bluuebunny/crossref_metadata_2025_split huggingface dataset:
Sequential combination of sacituzumab govitecan and talazoparib in metastatic triple negative breast cancer (mTNBC): Results from a phase II study.
Authors: Abelman Rachel Occhiogrosso , Spring Laura , Niemierko Andrzej , Abraham Elizabeth , McNeice Mary , Goff Jennifer , Valenti Amanda , Wander Seth Andrew , Isakoff Steven J. , Moy Beverly , Juric Dejan , Vidula Neelima , Waks Adrienne Gropper , Parsons Heather Anne , Ellisen Leif W. , Tolaney Sara M. , Bardia Aditya 
Published: June 2024

1102 Background: The antibody-drug conjugate (ADC) sacituzumab govitecan (SG) has demonstrated improvement in overall survival for patients with metastatic triple negative breast cancer (mTNBC). Despite great interest in enhancing efficacy of ADCs using combination therapy, there are no approved regimens. Preclinical data suggest that SG synergizes with Poly ADP-ribose polymerase inhibitors (PARPi) to induce DNA damage and cell death. Though the phase 1b study demonstrated intolerable myelosuppression with simultaneous dosing, tolerability was improved with sequential administration of SG and the PARPi talazoparib (Bardia AACR 2022). Here we report clinical outcomes from the phase II dose expansion cohort (NCT04039230). Methods: In a single-arm phase II study, adult patients with measurable mTNBC (per ASCO/CAP guidelines) were eligible. Starting dose was SG at 10mg/kg on days 1 and 8 with talazoparib 1mg on days 15-21. Growth factor (G-CSF) prophylaxis was required. The primary endpoint was the confirmed Objective Response Rate (ORR) calculated per RECIST v1.1 and secondary endpoints included progression-free survival (PFS) and overall survival (OS). The Clinical Benefit Rate (CBR) at 6 months was also measured. Results: From June 2021 to March 2023, 26 patients were enrolled. The median age was 54 (range, 35 to 81). Patients received a median of 2 prior therapy lines for metastatic disease (range, 0 to 7). 6/26 patients remain on treatment at time of data cutoff. Median PFS was 6.2 months (95% CI, 3.7 to 12.8), and median OS was 18.0 months (95% CI, 10.7 to not evaluable). The confirmed ORR was 30.1% (95% CI, 14 to 52) and the CBR at 6 months was 53.8% (95% CI, 33 to 73). Serious adverse events (AEs) were seen in 10 (38.5%) of patients; in 7 (26.9%) serious AEs were treatment related. The most common treatment related AEs were anemia (92.3%), neutropenia (88.5%), nausea (84.6%) fatigue (80.7%), and thrombocytopenia (65.3%). Grade ≥3 neutropenia and anemia were seen in 80.7% and 34.6% of cases, respectively. One or more dose reductions were required in 58.0% of patients. One patient with a germline BRCA mutation was treated for 625 days before disease progression. Updated biomarker and survival data will be presented at the meeting. Conclusions: In this single-arm phase II study, SG in combination with talazoparib was feasible and demonstrated preliminary evidence of efficacy. A randomized clinical trial is needed to determine if the SG-PARPi combination is superior to SG monotherapy. Clinical trial information: NCT04039230 .
Immune related adverse events in patients with breast cancer and autoimmune disease treated with immunotherapy.
