Surgical complications in combined rhinoplasty and endoscopic sinus surgery.

KEY POINTS: Complications in combined surgery are equivalent to ESS but are higher than rhinoplasty alone. The most common complications are pneumonia, stroke, and epistaxis. Rhinoplasty surgeries with graft use have a higher risk of complications.

Bcl-2 Up-Regulation Mediates Taxane Resistance Downstream of APC Loss.

Triple-negative breast cancer (TNBC) patients are treated with traditional chemotherapy, such as the taxane class of drugs. One such drug, paclitaxel (PTX), can be effective in treating TNBC; however, many tumors will develop drug resistance, which can lead to recurrence. In order to improve patient outcomes and survival, there lies a critical need to understand the mechanism behind drug resistance. Our lab made the novel observation that decreased expression of the Adenomatous Polyposis Coli (APC) tumor suppressor using shRNA caused PTX resistance in the human TNBC cell line MDA-MB-157. In cells lacking APC, induction of apoptosis by PTX was decreased, which was measured through cleaved caspase 3 and annexin/PI staining. The current study demonstrates that CRISPR-mediated APC knockout in two other TNBC lines, MDA-MB-231 and SUM159, leads to PTX resistance. In addition, the cellular consequences and molecular mechanisms behind APC-mediated PTX response have been investigated through analysis of the BCL-2 family of proteins. We found a significant increase in the tumor-initiating cell population and increased expression of the pro-survival family member Bcl-2, which is widely known for its oncogenic behavior. ABT-199 (Venetoclax), is a BH3 mimetic that specifically targets Bcl-2. ABT-199 has been used as a single or combination therapy in multiple hematologic malignancies and has shown promise in multiple subtypes of breast cancer. To address the hypothesis that APC-induced Bcl-2 increase is responsible for PTX resistance, we combined treatment of PTX and ABT-199. This combination treatment of CRISPR-mediated APC knockout MDA-MB-231 cells resulted in alterations in apoptosis, suggesting that Bcl-2 inhibition restores PTX sensitivity in APC knockout breast cancer cells. Our studies are the first to show that Bcl-2 functional inhibition restores PTX sensitivity in APC mutant breast cancer cells. These studies are critical to advance better treatment regimens in patients with TNBC.

Current gaps in emergency medicine core content education for oncologic emergencies: A targeted needs assessment.

Objective: The core content of emergency medicine (EM) residency training includes the management of oncologic emergencies; however, documented knowledge gaps continue to exist in this subtopic. This study represents a targeted needs assessment as indicated by Step 2 of Kern's curriculum design to determine the specific training gaps to be addressed within the oncologic EM curriculum. Methods: A multi-institutional cross-sectional survey of oncologists (surgical and medical) and emergency physicians (attendings and residents) was conducted during 2023 at five institutions. The voluntary survey consisted of general and specialty-specific questions exploring gaps in oncologic emergency-specific training/education topics. Descriptive statistics reported responses as frequencies and percentages. Results: Of the 833 surveys sent across the five sites, 302 (36.3%) were accessed by link; of these, 271 (89.7%) surveys were completed. There were no differences in the responses between early and later respondents and no differences in the characteristics of respondents between sites. A vast majority of the oncologist and EM groups (91.2% and 83.0%, respectively) reported a belief that emergency physicians would benefit from additional oncologic emergency training. Our survey identified 16 important topics for inclusion in an oncologic EM curriculum, including five topics not present on the 2022 Model of Clinical Practice of Emergency Medicine. Conclusions: Based on this needs assessment, an oncologic EM curriculum should include the topics listed under oncologic emergencies in the 2022 Model of the Clinical Practice of Emergency Medicine along with our respondent-identified topics of radiation therapy adverse effects, stem cell transplant complications, and the management of cancer-specific postsurgical complications, pain, and common diseases in patients with cancer.

Cesarean hysterectomy for placenta accreta spectrum: 3-2-1 approach.

