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PURPOSE: Preoperative therapy for pancreatic cancer represents a new treatment option with the potential to improve outcomes for patients, yet with complex risks. By not discussing the potential risks and benefits of new treatment options, clinicians may hinder patients from making informed decisions. METHODS: From 2017 to 2019, we conducted a mixed-methods study. First, we elicited clinicians' (n = 13 medical, radiation, and surgery clinicians), patients' (n = 18), and caregivers' (n = 14) perceptions of information needed for decision making regarding preoperative therapy and generated a list of key elements. Next, we audio-recorded patients' (n = 20) initial multidisciplinary oncology visits and used qualitative content analyses to describe how clinicians discussed this information and surveyed patients to ask if they heard each key element. RESULTS: We identified 13 key elements of information patients need when making decisions regarding preoperative therapy, including treatment complications, alternatives, logistics, and potential outcomes. Patients reported hearing infrequently about complications (eg, hospitalizations [n = 3 of 20]) and alternatives (n = 8 of 20) but frequently recalled logistics and potential outcomes (eg, likelihood of surgery [n = 19 of 20]). Clinicians infrequently discussed complications (eg, hospitalizations [n = 7 of 20]), but frequently discussed alternatives, logistics, and potential outcomes (eg, likelihood of surgery [n = 20 of 20]). No overarching differences in clinician discussion content emerged to explain why patients did or did not hear about each key element. CONCLUSION: We identified key elements of information patients with pancreatic cancer need when considering preoperative therapy. Patients infrequently heard about treatment complications and alternatives, while frequently hearing about logistics and potential outcomes, underscoring areas for improvement in educating patients about new treatment options in oncology.

PURPOSE: The financial toxicity of anticancer drugs is well-documented, but little is known about the costs of drugs used to manage cancer-associated symptoms. METHODS: We reviewed relevant guidelines and compiled drugs used to manage seven cancer-associated symptoms (anorexia and cachexia, chemotherapy-induced peripheral neuropathy, constipation, diarrhea, exocrine pancreatic insufficiency, cancer-associated fatigue, and chemotherapy-induced nausea and vomiting). Using GoodRx website, we identified the retail price (cash price at retail pharmacies) and lowest price (discounted, best-case scenario of out-of-pocket costs) for patients without insurance for each drug or formulation for a typical fill. We describe lowest prices here. RESULTS: For anorexia and cachexia, costs ranged from $5 US dollars (USD; generic olanzapine or mirtazapine tablets) to $1,156 USD (brand-name dronabinol solution) and varied widely by formulation of the same drug or dosage: for olanzapine 5 mg, $5 USD (generic tablet) to $239 USD (brand-name orally disintegrating tablet). For chemotherapy-induced peripheral neuropathy, costs of duloxetine varied from $12 USD (generic) to $529 USD (brand-name). For constipation, the cost of sennosides or polyethylene glycol was CONCLUSION: We highlight the high costs of many symptom control drugs and the wide variation in the costs of these drugs. These findings can guide patient-clinician discussions about cost-effectively managing symptoms, while promoting the use of less expensive formulations when possible.

PURPOSE: Colorectal cancer (CRC) incidence in patients younger than 50 years of age, commonly defined as early-onset (EO-CRC), is rising. EO-CRC often presents with distinct clinicopathologic features. However, data on prognosis are conflicting and outcomes with modern treatment approaches for metastatic disease are still limited. MATERIALS AND METHODS: We prospectively enrolled patients with metastatic CRC (mCRC) to a biobanking and clinical data collection protocol from 2014 to 2018. We grouped the cohort based on age at initial diagnosis: < 40 years, 40-49 years, and ≥ 50 years. We used regression models to examine associations among age at initial diagnosis, treatments, clinicopathologic features, and survival. RESULTS: We identified 466 patients with mCRC (45 [10%] age < 40 years, 109 [23%] age 40-49 years, and 312 [67%] age ≥ 50 years). Patients < 40 years of age were more likely to have received multiple metastatic resections (odds ratio [OR], 3.533; P = .0066) than their older counterparts. Patients with EO-CRC were more likely to receive triplet therapy than patients > 50 years of age (age < 40 years: OR, 6.738; P = .0002; age 40-49 years: OR, 2.949; P = .0166). Patients 40-49 years of age were more likely to have received anti-EGFR therapy (OR, 2.633; P = .0016). Despite differences in care patterns, age did not predict overall survival. CONCLUSION: Despite patients with EO-CRC receiving more intensive treatments, survival was similar to the older counterpart. However, EO-CRC had clinical and molecular features associated with worse prognoses. Improved biologic understanding is needed to optimize clinical management of EO-CRC. The cost-benefit ratio of exposing patients with EO-CRC to more intensive treatments has to be carefully evaluated.

Overcoming intrinsic resistance to immune checkpoint blockade for microsatellite stable (MSS) colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) remains challenging. We conducted a single-arm, non-randomized, phase II trial (NCT03104439) combining radiation, ipilimumab and nivolumab to treat patients with metastatic MSS CRC (n = 40) and PDAC (n = 25) with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. The primary endpoint was disease control rate (DCR) by intention to treat. DCRs were 25% for CRC (ten of 40; 95% confidence interval (CI), 13–41%) and 20% for PDAC (five of 25; 95% CI, 7–41%). In the per-protocol analysis, defined as receipt of radiation, DCR was 37% (ten of 27; 95% CI, 19–58%) in CRC and 29% (five of 17; 95% CI, 10–56%) in PDAC. Pretreatment biopsies revealed low tumor mutational burden for all samples but higher numbers of natural killer (NK) cells and expression of the HERVK repeat RNA in patients with disease control. This study provides proof of concept of combining radiation with immune checkpoint blockade in immunotherapy-resistant cancers. Ting and colleagues report the safety and efficacy of combined radiation and immunotherapy in a phase II trial on patients with MSS colorectal or pancreatic cancer and observe that disease control correlates with higher repetitive RNA transcription.

Background Skeletal muscle metrics on computed tomography (CT) correlate with clinical and patient‐reported outcomes. We hypothesize that aggregating skeletal muscle measurements from multiple vertebral levels and skeletal muscle gauge (SMG) better predict outcomes than skeletal muscle radioattenuation (SMRA) or ‐index (SMI) at a single vertebral level. Methods We performed a secondary analysis of prospectively collected clinical (overall survival, hospital readmission, time to unplanned hospital readmission or death, and readmission or death within 90 days) and patient‐reported outcomes (physical and psychological symptom burden captured as Edmonton Symptom Assessment Scale and Patient Health Questionnaire) of patients with advanced cancer who experienced an unplanned admission to Massachusetts General Hospital from 2014 to 2016. First, we assessed the correlation of skeletal muscle cross‐sectional area, SMRA, SMI, and SMG at one or more of the following thoracic (T) or lumbar (L) vertebral levels: T5, T8, T10, and L3 on CT scans obtained ≤50 days before index assessment. Second, we aggregated measurements across all available vertebral levels using percentile‐based averaging (PBA) to create the average percentile. Third, we constructed one regression model adjusted for age, sex, sociodemographic factors, cancer type, body mass index, and intravenous contrast for each combination of (i) vertebral level and average percentile, (ii) muscle metrics (SMRA, SMI, & SMG), and (iii) clinical and patient‐reported outcomes. Fourth, we compared the performance of vertebral levels and muscle metrics by ranking otherwise identical models by concordance statistic, number of included patients, coefficient of determination, and significance of muscle metric. Results We included 846 patients (mean age: 63.5 ± 12.9 years, 50.5% males) with advanced cancer [predominantly gastrointestinal (32.9%) or lung (18.9%)]. The correlation of muscle measurements between vertebral levels ranged from 0.71 to 0.84 for SMRA and 0.67 to 0.81 for SMI. The correlation of individual levels with the average percentile was 0.90–0.93 for SMRA and 0.86–0.92 for SMI. The intrapatient correlation of SMRA with SMI was 0.21–0.40. PBA allowed for inclusion of 8–47% more patients than any single‐level analysis. PBA outperformed single‐level analyses across all comparisons with average ranks 2.6, 2.9, and 1.6 for concordance statistic, coefficient of determination, and significance (range 1–5, μ = 3), respectively. On average, SMG outperformed SMRA and SMI across outcomes and vertebral levels: the average rank of SMG was 1.4, 1.4, and 1.4 for concordance statistic, coefficient of determination, and significance (range 1–3, μ = 2), respectively. Conclusions Multivertebral level skeletal muscle analyses using PBA and SMG independently and additively outperform analyses using individual levels and SMRA or SMI.

