Major Grade Research Articles

Perioperative TAS-118 plus oxaliplatin in patients with locally advanced gastric cancer: APOLLO-11 study

BackgroundWe investigated the feasibility of perioperative chemotherapy with S-1 and leucovorin (TAS-118) plus oxaliplatin in patients with locally advanced gastric cancer.MethodsPatients with clinical T3–4N1–3M0 gastric cancer received four courses of TAS-118 (40–60 mg/body, orally, twice daily for seven days) plus oxaliplatin (85 mg/m2, intravenously, day one) every two weeks preoperatively followed by gastrectomy with D2 lymphadenectomy, followed by postoperative chemotherapy with either 12 courses of TAS-118 monotherapy (Step 1) or eight courses of TAS-118 plus oxaliplatin (Step 2). The primary endpoints were completion rates of preoperative chemotherapy with TAS-118 plus oxaliplatin and postoperative chemotherapy with TAS-118 monotherapy (Step 1) or TAS-118 plus oxaliplatin (Step 2).ResultsAmong 45 patients enrolled, the preoperative chemotherapy completion rate was 88.9% (90% CI 78.0–95.5). Major grade ≥ 3 adverse events (AEs) were diarrhoea (17.8%) and neutropenia (8.9%). The R0 resection rate was 95.6% (90% CI 86.7–99.2). Complete pathological response was achieved in 6 patients (13.3%). Dose-limiting toxicity was not observed in 31 patients receiving postoperative chemotherapy (Step 1, n = 11; Step 2, n = 20), and completion rates were 90.9% (95% CI 63.6–99.5) for Step 1 and 80.0% (95% CI 59.9–92.9) for Step 2. No more than 10% of grade ≥ 3 AEs were observed in patients receiving Step 1. Hypokalaemia and neutropenia occurred in 3 and 2 patients, respectively, receiving Step 2. The 3-year recurrence-free and overall survival rates were 66.7% (95% CI 50.9–78.4) and 84.4% (95% CI 70.1–92.3), respectively.ConclusionsPerioperative chemotherapy with TAS-118 plus oxaliplatin with D2 gastrectomy is feasible.

Regorafenib is suitable for advanced colorectal cancer patients who have previously received trifluridine/tipiracil plus bevacizumab

Regorafenib is a standard salvage line therapy used for advanced colorectal cancer (CRC). Recently, trifluridine/tipiracil (TFTD) plus bevacizumab also showed promising efficacy as a salvage line therapy for advanced CRC. However, the efficacy and safety of regorafenib for patients with advanced CRC who have previously received TFTD plus bevacizumab is unclear. We retrospectively collected clinicopathologic data from patients with advanced CRC who received regorafenib after TFTD plus bevacizumab in multiple institutions between April 2017 and June 2020.Thirty-four advanced CRC patients who received regorafenib were analyzed. The median age was 66.5 (range 43–81 years), 11 patients were male, and all had an ECOG performance status(PS) of 0 or 1. Twenty-two patients had left-sided tumors, 18 patients had RAS mutants, and 1 patient had a BRAF V600E mutation. The response rate was 0%, and the disease control rate was 31%. The median progression-free survival was 70 days (95% CI: 56–91), and the overall survival was 233 days (95% CI: 188–324). Treatment was discontinued in 32 patients, and 28 (82%) discontinued treatment due to progressive disease. The major grade 3 and4 toxicities were proteinurea (29%), hypertension (26%), hand-foot syndrome(15%), and platelet decrease (6%). Regorafenib after TFTD plus bevacizumab showed efficacy similar to that of the previous study, and no new adverse events were observed.

Multicenter retrospective study of trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) for vulnerable patients with pretreated metastatic colorectal cancer (mCRC): WJOG14520G (TWILIGHT).

