Quality of Life and Real-time Patient Experience During Neoadjuvant Therapy: A Prospective Cohort Study.

OBJECTIVE: To use a customized smartphone application to prospectively measure QOL and the real-time patient experience during neoadjuvant therapy (NT). BACKGROUND: NT is increasingly used for patients with localized gastrointestinal (GI) cancers. There is little data assessing patient experience and quality of life (QOL) during NT for GI cancers. METHODS: Patients with GI cancers receiving NT were instructed on using a customized smartphone application through which the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, a validated measure of health-related QOL, was administered at baseline, every 30 days, and at the completion of NT. Participants also tracked their moods and symptoms and used free-text journaling functionalities in the application. Mean overall and subsection health-related QOL scores were calculated during NT. RESULTS: Among 104 enrolled patients, the mean age was 60.5 ± 11.5 years and 55% were males. Common cancer diagnoses were colorectal (40%), pancreatic (37%), and esophageal (15%). Mean overall FACT-G scores did not change during NT ( P = 0.987). While functional well-being scores were consistently the lowest and social well-being scores the highest, FACT subscores similarly did not change during NT (all P > 0.01). The most common symptoms reported during NT were fatigue, insomnia, and anxiety (39.3%, 34.5%, and 28.3% of patient entries, respectively). Qualitative analysis of free-text journaling entries identified anxiety, fear, and frustration as the most common themes, but also the importance of social support systems and confidence in health care providers. CONCLUSIONS: While patient symptom burden remains high, results of this prospective cohort study suggest QOL is maintained during NT for localized GI cancers.

Variation in Hospital Mortality After Complex Cancer Surgery: Patient, Volume, Hospital or Social Determinants?

INTRODUCTION: We sought to define the individual contributions of patient characteristics (PCs), hospital characteristics (HCs), case volume (CV), and social determinants of health (SDoH) on in-hospital mortality (IHM) after complex cancer surgery. METHODS: The California Department of Health Care Access and Information database identified patients who underwent esophagectomy (ES), pneumonectomy (PN), pancreatectomy (PD), or proctectomy (PR) for a malignant diagnosis between 2010 and 2020. Multi-level multivariable regression was performed to assess the proportion of variance explained by PCs, HCs, CV and SDoH on IHM. RESULTS: A total of 52,838 patients underwent cancer surgery (ES: n = 2,700, 5.1%; PN: n = 30,822, 58.3%; PD: n = 7530, 14.3%; PR: n = 11,786, 22.3%) across 294 hospitals. The IHM for the overall cohort was 1.7% and varied from 4.4% for ES to 0.8% for PR. On multivariable regression, PCs contributed the most to the variance in IHM (overall: 32.0%; ES: 21.6%; PN: 28.0%; PD: 20.3%; PR: 39.9%). Among the overall cohort, CV contributed 2.4%, HCs contributed 1.3%, and SDoH contributed 1.2% to the variation in IHM. CV was the second highest contributor to IHM among ES (5.3%), PN (5.3%), and PD (5.9%); however, HCs were a more important contributor among patients who underwent PR (8.0%). The unexplained variance in IHM was highest among ES (72.4%), followed by the PD (67.5%) and PN (64.6%) patient groups. CONCLUSIONS: PCs are the greatest underlying contributor to variations in IHM following cancer surgery. These data highlight the need to focus on optimizing patients and exploring unexplained sources of IHM to improve quality of surgical care.

Surgeon Perspectives on the Management of Aborted Cancer Surgery: Results of a Society of Surgical Oncology Member Survey.

BACKGROUND: While surgery is generally necessary for most solid-organ cancers, curative-intent resection is occasionally aborted due to unanticipated unresectability or occult metastases. Following aborted cancer surgery (ACS), patients have unique and complex care needs and yet little is known about the optimal approach to their management. OBJECTIVE: The aim of this study was to define the practice patterns and perspectives of an international cohort of cancer surgeons on the management of ACS. METHODS: A validated survey assessing surgeon perspectives on patient care needs and management following ACS was developed. The survey was distributed electronically to members of the Society of Surgical Oncology (SSO). RESULTS: Among 190 participating surgeons, mean age was 49 ± 11 years, 69% were male, 61% worked at an academic institution, and most had a clinical practice focused on liver/pancreas (30%), breast (23%), or melanoma/sarcoma cancers (20%). Participants estimated that ACS occurred in 7 ± 6% of their cancer operations, most often due to occult metastases (67%) or local unresectability (30%). Most surgeons felt (very) comfortable addressing their patients' surgical needs (92%) and cancer treatment-related questions (90%), but fewer expressed comfort addressing psychosocial needs (83%) or symptom-control needs (69%). While they perceived discussing next available therapies as the patients' most important priority after ACS, surgeons reported avoiding postoperative complications as their most important priority (p < 0.001). While 61% and 27% reported utilizing palliative care and psychosocial oncology, respectively, in these situations, 46% noted care coordination as a barrier to addressing patient care needs. CONCLUSIONS: Results from this SSO member survey suggest that ACS is relatively common and associated with unique patient care needs. Surgeons may feel less comfortable assessing psychosocial and symptom-control needs, highlighting the need for novel patient-centered approaches.

Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study.

BACKGROUND: Uveal melanoma (UM) has a poor prognosis once liver metastases occur. The melphalan/Hepatic Delivery System (melphalan/HDS) is a drug/device combination used for liver-directed treatment of metastatic UM (mUM) patients. The purpose of the FOCUS study was to assess the efficacy and safety of melphalan/HDS in patients with unresectable mUM. METHODS: Eligible patients with mUM received treatment with melphalan (3.0 mg/kg ideal body weight) once every 6 to 8 weeks for a maximum of six cycles. The primary end point was the objective response rate (ORR). The secondary end points included duration of response (DOR), overall survival (OS), and progression-free survival (PFS). RESULTS: The study enrolled 102 patients with mUM. Treatment was attempted in 95 patients, and 91 patients received treatment. In the treated population (n = 91), the ORR was 36.3 % (95 % confidence interval [CI], 26.44-47.01), including 7.7 % of patients with a complete response. Thus, the study met its primary end point because the lower bound of the 95 % CI for ORR exceeded the upper bound (8.3 %) from the benchmark meta-analysis. The median DOR was 14 months, and the median OS was 20.5 months, with an OS of 80 % at 1 year. The median PFS was 9 months, with a PFS of 65 % at 6 months. The most common serious treatment-emergent adverse events were thrombocytopenia (15.8 %) and neutropenia (10.5 %), treated mostly on an outpatient basis with observation. No treatment-related deaths were observed. CONCLUSION: Treatment with melphalan/HDS provides a clinically meaningful response rate and demonstrates a favorable benefit-risk profile in patients with unresectable mUM (study funded by Delcath; ClinicalTrials.gov identifier: NCT02678572; EudraCT no. 2015-000417-44).

Intracystic injection of large surface area microparticle paclitaxel for chemoablation of intraductal papillary mucinous neoplasms: Insights from an expanded access protocol.

AIMS: A novel large surface area microparticle paclitaxel (LSAM-PTX) has unique properties of long retention in cystic spaces while maintaining high drug concentration. We prospectively evaluated the safety and response of EUS-guided fine needle injection (EUS-FNI) of LSAM-PTX to chemoablate branch duct (BD)-IPMNs. METHODS: Subjects diagnosed with BD-IPMNs exhibiting at least one worrisome criteria and considered non-surgical were enrolled in a multicenter clinical trial (NCT03188991) and subsequently included in an Expanded Access Protocol (EAP) where they received EUS-FNI of LSAM-PTX (15 mg/mL). RESULTS: Six BD-IPMNs measuring (mean ± SD) 3.18 ± 0.76 cm in diameter among 5 subjects (mean age: 66 years) were treated by EUS-FNI of LSAM-PTX. A mean of 4 doses of LSAM-PTX (mean dose/cyst: 73 ± 31 mg) were administered, and subjects were followed for up to 32 months. The mean volume reduction/cyst ranged from 42 to 89% (9.58 ± 5.1 ml to 2.2 ± 1.1 ml (p = 0.016)). The mean surface area reduction ranged from 31 to 83% (21.9 ± 8.7 cm2 to 5.7 ± 2.5 cm2 (p = 0.009)). Higher dosing-frequency of EUS-FNI of LSAM-PTX significantly correlated with a reduction in cyst volume (R2 = 0.87, p = 0.03) and surface area (R2 = 0.83, p = 0.04). Comparing pre- and post-ablation samples, molecular analysis of the cyst fluid revealed a loss of IPMN-associated mutations in 5 cases (83.3%), while reemergence was observed in 1 case and persistence in 1 case. Intracystic changes (fibrosis/calcification) were observed in 83.3% (n = 5). One subject developed mild acute pancreatitis (1 of 22 EUS-FNIs of LSAM-PTX). CONCLUSION: In this EAP, EUS-FNI of LSAM-PTX into BD-IPMNs was safe and resulted in volume and surface area reduction, morphological changes, and loss of pathogenic mutations.

Association of Racial and Economic Privilege on Postoperative Outcomes Among Medicare Beneficiaries.

