Racial and survival disparities in inflammatory breast cancer (IBC) and non-IBC: a population-based study focused on Native Hawaiians and other Pacific Islanders.

Background: It is well known that race is an independent predictor of breast cancer mortality and advanced stage at diagnosis. Inflammatory breast cancer (IBC) is the most aggressive type of breast cancer and has distinct clinical and biological features. Previous studies have shown that Blacks have a higher incidence of IBC than Whites. However, the proportion of IBC and the role of race on prognosis in Native Hawaiian and other Pacific Islander (NH/PI) populations with breast cancer are poorly understood. In this study, we aimed to examine the proportion of IBC to non-IBC in NH/PIs and to identify the clinicopathological, biological, and socioeconomic factors associated with the overall survival of NH/PIs compared to other races. Methods: Utilizing a comprehensive cancer registry from the largest hospital in Hawaii, newly diagnosed primary invasive breast cancer patients diagnosed between 2000 and 2018 were identified. Univariate and multivariate Cox proportional hazards models were used to test the association between race and clinical outcomes. Variables with P-values <0.05 in the univariate analysis and race (variable of interest) were included in a multivariate analysis. Results: The cohort included 3691 patients, 60 of whom had IBC. NH/PI race had the highest proportion of IBC compared to other races (3.44%) but was not found to be an independent poor prognostic factor in IBC (HR 1.17 [95%CI 0.26-5.22]). Conversely, NH/PI race was associated with worse survival outcomes in patients with non-IBC (HR 1.65 [95%CI, 1.14-2.39]) along with other factors such as lack of insurance, underinsured status, triple-negative breast cancer (TNBC) subtype, age, and advanced clinical stage. Conclusions: The findings of this study highlight that NH/PIs had higher rates of IBC and inferior survival in non-IBC compared to other races but not in IBC. It is essential to disaggregate NH/PI race from Asians in future population-based research studies. Further research is needed to understand the factors contributing to higher rates of IBC and poor survival outcomes in NH/PIs with non-IBC as well as targeted interventions to improve breast cancer outcomes in this population to ultimately help improve survival rates and reduce health inequities in NH/PIs with breast cancer.

Tonsillar Metastasis of Hepatocellular Carcinoma: A Case Report and Review of the Literature.

A 63-year-old male with stage IV hepatocellular carcinoma (HCC), accompanied by lung and adrenal metastases, presented with oral bleeding. Physical examination disclosed bleeding from the tonsillar mass. A head and neck computed tomography identified a 2.4 cm enhancing lesion in the right anterior ethmoidal sinus, extending to the nasal region and medial orbit. Tonsillar mass biopsy confirmed HCC metastasis, immunopositive for Hepatocyte Paraffin 1 (HepPar1) and Arginase. He was treated with local radiotherapy (30 fractions). The unique presentation of severe bleeding from a tonsillar biopsy-proven HCC metastatic lesion underscores the rarity of head and neck involvement. Extrahepatic metastasis, particularly to the head and neck area likely due to hematogenous spread, may be a major independent predictor of poor outcomes in HCC patients. Local radiotherapy to achieve local hemostasis and reduce tumor bulk should be considered. In patients with known HCC having new oropharyngeal symptoms, HCC metastasis should be considered for a timely diagnosis. Despite its rarity, this manifestation signifies an unfavorable prognosis, reinforcing the imperative for a multidisciplinary approach to enhance therapeutic outcomes in these complex scenarios.

Blastoid Mantle Cell Lymphoma Presenting as an Oropharyngeal Mass.

Blastoid mantle cell lymphoma (MCL) is an extremely rare neoplasm with a dismal prognosis. MCL with an initial presentation in the oral cavity has been rarely reported. This report describes a 75-year-old male who presented with an oropharyngeal mass causing dysphonia and intermittent hypoxia. A biopsy and immunophenotyping confirmed MCL, favoring the blastoid variant. Imaging showed a 4.2 cm left oropharyngeal polypoid mass with extensive lymphadenopathy. His prognosis was considered unfavorable with elevated Ki-67 index, blastoid morphology, and p53 positivity of malignant cells. There was no central nervous system involvement. He received palliative radiation, resulting in profound tumor reduction and resolution of symptoms. An intensive chemoimmunotherapy was not deemed beneficial due to age, comorbidities, absence of TP53 mutation, and a personal preference for a less aggressive treatment. This case highlights the importance of risk-adapted and personalized management approaches in a very unique presentation of blastoid MCL.

