Terms Of Recurrence-free Survival Research Articles

A novel stratification scheme combined with internal arteries in CT imaging for guiding postoperative adjuvant transarterial chemoembolization in hepatocellular carcinoma: a retrospective cohort study.

Although postoperative adjuvant transarterial chemoembolization (PA-TACE) improves survival outcomes in a subset of patients with resected hepatocellular carcinoma (HCC), the lack of reliable biomarkers for patient selection remains a significant challenge. The present study aimed to evaluate whether computed tomography imaging can provide more value for predicting benefits from PA-TACE and to establish a new scheme for guiding PA-TACE benefits. In this retrospective study, patients with HCC who had undergone preoperative contrast-enhanced computed tomography and curative hepatectomy were evaluated. Inverse probability of treatment weight was performed to balance the difference of baseline characteristics. Cox models were used to test the interaction among PA-TACE, imaging features, and pathological indicators. An HCC imaging and pathological classification (HIPC) scheme incorporating these imaging and pathological indicators was established. This study included 1488 patients [median age, 52 years (IQR, 45-61 years); 1309 male]. Microvascular invasion (MVI) positive, and diameter >5cm tumors achieved a higher recurrence-free survival (RFS), and overall survival (OS) benefit, respectively, from PA-TACE than MVI negative, and diameter ≤5cm tumors. Patients with internal arteries (IA) positive benefited more than those with IA-negative in terms of RFS ( P =0.016) and OS ( P =0.018). PA-TACE achieved significant RFS and OS improvements in HIPC3 (IA present and diameter >5 cm, or two or three tumors) patients but not in HIPC1 (diameter ≤5cm, MVI negative) and HIPC2 (other single tumor) patients. Our scheme may decrease the number of patients receiving PA-TACE by ~36.5% compared to the previous suggestion. IA can provide more value for predicting the benefit of PA-TACE treatment. The proposed HIPC scheme can be used to stratify patients with and without survival benefits from PA-TACE.

Laparoscopic liver resection versus radiofrequency ablation for caudate lobe solitary hepatocellular carcinoma: A propensity score matching study.

This study aimed to compare the clinical efficacy of laparoscopic liver resection (LLR) and radiofrequency ablation (RFA) in treating solitary hepatocellular carcinoma (HCC) of the hepatic caudate lobe. Patients with hepatic caudate lobe HCC who underwent LLR or RFA at three hospitals in China between February 2015 and February 2021 were included. In total, 112 patients met the inclusion criteria, of whom 52 underwent RFA and 60 underwent LLR. The outcomes of the two groups were compared and analyzed using propensity score matching (PSM) method. There were no significant differences between the two groups in terms of sex, HBV/HCV positivity, AFP positivity (>100 ng/mL), tumor position, Child-Pugh score, or preoperative liver function tests (ALT, AST, TBIL, ALB, and PT) (p > 0.05). Compared to the LLR group, the RFA group had a shorter operation time, less intraoperative bleeding, and shorter postoperative hospital stay (p < 0.05). There was no statistically significant difference in overall postoperative complications between the two groups (p > 0.05). Despite the larger tumor size, the LLR group had better postoperative recurrence-free survival (RFS) (p = 0.00027) and overall survival (OS) (p = 0.0023) than the RFA group. After one-to-one PSM, 31 LLR patients and 31 RFA patients were selected for further analyses. The advantages of LLR over RFA were observed in terms of RFS (p < 0.0001) and OS (p = 0.00029). LLR should probably be recommended as the preferred method for solitary caudate lobe HCC.

Prognostic value of preoperative geriatric nutritional risk index in intrahepatic cholangiocarcinoma after hepatectomy: a single‑center retrospective cohort study.

Patients with malignant tumors are prone to develop nutritional disorders. The Geriatric Nutritional Risk Index (GNRI) is a new prognostic indicator for assessing the nutritional status. This study was performed to evaluate whether the preoperative GNRI can serve as a prognostic factor in patients with intrahepatic cholangiocarcinoma (ICC) undergoing curative surgery. This study included 123 consecutive patients with ICC who were treated with curative surgery. Kaplan-Meier analysis was performed to calculate the recurrence-free survival (RFS) and overall survival (OS), and Cox regression analysis was used to evaluate prognostic factors. Of the 123 patients, 82 were male and 41 were female. The median age of the patients was 70years, and the median follow-up period was 37.0months (interquartile range, 16.2-71.7months). The patients were classified by the median GNRI into a low GNRI group (GNRI < 105) and high GNRI group (GNRI ≥ 105). The patients in the low GNRI group had a significantly poorer prognosis in terms of RFS and OS than the patients in the high GNRI group (RFS, p = 0.0201; OS, p < 0.0001). Lymph node metastasis [hazard ratio (HR), 4.66; 95% confidence interval (CI), 2.46-8.85], postoperative complications (HR, 2.38; 95% CI, 1.32-4.31), and a low GNRI (HR, 2.53; 95% CI, 1.42-4.50) were independent poor prognostic factors for OS. The GNRI may be a useful prognostic indicator in patients with ICC undergoing curative hepatectomy.

Minimally Invasive Approach Provides Oncological Benefit in Patients with High Risk of Very Early Recurrence (VER) After Surgery for Intrahepatic Cholangiocarcinoma (iCCA).