121 Background: In the phase III SOLSTICE study, FTD/TPI plus BEV showed similar efficacy to capecitabine plus BEV as first-line treatment for patients with mCRC ineligible for full-dose combination chemotherapy with oxaliplatin [OX] or irinotecan [IRI] (intensive therapy). We evaluated clinical outcomes of FTD/TPI plus BEV as second- or later lines treatment for vulnerable patients, who were defined to be intolerant to intensive therapy. Methods: This was a multicenter retrospective study of vulnerable patients with unresectable mCRC who received FTD/TPI plus BEV as second- or later lines treatment between May 2014 and October 2020. Main eligibility criteria were histologically proven adenocarcinoma, ECOG PS 0-2, prior chemotherapy for unresectable disease, considered intolerant to intensive therapy, and underwent FTD/TPI plus BEV without prior exposure to at least one key cytotoxic agent (fluoropyrimidines [FP], OX, or IRI). Results: Of 96 patients enrolled from 26 Japanese hospitals, 93 patients were evaluable. Patient characteristics were as follows: median age, 79 years (range 21-90); male, 53%; ECOG PS 0-1, 89%; right-sided primary tumor, 30%; primary tumor resection, 86%; RAS mutant, 63%; BRAF mutant, 1%; second-line treatment, 80%; prior exposure to FP 100%, OX 50%, and IRI 15%. Main reasons for intolerance to intensive therapy were older age (65%), poor PS (20%), and renal failure (5%). Initial dose of FTD/TPI was reduced in 30 (32%) patients. The response rate was 5% and disease control rate was 68%. With median follow-up of 21.6 months, the median progression-free survival, time to treatment failure, and overall survival were 6.3, 4.5, and 18.6 months, respectively. Major grade >3 adverse events were neutropenia (54%), anemia (20%), thrombocytopenia (9%), hypertension (7%), and febrile neutropenia (2%). No treatment-related deaths were observed. The treatment was discontinued in 89 patients due to disease progression (n = 72), patient’s refusal (n = 10), and adverse events (n = 6). After FTD/TPI plus BEV, chemotherapies such as regimens including IRI or OX (n = 20), regorafenib (n = 16), and anti-EGFR antibody monotherapy (n = 7) were performed in 42 patients. Conclusions: FTD/TPI plus BEV as second- or later lines treatment for vulnerable patients with mCRC showed promising clinical activity and acceptable safety profile. This study suggested that FTD/TPI plus BEV could be a treatment option for vulnerable patients with pretreated mCRC. Clinical trial information: UMIN000044136 .

Digital Quantification of Tumor Cellularity as a Novel Prognostic Feature of Non–Small Cell Lung Carcinoma

Non-small cell lung carcinoma is currently staged based on the size and involvement of other structures. Tumor size may be a surrogate measure of the total number of tumor cells. A recently revised reporting system for adenocarcinoma incorporates high-risk histologic patterns, which may have increased cellular density. Modern digital image analysis tools can be utilized to automate the quantification of cells. In this study, we tested the hypothesis that tumor cellularity can be used as a novel prognostic tool for lung cancer. Digital slides from The Cancer Genome Atlas lung adenocarcinoma (ADC) data set (n= 213) and lung squamous cell carcinoma (SCC) data set (n= 90) were obtained and analyzed using QuPath. The number of tumor cells was normalized with the surface area of the tumor to provide a measure of tumor cell density. Tumor cellularity was calculated by multiplying the size of the tumor with the cell density. Major histologic patterns and grade were compared with the tumor density of the lung ADC and lung SCC cases. The overall and progression-free survival were compared between groups of high and low tumor cellularity. High-grade histologic patterns in the ADC and SCC cases were associated with greater tumor densities compared with low-grade patterns. Cases with lower tumor cellularity had improved overall and progression-free survival compared with cases with higher cellularity. These results support tumor cellularity as a novel prognostic tool for non-small cell lung carcinoma that considers tumor stage and grade elements.

FAILURE TO RESCUE AFTER GASTRECTOMY: A NEW INDICATOR OF SURGICAL QUALITY.

The main treatment modality for gastric cancer is surgical resection with lymphadenectomy. Despite advances in perioperative care, major surgical complications can occur in up to 20% of cases. To determine the quality of surgical care employed, a new indicator called failure to rescue (FTR) was proposed, which assesses the percentage of patients who die after complications occur. To assess the rate of FTR after gastrectomy and factors associated with its occurrence. Patients with gastric cancer who underwent gastrectomy with curative intent were retrospectively evaluated. According to the occurrence of postoperative complications, patients were divided into FTR group (grade V complications) and rescued group (grade III/IV complications). Among the 731 patients, 114 had major complications. Of these patients, 76 (66.7%) were successfully treated for the complication (rescued group), while 38 (33.3%) died (FTR group). Patients in the FTR group were older (p=0.008; p<0.05), had lower levels of hemoglobin (p=0.021; p<0.05) and albumin (p=0.002; p<0.05), and a higher frequency of ASA III/IV (p=0.033; p<0.05). There were no differences between the groups regarding surgical and pathological characteristics. Clinicalcomplications had a higher mortality rate (40.0% vs 30.4%), with pulmonary complications (50.2%) and infections (46.2%) being the most lethal. Patients with major complications grade III/IV had worse survival than those without complications. The FTR rate was 33.3%. Advanced age, worse performance, and nutritional parameters were associated with FTR.