INTRODUCTION: Social determinants of health can play an important role in patient health. Privilege is a right, benefit, advantage, or opportunity that can positively affect all social determinants of health. We sought to assess variations in the prevalence of privilege among patient populations and define the association of privilege on postoperative surgical outcomes. METHODS: Medicare beneficiaries who underwent elective coronary artery bypass grafting, abdominal aortic aneurysm repair, total hip arthroplasty, total knee arthroplasty, colectomy, and lung resection were identified. The Index of Concentration of Extremes (ICE), a validated metric of both social spatial polarization and privilege was calculated and merged with county-level data obtained from the American Community Survey. Textbook outcome (TO) was defined as absence of postoperative complications, extended length of stay, 90-day mortality, and 90-day readmission. Multivariable regression analysis was performed to assess the relationship between ICE and TO. RESULTS: Among 1,885,889 Medicare beneficiaries who met inclusion criteria, 655,980 (34.8%) individuals resided in areas with the highest privilege (i.e., White, high-income homogeneity), whereas 221,314 (11.7%) individuals resided in areas of the lowest privilege (i.e., Black, low-income homogeneity). The overall incidence of TO was 66.2% (n = 1,247,558). On multivariable regression, residence in the most advantaged neighbourhoods was associated with a lower chance of surgical complications (odds ratio [OR] 0.90, 95% confidence interval [CI] 0.88-0.91), a prolonged length of stay (OR 0.81, 95% CI 0.79-82), 90-day readmission (OR 0.94, 95% CI 0.92-0.95), and 90-day mortality (OR 0.71, 95% CI 0.68-0.74) (all P < 0.001). Residence in the most privileged areas was associated with 19% increased odds of achieving TO (OR 1.19, 95% CI 1.18-1.21), as well as a 6% reduction in Medicare expenditures versus individuals in the least privileged counties (OR 0.94, 95% CI 0.94-0.94) (both P < 0.001). CONCLUSIONS: Privilege, based on the ICE joint measure of racial/ethnic and economic spatial concentration, was strongly associated with the likelihood to achieve an "optimal" TO following surgery. As healthcare is a basic human right, privilege should not be associated with disparities in surgical care.

Association of Surgical Approaches and Outcomes in Total Mesorectal Excision and Margin Status for Rectal Cancer.

INTRODUCTION: Despite being a key metric with a significant correlation with the outcomes of patients with rectal cancer, the optimal surgical approach for total mesorectal excision (TME) has not yet been identified. The aim of this study was to assess the association of the surgical approach on the quality of TME and surgical margins and to characterize the surgical and long-term oncologic outcomes in patients undergoing robotic, laparoscopic, and open TME for rectal cancer. METHODS: Patients with primary, nonmetastatic rectal adenocarcinoma who underwent either lower anterior resection or abdominoperineal resection via robotic (Rob), laparoscopic (Lap), or open approaches were selected from the US Rectal Cancer Consortium database (2007-2017). Quasi-Poisson regression analysis with backward selection was used to investigate the relationship between the surgical approach and outcomes of interest. RESULTS: Among the 664 patients included in the study, the distribution of surgical approaches was as follows: 351 (52.9%) underwent TME via the open approach, 159 (23.9%) via the robotic approach, and 154 (23.2%) via the laparoscopic approach. There were no significant differences in baseline demographics among the three cohorts. The laparoscopic cohort had fewer patients with low rectal cancer (<6 cm from the anal verge) than the robotic and open cohorts (Lap 28.6% versus Rob 59.1% versus Open 45.6%, P = 0.015). Patients who underwent Rob and Lap TME had lower intraoperative blood loss compared with the Open approach (Rob 200 mL [Q1, Q3: 100.0, 300.0] versus Lap 150 mL [Q1, Q3: 75.0, 250.0] versus Open 300 mL [Q1, Q3: 150.0, 600.0], P < 0.001). There was no difference in the operative time (Rob 243 min [Q1, Q3: 203.8, 300.2] versus Lap 241 min [Q1, Q3: 186, 336] versus Open 226 min [Q1, Q3: 178, 315.8], P = 0.309) between the three approaches. Postoperative length of stay was shorter with robotic and laparoscopic approach compared to open approach (Rob 5.0 d [Q1, Q3: 4, 8.2] versus Lap 5 d [Q1, Q3: 4, 8] versus Open 7.0 d [Q1, Q3: 5, 9], P < 0.001). There was no statistically significant difference in the quality of TME between the robotic, laparoscopic, and open approaches (79.2%, 64.9%, and 64.7%, respectively; P = 0.46). The margin positivity rate, a composite of circumferential margin and distal margin, was higher with the robotic and open approaches than with the laparoscopic approach (Rob 8.2% versus Open 6.6% versus Lap 1.9%, P = 0.17), Rob versus Lap (odds ratio 0.21; 95% confidence interval 0.05, 0.83) and Rob versus Open (odds ratio 0.5; 95% confidence interval 0.22, 1.12). There was no difference in long-term survival, including overall survival and recurrence-free survival, between patients who underwent robotic, laparoscopic, or open TME (Figure 1). CONCLUSIONS: In patients undergoing surgery with curative intent for rectal cancer, we did not observe a difference in the quality of TME between the robotic, laparoscopic, or open approaches. Robotic and open TME compared to laparoscopic TME were associated with higher margin positivity rates in our study. This was likely due to the higher percentage of low rectal cancers in the robotic and open cohorts. We also reported no significant differences in overall survival and recurrence-free survival between the aforementioned surgical techniques.

