Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial.

BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial.

Importance: Involvement of palliative care specialists in the care of medical oncology patients has been repeatedly observed to improve patient-reported outcomes, but there is no analogous research in surgical oncology populations. Objective: To determine whether surgeon-palliative care team comanagement, compared with surgeon team alone management, improves patient-reported perioperative outcomes among patients pursuing curative-intent surgery for high morbidity and mortality upper gastrointestinal (GI) cancers. Design, Setting, and Participants: From October 20, 2018, to March 31, 2022, a patient-randomized clinical trial was conducted with patients and clinicians nonblinded but the analysis team blinded to allocation. The trial was conducted in 5 geographically diverse academic medical centers in the US. Individuals pursuing curative-intent surgery for an upper GI cancer who had received no previous specialist palliative care were eligible. Surgeons were encouraged to offer participation to all eligible patients. Intervention: Surgeon-palliative care comanagement patients met with palliative care either in person or via telephone before surgery, 1 week after surgery, and 1, 2, and 3 months after surgery. For patients in the surgeon-alone group, surgeons were encouraged to follow National Comprehensive Cancer Network-recommended triggers for palliative care consultation. Main Outcomes and Measures: The primary outcome of the trial was patient-reported health-related quality of life at 3 months following the operation. Secondary outcomes were patient-reported mental and physical distress. Intention-to-treat analysis was performed. Results: In total, 359 patients (175 [48.7%] men; mean [SD] age, 64.6 [10.7] years) were randomized to surgeon-alone (n = 177) or surgeon-palliative care comanagement (n = 182), with most patients (206 [57.4%]) undergoing pancreatic cancer surgery. No adverse events were associated with the intervention, and 11% of patients in the surgeon-alone and 90% in the surgeon-palliative care comanagement groups received palliative care consultation. There was no significant difference between study arms in outcomes at 3 months following the operation in patient-reported health-related quality of life (mean [SD], 138.54 [28.28] vs 136.90 [28.96]; P = .62), mental health (mean [SD], -0.07 [0.87] vs -0.07 [0.84]; P = .98), or overall number of deaths (6 [3.7%] vs 7 [4.1%]; P > .99). Conclusions and Relevance: To date, this is the first multisite randomized clinical trial to evaluate perioperative palliative care and the earliest integration of palliative care into cancer care. Unlike in medical oncology practice, the data from this trial do not suggest palliative care-associated improvements in patient-reported outcomes among patients pursuing curative-intent surgeries for upper GI cancers. Trial Registration: ClinicalTrials.gov Identifier: NCT03611309.

Surgeon and medical student response to patient death.

BACKGROUND: Virtually all surgeons will experience patient death in their practice. Despite this, little is known about how surgeons cope with patient death or its potential adverse impact on surgeons' well-being. Education on how to respond to loss is not often incorporated into current wellness curricula in surgical training. In light of the ongoing COVID-19 pandemic and the significant hospital-related mortality, understanding surgical provider response to patient loss takes on unique import. METHODS: A retrospective analysis was performed following administration of a 10-item survey that assessed healthcare provider (HCP) experience with patient death, activities used to cope with patient loss, and symptoms HCPs experienced. Participants included surgical faculty, residents, surgical advance practice providers and medical students on their surgical clerkship. Demographic characteristics were recorded: age, gender, academic level. Chi-squared test or Fisher exact test compared proportionality between those that did and did not experience patient loss. Logistic regression generated odds ratios examining impact of patient loss on symptoms experienced and activities engaged in after patient loss. RESULTS: Fifty-six (75%) respondents experienced patient death. Common responses were to talk with colleagues (71%) and seek comfort from family/friends/partner (55%). Most respondents did not report symptoms related to patient death (53%); burnout was the most common symptom reported (36%). Respondents were less likely to seek interpersonal support for COVID-19-related death (P<0.008). Only 49% of participants received education on coping with patient death. CONCLUSIONS: Few surgeons receive training related to patient death. Optimal coping strategies are unknown but may mitigate potential negative impacts, including burnout. The data presented here also suggests the need to establish medical education designed to mitigate the distress associated with patient loss.

The RPL/RPS gene signature of melanoma CTCs associates with brain metastasis.