Given the high risk of complications associated with cesarean hysterectomy for placenta accreta spectrum (PAS), any surgical approach and technique can yield utility in reducing the surgical morbidity. Here, we propose the 3-2-1 approach as a schema to be implemented in the proper setting for the surgical management of a PAS cesarean hysterectomy. The 3-2-1 approach begins with the surgical dissection of three anatomical landmarks that ultimately facilitate a safe surgical site for the ligation and transection of the uterine vessels. First-step is identification of the three anatomical landmarks which are (i) posterior lower uterine segment peritoneum de-serosalization, (ii) identification of the ureters laterally, and (iii) anterior bladder dissection. Posterior-to-anterior progression avoids encountering dense adhesions and hypervascularity in the anterior lower uterine segment early in the surgery. Further, allows better mobilization of the uterus to identify the anatomical landmarks laterally and anteriorly. Second-step is to deploy the 2-hand technique where the surgeon places one hand anteriorly and the other hand posteriorly in the lower uterine segment below the placental bed. The surgeon brings both hands together with flexed fingers perpendicular to the uterine tissue and gently elevates the uterus and placenta out of the pelvis and ensures safe anatomical distance to surrounding structures. Third-step is the consideration of a supracervical hysterectomy. In summary, this 3-2-1 approach to reflect the anatomy of enlarged lower uterine segment in PAS is a stepwise schema that can aid surgeons in the completion of a cesarean hysterectomy, with the goal to improve surgical outcomes.

Building an adverse outcome pathway network for estrogen-, androgen- and steroidogenesis-mediated reproductive toxicity.

Introduction: Adverse Outcome Pathways (AOPs) can support both testing and assessment of endocrine disruptors (EDs). There is, however, a need for further development of the AOP framework to improve its applicability in a regulatory context. Here we have inventoried the AOP-wiki to identify all existing AOPs related to mammalian reproductive toxicity arising from disruption to the estrogen, androgen, and steroidogenesis modalities. Core key events (KEs) shared between relevant AOPs were also identified to aid in further AOP network (AOPN) development. Methods: A systematic approach using two different methods was applied to screen and search the entire AOP-wiki library. An AOPN was visualized using Cytoscape. Manual refinement was performed to remove AOPS devoid of any KEs and/or KERs. Results: Fifty-eight AOPs relevant for mammalian reproductive toxicity were originally identified, with 42 AOPs included in the final AOPN. Several of the KEs and KE relationships (KERs) described similar events and were thus merged to optimize AOPN construction. Sixteen sub-networks related to effects on hormone levels or hormone activity, cancer outcomes, male and female reproductive systems, and overall effects on fertility and reproduction were identified within the AOPN. Twenty-six KEs and 11 KERs were identified as core blocks of knowledge in the AOPN, of which 19 core KEs are already included as parameters in current OECD and US EPA test guidelines. Discussion: The AOPN highlights knowledge gaps that can be targeted for further development of a more complete AOPN that can support the identification and assessment of EDs.

Lymph Node Isolated Tumor Cells in Patients With Endometrial Cancer.

