bluuebunny/crossref_metadata_2025_split huggingface dataset:
Anthracycline exposure and breast cancer risk in female Hodgkin lymphoma survivors.
Authors: Neppelenbroek Suzanne I.M. , Geurts Yvonne M. , Aleman Berthe M.P. , Janus Cecile P.M. , Rademakers Saskia E , de Weijer Roel J. , Van Der Maazen Richard W.M. , Zijlstra Josée M. , Beijert Max , Verschueren Karijn M.S. , Ta Bastiaan , Nijziel Marten R. , Posthuma Eduardus F.M. , Kersten Marie José , Muller Karin , te Boome Liane , Bilgin Yavuz , de Jongh Eva , Schaapveld Michael , Van Leeuwen Flora 
Published: June 2021

12074 Background: Female Hodgkin lymphoma (HL) survivors treated with chest radiotherapy (RT) at a young age have a strongly increased risk of breast cancer (BC). Recently concern has been raised that anthracyclines may also increase BC risk, based on studies in childhood cancer survivors with/without a history of chest RT. So far, the association between anthracyclines and BC risk has not been examined in cancer survivors treated at adolescent/adult ages. Now that RT dose and volumes are decreasing, the potential contribution of anthracyclines to BC risk is an important issue. Methods: We assessed BC risk in a cohort of 2314 female 5-year HL survivors, treated at ages 15-50 years and diagnosed between 1965 and 2008 in 20 Dutch hospitals. Treatment factors were time-dependently included in the analysis, focusing on the effect of anthracycline exposure on BC risk. Results: After a median follow-up of 18.8 years, 258 women developed invasive BC or ductal carcinoma in situ as a subsequent malignancy. The 30-year cumulative incidence was 15.0% (95% Confidence Interval (CI) 12.8-17.4%). Mantle field RT (or other RT involving both axillae) was associated with increased risk of BC (Hazard ratio (HR) 1.9; 95% CI 1.2-2.8) compared to no supradiaphragmatic RT or RT to the neck only (Table 1). Gonadotoxic treatment (>4.2 g/m2 procarbazine or pelvic RT) significantly decreased this risk. In a multivariable analysis, anthracycline exposure was associated with increased BC risk (HR 1.8; 95% CI 1.3-2.5) in patients who received a cumulative dose of >200 mg/m2. Among patients exposed to gonadotoxic treatment, the HR of BC associated with >200mg/m2 anthracyclines was 3.8 (95% CI 2.0-7.2), with a trend for higher risk with higher anthracycline dose (HR 1.58 per 100mg/m2 anthracycline, p<0.001). Conclusions: Our results suggest an association of anthracyclines with BC risk in HL survivors. Also when accounting for the protective effect of gonadotoxic treatment on RT-associated BC risk, anthracyclines significantly contributed to a higher BC risk.[Table: see text]
Dermatologic diagnoses in oncology patients of color on anticancer therapy: Five-year retrospective review of outpatient dermatology consultations.
Authors: Wilson Britney N. , Sun Mary , Lacouture Mario E. , Noor Sarah 
Published: June 2021