Biomarker Discordances and Alterations Observed in Breast Cancer Treated with Neoadjuvant Chemotherapy: Causes, Frequencies, and Clinical Significances

Biomarker discordances and alterations can be encountered between tru-cut biopsy and residual tumor in breast cancer treated with neoadjuvant chemotherapy (NACTx). We aimed to investigate the effect of NACTx on major biomarker expression (ER, PR, HER2, Ki-67) and tumor grade, the frequency and causes of receptor discordances, and the clinical significance of changes in terms of adjuvant therapy need and chemosensitivity. In this retrospective study, ER, PR, HER2, and Ki-67 expression and tumor grades were compared between pre- and post-NACTx tumor samples using the Wilcoxon signed-rank test. The frequencies of receptor discordances and the need for new adjuvant therapy due to discordances were calculated. The effect of patient and tumor characteristics and NACTx regimens on discordances was investigated using multivariate analysis. Using histopathological examinations, residual tumors were divided into chemotherapy-responsive and chemotherapy-unresponsive tumors. Biomarker changes in both groups were analyzed for predictability of chemosensitivity. Of the 169 patients who received NACTx, 102 patients having enough residual tumors in the surgical pathology specimen were enrolled in the study. Histopathologically, about 70% of tumors were partially responsive to NACTx and 30% were unresponsive (chemo-resistant). The concordance and discordance rates were 95.1% versus 4.9% for ER (p = 0.180), 97.1% versus 2.9% for PR (p = 0.083), and 89.2% versus 10.8% for HER2 (p = 0.763), respectively. In addition, 15% of hormone receptor (HR)-negative patients became HR(+) and 5.7% of HER2(-) patients became HER2(+) in the residual tumors, requiring adjuvant endocrine or anti-HER2 therapy. In particular, 18% of triple-negative patients became HR(+) and 12% became HER2(+). HER2 loss was detected in 40% of HER2(+) patients. Multivariate logistic regression analysis revealed that lower estrogen expression (p = 0.046), a smaller tumor size (p = 0.029), and anti-HER2 therapy (p < 0.001) have independent efficacy on ER discordance, PR discordance, and HER2 discordance, respectively. Ki-67 and PR expression significantly decreased in chemotherapy-responsive tumors (p = 0.001 and p = 0.004), and the tumor grade increased in chemotherapy-unresponsive tumors (p = 0.034). Approximately 3-5% of HR discordance and about 10% of HER2 discordance can be observed in breast cancer after currently used NACTx regimens. Discordances are bi-directional (from positive to negative and vice versa), and their causes are multifactorial; they should be assessed accordingly. The NACTx effect alone cannot explain observed discordances but can cause biomarker alterations. The change in receptor status from positive to negative, especially HER2 loss, is mainly associated with the NACTx effect. However, the shift from negative to positive is thought to be primarily related to intratumoral heterogeneity. Receptor statuses becoming positive are of more clinical importance due to adjuvant therapy requirements. Biomarker alterations in PR, Ki-67, and tumor grade can provide predictive information about tumor chemosensitivity.

A prospective multicenter phase II study of FOLFIRINOX as a first-line treatment for patients with advanced and recurrent biliary tract cancer

SummaryGiven the promising activity and tolerability of FOLFIRINOX as a second-line treatment for advanced biliary tract cancer (BTC), it can be an attractive first-line treatment option as well.This is a single-arm, open-label, multicenter phase II study to evaluate the safety and efficacy of FOLFIRINOX as a first-line treatment for patients with advanced BTC. Primary endpoint was progression-free survival (PFS), and the secondary endpoints included overall survival (OS), tumor response and safety. This study defined primary endpoint might be met when the lower limit value of 80% confidence interval [CI] of the median PFS ≥ 6.0 months.Between June 2016 and March 2020, 35 BTC patients (21 intrahepatic, 10 extrahepatic, 2 gallbladder, 2 ampulla) including 26 unresectable and 9 recurrent disease were enrolled. After a median follow-up of 13.9 months, the median PFS and OS were 7.4 (80% CI, 5.5–7.5) and 14.7 (80% CI, 11.8–15.7) months, respectively. Complete response was achieved in 1 (2.9%) and partial response in 10 (28.6%), giving an objective response rate of 31.4% and disease control rate of 74.3%. Major grade 3–4 adverse events included neutropenia (54.3%), leukopenia (34.4%), febrile neutropenia (17.1%), thrombocytopenia (8.6%), cholangitis (8.6%), anemia, nausea, diarrhea, and peripheral sensory neuropathy (2.9% each).FOLFIRINOX was well tolerable in patients with advanced BTC, however, this study did not meet the primary endpoint to conduct a phase III trial. Thus, further explorations are required to find a subset of patients and/or certain clinical scenario which might be beneficial from FOLFIRINOX.