Surgery for intrahepatic cholangiocarcinoma (iCCA) is jeopardized by significant risk of early recurrence (≤ 6 months). The aim of the present study is to analyze the oncological benefit provided by laparoscopic over open approach for iCCA in patients with high risk of very early recurrence (VER). A total of 532 liver resections (LR) were performed for iCCA [265 by minimally invasive surgery (MIS) and 267 with open approach, matched through a 1:1 propensity score] and stratified using the postoperative prediction model of VER. Outcomes were compared between open and laparoscopic approaches, specifically evaluating oncological benefit. The percentage of patients with high risk of VER was similar (32.7% in the laparoscopic group and 35.3% in the open group, pNS). The number of retrieved nodes as well as the rate and depth of negative resection margins were comparable between laparoscopic and open. The surgery-adjuvant treatment interval was shorter in laparoscopic patients in the overall series, as well in the subgroup of high risk of VER. The rate of patients starting adjuvant treatments within 2 months from surgery was higher in laparoscopic group compared with open group. In VER high-risk group both disease-free survival (DFS) and overall survival (OS) were significantly improved in MIS compared with open group (p = 0.032 and p = 0.026, respectively). In patients with high risk of VER, laparoscopy translates into an advantage in terms of recurrence-free survival, likely related to lower biological impact of surgery, together with a shorter interval between surgery and start of adjuvant treatments, even allowing for a higher number of patients to start adjuvant therapies within 2 months from resection.

Adjuvant chemotherapy in pancreatic cancer at different AJCC stages: a propensity score matching analysis

ObjectiveIn the treatment of resectable pancreatic cancer, adjuvant chemotherapy is viewed as essential. However, it is yet unclear how well adjuvant chemotherapy works at different illness stages. This study aims to investigate the efficacy of adjuvant chemotherapy in various pancreatic cancer stages.Materials and methodsPatients with pancreatic cancer who underwent surgical intervention at Sun Yat-sen University Cancer Center between January 2018 and January 2021 were included in this retrospective analysis.Results168 patients were divided into two groups: the group receiving adjuvant chemotherapy (AC) and the group receiving independent surgery (no-AC). Survival analysis reveals that among stage I patients, the AC group demonstrates significant superiority over the no-AC group in terms of recurrence-free survival (RFS) and overall survival (OS) (P = 0.0028; P = 0.022). While there was no discernible difference in RFS between the AC and no-AC groups for patients with stage II illness (P = 0.69), the AC group significantly outperformed the no-AC group in terms of OS (P = 0.047). There was no discernible difference in RFS or OS between the AC and no-AC groups for patients with stage III pancreatic cancer (P = 0.40 and P = 0.20, respectively).ConclusionsThe administration of adjuvant chemotherapy has been shown to improve the prognosis of patients diagnosed with stage I and II pancreatic cancer. However, its efficacy is limited in individuals with stage III pancreatic cancer. Therefore, there is an urgent need to investigate and develop more effective therapeutic options for patients in the advanced stage.

Lunchbox trial: A randomized phase III trial of cisplatin and irradiation followed by carboplatin and paclitaxel versus sandwich therapy of carboplatin and paclitaxel followed by irradiation then carboplatin and paclitaxel for advanced endometrial carcinoma

BackgroundThe objective was to compare sequencing strategies for treatment of advanced endometrial carcinoma. MethodsPatients were eligible if they had FIGO 2009 Stage III or IVA endometrial carcinoma or Stage I or II serous or clear cell endometrial carcinoma and positive cytology. Patients were randomized to: Cisplatin 50 mg/m2 IV Days 1 and 29 plus radiation followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles (chemoRT then chemo) vs. Carboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by radiation followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles (sandwich therapy). Futility analysis was planned. The primary objective was to determine if chemoRT then chemo improves recurrence-free survival (RFS) compared to sandwich therapy. ResultsOf the 48 patients enrolled at 8 sites, 42 patients were eligible for futility analysis, and the trial was closed early. The median follow-up was 30.9 months. The 3-year RFS was 85.7% (95% confidence interval [CI], 62 to 95) in the chemoRT then chemo arm and 73.4% (95% CI, 43 to 89) in the sandwich therapy group (p = 0.58). The 3-year overall survival (OS) was 88.4% (95% CI, 61 to 97) in the chemoRT then chemo arm and 80.9% (95% CI, 51 to 93) in the sandwich therapy group (p = 0.55). ConclusionThere was no observed significant difference between chemoRT then chemo compared to sandwich therapy in terms of RFS, OS, or adverse events, although the trial was underpowered and closed early due to low accrual.

Refining MRI-based criteria for portal vein invasion in hepatocellular carcinoma: improving sensitivity beyond portal vein tumor thrombosis.