Patient-Reported Financial Burden of Treatment for Colon or Rectal Cancer.

Importance: The longitudinal experience of patients is critical to the development of interventions to identify and reduce financial hardship. Objective: To evaluate financial hardship over 12 months in patients with newly diagnosed colorectal cancer (CRC) undergoing curative-intent therapy. Design, Setting, and Participants: This prospective, longitudinal cohort study was conducted between May 2018 and July 2020, with time points over 12 months. Participants included patients at National Cance Institute Community Oncology Research Program sites. Eligibility criteria included age at least 18 years, newly diagnosed stage I to III CRC, not started chemotherapy and/or radiation, treated with curative intent, and able to speak English. Data were analyzed from December 2022 through April 2023. Main Outcomes and Measures: The primary end point was financial hardship, measured using the Comprehensive Score for Financial Toxicity (COST), which assesses the psychological domain of financial hardship (range, 0-44; higher score indicates better financial well-being). Participants completed 30-minute surveys (online or paper) at baseline and 3, 6, and 12 months. Results: A total of 450 participants (mean [SD] age, 61.0 [12.0] years; 240 [53.3%] male) completed the baseline survey; 33 participants (7.3%) were Black and 379 participants (84.2%) were White, and 14 participants (3.1%) identified as Hispanic or Latino and 424 participants (94.2%) identified as neither Hispanic nor Latino. There were 192 participants (42.7%) with an annual household income of $60 000 or greater. There was an improvement in financial hardship from diagnosis to 12 months of 0.3 (95% CI, 0.2 to 0.3) points per month (P < .001). Patients with better quality of life and greater self-efficacy had less financial toxicity. Each 1-unit increase in Functional Assessment of Cancer Therapy-General (rapid version) score was associated with an increase of 0.7 (95% CI, 0.5 to 0.9) points in COST score (P < .001); each 1-unit increase in self-efficacy associated with an increase of 0.6 (95% CI, 0.2 to 1.0) points in COST score (P = .006). Patients who lived in areas with lower neighborhood socioeconomic status had greater financial toxicity. Neighborhood deprivation index was associated with a decrease of 0.3 (95% CI, -0.5 to -0.1) points in COST score (P = .009). Conclusions and Relevance: These findings suggest that interventions for financial toxicity in cancer care should focus on counseling to improve self-efficacy and mitigate financial worry and screening for these interventions should include patients at higher risk of financial burden.

Clinical characteristics, racial inequities, and outcomes in patients with breast cancer and COVID-19: A COVID-19 and cancer consortium (CCC19) cohort study.

Background: Limited information is available for patients with breast cancer (BC) and coronavirus disease 2019 (COVID-19), especially among underrepresented racial/ethnic populations. Methods: This is a COVID-19 and Cancer Consortium (CCC19) registry-based retrospective cohort study of females with active or history of BC and laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection diagnosed between March 2020 and June 2021 in the US. Primary outcome was COVID-19 severity measured on a five-level ordinal scale, including none of the following complications, hospitalization, intensive care unit admission, mechanical ventilation, and all-cause mortality. Multivariable ordinal logistic regression model identified characteristics associated with COVID-19 severity. Results: 1383 female patient records with BC and COVID-19 were included in the analysis, the median age was 61 years, and median follow-up was 90 days. Multivariable analysis revealed higher odds of COVID-19 severity for older age (aOR per decade, 1.48 [95% CI, 1.32-1.67]); Black patients (aOR 1.74; 95 CI 1.24-2.45), Asian Americans and Pacific Islander patients (aOR 3.40; 95 CI 1.70-6.79) and Other (aOR 2.97; 95 CI 1.71-5.17) racial/ethnic groups; worse ECOG performance status (ECOG PS ≥2: aOR, 7.78 [95% CI, 4.83-12.5]); pre-existing cardiovascular (aOR, 2.26 [95% CI, 1.63-3.15])/pulmonary comorbidities (aOR, 1.65 [95% CI, 1.20-2.29]); diabetes mellitus (aOR, 2.25 [95% CI, 1.66-3.04]); and active and progressing cancer (aOR, 12.5 [95% CI, 6.89-22.6]). Hispanic ethnicity, timing, and type of anti-cancer therapy modalities were not significantly associated with worse COVID-19 outcomes. The total all-cause mortality and hospitalization rate for the entire cohort was 9% and 37%, respectively however, it varied according to the BC disease status. Conclusions: Using one of the largest registries on cancer and COVID-19, we identified patient and BC-related factors associated with worse COVID-19 outcomes. After adjusting for baseline characteristics, underrepresented racial/ethnic patients experienced worse outcomes compared to non-Hispanic White patients. Funding: This study was partly supported by National Cancer Institute grant number P30 CA068485 to Tianyi Sun, Sanjay Mishra, Benjamin French, Jeremy L Warner; P30-CA046592 to Christopher R Friese; P30 CA023100 for Rana R McKay; P30-CA054174 for Pankil K Shah and Dimpy P Shah; KL2 TR002646 for Pankil Shah and the American Cancer Society and Hope Foundation for Cancer Research (MRSG-16-152-01-CCE) and P30-CA054174 for Dimpy P Shah. REDCap is developed and supported by Vanderbilt Institute for Clinical and Translational Research grant support (UL1 TR000445 from NCATS/NIH). The funding sources had no role in the writing of the manuscript or the decision to submit it for publication. Clinical trial number: CCC19 registry is registered on ClinicalTrials.gov, NCT04354701.

