bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prevalence and risk factors for self-reported sexual dysfunction in Hispanic female breast cancer survivors 0-3 years post-cancer treatment: Results of a single-center retrospective study.
Authors: Guest Rosalind , Zanville Noah , Morin Lisellet , Rubens Muni , Currier M. Beatriz 
Published: June 2021

e24039 Background: Improvements in breast cancer screening and treatment have improved survival for many women in the U.S. However, side-effects associated with cancer treatment remain a serious issue for survivors. It is estimated that up to half or more of female breast cancer survivors (BSC) report unwanted changes in sexual function following cancer treatment. Studies have also suggested that both younger BCS and Hispanic women may be at higher risk for developing sexual dysfunction following treatment. However, women of Hispanic origin remain highly underrepresented in research on sexual dysfunction, despite being one of the fastest growing racial/ethnic populations in the U.S. The purpose of this study was to compare the prevalence and risk factors for sexual dysfunction between Hispanic and non-Hispanic BCS during the first-three years post-cancer treatment. Methods: Data for this single-center, non-randomized, retrospective study came from a database of self-reported symptom data collected as part of routine clinical practice in our institution’s Survivorship Clinic. Results: Over a 2.8-year period between Apr. 2017 and Dec. 2019, a total 815 female BCS were evaluated for sexual dysfunction. Nearly two-thirds (63.0%) of BCS identified as Hispanic, and 37.0% (n = 302) of BCS identified as non-Hispanic. Mean age of the sample was 58.4 ± 11.7 (range: 24.2–91.8). Results found that approximately a quarter (25.8%) of BCS reported “vaginal dryness, discharge, or pain with intercourse” at their initial survivorship visit. Rates of sexual dysfunction were nearly identical between Hispanic and Non-Hispanic BCS (25.7% vs. 25.8%; p = 0.975). Consistent with previous studies, BCS who reported sexual dysfunction tended to be younger, on average (53.7±10.5 years vs. 60.0 ±11.6 years; p = 0.002) and more likely to have been diagnosed with Stage 2 or 3 cancer (p = 0.038) than BCS not reporting sexual dysfunction. Multivariate logistic regression models using age, race, stage of cancer, chemotherapy, radiation type, and hormone therapy as predictors confirmed this association between younger age and likelihood of sexual dysfunction, showing that for every one-year younger BCS were at their initial survivorship visit, the odds of reporting sexual dysfunction at the initial survivorship visit increased by approximately 6.5% (OR: 0.943, 95% CI: 0.927-0.96; p < .0001). Conclusions: Results suggest that signs/symptoms such as vaginal dryness, discharge, or pain with intercourse are common for both Hispanic and non-Hispanic BCS following treatment, affecting as many as one in four BCS. Results also show that symptoms are prevalent among younger BCS. Together, results underscore the need for clinicians to be prepared to assess and manage sexual dysfunction, especially in younger BCS.
An online pilot survey to assess collateral damage related to male breast cancer treatment.
Authors: Attai Deanna J. , Eshraghi Leah , Love Susan M. 
