Real time ex vivo chemosensitivity assay for pancreatic adenocarcinoma.

BACKGROUND: Patient-derived organoids (PDOs) and xenografts (PDXs) have been extensively studied for drug-screening. However, their usage is limited due to lengthy establishment time, high engraftment failure rates and different tumor microenvironment from original tumors. To overcome the limitations, we developed real time-live tissue sensitivity assay (RT-LTSA) using fresh tumor samples. METHODS: Tissue slices from resected pancreatic cancer samples were placed in 96-well plates, and the slices were treated with chemotherapeutic agents. The correlation between the chemo-sensitivity of tissue slices and each patient's clinical outcome was analyzed. RESULTS: The viability and tumor microenvironment of the tissue slices are well-preserved over 5 days. The drug sensitivity assay results are available within 5 days after tissue collection. While all 4 patients who received RT-LTSA sensitive adjuvant regimens did not develop recurrence, 7 of 8 patients who received resistant adjuvant regimens developed recurrence. We observed significantly improved disease-free survival in the patients who received RT-LTSA sensitive adjuvant regimens (median: not reached versus 10.6 months, P = 0.02) compared with the patient who received resistant regimens. A significant negative correlation between RT-LTSA value and relapse-free survival was observed (Somer's D: -0.58; P = 0.016). CONCLUSIONS: RT-LTSA which maintains the tumor microenvironment and architecture as found in patients may reflect clinical outcome and could be used as a personalized strategy for pancreatic adenocarcinoma. Further, studies are warranted to verify the findings.

Benchmarks and Geographic Differences in Gallbladder Cancer Surgery: An International Multicenter Study.

BACKGROUND: High-quality surgery plays a central role in the delivery of excellent oncologic care. Benchmark values indicate the best achievable results. We aimed to define benchmark values for gallbladder cancer (GBC) surgery across an international population. PATIENTS AND METHODS: This study included consecutive patients with GBC who underwent curative-intent surgery during 2000-2021 at 13 centers, across seven countries and four continents. Patients operated on at high-volume centers without the need for vascular and/or bile duct reconstruction and without significant comorbidities were chosen as the benchmark group. RESULTS: Of 906 patients who underwent curative-intent GBC surgery during the study period, 245 (27%) were included in the benchmark group. These were predominantly women (n = 174, 71%) and had a median age of 64 years (interquartile range 57-70 years). In the benchmark group, 50 patients (20%) experienced complications within 90 days after surgery, with 20 patients (8%) developing major complications (Clavien-Dindo grade ≥ IIIa). Median length of postoperative hospital stay was 6 days (interquartile range 4-8 days). Benchmark values included ≥ 4 lymph nodes retrieved, estimated intraoperative blood loss ≤ 350 mL, perioperative blood transfusion rate ≤ 13%, operative time ≤ 332 min, length of hospital stay ≤ 8 days, R1 margin rate ≤ 7%, complication rate ≤ 22%, and rate of grade ≥ IIIa complications ≤ 11%. CONCLUSIONS: Surgery for GBC remains associated with significant morbidity. The availability of benchmark values may facilitate comparisons in future analyses among GBC patients, GBC surgical approaches, and centers performing GBC surgery.

The impact of age and comorbidity on localized pancreatic cancer outcomes: A US retrospective cohort analysis with implications for surgical centralization.