Authors: Vidula Neelima , Hutchinson Jennifer , McLaren Abigail , Ryan Lianne , Niemierko Andrzej , Bardia Aditya 
Published: June 2024

1103 Background: Pembrolizumab is approved for early and advanced triple negative breast cancer (TNBC), and atezolizumab was approved for advanced TNBC. Toxicity of immunotherapy (IO) and immune related adverse events (irAEs) in patients with breast cancer with an underlying autoimmune disease are not well understood as autoimmune disease is often an exclusion criterion in immunotherapy trials. Understanding real-world IO toxicity and irAEs in patients with breast cancer and autoimmune disease may inform clinical decision making. Methods: We studied IO toxicity and irAEs in patients with early and metastatic breast cancer, and underlying autoimmune disease vs. those without autoimmune disease (at IO start) who received IO at an academic institution. A retrospective review was conducted to identify IO toxicity and irAEs (CTCAE v 5.0). Cohorts were compared with Pearson’s chi-squared test (categorical variables) and Wilcoxon rank-sum test (continuous variables), with p<0.05 for statistical significance. Results: Cohorts had 23 patients with breast cancer and ≥1 autoimmune disease (AD) prior to receipt of IO (thyroid: 48%, rheumatologic: 26%, gastrointestinal: 13%, dermatologic: 9%), and 106 patients with breast cancer but without autoimmune disease (non-AD). Median age at IO start was 63 (interquartile range [IQR] 54-69) in AD vs. 50 in non-AD (IQR 39-59). Stage I-III/IV distribution was 39%/61% for AD and 67%/33% in non-AD. IO was mainly pembrolizumab (AD: 87%; non-AD: 85%) vs. atezolizumab. Table depicts characteristics of IO toxicity. A significantly higher overall rate of irAEs was seen in AD (96%) vs. non-AD (59%) [p<0.001]. Significantly greater immune related transaminitis was observed in AD (52%) vs. non-AD (24%) [p=0.006]. Immune related hypothyroidism (AD: 30% vs. non-AD: 15%, p=0.08), nephritis (AD: 9% vs. non-AD 2%, p=0.08), and hyperthyroidism (AD: 9% vs. non-AD: 3%, p=0.19) had numerically higher rates in AD, but these findings did not achieve statistical significance. Flare of the baseline AD with IO was observed in 6/23 (26%) patients, and 50% of flares occurred within 1 month of starting IO (range 1-5 months). Management of irAEs was similar in AD vs. non-AD, and rates of full resolution of irAEs were similar (AD: 55%; non-AD: 61%, p=0.65). Late onset irAEs (> 3 months after IO discontinuation) were rare (AD: 12%; non-AD: 4%, p=0.21). Conclusions: A higher overall rate of irAEs was observed in patients with underlying autoimmune disease, including greater immune related transaminitis and flare of the underlying autoimmune disease, suggesting the need for close monitoring of irAEs in this population. [Table: see text]
The influence of sarcopenia and myosteatosis on severe laboratory toxicity and overall mortality in older adults with cancer receiving chemotherapy.
Authors: Papadopoulos Efthymios , Wong Andy Kin On , Law Sharon Hiu Ching , Costa Sarah , Cheung Angela , Rozenberg Dmitry , Alibhai Shabbir M.H. 
Published: June 2024

12131 Background: Older adults with cancer often present with suboptimal muscle quantity and quality prior to treatment due to disease-related catabolic effects combined with the aging process. Muscle catabolism is further exacerbated by cancer treatments leading to worse metabolic health, patient quality of life, and clinical outcomes. Our objective was to examine the impact of sarcopenia and myosteatosis on severe laboratory toxicity and overall mortality in older adults with cancer receiving chemotherapy. Methods: This was a retrospective cohort study of older adults who had undergone chemotherapy at the Princess Margaret Cancer Centre, Toronto, Canada from June 2015 to June 2022. A computed tomography scan after diagnosis but prior to treatment was used to assess skeletal muscle index (SMI) and skeletal muscle density (SMD) for each participant. Sarcopenia was defined as the presence of low muscle strength (grip strength <35.5kg for males and <20kg for females), low SMI, and low physical performance (walking speed <0.8m/s or a total Short Physical Performance Battery score of ≤8) prior to chemotherapy initiation. Myosteatosis was assessed through SMD in Hounsfield Units using previously published cut-offs. Severe laboratory toxicity was defined as occurrence of a grade ≥3 adverse event per the Common Terminology Criteria for Adverse Events (version 4.0). Severe laboratory toxicity and overall mortality were assessed from treatment initiation until treatment termination or loss to follow up. Multivariable logistic regression was used to determine the role of sarcopenia and myosteatosis in predicting occurrence of severe laboratory toxicity. Multivariable Cox regression was used to assess the risk of overall mortality. Results: A total of 115 older adults (mean age: 77.1 y) were included, of whom 63.5% had metastatic disease. Sarcopenia was identified in 27% of the cohort, whereas 80% had myosteatosis. A total of 132 severe laboratory toxicities occurred during the study period in 41 participants (35.7%). Sarcopenia was a significant predictor of severe laboratory toxicity (adjusted odds ratio (aOR)=3.19, 95%CI= 1.19 to 8.52, p= 0.012) after adjusting for sex, body mass index, and hemoglobin. Myosteatosis was significantly associated with overall mortality (adjusted hazard ratio (aHR)= 2.51, 95%CI= 1.12-5.61, p=0.025) after adjusting for albumin, alkaline phosphatase, and treatment intent. Conclusions: Sarcopenia may be used to inform the risk of severe laboratory toxicity in older adults prior to chemotherapy. Pre-treatment myosteatosis defined by low SMD predicts overall mortality in the same cohort. Optimization of skeletal muscle health through targeted exercise and nutritional interventions may improve patient quality of life and clinical outcomes in older adults with cancer receiving chemotherapy.