Importance: Isolated tumor cells (ITCs) are the histopathological finding of small clusters of cancer cells no greater than 0.2 mm in diameter in the regional lymph nodes. For endometrial cancer, the prognostic significance of ITCs is uncertain. Objective: To assess clinico-pathological characteristics and oncologic outcomes associated with ITCs in endometrial cancer. Design, Setting, and Participants: This retrospective cohort study using the National Cancer Database included patients with endometrial cancer who had primary hysterectomy and nodal evaluation from 2018 to 2020. Patients with microscopic and macroscopic nodal metastases and distant metastases were excluded. Data were analyzed from June to September 2023. Exposure: Regional nodal status with ITCs (N0[i+] classification) or no nodal metastasis (N0 classification). Main Outcomes and Measures: (1) Clinical and tumor characteristics associated with ITCs, assessed with multivariable binary logistic regression model, and (2) overall survival (OS) associated with ITCs, evaluated by nonproportional hazard analysis with restricted mean survival time at 36 months. Results: A total of 56 527 patients were included, with a median (IQR) age of 64 (57-70) years. The majority had T1a lesion (37 836 [66.9%]) and grade 1 or 2 endometrioid tumors (40 589 [71.8%]). ITCs were seen in 1462 cases (2.6%). In a multivariable analysis, ITCs were associated with higher T classification, larger tumor size, lymphovascular space invasion (LVSI), and malignant peritoneal cytology. Of those tumor factors, LVSI had the largest association with ITCs (7.9% vs 1.4%; adjusted odds ratio [aOR], 4.37; 95% CI, 3.87-4.93), followed by T1b classification (5.3% vs 1.3%; aOR, 2.62; 95% CI, 2.30-2.99). At the cohort level, 24-month OS rates were 94.3% (95% CI, 92.4%-95.7%) for the ITC group and 96.1% (95% CI, 95.9%-96.3%) for the node-negative group, and the between-group difference in expected mean OS time at 36 months was 0.35 (SE, 0.19) months, but it was not statistically significant (P = .06). There was a statistically significant difference in OS when the low-risk group (stage IA, grade 1-2 endometrioid tumors with no LVSI) was assessed per nodal status and adjuvant therapy use (P < .001): (1) among the cases treated with surgical therapy alone, 24-month OS rates were 95.9% (95% CI, 89.5%-98.5%) for the ITC group and 98.8% (95% CI, 98.6%-99.0%) for the node-negative group, and the between-group mean OS time difference at 36 months was 0.61 (SE, 0.43) months (P = .16); and (2) among the cases with ITCs, adjuvant therapy (radiotherapy alone, systemic chemotherapy alone, or both) was associated with improved survival compared with no adjuvant therapy (24-month OS rates, 100% vs 95.9%; between-group mean OS time difference at 36 months, 0.95 [SE, 0.43] months; P = .03). Conclusions and Relevance: In this cohort study of patients with surgically staged endometrial cancer, the results of exploratory analysis suggested that presence of ITCs in the regional lymph node may be associated with OS in the low-risk group. While adjuvant therapy was associated with improved OS in the low-risk group with ITCs, careful interpretation is necessary given the favorable outcomes regardless of adjuvant therapy use. This hypothesis-generating observation in patients with low-risk endometrial cancer warrants further investigation, especially with prospective setting.

Energy-Based Devices for the Treatment of Cutaneous Verrucae: A Systematic Review.

BACKGROUND: Warts are one of the most common benign neoplasms caused by human papillomavirus infection and often pose a therapeutic challenge. OBJECTIVE: To summarize the current evidence on the safety and efficacy of laser and energy-based devices for the treatment of cutaneous verrucae. METHODS: A comprehensive systematic review of the literature on laser and energy-based devices for the treatment of cutaneous verrucae was performed. RESULTS: A total of 904 unique studies were identified, of which 109 were included in this review. The most commonly used lasers as a single treatment modality for verrucae included the long-pulsed Nd:Yag (n = 20) and pulsed dye (n = 18) lasers. Other modalities included the CO2 ablative laser (n = 10), photodynamic therapy (n = 11), local hyperthermia (n = 11), microwave therapy (n = 2), and nanopulse stimulation (n = 1). Other studies combined energy-based modalities with additional treatments, such as retinoids, imiquimod, and intralesional bleomycin. Overall, such devices were generally well-tolerated, with only a mild side effect profile. CONCLUSION: Overall, the use of laser and energy-based devices is a safe and well-tolerated option for cutaneous verrucae that is relatively less invasive than surgical interventions. Future studies using more consistent outcome assessment tools will be valuable to help clinicians develop device-specific protocols and treatment regimens to ensure replicable and effective outcomes.

Low-grade endometrioid endometrial cancer with adnexal only metastasis: Evaluation of de-escalation of adjuvant therapy.