To investigate the imaging features indicating portal vein invasion (PVI) of hepatocellular carcinoma (HCC) on gadoxetic acid-enhanced MRI and to create more accurate diagnostic criteria than the presence of portal vein tumor thrombosis (PVTT) on MRI. This retrospective study included patients with surgically resected HCC larger than 5 cm, and the presence of PVI was investigated. On MRI, we evaluated the image findings of portal vein occlusion, the parenchymal signal change caused by hemodynamic alterations of the portal vein, and their combination showing the highest odds ratio (OR) to define the diagnostic criteria for radiological PVI detection (rPVI criteria). The diagnostic performance and recurrence-free survival were compared between the rPVI criteria and the presence of PVTT using McNemar's test and Kaplan-Meier method, respectively. Interobserver agreement was evaluated using Cohen's weighted ĸ statistics. Of 189 enrolled patients, 25 (13.2%) had PVI on histology. To diagnose PVI on MRI, either peripheral wedge-shaped arterial peritumoral hyperemia with an abrupt cut-off of a portal vein or the presence of PVTT had the highest OR (41.67, p<0.001). The sensitivity of PVI was significantly increased under this diagnostic criterion (64.0% to 88.0%; p=0.031) with comparable accuracy (95.2% vs. 94.7%; p>0.999). In terms of recurrence-free survival, the patient group with rPVI was significantly worse (p=0.017) compared with the patients without rPVI. Interobserver agreement of radiologic findings was substantial (ĸ=0.64). Diagnostic criteria for radiologically PVI detection increase the sensitivity more than the only presence of PVTT.

A retrospective cohort study of the impact of peripheral blood gamma- delta T cells to prognosis of nonmetastatic renal cell cancer after curative resection

AimGamma-delta-T cells (γδT) have potential antitumor roles and have recently been applied in adoptive immunotherapy. In the present study, we focused on the proportion of γδT cells in the peripheral blood just before surgery for renal cell cancer (RCC) and investigated whether their proportion affected recurrence-free survival (RFS) and overall survival (OS) retrospectively. Patients and MethodsA total of 137 patients with localized, non-metastatic RCC who received surgery at our institutes were analyzed retrospectively. The patients were divided into 2 groups: normal and low γδT cell groups based on the proportion of peripheral blood γδT cells. Kaplan–Meier curves were constructed to access the association of the proportion of peripheral blood γδT cells to RFS and OS. Cox regression were also constructed to access the risks to prognosis. Uni- and multivariate logistic regressions were performed to access associations between risk factors and, RFS and OS. ResultsAmong 137 patients, 40 had a proportion of γδT cells in peripheral blood of less than 1%, which was below the normal range. The remaining 97 patients had these cells in peripheral blood at 1% or higher. In the groups with low γδT cells, 13 patients had recurrences, and 9 patients dies during the observation period. In the groups with normal γδT cells, 16 patients had recurrences, and 8 patients died. The normal γδT cell group demonstrated significantly better prognosis in terms of RFS and OS. Multivariate analysis revealed that a low hemoglobin level, a low proportion of γδT cells, and a high pathological T stage (pT) were statistically independent risk factors for RFS. Age, albumin, C-reactive protein (CRP), % γδT cells, and pT were statistically significant factors affecting OS and only pT was an independent risk factor by multivariate analysis. ConclusionA low proportion of γδT cells was identified as one of the risk factors for RFS. Our findings will provide clues to develop strategies for early intervention in preventing recurrence even after complete resection of RCC and, such as adoptive immunotherapy using autologous γδT cells in patients with a low proportion of γδT cells.

Comparison of hyperthermic intravesical chemotherapy and Bacillus Calmette-Guerin therapy in high-risk non-muscle invasive bladder cancer: a matched-pair analysis.

To compare adjuvant hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C and standard Bacillus Calmette-Guerin (BCG) therapy in terms of oncological outcomes and adverse events in patients with high-risk non-muscle-invasive bladder cancer (NMIBC). The data of patients with high-risk papillary NMIBC treated with adjuvant intravesical BCG instillations or HIVEC in our institution between June 2017 and August 2022 were analyzed retrospectively. Twenty-four patients who received HIVEC were matched 1:1 with patients receiving BCG therapy based on tumor characteristics (tumor stage and grade), age, gender, smoking status, and the number of tumors (single or multiple). HIVEC and standard BCG treatments were compared in terms of recurrence-free survival (RFS), progression-free survival (PFS), and adverse events. Forty-eight patients (24 in the BCG group and 24 in the HIVEC group) were included in the study. The median follow-up times of the BCG and HIVEC groups were 32 [interquartile range (IQR): 28.0-47.8] and 28 (IQR: 16.7-41.8) months, respectively (p = 0.11). There was no significant difference between the groups in terms of the 24-month RFS (BCG 83% vs HIVEC 88%, p = 0.64) and the 24-month PFS (BCG 100% vs HIVEC 94%, p = 0.61). Regarding the safety profile, at least one adverse event occurred in 13 (54%) of the patients in the BCG group and 12 (50.0%) of those in the HIVEC group (p = 0.77). This study demonstrated that HIVEC with mitomycin C has a similar oncological efficacy and safety profile to standard BCG therapy in high-risk NMIBC.

Development and validation of a nomogram based on preoperative variables for predicting recurrence-free survival in stage IA lung adenocarcinoma.