Evaluating the caregiver experience during neoadjuvant therapy for pancreatic ductal adenocarcinoma.

INTRODUCTION: Neoadjuvant therapy (NT) is increasingly recommended for patients with localized pancreatic ductal adenocarcinoma (PDAC). Recent research has highlighted the significant treatment burden that patients experience during NT, but caregiver well-being during NT is poorly understood. METHODS: A cross-sectional mixed-methods analysis of primary caregivers of patients with localized PDAC receiving NT was undertaken. All patients completed the Caregiver Quality of Life Index-Cancer (CQOLC) survey, while semi-structured interviews were conducted among a convenience sample of participants. RESULTS: Among 28 caregivers, the mean age was 60.1 years, and most were patient spouses/significant others (71.4%). Patients had resectable (18%), borderline resectable (46%), or locally advanced (36%) PDAC with a mean treatment duration of 2.9 months at the time of their caregiver's enrollment. Most caregivers felt that they received adequate emotional/psychosocial support (80%) and understood the rationale for NT (93%). A majority (60%) reported that caregiving responsibilities impacted their daily lives and required a decrease in their work hours, leading to financial challenges (47%). While overall QOL was moderate (mean 83 ± 21.1, range 0-140), "emotional burden" (47.3 ± 20.9), and "positive adaption" (57.3 ± 13.9) were the lowest ranked CQOLC subsection scores. DISCUSSION: Caregivers of patients with PDAC undergoing NT experience significant emotional symptoms and impact on their daily lives. Assessing caregiver needs and providing resources during NT should be a priority.

Impact of Medicaid expansion on the multimodal treatment of biliary tract cancer.

INTRODUCTION: The impact of Medicaid expansion (ME) on the treatment of patients with cancer remains controversial, especially individuals requiring complex multidisciplinary care. We sought to evaluate the impact of Medicaid expansion (ME) on receipt of multimodal care, including surgical resection, for Stage I-III biliary tract cancer (BTC). METHODS: Patients diagnosed with BTC between 40 and 65 years of age were identified from the National Cancer Database and divided into pre- (2008-2012) and post- (2015-2018) ME cohorts. Difference-in-difference (DID) analysis was used to determine the impact of ME on the utilization of surgery and multimodal chemotherapy and/or radiotherapy treatment for BTC. RESULTS: Among 12,415 patients with BTC (extrahepatic, n = 5622, 45.3%; intrahepatic, n = 4352, 35.1%; gallbladder, n = 1944, 15.7%; overlapping, n = 497, 4.0%), 5835 (47.0%) and 6580 (53.0%) patients were diagnosed before versus after ME, respectively. Overall utilization of surgery (OR 1.13, 95% CI 1.02-1.26) and multimodality therapy (OR 1.13, 95% CI 1.01-1.27) increased in states that adopted ME. Utilization of surgery among uninsured/Medicaid patients in ME states increased relative to patients living in non-ME states (∆+10.1%, p = 0.01). Similarly, the use of multimodal treatment increased among uninsured/Medicaid patients living in ME versus non-ME states (∆+6.4%, p = 0.04); in contrast, there were no difference among patients with other insurance statuses (overall: ∆+1.5%, private: ∆-2.0%, other: ∆+3.9%, all p > 0.5). Uninsured/Medicaid patients with BTC who lived in a ME state had a lower risk of long-term death in the post-ME era (HR 0.81, 95% CI 0.67-0.98; p = 0.03). CONCLUSIONS: Implementation of ME positively impacted survival among patients who underwent surgical and multimodal treatment for Stage I-III BTC.

Association of surgeon-patient sex concordance with postoperative outcomes following complex cancer surgery.

BACKGROUND AND OBJECTIVES: Sex concordance may impact the therapeutic relationship and provider-patient interactions. We sought to define the association of surgeon-patient sex concordance on postoperative patient outcomes following complex cancer surgery. METHODS: Patients who underwent surgery for lung, breast, hepato-pancreato-biliary, or colorectal cancer between 2014 and 2020 were identified from the Medicare Standard Analytic Files. The impact of surgeon-patient sex concordance or discordance on achieving an optimal postoperative textbook outcome (TO) was assessed using multivariable logistic regression. RESULTS: Among 495 628 patients, 241 938 (48.8%) patients were sex concordant with their surgeon while 253 690 (51.2%) patients were sex discordant. Sex discordance between surgeon and patient was associated with a decreased likelihood to achieve a postoperative TO (odds ratio [OR]: 0.95, 95% CI: 0.93-0.97; p < 0.001). Sex discordance was associated with a higher risk of complications (OR: 1.05, 95% CI: 1.03-1.07; p < 0.001) and 90-day mortality (OR: 1.05, 95% CI: 1.01-1.09; p = 0.011). Of note, male patients treated by female surgeons (OR: 0.96, 95% CI: 0.93-0.99; p = 0.017) had a similar lower likelihood to achieve a TO as female patients treated by male surgeons (OR: 0.90, 95% CI: 0.86-0.93; p < 0.001). CONCLUSIONS: Sex discordance was associated with a reduced likelihood of achieving an "optimal" postoperative course following complex cancer surgery.