12084 Background: Dermatologic toxicities from cancer treatments affecting patients from racial and ethnic minority backgrounds or skin of color (SOC) patients is an understudied area of research. These patients are also significantly underrepresented in therapeutic clinical trials, limiting complete understanding of toxicities associated with cancer therapies. Current treatment algorithms for dermatological adverse events (dAE) also do not take into account possible biologic differences in different skin types affecting toxicity presentation and treatment response. In this study we summarize the demographic, clinical, and treatment characteristics of oncology patients from racial and ethnic minority backgrounds who developed dermatologic adverse events related to cancer therapies. Methods: We performed a retrospective review of all SOC patients (Asian, Black, Hispanic) on active cancer therapy who received outpatient dermatology consultation at Memorial Sloan Kettering Cancer Center from January 1, 2014 to December 31, 2019. Electronic health record information for 2917 patients was obtained. A computational keyword-based text analysis of medical chart text, developed in consultation with a board-certified dermatologist, was performed to determine dermatologic diagnoses categories for each patient. All analyses were conducted using R statistical programming software, version 4.2.06. Results: There were 2917 outpatient dermatology consultations. Our population consisted of 1992 (68.29%) females and 925 (31.71%) males with a mean age of 53 (range 0-97). There were 35.55% Black, 41.28% Asian, 1.02% (30) Native American or Alaskan Native, 0.17% (5) Native Hawaiian or Other Pacific Islander. 729 were Hispanic ethnicity of which 641 were Caucasian. A total of 4,026 dermatologic diagnoses occurred in the study population. Bacterial infections were the most commonly observed, occurring in 15% of patients. Nail disorders were the second most common dAE, occurring in 14% of the study population, followed by eczema/eczematous reactions at 9%. In all racial groups, eczema/eczematous reactions, nail disorders, and dermatomyositis were in the top five most common observed dAEs. Asian patients made up the largest proportion of those who had morbilliform rash dAEs (55%) while Black patients made up the largest proportion of those with hyperpigmentation dAEs (54%) and vascular insufficiency dAEs (47%). Conclusions: The findings from our study indicate that pigmentary changes, bacterial infections, eczema/eczematous reactions, and nail disorders are the most common dAE types that occurred in our group of SOC patients. We hope to use this information to aid in the development of specific management strategies within the field of supportive oncodermatology to meet the needs of minority patient populations.
Province-wide analysis of patient reported outcomes for stage IV non-small cell lung cancer.
Authors: Tjong Michael Chandra , Doherty Mark , Tan Hendrick , Chan Wing , Zhao Haoyu , Hallet Julie , Darling Gail Elizabeth , Kidane Biniam , Wright Frances Catriona , Mahar Alyson , Davis Laura E , Delibasic Victoria , Parmar Ambika , Mittmann Nicole , Coburn Natalie G. , Louie Alexander V 
Published: June 2021

12092 Background: Stage IV NSCLC patients have significant disease and treatment-related morbidity. In Ontario, Canada, cancer patients complete Edmonton Symptom Assessment System (ESAS) questionnaires, a tool that elicits patients’ self-reported severity of common cancer-associated symptoms at clinical encounters. ESAS domains are: anxiety, depression, drowsiness, appetite, nausea, pain, shortness of breath, tiredness and well-being. The purpose of this study is to examine moderate-to-severe symptom burden in the 12 months following a diagnosis of stage IV NSCLC. Methods: Using administrative databases and unique encoded identifiers, stage IV NSCLC diagnosed between January 2007 and September 2018 were evaluated for symptom screening with ESAS in the 12 months following diagnosis. Proportion of patients reporting moderate-to-severe score (i.e. ESAS ≥4) in each domain within 12 months were calculated. Patients reporting moderate-to-severe within the different ESAS domains of were plotted over time. Multivariable (MV) Poisson regression models with potential covariates such as age, sex, Elixhauser comorbidity index, income quintiles, and lung cancer treatments received were constructed to identify factors associated with moderate-to-severe symptoms. Results: Of 22,799 stage IV NSCLC patients, 13,289 (58.3%) had completed ESAS (84,373 unique assessments) in the year following diagnosis. Patients with older age, high comorbidity, and not receiving active cancer therapy were less likely to complete ESAS. Most (94.4%) reported at least 1 moderate-to-severe score. Most prevalent moderate-to-severe ESAS symptoms within 12 months after diagnosis were tiredness (84.1%), lack of wellbeing (80.7%), low appetite (71.7%), and shortness of breath (67.8%); nausea was the least prevalent (34.6%). Most symptoms peaked at diagnosis and persisted in the year after diagnosis. On adjusted MV analyses, patients with high comorbidity, low income, and urban residency were associated with increased moderate-to-severe symptoms. Moderate-to-severe scores in all ESAS symptoms were associated with delivery of radiotherapy within 2 weeks prior, while moderate-to-severe nausea, drowsiness, tiredness, low appetite, and lack of wellbeing were associated with delivery of systemic therapy within preceding 2 weeks. Conclusions: In this population-based analysis of stage IV NSCLC PROs in the year following diagnosis, moderate-to-severe symptoms were highly prevalent and persistently high, underscoring the need to address supportive requirements in this at-risk population.
A randomized, double-blind, multicenter, phase III study of fosnetupitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving doxorubicin-cyclophosphamide/epirubicin-cyclophosphamide (AC/EC) based highly emetogenic chemotherapy: CONSOLE-BC.
Authors: Tsurutani Junji , Matsuura Kazuo , Inoue Kenichi , Tanabe Yuko , Taira Tetsuhiko , Kubota Kaoru , Tamura Tomohide , Saeki Toshiaki 
Published: June 2021