Introduction: Age and comorbidity are independently associated with worse outcomes for pancreatic adenocarcinoma (PDAC). However, the effect of combined age and comorbidity on PDAC outcomes has rarely been studied. This study assessed the impact of age and comorbidity (CACI) and surgical center volume on PDAC 90-day and overall survival (OS). Methods: This retrospective cohort study used the National Cancer Database from 2004 to 2016 to evaluate resected stage I/II PDAC patients. The predictor variable, CACI, combined the Charlson/Deyo comorbidity score with additional points for each decade lived ≥50 years. The outcomes were 90-day mortality and OS. Results: The cohort included 29,571 patients. Ninety-day mortality ranged from 2 % for CACI 0 to 13 % for CACI 6+ patients. There was a negligible difference (1 %) in 90-day mortality between high- and low-volume hospitals for CACI 0-2 patients; however, there was greater difference for CACI 3-5 (5 % vs. 9 %) and CACI 6+ (8 % vs. 15 %). The overall survival for CACI 0-2, 3-5, and 6+ cohorts was 24.1, 19.8, and 16.2 months, respectively. Adjusted overall survival showed a 2.7 and 3.1 month survival benefit for care at high-volume vs. low-volume hospitals for CACI 0-2 and 3-5, respectively. However, there was no OS volume benefit for CACI 6+ patients. Conclusions: Combined age and comorbidity are associated with short- and long-term survival for resected PDAC patients. A protective effect of higher-volume care was more impactful for 90-day mortality for patients with a CACI above 3. A centralization policy based on volume may have greater benefit for older, sicker patients. Key message: Combined comorbidity and age are strongly associated with 90-day mortality and overall survival for resected pancreatic cancer patients. When assessing the impact of age and comorbidity on resected pancreatic adenocarcinoma outcomes, 90-day mortality was 7 % higher (8 % vs. 15 %) for older, sicker patients treated at high-volume vs. low-volume centers but only 1 % (3 % vs. 4 %) for younger, healthier patients.

Simultaneous Hepatic and Visceral Resection: Preoperative Risk Stratification and Implications on Return to Intended Oncologic Therapy.

PURPOSE: Sequence of therapies for synchronous liver metastasis (LM) is complex, with data supporting individualized approaches, although no guiding tools are currently available. We assessed the impact of simultaneous hepatic and visceral resections (SHVR) on textbook outcome (TO) and return to intended oncologic therapy (RIOT), and provide risk-stratification tools to guide individualized decision making and counseling. METHODS: Patients with synchronous LM undergoing hepatectomy ± SHVR were included (2015-2021). Primary and secondary outcomes were TO and RIOT (days), respectively. Using multivariable modeling, a risk score for TO was developed. Decision tree analysis using recursive partitioning was performed for hierarchical risk stratification. The associations between SHVR, TO, and RIOT were examined. RESULTS: Among 533 patients identified, 124 underwent SHVR. TO overall was 71.7%; 79.2% in the non-SHVR group and 46.8% in the SHVR group (p < 0.001). SHVR was the strongest predictor of non-TO (right colon/small bowel: odds ratio [OR] 4.63, 95% confidence interval [CI] 2.65-8.08; left colon/rectum: OR 6.09, 95% CI 2.59-14.3; stomach/pancreas: OR 6.69, 95% CI 1.46-30.7; multivisceral: OR 10.9, 95% CI 3.03-39.5). A composite score was developed yielding three risk strata for TO (score 0-2: 89% vs. score 3-5: 67% vs. score ≥ 6: 37%; p < 0.001). Decision tree analysis was congruent, identifying SHVR as the most important determinant of TO. In patients with colorectal LM, SHVR was associated with delayed time to RIOT (p = 0.004); the risk-stratification tool for TO was equally predictive of RIOT (p < 0.01). CONCLUSIONS: SHVR is associated with reduced likelihood of TO and in turn delayed RIOT. As SHVR is increasingly performed in order to consolidate cancer care, patient selection considering these different outcomes is critical.

Clockwise Anterior-to-Posterior-Double Isolation (CAP-DI) Approach for Portal Lymphadenectomy in Biliary Tract Cancer: Technique, Yield, and Outcomes.

Background: Portal lymphadenectomy (PLND) is the current standard for oncologic resection of biliary tract cancers (BTCs). However, published data show it is performed infrequently and often yields less than the recommended 6 lymph nodes. We sought to identify yield and outcomes using a Clockwise Anterior-to-Posterior technique with Double Isolation of critical structures (CAP-DI) for PLND. Methods: Consecutive patients undergoing complete PLND for BTCs using CAP-DI technique were identified (2015−2021). Lymph node (LN) yield and predictors of LN count were examined. Secondary outcomes included intraoperative and postoperative outcomes, which were compared to patients having hepatectomy without PLND. Results: In total, 534 patients were included; 71 with complete PLND (36 gallbladder cancers, 24 intrahepatic cholangiocarcinomas, 11 perihilar cholangiocarcinomas) and 463 in the control group. The median PLND yield was 5 (IQR 3−8; range 0−17) and 46% had at least 6 nodes retrieved. Older age was associated with lower likelihood of ≥6 node PLND yield (p = 0.032), which remained significant in bivariate analyses with other covariates (p < 0.05). After adjustment for operative factors, performance of complete PLND was independently associated with longer operative time (+46.4 min, p = 0.001), but no differences were observed in intraoperative or postoperative outcomes compared to the control group (p > 0.05). Conclusions: Yield following PLND frequently falls below the recommended minimum threshold of 6 nodes despite a standardized stepwise approach to complete clearance. Older age may be weakly associated with lower PLND yield. While all efforts should be made for complete node retrieval, failure to obtain 6 nodes may be an unrealistic metric of surgical quality.