Association between social determinants of health and delayed postoperative adjuvant therapy among patients undergoing resection of pancreatic cancer.

BACKGROUND AND OBJECTIVES: Pancreatic cancer (PDAC) requires a multimodality approach. We sought to define the association between social determinants of health (SDOH) and delayed or nonreceipt of adjuvant chemotherapy (aCT) among patients undergoing PDAC resection. METHODS: Data on patients who underwent PDAC resection between 2014 and 2020 were identified from Medicare Standard Analytic Files and merged with the county-level social vulnerability index (SVI). Mediation analysis defined the association between SVI subthemes and aCT receipt. RESULTS: Among 24 078 patients, 47.7% received timely aCT, 17.7% received delayed aCT, and 34.6% did not receive any aCT. High SVI was associated with delay (odds ratio [OR] 1.22, 95% confidence interval [CI] 1.10-1.34) and nonreceipt of aCT (OR 1.30, 95% CI 1.20-1.41) (both p < 0.05). 73.1% of the variation in timely aCT receipt was directly attributable to SVI, whereas 26.9% of the effect was due to indirect mediators including hospital volume (6.4%), length-of-stay (7.9%) and postoperative complications (12.6%). Socioeconomic status (delayed aCT: OR 1.25, 95% CI 1.13-1.38; nonreceipt aCT: OR 1.25, 95% CI 1.15-1.36) and household composition and disability (delayed aCT: OR 1.30, 95% CI 1.17-1.43; nonreceipt aCT: OR 1.19, 95% CI 1.09-1.29) were associated with receipt of aCT (both p < 0.001). CONCLUSIONS: Most of the disparities in receipt of aCT after PDAC surgery are driven by underlying SDOH such as SVI.

Association of omental pedicled flap with anastomotic leak following low anterior resection for rectal cancer.

BACKGROUND AND OBJECTIVES: Anastomotic leak following colorectal anastomosis adversely impacts short-term, oncologic, and quality-of-life outcomes. This study aimed to assess the impact of omental pedicled flap (OPF) on anastomotic leak among patients undergoing low anastomotic resection (LAR) for rectal cancer using a multi-institutional database. METHODS: Adult rectal cancer patients in the US Rectal Cancer Consortium, who underwent a LAR for stage I-III rectal cancer with or without an OPF were included. Patients with missing data for surgery type and OPF use were excluded from the analysis. The primary outcome was the development of anastomotic leaks. Multivariable logistic regression was used to determine the association. RESULTS: A total of 853 patients met the inclusion criteria and OPF was used in 106 (12.4%) patients. There was no difference in age, sex, or tumor stage of patients who underwent OPF versus those who did not. OPF use was not associated with an anastomotic leak (p = 0.82), or operative blood loss (p = 0.54) but was associated with an increase in the operative duration [ß = 21.42 (95% confidence interval = 1.16, 41.67) p = 0.04]. CONCLUSIONS: Among patients undergoing LAR for rectal cancer, OPF use was associated with an increase in operative duration without any impact on the rate of anastomotic leak.

Short-course radiation with consolidation chemotherapy does not increase operative morbidity compared to long-course chemoradiation: A retrospective study of the US rectal cancer consortium.

BACKGROUND AND OBJECTIVES: Neoadjuvant short-course radiation and consolidation chemotherapy (SC TNT) remains less widely used for rectal cancer in the United States than long-course chemoradiation (LCRT). SC TNT may improve compliance and downstaging; however, a longer radiation-to-surgery interval may worsen pelvic fibrosis and morbidity with total mesorectal excision (TME). A single, US-center retrospective analysis has shown comparable risk of morbidity after neoadjuvant short-course radiation with consolidation chemotherapy (SC TNT) and long-course chemoradiation (LCRT). Validation by a multi-institutional study is needed. METHODS: The US Rectal Cancer Consortium database (2010-2018) was retrospectively reviewed for patients with nonmetastatic, rectal adenocarcinoma treated with neoadjuvant LCRT or SC TNT before TME. The primary endpoint was severe postoperative morbidity. Cohorts were compared by univariate analysis. Multivariable logistic regression modeled the odds of severe complication. RESULTS: Of 788 included patients, 151 (19%) received SC TNT and 637 (81%) LCRT. The SC TNT group had fewer distal tumors (33.8% vs. 50.2%, p < 0.0001) and more clinical node-positive disease (74.2% vs. 47.6%, p < 0.0001). The intraoperative complication rate was similar (SC TNT 5.3% vs. 4.4%, p = 0.65). There was no difference in overall postoperative morbidity (38.4% vs. 46.3%, p = 0.08). Severe morbidity was similar with low anterior resection (9.1% vs. 15.3%, p = 0.10) and abdominoperineal resection (24.4% vs. 29.7%, p = 0.49). SC TNT did not increase the odds of severe morbidity relative to LCRT on multivariable analysis (OR 0.64, 95% CI 0.37-1.10). CONCLUSIONS: SC TNT does not increase morbidity after TME for rectal cancer relative to LCRT. Concern for surgical complications should not discourage the use of SC TNT when aiming to increase the likelihood of complete clinical response.