The influence of psychosocial factors on first-time chemotherapy-induced nausea and vomiting: A prospective multicenter cohort study.
Authors: Shi Xiaoxiao , Xu Liang , Liu Jie , Wang Ying , Yang Xiaoyun , Zhuo Hongyu , Zhang Jie , Chen Ye , Xiao Hongmei , Xie Ke , Zhong Wuning , Jiang Yu , Deng Yaotiao 
Published: June 2024

12135 Background: Previous studies have suggested that if cancer patients experience no chemotherapy-induced nausea and vomiting (CINV) or mild symptoms during their first chemotherapy cycle, they are less likely to experience CINV in subsequent cycles, suggesting that the optimal intervention time may be before the first chemotherapy cycle. Consequently, attention should be paid to relevant risk factors. Currently, there is a lack of data on psychosocial risk factors related to chemotherapy among cancer patients in China. Methods: This study was a multicenter, prospective cohort study that included cancer patients from seven hospitals' oncology departments who were scheduled to undergo their first chemotherapy cycle. The chemotherapy regimens administered were either highly or moderately emetogenic protocols. Demographic and baseline clinical characteristics were recorded by clinical oncologists. Participants were asked to complete the Distress Thermometer (DT), the Mini-Mental Adjustment to Cancer (Mini-MAC), and a risk factor questionnaire the day before chemotherapy, and to keep a daily diary describing their CINV experiencing for 21 days after chemotherapy. Results: Between October 2022 and November 2023, a total of 1100 cancer patients were enrolled in this study and 972 cancer patients completed all the questionnaires. A total of 64.1% reported CINV during the first chemotherapy cycle. In logistic regression analysis, CINV was predicted by higher PS score (OR=1.411, p=0.049), highly emetogenic regimens (OR=1.846, p=0.004), failure to follow anti-emetics guidelines (OR=2.323, p<0.001), history of nausea/vomiting for other reasons(OR=1.817, p=0.001), lower number of hours slept before the night of chemotherapy (OR=8.987, p<0.001), expectancy of CINV(OR=1.505, p=0.032), maladaptive coping (OR = 1.03, p = 0.024) and distress (OR = 1.157, p =0.021). Conclusions: Psychosocial factors significantly correlate with chemotherapy-induced nausea and vomiting (CINV) among Chinese cancer patients. These findings underscore the importance of integrating psychosocial assessments into the management of CINV, potentially improving treatment outcomes and patient experiences.
The positive impact of Medicaid expansion on melanoma stage at presentation.
Authors: Win Shwe , Amini Arya , Modi Badri , Wang Edward Wenge , Villalona-Calero Miguel Angel , Salgia Ravi , Muddasani Ramya , Chan Aaron , Xing Yan 
Published: June 2024

1533 Background: This study aims to evaluate the impact of the Affordable Care Act Medicaid expansion on melanoma stage at presentation. Methods: 12,667 non-elderly patients (age 40-64) who were newly diagnosed with melanoma and known Medicaid expansion status were identified from The National Cancer Database. We excluded patients with private insurance, Medicare, or other government or unknown insurance. The time period for the cohort spanned from 2010 to 2020 which includes pre-expansion (2010-2013) and post-expansion periods (2014-2020). Year-to-year trend analysis and difference-in-difference (DID) analysis was performed to analyze tumor staging between states with Medicaid expansion (MES) and without Medicaid expansion (non-MES) before and after the expansion. Results: Out of the 12,667 melanoma patients (56% male, 95% white), 41% of patients were uninsured and 59% had Medicaid during 2010 to 2020. The percentage of patients without insurance decreased significantly from 51% in 2010 to 16% in 2020. There were 21% of patients with stage III and 18% with stage IV melanoma. The trend of melanoma stage at presentation over the study period was shown (Table). Notably, the stage IV melanoma at presentation decreased from 21% to 17% from 2010 to 2020 in MES. In contrast, stage IV melanoma at presentation increased from 20% to 23% over the same period of time in non-MES. After adjusting for confounders, DID analysis revealed a statistically significant decrease in stage IV melanoma at presentation (DID -0.04, p < 0.001) as well as a statistically significant decrease in 3 year mortality (DID -0.05, p < 0.001) between MES and non-MES before and after Medicaid expansion. In addition, the use of immunotherapy in stage IV melanoma in MES was significantly higher than non-MES (47% vs 41%, p < 0.001). Conclusions: The findings reveal the positive impact of Medicaid expansion on melanoma stage at presentation and suggest that improved access to healthcare services can facilitate diagnosing early-stage melanoma and decreasing mortality rate. Despite these findings, there are still 16% of patients who still do not have insurance in 2020 which indicates that continued effort is needed to improve the outcomes of these uninsured patients.[Table: see text]
Navigating disparities: Insights from a colorectal cancer screening program in federally qualified community healthcare centers.