Published: June 2021

e24046 Background: Fewer than 1% of all cases of breast cancer occur in men, and little is known about the late effects of the disease and its treatment in this population. We developed a pilot survey with the aim of identifying primary areas of concern among men who have been treated for breast cancer. The findings will be used to develop a more comprehensive survey assessing the late effects or collateral damage of male breast cancer treatment. Methods: An anonymous survey was developed with the assistance of patient advocates from the Male Breast Cancer Coalition (MBCC). The survey asked for the men’s current age and contained five open-ended questions. Respondents were asked to (1) describe the most significant types of collateral damage they had experienced; (2) share the effects of disease and treatment on areas of their lives (physical, emotional, psychological, financial); (3) identify resources they had found to be helpful; and (4) provide advice to other men with breast cancer. The fifth question allowed for additional free-text entry. The survey, distributed by the Dr. Susan Love Foundation for Breast Cancer Research and MBCC via social media postings and email, was open from January to February 2021. Results: Sixty-eight men responded to the survey. Mean age of respondents was 62.9 (range 34 - 87). Sexual dysfunction, peripheral neuropathy, musculoskeletal complaints, and fatigue were the most commonly reported collateral damage symptoms. In their open-ended answers, many respondents expressed anxiety about and fear of recurrence, being self-conscious regarding their appearance, and negative effects on sexual function and intimacy. Some described the social isolation of being a man with breast cancer, and several discussed job loss and financial hardship as a result of their diagnosis and treatment. Online resources, including MBCC, were popular sources of support, as were family, friends, and faith. The respondents’ advice to other men with breast cancer included many recommendations to “be your own advocate,” seek out others for support and networking, and “prepare for a pink world.” Conclusions: This pilot study provides important preliminary information regarding late effects and collateral damage of male breast cancer and its treatments, as well as insights into the male breast cancer experience not captured in prior work. This information will be used to inform a more comprehensive project that assesses collateral damage and quality of life among men who have been treated for breast cancer. The findings also will be used to develop recommendations on how to educate clinicians about the needs of male breast cancer survivors and how to better alleviate the late effects and collateral damage they experience.
Analysis of opioid and adjunctive pain medication prescriptions in lung cancer patients.
Authors: Bleiberg Benjamin Aaron , Westbrook Kyle Andrew , Ahn Chul , Khan Saad A. 
Published: June 2021

e24073 Background: Between 1999-2018, the CDC reported 232,000 deaths from prescription opioids. Lung cancer patients receive many opioid and adjunctive pain medication prescriptions. The frequency, duration, and impact of these prescriptions is unknown. Methods: We used the electronic medical record to catalogue opioid and adjunctive pain medication prescriptions given to adult cancer patients at our academic and county-affiliated health systems from 2009-2016. We identified the association of opioid and adjunctive pain medication use with patient characteristics including cancer stage and radiation therapy. Results: 1510 lung cancer patients were identified, of which 1061 had opioid prescriptions (70%). Of patients with prescriptions: hydrocodone was prescribed to 90%, morphine 35%, hydromorphone 17%, fentanyl 16%, and oxycodone 13%. 330/1061 patients had adjunctive medication prescriptions, of which, gabapentin was prescribed to 90%, pregabalin 14% and carbamazepine 2%. 296/330 patients prescribed adjunctive medications also had an opioid prescription with the following frequency: hydrocodone 90%, hydromorphone 33%, fentanyl 27%, morphine 41%, and oxycodone 23% 7/1061 patients with opioids had naloxone prescribed. Opioid usage by cancer stage is shown in the table. 211/1510 patients (13%) had prescriptions for ≥3 different opioids; 97/330 (33%) patients with adjunctive prescriptions, had prescriptions for ≥3 different opioids. Of patients treated with radiation for >4 weeks, 66% received opioids, with the proportion receiving opioids increasing with each fraction of radiation up to a rate of 90% with 5 or more fractions. 87% of patients prescribed opioids alone had an active opioid prescription 3 months after their last date of radiation as did 91% of those prescribed adjunctive medications in addition to opioids. In the total dataset: 55% of patients were from the university system and 45% were from the county system and other settings. Of the lung cancer patients with opioid prescriptions: 69% were from the university system and 31% were from other settings. Conclusions: Opioids are commonly prescribed in patients with any stage of lung cancer, particularly those with stage >1 with hydrocodone being the most prescribed. In the period under study, adjunctive medications such as gabapentin were prescribed much less than and rarely without opioids. Some lung cancer patients received ≥3 distinct opioids, with higher rates seen in those with adjunctive medicine prescriptions. Further studies to evaluate system wide opioid prescribing trends and discrepancies related to demographic factors are needed.[Table: see text]
A PAncreatic cancer screening study in individuals with New-onset or DeteriOrating diabetes MEllitus (PANDOME study).