Prophylactic defunctioning stomas improve clinical outcomes of anastomotic leak following rectal cancer resections: An analysis of the US Rectal Cancer Consortium.

PURPOSE: Anastomotic leak (AL) is a complication of low anterior resection (LAR) that results in substantial morbidity. There is immense interest in evaluating immediate postoperative and long-term oncologic outcomes in patients who undergo diverting loop ileostomies (DLI). The purpose of this study is to understand the relationship between fecal diversion, AL, and oncologic outcomes. METHODS: This is a retrospective multicenter cohort study using patient data obtained from the US Rectal Cancer Consortium database compiled from six academic institutions. The study population included patients with rectal adenocarcinoma undergoing LAR. The primary outcome was the incidence of AL among patients who did or did not receive DLI during LAR. Secondary outcomes included risk factors for AL, receipt of adjuvant therapy, 3-year overall survival, and 3-year recurrence. RESULTS: Of 815 patients, 38 (4.7%) suffered AL after LAR. Patients with AL were more likely to be male, have unintentional preoperative weight loss, and are less likely to undergo DLI. On multivariable analysis, DLI remained protective against AL (p < 0.001). Diverted patients were less likely to undergo future surgical procedures including additional ostomy creation, completion proctectomy, or pelvic washout for AL. Subgroup analysis of 456 patients with locally advanced disease showed that DLI was correlated with increased receipt of adjuvant therapy for patients with and without AL on univariate analysis (SHR:1.59; [95% CI 1.19-2.14]; p = 0.002), but significance was not met in multivariate models. CONCLUSION: Lack of DLI and preoperative weight loss was associated with anastomotic leak. Fecal diversion may improve the timely initiation of adjuvant oncologic therapy. The long-term outcomes following routine diverting stomas warrant further study.

Reporting time toxicity in prospective cancer clinical trials: A scoping review.

PURPOSE: This review aimed to assess the measurement and reporting of time toxicity (i.e., time spent receiving care) within prospective oncologic studies. METHODS: On July 23, 2023, PubMed, Scopus, and Embase were queried for prospective or randomized controlled trials (RCT) from 1984 to 2023 that reported time toxicity as a primary or secondary outcome for oncologic treatments or interventions. Secondary analyses of RCTs were included if they reported time toxicity. The included studies were then evaluated for how they reported and defined time toxicity. RESULTS: The initial query identified 883 records, with 10 studies (3 RCTs, 2 prospective cohort studies, and 5 secondary analyses of RCTs) meeting the final inclusion criteria. Treatment interventions included surgery (n = 5), systemic therapies (n = 4), and specialized palliative care (n = 1). The metric "days alive and out of the hospital" was used by 80% (n = 4) of the surgical studies. Three of the surgical studies did not include time spent receiving ambulatory care within the calculation of time toxicity. "Time spent at home" was assessed by three studies (30%), each using different definitions. The five secondary analyses from RCTs used more comprehensive metrics that included time spent receiving both inpatient and ambulatory care. CONCLUSIONS: Time toxicity is infrequently reported within oncologic clinical trials, with no standardized definition, metric, or methodology. Further research is needed to identify best practices in the measurement and reporting of time toxicity to develop strategies that can be implemented to reduce its burden on patients seeking cancer care.

Impact of Community Privilege on Access to Care Among Patients Following Complex Cancer Surgery.