Background The Pancreatic Cancer Action Network (PanCAN) Patient Registry is an online, pancreatic cancer‐specific, global registry enabling patients to self‐report sociodemographics, disease/management characteristics, and patient‐reported outcomes (PROs). We sought to describe the creation, user experience, and research potential of the PanCAN Registry. Methods We obtained data to describe (1) the creation of the Registry (questionnaire development, marketing efforts, and regulatory considerations); (2) the user experience (user characteristics and interactions with the registry following inception); and (3) the research potential of the registry (comparing PROs and treatment patterns by age [±65 years] and treatment site [community or academic] for users with de novo metastatic disease). Results The Registry was conceived as part of PanCAN’s strategic plan for a personalized therapy initiative. PanCAN staff and disease expert consultants developed questionnaires hosted on an electronic PRO platform. Users had the option to include their data in research efforts, and the Registry platform received institutional review board approval. From 7/2015 to 12/2020, 2187 patients visited the registry and 1697 (77.6%) completed at least one survey (median age = 64 years [range: 24–90], 47.9% women, 88.7% White, 34.0% metastatic disease). Among patients with metastatic disease (N = 567), 46.0% were ≥65 years old and 67.5% received treatment at community sites. Patients ≥65 years reported feeling less hopeful about the treatment plan (12.4% vs. 24.3%, p = 0.003), and patients treated at community sites reported more frequent treatment breaks of >2 weeks (58.2% vs. 28.1%, p, The Pancreatic Cancer Action Network (PanCAN) Patient Registry is a voluntary, global, pancreatic cancer‐specific registry enabling patients to self‐report sociodemographics, disease/ management characteristics, and patient‐reported outcomes. In this manuscript, based on over 2000 patients visiting the PanCAN Registry over a 5‐year period, we describe its creation, user experience, and research potential, which can guide future registry building efforts (including standardized patient‐reported outcomes collection).

Background Although balancing treatment efficacy with risks of complications is critical for older adults with aggressive non-Hodgkin lymphoma (NHL), few studies have described these patients’ clinical outcomes, rates of toxicities, and health care utilization. Methods We conducted a retrospective analysis of adults ≥65 years diagnosed with aggressive NHL and receiving systemic therapy at Massachusetts General Hospital from April 2000 to July 2020. We abstracted patient characteristics, clinical outcomes, treatment toxicity, unplanned hospitalizations, and intensive care unit (ICU) admissions within 6 months of treatment initiation from the medical record. Using multivariable logistic regression, we examined factors associated with rates of grade 3+ nonhematologic toxicity and unplanned hospitalization. Results Among 295 patients (median age, 73 years; 39.0% female), 5-year overall survival (OS) was 74.2%. Five-year OS by age group (65–69, 70–74, 75–79, and 80+ years) was 82.2%, 72.0%, 73.6%, and 66.4%, respectively. Overall, 42.4% experienced grade 3+ toxicity, with 8.1% experiencing grades 4–5. The rates of unplanned hospitalization and ICU admission were 41.0% and 6.1%, respectively. In multivariable analysis, hypoalbuminemia (odds ratio [OR], 4.29; p Conclusions The majority of older adults receiving upfront therapy for aggressive NHL survive beyond 5 years, yet nearly half experience substantial treatment toxicities and unplanned hospitalizations. Our findings underscore the need for supportive care interventions to enhance the care experience of this population. Implications for Practice The results of this study highlight the potential benefits of intensive chemoimmunotherapy for the majority of older adults with aggressive non-Hodgkin lymphoma, even at advanced ages. Nearly half of older adults experienced substantial treatment toxicities and unplanned hospitalizations, emphasizing the unmet need for supportive care interventions in this population. The present study also identified hypoalbuminemia and patient comorbidity score as factors associated with grade 3+ nonhematologic toxicity and unplanned hospitalization. These findings may guide the development and implementation of targeted supportive care interventions in high-risk older adults with aggressive non-Hodgkin lymphoma.

Background Phase 1 trials are increasingly important in the molecularly driven era of oncology, but few studies have examined phase 1 participation disparities. The authors of this study investigated factors associated with phase 1 versus phase 2/3 trial enrollment. Methods They authors conducted a cross-sectional study using serial samples of patients age ≥18 years enrolling on cancer trials from October 2011 to November 2014 at an academic cancer center. They used univariable and multivariable logistic regression models to analyze sociodemographic and clinical associations with phase 1 versus phase 2/3 trial enrollment. Results Among 3103 patients enrolled in cancer trials, 2657 unique patients participated in phase 1/2/3 trials. For patients enrolled in phase 1 (n = 1401) versus phase 2/3 (n = 1256) trials, we found no significant differences by age, insurance status, marital status, and income. Overall, 1216 (93%) White, 72 (6%) Asian, and 21 (2%) Black patients enrolled on phase 1 trials, whereas 1068 (93%) White, 40 (3%) Asian, and 43 (4%) Black patients enrolled on phase 2/3 trials. Adjusting for age, sex, race, ethnicity, insurance status, marital status, income, cancer type, disease status, travel distance, and trial year, compared with White patients, Black patients had lower phase 1 enrollment (odds ratio [OR], 0.46; 95% confidence interval [CI], 0.25-0.82), as did Hispanic/Latino (OR, 0.25; 95% CI, 0.08-0.79) and male patients (OR, 0.77; 95% CI, 0.62-0.94). Asian patients had higher phase 1 enrollment (OR, 1.38; 95% CI, 0.88-2.16). Conclusions Disparities in phase 1 versus phase 2/3 cancer clinical trial enrollment underscore the urgent need for interventions addressing inequities in early-phase trial participation. Lay summary Phase 1 trials are of increasing importance in oncology. The authors of the study analyzed all patients enrolling on cancer clinical trials at a large academic cancer center from October 2011 to November 2014. Among the 2657 trial participants, when age, sex, race, ethnicity, insurance status, marital status, income, cancer type, disease status, travel distance, and trial year were taken into account, Black, Hispanic/Latino, and male patients were less likely to enroll on phase 1 trials versus phase 2/3 trials. These findings suggest a need for targeted interventions to improve access to and education about phase 1 trials for Black and Hispanic/Latino patients.

Background Medical financial burden includes material, behavioral, and psychological hardship and has been underinvestigated among adult survivors of childhood cancer. Methods A survey from 698 survivors and 210 siblings from the Childhood Cancer Survivor Study was analyzed. The intensity of financial hardship was estimated across 3 domains: 1) material, including conditions that arise from medical expenses; 2) behavioral, including coping behaviors to manage medical expenses; and 3) psychological hardship resulting from worries about medical expenses and insurance, as measured by the number of instances of each type of financial hardship (0, 1-2, and ≥3 instances). Multivariable logistic regressions were conducted to examine the clinical and sociodemographic predictors of experiencing financial hardship (0-2 vs ≥3 instances). Results The intensity of financial hardship did not significantly differ between survivors and siblings. Survivors reported more instances of material hardship than siblings (1-2 instances: 27.2% of survivors vs 22.6% of siblings; ≥3 instances: 15.9% of survivors vs 11.4% siblings; overall P = .03). In multivariable regressions, insurance was protective against all domains of financial hardship (behavioral odds ratio [OR], 0.12; 95% confidence interval [CI], 0.06-0.22; material OR, 0.37; 95% CI, 0.19-0.71; psychological OR, 0.10; 95% CI, 0.05-0.21). Survivors who were older at diagnosis, female, and with chronic health conditions generally had higher levels of hardship. Brain radiation and alkylating agents were associated with higher levels of hardship. Conclusions Material, behavioral, and psychological financial burden among survivors of childhood cancer is common.

Purpose: Detection of persistent circulating tumor DNA (ctDNA) after curative-intent surgery can identify patients with minimal residual disease (MRD) who will ultimately recur. Most ctDNA MRD assays require tumor sequencing to identify tumor-derived mutations to facilitate ctDNA detection, requiring tumor and blood. We evaluated a plasma-only ctDNA assay integrating genomic and epigenomic cancer signatures to enable tumor-uninformed MRD detection. Experimental Design: A total of 252 prospective serial plasma specimens from 103 patients with colorectal cancer undergoing curative-intent surgery were analyzed and correlated with recurrence. Results: Of 103 patients, 84 [stage I (9.5%), II (23.8%), III (47.6%), IV (19%)] had evaluable plasma drawn after completion of definitive therapy, defined as surgery only (n = 39) or completion of adjuvant therapy (n = 45). In “landmark” plasma drawn 1-month (median, 31.5 days) after definitive therapy and >1 year follow-up, 15 patients had detectable ctDNA, and all 15 recurred [positive predictive value (PPV), 100%; HR, 11.28 (P < 0.0001)]. Of 49 patients without detectable ctDNA at the landmark timepoint, 12 (24.5%) recurred. Landmark recurrence sensitivity and specificity were 55.6% and 100%. Incorporating serial longitudinal and surveillance (drawn within 4 months of recurrence) samples, sensitivity improved to 69% and 91%. Integrating epigenomic signatures increased sensitivity by 25%–36% versus genomic alterations alone. Notably, standard serum carcinoembryonic antigen levels did not predict recurrence [HR, 1.84 (P = 0.18); PPV = 53.9%]. Conclusions: Plasma-only MRD detection demonstrated favorable sensitivity and specificity for recurrence, comparable with tumor-informed approaches. Integrating analysis of epigenomic and genomic alterations enhanced sensitivity. These findings support the potential clinical utility of plasma-only ctDNA MRD detection. See related commentary by Bent and Kopetz, p. 5449

Background: Low muscle mass (quantity) is common in patients with advanced cancer, but little is known about muscle radiodensity (quality). We sought to describe the associations of muscle mass and radiodensity with symptom burden, healthcare use, and survival in hospitalized patients with advanced cancer. Methods: We prospectively enrolled hospitalized patients with advanced cancer from September 2014 through May 2016. Upon admission, patients reported their physical (Edmonton Symptom Assessment System [ESAS]) and psychological (Patient Health Questionnaire-4 [PHQ-4]) symptoms. We used CT scans performed per routine care within 45 days before enrollment to evaluate muscle mass and radiodensity. We used regression models to examine associations of muscle mass and radiodensity with patients’ symptom burden, healthcare use (hospital length of stay and readmissions), and survival. Results: Of 1,121 patients enrolled, 677 had evaluable muscle data on CT (mean age, 62.86 ± 12.95 years; 51.1% female). Older age and female sex were associated with lower muscle mass (age: B, –0.16; PPPP=.014), and higher BMI was associated with higher muscle mass (B, 0.58; PPPP=.016), ESAS-Total (B, –0.29; P=.002), PHQ-4-Depression (B, –0.03; P=.006), and PHQ-4-Anxiety (B, –0.03; P=.008) symptoms, as well as decreased hospital length of stay (B, –0.07; P=.005), risk of readmission or death in 90 days (odds ratio, 0.97; PPConclusions: Although muscle mass (quantity) only correlated with survival, we found that muscle radiodensity (quality) was associated with patients’ symptoms, healthcare use, and survival. These findings underscore the added importance of assessing muscle quality when seeking to address adverse muscle changes in oncology.