OBJECTIVE: To assess survival outcomes of stage IA3 endometrial cancer and the association of adjuvant therapy and survival. METHODS: The National Cancer Database was retrospectively queried to examine 594 and 1455 patients with stage IA3 and IIIA1 endometrial cancer, respectively, from 2010-2015. Overall survival (OS) was examined based on adjuvant therapy: multimodal combination chemotherapy and external beam radiotherapy, chemotherapy alone, external beam radiotherapy alone, and none. RESULTS: For stage IA3 disease, 109 (18.4%) patients did not receive adjuvant therapy. The 5-year OS rates for the no adjuvant therapy group and the combination group were 86.3% and 91.4%, respectively (adjusted-hazard ratio [aHR] 1.23, 95% confidence interval [CI] 0.70-2.18). This survival association was consistent when compared to chemotherapy alone (5-year OS rates 86.3% vs 86.3%, aHR 1.11, 95%CI 0.67-1.83). The results were similar among those who underwent nodal evaluation (5-year OS rates, 92.6%, 86.6%, and 89.4% for combination therapy, chemotherapy alone, and no adjuvant therapy), including grade 1 lesions (96.2%, 89.4%, and 100%, respectively). In grade 2 lesions, 5-year OR rates was modestly lower for no adjuvant therapy than combination therapy (89.4%, 84.0%, and 82.7% for combination, chemotherapy alone, and no adjuvant therapy, P = 0.03). For stage IIIA1 disease, omission of adjuvant therapy was associated with decreased OS compared to combination therapy (43.2% vs 73.1%, aHR 1.65, 95%CI 1.30-2.11) or chemotherapy alone (43.2% vs 67.1%, aHR 1.62, 95%CI 1.32-1.99). CONCLUSION: The results of this investigation suggest that survival effects of adjuvant therapy differ for stage IA3 and IIIA1 diseases. Patients with stage IA3 disease have overall good prognosis regardless of adjuvant therapy particularly grade 1 lesions, partly supporting the FIGO committee suggestion for adjuvant therapy de-escalation in stage IA3 endometrial cancer.

Telemedicine vs Telephone Consultations and Medication Prescribing Errors Among Referring Physicians: A Cluster Randomized Crossover Trial.

Importance: Critically ill children presenting to emergency departments (EDs) in non-children's hospitals are at high risk for experiencing medical errors, including medication errors. Video telemedicine consultations with pediatric specialists have the potential to reduce the risk of medication errors beyond the current standard of care, telephone consultations. Objective: To compare the rates of ED physician-related medication errors among critically ill children randomized to receive either video telemedicine or telephone consultations. Design, Setting, and Participants: This cluster randomized, unbalanced crossover trial was conducted at 15 community EDs in northern California between September 2014 and March 2018. Analyses were conducted from May 2022 to January 2023. Participants included acutely ill children younger than 15 years presenting to a participating ED. Interventions: Participating EDs were randomized to use video telemedicine or telephone for consultations with pediatric critical care physicians according to 1 of 4 unbalanced (3 telemedicine to 1 telephone) crossover treatment assignment sequences. Main Outcomes and Measures: Pharmacists reviewed medical records to document physician-related medication errors using a previously validated instrument. Multilevel logistic regression analyses were performed to create models with the medication order as the unit of analysis and adjusting for age, the log-transformed Revised Pediatric Emergency Assessment Tool score, and hospital study period. Results: A total of 696 patient encounters were included in the trial (mean [SD] age, 4.2 [4.6] years; median [IQR] age, 2.1 [0.5-2.1] years; 304 female [43.7%]), with 537 patient encounters (77.2%) assigned to video telemedicine and 159 patient encounters (22.8%) assigned to telephone. At least 1 physician-related medication error occurred for 87 patients (12.5%), including 20 of 159 patients (12.6%) in the telephone cohort and 67 of 537 patients (12.5%) in the telemedicine cohort. Of the 2414 medication orders, errors occurred in 124 cases (5.1%), including 26 of 513 orders (5.1%) in the telephone cohort and 98 of 1901 orders (5.2%) in the telemedicine cohort. In the multivariable analysis, the adjusted odds ratio of experiencing a medication error among those assigned to telemedicine was 0.86 (95% CI, 0.49-1.52; P = .61). Conclusions and Relevance: This cluster randomized crossover trial found no statistically significant differences in physician-related medication errors between critically ill children assigned to receive telephone consultations vs video telemedicine consultations. Trial Registration: ClinicalTrials.gov Identifier: NCT02877810.