Clinical Outcomes of Everolimus Rechallenge in Patients with Pancreatic Neuroendocrine Neoplasms with No Other Treatment Options.

The clinical outcomes of everolimus rechallenge in patients with pancreatic neuroendocrine neoplasms (PNENs) are unknown. This study aimed to investigate the treatment outcomes and safety of everolimus rechallenge treatment with PNENs. Clinical data of everolimus-treated patients with PNENs at two institutions were collected. Patients who underwent everolimus rechallenge were included in the study. We analyzed the progression-free survival (PFS) and treatment response associated with everolimus rechallenge and the adverse events. Between 2008 and 2020, 117 patients received initial treatment with everolimus, of which 14 patients received everolimus rechallenge. With regard to the grade of PNENs, there were 2 cases of G1, 11 cases of G2, and 1 case of G3. The median rechallenge PFS was 5.7 months. The objective response rate was 21.4%. the disease control rate was 71.4%. The only major grade 3 or 4 adverse event was neutropenia (n = 1, 7.1%). No other severe adverse event was observed. The outcomes and safety of everolimus rechallenge were verified, and it was deemed an acceptable treatment. Everolimus rechallenge may provide a new drug therapy for patients with advanced PNENs for whom no other drug treatment option is available.

High-Dose Spatially Fractionated Radiotherapy, Lattice Radiotherapy in Bulky Tumors: Results after One Year Follow-Up

<h3>Purpose/Objective(s)</h3> Spatially Fractionated Radiotherapy (SFRT) or Lattice Radiotherapy (LRT) is a radiotherapy technique that allows to deliver a very high radiation doses spheres inside the tumor in a single fraction, maintaining low dose in OAR, generating an inhomogeneous dose distribution inside the GTV and maintains the PTV marginal dose within planned dose within a multifraction treatment. This can be an option for bulky unresectable tumors with poor local control with standard radiotherapy. The main objective of this study is to assess LTR toxicity in patients with tumors greater than 45 cc and poor candidates for other treatment modalities. <h3>Materials/Methods</h3> From 1 January 2020 to 31 December 2020, 21 patients were treated in our institution. We prescribe 1 cm spheres with a maximum dose over 15 Gy in a single fraction and at least 4 vertices distributed inside of GTV. PTV dose continues as standard dose fractionation of 2.5-3Gy in the LRT session as prescribed in conventional or hypofractionated treatment. Simulation and treatment delivery is as SBRT. LTV (Lattice Tumor Volume) is the structure inside GTV where the VTV spheres (Vertex Tumor Volume), overdose volumes, are located, separated by 2.5-3.0 cm. VV (Valley Volume) is the subtraction of GTV-VTV that must be under 5 Gy. <h3>Results</h3> 21 patients (66,6% of tumors were in the thorax, 28,6% abdomen/pelvis and 4,8% head and neck) were treated. The median follow-up was 12 months (3-25). The median age of the patients was 64 years old (42-84). The median GTV volume was 236cc (80-896cc) and 73 mm (47– 123mm) in greatest axial diameter. The analysis of the results showed 4 patients with complete response (20%), 12 with partial response (57%) and 5 with stable disease (23%). Tumor reduction bigger than 50% has been observed in 75% of cases 2 weeks after LTR session. Local control was 75% at 6 months. Cumulative probability of survival was 76% (95% CI 51-89%) and 59% (95% CI 33-77%) at 6 and 12 months respectively. No additional toxicity has been related. No major grade 3 toxicities were reported according to CTCAE v5.0 grading. <h3>Conclusion</h3> Our experience with LTR protocol is feasible as a technique to be included in radiotherapy treatments for poor prognosis bulky tumors, with reproducibility and adaptability. Our early results confirm good local response and no added toxicity. Further large prospective studies are required to validate these results.