American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the diagnosis of malignancy in biliary strictures of undetermined etiology: summary and recommendations.

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy provides an evidence-based approach for the diagnosis of malignancy in patients with biliary strictures of undetermined etiology. This document was developed using the Grading of Recommendations Assessment, Development and Evaluation framework and addresses the role of fluoroscopic-guided biopsy sampling, brush cytology, cholangioscopy, and EUS in the diagnosis of malignancy in patients with biliary strictures. In the endoscopic workup of these patients, we suggest the use of fluoroscopic-guided biopsy sampling in addition to brush cytology over brush cytology alone, especially for hilar strictures. We suggest the use of cholangioscopic and EUS-guided biopsy sampling especially for patients who undergo nondiagnostic sampling, cholangioscopic biopsy sampling for nondistal strictures and EUS-guided biopsy sampling distal strictures or those with suspected spread to surrounding lymph nodes and other structures.

American Society for Gastrointestinal Endoscopy guideline on role of endoscopy in the diagnosis of malignancy in biliary strictures of undetermined etiology: methodology and review of evidence.

Biliary strictures of undetermined etiology pose a diagnostic challenge for endoscopists. Despite advances in technology, diagnosing malignancy in biliary strictures often requires multiple procedures. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was used to rigorously review and synthesize the available literature on strategies used to diagnose undetermined biliary strictures. Using a systematic review and meta-analysis of each diagnostic modality, including fluoroscopic-guided biopsy sampling, brush cytology, cholangioscopy, and EUS-guided FNA or fine-needle biopsy sampling, the American Society for Gastrointestinal Endoscopy Standards of Practice Committee provides this guideline on modalities used to diagnose biliary strictures of undetermined etiology. This document summarizes the methods used in the GRADE analysis to make recommendations, whereas the accompanying article subtitled "Summary and Recommendations" contains a concise summary of our findings and final recommendations.

The Effect of Proton Pump Inhibitor Use on Survival of Patients With Colorectal Cancer: A Study of a Racially Diverse Population.

Introduction Proton pump inhibitor (PPI) use is increasing in the general population. Chronic PPI use can lead to hypergastrinemia, which has been purported to increase the risk of developing colorectal cancer (CRC). Several studies have failed to report any association between PPI use and the risk of CRC. However, little is known about the effect of PPI use on CRC survival. In this retrospective analysis, we studied the effect of PPI use on CRC survival in a racially diverse population. Methods Data were abstracted for 1050 consecutive patients diagnosed with CRC from January 2007 to December 2020. The Kaplan-Meier curve was created to study the effect of PPI exposure compared to no exposure on overall survival (OS). Univariate and multivariate analyses were performed to investigate predictors of survival. Results Complete data were available for 750 patients with CRC, 52.5% were males, 22.7% were Whites, 60.1% were Asians, and 17.2% were Pacific Islanders. A total of 25.6% of patients had a history of PPI use. Moreover, 79.2% had hypertension, 68.8% had hyperlipidemia, 38.0% had diabetes mellitus, and 30.2% had kidney disease. There was no difference in median OS among PPI users compared to non-users, p value=0.4. Age, grade, and stage were predictors of inferior OS. No significant association was noticed with gender, race, comorbidities, or treatment with chemotherapy. Conclusion In this retrospective analysis of a racially diverse population of CRC patients, we found that PPI use was not associated with worse OS. Until high-quality prospective data are available, physicians should not stop PPIs that are clinically indicated.