Melanoma brain metastasis (MBM) is linked to poor prognosis and low overall survival. We hypothesized that melanoma circulating tumor cells (CTCs) possess a gene signature significantly expressed and associated with MBM. Employing a multi-pronged approach, we provide first-time evidence identifying a common CTC gene signature for ribosomal protein large/small subunits (RPL/RPS) which associate with MBM onset and progression. Experimental strategies involved capturing, transcriptional profiling and interrogating CTCs, either directly isolated from blood of melanoma patients at distinct stages of MBM progression or from CTC-driven MBM in experimental animals. Second, we developed the first Magnetic Resonance Imaging (MRI) CTC-derived MBM xenograft model (MRI-MBM CDX) to discriminate MBM spatial and temporal growth, recreating MBM clinical presentation and progression. Third, we performed the comprehensive transcriptional profiling of MRI-MBM CDXs, along with longitudinal monitoring of CTCs from CDXs possessing/not possessing MBM. Our findings suggest that enhanced ribosomal protein content/ribogenesis may contribute to MBM onset. Since ribosome modifications drive tumor progression and metastatic development by remodeling CTC translational events, overexpression of the CTC RPL/RPS gene signature could be implicated in MBM development. Collectively, this study provides important insights for relevance of the CTC RPL/RPS gene signature in MBM, and identify potential targets for therapeutic intervention to improve patient care for melanoma patients diagnosed with or at high-risk of developing MBM.

Adherence to surveillance colonoscopy guidelines in patients following curative-intent colorectal cancer resection.

BACKGROUND: Current guidelines recommend that patients who have undergone curative-intent resection for colorectal cancer (CRC) should undergo colonoscopy one year following their surgery or at six months post-operatively if a pre-operative colonoscopy was not performed due to an obstructing lesion. We sought to determine adherence to postoperative surveillance colonoscopy guidelines in our National Cancer Institute designated comprehensive cancer center and potentially identify factors associated with non-adherence. MATERIALS AND METHODS: A retrospective review of 100 patients who underwent curative-intent CRC resection was performed between 2013 and 2019. Patients were divided into two groups based upon adherence to surveillance colonoscopy guidelines. Demographic, tumor, and postoperative variables were analyzed. RESULTS: The median age of all patients was 62. Fifty-seven percent of patients were male. Thirty-eight patients underwent surveillance colonoscopy in accordance with current guidelines. Sixty-two patients did not undergo surveillance colonoscopy postoperatively or did so outside of the National Comprehensive Cancer Network guidelines. Factors associated with non-adherence to surveillance colonoscopy included presence of comorbidities, albumin less than 3.5, and performance of a pre-operative colonoscopy. CONCLUSIONS: Adherence to surveillance colonoscopy guidelines was low among our patients. Efforts should be directed toward patients at increased risk for non-adherence to surveillance colonoscopy guidelines.

Current Guidelines for Integration of Palliative Care in Oncology.

Multiple cancer societies and professional medical organizations recommend integration of palliative care into routine oncology care. A growing body of literature supports the benefits of palliative care in patients with cancer. Palliative care improves pain and other symptoms, enhances quality of life, and reduces depression. The best method and timing for integration of palliative care is unclear. Multiple barriers exist that prevent optimal palliative care integration; these barriers will require additional education and research to overcome.

Artificial Nutrition in Patients with Advanced Malignancy.

Cancer is a progressive disease that can lead to malnutrition and cachexia. Artificial nutrition is a medical therapy used to combat malnutrition in these patients. In this article, the authors discuss factors affecting the decision to use artificial nutrition, including the patient's mental and physical health, technical factors of the procedures used to deliver artificial nutrition, and the oncologic factors affecting treatment. Through this review, the authors provide guidelines on who is and is not likely to benefit from therapy, available routes of administration, and necessary factors to consider for appropriate decision-making for palliative patients and those with advanced cancers."

A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC).

Background: Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers. Objectives and Hypotheses: Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients. Methods: Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization. Setting: Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020. Participants: Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer. Interventions: In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team. Main Outcomes and Measures: Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used. Ethics and Dissemination: This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018).

Introduction: Role of palliative care for the surgical patient.

Palliative care (PC) seeks to improve the quality of life for patients facing serious illness. Several oncology organizations have guidelines about PC, reflecting the need to integrate PC into standard oncology care. Many surgical patients do not receive PC despite the need for these services and established surgical PC competencies. Recent educational and research efforts reveal increased appreciation of the need and benefit of integrating PC services with cancer care in general, and surgical care, specifically.

Prognostication in oncology.