Hospital Surgical Volume Is Poorly Correlated With Delivery of Multimodal Treatment for Localized Pancreatic Cancer: A National Retrospective Cohort Study.

Using Donabedian's quality of care model, this study assessed process (hospital multimodal treatment) and structure (hospital surgical case volume) measures to evaluate localized pancreatic cancer outcomes. Background: Treatment at high surgical volume hospitals has been shown to improve short-term outcomes. However, multimodal treatment-surgery and chemotherapy-is the standard of care yet only received by 35% of US patients and has not been examined at the hospital level. Methods: The National Cancer Database was used to identify a cohort of clinical stage I pancreatic cancer patients eligible for multimodal treatment from 2004 to 2016. Hospital multimodal treatment was defined as the number of patients receiving surgery and chemotherapy by the number of eligible patients per hospital. Descriptive statistics and survival analyses were conducted. Results: A total of 16,771 patients met inclusion criteria, of whom 68.0% received curative-intent surgery and 35.8% received multimodal treatment. There was poor correlation between hospital surgical volume and delivery of multimodal treatment (Spearman correlation 0.214; P < 0.001). Of patients cared for at the highest surgical volume hospitals, 18.8% and 52.1% were treated at hospitals with low (0%-25%) and moderate (>25%-50%) multimodal treatment delivery, respectively. Higher hospital multimodal treatment delivery was associated with improved overall survival. Discussion: Although the volume-outcome relationship for pancreatic cancer has demonstrated improved outcomes, this work identified poor correlation between hospital surgical volume and delivery of multimodal treatment. The role of care coordination in the delivery of multimodal treatment warrants further investigation as it is associated with improved survival for patients with localized pancreatic cancer.

Prophylactic Perioperative Antibiotics in Open Pancreaticoduodenectomy: When Less Is More and When It Is Not. A National Surgical Quality Improvement Program Propensity-Matched Analysis.

INTRODUCTION: We hypothesized that first-generation cephalosporins (G1CEP) provide adequate antimicrobial coverage for pancreaticoduodenectomy (PD) when no biliary stent is present but might be inferior to second-generation cephalosporins or broad-spectrum antibiotics (G2CEP/BS) in decreasing surgical-site infection (SSI) rates when a biliary stent is present. METHODS: The National Surgical Quality Improvement Program 2014-2019 was used to select patients who underwent elective open PD. We divided the population into no-stent versus stent groups based on the status of biliary drainage and then divided each group into G1CEP versus G2CEP/BS subgroups based on the choice of perioperative antibiotics. We matched the subgroups per a propensity score match and analyzed postoperative outcomes. RESULTS: Six thousand two hundred forty five cases of 39,779 were selected; 2821 in the no-stent (45.2%) versus 3424 (54.8%) in the stent group. G1CEP were the antibiotics of choice in 2653 (42.5%) versus G2CEP/BS in 3592 (57.5%) cases. In the no-stent group, we matched 1129 patients between G1CEP and G2CEP/BS. There was no difference in SSI-specific complications (20.3% versus 21.0%; P = 0.677), general infectious complications (25.7% versus 26.9%; P = 0.503), PD-specific complications, overall morbidity, length of stay, or mortality. In the stent group, we matched 1244 pairs. G2CEP/BS had fewer SSI-specific complications (19.9% versus 26.6%; P < 0.001), collections requiring drainage (9.6% versus 12.9%; P = 0.011), and general infectious complications (28.5% versus 34.1%; P = 0.002) but no difference in overall morbidity, mortality, length of stay, and readmission rates. CONCLUSIONS: G2CEP/BS are associated with reduced rates of SSI-specific and infectious complications in stented patients undergoing open elective PD. In patients without prior biliary drainage, G1CEP seems to provide adequate antimicrobial coverage.