This study aimed to establish a nomogram for predicting risk of recurrence and provide a model for decision-making between lobectomy and sublobar resection in patients with stage IA lung adenocarcinoma. Patients diagnosed with stage IA lung adenocarcinoma (LUAD) between December 2010 and October 2018 from Cancer Hospital Chinese Academy of Medical Sciences were included. Patients were randomly assigned to training and validation cohorts, accounting for 70% and 30% of the total cases, respectively. We collected laboratory variables before surgery. Univariate and multivariate analyses were performed in the training cohort to identify variables significantly associated with recurrence-free survival (RFS) which were subsequently used to construct a nomogram. Validation was conducted in both cohorts. A receiver operating characteristic curve was used to determine the optional cutoff values of the scores calculated from the nomogram. Patients were then divided into low- and high-risk groups. Survival was performed to determine if the nomogram could guide the operation method. A total of 543 patients were included in this study. Gender, albumin level, carcinoembryonic antigen level and cytokeratin-19-fragment level were included in the nomogram. In both cohorts, the nomogram stratified the patients into high- and low-risk groups in terms of RFS. In particular, there was a significant difference in RFS between lobectomy and sublobar resection in the high-risk group. Gender, albumin level, carcinoembryonic antigen level and cytokeratin-19-fragment level are valuable markers in predicting recurrence and can guide surgical practice in patients with stage IA LUAD.

Brachytherapy and surgery versus surgery alone for IB2 (FIGO 2018) cervical cancers: A FRANCOGYN study

ObjectiveEvaluation of the management by first brachytherapy followed by radical hysterectomy (Wertheim type) compared to radical hysterectomy alone (Wertheim type) for the treatment of IB2 cervical cancer. MethodsData from women with histologically proven FIGO stage IB2 cervical cancer treated between April 1996 and December 2016 were retrospectively abstracted from twelve French institutions with prospectively maintained databases. ResultsOf the 211 patients with FIGO stage IB2 cervical cancer without lymph node involvement included, 136 had surgical treatment only and 75 had pelvic lymph node staging and brachytherapy followed by surgery. The surgery-only group had significantly more adjuvant treatment (29 vs. 3; p = 0.0002). A complete response was identified in 61 patients (81%) in the brachytherapy group. Postoperative complications were comparable (63,2% vs. 72%, p = 0,19) and consisted mainly of urinary (36vs. 27) and digestive (31 vs 22) complications and lymphoceles (4 vs. 1). Brachytherapy had no benefit in terms of progression-free survival (p = 0.14) or overall survival (p = 0.59). However, for tumors of between 20 and 30 mm, preoperative brachytherapy improved recurrence-free survival (p = 0.0095) but not overall survival (p = 0.41). This difference was not observed for larger tumors in terms of either recurrence-free survival (p = 0.55) or overall survival (p = 0.95). ConclusionOur study found that preoperative brachytherapy had no benefit for stage IB2 cervical cancers in terms of recurrence-free survival or overall survival. For tumor sizes between 2 and 3 cm, brachytherapy improves progression-free survival mainly by reducing pelvic recurrences without improving overall survival.

Italian nivolumab Expanded Access Programme in melanoma adjuvant setting: patient outcomes and safety profile

IntroductionThe CheckMate 238 randomised study demonstrated the relevant benefit in terms of recurrence-free survival (RFS) of nivolumab versus ipilimumab in resected stage IIIB-C or IV melanoma patients with a tolerable safety profile. Materials and methodsFrom November 2018 to June 2019, 611 patients with stage III and IV resected melanoma were enroled to receive nivolumab as part of an Italian Expanded Access Programme (EAP). According to stages, 77% were stage III while 141 (23%) were stage IV with no evidence of disease (NED). Among stage III, 121 patients had IIIA (19.8%). ResultsAfter a median follow-up of 23 months, the RFS in the Intention-to-Treat (ITT) population was 76.6% at 1 year and 59.6% at 2 years; 1- and 2-year distant metastasis–free survival were 83.7% and 71.2%, respectively. The overall survival rate in the ITT population was 93.8% at 1 year and 85.5% at 2 years. No significant differences in RFS were observed according to BRAF status. Treatment-related adverse events of grades 3–4 occurred in 11.5% of patients. ConclusionThis paper reports the results of the Italian Nivolumab EAP in the adjuvant setting of stage III and IV NED melanoma patients. Our results confirm in a real-life setting the clinical activity and safety of nivolumab reported in the CheckMate238 registrative/pivotal. The enroled cohort of 611 patients highlights the relevant clinical need in this setting, also confirmed by the very short accrual time, representing one of the largest series reported as adjuvant EAP with the longest follow-up.

Benefits of lymphadenectomy for upper tract urothelial carcinoma only located in the lower ureter: a bicentre retrospective cohort study.