Exploring Course Components as Predictors of Academic Success in an Online Psychology Course

Online higher education is experiencing growth in enrolment and development which creates a need to continually evaluate the efficacy of online course delivery. Prior research reported that performance in online education is equivalent to traditional face-to-face delivery; however, minimal research exists to identify which elements of course design predict academic success. We aimed to identify which specific course components are predictors of (a) final course grade, (b) continuous assessment grade, and (c) major assessment grade in an online, undergraduate psychology course using data collated by the Learning Management System. We also addressed gaps in existing knowledge by exploring group differences within scores on significant predictors of course outcomes to determine whether these varied according to student characteristics. We found the number of times students visited the course site, viewed activities, and posted in activities significantly predicted students’ final course grade, continuous assessment grades, and major assessment grades. The total variance explained by the regression models, was however, relatively low and therefore there may be additional factors not considered in the present study that may predict grades. We also found non-traditional, female, domestic students, enrolled part-time and in an online degree accessed the course site, viewed activities, and posted in activities significantly more frequently than their counterparts. Universities offering online courses should provide students with regular activities and opportunities to participate in course content to promote online learning and academic success.

389P Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment for metastatic colorectal cancer: WJOG9216G (RECAST)

FOLFIRI plus bevacizumab (BEV) is widely used as first-line treatment for metastatic colorectal cancer (mCRC), and FOLFOXIRI plus BEV is an option. Clinical outcomes of ramucirumab (RAM) combined with FOLFIRI and FOLFOXIRI in first-line treatment are not well known. We conducted a randomized phase II study to assess the superiority of FOLFOXIRI plus RAM over FOLFIRI plus RAM as first-line treatment for mCRC. Main eligibility criteria were unresectable colorectal adenocarcinoma, age 20-75 years, ECOG PS <1, no previous chemotherapy, measurable lesions, and wild-type or heterozygous UGT1A1 *28/*6. In arm A, patients received FOLFIRI (irinotecan [IRI] 180 mg/m2, l-leucovorin [l-LV] 200 mg/m2, bolus 5-fluorouracil [5-FU] 400 mg/m2, continuous 5-FU 2400 mg/m2) plus RAM (8 mg/kg) biweekly until disease progression. In arm B, patients received 8 cycles of FOLFOXIRI (oxaliplatin 85 mg/m2, IRI 165 mg/m2, l-LV 200 mg/m2, continuous 5-FU 3200 mg/m2) plus RAM biweekly followed by 5-FU/l-LV plus RAM. The primary endpoint was confirmed objective response rate (ORR). The sample size was 120, assuming ORRs of 50/70% in arm A/B with 80% power at a 10% α-level (one-sided). A total of 122 patients were randomized (59/63 in arm A/B) from Jun 2017 to Sep 2020. The baseline characteristics in arm A/B were as follows: median age 64/65, male 66/70%, right colon 29/30%, RAS mutant 61/67%, BRAF mutant 9/3%, liver-limited disease 32/19%. 50/51 (84.7/81.0%) patients in arm A/B completed 8 cycles. The ORRs in arm A/B were 57.6/60.3% (odds ratio 1.11, p=0.76). With median follow-up of 27.4/25.3 months in arm A/B, median progression free survival (PFS) was 11.7/10.5 months (hazard ratio 1.13, p=0.57). R0 resection was performed in 10/6 (16.9/9.5%) patients in arm A/B. Major grade >3 adverse events (incidence in arm A/B) were neutropenia (44.1/72.6%), hypertension (15.3/19.4%), proteinuria (13.6/12.9%), anorexia (3.4/14.5%), febrile neutropenia (3.4/11.3%), and diarrhea (1.7/8.1%). FOLFOXIRI plus RAM did not show significant superiority in terms of ORRs and PFS compared with FOLFIRI plus RAM as first-line treatment for mCRC.

Upaya Pengenalan Huruf Menggunakan Metode SAL pada Siswa Kelas Nol Besar di TK Dahlia Mataram Semester Genap Tahun Pelajaran 2021/2022

This research aims to determine the application of the SAL method in introducing letters to students in class zero major at Kindergarten Dahlia Mataram even semester of the 2021/2022 academic year. This research was designed using Classroom Action Research. The subjects in this study were students in class zero at TK Dahlia Mataram, totaling 15 students consisting of 6 girls and 9 boys. With research procedures: (1) planning stage, (2) action implementation stage (3) observation stage (4) reflection stage. The results of the study show that: proper use of the SAL method can introduce letters effectively to students in major zero grade at TK Dahlia Mataram even semester of the 2021/2022 academic year. Furthermore, the researcher recommends: (1) teachers who have the same difficulties can apply the SAL learning method to introduce letters to students. (2) in order to get maximum results, it is hoped that the teacher will make learning more interesting and varied

Moderate grade subglottic stenosis in children: Laryngotracheal reconstruction versus cricotracheal resection and anastomosis.