Patient-caregiver dyads in pancreatic cancer: identification of patient and caregiver factors associated with caregiver well-being.

We aimed to examine the psychosocial well-being in the pancreas cancer patient-caregiver dyad, and determine patient and caregiver characteristics that predict caregiver distress. This was a cross-sectional, observational study. Demographics and caregiving characteristics were gathered from patients and caregivers. Caregivers completed validated instruments investigating anxiety, depression, perceived stress and caregiver burden. Over a period of eleven months, 128 patient-caregiver dyads were enrolled. Patient and caregiver distress scores were not associated with patient clinical disease burden. Patient distress was a significant predictor of concurrent caregiver distress, anxiety, depression, and perceived burden. Younger caregivers were also associated with higher caregiver anxiety and perceived burden. Additionally, number of caregiving activities and caregiver overall health status were predictors of concurrent caregiver depression and perceived stress. Certain pancreatic cancer patient and caregiver variables may negatively impact the well-being of caregivers. Future efforts should focus on development and implementation of comprehensive caregiver support programs for those at risk for psychosocial distress.

Surgical Approach does not Affect Return to Intended Oncologic Therapy Following Pancreaticoduodenectomy for Pancreatic Adenocarcinoma: A Propensity-Matched Study.

BACKGROUND: The effect of minimally invasive pancreaticoduodenectomy (MIPD), including laparoscopic and robotic pancreaticoduodenectomy (LPD and RPD, respectively), on compliance and time to return to intended oncologic therapy (RIOT) for pancreatic ductal adenocarcinoma (PDAC) remains unknown. PATIENTS AND METHODS: Patients with nonmetastatic PDAC were analyzed in the National Cancer Database (NCDB). Three groups were matched per propensity score: open pancreaticoduodenectomy (OPD) and MIPD, LPD and RPD, and converted and nonconverted patients. RIOT rates and time to RIOT were examined. RESULTS: A total of 14,135 patients were included: 11,834 (83.7%) underwent OPD and 2301 (16.3%) underwent MIPD. After score matching, RIOT rates (67.2 vs. 65.3%; p = 0.112) and RIOT within 8 weeks (57.7 vs. 56.4%; p = 0.276) were similar among MIPD and OPD groups, and approach was not a significant predictor of RIOT on multivariable regression. Neither RIOT nor time to RIOT were different among LPD and RPD groups (63.9 vs. 67.0%, and 58.4 vs. 56.9%, respectively). Compared with LPD, RPD was associated with lower conversion rates (HR 0.519; p < 0.001), and conversion was associated with longer median time to RIOT (10 vs. 8 weeks; p = 0.041). CONCLUSION: In this national cohort, approach did not impact RIOT rates or time to RIOT for patients with PDAC. While conversion was associated with longer median time to RIOT, readiness to commence adjuvant therapy was similar for LPD and RPD.

Anatomic patterns of recurrence in biliary tract cancers: does primary tumor site matter?

Background: Recommendations for postoperative surveillance and adjuvant therapy following curative-intent resection for biliary tract cancers-including intrahepatic and extrahepatic cholangiocarcinoma (IHCCA and EHCCA) and primary gallbladder cancer (GBC)-are uniform across primary tumor site. However, these tumors may have distinct patterns of recurrence. Methods: A retrospective observational cohort study was performed at a specialty cancer center. Patients undergoing resection of IHCCA, EHCCA, and GBC were identified (2005-2020). Recurrence-free survival (RFS) was estimated using Kaplan-Meier and Cox proportional hazard methods. Anatomic patterns of initial site of recurrence were described and compared. Results: There were 142 patients included; 50 IHCCA, 32 EHCCA, and 60 GBC. Median RFS was 30.8 months, which was not significantly different between IHCCA, EHCCA, or GBC in univariate analysis or after adjustment. Nodal positivity was significantly associated with poor RFS (HR 3.92, P≤0.001). The most common initial site of recurrence overall was intrahepatic (n=49/64, 77%), in isolation (n=32) or synchronous with other site of recurrence (n=17). Significant differences in anatomic pattern of recurrence were observed (P=0.049) with IHCCAs more commonly recurring with simultaneous hepatic-pulmonary disease (n=5/22, 23%; EHCCA n=2/19, 10%; GBC n=1/23, 4%), GBC more commonly recurring within the porta (n=7/23, 30%; IHCCA n=0; EHCCA n=1/19, 5%), and EHCCA more commonly recurring within the peritoneum (n=5/19, 26%; IHCCA n=2/22, 9%, GBC n=2/23, 9%). Conclusions: Patterns of initial recurrence appear to differ between primary tumor site, likely reflecting underlying differences in anatomy and biology. These data could help inform future studies for adjuvant therapy as well as timing and anatomic focus for surveillance imaging.