Upper tract urothelial carcinoma (UTUC) is a rare and highly malignant urothelial tumor originating from the renal pelvis and ureter associated with poor prognosis. It has been established that 70% of ureteral tumors occur in the lower ureter. Radical nephroureterectomy (RNU) with ipsilateral bladder cuff excision is regarded as the standard treatment for UTUC. Current evidence supports the role of lymph node dissection (LND) in determining tumor staging, but no consensus has been reached on the potential survival benefits. The present study retrospectively analyzed cases of UTUC limited to the lower ureter to evaluate the survival benefits of LND during RNU. The present study retrospectively analyzed data from patients with UTUC limited to the lower ureter from two medical centers from 2000 to 2016 and assessed the survival outcomes, including recurrence-free survival (RFS) and cancer specific survival (CSS). During subgroup analysis, we stratified by pathological tumor (pT) stages and postoperative adjuvant chemotherapy (AC). The study cohort included 297 patients separated into LND (n=111) and non-LND (n=186) groups. The two groups were comparable except for the pathological N stage. The LND group was associated with superior survival in terms of RFS (27.0% vs. 18.3%, p=0.044) and CSS (53.2 vs. 39.8%, p=0.031) compared to the non-LND group (n=186). In pT2-4 patients, the LND group was associated with better 3-year RFS (50.5% vs. 32.3%, p<0.05), 5-year RFS (29.7% vs. 12.0%, p<0.05), and overall RFS (18.7% vs. 6.0%, p<0.05) than the non-LND group. Besides, the LND group was associated with a significantly better 3-year CSS (68.1% vs. 49.6%, p=0.003), 5-year CSS (51.6% vs. 30.8%, p<0.05) and overall CSS (45.1% vs. 24.1%, p<0.05). In patients that underwent AC, the LND group had better survival benefits in terms of RFS (29.4 vs. 16.7%, p=0.023) and CSS (52.9% vs. 40.5%, p=0.038) compared to the non-LND group. LND has survival benefits in patients with UTUC localized to the lower ureter, especially for≥pT2 stage UTUC and AC cohorts. Overall, the therapeutic effect of LND in UTUC cannot be replaced by AC.

Outcomes of the Tall-Cell Variant of Papillary Thyroid Carcinoma in Patients with Different Ages: A 17-Year Mono-Institutional Experience

The tall-cell variant of papillary thyroid carcinoma (TCPTC) is the most common aggressive variant of papillary thyroid carcinoma (PTC) and typically occurs in older patients. In this study, we analyzed retrospectively the largest mono-institutional series of PTCs with tall-cell features (989 patients) over a 17-year period, re-evaluating tumors based on age at presentation and outcomes in different age groups. We divided patients into three age groups following different criteria (the criterion from the American Joint Committee on Cancer Tumor Node Metastasis (AJCC TNM) guidelines, criterion for the statistical division into tertiles and adolescent/post-adolescent criterion) to analyze the clinicopathological characteristics in different age groups, especially in terms of recurrence-free survival (RFS) and distant recurrence-free survival (DRFS). We obtained three main results: 1. the population is distributed among the different age groups, and therefore, this type of cancer is not exclusively found among those of an older age; 2. in the RFS analysis, we can see a higher probability of local recurrence in the younger and older groups and, unexpectedly, a lower probability of local recurrence in the "median age" group; and 3. in the DRFS analysis, we can observe a higher probability of distant recurrence in older patients. From a molecular perspective, no significant differences in the mutational status of BRAF were detected according to different age groups, while mutations in the TERT promoter were exclusively present in older patients of all age groups, highlighting the potential prognostic implications of TERT promoter mutations in PTCs. In conclusion, the results of this series confirm that TC morphology alone in PTCs does not have the same negative prognostic significance in the younger population as in the older population. The reason for these different outcomes remains unclear and needs further studies.

MP63-12 THE EFFECTS OF SEQUENTIAL MITOMYCIN AND BACILLUS CALMETTE-GUÉRIN TREATMENT VERSUS BACILLUS CALMETTE-GUÉRIN MONOTHERAPY IN PATIENTS WITH HIGH-RISK NON-MUSCLE INVASIVE BLADDER CANCER: MITO-BCG (EUDRACT-2017-004540-37)

You have accessJournal of UrologyCME1 Apr 2023MP63-12 THE EFFECTS OF SEQUENTIAL MITOMYCIN AND BACILLUS CALMETTE-GUÉRIN TREATMENT VERSUS BACILLUS CALMETTE-GUÉRIN MONOTHERAPY IN PATIENTS WITH HIGH-RISK NON-MUSCLE INVASIVE BLADDER CANCER: MITO-BCG (EUDRACT-2017-004540-37) Cosimo DE Nunzio, Costantino Leonardo, Antonio Carbone, Antonio Luigi Pastore, Riccardo Lombardo, Antonio Nacchia, Antonio Cicione, Beatrice Turchi, Giorgia Tema, and Andrea Tubaro Cosimo DE NunzioCosimo DE Nunzio More articles by this author , Costantino LeonardoCostantino Leonardo More articles by this author , Antonio CarboneAntonio Carbone More articles by this author , Antonio Luigi PastoreAntonio Luigi Pastore More articles by this author , Riccardo LombardoRiccardo Lombardo More articles by this author , Antonio NacchiaAntonio Nacchia More articles by this author , Antonio CicioneAntonio Cicione More articles by this author , Beatrice TurchiBeatrice Turchi More articles by this author , Giorgia TemaGiorgia Tema More articles by this author , and Andrea TubaroAndrea Tubaro More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003321.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Aim of our study was to evaluate recurrence free survival of sequential Mitomycin and Bacillus Calmette-Guérin (BCG) treatment versus BCG monotherapy in patients with High risk Non-Muscle Invasive Bladder Cancer. METHODS: MITO-BCG is an open-label phase 4 study designed to evaluate the efficacy and safety of the sequential MMC and BCG combination treatment in patients with high-risk NMIBC. Eligibility criteria: males with a diagnosis of High risk NMIBC (T1 tumor, G3, CIS, or multiple and recurrent and large (>3 cm) Ta, G1G2 tumors or patients in the last EAU recurrence category EAU/EORTC recurrence score ≥10), age >40 years and <75 years, ability of consent. Patients are randomized in two groups: first with BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with 81 mg Connaught strain BCG and second receiving BCG treatment with the same protocol with a 40 mg mitomycin instillation the day before. Response will be assessed using cystoscopy and urine citology every 12 weeks for 2 years. Primary end points are recurrence rate; secondary end points are overall toxicity. RESULTS: The protocol study started on March 2019. Nowadays we enrolled 72 patients with a median age of 67 (IQR 59/73). Overall, 41 (57%) patients were randomized in the group of sequential combination therapy and 31 (43%) in the group of monotherapy with BCG. Mean Follow-up was 71±50 months. In BCG group 6/31 (19%) presented a recurrence while 10/41 (24 %) presented a recurrence in the combination group (p=0,611). On Cox regression analysis no differences were recorded in terms of recurrence when comparing both groups (HR: 1,23 95% CI: 0,46-3,50; p=0,640) (Figure). During follow-up only one patient experienced progression. Only 9 patients experienced adverse events with 8/9 grade I and one grade 4 (orchiectomy). No statistically significant differences were recorded in terms of complications between groups. CONCLUSIONS: The interim analysis of the Mito-BCG study suggests no differences in terms of recurrence free survival when comparing BCG alone vs sequential Mitomicin and BCG treatment. Both treatments present good and comparable tollerability. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e876 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Cosimo DE Nunzio More articles by this author Costantino Leonardo More articles by this author Antonio Carbone More articles by this author Antonio Luigi Pastore More articles by this author Riccardo Lombardo More articles by this author Antonio Nacchia More articles by this author Antonio Cicione More articles by this author Beatrice Turchi More articles by this author Giorgia Tema More articles by this author Andrea Tubaro More articles by this author Expand All Advertisement PDF downloadLoading ...

