% (95%CI,100%-100%). The OS rate at 12 months was 100% (95%CI, 100%-100%). 18 pts experienced treatment related adverse events, including nausea (n=6, G2), neutropenia (n=4, G2), fatigue (n=3, G2), increased AST/ALT (n=3,G2), fever (n=2, G3) and myalgia (n=1, G2). Conclusions: Our interim results supported the use of IAC combined with tislelizumab and BCG as a promising bladder-preserving strategy for HR NMIBC pts. Clinical trial information: ChiCTR2200067156 .

Efficacy of nivolumab plus ipilimumab in T1aN0M0 renal cell carcinoma (RCC) patients: Results from 3-year follow-up of the phase 2 pilot study.

536 Background: Some patients with primary renal cell carcinoma (RCC) are not candidates for surgery or nephron-sparing interventions due to various factors, such as the presence of a functional single kidney with a central, high-complexity tumor. This study aimed to evaluate whether a combination of nivolumab and ipilimumab could eliminate the primary tumor in patients with T1aN0M0 RCC. Methods: This prospective, multicenter, phase 2 pilot study enrolled patients with biopsy-confirmed clear-cell RCC (cT1a) ≤4 cm, no metastases, and who were ineligible for surgery or nephron-sparing procedures. Patients were treated with ipilimumab (1 mg/kg) every 3 weeks for four doses, alongside nivolumab (240 mg) every 2 weeks for eight doses. The primary endpoint was the complete response rate. Simon's two-stage design was used, testing the null hypothesis of a true complete response rate of 11%. A type I error rate of 0.05 and a power of 0.9 were set, with the null hypothesis rejected if 3 or more responses were observed in 8 patients. Results: From February 2020 to June 2021, 8 patients were enrolled, with a median age of 77.9 years (range 73–89). The cohort was entirely Caucasian, predominantly male (75%), and 62.5% had centrally located tumors. Six patients had moderate to severe comorbidities. All patients completed the immunotherapy without experiencing grade ≥2 adverse events. After a median follow-up of 37.4 months (95% CI 31.7–44.5), no complete responses were observed. However, partial responses were seen in 4 patients (50%), with continued tumor reduction after therapy. The median tumor size decreased from 3.11 cm (range 2.2–3.9) to 1.89 cm (range 1.1–4.0). Tumor shrinkage was observed in 6 patients (75%), while 1 patient experienced a slight tumor enlargement (+0.5 cm, +13%) after 9 months. The 3-year progression-free survival rate was 100%. Data on 5-year overall survival will be reported later. Conclusions: Although complete tumor regression was not achieved, immunotherapy with nivolumab and ipilimumab led to significant and durable tumor shrinkage in two-thirds of T1aN0M0 RCC patients, with minimal toxicity, making it a viable option for patients with significant comorbidities. Further data on long-term survival are awaited. Clinical trial information: NCT04134182 .

Results of Stereotactic Body Radiation Therapy for Primary Renal Cell Carcinoma in a Large Multicenter Series.

Results of Stereotactic Body Radiation Therapy for Primary Renal Cell Carcinoma in a Large Multicenter Series.

Adjuvant therapy with somatostatin analogs for recurrent gastric neuroendocrine tumors type 1.

665 Background: Neuroendocrine gastric tumors (gNETs) type 1 are associated with chronic autoimmune atrophic gastritis, hypergastrinemia and usually have multifocal lesions and high frequency of recurrence (up to 70% for 2 years). Somatostatin analogs (SA) showed promising data in neoadjuvant setting with 84% of complete responses in a small retrospective trial. The aim of this study was to evaluate the efficacy of adjuvant treatment with SA for recurrent gNETs type 1. Methods: This retrospective, single-center study included patients (pts) with recurrent gNETs who received adjuvant treatment with SA. Recruitment of pts was carried out from 2012 to February 2024. Results: The study included 35 pts, 33 females and 2 males. Endoscopic mucosal resection (EMR) was performed in 34 cases (97.1%), gastric resection in 1 (2.9%). The median of previous EMR was 2 (1-6) procedures. Most of the pts have multifocal lesions – 28 (80%), the median of lesions is 5. The median tumor size – 6 mm, tumor size &gt;10 mm was observed in 2 cases (5.7%), one of them had N+. The median of ki67 was 3,5% (1-10%), grade 1 (G) - 14 (40%) and G2 - 21 (60%). All pts received adjuvant therapy with SA, 33 (94.3%)long-active releasing octreotide30 mg and 2 (5.7%) lanreotide 120 mg every 4 weeks. The time of SA therapy was &lt;12 months in 23 cases (65.7%) and ≥12 months in 12 (34.3%). The median of follow-up was 30.5 months. The median disease-free survival (DFS) was not reached (95% CI, 67-NR). We compared median DFS after previous EMR (DFS1) without adjuvant SA and DFS after EMR with adjuvant SA (DFS2). The DFS2 was significantly higher – median of DFS1 was 8.8 months (95% CI, 2.7-14.9) not reached (95% CI, 67-NR, p&lt;0.01) . Adjuvant treatment with SA ≥12 months was associated with improved DFS compared to &lt;12 months – not reached (95% CI, 58.1-NR) versus 61 months (95% CI, 26.2-96.2, p=0.05). Adjuvant SA reduced gastrin levels after a year of therapy by ≥50% from baseline in 13 cases (37.1%). Conclusions: Adjuvant treatment with SA significantly improved DFS and should be considered for recurrent and multifocal gNETs type 1. Duration of therapy ≥12 months was significantly associated with improvement in DFS compared with shorter duration of therapy.