Authors: Frank Richard C. , Lo Tammy , Jin Dugho , Ferreira Cornelius , Seshadri Ramanathan , Dong Xiang Da (Eric) , Bauman James , Anand Naveen , Lee Ronald 
Published: June 2021

TPS10607 Background: Pancreatic adenocarcinoma (PC) has a persistently high mortality as it presents in the advanced stages and has largely not benefited from the genomic and immunotherapeutic revolutions in oncology. Improvements in screening to detect early stage cancers are therefore urgently needed. Screening studies such as those from the International CAPS Consortium have demonstrated improved survivals in hereditary high risk individuals. In the sporadic population, individuals with new-onset diabetes (NOD) or long-standing deteriorating diabetes (DD) are at substantially increased risk of PC in the 12 months following these diagnoses and have been proposed as target populations for screening efforts. This trial will study the benefits of PC screening in the latter populations in a community setting. Methods: Individuals ≥ 50 years of age with either NOD or DD will be eligible. Criteria for NOD (within the past 12 months) include: fasting blood glucose ≥ 126 mg/dL, random blood glucose ≥ 200 mg/dL, or HbA1c ≥ 6.5%, with confirmed prior normal values. For those without prior glycemic values, a HbA1c ≥ 7.0% is required. Transition from pre-diabetes requires an increase in HgA1c of ≥ 0.5%. DD is defined by an increase in HbA1c of ≥ 2% within the past six months that is not associated with medication non-compliance or weight gain. Study participants will undergo every 6 months: evaluation by an APRN, testing for anxiety and depression and blood donation for biobanking purposes. High resolution MRI/MRCP with gadolinium will be performed at study entry and annually for 2 years. Images will be reviewed at a multi-disciplinary tumor board consisting of body-image certified radiologists, interventional gastroenterologists, hepatobiliary surgeons and medical oncologists. MRI results will be classified according to a novel PANC-RADS system. High-risk pancreatic findings will be further interrogated by endoscopic ultrasound (EUS). Study endpoints include detection rate of high-risk lesions, referrals for EUS and surgery and detection of incidental findings leading to unnecessary procedures. Adverse psychological impacts will be assessed through HADS testing. Target accrual: 500 patients within 3 years. Clinical trial information: NCT03937453 .
A multicenter, open-label, uncontrolled phase II study of ONO-4538 for cutaneous angiosarcoma (Angio Check study).
Authors: Fujisawa Yasuhiro , Yoshino Koji , Isei Taiki , Namikawa Kenjiro , Fujimura Taku , Yasuda Masahito , Yamamoto Yuki , Uchi Hiroshi , Yanagi Teruki , Kato Hiroshi , Otsuka Atsushi 
Published: June 2021

TPS11579 Background: Cutaneous angiosarcoma (CAS) is a rare sarcoma and advanced cases face a complex treatment regimen and dismal prognosis. Several cytotoxic agents (anthracycline, taxane, and gemcitabine) and targeted therapies (bevacizumab and sorafenib) have been tested for advanced disease in clinical trials with poor results. Since CAS commonly develops in elderly patients, high-grade adverse events from treatment may not be ideal and thus therapies featuring durable response and low comorbidity are in great demand. Recent studies suggest that CAS has a distinct genomic profile, including higher tumor mutational burden (TMB), compared to angiosarcomas developed in other sites. Moreover, we have shown that CAS with higher PD-1/L1 in the tumor microenvironment had statistically better overall survival compared with those without, indicating CAS susceptibility to immune checkpoint blockade therapy. However, to date, reports of immune checkpoint inhibitors for CAS are nonexistent. Methods: The present study is a phase 2, multicenter, single-arm clinical trial of ONO-4538 (nivolumab, 480 mg IV every 4 weeks) for patients with unresectable or metastatic CAS refractory to first-line paclitaxel. Twenty-three patients with advanced CAS will be enrolled at 11 sites in Japan with a primary objective to assess the confirmed response rate (H0 p < 5%, H1: p > 20%) to nivolumab. Secondary endpoints include PFS, OS, time to response, and adverse events. A correlative aim includes assessing tissue biomarkers using whole-genome sequencing (1023 genes including interferon-gamma associated genes and other known factors associated with response to immune checkpoint inhibitors) for association with response to nivolumab. The study started in April 2020 and remains open with 7 patients enrolled at time of Clinical trial information: UMIN000043039.