ObjectiveThe surgical treatment of choice of pediatric moderate subglottic stenosis (major grade II and minor grade III SGS or 60–80% lumen obstruction) remains controversial. Laryngotracheal reconstruction (LTR) (with anterior ± posterior grafts for airway expansion) and partial crico-tracheal resection (PCTR) are the mainly described open surgical techniques. We reviewed our pediatric cases with moderate subglottic stenosis to determine the efficacy of LTR versus PCTR.MethodsA retrospective study of all children between 0 and 18 years that underwent open reconstructive airway surgery between 2012 and 2019. Children who had either acquired or congenital moderate subglottic stenosis (late grade II and early grade III: 60–80% lumen obstruction) were selected.ResultsTwenty-six children with moderate-grade subglottic stenosis were included. Seventeen were treated with LTR and nine with PCTR. No significant differences were observed between LTR and PCTR-treated cases. Decannulation rates were similar, as well as the functional results.ConclusionBoth LTR and PCTR are valid treatment options for moderate subglottic stenosis. This study indicates to perform the surgery that is most suitable for the characteristics of the patients’ stenosis, the surgeons’ expertise and preference, and the working infrastructure.

A Decade of Robotic-Assisted Radical Nephrectomy with Inferior Vena Cava Thrombectomy: A Systematic Review and Meta-Analysis of Perioperative Outcomes.

Open radical nephrectomy with inferior vena cava thrombectomy (O-CT) is standard management for renal cell carcinoma with inferior vena cava thrombus. First reported a decade ago, robotic-assisted radical nephrectomy with inferior vena cava thrombectomy (R-CT) is a minimally invasive option for this disease. We aimed to perform a systematic review to assess the safety and feasibility of R-CT in terms of perioperative outcomes and compare the outcomes between R-CT and O-CT. The PubMed®, Scopus®, Cochrane Central Register of Controlled Trials and Web of ScienceTM databases were searched using the free-text and MeSH terms "renal cell carcinoma," "inferior vena cava," "thrombosis" or "thrombus," "robot" and "thrombectomy." Studies reporting perioperative outcomes of R-CT and studies comparing R-CT with O-CT were included. The review was done in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The search retrieved 28 articles describing R-CT, including 7 comparative studies. This systematic review included 1,375 patients, out of which 329 patients were in single-arm studies and 1,046 patients were in comparative studies. Of the 329 patients who underwent R-CT, 14.7% were level I, 60.9% level II, 20.4% level III and 2.5% level IV thrombus. Operative time ranged from 150 to 530 minutes; blood transfusion was administered in 38.2% (126). The overall complication rate was 30.3% (99). R-CT, in comparison to O-CT, was associated with a lower blood transfusion rate (18.4% vs 64.3%, p=0.002) and a lower complication rate (14.5% vs 36.7%, p=0.005). Major complication and 30-day mortality rates were similar in both groups. R-CT has acceptable perioperative outcomes in carefully selected patients. Compared with O-CT, R-CT is associated with a lower blood transfusion rate and fewer overall complications. In experienced hands with carefully selected patients, R-CT is feasible and safe, with acceptable outcomes; however, selection bias limits definitive inference of these results, and optimal patient selection criteria remain to be described.

Is irreversible electroporation (IRE) an effective and safe ablation method for local advanced pancreatic cancer: A meta-analysis

To evaluate the safety and efficacy of irreversible electroporation (IRE) for treating local advanced pancreatic carcinoma. Relevant literature published from January 1, 2010, to July 1, 2021, was retrieved from PubMed and EMBASE databases. The following keywords were applied: " IRE, "Irreversible electrophoresis, "pancreatic cancer, "ablation, "and " ablation therapy. "The primary outcomes was IRE related significant complications rate. 19 studies were included, a total of 984 patients had undergone IRE. The probability of IRE-related major (Grade 3–5) complications rate was 17% (95% CI: 10–28%). 2 deaths related to IRE procedure were reported. The median overall survival time since IRE ranged from 6.1 to 27 months. Patients treated with IRE combined with surgical resection or standard chemotherapy showed a longer overall survival. IRE can benefit the survival of patients with locally advanced pancreatic cancer, but related adverse events should be treated with caution.