OBJECTIVE: We sought to define the impact of community privilege on variations in travel patterns and access to care at high-volume hospitals for complex surgical procedures. BACKGROUND: With increased emphasis on centralization of high-risk surgery, social determinants of health play a critical role in preventing equitable access to care. Privilege is a right, benefit, advantage, or opportunity that positively impacts all social determinants of health. METHODS: The California Office of State-wide Health Planning Database identified patients who underwent esophagectomy (ES), pneumonectomy (PN), pancreatectomy (PA), or proctectomy (PR) for a malignant diagnosis between 2012 and 2016 and was merged using ZIP codes with the Index of Concentration of Extremes, a validated metric of both spatial polarization and privilege obtained from the American Community Survey. Clustered multivariable regression was performed to assess the probability of undergoing care at a high-volume center, bypassing the nearest and high-volume center, and total real driving time and travel distance. RESULTS: Among 25,070 patients who underwent a complex oncologic operation (ES: n=1216, 4.9%; PN: n=13,247, 52.8%; PD: n=3559, 14.2%; PR: n=7048, 28.1%), 5019 (20.0%) individuals resided in areas with the highest privilege (i.e., White, high-income homogeneity), whereas 4994 (19.9%) individuals resided in areas of the lowest privilege (i.e., Black, low-income homogeneity). Median travel distance was 33.1 miles (interquartile range 14.4-72.2). Roughly, three-quarters of patients (overall: 74.8%, ES: 35.0%; PN: 74.3%; PD: 75.2%; PR: 82.2%) sought surgical care at a high-volume center. On multivariable regression, patients residing in the least advantaged communities were less likely to undergo surgery at a high-volume hospital (overall: odds ratio 0.65, 95% CI 0.52-0.81). Of note, individuals in the least privileged areas had longer travel distances (28.5 miles, 95% CI 21.2-35.8) to reach the destination facility, as well as over 70% greater odds of bypassing a high-volume hospital to undergo surgical care at a low-volume center (odds ratio 1.74, 95% CI 1.29-2.34) versus individuals living in the highest privileged areas. CONCLUSIONS AND RELEVANCE: Privilege had a marked effect on access to complex oncologic surgical care at high-volume centers. These data highlight the need to focus on privilege as a key social determinant of health that influences patient access to and utilization of health care resources.

Variations in Travel Patterns Affect Regionalization of Complex Cancer Surgery in California.

INTRODUCTION: Regionalization of complex surgical procedures may improve healthcare quality. We sought to define the impact of regionalization on access to high-volume hospitals for complex oncologic procedures in the state of California. METHODS: The California Department of Health Care Access and Information Database (2012-2016) identified patients who underwent esophagectomy (ES), pneumonectomy (PN), pancreatectomy (PA), or proctectomy (PR). Geospatial analysis was conducted to determine travel patterns. Clustered multivariable regression was performed to assess the probability of receiving care at a high-volume center. RESULTS: Among 25,070 patients (ES: n = 1216, 4.9%; PN: n = 13,247, 52.8%; PD: n = 3559, 14.2%; PR: n = 7048, 28.1%), 6575 (26.2%) individuals resided within 30 min, 11,046 (44.1%) resided within 30-60 min, 7125 (28.4%) resided within 60-90 min, and 324 (1.3%) resided beyond a 90-min travel window from a high-volume center. Median travel distance was 13.4 miles (interquartile range [IQR] 6.0-28.7). On multivariable regression, patients residing further away were more likely to bypass a low-volume center to undergo care at a high-volume hospital (odds ratio 1.32, 95% confidence interval 1.12-1.55) versus individuals residing closer to high-volume centers. Approximately one-third (29.7%) of patients lived beyond a 1-h travel window to the nearest high-volume hospital, of whom 5% traveled over 90 min. While hospital mortality rates across different travel time windows did not differ, surgery at a high-volume center was associated with an overall 1.2% decrease in in-hospital mortality. CONCLUSIONS: Regionalization of complex cancer surgery may be associated with a significant travel burden for a large subset of patients with complex cancer.

Impact of Food Insecurity on Outcomes Following Resection of Hepatopancreaticobiliary Cancer.

INTRODUCTION: Food insecurity (FI) may predispose individuals to suboptimal nutrition, leading to chronic disease and poor health outcomes. We sought to assess the impact of county-level FI on postoperative outcomes among patients undergoing resection of hepatopancreaticobiliary (HPB) cancer. METHODS: Patients who were diagnosed with HPB cancer between 2010 and 2015 were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Data on annual county-level FI were obtained from the Feeding America: Mapping the Meal Gap report and were categorized into tertiles. Textbook outcome was defined as no extended length of stay, perioperative complications, 90-day readmission, and 90-day mortality. Multiple logistic regression and Cox regression models were used to assess outcomes and survival relative to FI. RESULTS: Among 49,882 patients (hepatocellular: n = 11,937, 23.9%; intrahepatic cholangiocarcinoma: n = 2111, 4.2%; extrahepatic cholangiocarcinoma: n = 4047, 8.1%; gallbladder: n = 2853, 5.7%; pancreatic: n = 28,934, 58.0%), 6702 (13.4%) patients underwent a surgical resection. Median age was 75 years (interquartile range 69-82), and most patients were male (n = 25,767, 51.7%) and self-identified as White (n = 36,381, 72.9%). Overall, 5291 (10.6%) and 39,664 (79.5%) individuals resided in low or moderate FI counties, respectively, while 4927 (9.8%) patients resided in high FI counties. Achievement of textbook outcome (TO) was 56.3% (n = 6702). After adjusting for competing risk factors, patients residing in high FI counties had lower odds to achieve a TO versus individuals living in low FI counties (odds ratio 0.69, 95% confidence interval [CI] 0.54-0.88, p = 0.003). In addition, patients residing in moderate and high FI counties had a greater risk of mortality at 1- (referent, low, moderate: hazard ratio [HR] 1.09, 95% CI 1.05-1.14; high: HR 1.14, 95% CI 1.08-1.21), 3- (referent, low, moderate: HR 1.09, 95% CI 1.05-1.14; high: HR 1.14, 95% CI 1.08-1.21), and 5- (referent, low, moderate: HR 1.05, 95% CI 1.01-1.09; high: HR 1.07, 95% CI 1.02-1.13) years versus individuals from low FI counties. CONCLUSIONS: FI was associated with adverse perioperative outcomes and long-term survival following resection of an HPB malignancy. Interventions directed towards mitigating nutritional inequities are needed to improve outcomes among vulnerable HPB populations.