15 years of patient-reported outcomes in clinical trials leading to GU cancer drug approvals: a systematic review on the quality of data reporting and analysis.

Background: Standardized, high-quality PRO data reporting is crucial for patient centered care in the field of oncology, especially in clinical trials that establish standard of care. This study evaluated PRO endpoint design, conduct and reporting methods in FDA approved drugs for GU malignancies. Methods: A systematic review of the FDA archives identified GU cancer drug approvals from Feb 2007 to July 2022. ClinicalTrials.gov and PubMed were used to retrieve relevant data. PRO data was screened, and analytic tools, interpretation methods in the published papers and study protocols were reviewed. Compliance with PRO reporting standards were assessed using PRO Endpoint Analysis Score (PROEAS), a 24-point scoring scale from Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium (SISAQOL). Findings: We assessed 40 trial protocols with 27,011 participants, resulting in 14 renal cell cancer (RCC), 16 prostate cancer (PC), and 10 urothelial cancer (UC) approvals. PRO data was published for 27 trials, with 23 PRO publications (85%) focusing solely on PRO data, while 4 (15%) included PRO data in the original paper. Median time between primary clinical and secondary paper with PRO data was 10.5 months (range: 9-25 months). PROs were not planned as primary endpoints for any study but 14 (52%) reported them as secondary, 10 (37%) as exploratory outcomes, and 3 (11%) lacked any clarity on PRO data as endpoint. Mean PROEAS score of all GU cancers was 11.10 (range: 6-15), RCC (11.86, range: 6-15), UC (11.50, range: 9-14), and PC (10.56, range: 6-15). None met all the SISAQOL recommendations. Interpretation: Low overall PROEAS score and delays in PRO data publication in GU cancer drug trials conducted in the past decade emphasize the need for improvement in quality of design and conduct of PRO endpoint in future trials and accelerated publication of PRO endpoints, using standardized analysis, and prespecified hypothesis driven endpoint. These improvements are essential for facilitating interpretation and application of PRO study findings to define patient care. Funding: None.

An absence of translated consent forms limits oncologic clinical trial enrollment for limited English proficiency participants.

OBJECTIVES: A lack of diversity amongst participants in cancer clinical trials has raised scrutiny over the past decade. Patients with limited English proficiency (LEP) are further excluded. One modifiable reason for low LEP participation is a lack of non-English consent forms. METHODS: We queried the clinical trials registry database at an academic hospital serving a predominantly Spanish-speaking patient population. Clinical trials related to gynecology oncology were evaluated for the availability of fully translated Spanish consent forms, the racial and ethnic identification of enrolled patients, and the number of signed Spanish consents. Enrolment data was compared before and after 2019, when institutional financial support for document translation was withdrawn. RESULTS: Sixteen gynecologic oncology clinical trials were opened between 2014 and 2022, with 10 trials enrolling 128 patients. Eight trials opened prior to 2019, all with fully translated consent forms. Seven of these trials enrolled 99 participants, 70% of whom identified as Hispanic and 60% who signed a Spanish consent. Eight trials opened after 2019 and one had a fully translated consent form. Three of the trials enrolled 29 participants, with 10% of subjects identifying as Hispanic and none signing a Spanish consent form. CONCLUSIONS: There was a decrease in fully translated clinical trial consent forms for gynecologic oncology studies following the loss of subsidized translation services in our single institution with a predominantly LEP population. This correlated with a decrease in enrollment of Hispanic subjects. To increase enrollment of diverse participants, including those with LEP, simple actions such as fully translating consent forms would help maintain equity in research conduct and improve clinical outcomes through trial involvement.

Quantifying the Subjective Experience of Nasal Obstruction: A Review.