Clinical Characteristics, Racial Inequities, and Outcomes in Patients with Breast Cancer and COVID-19: A COVID-19 and Cancer Consortium (CCC19) Cohort Study.

Background: Limited information is available for patients with breast cancer (BC) and coronavirus disease 2019 (COVID-19), especially among underrepresented racial/ethnic populations. Methods: This is a COVID-19 and Cancer Consortium (CCC19) registry-based retrospective cohort study of females with active or history of BC and laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection diagnosed between March 2020 and June 2021 in the US. Primary outcome was COVID-19 severity measured on a five-level ordinal scale, including none of the following complications, hospitalization, intensive care unit admission, mechanical ventilation, and all-cause mortality. Multivariable ordinal logistic regression model identified characteristics associated with COVID-19 severity. Results: 1,383 female patient records with BC and COVID-19 were included in the analysis, the median age was 61 years, and median follow-up was 90 days. Multivariable analysis revealed higher odds of COVID-19 severity for older age (aOR per decade, 1.48 [95% CI, 1.32 - 1.67]); Black patients (aOR 1.74; 95 CI 1.24-2.45), Asian Americans and Pacific Islander patients (aOR 3.40; 95 CI 1.70 - 6.79) and Other (aOR 2.97; 95 CI 1.71-5.17) racial/ethnic groups; worse ECOG performance status (ECOG PS ≥2: aOR, 7.78 [95% CI, 4.83 - 12.5]); pre-existing cardiovascular (aOR, 2.26 [95% CI, 1.63 - 3.15])/pulmonary comorbidities (aOR, 1.65 [95% CI, 1.20 - 2.29]); diabetes mellitus (aOR, 2.25 [95% CI, 1.66 - 3.04]); and active and progressing cancer (aOR, 12.5 [95% CI, 6.89 - 22.6]). Hispanic ethnicity, timing and type of anti-cancer therapy modalities were not significantly associated with worse COVID-19 outcomes. The total all-cause mortality and hospitalization rate for the entire cohort was 9% and 37%, respectively however, it varied according to the BC disease status. Conclusions: Using one of the largest registries on cancer and COVID-19, we identified patient and BC related factors associated with worse COVID-19 outcomes. After adjusting for baseline characteristics, underrepresented racial/ethnic patients experienced worse outcomes compared to Non-Hispanic White patients.

Patient Understanding of Oncologic Radiology Reports: Is Access to Electronic Medical Records Helpful?

Access to electronic medical record (EMR) patient portals made it easier for patients to quickly acquire the results of their radiology studies. However, there is little research on how well oncology patients understand the findings of radiology reports presented in the online portal without patient-physician discussion. This study assessed oncology patients' confidence and accuracy in interpreting radiology reports either with or without layman translations. A survey based on a radiology report was administered to oncology patients and caregivers. Two versions of the radiological report were randomly distributed, either a standard report or one with layman translations to evaluate participant understanding and accuracy of interpreting radiological results. Among 85 participants, a majority (67.8%) reported wanting patient portal access to radiological reports, yet less than a quarter (21.2%) felt confident in reading and interpreting radiological reports. Univariate binary logistic regression models showed that participants who read the lay report were 8 times more likely to find the radiology report easy to read. This research demonstrated that the inclusion of layman translation of standard radiology reports improves oncology patients' and caregivers' understanding of such reports with statistically significant and clinically meaningful increases in readability.

Pancreatic cancer among Pacific Islanders: a comprehensive analysis of an understudied racial group.