12094 Background: Fosnetupitant (FN) is a phosphorylated pro-drug of netupitant that has high binding affinity and selectivity for the neurokinin 1 receptor and a long half-life of 70 h. Recent studies have reported that fosaprepitant (FA) has a risk for developing injection site reactions (ISRs) in patients with breast cancer who receive doxorubicin-cyclophosphamide/epirubicin-cyclophosphamide (AC/EC)-based treatments. Previous studies have shown that FN may have a low risk of ISRs and could potentially address this unmet medical need. The present study (JapicCTI-194691) was intended to evaluate the safety profile, including ISRs, of FN in patients receiving AC/EC treatment. For exploratory purposes, we set the FA group as the exploratory arm. A separate pivotal phase 3 study (JapicCTI-194611) was conducted to verify the efficacy and safety of FN compared with FA in patients receiving cisplatin-based chemotherapy. Methods: Patients scheduled to receive AC/EC were randomly assigned 1:1 to receive FN 235 mg or FA 150 mg in a double-blind manner, in combination with intravenous palonosetron (PALO) 0.75 mg and dexamethasone (DEX) 9.9 mg on day 1. The stratification factors were age class ( < 55 years vs. ≥55 years) and site. The primary endpoint was the incidence of treatment-related adverse events (TRAEs) of FN. In addition, the ISRs were investigated as secondary endpoints. Efficacy outcomes were also evaluated as secondary endpoint. Results: Between April 2019 and March 2020, total 102 patients were enrolled in the study. Fifty-two patients were randomized to the FN group and 50 to the FA group, and all of them were treated with the study drug and evaluated for safety. The baseline characteristics were generally balanced, except for the history of motion sickness (54.9% vs. 44.9%) and non-smokers (78.4% vs. 63.3%) in the FN and FA groups, respectively, which are considered as risk factors for chemotherapy-induced nausea and vomiting. The primary endpoint, the incidence of TRAEs was 21.2% (n = 11) (95% CI 11.1% – 34.7%) in the FN group, which was similar to that in the FA group [22.0% (n = 11) (95% CI 11.5% - 36.0%) ]. Any cause or treatment-related ISRs were observed in 5.8% (n = 3) and 0% (n = 0), respectively, in the FN group and 26.0% (n = 13) and 10.0% (n = 5), respectively, in the FA group. The overall (0–120 h) complete response (no emetic event and no rescue medication) rate standardized by age category was 45.9% (n = 23) in the FN group and 51.3% (n = 25) in the FA group. Conclusions: The safety of FN in combination with PALO and DEX was favorable. Risk of ISR by FN was quite low in the AC/EC setting. Clinical trial information: JapicCTI-194691.
A phase III, randomized, double-blind, multicenter, active control study of fosnetupitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC): CONSOLE.
Authors: Shiraishi Yoshimasa , Hata Akito , Inui Naoki , Okada Morihito , Morise Masahiro , Akiyoshi Kohei , Takeda Masayuki , Watanabe Yasutaka , Sugawara Shunichi , Shinagawa Naofumi , Kubota Kaoru , Saeki Toshiaki , Tamura Tomohide 
Published: June 2021