The Addition of Chemoradiation to Adjuvant Chemotherapy is Associated With Improved Survival Following Upfront Surgical Resection for Pancreatic Cancer With Nodal Metastases.

BACKGROUND: It is unclear whether the addition of chemoradiation (CRT) to adjuvant chemotherapy (CT) following upfront resection of pancreatic ductal adenocarcinoma (PDAC) provides any benefit. While some studies have suggested a benefit to combined modality therapy (CMT) (adjuvant CT plus CRT), it is not clear if this benefit was related to increased CT usage in patients who received CMT. We sought to clarify the use of CMT in patients who underwent upfront resection of PDAC. METHODS: Patients with non-metastatic PDAC were retrospectively identified from the linked SEER-Medicare database. Those who underwent upfront resection were identified and divided into two cohorts - patients who received adjuvant CT and patients who received adjuvant CMT. Cohorts were compared. Univariate analysis described patient characteristics. Kaplan-Meier and multivariable Cox proportional hazards modeling were used to estimate overall survival (OS). RESULTS: 3555 patients were identified; 856 (24%) received CT and 573 (16%) received CMT. The median number of CT doses was 11 for both groups. Patients who received CMT were younger, diagnosed in the earlier time frame, and had fewer comorbidities. The median OS was 21 months and 18 months for those treated with CMT and CT (P < .0001), respectively, but when stratified by nodal status, the association with improved OS in the CMT cohort was only observed in node-positive patients. On multivariable analysis, receipt of CMT and removal of >15 lymph nodes decreased the risk of death (P < .05). DISCUSSION: Receipt of CMT following upfront resection for PDAC was associated with improved survival, which was confined to node-positive patients. The role of adjuvant CMT in PDAC with nodal metastases warrants further study.

Perioperative Carcinoid Crisis: A Systematic Review and Meta-Analysis.

BACKGROUND: Surgery is the only curative option for patients with neuroendocrine tumors (NET) and is also indicated for debulking of liver metastasis. Intraoperative carcinoid crisis (CC) is thought to be a potentially lethal complication. Though perioperative octreotide is often recommended for prevention, recent NET society guidelines raised concerns regarding limited data supporting its use. We sought to evaluate existing evidence characterizing CC and evaluating the efficacy of prophylactic octreotide. METHODS: A systematic review was performed on studies including patients having surgery for well-differentiated NET and/or NET liver metastasis (2000-2021), and reporting data on the incidence, risk factors, or prognosis of CC, and/or use of prophylactic octreotide. Meta-analysis was performed using random-effects models. RESULTS: Eight studies met inclusion criteria (n = 943 operations). The pooled incidence of CC was 19% (95% CI [0.06-0.36]). Liver metastasis (odds ratio 2.85 [1.49-5.47]) and gender (male 0.58 [0.34-0.99]) were the only significant risk factors. The occurrence of CC was associated with increased risk of major postoperative complications (2.12 [1.03-4.35]). The use of prophylactic octreotide was not associated with decreased risk of CC (0.73 [0.32-1.66]). Notably, there was no standard prophylactic octreotide strategy used. CONCLUSIONS: Intraoperative carcinoid crisis is a common complication occurring in up to 20% of patients with midgut NET and/or liver metastasis undergoing surgery. Prophylactic octreotide may not provide an efficient way to prevent this complication. Future studies should focus on prospective evaluation of well-defined prophylactic protocols using a standardized definition for CC.

Parenchyma-Sparing Central Hepatectomy Versus Extended Resections for Liver Tumors: a Value-Based Comparative Analysis.