OBJECTIVE: Racial disparities in care and outcome have been demonstrated for several cancers, but it is not clear that a similar discrepancy exists for pancreatic cancer. Furthermore, there are limited data describing the pancreatic cancer experience of Pacific Islanders. The primary objective of this study was to analyze the clinical characteristics, treatment, and outcomes of Pacific Islander patients with pancreatic cancer. DESIGN: We obtained data for a consecutive sample of pancreatic adenocarcinoma patients who presented to the largest hospital in Hawaii from 1 January 2000, through 31 December 2019. Analyses were performed for the entire population and separately for patients who had their cancer resected. Overall survival was calculated by the Kaplan-Meier method. Cox proportional hazards regression models were constructed to determine the prognostic capacity of clinical and pathologic factors. RESULTS: A total of 1040 patients were included in the final analysis. Pacific islanders presented at a significantly younger age compared to Whites or Asians and had the highest Medicaid rate. There were no statistically significant racial differences in stage at presentation or treatments. We did not demonstrate an association between race and survival on univariate analysis, nor after adjusting for demographic and tumor factors. Age, stage, and treatment were significantly associated with survival for both univariate and multivariate analyses. CONCLUSION: We did not demonstrate disparate outcomes among Pacific Islanders with pancreatic cancer. This is likely due in part to the absence of a screening test and the notable poor prognosis of pancreatic adenocarcinoma. Furthermore, equity in treatment may have contributed to racial parity in survival.

Racial Disparities in Patient-Provider Communication During Telehealth Visits Versus Face-to-face Visits Among Asian and Native Hawaiian and Other Pacific Islander Patients With Cancer: Cross-sectional Analysis.

BACKGROUND: Telehealth visits increase patients' access to care and are often rated as "just as good" as face-to-face visits by oncology patients. Telehealth visits have become increasingly more common in the care of patients with cancer since the advent of the COVID-19 pandemic. Asians and Pacific Islanders are two of the fastest growing racial groups in the United States, but there are few studies assessing patient satisfaction with telemedicine among these two racial groups. OBJECTIVE: Our objective was to compare satisfaction with communication during telehealth visits versus face-to-face visits among oncology patients, with a specific focus on Asian patients and Native Hawaiian and other Pacific Islander (NHOPI) patients. METHODS: We surveyed a racially diverse group of patients who were treated at community cancer centers in Hawaii and had recently experienced a face-to-face visit or telehealth visit. Questions for assessing satisfaction with patient-physician communication were adapted from a previously published study of cancer survivors. Variables that impact communication, including age, sex, household income, education level, and cancer type and stage, were captured. Multivariable logistic models for patient satisfaction were created, with adjustments for sociodemographic factors. RESULTS: Participants who attended a face-to-face visit reported higher levels of satisfaction in all communication measures than those reported by participants who underwent a telehealth encounter. The univariate analysis revealed lower levels of satisfaction during telehealth visits among Asian participants and NHOPI participants compared to those among White participants for all measures of communication (eg, when asked to what degree "[y]our physician listened carefully to you"). Asian patients and NHOPI patients were significantly less likely than White patients to strongly agree with the statement (P<.004 and P<.007, respectively). Racial differences in satisfaction with communication persisted in the multivariate analysis even after adjusting for sociodemographic factors. There were no significant racial differences in communication during face-to-face visits. CONCLUSIONS: Asian patients and NHOPI patients were significantly less content with patient-physician communication during telehealth visits when compared to White patients. This difference among racial groups was not seen in face-to-face visits. The observation that telehealth increases racial disparities in health care satisfaction should prompt further exploration.

FOLFOXIRI in Pregnant Women with Colorectal Cancer: A Case Report and Review of the Literature.

Colorectal cancer (CRC) in pregnancy is rare and often presents at a late stage due to the masking of signs by pregnancy. A typical chemotherapeutic regimen for stage III and IV CRC comprised 5-Fluorouracil (5-FU) and oxaliplatin. The treatment of CRC during pregnancy is complicated owing to the potential risk of teratogenicity with chemotherapy, especially in the first trimester. Data suggest that the administration of chemotherapy beyond the first trimester may be relatively safe. Previous reports have shown success with the use of FOLFOX (folinic acid, 5-FU, oxaliplatin) and FOLFIRI (folinic acid, 5-FU, irinotecan) during pregnancy. Moreover, neoadjuvant FOLFOXIRI (folinic acid, 5-FU, oxaliplatin, irinotecan) resulted in improved outcomes when compared to standard preoperative chemoradiotherapy in the treatment of locally advanced and metastatic CRC. The use of FOLFOXIRI in pregnancy is not currently documented, and therefore, the outcomes of using this chemotherapeutic regimen are unclear. The aim of this case report was to demonstrate the use of FOLFOXIRI in pregnancy. A retrospective chart review was performed to assess the clinical course and fetal outcome of 2 patients presented in this case report. FOLFOXIRI was initiated in two pregnant women with nonmetastatic and metastatic CRC, resulting in successful delivery of healthy infants. FOLFOXIRI is an effective chemotherapy regimen for the treatment of advanced CRC and may be used during the second and third trimesters of pregnancy.