PD40-11 PREOPERATIVE ALBUMINURIA REFLECTS TUMOR AGGRESSIVENESS IN RENAL CELL CARCINOMA

You have accessJournal of UrologyCME1 Apr 2023PD40-11 PREOPERATIVE ALBUMINURIA REFLECTS TUMOR AGGRESSIVENESS IN RENAL CELL CARCINOMA Seung-hwan Jeong, Hyeong Dong Yuk, Chang Wook Jeong, Ja Hyeon Ku, Hyeon Hoe Kim, and Cheol Kwak Seung-hwan JeongSeung-hwan Jeong More articles by this author , Hyeong Dong YukHyeong Dong Yuk More articles by this author , Chang Wook JeongChang Wook Jeong More articles by this author , Ja Hyeon KuJa Hyeon Ku More articles by this author , Hyeon Hoe KimHyeon Hoe Kim More articles by this author , and Cheol KwakCheol Kwak More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003345.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In kidney cancer, it is well known that tumor necrosis is associated with poor prognosis in recurrence free survival and overall survival. Tumor necrosis accompanies tubular necrosis which may induces albuminuria as seen in acute tubular necrosis. However, there was no study the association of tumor necrosis and albuminuria and its clinical implications. In this study we analyzed whether preoperative albuminuria is related to tumor necrosis and prognosis in terms of recurrence free survival. METHODS: In this study, we retrospectively analyzed kidney cancer patients underwent partial or radical nephrectomy who is consequently enrolled in prospective patient registry system of Seoul National University, SUPER-RCC-Nx from March 2016 to August 2018. Statistical analysis was performed using XLSTAT. For the categorical variables chi-square test was conducted and for the numerical variables two-tailed t test was conducted. Kaplan-Meier analysis revealed recurrence free survival comparing two groups. Cox proportional hazards regression was conducted for multivariate analysis RESULTS: In total of 674 enrolled patients, tumor necrosis was observed in 293 patients. Tumor necrosis was significantly associated with old age, higher pathologic T stage, and poor histologic grade. Notably preoperative albuminuria was observed in 55.6% of tumor necrosis group while only 25.5% exhibited albuminuria in tumor necrosis negative group (p<0.0001). Furthermore, there was no difference in albuminuria patients between tumor necrosis positive and negative group after partial or radical nephrectomy (p=0.11). In subgroup analysis conducted on tumor necrosis positive group, albuminuria was associated with higher pathologic T stage and Fuhrman grade. Moreover, Cox proportional hazard regression analysis revealed that albuminuria is independent prognostic factor associated with higher recurrence rate with hazard ratio of 2.433 (1.427 – 4.15, p=0.001). CONCLUSIONS: In kidney cancer, tumor necrosis is associated with albuminuria which can be reversed after partial or radical nephrectomy. In subgroup analysis of tumor necrosis positive group, it is definite that higher tumor extent is associated with albuminuria. In tumor necrosis positive patients, albuminuria is worse prognosis factor. Source of Funding: This research was supported by a Basic Science Research Program through National Research Foundation of Korea, funded by the Ministry of Science and ICT (2022R1A2C1012657) and by Seoul National University Hospital (0320210060) © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1056 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Seung-hwan Jeong More articles by this author Hyeong Dong Yuk More articles by this author Chang Wook Jeong More articles by this author Ja Hyeon Ku More articles by this author Hyeon Hoe Kim More articles by this author Cheol Kwak More articles by this author Expand All Advertisement PDF downloadLoading ...