A randomized phase II trial of cabozantinib combined with PD-1 and CTLA-4 inhibition in metastatic soft tissue sarcoma.
Authors: Eulo Vanessa Anne , Wilky Breelyn A. , Luo Jingqin , Hirbe Angela C. , Weiss Mia C. , Oppelt Peter John , Abaricia Sarah , Toeniskoetter Jacqui , Ruff Tyler , Maki Robert G , Van Tine Brian Andrew 
Published: June 2021

TPS11583 Background: Soft tissue sarcomas (STS) are rare malignancies with poor prognosis in the metastatic setting. Current standard therapy includes anthracycline based chemotherapy. Cabozantinib is a multikinase inhibitor that has demonstrated efficacy in solid tumors such as renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). A phase II study of cabozantinib in advanced STS is underway. Cabozantinib in combination with immune checkpoint blockade has shown clinical benefit in several tumor types including HCC, RCC, non-small cell lung cancer, and urothelial carcinoma. Since cabozantinib may alter PD-1 expression in regulatory T-cells and promote an immune permissive environment, we hypothesize that combining cabozantinib with immune checkpoint inhibition is a therapeutic strategy that will be more effective than cabozantinib alone. Additionally, the design of the trial will allow assessment of whether pretreatment with cabozantinib will enhance the efficacy of nivolumab and ipilimumab alone. Methods: This is an open label, multicenter, randomized phase II clinical trial of cabozantinib (60mg orally daily as a single agent, 40mg in combination) with or without combination Ipilimumab (ipi, 1mg/kg IV every 3 weeks for 4 doses) and Nivolumab (nivo, 3mg/kg IV every 3 weeks for four doses, then 480mg IV every 4 weeks) in patients (pts) with unresectable or metastatic STS refractory to up to two lines of chemotherapy. 105 pts with non-translocation driven sarcomas will be enrolled at three US sites and randomized 2:1 to the combination group. Pts will be stratified by prior pazopanib use and balanced for histologies. Patients who progress on arm A will cross over to combination therapy (arm B). The primary efficacy endpoint is objective response rate (ORR) by RECIST 1.1. 35 patients in Cohort A (cabozantinib alone) and 70 patients in Cohort B (cabozantinib plus ipi/nivo) will be required to detect an increase of the ORR from 10% in cohort A to 30% in cohort B with 81% power with a one-sided alpha level of 10%. Key eligibility criteria include: at least 18 years of age, ECOG performance status of 0 or 1, ≤2 prior lines of therapy and measurable disease. Exclusion criteria include: translocation-driven sarcoma except alveolar soft part sarcoma (ASPS), prior immunotherapy, and chronic use of corticosteroids or other immunosuppression. Secondary endpoints are safety, overall and progression free survival, disease control rate, and response rate to ipilimumab and nivolumab after cabozantinib pretreatment. Mandatory tumor biopsies pre-treatment and at 6 weeks will be obtained. Peripheral blood will be collected for circulating immune phenotyping. Enrollment will occur at 3 participating institutions and is expected to be completed in 2022. Clinical trial information: NCT04551430.
Phase I/Ib study with INT-1B3, a novel LNP-formulated micro-RNA (miR-193a-3p mimic) therapeutic for patients with advanced solid cancer.