Impact of Breast Cancer Awareness Month on Public Interest in the United States between 2012 and 2021: A Google Trends Analysis.

Breast Cancer Awareness Month (BCAM) has a long history of over 30 years, established in 1985 to occur every October, and the National Breast Cancer Foundation now leads the operation. There have been no studies to evaluate the impact of the BCAM on public awareness of breast cancer. We analyzed the impact of BCAM on public awareness of breast cancer in the U.S. from 2012 to 2021 using the relative search volume (RSV) of Google Trends as a surrogate. We also analyzed the impact of Lung Cancer Awareness Month (LCAM) and Prostate Cancer Awareness Month (PCAM) on public awareness of lung and prostate cancer, respectively, to see differences in their effectiveness among the health observances for the top three most common cancers in the U.S. We performed a joinpoint regression analysis to identify statistically significant time points of a change in trend. There were joinpoints around BCAM for "Breast cancer" every year from 2012 to 2021, with a significant increase in the weekly RSVs from 21.9% to 46.7%. Except for 2013 and 2015 for "Lung cancer", when significant increases in the RSV at 1.8% and 1.2% per week were observed around LCAM, no joinpoints were noted around LCAM or PCAM. These results imply that BCAM has successfully improved the public awareness of breast cancer in the U.S. compared to other representative health observances, likely due to the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.

Pre-Diagnosis Aspirin Use Has No Effect on Overall Survival in Patients With Colorectal Cancer: A Study of a Multi-Racial Population.

Introduction Aspirin has been associated with a reduction in mortality in patients diagnosed with colorectal cancer (CRC). A possible mechanism for this is related to the programmed cell death 1 (PD-1) immune checkpoint pathway. Aspirin may have a synergistic effect with PD-1 inhibitors via inhibition of prostaglandin E2 (PGE2) production, which can reverse the ability of tumor cells to evade the immune system. This appears to be strongest in cancers that express PI3 kinase (PI3K) signaling activity, which aspirin downregulates. However, the benefit of pre-diagnosis aspirin use on CRC overall survival (OS) and cancer-specific survival is still controversial, and most studies have been performed in racially homogenous populations. Our study examines the effect of pre-diagnosis aspirin therapy on OS in a racially diverse group of patients with CRC. Methods This is a retrospective chart review of 782 patients diagnosed with CRC from January 2007 to December 2020. Kaplan-Meier curve was created to study the association of aspirin exposure compared to no exposure on OS. In addition, univariate and multivariate binary logistic regression analyses were done to investigate potential predictors of survival. Results Of the 782 patients with CRC, 55.1% were males, 22.2% whites, 58.5% Asians, and 17.7% Pacific-Islanders. Moreover, 38.4% of the patients had a history of aspirin use, 79% of them used it for more than one year. There were more patients with hypertension (HTN), hyperlipidemia (HLD), diabetes mellitus (DM), and chronic kidney disease (CKD) among those with a history of aspirin use. There was no difference in one, three, and five-year OS among aspirin users compared to non-users, p-value = 0.63. Age, grade, and stage were potential predictors of worsened OS. However, treatment with chemotherapy and CKD were potential predictors of worsened OS on univariate analysis only. No significant association was noticed with gender, tumor location, or other associated comorbidities. Conclusion The effect of pre-diagnosis aspirin use on CRC survival is not clear. In this retrospective analysis of a racially diverse population of CRC patients, we found that aspirin use was not associated with improved OS. Therefore, physicians should be careful about using aspirin as adjuvant therapy in CRC patients until high-quality prospective data are available, given the potential associated complications.

Disaggregating Data on Pacific Islander Gastric Cancer Patients Reveals Survival Disparity.