Introduction Oncologists have increasingly been proponents of shared decision making (SDM) to enhance patient outcomes and reduce unnecessary health care spending. However, its effect on patient out-of-pocket costs is unknown. This study investigated the relationship between patient preferences for SDM and financial toxicity (FT) in patients with metastatic breast cancer (MBC). Patients and Methods This cross-sectional study utilized surveys of women aged ≥ 18 with MBC who received care at two academic hospitals in Alabama from 2017 to 2019. Patients self-reported their SDM preference (Control Preferences Scale) and FT (Comprehensive Score for Financial Toxicity [COST] tool; 11-item scale, with lower scores indicating worse FT). Effect sizes were calculated using the proportion of variance explained (R2) or Cramer’s V. Differences in FT by SDM preference were estimated using mixed models clustered by site and treating medical oncologist. Results In 95 women with MBC, 44% preferred SDM, 29% preferred provider-driven decision making, and 27% preferred patient-driven decision making. Patients preferring SDM were more often college educated (53% vs. 39%; V = 0.12) with an income greater than $40,000/y (55% vs. 43%; V = 0.18). Overall median COST was 22 (interquartile range, 16-29). After adjusting for patient demographic and clinical characteristics, patients preferring patient-driven decision making trended toward worse FT (COST 17: 95% confidence interval, 12-22) compared to those preferring SDM (COST 19: 95% confidence interval, 15-23) and those preferring provider-driven decision making (COST 22: 95% confidence interval, 17-27). Conclusion Patients preferring more patient-driven decision making reported worse FT, although differences did not reach statistical significance. Further research is needed to understand this relationship.

BACKGROUND: Healthcare policies have focused on centralizing care to high-volume centers in an effort to optimize patient outcomes. However, little is known about patients’ and caregivers’ considerations and selection process when selecting hospitals for care. We aim to explore how patients and caregivers select hospitals for complex cancer care and to develop a taxonomy for their selection considerations. METHODS: Qualitative study in which data were gathered from in-depth interviews conducted from March to November 2019 among patients with hepatopancreatobiliary cancers who were scheduled to undergo a pancreatectomy (n=20) at a metropolitan, urban regional or suburban medical center and their caregivers (n=10). RESULTS: The interviews revealed 6 broad domains that characterized hospital selection considerations: hospital factors, team characteristics, travel distance to hospital, referral or recommendation, continuity of care, and insurance considerations. The identified domains were similar between participants seen at the metropolitan center and urban/suburban medical centers with the following exceptions: participants receiving care specifically at the metropolitan center noted operative volume and access to specific services like clinical trials in their hospital selection; participants receiving care at urban/suburban centers noted health insurance considerations and having access to existing medical records in their hospital selection. CONCLUSIONS: This study delineates the many considerations of patients and caregivers when selecting hospitals for complex cancer care. These identified domains should be incorporated into the development and implementation of centralization policies to help increase patient access to high quality cancer care that is consistent with their priorities and needs.

Background In patients with pancreas adenocarcinoma (PDAC), performing endoscopic ultrasound (EUS)-guided fiducial placement at the time of initial EUS-guided biopsies may obviate a second procedure, streamline care, and improve resource utilization. However, the safety of this combined approach is understudied. Methods We retrospectively identified and reviewed cases at a single institution in which patients with PDAC underwent EUS-guided biopsy and same session fiducial placement. Patient and procedural characteristics were abstracted. Intraprocedural and postprocedural adverse events were classified according to the American Society for Gastrointestinal Endoscopy Lexicon for Adverse Events. The percentage of "definite" and "probable" adverse events occurring within 14 days of the procedure was calculated. Results Thirty-three patients were included in this series (median age 64, 42% male). The median numbers of biopsies performed and fiducials placed were 3 (range 2-7) and 4 (range 1-4), respectively, per patient. A 22-gauge needle was used for the majority of biopsies (81.8%) and all fiducial placements (100%). No definite and one probable adverse event of mild postprocedural pain was noted (3.0%, 1/33). There were no episodes of significant bleeding, pancreatitis or infection. Fiducials were successfully used in the administration of radiation to all patients. Conclusion We report a low risk of adverse events in the setting of combined EUS-guided biopsy and fiducial placement. In the appropriate setting, this approach may streamline care for patients with PDAC while avoiding time, cost, and risks associated with an additional procedure or impacting radiation therapy. Larger, controlled studies are needed to validate the safety and efficacy of this combined approach.

Purpose Chemotherapy-induced nausea and vomiting (CINV) contributes to avoidable acute care, a metric now tracked in Medicare's oncology outcome measure. CINV is preventable, yet guidelines are often not followed. We sought to quantify acute care involving CINV and other avoidable toxicities after highly emetogenic chemotherapy (HEC) to identify excess risk and assess clinician adherence to antiemesis guidelines for HEC. Materials and Methods We retrospectively evaluated U.S. electronic health records (2012-2018) using Medicare's OP-35 outcome measure to identify avoidable acute care involving any of 10 toxicities, including CINV, after HEC regimens relative to non-HEC. Antiemetic guideline adherence was defined as use ofneurokinin-1 (NKl) receptor antagonists Q5 (RAs) plus 5-hydroxytryptamine type 3 RA+ dexamethasone at HEC initiation. Results Among 17,609 patients receiving HEC, acute care rates associated with HEC chemotherapy included 32% cisplatin, 31% carboplatin, and 21% anthracycline/cyclosphospharnide (AC), with 76% meeting the criteria as avoidable events. Oxaliplatin rates were 29%. Avoidable acute care occurred 1.83 times (95% confidence interval, 1.76-1.91, p < .0001) as often after HEC versus non-HEC excluding oxaliplatin; CINV-related acute care occurred 2.29 times as often. Nonadherence to antiemesis guidelines occurred in 34% and 24% of cisplatin and AC courses, respectively, because of omission of a NKl RA. Conclusions Patients treated with HEC regimens experienced high avoidable acute care use, 1.8 times the risk seen for other chemotherapy. Nonadherence to guideline-directed antiemetic prophylaxis highlights the need to ensure adherence to antiemetic guidelines, including the use of NKl RA in HEC. Implications for Practice After survival, perhaps the most important goal in oncology is limiting avoidable acute care, a goal now used by Medicare to impact cancer reimbursement. This study found that patients treated with highly emetogenic chemotherapy (HEC) regimens had high rates of avoidable acute care use, 1.8 times the risk seen for other chemotherapy. A substantial proportion of the avoidable acute care involved chemotherapy-induced nausea and vomiting. Results showed that incomplete adherence to national antiemetic guidelines for HEC regimens primarily driven by omission of upfront neurokinin-1 receptor antagonist use, suggesting that improved adherence can meaningfully resolve this gap in quality and cost of care.

BACKGROUND Patient-reported outcomes (PROs) assessing quality of life (QOL) and symptom burden correlate with clinical outcomes in patients with cancer. However, to the authors' knowledge, data regarding associations between PROs and treatment response are lacking. METHODS The authors prospectively approached consecutive patients with advanced gastrointestinal cancer who were initiating a new treatment. Prior to treatment, patients reported their QOL (Functional Assessment of Cancer Therapy-General [FACT-G], 4 subscales: Functional, Physical, Emotional, Social; higher scores indicate better QOL) and symptom burden (Edmonton Symptom Assessment System [ESAS], Patient Health Questionnaire-4 [PHQ-4]; higher scores represent greater symptoms). Regression models were used to examine associations of baseline PROs with treatment response (clinical benefit or progressive disease [PD] at time of first scan), healthcare utilization, and survival. RESULTS From May 2019 to April 2020, a total of 112 patients with advanced gastrointestinal cancer were enrolled. For treatment response, 64.3% had CB and 35.7% had PD. Higher baseline ESAS-Physical (odds ratio, 1.04; P = .027) and lower FACT-G Functional (odds ratio, 0.92; P = .038) scores were associated with PD. Higher ESAS-Physical (hazard ratio [HR], 1.03; P = .044) and lower FACT-G Total (HR, 0.96; P = .005), FACT-G Physical (HR, 0.89; P < .001), and FACT-G Functional (HR, 0.87; P < .001) scores were associated with a greater hospitalization risk. Lower FACT-G Total (HR, 0.96; P = .009) and FACT-G Emotional (HR, 0.86; P = .012) scores as well as higher ESAS-Total (HR, 1.03; P = .014) and ESAS-Physical (HR, 1.04; P = .032) scores were associated with worse survival. CONCLUSIONS Baseline PROs are associated with treatment response in patients with advanced gastrointestinal cancer, namely physical symptoms and functional QOL, in addition to health care use and survival. The findings of the current study support the association between PROs and important clinical outcomes, including the novel finding of treatment response.