Abstract OT1-06-01: Preservation of axillary lymph nodes in breast cancer patients undergoing mastectomy with 1-2 metastatic sentinel lymph nodes: The current status and future perspectives of the multicenter randomized clinical trial SINODAR-ONE

Abstract Introduction: Axillary lymph node dissection (ALND) has always been part of breast cancer (BC) treatment. However, during the past 25 years, the surgical management of the axilla has shifted towards a more conservative approach. Until now, ALND has remained the standard surgical technique when the sentinel lymph node (SLN) is macrometastatic. However, ALND may now be considered overtreatment for early-stage BC. The SINODAR-ONE trial is a prospective non-inferiority multicenter randomized study aimed at assessing the role of ALND in patients undergoing either breast-conserving surgery (BCS) or mastectomy for T1-2 BC presenting 1-2 macrometastatic SLNs. Objectives: The primary endpoint was to evaluate whether sentinel lymph node biopsy (SLNB) only was associated with clinically relevant worsening of the prognosis compared with ALND in terms of overall survival (OS). The secondary endpoint was to evaluate whether there was increased regional (lymph node recurrence) or distant recurrence in terms of recurrence-free survival (RFS) in patients with macrometastatic SLN who did not undergo ALND. Methods: Patients were randomly assigned (1:1 ratio) to either removal of ≥10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm). Results: The trial started in April 2015 and ceased in April 2020, involving 889 patients. The majority of the patients (75.2%) underwent BCS; 328 of 439 patients (74.7%) in the standard treatment arm, and 333 of 440 patients (75.7%) in the experimental treatment arm. 218 patients (24.8%) underwent mastectomy. SLN status at randomization was comparable between the two groups of treatment, with a median number of two SLNs removed and a median number of one positive SLN in both arms. The median number of non-SLNs identified at definitive histopathological evaluation was 16 (interquartile range [IQR] 12–21) in the ALND group. Overall, 193 of 439 patients (44.0%) in the standard treatment arm had additional macrometastases in the removed axillary lymph nodes. However, the median number of positive non SLNs was 0 (IQR 0–1) in the ALND group. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with a 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with a 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB only arm, respectively (p = 0.936). Conclusion: The 3-year survival and relapse rates of T1-2 BC patients with 1-2 macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND in patients undergoing BCS. However, given the low number of patients treated with mastectomy, there is no certainty that ALND omission can be extended also to this sub-group. In order to collect further evidence regarding the safety of the experimental treatment in patients candidates for mastectomy, the reopening of the enrollment of these patients as part of a single-arm experimental study started in June 2022. Citation Format: Damiano Gentile, Wolfgang Gatzemeier, Andrea Sagona, Erika Barbieri, Alberto Testori, Valentina Errico, Alberto Bottini, Simone Di Maria Grimaldi, Giulia Caraceni, Luca Boni, Paolo Bruzzi, Bethania Fernandes, Davide Franceschini, Ruggero Spoto, Rosalba Torrisi, Marta Scorsetti, Armando Santoro, Giuseppe Canavese, Corrado Tinterri. Preservation of axillary lymph nodes in breast cancer patients undergoing mastectomy with 1-2 metastatic sentinel lymph nodes: The current status and future perspectives of the multicenter randomized clinical trial SINODAR-ONE [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-06-01.

Abstract P2-11-01: Secondary endocrine resistance and high Ki-67 labeling index (≥20%) in patients with low genomic risk identified by 21-gene recurrence score

Abstract Introduction: Although breast cancer with high Ki-67 index are likely to have high genomic risk, some of these might have low genomic risk. In ER+HER2- breast cancer patients with low genomic risk identified by the 21-gene assay, we addressed a clinical significance of Ki-67 index in terms of recurrence-free survival (RFS). Methods: We retrospectively identified 2,295 patients with ER+HER2- breast cancer who underwent the 21-gene assay (Oncotype DX®). High Ki-67 LI was defined as 20% or greater, and low genomic risk was defined by recurrence score (RS) from the assay (&amp;lt; 26). Recurrence after 3 year was regarded as secondary endocrine resistance, which is defined as recurrence while on 2 years of adjuvant endocrine treatment. Results: In all patients, Ki67 index assigned 870 (38%) as the high and 1,425 (62%) as the low groups. Thirty percent (263/870) of the high Ki67 index had high genomic risk, whereas 84/1425 (6%) of the low Ki67 did. Among the patients with low genomic risk who did not receive chemotherapy (n=1,807), high Ki67 index was an independent poor risk factor for recurrence. Furthermore, recurrence after 3 years differed significantly according to Ki-67 index (P=0.003), whereas recurrence within 3 years did not differ (P=0.900). Multivariable analysis demonstrated high Ki67 index as a risk factor for recurrence after 3 years (hazard ratio 3.12; 95% confidence interval, 1.28–7.66). Conclusions: In ER+HER2- breast cancer with low genomic risk identified by 21-gene RS, high Ki67 index is associated with secondary endocrine resistance. Novel approach with CDK4/6 inhibitors is demanded to overcome secondary endocrine resistance in tumors with high Ki67/low genomic profile. Citation Format: Janghee Lee, Hakyoung Kim, Soong June Bae, Jong Won Lee, Byung Ho Son, Sei Hyun Ahn, Joon Jeong, Sae Byul Lee, Sung Gwe Ahn. Secondary endocrine resistance and high Ki-67 labeling index (≥20%) in patients with low genomic risk identified by 21-gene recurrence score [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-11-01.