A Matched Case-Control Study of the Relationship Between Radiation Dose to the Internal Mammary Lymph Nodes and Clinical Outcomes in Patients With and Without Internal Mammary Lymph Node Relapses.

A Matched Case-Control Study of the Relationship Between Radiation Dose to the Internal Mammary Lymph Nodes and Clinical Outcomes in Patients With and Without Internal Mammary Lymph Node Relapses.

A Fully Automated Artificial Intelligence-Based Approach to Predict Renal Function After Radical or Partial Nephrectomy.

A Fully Automated Artificial Intelligence-Based Approach to Predict Renal Function After Radical or Partial Nephrectomy.

Automated radiomics model for preoperative pancreatic neuroendocrine tumor grade prediction.

655 Background: Pancreatic neuroendocrine tumors (PNETs) have varying biologic behavior based on factors including tumor grade. Many prognostic factors can only be determined post-pancreatectomy; thus, are unable to guide clinical decision making preoperatively. This is particularly relevant in small, non-functional (NF)-PNETs. Imaging analysis with radiomics may be able to elucidate biologic data such as tumor grade, without the need for tissue sampling. Our study aims to create an automatic pipeline from segmentation to radiomics-signature building to preoperatively predict tumor grade. Methods: Patients that underwent resection between 2003-21 with adequate preoperative arterial phase CT scans were divided into training and validation cohorts. In the training cohort, the pancreas and tumor region were manually segmented and used to train an auto-segmentation model. The validation cohort then underwent automatic segmentation. A total of 255 radiomics features were extracted from the tumor region. Correlated features were removed, and the minimum redundancy maximum relevance (mRMR) method was used to select the final feature set. These features were used to train a Support Vector Machine (SVM)-based classifier through the training cohort to predict grade, which was dichotomized into grade I versus II/III. The radiomic based prediction model was then evaluated in the automatically segmented validation cohort. Results: A total of 186 patients were identified and divided into training (n = 140) and validation (n = 46) cohorts. Median age was 57 (27, 85) and 52% were male. 113 (62%) and 70 (38%) patients were grades I and II/III, respectively. Median tumor size was 24 mm (6, 200) and 43 (26%) patients had positive nodal disease. The auto-segmentation model was able to accurately segment the tumor region in 33 (72%) patients of the validation cohort. In the training cohort (n = 140), the radiomics-signature produced an area under the curve (AUC) of 0.87 (0.81, 0.93). Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were 0.94 (0.9, 0.98), 0.74 (0.66, 0.81), 0.72 (0.65, 0.80) and 0.97 (0.94, 1.00) respectively. In the auto-segmented validation cohort (n = 33), the radiomics model produced an AUC of 0.75 (0.61, 0.90). Sensitivity, specificity, PPV and NPV were 0.88 (0.77, 0.99), 0.62 (0.46, 0.79), 0.71 (0.56, 0.87) and 0.83 (0.71, 0.96), respectively. Conclusions: The proposed auto-segmentation model was able to automatically identify tumor regions with a high degree of accuracy. Similarly, the subsequent radiomics-signature was also able to strongly discern PNET grade. This automatic pipeline bypasses manual segmentation and could help incorporate a radiomics-signature into preoperative clinical decision-making for PNETs.