Selecting study endpoints in prospective cancer cachexia trials remains poorly defined. The aim of this study was to further evaluate associations in changes in weight, body composition, functional outcomes, and patient-reported outcomes (PROs) in patients with metastatic cancer. We completed a 2-year (2016–2018) observational study in patients with metastatic solid cancer and ECOG performance status 0 to 2 while receiving chemotherapy and/or immunotherapy. We completed assessments at study enrollment and 3 months from enrollment. We analyzed longitudinal changes in weight and body composition using validated methods. Functional assessments included the 6-Min Walk Test, Timed Up and Go Test, and Short Physical Performance Battery. PROs included the Functional Assessment of Anorexia/Cachexia Therapy and Functional Assessment of Cancer Therapy Fatigue. We analyzed changes in body composition and functional assessment using paired t tests. Additionally, we utilized linear regression models to assess relationships between changes in body composition and function outcomes and PROs, adjusting for age and sex. A total of 57 patients completed baseline assessments, but 19 patients did not complete 3-month assessments (5 died, 1 hospice, 13 withdrew). Of the 38 patients with complete data, the mean age was 61.8 years and 47% were female. Metastatic cancer types included 71% gastrointestinal, 13% lung, and 8% gynecologic. Half received chemotherapy, 16% immunotherapy, and 34% a combination. From enrollment to 3 months, we did not observe a change in weight or skeletal muscle but did find an increase in total adipose tissue (16.9 ± 52.4 cm2, 95% CI − 33.79–0.63; p = 0.059; ~ 1.5 pounds). We did not observe any association with changes in weight with any functional outcomes or PROs. However, greater losses in skeletal muscle were associated with greater declines in physical function (6-Min Walk Test [B = 0.04, p = 0.01], Short Physical Performance Battery [B = 2.44, p

Background Burdens related to time spent receiving cancer care may be substantial for patients with incurable, life‐limiting cancers such as metastatic breast cancer (MBC). Estimates of time spent on health care are needed to inform treatment‐related decision‐making. Methods Estimates of time spent receiving cancer‐related health care in the initial 3 months of treatment for patients with MBC were calculated using the following data sources: (a) direct observations from a time‐in‐motion quality improvement evaluation (process mapping); (b) cross‐sectional patient surveys; and (c) administrative claims. Average ambulatory, inpatient, and total health care time were calculated for specific treatments which differed by antineoplastic type and administration method, including fulvestrant (injection, hormonal), letrozole (oral, hormonal), capecitabine (oral, chemotherapy), and paclitaxel (infusion, chemotherapy). Results Average total time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on treatment. The greatest time contributions were time spent traveling for care and on inpatient services. Time with providers contributed modestly to total care time. Patients receiving infusion/injection treatments, compared with those receiving oral therapy, spent more time in ambulatory care. Health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents. Conclusion Time spent traveling and receiving inpatient care represented a substantial burden to patients with MBC, with variation in time by treatment type and administration method., In patients with metastatic breast cancer, time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on type of treatment received and its administration method. The greatest time contributions were time spent traveling for care and on inpatient services, and health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents.

Background Patient-reported medical status and treatment goal are measures of prognostic understanding with demonstrated relationships to important clinical and patient-reported outcomes in the general cancer population. Among older adults, relationships between these measures and other patient-reported (quality of life [QOL], symptoms, functional impairment) and clinical (hospitalization risk, survival) outcomes remains unclear. Methods We enrolled patients ≥70 with advanced gastrointestinal cancers, collecting patient-reported medical status (terminally ill vs not), treatment goal (curative vs non-curative), QOL (EORTC-Elderly Cancer Patients), symptoms (Edmonton Symptom Assessment System [ESAS]), and functional impairment (activities of daily living [ADLs]). We also obtained information about hospitalizations and survival. To explore relationships between patient-reported medical status, treatment goal, QOL, symptoms, functional impairment, hospitalizations, and survival, we used regression models adjusted for age, sex, and education. Results Of 103 patients, 49.5% reported terminally ill status and 64.0% a non-curative treatment goal. Terminally ill status was associated with worse QOL (EORTC illness burden: 53.59 vs 35.26, p = 0.001), higher symptom burden (ESAS: 28.15 vs 16.79, p = 0.002), more functional impairment (ADLs: 3.63 vs 5.24, p = 0.006), greater hospitalization risk (HR = 2.41, p = 0.020), and worse survival (HR = 1.93, p = 0.010). We did not find associations between patient-reported treatment goal and these outcomes. Conclusions In older adults with advanced cancer, report of terminally ill status was associated with other important patient-reported and clinical outcomes, suggesting disease severity may inform illness perceptions. We did not find similar associations for patient-reported treatment goal, indicating that questions related to medical status and treatment goal measure different constructs and more nuanced measures are needed.

Background: Studies have shown gaps in prognostic understanding among patients with cancer. However, few studies have explored patients’ perceptions of their treatment goals versus how they perceive their oncologist’s goals, and the association of these views with their psychological distress. Methods: We conducted a cross-sectional study of 559 patients with incurable lung, gastrointestinal, breast, and brain cancers. The Prognosis and Treatment Perception Questionnaire was used to assess patients’ reports of their treatment goal and their oncologist’s treatment goal, and the Hospital Anxiety and Depression Scale was used to assess patients’ psychological symptoms. Results: We found that 61.7% of patients reported that both their treatment goal and their oncologist’s treatment goal were noncurative, whereas 19.3% reported that both their goal and their oncologist’s goal were to cure their cancer, 13.9% reported that their goal was to cure their cancer whereas their oncologist’s goal was noncurative, and 5% reported that their goal was noncurative whereas their oncologist’s goal was curative. Patients who reported both their goal and their oncologist’s goal as noncurative had higher levels of depression (B=0.99; P=.021) and anxiety symptoms (B=1.01; P=.015) compared with those who reported that both their goal and their oncologist’s goal was curative. Patients with discordant perceptions of their goal and their oncologist’s goal reported higher anxiety symptoms (B=1.47; P=.004) compared with those who reported that both their goal and their oncologist’s goal were curative. Conclusions: One-fifth of patients with incurable cancer reported that both their treatment goal and their oncologist’s goal were to cure their cancer. Patients who acknowledged the noncurative intent of their treatment and those who perceived that their treatment goal was discordant from that of their oncologist reported greater psychological distress.

BACKGROUND Patients with advanced cancer and their caregivers have substantial misperceptions regarding hospice, which contributes to its underuse. METHODS The authors conducted a single-site randomized trial of a video educational tool versus a verbal description of hospice in 150 hospitalized patients with advanced cancer and their caregivers. Patients without a caregiver were eligible. Intervention participants (75 patients and 18 caregivers) viewed a 6-minute video depicting hospice. Control participants (75 patients and 26 caregivers) received a verbal description identical to the video narrative. The primary outcome was patient preference for hospice. Secondary outcomes included patient and/or caregiver knowledge and perceptions of hospice, and hospice use. RESULTS Between February 2017 and January 2019, approximately 55.7% of eligible patients (150 of 269 eligible patients) and 44 caregivers were enrolled. After the intervention, there was no difference noted with regard to patients' preferences for hospice (86.7% vs 82.7%; P = .651). Patients in the video group reported greater knowledge regarding hospice (9.0 vs 8.4; P = .049) and were less likely to endorse that hospice is only about death (6.7% vs 21.6%; P = .010). Among deceased patients, those assigned to the intervention were more likely to have used hospice (85.2% vs 63.6%; P = .01) and to have had a longer hospice length of stay (median, 12 days vs 3 days; P

PURPOSE: In patients with metastatic breast cancer (MBC), low health insurance literacy may be associated with adverse material conditions, psychological response, and coping behaviors because of financial hardship (FH). This study explored the relationship between health insurance literacy and FH in women with MBC. METHODS: This cross-sectional study used data collected from 84 women receiving MBC treatment at 2 southeastern cancer centers. Low health insurance literacy was defined as not knowing premium or deductible costs. FH was defined by lifestyle changes as a result of medical expenses, financial toxicity, and medical care modifications attributable to cost. Mean differences were calculated using Cramer’s V. Associations between health insurance literacy and FH were estimated with adjusted linear models. RESULTS: Half of the surveyed patients had low health insurance literacy, 26% were underinsured, 45% had private insurance, 39% had Medicare, and 15% had Medicaid. Patients with low health insurance literacy more often reported borrowing money (19% v 4%; V = 0.35); an inability to pay for basic necessities like food, heat, or rent (10% v 4%; V = 0.18); and skipping a procedure (8% v 1%; V = 0.21), medical test (7% v 0%; V = 0.30), or treatment (4% v 0%; V = 0.20) compared with patients with high health insurance literacy. Median Comprehensive Score for Financial Toxicity was 23 (interquartile range, 17-29). In adjusted models, health insurance literacy was not associated with financial toxicity. CONCLUSION: Low health insurance literacy was common in women receiving MBC treatment. Additional research to increase health insurance literacy could lessen undesirable material FH and unnecessary behavioral FH associated with cancer-related care.