Authors: Amin Robby , Turner Christopher , Santellano Brenda , Odhiambo Lorriane A. , Fleming Sable , Ibrahim Samah , Mitchell Katreena , Merchant Cynthia , Patten Douglas , Desai Koosh , Hotz James , Durham Lynn M. , Gabram Sheryl G. A. , Cortes Jorge E. , Islam KM Monirul 
Published: June 2024

1537 Background: Colorectal cancer (CRC) is the second leading cause of cancer deaths in Georgia. Despite evidence for the effectiveness of CRC screening, disparities in access are prevalent in underserved populations. Georgia’s Federally Qualified Health Centers (FQHCs) struggle with low screening rates (42.8%), partly due to Georgia’s lack of Medicaid expansion, poor access to health services in rural areas, and deficiencies in coordinated strategies. The Georgia Colorectal Cancer Control Program (GCRCCP) was funded by the Centers for Disease Control and Prevention to implement evidence-based interventions (EBIs) in qualifying FQHCs across South Georgia. Here, we assess the program's impact on clinic-level screening rates (SR). Methods: Fourteen clinics with 12,159 CRC-eligible patients (ages 50-75) were enrolled from East Georgia Healthcare Center (EGHC) and Albany Area Primary Health Center (AAPHC). FQHC clinics had to have a SR below 60% to participate in the program. In addition to the EBIs (provider assessment and feedback, provider reminders, patient reminders, reducing structural barriers), the GCRCCP integrated provider education using the ECHO Model and navigation through a nationally recognized, evidence-based patient navigation program. We compared baseline (2020 and 2021) and follow-up data (2022) to determine the average change in SR over time, overall, and by demographic sub-groups. Results: The overall change in SR for the 14 clinics was +6.7%, from a baseline average of 45.3% to 52% in 2022. The average change in SR for EGHC clinics (n=9) was +11.5% (from 32.2 to 43.7%). Women had a higher SR (44.9%) than men (41.8%), but both realized an increase in SR, +10.5% and +9.1%. Non-Hispanic Black Americans (NHBA) experienced a higher increase in SR, +13.7% (from 37.2 to 50.9%) than their Non-Hispanic White (NHW) counterparts (+7.5% (from 29.8 to 37.3%)). The uninsured vs. insured followed a similar pattern (+15.3% (from 17.8 to 33.1%)) vs. +2.1 (from 45.9 to 48%). The average change in SR for AAPHC clinics (n=5) was +1.8% (from 58.4 to 60.2%). There was a decline in SR for men, -8.6% (from 64 to 55.4%), and an increase for women, +3.8% (from 58.2 to 62%). NHBA had a decrease in SR, -0.8% (from 61.2 to 61%), while NHW Americans had an increase in SR, +0.2% (from 53.8 to 54.2%). The uninsured and insured groups realized minimal increases of +0.6% (from 46 to 46.6%) and +0.8% (from 62 to 62.8%), respectively. Conclusions: The implementation of EBIs and patient navigation show varied potential to reduce disparities in accessing CRC screening in underserved populations. FQHC clinics that sustain implementation activities and workflow processes can benefit communities long-term and improve health equity.
Time to treatment initiation of lung cancer and contributing factors from 2015-2020 utilizing Surveillance, Epidemiology and End Results program database.