Prognostication involves formulation and communication about the expected course of the disease and is unique in surgical oncology because of the need to incorporate patient, procedural, and cancer-related factors. Several tools and techniques are available to assist physicians in formulating prognosis on the basis of these factors. Use of established communication techniques are effective in discussing prognosis. In situations with prognostic uncertainty, use of the best case/worst case/most likely case or time-limited trial of therapy can be helpful.

Desmoplastic Small Round Blue Cell Tumor: A Review of Treatment and Potential Therapeutic Genomic Alterations.

Desmoplastic small round blue cell tumors (DSRCTs) originate from a cell with multilineage potential. A molecular hallmark of DSRCT is the EWS-WT1 reciprocal translocation. Ewing sarcoma and DSRCT are treated similarly due to similar oncogene activation pathways, and DSRCT has been represented in very limited numbers in sarcoma studies. Despite aggressive therapy, median survival ranges from 17 to 25 months, and 5-year survival rates remain around 15%, with higher survival reported among those undergoing removal of at least 90% of tumor in the absence of extraperitoneal metastasis. Almost 100% of these tumors contain t(11;22) (p13;q12) translocation, and it is likely that EWS-WT1 functions as a transcription factor possibly through WT1 targets. While there is no standard protocol for this aggressive disease, treatment usually includes the neoadjuvant HD P6 regimen (high-dose cyclophosphamide, doxorubicin, and vincristine (HD-CAV) alternating with ifosfamide and etoposide (IE) chemotherapy combined with aggressively attempted R0 resection). We aimed to review the molecular characteristics of DSRCTs to explore therapeutic opportunities for this extremely rare and aggressive cancer type.

Palliative Care for American Indians and Alaska Natives: A Review of the Literature.

BACKGROUND: Little is known about optimal palliative and end-of-life care for American Indians and Alaska Natives (AIs/ANs). METHODS: We searched MEDLINE, the Cochrane library, EBSCOhost, (PsycINFO, CINAHL Complete), and the University of New Mexico (UNM) Health Sciences Library and Informatics Center Native Health Database for search terms related to palliative care and AIs/ANs as of December 1, 2015. We included English language, peer-reviewed articles describing palliative care projects, programs, or studies in AI/AN populations or communities. We excluded case series, opinion or reflection pieces, and dissertations and articles addressing Pacific Islanders. RESULTS: Our search strategy yielded 294 references, of which we included 10 publications. Study methods and outcome measures were heterogeneous, and many studies were small and/or subject to multiple biases. Common themes included the importance of culturally appropriate communication, multiple barriers to treatment, and less frequent use of advance directives than other populations. CONCLUSIONS: Heterogeneity of study types, population, and small sample sizes makes it hard to draw broad conclusions regarding the best way to care for AIs/ANs. More studies are needed to assess this important topic.

Estimation of Risk in Cancer Patients Undergoing Palliative Procedures by the American College of Surgeons Risk Calculator.

BACKGROUND: Surgical palliation is defined as the use of a procedure to relieve symptoms. The American College of Surgeons Risk Calculator (ACSRC) was created based on data from the National Surgical Quality Improvement Program to predict the risk of surgical complications on a patient-specific level. Whether the ACSRC can accurately predict the risk of postoperative complications following palliative procedures in cancer patients is unknown. The purpose of this study was to determine if the ACSRC accurately predicted postoperative complication rates in this setting. STUDY DESIGN: A prospectively maintained, surgical oncology database of patient outcomes from 2011 to 2013 was queried. Data extracted included the following: demographics, comorbidities, site and stage of cancer, type of procedure, and post-operative complication rate and type. Risk assessment was performed for each patient using the ACSRC. Predicted outcomes were compared to actual outcomes for length of stay (LOS), complications, and death. Main outcome measures were differences in actual versus predicted outcomes. RESULTS: Thirty-two patients were included. Occurrence of any complication was significantly lower than predicted (31% vs. 59%, p < 0.05). The predicted LOS, however, was 2.9 days; significantly lower than 5.4 days (p < 0.05). CONCLUSION: The ACSRC is a powerful tool for aid in surgical decision-making; however, in the case of palliative procedures for cancer patients, it overestimated the risk of postoperative complications and underestimated the LOS. Overestimation of post-operative complications could result in fewer patients being offered potentially beneficial palliative procedures.

Utilization of palliative care consultation service by surgical services.