Background Shared decision-making (SDM) occurs when a patient partners with their oncologist to integrate personal preferences and values into treatment decisions. A key component of SDM is the elicitation of patient preferences and values, yet little is known about how and when these are elicited, communicated, prioritized, and documented within clinical encounters. Methods This cross-sectional study evaluated nationwide data collected by CancerCare to better understand current patterns of SDM between patients and their oncology clinicians. Patient surveys included questions about the importance of quality-of-life preferences and discussions regarding quality-of-life priorities with their clinicians. Clinician surveys included questions about the discussion of quality-of-life priorities and preferences with patients, the effect of quality-of-life priorities on treatment recommendations, and quality-of-life priority documentation in practice. Results Patient survey completers (n = 320; 33% response rate) were predominantly women (95%), had a diagnosis of breast cancer (59%), or were receiving active cancer treatment (59%). Clinician survey completers (n = 112; 5% response rate) predominately identified as hematologists or oncologists (66%). Although 67% of clinicians reported knowing their patients' personal quality-of-life priorities and preferences before finalizing treatment plans, only 37% of patients reported that these discussions occurred before treatment initiation. Most patients (95%) considered out-of-pocket expenses important during treatment planning, yet only 59% reported discussing out-of-pocket expenses with their clinician before finalizing treatment plans. A majority of clinicians (52%) considered clinic questionnaires as feasible to document quality-of-life priorities and preferences. Conclusions Patients and clinicians reported that preferences related to quality-of-life should be considered in treatment decision making, yet barriers to SDM, preference elicitation, and documentation remain.

Background: Oncologists often struggle with managing the unique care needs of older adults with cancer. This study sought to determine the feasibility of delivering a transdisciplinary intervention targeting the geriatric-specific (physical function and comorbidity) and palliative care (symptoms and prognostic understanding) needs of older adults with advanced cancer. Methods: Patients aged ≥65 years with incurable gastrointestinal or lung cancer were randomly assigned to a transdisciplinary intervention or usual care. Those in the intervention arm received 2 visits with a geriatrician, who addressed patients’ palliative care needs and conducted a geriatric assessment. We predefined the intervention as feasible if >70% of eligible patients enrolled in the study and >75% of eligible patients completed study visits and surveys. At baseline and week 12, we assessed patients’ quality of life (QoL), symptoms, and communication confidence. We calculated mean change scores in outcomes and estimated intervention effect sizes (ES; Cohen’s d) for changes from baseline to week 12, with 0.2 indicating a small effect, 0.5 a medium effect, and 0.8 a large effect. Results: From February 2017 through June 2018, we randomized 62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age, 72.3 years; cancer types: 56.5% gastrointestinal, 43.5% lung). Among intervention patients, 82.1% attended the first visit and 79.6% attended both. Overall, 89.7% completed all study surveys. Compared with usual care, intervention patients had less QoL decrement (–0.77 vs –3.84; ES = 0.21), reduced number of moderate/severe symptoms (–0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs –0.80; ES = 0.38). Conclusions: In this pilot trial, enrollment exceeded 55%, and >75% of enrollees completed all study visits and surveys. The transdisciplinary intervention targeting older patients’ unique care needs showed encouraging ES estimates for enhancing patients’ QoL, symptom burden, and communication confidence.

BACKGROUND This study examined factors associated with potentially burdensome end-of-life (EOL) transitions between care settings among older adults with advanced cancer in nursing homes (NHs). METHODS A retrospective analysis of deceased older NH residents with poor-prognosis solid tumors was conducted with Medicare claims and the Minimum Data Set. A potentially burdensome transition was defined as 2 or more hospitalizations or an intensive care unit admission in the last 90 days of life. RESULTS Among 34,670 subjects, many had moderate to severe cognitive impairment (53.8%), full dependence in activities of daily living (ADLs; 66.5%), and comorbidities such as congestive heart failure (CHF; 29.3%) and chronic obstructive pulmonary disease (34.1%). Only 56.3% of the patients used hospice at any time in the 90 days before death; 36.0% of the patients experienced a potentially burdensome EOL transition, and this was higher among patients who did not receive hospice (45.4% vs 28.7%; P

Background & Aims Despite evidence for the benefits of palliative care (PC) referrals and early advance care planning (ACP) discussions for patients with chronic diseases, patients with end-stage liver disease (ESLD) often do not receive such care. We sought to examine physicians’ perceptions of the barriers to PC and timely ACP discussions for patients with ESLD. Methods We conducted a cross-sectional survey of hepatologists and gastroenterologists who provide care to adult patients with ESLD, recruited from the American Association for the Study of Liver Diseases 2018 membership registry. Using a questionnaire adapted from prior studies, we assessed physicians’ perceptions of barriers to PC use and timely ACP discussions; 396 of 1236 eligible physicians (32%) completed the questionnaire. Results The most commonly cited barriers to PC use were cultural factors that affect perception of PC (by 95% of respondents), unrealistic expectations from patients about their prognosis (by 93% of respondents), and competing demands for clinicians’ time (by 91% of respondents). Most respondents (81%) thought that ACP discussions with patients who have ESLD typically occur too late in the course of illness. The most commonly cited barriers to timely ACP discussions were insufficient communication between clinicians and families about goals of care (by 84% of respondents) and insufficient cultural competency training about end-of-life care (81%). Conclusion There are substantial barriers to use of PC and timely discussions about ACP—most hepatologists and gastroenterologists believe that ACP occurs too late for patients with ESLD. Strategies are needed to overcome barriers and increase delivery of high-quality palliative and end-of-life care to patients with ESLD.

Clinical trials are imperative for testing novel cancer therapies, advancing the science of cancer care, and determining the best treatment strategies to enhance outcomes for patients with cancer. However, barriers to clinical trial enrollment contribute to low participation in cancer clinical trials. Many factors play a role in the persistently low rates of trial participation, including financial barriers, logistical concerns, and the lack of resources for patients and clinicians to support clinical trial enrollment and retention. Furthermore, restrictive eligibility criteria often result in the exclusion of certain patient populations, which thus adds to the widening disparities seen between patients who enroll in trials and those treated in routine practice. Moreover, additional factors, such as difficulty by patients and clinicians in coping with the uncertainty inherent to clinical trial participation, contribute to low trial enrollment and represent key components of the decision-making process. Specifically, patients and clinicians may struggle to assess the risk-benefit ratio and may incorrectly estimate the probability and severity of challenges associated with clinical trial participation, thus complicating the informed consent process. Importantly, research has increasingly focused on overcoming barriers to clinical trial enrollment. A promising solution involves the use of patient navigators to help enhance clinical trial recruitment, enrollment, and retention. Although clinical trials are essential for improving and prolonging the lives of patients with cancer, barriers exist that can impede trial enrollment; yet, efforts to recognize and address these barriers and enhance trial enrollment are being investigated.

PURPOSE: Patients with cancer often prefer to avoid time in the hospital; however, data are lacking on the prevalence and predictors of potentially avoidable readmissions (PARs) among those with advanced cancer. METHODS: We enrolled patients with advanced cancer from September 2, 2014, to November 21, 2014, who had an unplanned hospitalization and assessed their patient-reported symptom burden (Edmonton Symptom Assessment System) at the time of admission. For 1 year after enrollment, we reviewed patients’ health records to determine the primary reason for every hospital readmission and we classified readmissions as PARs using adapted Graham’s criteria. We examined predictors of PARs using nonlinear mixed-effects models with binomial distribution. RESULTS: We enrolled 200 (86.2%) of 232 patients who were approached. For these 200 patients, we reviewed 277 total hospital readmissions and identified 108 (39.0%) of these as PARs. The most common reasons for PARs were premature discharge from a prior hospitalization (30.6%) and failure of timely follow-up (28.7%). PAR hospitalizations were more likely than non-PAR hospitalizations to experience symptoms as the primary reason for admission (28.7% v 13.0%; P = .001). We found that married patients were less likely to experience PARs (odds ratio, 0.30; 95% CI, 0.15 to 0.57; P < .001) and that those with a higher physical symptom burden were more likely to experience PARs (odds ratio, 1.03; 95% CI, 1.01 to 1.05; P = .012). CONCLUSION: We observed that a substantial proportion of hospital readmissions are potentially avoidable and found that patients’ symptom burdens predict PARs. These findings underscore the need to assess and address the symptom burden of hospitalized patients with advanced cancer in this highly symptomatic population.