BACKGROUND: Parenchyma-sparing (PS) liver resection is recommended for liver tumors. The value of PS-approaches as compared to more extended resections is unknown. We sought to examine value-based differences (quality/cost) of central hepatectomy (CH) versus more extended resections. METHODS: A retrospective cohort study including consecutive patients having CH or right/extended hepatectomies (R/EH) at a high-volume cancer center was performed (2015-2019). The primary outcome was the value ratio, calculated as quality/cost. Quality was defined as the proportion of patients achieving a textbook outcome. Perioperative actual direct costs ($USD) for each patient were abstracted from institutional financial records spanning throughout the perioperative period. Value ratios were calculated and compared for each approach; sensitivity analysis was performed by modelling TO and cost thresholds. RESULTS: Among 651 hepatobiliary operations (426 liver resections), 90 patients met inclusion criteria: 19 CH and 71 R/EH. TO occurred in 68% and 69% of CH and R/EH, respectively (P = 0.96). Mean direct costs were $21,826 for CH and $28,599 for R/EH (P = 0.008). CH provided a greater value (value ratio CH = 0.33 vs. R/EH = 0.26; P = 0.004) with a shift favoring R/EH only when the TO threshold for CH was below 51% (CH = 0.23 vs. R/EH = 0.24) or that of R/EH was over 90% (CH = 0.31 vs. R/EH = 0.32). CONCLUSIONS: These findings support a PS approach for central liver tumors (central hepatectomy) as it offers higher value than more extended resections. In the context of high-volume centers with outcomes within established national benchmarks, patients with central tumors should be considered for CH over more extended non-PS approaches.

Surgical approach to pancreaticoduodenectomy for pancreatic adenocarcinoma: uncomplicated ends justify the means.

BACKGROUND: Pancreaticoduodenectomy (PD) remains the cornerstone of managing pancreatic ductal adenocarcinoma (PDAC) of the pancreas head/neck, but it is associated with high morbidity. We hypothesize that, in absence of pancreatectomy-specific morbidity (PSM), minimally invasive PD (MIPD) provides improved short-term outcomes compared to open PD (OPD). METHODS: NSQIP pancreatectomy-targeted database 2014-2019 was utilized. PSM was defined as the occurrence of delayed gastric emptying (DGE) and/or post-operative pancreatic fistula (POPF). The cohort was divided into No-PSM and PSM groups. Propensity score match was applied in each group to compare outcomes of MIPD vs. OPD. RESULTS: 8,121 patients were selected. Patients were divided into No-PSM (N = 6267) and PSM (N = 1854) groups. In No-PSM group, we matched 1656 OPD to 552 MIPD patients. MIPD had longer operations (423 vs. 359 min; p < 0.001) but less overall morbidity (22.1% vs. 29.1%; p = 0.001) mostly attributed to less bleeding and sepsis. MIPD patients also had a one-day shorter median LOS (6 vs. 7 days; p = 0.005) and higher rates of home discharge (92.8% vs. 89.6%; p = 0.027). No difference was noted in mortality and 30-day readmission. In PSM group, 441 OPD were matched to 147 MIPD peers. MIPD had longer operations but without short-term benefits. General morbidity (61.2% vs. 61.9%), median LOS (12 vs. 12 days), mortality (2.7% vs. 1.8%), and readmission rates (32.7% vs. 26.5%) were similar. Same conclusions were drawn in the per-protocol analysis. CONCLUSION: PSM is common following PD for PDAC. In the absence of PSM, MIPD is associated with less postoperative morbidity and shorter LOS.

Adjuvant Chemoradiotherapy in Resected Pancreatic Ductal Adenocarcinoma: Where Does the Benefit Lie? A Nomogram for Risk Stratification and Patient Selection.