The influence of UGT1A1 polymorphisms on modified FOLFIRINOX dose in double-variant-type patients with advanced pancreatic cancer

BackgroundUGT1A1 polymorphisms should be considered when using irinotecan-containing regimens, especially in patients with a double-variant-type (DV), including homozygous for UGT1A1*28 and UGT1A1*6 and heterozygous for both UGT1A1*28 and UGT1A1*6. We investigated the safety and efficacy of modified FOLFIRINOX (mFOLFIRINOX) (irinotecan 80 mg/m2) in patients having DV.MethodsPatients with advanced pancreatic cancer who had received FOLFIRINOX between January 2015 and December 2019 were included in this study. Non-DV patients received the standard mFOLFIRINOX (irinotecan 150 mg/m2) as first-line (non-DV1) or second-line therapy (non-DV2); however, DV patients received mFOLFIRINOX (irinotecan 80 mg/m2) as the second-line therapy (DV2). We retrospectively evaluated the safety and efficacy of the lowered irinotecan dose in the DV2 group relative to the non-DV1 (safety) or non-DV2 (safety and efficacy) groups.ResultsA total of 235 patients were eligible for this study with 118 patients in the non-DV1, 106 in the non-DV2, and 11 in the DV2 groups. Major grade 3–4 adverse events were neutropenia (33.9, 31.1, and 18.2%) and febrile neutropenia (6.8, 3.8, and 9.1%) in the non-DV1, non-DV2, and DV2 groups, respectively. The median progression-free survival was 3.4 months in the non-DV2 group, and 4.4 months in the DV2 group. The overall survival from the date of starting second-line chemotherapy was 8.8 months in the non-DV2 group and 11.5 months in the DV2 group.ConclusionsBased on our findings, the safety and efficacy of mFOLFIRINOX (irinotecan 80 mg/m2) in DV patients were comparable with the standard mFOLFIRINOX (irinotecan 150 mg/m2) in non-DV patients.

MP24-09 RISK OF PSEUDOANEURYSM AND COMPLICATIONS AFTER PARTIAL NEPHRECTOMY: COMPARISON OF TUMOR ENUCLEATION TO STANDARD MARGIN TECHNIQUE

You have accessJournal of UrologyCME1 May 2022MP24-09 RISK OF PSEUDOANEURYSM AND COMPLICATIONS AFTER PARTIAL NEPHRECTOMY: COMPARISON OF TUMOR ENUCLEATION TO STANDARD MARGIN TECHNIQUE Nicholas Elliott, Jae Han Lee, Hiten Patel, Whitney Halgrimson, Keshava Gali, Nicholas Lanzotti, Goran Rac, Marcus Quek, and Gopal Gupta Nicholas ElliottNicholas Elliott More articles by this author , Jae Han LeeJae Han Lee More articles by this author , Hiten PatelHiten Patel More articles by this author , Whitney HalgrimsonWhitney Halgrimson More articles by this author , Keshava GaliKeshava Gali More articles by this author , Nicholas LanzottiNicholas Lanzotti More articles by this author , Goran RacGoran Rac More articles by this author , Marcus QuekMarcus Quek More articles by this author , and Gopal GuptaGopal Gupta More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002563.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Partial nephrectomy (PN) is the gold standard for the resection of amenable small renal masses. Some surgeons have adopted tumor enucleation (TE) over the standard margin PN (SPN) technique based on preservation of healthy renal parenchyma by following the tumor pseudocapsule. However, TE may also confer additional advantages due to avoidance of sharp incision including reduction in perioperative and bleeding complications. Therefore, we evaluated the rate of pseudoaneurysms and other complications following TE vs SPN. METHODS: A retrospective cohort study of patients undergoing PN (TE and SPN) between 2008 and 2020 was conducted. Baseline characteristics, comorbidities including chronic kidney disease and Charlson Comorbidity Index (CCI), prior surgical history, tumor size, clinical stage, and RENAL nephrometry score were captured. Clavien-Dindo complications including pseudoaneurysm were compared between the TE and SPN cohorts with univariable and multivariable logistic regression models. RESULTS: A total of 467 patients were included, 176 (37.7%) receiving TE and 291 (62.3%) SPN. There were no differences in baseline characteristics such as comorbidity, tumor size, clinical stage, or nephrometry score between groups. Conversion rates were similar but Clavien-Dindo complication rates were significantly less likely for TE with 19 (10.8%) compared to SPN with 68 (23.4%) (multivariable OR 2.55 (95%CI 1.45-4.51), p=0.001). Major Clavien-Dindo grade ≥3 complications were infrequent, but with notably lower rates for TE vs. SPN (2 (1.1%) vs. 22 (7.6%), multivariable OR 8.83 (95%CI 1.84-42.46), p=0.01). Reduction in bleeding complications was a major driver (1.7% vs. 6.2%, p=0.02) with no pseudoaneurysm events following TE compared to 13 following SPN (0.0% vs 2.8%, p=0.004). Need for interventional radiology largely reflected pseudoaneurysm differences (0 (0.0%) TE vs 14 (3.0%) SPN, p=0.003). Readmission occurred less often after TE vs. SPN (3.4% vs. 8.6%, p=0.03). CONCLUSIONS: Patients receiving TE experienced no clinically significant pseudoaneurysm formation and were less likely to have any bleeding complication or major Clavien-Dindo complication postoperatively. TE is a safe option for PN with avoidance of sharp excision optimizing perioperative parameters along with known benefits in renal function. TE may be preferred when minimizing morbidity aligns with patient selection and preferences. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e396 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Nicholas Elliott More articles by this author Jae Han Lee More articles by this author Hiten Patel More articles by this author Whitney Halgrimson More articles by this author Keshava Gali More articles by this author Nicholas Lanzotti More articles by this author Goran Rac More articles by this author Marcus Quek More articles by this author Gopal Gupta More articles by this author Expand All Advertisement PDF downloadLoading ...