Financial barriers may discourage some patients with from participating in cancer clinical trials. This study sought to assess the effect of an equity intervention on the financial burden of clinical trial participants., Background. The financial burden experienced by patients with cancer represents a barrier to clinical trial participation, and interventions targeting patients’ financial concerns are needed. We sought to assess the impact of an equity intervention on clinical trial patients’ financial burden. Materials and Methods. We developed an equity intervention to reimburse nonclinical expenses related to trials (e.g., travel and lodging). From July 2015 to July 2017, we surveyed intervention and comparison patients matched by age, sex, cancer type, specific trial, and trial phase. We longitudinally assessed financial burden (e.g., trial‐related travel and lodging cost concerns, financial wellbeing [FWB] with the COmprehensive Score for financial Toxicity [COST] measure) at baseline, day 45, and day 90. We used longitudinal models to assess intervention effects over time. Results. Among 260 participants, intervention patients were more likely than comparison patients to have incomes under $60,000 (52% vs. 24%, p < .001) and to report travel‐related (41.0% vs. 6.8%, p < 0.001) and lodging‐related (32.5% vs. 2.0%, p < .001) cost concerns at baseline. Intervention patients were more likely to report travel to appointments as their most significant financial concern (24.0% vs. 7.0%, p = .001), and they had worse FWB than comparison patients (COST score: 15.32 vs. 23.88, p < .001). Over time, intervention patients experienced greater improvements in their travel‐related (−10.0% vs. +1.2%, p = .010) and lodging‐related (−3.9% vs. +4.0%, p = .003) cost concerns. Improvements in patients reporting travel to appointments as their most significant financial concern and COST scores were not statistically significant. Conclusion. Cancer clinical trial participants may experience substantial financial issues, and this equity intervention demonstrates encouraging results for addressing these patients’ longitudinal financial burden. Implications for Practice. Clinical trials are critical for developing novel therapies for patients with cancer, yet financial barriers may discourage some patients from participating in cancer clinical trials. This study found that patients who received financial assistance from an equity intervention experienced significant improvements over time in their concerns about the cost of travel and lodging associated with clinical trials compared with comparison patients who did not receive financial assistance from the equity intervention. Among cancer clinical trial participants, an equity intervention shows potential for addressing patients' concerns regarding clinical trial‐related travel and lodging expenses.

Definitive chemoradiation (CRT) results in high cure rates of anal cancer, with advanced radiation (RT) techniques improving toxicity. However, there is limited data regarding these patients’ sexual function (SF), quality of life (QOL), and mood. We hypothesized that anal cancer treatment would result in detrimental effects on SF, QOL, and mood. We prospectively surveyed patients with anal cancer treated with definitive CRT. We assessed SF for women with the Female Sexual Function Index (FSFI) and for men with the International Index of Erectile Function (IIEF). For all patients, we assessed QOL using EORTC QLQ-C30 and CR29 and mood using the Hospital Anxiety and Depression Scale (HADS). We reported descriptive statistics for SF, QOL, and mood and used univariate analysis to evaluate predictors of SF for women. Of 50 eligible patients, 84% completed the surveys. Median time from RT until survey was 36 months (1–97 months). Women (n = 34) reported poor SF overall (mean FSFI score = 15, scale 2–36, standard deviation (SD) 10.4). Most women reported poor SF related to satisfaction, desire, orgasm, arousal, pain, and lubrication. Men (n = 8) also had poor overall satisfaction (mean IIEF score = 6.1, scale 2–10, SD 3.6). Men reported poor erectile function and lower satisfaction with intercourse. Mean QLQ-C30 QOL score was 86.5 (SD 16.3). Results from EORTC QLQ-CR-20 demonstrated patients experienced poor sexual interest. Per HADS, 2.5% reported depression and 18% anxiety. Patients with anal cancer experience sexual dysfunction after RT, with QOL and mood symptoms similar to patients with other cancers. Our data support the need for ongoing efforts to understand and address issues with SF, QOL, and mood following RT for these patients.

The implementation of upfront, preoperative habilitation (“prehabilitation”), as opposed to postoperative habilitation (rehabilitation), provides a unique opportunity to optimize surgical outcomes, while ensuring that patients receive necessary conditioning that may otherwise be significantly delayed by postoperative complications. In this review, opportunities to design, implement, monitor, and evaluate a surgical prehabilitation program in colorectal surgery are discussed, and broken down to include emotional, physical, and nutritional aspects of care in the preoperative setting.

Objective: The purpose of this article is to review tumor staging systems for gastrointestinal tumors including pancreatic adenocarcinoma, hepatocellular carcinoma, cholangiocarcinoma, gastric adenocarcinoma, small bowel adenocarcinoma, rectal carcinoma, and anal carcinoma and identify the key imaging findings (“tipping points”), which change patient management based on changes in tumor staging. Conclusion For all malignant gastrointestinal tumors, there are key imaging findings (“tipping points”) including tumor size, tumor extension, lymphadenopathy, vascular invasion, and distant metastasis that dictate patient management and prognosis, based on changes in tumor stage. In interpreting these imaging studies, radiologists should be cognizant of these “tipping points” to guide patient management.

Background Survival in patients with metastatic colorectal cancer (mCRC) has been associated with tumor mutational status, muscle loss, and weight loss. We sought to explore the combined effects of these variables on overall survival. Materials and Methods We performed an observational cohort study, prospectively enrolling patients receiving chemotherapy for mCRC. We retrospectively assessed changes in muscle (using computed tomography) and weight, each dichotomized as >5% or ≤5% loss, at 3, 6, and 12 months after diagnosis of mCRC. We used regression models to assess relationships between tumor mutational status, muscle loss, weight loss, and overall survival. Additionally, we evaluated associations between muscle loss, weight loss, and tumor mutational status. Results We included 226 patients (mean age 59 ± 13 years, 53% male). Tumor mutational status included 44% wild type, 42% RAS‐mutant, and 14% BRAF‐mutant. Patients with >5% muscle loss at 3 and 12 months experienced worse survival controlling for mutational status and weight (3 months hazard ratio, 2.66; p < .001; 12 months hazard ratio, 2.10; p = .031). We found an association of >5% muscle loss with BRAF‐mutational status at 6 and 12 months. Weight loss was not associated with survival nor mutational status. Conclusion Increased muscle loss at 3 and 12 months may identify patients with mCRC at risk for decreased overall survival, independent of tumor mutational status. Specifically, >5% muscle loss identifies patients within each category of tumor mutational status with decreased overall survival in our sample. Our findings suggest that quantifying muscle loss on serial computed tomography scans may refine survival estimates in patients with mCRC. Implications for Practice In this study of 226 patients with metastatic colorectal cancer, it was found that losing >5% skeletal muscle at 3 and 12 months after the diagnosis of metastatic disease was associated with worse overall survival, independent of tumor mutational status and weight loss. Interestingly, results did not show a significant association between weight loss and overall survival. These findings suggest that muscle quantification on serial computed tomography may refine survival estimates in patients with metastatic colorectal cancer beyond mutational status., Cancer cachexia has traditionally been defined using weight loss; however, loss of skeletal muscle may be a more objective measure. This article reports the results of a retrospective study that assessed whether skeletal muscle loss is associated with overall survival in patients with metastatic colorectal cancer, independent of tumor mutational status and weight loss.

Distress management (DM) (screening and response) is an essential component of cancer care across the treatment trajectory. Effective DM has many benefits, including improving patients' quality of life; reducing distress, anxiety, and depression; contributing to medical cost offsets; and reducing emergency department visits and hospitalizations. Unfortunately, many distressed patients do not receive needed services. There are several multilevel barriers that represent key challenges to DM and affect its implementation. The Consolidated Framework for Implementation Research was used as an organizational structure to outline the barriers and facilitators to implementation of DM, including: 1) individual characteristics (individual patient characteristics with a focus on groups who may face unique barriers to distress screening and linkage to services), 2) intervention (unique aspects of DM intervention, including specific challenges in screening and psychosocial intervention, with recommendations for resolving these challenges), 3) processes for implementation of DM (modality and timing of screening, the challenge of triage for urgent needs, and incorporation of patient-reported outcomes and quality measures), 4) organization-inner setting (the context of the clinic, hospital, or health care system); and 5) organization-outer setting (including reimbursement strategies and health-care policy). Specific recommendations for evidence-based strategies and interventions for each of the domains of the Consolidated Framework for Implementation Research are also included to address barriers and challenges.

A growing proportion of cancer survivors experience financial toxicity. However, the psychological burden of cancer costs and associated mental health outcomes require further investigation. We assessed prevalence and predictors of self-reported financial worry and mental health outcomes among cancer survivors. Data from the 2013–2018 National Health Interview Survey (NHIS) for adults reporting a cancer diagnosis were used. Multivariable ordinal logistic regressions defined adjusted odds ratios (AORs) of reporting financial worry by relevant sociodemographic variables, and sample weight-adjusted prevalence of financial worry was estimated. The association between financial worry and psychological distress, as defined by the six-item Kessler Psychological Distress Scale was also assessed. Among 13,361 survey participants (median age 67; 60.0% female), 9567 (71.6%) self-reported financial worry, including worries regarding costs of paying for children’s college education (62.7%), maintaining one’s standard of living (59.7%), and medical costs due to illness or accident (58.3%). Female sex, younger age, and Asian American race were associated with increased odds of financial worry (P < 0.05 for all). Of 13,218 participants with complete responses to K6 questions, 701 (5.3%) met the threshold for severe psychological distress. Participants endorsing financial worry were more likely to have psychological distress (6.6 vs. 1.2%, AOR 2.89, 95% CI 2.03–4.13, P< 0.001) with each additional worry conferring 23.9% increased likelihood of psychological distress. A majority of cancer survivors reported financial worry, which was associated with greater odds of reporting psychological distress. Policies and guidelines are needed to identify and mitigate financial worries and psychologic distress among patients with cancer, with the goal of improving psychological well-being and overall cancer survivorship care.