INTRODUCTION: The impact of adjuvant sequential chemoradiotherapy (CRT) on survival in resected pancreatic ductal adenocarcinoma (PDAC) remains unclear and warrants further investigation. METHODS: NCDB patients with R0/R1 resected PDAC who received adjuvant chemotherapy without CRT or followed by CRT per RTOG-0848 protocol were included. Cox regression for 5-year overall survival (OS) was performed and used to construct a pathologic nomogram in patients who did not receive CRT. A risk score was calculated and patients were divided into low-risk and high-risk groups. Patients from each risk stratum were matched for the receipt of CRT to assess the added benefit of CRT on survival. The Kaplan-Meier analysis was performed to compare OS. RESULTS: A total of 7146 patients were selected, 1308 (18.3%) received CRT per RTOG-0848. Cox regression concluded grade, T stage, N stage, node yield < 12, R1, and LVI as significant predictors of 5-year OS which were used to construct the risk score. Matched analysis in low-risk patients (score 0-79) showed no difference in OS between CRT vs. no CRT (47.6 ± 5.7 vs. 45.1 ± 3.9 months; p = 0.847). OS benefit was 3% at 1 year, - 4% at 2 years, and 4% at 5 years. In high-risk patients (score 80-100), median OS was higher in CRT vs. no CRT (24.8 ± 0.7 vs. 21.7 ± 0.8 months; p = 0.043). Absolute OS benefit was 13% at 1 year, 5% at 2 years, and - 1% at 5 years. CONCLUSION: CRT has a short-lived impact on OS in resected PDAC that is only evident in high-risk patients. In this subset, survival benefit peaks at 1 year and subsides at 3 to 5 years following PDAC resection.

The Florida Pancreas Collaborative Next-Generation Biobank: Infrastructure to Reduce Disparities and Improve Survival for a Diverse Cohort of Patients with Pancreatic Cancer.

Background: Well-annotated, high-quality biorepositories provide a valuable platform to support translational research. However, most biorepositories have poor representation of minority groups, limiting the ability to address health disparities. Methods: We describe the establishment of the Florida Pancreas Collaborative (FPC), the first state-wide prospective cohort study and biorepository designed to address the higher burden of pancreatic cancer (PaCa) in African Americans (AA) compared to Non-Hispanic Whites (NHW) and Hispanic/Latinx (H/L). We provide an overview of stakeholders; study eligibility and design; recruitment strategies; standard operating procedures to collect, process, store, and transfer biospecimens, medical images, and data; our cloud-based data management platform; and progress regarding recruitment and biobanking. Results: The FPC consists of multidisciplinary teams from fifteen Florida medical institutions. From March 2019 through August 2020, 350 patients were assessed for eligibility, 323 met inclusion/exclusion criteria, and 305 (94%) enrolled, including 228 NHW, 30 AA, and 47 H/L, with 94%, 100%, and 94% participation rates, respectively. A high percentage of participants have donated blood (87%), pancreatic tumor tissue (41%), computed tomography scans (76%), and questionnaires (62%). Conclusions: This biorepository addresses a critical gap in PaCa research and has potential to advance translational studies intended to minimize disparities and reduce PaCa-related morbidity and mortality.

Overall Body Composition and Sarcopenia Are Associated with Poor Liver Hypertrophy Following Portal Vein Embolization.

PURPOSE: To explore whether body composition and/or sarcopenia are associated with liver hypertrophy following portal vein embolization (PVE) in patients with colorectal liver metastases (CLM). METHODS: Patients with CLM who underwent right PVE prior to a planned right hepatectomy were identified from the institutional liver database from 2004 to 2014. Patients were excluded due to previous liver-directed therapy/hepatectomy, right PVE + segment IV embolization, or planned 2-stage hepatectomy. Advanced imaging software was used to measure body compartment volumes (cm2), which were standardized to height (m2) to create an index: skeletal muscle index (SMI), subcutaneous adipose index (SAI), and visceral adipose index (VAI). SMI, gender, and body mass index (BMI) were used to define sarcopenia. The main outcome of interest was hypertrophy of the future liver remnant (FLR) following PVE, which was reported as degree of hypertrophy (DH) and kinetic growth rate (KGR). RESULTS: Patients were evenly divided into three KGR groups: lower third (KGR:0.7-2.0%), middle third (KGR:2.0-4.1%), and upper third (KGR:4.2-12.3%). Patients in the lower third KGR group had a lower VAI (31.0 vs 53.0 vs 54.5 cm2/m2, p = 0.042) and were more commonly sarcopenic (60%) compared to the upper third (20%, p = 0.025). Eighteen patients (40%) met criteria for sarcopenia. Sarcopenic patients had a lower VAI (29.1 vs 57.4 cm2/m2, p = 0.004), lesser degree of hypertrophy (8.3% vs 15.2%, p = 0.009), and lower KGR (2.0% vs 4.0%, p = 0.012). CONCLUSION: Sarcopenia and associated body composition indices are strongly associated with clinically relevant impaired liver regeneration, which may result in increased liver-specific complications following hepatectomy for CLM.