Nasal obstruction is an exceedingly common problem and challenging to treat due to its multifactorial etiology. Therefore, measuring treatment outcomes of nasal obstruction can be equally complex yet vital to appropriately assessing symptom improvement or resolution. Both physiologic and anatomic assessments of the nasal airway exist in addition to validated patient-reported outcome measures (PROMs), which objectify subjective nasal obstruction and sinonasal symptoms. Correlation between objective and subjective treatment outcome measures is controversial with clinical guidelines favoring the use of PROMs for surgical treatment of nasal obstruction. In this review, the anatomic and physiologic measurements of the nasal airway and validated PROMs will be discussed, as well as the rationale for implementing PROMs into the rhinoplasty surgeon's practice.

Barriers, Facilitators, and Strategies for Developing a Culturally Informed Lifestyle Intervention for Native Hawaiian, CHamoru, and Filipino Breast Cancer Survivors: Mixed-Methods Findings from Focus Group Participants.

Breast cancer disproportionately impacts Native Hawaiian, CHamoru, and Filipino women. Few culturally informed interventions addressing breast cancer survivors exist and none have been developed or tested specifically for Native Hawaiian, CHamoru, and Filipino women. This study aimed to conduct focus groups with Native Hawaiian, CHamoru, and Filipino women previously diagnosed with breast cancer to inform future research in Guam and Hawai'i. Convenience sampling and grounded theory approaches were used. Focus group sessions were conducted during summer 2023 and included questions to understand the barriers, motivators, and implementation recommendations for lifestyle interventions aimed at reducing the risk for breast cancer recurrence among the target population. Data saturation was reached after a total of seven focus groups (an average of four survivors/group per site) were conducted (three in Hawai'i and four in Guam), which represented 28 breast cancer survivors. Themes from the focus groups emerged around developing support systems with other survivors, providing physical activity and nutrition intervention activities and materials in multiple formats, and incorporating activities and foods that accommodate the side effects of breast cancer treatments and are culturally relevant. The average desired intervention length was eight weeks. These findings will inform the development and feasibility testing of a culturally informed lifestyle intervention for breast cancer survivors in Guam and Hawai'i.

Systemic lupus erythematosus nephritis and COVID-19 disease.

Of the more than 20 studies published on SLE patients with COVID-19, none of the studies focused on lupus nephritis. We report the outcomes of renal biopsy-proven systemic lupus erythematosus (SLE) nephritis patients after COVID-19 disease. Our institute has been declared as a state COVID-19 hospital in the last week of March 2020. From then till now, we have admitted and managed COVID-19 patients from several districts of Andhra Pradesh and neighbouring states. We collected the data of patients with SLE nephritis contemporaneously from admission to the outcomes on a computerised proforma. We had identified sixteen patients with SLE nephritis who were admitted with COVID-19 disease. Of them, fourteen were females and two were males. The mean age was 29.3 years. Out of sixteen patients, seven required a mechanical ventilator and dialysis and eventually succumbed. One more patient died due to disseminated tuberculosis. Our results suggested that with an approximately 50% mortality rate, the COVID-19 disease had a calamitous effect on SLE nephritis patients. Key Points • We identified the significant risk factors for mortality: younger age, higher serum creatinine at presentation, higher CT severity score and lower serum albumin. • After the analysis done for this article, we decided to reduce the medications for SLE nephritis to prednisolone 10 mg/day when COVID-19 disease is contracted.

Emergency department use by patients who received chimeric antigen receptor T cell infusion therapy.