Purpose/Objective(s) Early phase clinical trials (EP-CTs) investigate novel oncology treatment options with the goal of improving response rates, decreasing toxicity, and improving survival. Utilization of palliative radiation (RT) in the EP-CT population is poorly characterized, but greater understanding is needed to aid with optimizing symptom management and extending time on trial. Materials/Methods We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs at our phase I clinical trials center from 2017-2019 to obtain demographic and clinical factors and to evaluate the influence of treatment utilization including the timing of palliative radiation therapy on clinical outcomes, including time on trial, and emergency room visits or hospitalizations. Results Among 241 patients enrolled on EP-CT (median age 63.2 years [range 23-84.3 years]; 52.7% female, 97.1% metastatic cancer), the most common primary cancer types were gastrointestinal (26.0%), lung (23.6%), and breast (11.6%). Eighty patients (33.2%) received palliative RT with a total of 241 treatment courses [median courses: 2 (range 1 – 21), median fractions: 5 (range 1 – 26)]. The most common sites of palliative RT were the brain (41%), spine (13.8%), and long bone (10%). Approximately half of patients (48.8%) received their first course of palliative RT before EP-CT enrollment versus 47.5% (n = 38) following completion of EP-CT and 3.7% (n = 3) during EP-CT. Median time on EP-CT by timing of first palliative RT treatment was 63 days (pre-EP-CT), 68.5 days (after EP-CT), and 156 days (during EP-CT). Among patients receiving palliative RT before or during EP-CT enrollment, there were fewer ED visits or hospitalizations versus patients who received palliative RT after EP-CT completion (30.1% vs 50.0%, P = 0.042). Conclusion In a cohort of advanced cancer patients enrolled in EP-CTs, palliative RT was utilized in one-third of patients at some point during their care. Those who received palliative RT prior to or during EP-CT enrollment experienced fewer ED visits and hospitalizations compared to those who received it after EP-CT. While rare, those patients who received palliative RT while on EP-CT experienced a markedly longer time on trial, highlighting the potential benefits of EP-CT trial designs that allow for palliative RT while remaining on study. Additional research is warranted to characterize the impact of palliative RT on the EP-CT trial experience.

Background Caregivers of adults with cancer often report a different understanding of the patient's prognosis than the oncologist. We examine the associations of caregiver–oncologist prognostic concordance with caregiver depressive symptoms, distress, and quality of life (QoL). We also explore whether these relationships differed by caregiver environment mastery, an individual's sense of control, and effectiveness in managing life situations. Materials and Methods We used data from a national geriatric assessment cluster-randomized trial (URCC 13070) that recruited patients aged 70 years and older with incurable cancer considering any line of cancer treatment at community oncology practices, their caregivers, and their oncologists. At enrollment, caregivers and oncologists estimated the patient's prognosis (0–6 months, 7–12 months, 1–2 years, 2–5 years, and >5 years; identical responses were concordant). Caregivers completed the Ryff's environmental mastery at enrollment. At 4–6 weeks, caregivers completed the Patient Health Questionnaire-2 (depressive symptoms), distress thermometer, and 12-Item Short-Form Health Survey (quality of life [QoL]). We used generalized estimating equations in models adjusted for covariates. We then assessed the moderation effect of caregiver mastery. Results Of 411 caregiver–oncologist dyads (mean age = 66.5 years), 369 provided responses and 28% were concordant. Prognostic concordance was associated with greater caregiver depressive symptoms (β = 0.30; p = .04) but not distress or QoL. A significant moderation effect for caregiver depressive symptoms was found between concordance and mastery (p = .01). Specifically, among caregivers with low mastery (below median), concordance was associated with greater depressive symptoms (β = 0.68; p = .003). Conclusions Caregiver–oncologist prognostic concordance was associated with caregiver depressive symptoms. We found a novel moderating effect of caregiver mastery on the relationship between concordance and caregiver depressive symptoms. Implications for Practice Caregiver–oncologist prognostic concordance is associated with greater caregiver depressive symptoms, particularly in those with low caregiver mastery. When discussing prognosis with caregivers, physicians should be aware that prognostic understanding may affect caregiver psychological health and should assess their depressive symptoms. In addition, while promoting accurate prognostic understanding, physicians should also identify strengths and build resilience among caregivers.

Background: Social support plays a crucial role for patients with aggressive hematologic malignancies as they navigate their illness course. The aim of this study was to examine associations of social support with overall survival (OS) and healthcare utilization in this population. Methods: A cross-sectional secondary analysis was conducted using data from a prospective longitudinal cohort study of 251 hospitalized patients with aggressive hematologic malignancies at Massachusetts General Hospital from 2014 through 2017. Natural Language Processing (NLP) was used to identify the extent of patients’ social support (limited vs adequate as defined by NLP-aided chart review of the electronic health record). Multivariable regression models were used to examine associations of social support with (1) OS, (2) death or readmission within 90 days of discharge from index hospitalization, (3) time to readmission within 90 days, and (4) index hospitalization length of stay. Results: Patients had a median age of 64 years (range, 19–93 years), and most were White (89.6%), male (68.9%), and married (65.3%). A plurality of patients had leukemia (42.2%) followed by lymphoma (37.9%) and myelodysplastic syndrome/myeloproliferative neoplasm (19.9%). Using NLP, we identified that 8.8% (n=22) of patients had limited social support. In multivariable analyses, limited social support was associated with worse OS (hazard ratio, 2.00; P=.042) and a higher likelihood of death or readmission within 90 days of discharge (odds ratio, 3.11; P=.043), but not with time to readmission within 90 days or with index hospitalization length of stay. Conclusions: In this cohort of hospitalized patients with aggressive hematologic malignancies, we found associations of limited social support with lower OS and a higher likelihood of death or readmission within 90 days of hospital discharge. These findings underscore the utility of NLP for evaluating the extent of social support and the need for larger studies evaluating social support in patients with aggressive hematologic malignancies.

Introduction: Coronary vasospasm is a side effect of 5-FU (fluorouracil). Beyond switching chemotherapy regimens, there are no established treatments for vasospasm. Limited data exist regarding the efficacy of calcium channel blockers (CCBs) and/or nitrates with 5-FU vasospasm. Methods: We conducted a retrospective analysis of all patients at Massachusetts General Hospital who were diagnosed with 5-FU coronary vasospasm. As part of institutional practice, those referred to cardio-oncology receive pre-treatment with vasospasm therapies (either combination [nitrates and CCBs] or single agent therapy [nitrates or CCBs]) prior to re-challenge with 5-FU. Our primary outcomes were the safety and effectiveness of this cardiac pre-treatment approach. Results: Among 7,711 patients who received 5-FU from Jan 2001 to Jul 2017, 86 (1.11%) developed coronary vasospasm. Overall 64 patients continued to receive subsequent 5-FU, while 22 stopped. Of the 64 who continued, 60 were referred to cardio-oncology and prescribed CCBs and/or nitrates prior to subsequent 5-FU. Of these 60, 52% (31/60) received both nitrates and CCBs, 20% (12/60) received CCBs alone, and 28% (17/60) received nitrates alone, while 4 continued 5-FU without cardiac pre-treatment. Chest pain (without a myocardial infarct) recurred in 11.7% (7/60) among those who received cardiac pre-treatment vs. 50% (2/4) among those who did not (P=0.033). When those who stopped were compared to those who continued 5-FU (with cardiac pre-treatment), the cardiovascular profile, stage and type of cancer were similar. As compared to patients who stopped 5-FU, those who continued after nitrates/CCBs had improved progression free (HR 0.56, P=0.076 [95% CI 0.30-1.06]) and overall (HR 0.29, P Conclusion: In the largest report of 5-FU associated vasospasm, re-challenge after pre-treatment with CCBs and nitrates was safe and effective, thus allowing patients to receive additional 5-FU.

Background: Little is known about how patients with incurable cancer and caregivers differ in their prognostic awareness, and the relationship between caregiver prognostic awareness and their psychological distress. Objective: To investigate prognostic awareness in caregivers of patients with incurable cancer and prognostic discordance in patient–caregiver dyads and its association with psychological distress. Design: This is a cross-sectional study. Setting/Subjects: In total, subjects were 390 caregivers of adults with incurable lung, gastrointestinal, and brain cancers at a cancer center in the northeastern United States. Measurements: The Prognosis and Treatment Perceptions Questionnaire was used to assess prognostic awareness and Hospital Anxiety and Depression Scale to assess psychological distress. Results: In total, 39.7% (n = 147/370) and 17.3% (n = 64/370) caregivers reported clinically significant anxiety and depression symptoms. And 53.7% of caregivers reported the patients' cancer as “curable” and 44.1% reported the cancer was “not terminal.” Caregivers' report of curability was not associated with their anxiety (odds ratio [OR] = 0.99, p = 0.93) or depression (OR = 1.05, p = 0.32) symptoms. Among 42.5% (124/292) and 26.0% (76/292) of dyads (n = 292), both patients and their caregivers agreed in their perception of the cancer as curable and incurable, respectively. In 19.9% of dyads (n = 58), patients reported their cancer as curable, while their caregivers reported it as incurable. In 11.6% of dyads (n = 34), patients reported the cancer as incurable while caregivers reported it as curable. Conclusions: More than half of caregivers have misperceptions about the patients' likelihood of cure, and one-third of patient–caregiver dyads have discordant perceptions. Supportive care interventions may facilitate conversations and enhance prognostic understanding in patients with incurable cancer and their caregivers.