BACKGROUND: Palliative medicine was recognized as a unique medical specialty in 2006. Since that time, the number of hospital-based palliative care services has increased dramatically. It is unclear how palliative care consultation services (PCCS) are utilized by surgical services. The purpose of this study was to examine utilization of PCCS by surgical services compared to medical services at the University of New Mexico. METHODS: A database of palliative care consultations performed at University of New Mexico Hospital between 2009 and 2013 was queried to identify consultations requested by surgical vs. medical services. Demographic, clinical, and outcome variables were compared. RESULTS: A total of 521 consultations were analyzed: 441 (85%) consultations from medical and 80 (15%) consultations from surgical services. Surgical patients were older than medical patients and more likely to be in an intensive care unit (ICU) at the time of consultation. There was no difference between referring services in indication for palliative care consultation or time from hospital admission to consultation. Surgical patients were more likely to die in the hospital compared to medical patients. Among patients discharged from the hospital alive, there was no difference between the groups in discharge disposition. More patients in both groups had a change from full code to do-not-resuscitate (DNR) status following palliative care consultation. CONCLUSIONS: Referrals for palliative care consultations are much less common from surgical than medical services. Characteristics of surgical patients suggest that palliative care consultations are reserved for older patients, critically ill patients, and those more likely to be at end-of-life. Our findings suggest the possible need for increased palliative care consultations among less critically ill patients and/or those with an improved prospect of recovery.

Pediatric melanoma in New Mexico American Indians, Hispanics, and non-Hispanic whites, 1981-2009.

BACKGROUND: Pediatric melanoma rates are increasing nationally. Our purpose was to determine the incidence of melanoma in New Mexico's (NM's) American Indian, Hispanic, and non-Hispanic white children. METHODS: A retrospective review (1981 to 2009) of the NM Tumor Registry was conducted. Melanomas diagnosed in children <19 years of age were identified. Average annual age-adjusted incidence rates per million were calculated. RESULTS: Sixty-four cases were identified. Rates per million were 7.4 for non-Hispanic whites, 2.1 for Hispanics, and 3.3 for American Indians. Fifty-nine percent were women. Fifty-five (86%) cases were localized, 6 (9%) were regional, and 1 (3%) case was metastatic. Majority of cases (49/64; 77%) occurred in children >14 years of age. American Indians presented with thicker melanomas as compared to whites and Hispanics. CONCLUSIONS: Incidence rates for pediatric melanoma in NM are highest for non-Hispanic whites. Distant metastasis is uncommon. Melanoma in children is rare, but practitioners must be aware of its occurrence for prompt diagnosis and treatment.

Challenges in deactivating a total artificial heart for a patient with capacity.

The use of mechanical circulatory support (MCS) devices has increased sixfold since 2006. Although there is an established legal and ethical consensus that patients have the right to withdraw and withhold life-sustaining interventions when burdens exceed benefits, this consensus arose prior to the widespread use of MCS technology and is not uniformly accepted in these cases. There are unique ethical and clinical considerations regarding MCS deactivation. Our center recently encountered the challenge of an awake and functionally improving patient with a total artificial heart (TAH) who requested its deactivation. We present a narrative description of this case with discussion of the following questions: (1) Is it ethically permissible to deactivate this particular device, the TAH? (2) Are there any particular factors in this case that are ethical contraindications to proceeding with deactivation? (3) What are the specific processes necessary to ensure a compassionate and respectful deactivation? (4) What proactive practices could have been implemented to lessen the intensity of this case's challenges? We close with a list of recommendations for managing similar cases.

Treatment options and surveillance strategies after therapy for hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver and the third leading cause of cancer death worldwide. Recurrence rates after curative intent treatment for HCC are high; 5-year disease-free survival ranges from only 19 to 81 %. There is no direct evidence to guide the optimal frequency and method of surveillance for recurrent HCC after curative intent treatment. In contrast, there is strong evidence supporting both primary screening for HCC in patients with chronic liver disease. After resection, HCC tends to recur locally, whereas the pattern after transplantation is more at extrahepatic sites. In theory, if an HCC recurrence is discovered early, more therapeutic options are available for treatment of the recurrent HCC. As such, close surveillance after curative intent therapy may have the potential to prolong survival. We herein review the available literature derived from primary surveillance of patients with cirrhosis, as well as data on postoperative surveillance of HCC patients. In aggregate, although data remain scarce, close surveillance with α-fetoprotein and cross-sectional imaging every 3-4 months for 3 years after curative intent therapy, followed by surveillance every 6-12 months thereafter, seems the most prudent approach to follow-up of patients with HCC in the postsurgical setting.