PURPOSE: The incidence and prognosis of Pacific Islanders with gastric cancer is not well documented as previous studies have often aggregated this population with Asians. The purpose of our study was to describe patient and tumor characteristics, as well as prognostic factors of Pacific Islanders with gastric cancer. METHODS: Patients diagnosed with gastroesophageal junction or gastric adenocarcinoma between 2000 and 2014 were identified in the tumor registry of the largest hospital in Hawaii. Overall survival of Asians, Whites, and Pacific Islanders were calculated using the Kaplan-Meier method and log-rank test. Cox proportional hazards regression models were constructed to assess predictors of survival adjusting for clinical and pathological factors. RESULTS: A total of 615 patients were included in the final analysis. Pacific Islanders were found to present at a younger age, were more often uninsured or had Medicaid insurance, and were diagnosed with a higher stage of cancer compared to their Asian and White counterparts. Pacific Islanders were less likely to undergo surgery even after adjusting for stage. Race was a prognostic factor and survival was lowest among Pacific Islanders, but only if the model was unadjusted for treatment. CONCLUSIONS: We present an analysis of the largest cohort of Pacific Islander gastric cancer patients. Pacific Islanders have different sociodemographic characteristics and inferior survival compared to Asian patients and should be independently studied.

Overcoming racial disparities in cancer clinical trial enrollment of Asians and Native Hawaiians.

Background: Asians and Native Hawaiians are two of the fastest growing minority populations in the United States, however these racial minority groups are severely underrepresented in clinical trials. This study looks at cancer clinical trial accrual among Asians and Native Hawaiians in a community-based network with a mission of increasing minority accrual to studies. Methods: The University of Hawaii Cancer Center (UHCC) network enrolls patients to treatment and non-treatment cancer studies. Enrollment on studies opened between 2009 and 2013 were obtained from UHCC's clinical trial management system. Incidence of cancer by race was acquired from the Hawaii Tumor Registry. Enrollment fractions were compared for the most common races in the state: White, Asian (specifically Chinese, Filipino, Japanese), and Native Hawaiian. Results: Whites comprised the largest proportion of cancer patients and participants in trials. Asians and Native Hawaiians were enrolled into cancer clinical trials at the same or higher enrollment fraction compared to Whites. Chinese, Japanese, and Native Hawaiian patients participated in treatment trials significantly more often than Whites (p < 0.05). Similarly, Chinese and Native Hawaiians enrolled in non-treatment trials at a significantly higher rate compared to Whites (p < 0.05). Conclusions: The UHCC network has instituted many strategies to increase minority accrual that have likely led to Asian and Native Hawaiian patients participating in studies at least as often as White patients. The strategies implemented at UHCC may benefit similar communities with a high number of minority cancer patients.

Phase Ib study of patients with metastatic castrate-resistant prostate cancer treated with different sequencing regimens of atezolizumab and sipuleucel-T.

BACKGROUND: Combining an immune checkpoint inhibitor with a tumor vaccine may modulate the immune system to leverage complementary mechanisms of action that lead to sustained T-cell activation and a potent prolonged immunotherapeutic response in metastatic castration resistant prostate cancer (mCRPC). METHODS: Subjects with asymptomatic or minimally symptomatic mCRPC were randomly assigned in a 1:1 ratio to receive either atezolizumab followed by sipuleucel-T (Arm 1) or sipuleucel-T followed by atezolizumab (Arm 2). The primary endpoint was safety, while secondary endpoints included preliminary clinical activity such as objective tumor response and systemic immune responses that could identify key molecular and immunological changes associated with sequential administration of atezolizumab and sipuleucel-T. RESULTS: A total of 37 subjects were enrolled. The median age was 75.0 years, median prostate specific antigen (PSA) was 21.9 ng/mL, and subjects had a median number of three prior treatments. Most subjects (83.8%) had at least one treatment-related adverse event. There were no grade 4 or 5 toxicities attributed to either study drug. Immune-related adverse events and infusion reactions occurred in 13.5% of subjects, and all of which were grade 1 or 2. Of 23 subjects with Response Evaluation Criteria in Solid Tumors measurable disease, only one subject in Arm 2 had a partial response (PR) and four subjects overall had stable disease (SD) at 6 months reflecting an objective response rate of 4.3% and a disease control rate of 21.7%. T-cell receptor diversity was higher in subjects with a response, including SD. Immune response to three novel putative antigens (SIK3, KDM1A/LSD1, and PIK3R6) appeared to increase with treatment. CONCLUSIONS: Overall, regardless of the order in which they were administered, the combination of atezolizumab with sipuleucel-T appears to be safe and well tolerated with a comparable safety profile to each agent administered as monotherapy. Correlative immune studies may suggest the combination to be beneficial; however, further studies are needed. TRIAL REGISTRATION NUMBER: NCT03024216.