Post-recurrent survival of a phase III trial comparing adjuvant chemotherapy with docetaxel plus S-1 versus S-1 alone in stage III gastric cancer: A post-hoc analysis of the START-2 trial (JACCRO GC-07).

371 Background: The START-2 trial showed docetaxel plus S-1 (DS) was superior to S-1 alone (S-1) in terms of recurrence-free survival (RFS) and overall survival (OS) as the adjuvant chemotherapy for stage III gastric cancer patients (pts) (J Clin Oncol 2019, Gastric Cancer 2022). However, the optimal treatment strategy has been controversial for pts who develop recurrence after DS. Methods: We investigated the post-recurrence survival (PRS) of pts who developed recurrence during and after adjuvant chemotherapy using the results of the START-2. The PRS was analyzed according to time to recurrence or treatment regimens. Also, survival rates were estimated by the Kaplan-Meier methods. A cox proportional hazards model was used to calculate hazard ratio (HR). The PRS was defined as the interval from the date of recurrence to the date of death from any cause. Results: A total of 361 pts had confirmed recurrence (154 of 441 pts in the DS group and 207 of 452 pts in the S-1 group). In pts with recurrence, 109 of 154 pts in the DS group and 156 of 207 pts in the S-1 group received chemotherapy. Median PRS were 12.9 months (mo) (95% confidence interval [CI] 10.7-16.7) in the DS group and 13.5 mo (95% CI 10.7-16.2) in the S-1 group (HR 1.09, 95% CI 0.83-1.44, p = 0.52). In the DS group and S-1 group, 69 and 95 pts received platinum-based (cisplatin or oxaliplatin) regimen, 25 and 44 received taxane (paclitaxel or docetaxel), 14 and 17 received other regimens (such as fluoropyrimidine monotherapy or irinotecan), respectively. Median PRS was significantly longer in pts who received platinum-based regimen compared with non-platinum regimen in the DS group (p = 0.0039), whereas there was no significant difference in the S-1 group (p = 0.07). In comparison of PRS between pts treated with platinum-based regimen and taxane-based one, HR was 0.46 (95% CI, 0.28-0.76, p=0.0019) in the DS group and 0.69 (95% CI, 0.47-1.02, p=0.063) and the S-1 group. In pts with recurrence during or less than 6 mo from completion of DS, median PRS was significantly longer in pts who received platinum- based regimen compared to taxane-based one. Whereas, there was no statistically significance in the PRS between the 2 regimens for recurrence in pts with recurrence during or less than 6 mo from completion of S-1. Among pts with recurrence after 6 mo or later, median PRS was favorable in pts treated with platinum-based regimen in both DS and S-1 group although no statistical significance. Conclusions: The addition of docetaxel to S-1 in adjuvant treatment of stage III gastric cancer did not affect PRS. Platinum-based chemotherapy might be a favorable choice for pts with recurrence during or after completion of docetaxel plus S-1 as adjuvant chemotherapy, especially in pts with a RFS of less than 6mo. Further prospective studies are warranted to validate these findings. Clinical trial information: UMIN000010337 .

An MRI-based Radiomics Approach to Improve Breast Cancer Histological Grading

Nottingham histological grade (NHG) 2 breast cancer has an intermediate risk of recurrence, which is not informative for therapeutic decision-making. We sought to develop and independently validate an MRI-based radiomics signature (Rad-Grade) to improve prognostic re-stratification of NHG 2 tumors. Nine hundred-eight subjects with invasive breast cancer and preoperative MRI scans were retrospectively obtained. The NHG 1 and 3 tumors were randomly split into training and independent test cohort, with the NHG 2 as the prognostic validation set. From MRI image features, a radiomics-based signature predictive of the histological grade was built by use of the LASSO logistic regression algorithm. The model was developed for identifying NHG 1 and 3 radiological patterns, followed with re-stratification of NHG 2 tumors into Rad-Grade (RG)2-low (NHG 1-like) and RG2-high (NHG 3-like) subtypes using the learned patterns, and the prognostic value was assessed in terms of recurrence-free survival (RFS). The Rad-Grade showed independent prognostic value for re-stratification of NHG 2 tumors, where RG2-high had an increased risk for recurrence (HR 2.20, 1.10-4.40, p=0.026) compared with RG2-low after adjusting for established risk factors. RG2-low shared similar phenotypic characteristics and RFS outcomes with NHG 1, and RG2-high with NHG 3, revealing that the model captures radiomic features in NHG 2 that are associated with different aggressiveness. The prognostic value of Rad-Grade was further validated in the NHG2 ER+ (HR 2.53, 1.13-5.56, p=0.023) and NHG 2 ER+LN- (HR 5.72, 1.24-26.44, p=0.025) subgroups, and in specific treatment contexts. The radiomics-based re-stratification of NHG 2 tumors offers a cost-effective promising alternative to gene expression profiling for tumor grading and thus may improve clinical decisions.