Immune checkpoint blockade has limited efficacy in microsatellite stable (MSS) colorectal (CRC) and pancreatic (PDAC) cancer. Preclinical models have demonstrated the use of radiation to activate the innate immune response and stimulate responsiveness to immune checkpoint blockade. Here, we describe a Phase 2 trial of radiation therapy combined with combined anti-CTLA4 (ipilimumab) and anti-PD1 (nivolumab) antibodies in MSS CRC and PDAC. In the per protocol analysis disease control rate was 37% (10/27) in CRC and 29% (5/17) in PDAC with an overall response rate of 15% (4/27) and 18% (3/17), respectively. Whole exome and RNA sequencing of biopsies from 17 patients revealed low tumor mutational burden in all tumors, but a notable upregulation of interferon stimulated genes with concordant high expression of multiple repeat RNA transcripts in responders. Altogether, this study provides foundational human proof of concept of radiation with combination immune checkpoint blockade therapy in otherwise immunotherapy resistant cancers.

In the oncology setting, data on the relationship between body composition, patient-reported outcomes, and patient outcomes are limited. This editorial outlines the available data and discusses the potential for using such information as a strategy to predict and enhance patient outcomes.

Purpose: ctDNA offers a promising, noninvasive approach to monitor therapeutic efficacy in real-time. We explored whether the quantitative percent change in ctDNA early after therapy initiation can predict treatment response and progression-free survival (PFS) in patients with metastatic gastrointestinal cancer. Experimental Design: A total of 138 patients with metastatic gastrointestinal cancers and tumor profiling by next-generation sequencing had serial blood draws pretreatment and at scheduled intervals during therapy. ctDNA was assessed using individualized droplet digital PCR measuring the mutant allele fraction in plasma of mutations identified in tumor biopsies. ctDNA changes were correlated with tumor markers and radiographic response. Results: A total of 138 patients enrolled. A total of 101 patients were evaluable for ctDNA and 68 for tumor markers at 4 weeks. Percent change of ctDNA by 4 weeks predicted partial response (PR, P < 0.0001) and clinical benefit [CB: PR and stable disease (SD), P < 0.0001]. ctDNA decreased by 98% (median) and >30% for all PR patients. ctDNA change at 8 weeks, but not 2 weeks, also predicted CB (P < 0.0001). Four-week change in tumor markers also predicted response (P = 0.0026) and CB (P = 0.022). However, at a clinically relevant specificity threshold of 90%, 4-week ctDNA change more effectively predicted CB versus tumor markers, with a sensitivity of 60% versus 24%, respectively (P = 0.0109). Patients whose 4-week ctDNA decreased beyond this threshold (≥30% decrease) had a median PFS of 175 days versus 59.5 days (HR, 3.29; 95% CI, 1.55–7.00; P < 0.0001). Conclusions: Serial ctDNA monitoring may provide early indication of response to systemic therapy in patients with metastatic gastrointestinal cancer prior to radiographic assessments and may outperform standard tumor markers, warranting further evaluation.

Background Symptoms of advanced hepatocellular carcinoma (HCC) represent a substantial burden for the patient and are important endpoints to assess when evaluating treatment. Patient-reported outcomes were evaluated in subjects with advanced HCC and baseline alpha-fetoprotein (AFP) ≥400 ng/mL treated with second-line ramucirumab. Patients and methods Patients with AFP≥400 ng/mL enrolled in the REACH or REACH-2 phase 3 studies were used in this analysis. Eligible patients had advanced HCC, Child-Pugh A, Eastern Cooperative Oncology Group performance status 0/1 and prior sorafenib. Patients received ramucirumab 8 mg/kg or placebo once every 2 weeks. Disease-related symptoms and health-related quality of life (HRQoL) were assessed with the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index (FHSI)-8 and EuroQoL-5-Dimensions (EQ-5D) instruments, respectively. Time to deterioration (TTD) (≥3-point decrease in FHSI-8 total score;≥0.06-point decrease in EQ-5D score, from randomisation to first date of deterioration) was determined using Kaplan-Meier estimation and the Cox proportional hazards model. Both separate and pooled analyses for REACH AFP≥400 ng/mL and REACH-2 patients were conducted. Results In the pooled population with AFP ≥400 ng/mL (n=542; ramucirumab, n=316; placebo, n=226), median TTD in FHSI-8 total score was prolonged with ramucirumab relative to placebo (3.3 vs 1.9 months; HR 0.725; (95% CI 0.559 to 0.941); p=0.0152), including significant differences in back pain (0.668; (0.497 to 0.899); p=0.0044), weight loss (0.699; (0.505 to 0.969); p=0.0231) and pain (0.769; (0.588 to 1.005); p=0.0248) symptoms. TTD in EQ-5D score was not significantly different between ramucirumab and placebo groups (median 2.9 vs 1.9 months). Results in the individual trials were consistent with these findings. Conclusions Ramucirumab in second-line treatment of advanced HCC demonstrates consistent benefit in the delay of deterioration in disease-related symptoms with no worsening of HRQoL. Taken with previously demonstrated ramucirumab-driven survival benefits in this setting, these data may inform patient–clinician discussions about the benefit–risk profile of this therapy. Trial registration number NCT01140347 ; NCT02435433 , NCT02435433 .

Background Little is known about end‐of‐life care among patients with pancreatic adenocarcinoma (PDAC). We used the Surveillance, Epidemiology, and End Results‐Medicare linked database to analyze patterns of hospice use and end‐of‐life treatment in patients with PDAC. Methods We included patients diagnosed with PDAC between 2000‐2011 and who had died by December 31, 2012. We assessed patterns of hospice use, chemotherapy receipt, and intensive care unit (ICU) admissions at end‐of‐life. We used multivariable logistic regression to investigate predictors of end‐of‐life care. Results In our cohort of 16 309 patients, 70.5% enrolled in hospice, of which 29.1% enrolled in the last 7 days of life. Use of hospice increased over time, from 61.6% in 2000 to 77.5% in 2012 (P‐value for trend

In pancreatic adenocarcinoma (PDAC), increasing tumor size usually correlates with a worse prognosis. However, patients with a very small primary tumor who experience lymph node involvement may have a different disease biology. This study sought to determine the interaction between tumor size and lymph node involvement in terms of overall survival (OS).The study identified 17,073 patients with a diagnosis of M0 resected PDAC between 1983 and 2013 using the Surveillance, Epidemiology, and End Results database. The patients were stratified by lymph node involvement (N0 vs N+) and T stage (T1a-T1b vs T1c vs T2 vs T3 vs T4). The Kaplan-Meier method was used to estimate OS, and Cox regression analysis was used to compare survival between subgroups after adjustment for patient-specific factors.Lymph node involvement and T stage significantly interacted (p 0.001). Among the patients with node-negative disease, 5-year OS decreased monotonically with increasing T stage (59.1%, 30.6%, 22.9%, 16.6%, and 8.0%, respectively; p 0.001). In contrast, among the patients with node-positive disease, those with T1a-T1b tumors ( 10 mm) had worse 5-year OS than those with T1c tumors (7.4% vs 17.6%; adjusted hazard ratio, 0.70; 95% confidence interval, 0.50-0.97; p = 0.034) and similar survival compared with those who had T2, T3, or T4 tumors (9.7%, 8.2%, and 4.8%, respectively; p 0.2 in all cases).Among patients with lymph node-positive PDAC, very small primary tumors are associated with decreased OS. This finding raises the possibility that small tumors capable of lymph node metastasis might represent more biologically aggressive cancers.

Recent reports demonstrate inferior outcomes associated with primary right‐sided vs left‐sided colorectal tumors in patients with metastatic colorectal cancer (mCRC). We sought to describe our experience with mCRC patients on whom we have molecular data to determine whether primary tumor sidedness was an independent prognostic marker for overall survival (OS). mCRC patients with documented primary tumor sidedness who received mutational profiling between 2009 and 2014 were identified (n = 367, median follow‐up 30.4 months). Mutational profiling for >150 mutations across commonly mutated cancer genes including RAS, PIK3CA, BRAF, and PTEN as well as treatment data, including receipt of a biologic agent, were collected. Univariable/multivariable models were used to analyze relationships between collected data and OS. Among 367 patients, sidedness breakdown was as follows: 234 left (64%), 133 right (36%). 56% were male, with a median age at diagnosis of 57 (range 24‐89). A total of 143 patients had RAS mutations. Five‐year OS was 41%, median OS was 54 months (range 1‐149). Five‐year OS for left‐ vs right‐sided tumors was 46% vs 24% (P