Intrahepatic flow diversion prior to segmental Yttrium-90 radioembolization for challenging tumor vasculature

BackgroundHepatic tumors with complex vascular supply or poor relative perfusion are prone to decreased rates of objective response. This is compounded in the setting of Yttrium-90 (Y90) transarterial radioembolization (TARE), which is minimally embolic and flow-dependent, relying on high threshold dose for complete response. ObjectiveWe describe our experience with intrahepatic flow diversion (FD) prior to TARE of hepatocellular carcinoma (HCC) with challenging vascular supply. Materials and methodsBetween April 2014 and January 2020, 886 cases of coinciding MAA or TARE and bland embolization or temporary occlusion were identified. Intraprocedural embolizations performed for more routine purposes were excluded. FD was performed by bland embolization or temporary occlusion of vessels supplying non-malignant parenchyma in cases where flow was not preferential to target tumor. Lesion characteristics, vascular supply, treatment approach, angiography, and adverse events (AEs) were reviewed. Radiographic response was assessed using mRECIST criteria. Results22 cases of FD of focal HCC were identified. Embolics included calibrated microspheres (n ​= ​11), microcoils (n ​= ​4), gelfoam (n ​= ​3), temporary balloon occlusion (n ​= ​2) and temporary deployment of a microvascular plug (n ​= ​1). Post-treatment SPECT-CT dosimetry coverage was concordant with target lesions in all cases. Mean follow-up was 16.7 months (1.4–45 ​mos). Tumor-specific response per mRECIST was 41% complete response, 50% objective response, and 59% disease control rate. No major adverse events or grade 3/4 hepatotoxicity were reported. ConclusionOur findings suggest that FD prior to TARE is safe and potentially effective in treating HCC with complex vascular supply or poor tumor perfusion.

Hair safe study: Effects of scalp cooling on hair preservation and hair regrowth in breast cancer patients receiving chemotherapy - A prospective interventional study

Hair safe study: Effects of scalp cooling on hair preservation and hair regrowth in breast cancer patients receiving chemotherapy - A prospective interventional study

Novel triangle method for evaluation of fracability in transitional shale: Case study from well ZXY-1 in the southern North China Basin

Fracability is a property widely used to evaluate whether reservoirs can effectively fracture to increase production capacity. The brittleness index, which is used to evaluate reservoir fracability, is calculated via various methods, and the evaluation process of the brittleness index is complicated and not sufficiently intuitive. Thus, we used triangle method to evaluate reservoir fracability. The shale composition is classified into strong (quartz + pyrite), moderate (carbonate + plagioclase + siderite), and poor (clay + TOC + porosity) fracability based on the mechanical parameters of each shale component, which were integrated as the endpoints of the triangle method. Meanwhile, the triangle method is divided into four fracability evaluation grades: strong (I), moderate (II), weak (III) and poor (IV) fracability; each major evaluation grade has four sub-categories: best for fracturing (1), better for fracturing (2), poor for fracturing (3) and worst for fracturing (4). The triangle method is simpler and more convenient than the conventional method, dividing the fracability evaluation grades more specifically. The difference in fracability between samples can be shown intuitively, which enhances the accuracy and reliability of the evaluation of transitional shales and provides theoretical support for reservoir reconstruction.