Background: Chimeric antigen receptor T cell infusion (CAR T) therapy has revolutionized the treatment of hematologic malignancies, but treatment-related toxicities are of concern. Understanding the timing and reasons for which patients present to the emergency department (ED) after CAR T therapy can assist with the early recognition and management of toxicities. Methods: A retrospective observational cohort study was conducted for patients who had undergone CAR T therapy in the past 6 months and visited the ED of The University of Texas MD Anderson Cancer Center between 04/01/2018 and 08/01/2022. The timing of presentation after CAR T product infusion, patient characteristics, and outcomes of the ED visit were examined. Survival analyses were conducted using Cox proportional hazards regression and Kaplan-Meier estimates. Results: During the period studied, there were 276 ED visits by 168 unique patients. Most patients had diffuse large B-cell lymphoma (103/168; 61.3%), multiple myeloma (21/168; 12.5%), or mantle cell lymphoma (16/168; 9.5%). Almost all 276 visits required urgent (60.5%) or emergent (37.7%) care, and 73.5% of visits led to admission to the hospital or observation unit. Fever was the most frequent presenting complaint, reported in 19.6% of the visits. The 30-day and 90-day mortality rates after the index ED visits were 17.0% and 32.2%, respectively. Patients who had their first ED visit >14 days after CAR T product infusion had significantly worse overall survival (multivariable hazard ratio 3.27; 95% confidence interval 1.29-8.27; P=0.012) than patients who first visited the ED within 14 days of CAR T product infusion. Conclusion: Cancer patients who receive CAR T therapy commonly visit the ED, and most are admitted and/or require urgent or emergent care. During early ED visits patients mainly present with constitutional symptoms such as fever and fatigue, and these early visits are associated with better overall survival.

Traditional and new lifestyle interventions to prevent breast cancer recurrence (TANICA): a qualitative study.

PURPOSE: Breast cancer is the second cause of death from cancer in Guam and Hawai'i and disproportionately impacts Native Hawaiian, CHamoru, and Filipino women. Although a few culturally informed interventions addressing breast cancer survivorship exist, none have been developed or tested for Native Hawaiian, CHamoru, and Filipino women. To address this, the TANICA study began with key informant interviews in 2021. METHODS: Purposive sampling and grounded theory approaches were used to conduct semi-structured interviews with individuals experienced in providing healthcare or implementing community programs and/or research with ethnic groups of interest in Guam and Hawai'i. A literature review and expert consultation identified intervention components, engagement strategies, and settings. Interview questions aimed to understand the relevance of evidence-based interventions and explored socio-cultural factors. Participants completed demographics and cultural affiliation surveys. Interviews were independently analyzed by trained researchers. Themes were mutually agreed upon by reviewers and key themes were identified based on frequencies. RESULTS: Nineteen interviews were conducted in Hawai'i (n=9) and Guam (n=10). Interviews confirmed the relevance of most of the previously identified evidence-based intervention components for Native Hawaiian, CHamoru, and Filipino breast cancer survivors. Ideas around culturally responsive intervention components and strategies emerged that were shared across and unique to each ethnic group and site. CONCLUSION: Evidence-based intervention components appear relevant, yet cultural and place-based strategies are needed for Native Hawaiian, CHamoru, and Filipino women in Guam and Hawai'i. Future research should triangulate these findings with the lived experiences of Native Hawaiian, CHamoru, and Filipino breast cancer survivors to develop culturally informed interventions.

Impact of a Training Program on Oncology Nurses' Confidence in the Provision of Self-Management Support and 5As Behavioral Counseling Skills.

BACKGROUND: Cancer patients and their families play a central role in the self-management of the medical, emotional, and lifestyle consequences of cancer. Nurses with training in self-management support can enable cancer patients to better manage the effects of cancer and treatment. METHODS: As part of a randomized controlled trial, we developed a training program to build nurses' confidence in the provision of self-management support (SMS). The SMS skills taught were adapted from the Stanford Peer Support training programs and embedded within the 5As (Assess, Advise, Agree, Assist, and Arrange) behavioral counseling process. We evaluated the impact of the training program on oncology nurses' and coaches' confidence using a Student's t-test for paired samples in a nonrandomized, one-group pre/postsurvey. RESULTS: Participants were experienced oncology nurses from three participating cancer centers. A two-tailed Student's t-test for paired samples showed a significant improvement in nurses' confidence for the 15 SMS microskills targeted in the training between the pretest and post-test as follows: for Center 1, a mean difference of 0.79 (t = 7.18, p ≤ 0.00001); for Center 2, a mean difference of 0.73 (t = 8.4, p ≤ 0.00001); for Center 3, a mean difference of 1.57 (t = 11.45, p ≤ 0.00001); and for coaches, a mean difference of 0.52 (t = 7.6, p ≤ 0.00001). CONCLUSIONS: Our training program improved oncology staff nurses' and cancer coaches' confidence in 15 SMS microskills and has potential for SMS training of nurses in routine care.