Authors: Kotecki Nuria , Opdam Frans , Robbrecht Debbie , Strijbos Michiel , Kroon Karlijn , Janicot Michel , Yahyanejad Sanaz , Telford Bryony , van den Bosch Marion , Alemdehy Farshid , de Gunst Thijs , den Boer Harm , Vos Rogier M. , van Pinxteren Laurens , Schaapveld Roel 
Published: June 2021

TPS2666 Background: MicroRNAs (miR) are naturally-occurring small non-coding RNA molecules involved in the regulation of gene expression and their dysregulation plays a fundamental role in several pathological conditions including cancer. The miR-193a-3p acts as a tumor suppressor and is downregulated in many cancer types. INT-1B3 is a novel lipid-nanoparticle (LNP) formulated 1B3, a 22-nucleotide double stranded chemically-modified miR-193a-3p mimic. INT-1B3 showed significant tumor growth inhibition in a large panel of human and syngeneic tumor models. It directly targets tumor cells and the tumor microenvironment by specific modulation of multiple signaling pathway components. Furthermore, in syngeneic mice models for e.g. TNBC (4T1) and HCC (H22), INT-1B3 was able to modulate the immune tumor microenvironment by turning ‘cold’ tumors into ‘hot’ tumors via upregulation of cytokines (e.g., IL-2 and IFN-g), decreasing immunosuppressive cells/Treg (e.g., CD4+ /LAG3+ and CD3+ /FoxP3+) and triggering cytotoxic CD8+ T cell-mediated long-term memory immune protection against re-challenge with tumor cells. These preclinical results suggest potential clinical benefit in a broad range of cancer indications, and a reduced potential to develop drug resistance due to its multi-targeted mode of action. Methods: This is a 2-part, multi-center, open-label, multiple ascending dose, first-in-human, clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of INT-1B3 in the treatment of patients with advanced solid tumors. The phase 1 part follows a ‘hybrid’ 3+3 study design in ‘all-comer’ cancer patients enrolled and treated in cohorts to define the recommended phase 2 dose (RP2D). Upon completion of the dose escalation phase of the study, 2 expansion cohorts are planned to further confirm the safety, tolerability, and preliminary efficacy of the RP2D of INT-1B3 in patients with hepatocellular carcinoma and triple negative breast cancer. Major eligibility criteria include evaluable disease according to RECIST 1.1 and no more than one prior line of anti-PD-1/PD-L1 therapy. Patients will receive INT-1B3 via 60-min i.v. infusions twice a week in 21-day cycles. The first patient was enrolled on January the 14th 2021. Clinical trial information: NCT04675996.
Trial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101).
Authors: Hong David S. , Strickler John H. , Fakih Marwan , Falchook Gerald Steven , Li Bob T. , Durm Greg Andrew , Burns Timothy F. , Ramalingam Suresh S. , Goldberg Sarah B. , Frank Richard C. , Marrone Kristen , Shu Catherine A. , Gandara David R. , Soman Neelesh , Henary Haby Adel , Govindan Ramaswamy 
Published: June 2021

TPS2669 Background: Kirsten rat sarcoma viral oncogene homolog ( KRAS) p.G12C mutation is an oncogenic driver mutation in several solid tumors. Sotorasib is a specific, irreversible, small molecule inhibitor of KRASG12C that has demonstrated durable clinical benefit in NSCLC, with mild and manageable toxicities. The combination of sotorasib with other anticancer therapies may enhance antitumor efficacy. This master protocol is designed to evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of multiple sotorasib combinations in patients (pts) with KRASp.G12C mutated solid tumors. Herein, we overview 1 monotherapy and 11 combination cohorts. Methods: This is a phase 1b, open-label study evaluating sotorasib alone and in combination regimens (Table) in pts with advanced KRAS p.G12C mutated solid tumors. Dose exploration will evaluate the safety and tolerability of sotorasib alone and in combination regimens; dose expansion will then verify the safety and tolerability profile of sotorasib regimens and assess antitumor efficacy. Key eligibility criteria include locally-advanced or metastatic solid tumor with KRAS p.G12C mutation identified through molecular testing in pts who have received ≥1 lines of prior systemic therapy. Primary endpoints include dose-limiting toxicities and treatment-emergent or treatment-related adverse events. Secondary endpoints include PK profile of combination regimens and efficacy (eg, objective response, disease control, duration of response, progression-free survival, and duration of stable disease assessed per RECIST 1.1). Enrollment began in December 2019 and is ongoing. Clinical trial information: NCT04185883. [Table: see text]