Association of Race/Ethnicity, Persistent Poverty, and Opioid Access Among Patients with Gastrointestinal Cancer Near the End of Life.

BACKGROUND: Social determinants of health (SDoH) can impact access to healthcare. We sought to assess the association between persistent poverty (PP), race/ethnicity, and opioid access among patients with gastrointestinal cancer near the end-of-life (EOL). METHODS: SEER-Medicare patients with gastric, liver, pancreatic, biliary, colon, and rectal cancer were identified between 2008 and 2016 near EOL, defined as 30 days before death or hospice enrolment. Data were linked with county-level poverty from the American Community Survey and the US Department of Agriculture (2000-2015). Counties were categorized as never high-poverty (NHP), intermittent high-poverty (IHP) and persistent poverty (PP). Trends in opioid prescription fills and daily dosages (morphine milligram equivalents per day) were examined. RESULTS: Among 48,631 Medicare beneficiaries (liver: n = 6551, 13.5%; pancreas: n = 13,559, 27.9%; gastric: n = 5486, 1.3%; colorectal: n = 23,035, 47.4%), there was a steady decrease in opioid prescriptions near EOL. Black, Asian, Hispanic, and other racial groups had markedly decreased odds of filling an opioid prescription near EOL (Black: OR 0.84, 95% CI 0.79-0.90; Asian: OR 0.86, 95% CI 0.79-0.94; Hispanic: OR 0.90, 95% CI 0.84-0.95; Other: OR 0.83, 95% CI 0.74-0.93; all p < 0.05). Even after filling an opioid prescription, this subset of patients received lower daily doses versus White patients (Black: -16.5 percentage points, 95% CI -21.2 to -11.6; Asian: -11.9 percentage points, 95% CI -18.5 to -4.9; Hispanic: -19.1 percentage points, 95%CI -23.5 to -14.6; all p < 0.05). The disparity in opioid access and average daily doses among was attenuated in IHP/PP areas for Asian, Hispanic, and other racial groups, yet exacerbated among Black patients. CONCLUSIONS: Race/ethnicity-based disparities in EOL pain management persist with SDoH-based variations in EOL opioid use. In particular, PP impacted EOL opioid access and utilization.

Patient Experiences After Aborted Cancer Surgery: A Qualitative Study.

BACKGROUND: Surgical resection is a necessary component of curative-intent treatment for most solid-organ cancers but is occasionally aborted, most often due to occult metastatic disease or unanticipated unresectability. Despite its frequency, little research has been performed on the experiences, care needs, and treatment preferences of patients who experience an aborted cancer surgery. METHODS: Semistructured interviews of patients who had previously experienced an aborted cancer surgery were conducted, focusing on their recalled experiences and stated preferences. All interviews were audio recorded, transcribed, and coded by two independent researchers by using NVivo 12. An integrative approach to qualitative analysis was used-both inductive and deductive methods-and iteratively identifying themes until saturation was reached. RESULTS: Fifteen patients with an aborted cancer surgery participated in the interviews. Cancer types included pancreatic (n = 9), cholangiocarcinoma (n = 3), hepatocellular carcinoma (n = 1), gallbladder (n = 1), and neuroendocrine (n = 1). The most common reasons for aborting surgery included local tumor unresectability (n = 8) and occult metastatic disease (n = 7). Five subthemes that characterized the patient experience following an aborted cancer surgery emerged, including physical symptoms, emotional responses, impact on social and life factors, coping mechanisms, and support received. CONCLUSIONS: This qualitative study characterizes the impact of aborted cancer surgery on multiple domains of quality of life: physical, emotional, social, and existential. These results highlight the importance of developing patient-centered interventions that focus on enhancing quality of life after aborted cancer surgery.