A phase 1 study of veliparib (ABT-888) plus weekly carboplatin and paclitaxel in advanced solid malignancies, with an expansion cohort in triple negative breast cancer (TNBC) (ETCTN 8620).

BACKGROUND: Veliparib is a poly-ADP-ribose polymerase (PARP) inhibitor, and it has clinical activity with every 3 weeks carboplatin and paclitaxel. In breast cancer, weekly paclitaxel is associated with improved overall survival. We aimed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of veliparib with weekly carboplatin and paclitaxel as well as safety, pharmacokinetics, and preliminary clinical activity in triple negative breast cancer (TNBC). METHODS: Patients with locally advanced/metastatic solid tumors and adequate organ function were eligible. A standard 3 + 3 dose-escalation design was followed by a TNBC expansion cohort. Veliparib doses ranging from 50 to 200 mg orally bid were tested with carboplatin (AUC 2) and paclitaxel (80 mg/m2) given weekly in a 21-day cycle. Adverse events (AE) were evaluated by CTCAE v4.0, and objective response rate (ORR) was determined by RECIST 1.1. RESULTS: Thirty patients were enrolled, of whom 22 had TNBC. Two dose-limiting toxicities were observed. The RP2D was determined to be 150 mg PO bid veliparib with weekly carboplatin and paclitaxel 2 weeks on, 1 week off, based on hematologic toxicity requiring dose reduction in the first 5 cycles of treatment. The most common grade 3/4 AEs included neutropenia, anemia, and thrombocytopenia. PK parameters of veliparib were comparable to single-agent veliparib. In 23 patients with evaluable disease, the ORR was 65%. In 19 patients with TNBC with evaluable disease, the ORR was 63%. CONCLUSION: Veliparib can be safely combined with weekly paclitaxel and carboplatin, and this triplet combination has promising clinical activity.

Comparison of cataract surgery outcomes in English proficient and limited English proficiency patients.

PURPOSE: To determine differences in cataract surgery outcomes between English proficient (EP) and limited English proficiency (LEP) patients. SETTING: Sue Anschutz-Rodgers Eye Center, Aurora, Colorado. DESIGN: Retrospective. METHODS: Patients who underwent phacoemulsification at the Sue Anschutz-Rogers Eye Center between January 2014 and February 2020 were included. Patients who self-identified as needing or preferring an interpreter in medical encounters were defined as LEP. Differences in surgical characteristics and outcomes including cataract maturity, surgical complexity, and surgical complications were analyzed. RESULTS: 868 eyes (6.4%) were identified from LEP patients. LEP patients were more likely to have mature cataracts (5.1% vs 2.3%, P < .0001). LEP patients' surgeries were more likely to be considered complex (27.8% vs 15.3%, P < .0001) and use higher cumulative dissipated energy (mean of 9.5 [SD = 9.5] vs 7.2 [SD = 7.1], P < .0001). Preoperative visual acuity was worse in LEP patients (logMAR 0.566 [SD = 0.64] vs 0.366 [SD = 0.51], P < .0001) but showed greater improvement after surgery (logMAR 0.366 [SD = 0.54] vs 0.254 [SD = 0.41], P < .0001). There were no significant differences in operative time, intraoperative or postoperative complications. More LEP patients were on steroids 4 weeks postoperatively when compared with EP patients (14.6% vs 10.1%, P < .0002). LEP patients were less likely to undergo subsequent YAG capsulotomy (7.3% vs 12.8%, P < .0001). CONCLUSIONS: Disparities in cataract outcomes between EP and LEP patients was demonstrated. Further research into ophthalmic health disparities for LEP patients is needed to understand the root causes and how they can be addressed.