Transarterial Radioembolization for Hepatocellular Carcinoma with Major Vascular Invasion: A Nationwide Propensity Score-Matched Analysis with Target Trial Emulation.

PURPOSE: To examine National Cancer Database (NCDB) data to comparatively evaluate overall survival (OS) between patients undergoing transarterial radioembolization (TARE) and those undergoing systemic therapy for hepatocellular carcinoma with major vascular invasion (HCC-MVI). METHODS: One thousand five hundred fourteen patients with HCC-MVI undergoing first-line TARE or systemic therapy were identified from the NCDB. OS was compared using propensity score-matched Cox regression and landmark analysis. Efficacy was also compared within a target trial framework. RESULTS: TARE usage doubled between 2010 and 2015. Intervals before treatment were longer for TARE than for systemic therapy (mean [median], 66.5 [60] days vs 46.8 (35) days, respectively, P < .0001). In propensity-score-matched and landmark-time-adjusted analyses, TARE was found to be associated with a hazard ratio of 0.74 (95 % CI, 0.60-0.91; P = .005) and median OS of 7.1 months (95 % CI, 5.0-10.5) versus 4.9 months (95 % CI, 3.9-6.5) for systemically treated patients. In an emulated target trial involving 236 patients with unilobular HCC-MVI, a low number of comorbidities, creatinine levels <2.0 mg/dL, bilirubin levels <2.0 mg/dL, and international normalized ratio <1.7, TARE was found to be associated with a hazard ratio of 0.57 (95 % CI, 0.39-0.83; P = .004) and a median OS of 12.9 months (95 % CI, 7.6-19.2) versus 6.5 months (95 % CI, 3.6-11.1) for the systemic therapy arm. CONCLUSIONS: In propensity-score-matched analyses involving pragmatic and target trial HCC-MVI cohorts, TARE was found to be associated with significant survival benefits compared with systemic therapy. Although not a substitute for prospective trials, these findings suggest that the increasing use of TARE for HCC-MVI is accompanied by improved OS. Further trials of TARE in patients with HCC-MVI are needed, especially to compare with newer systemic therapies.

A 95-gene signature stratifies recurrence risk of invasive disease in ER-positive, HER2-negative, node-negative breast cancer with intermediate 21-gene signature recurrence scores.

PURPOSE: A subset of patients with intermediate 21-gene signature assay recurrence score may benefit from adjuvant chemoendocrine therapy, but a predictive strategy is needed to identify such patients. The 95-gene signature assay was tested to stratify patients with intermediate RS into high (95GC-H) and low (95GC-L) groups that were associated with invasive recurrence risk. METHODS: Patients with ER-positive, HER2-negative, node-negative breast cancer and RS 11-25 who underwent definitive surgery and adjuvant endocrine therapy without any cytotoxic agents were included. RNA was extracted from archived formalin-fixed, paraffin-embedded samples, and 95-gene signature was calculated. RESULTS: 206 patients had RS of 11-25 (95GC-L, N = 163; 95GC-H, N = 43). In Cox proportional hazards model, 95GC-H was significantly associated with shorter time to recurrence than was 95GC-L (HR 5.94; 95%CI 1.81-19.53; P = 0.005). The correlation between 95-gene signature and 21-gene signature assay scores was not strong (correlation coefficient r = 0.27), which might suggest that 95-gene signature reflects biological characteristics differing from what 21-gene signature shows. CONCLUSIONS: The 95-gene signature stratifies patients with ER-positive, HER2-negative, node-negative invasive breast cancer and intermediate RS of 11-25 into high and low groups that are associated with recurrence risk of invasive disease. Further retrospective analysis in the prospectively accrued TAILORx population is warranted to confirm that 95-gene signature can identify patients who would benefit from adjuvant chemoendocrine therapy.