Authors: Di Vanna Mariela , Qaiser Saria , Shambhavi Shreya , Seeburun Sheilabi , MEDIK YUSRA B. , Iglesias Jose 
Published: June 2024

1540 Background: Time from diagnosis of cancer to definitive therapy, or time to treatment initiation (TTI), has significant impact on prognosis. Kohorana et al performed an observational study in 2019 that found that TTI has increased in the United States with an absolute increased risk of mortality ranging from 1.2-3.2% per week in early-stage breast, lung, renal and pancreatic cancers. This study aims at identifying contributing factors and trends that can assist in shortening TTI of lung cancer. Methods: This is a retrospective cohort study conducted by review of Surveillance, Epidemiology and End Results Program database. Participants included 212,607 adults ages 18 and older diagnosed with lung cancer during 2015-2020. Variables contributing to TTI were studied like age, sex, race, marital status, geographic location, household income, stage and grade. TTI was measured as less than 30 days and greater than 30 days. ANOVA analysis was performed with SPSS and BlueSky Statistics, with p-value of <0.05 as significant. Results: TTI was 1.30 months in males and 1.31 months in females (p=0.038). In patients less than 65 years, TTI was 1.14 months, while those greater than 65 had a delay of 1.38 months (p<0.001). White patients had TTI of 1.26 months versus non-white patients, 1.44 months (p<0.001). Married patients had TTI of 1.24 months versus 1.44 months in widowed patients (P<0.001). Income less than $35,000 had less TTI (1.22 months) than income greater than $75,000 (1.33 months) (p<0.001), but the population earning <$35,000 was smaller (n=3,082) compared to >$75,000 (n=209,525), therefore not representative of the total population. Metropolitan had longer TTI than nonmetropolitan at 1.34 months versus 1.24 months, p<0.001. Grade IV had shorter TTI at 0.94 months with grades I and II having TTI of 1.42 and 1.46 months, respectively (p<0.001). Localized cancers had the longest TTI at 1.71 months versus distant at 1.01 months (p<0.001). More aggressive cancers had shorter TTI such as grade IV + distant at 0.76 months versus grade I + localized at 1.42 months. Association between grade and stage and impact on TTI was significant at p<0.001. Conclusions: This study revealed significant factors influencing the duration from cancer diagnosis to treatment among adult patients greater than 18 years old diagnosed with lung cancers. Shorter TTI intervals were observed for females, younger individuals (<65 years-old), white patients, married and those with higher tumor grades and distant cancer. Addressing these disparities requires targeted interventions that consider socioeconomic status, geographic location and cancer characteristics to ensure equitable access to timely and high-quality cancer care. Further investigation is warranted to fully understand the impact of factors such as household income and regional variations on treatment delays.
Symptoms reported by patients using an ePRO compared with those reported to nurses via telephone triage.
Authors: Kolodziej Michael A. , Ascha Mustafa S. , Frank Andrew , Hopper Chantel , Blau Sibel , Schaefer Eric S. , Telivala Bijoy , Kwiatkowsky Lavi 
Published: June 2024

1542 Background: It is unclear how symptoms reported by an electronic patient-reported outcomes (ePRO) tool compare to symptoms reported to triage nurses by patient-initiated telephone calls. This work describes symptoms reported using each of these methods, and the percent of patients requiring an acute office visit triggered by these symptom reports. Methods: Among patients diagnosed with breast, lung, or colon cancer at three community oncology practices from 2020 to 2023, we examined ePRO symptom reports and compared these with symptoms reported via telephone triage to nurses by patients not using the ePRO tool. Results: 3,509 patients reported symptoms by ePROs, and 9,071 patients only reported by phone. Among patients reporting by ePRO, 2,162 submitted both ePROs and used telephone triage services. The most common symptoms that patients reported by ePRO reports (47,284 reports) were weakness / fatigue (72.9% of patients), pain (62.0%), nausea (39.2%), and headache (33.1%). The most common symptoms that patients reported by phone reports (19,344 reports) were pain (32.9%), weakness / fatigue (13.4%), swelling (11.1%), cough (10.3%), and diarrhea (9.4%). The median number of reports in the ePRO group was 6.0 (mean 13.5, IQR: 2.0, 15.0) per patient and the median number of reports in the phone triage group was 1.0 (mean 2.1, IQR: 1.0, 2.0) per patient. The most common high-urgency symptoms in the ePRO group (defined by practice defined symptom threshold) were weakness / fatigue (67.2% of patients), pain (55.7%), headache (40.2%), nausea (32.0%), and difficulty breathing (29.2%), while the most common high-urgency symptoms (as determined by the triage nurse) in the phone triage group were pain (32.4%), weakness / fatigue (11.8%), swelling (11.4%), fever/chills (10.1%), and cough (9.7%). More patients reported high-urgency symptoms by ePRO (n = 1,873, 53.4%) compared to those reported by phone triage (n = 2,448, 27.0%). Of patients in the ePRO group with a severe symptom who visited a site with acute care visits data, 330 patients (45.4%) had an acute care visit within 72 hours of a symptom report compared to 745 patients (47.5%) in the telephone triage group. Conclusions: Patients using ePROs reported more symptoms than patients reporting by phone, possibly because electronic reporting allows patients to easily communicate symptoms to care providers and receive prompt attention. Pain and weakness/fatigue were the most common urgent symptoms in both groups. The need for an acute care visit was the same in both groups. Further refinement of the ePRO tool including standardization of symptom thresholds, more uniform implementation in practices, and patient education with respect to optimal use of the ePRO may enable practices to replace telephone triage with ePROs.