12099 Background: Fosnetupitant (FN) is a phosphorylated pro-drug of netupitant that has high binding affinity for the neurokinin-1 (NK-1) receptor and a long half-life of 70 h. This phase 3 study is the first head-to-head study to compare two NK-1 receptor antagonists, FN and fosaprepitant (FA), in combination with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (JapicCTI-194611). Methods: Patients scheduled to receive cisplatin (≥70 mg/m2) -based chemotherapy were randomly assigned 1:1 to receive FN 235 mg or FA 150 mg, in combination with palonosetron 0.75 mg and dexamethasone (9.9 mg on day 1, 6.6 mg on days 2-4). The stratification factors were sex, age category (<55 vs. ≥55 years), and site. The primary endpoint was the complete response (CR; no emetic events and no rescue medication) rate, stratified by sex and age category, during the overall phase (0-120 h) to show the non-inferiority (margin, -10%) of FN to FA. The secondary endpoints were: CR rate, complete protection rate, total control rate, no nausea rate, no emetic events rate in each period [i.e., acute (0-24 h), delayed (24-120 h), overall, 0-168 h and 120-168 h], time to treatment failure, and safety, including injection site reactions (ISRs). Assessment of efficacy was continued until 168 h after the initiation of cisplatin. Some eligible patients were evaluated for safety and efficacy of FN for up to four cycles. Results: Between February 2019 and March 2020, total 795 patients were enrolled in the study. The study drug was administered to 785 patients (n=392 in FN vs. n=393 in FA), and all of them were evaluated for efficacy and safety. Baseline characteristics were generally balanced between the two groups. The adjusted overall CR rate was 75.2% in FN vs. 71.0% in FA [MH common risk difference, 4.1%; 95% CI, -2.1% to 10.3%), thus demonstrating non-inferiority of FN to FA. Regarding the other secondary endpoints of efficacy until 168 h, FN was favorable against FA, especially the CR rate during 0-168 h (73.2% in FN vs. 66.9% in FA) (Table). The incidence rates of treatment-related adverse events were 22.2% in FN vs. 25.4% in FA, whereas those of ISRs with any cause or with treatment-related were 11.0% or 0.3% in FN vs 20.6% or 3.6% in FA, respectively ( p<0.001). Conclusions: FN demonstrated non-inferiority to FA, with a favorable safety profile and lower risk for ISRs. For the period beyond 120 h after initiation of chemotherapy, FN may have the potential to improve the prevention of “beyond delayed” CINV. Clinical trial information: JapicCTI-194611. [Table: see text]
A randomized controlled trial of cognitive behavior therapy for reducing anxiety and depressive symptoms in patients with locoregional advanced nasopharyngeal carcinoma.
Authors: Liu Feng , Fu Shengnan , Chen Yanzhu , Yan Ouying , Wu Xiangwei , Han Yaqian , Jiang Cuihong , Tong Fei , Zou Ran , Peng Wanglian , Wang Hui , Liu Xiaohong 
Published: June 2021

12121 Background: The purpose of this randomized trial was to compare the efficacy of cognitive behavioral therapy (CBT) versus treatment as usual (TAU) on anxiety and depression, response rates and acute adverse events in patients with locoregional advanced nasopharyngeal carcinoma (NPC) receiving chemoradiotherapy. To the best of our knowledge, this is the first randomized trial evaluating the effect of CBT for depression and anxiety in patients with locoregional advanced NPC treated with chemoradiotherapy. Methods: A total of 202 patients with diagnosis of stage III-IVa (8th AJCC) NPC were randomly assigned to receive CBT plus chemoradiotherapy (CBT group, n = 101) or treatment as usual (TAU) plus chemoradiotherapy (TAU group, n = 101). Patients in the CBT group received a series of six CBT sessions for 6 weeks during concurrent chemoradiotherapy. Depression and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS) score at baseline, the completion of chemoradiotherapy, 1 and 3 months after chemoradiotherapy. Response rates and adverse events were also evaluated. This trial is registered with chictr.org.cn, number ChiCTR2000034701. Results: Patients in the CBT group showed significantly less depression and anxiety than patients in the TAU group after the completion of CBT (P < 0.01). Complete response (CR) rate was significantly higher in CBT group than in TAU group (100% vs. 93.1%，P = 0.014). Compared with the TAU group, the CBT group showed a significantly lower incidence of acute adverse events including anemia, fatigue, mucositis, insomnia and weight losing (P < 0.05). Conclusions: The addition of CBT to chemoradiotherapy significantly reduced depressive and anxiety symptoms. CBT combined with chemoradiotherapy is associated with improved response rates, with reduced incidence of acute toxic effects in patients with locoregional advanced nasopharyngeal carcinoma. Clinical trial information: ChiCTR2000034701.
Patient reported sexual concerns in routine cancer care.
Authors: Lees Brittany , Vilasagar Smitha , Brown Jubilee , Clark Peter E , McKibben Maxim , Meadors Patrick , Sabir Sasha , Smith Shannon M , York Beth , Walsh Declan 
Published: June 2021

12128 Background: Sexual health is an important component of overall well-being and can be adversely impacted by chemotherapy, surgery, radiation, in addition to the psychological effects of cancer treatments. Sexual health is challenging to discuss and may be overlooked or avoided during cancer care. Methods: Patients presenting for consultation in an outpatient multisite cancer center completed electronic distress screening (EDS) between January 2017 and December 2020. The EDS contains 42 questions; demographic information, cancer symptoms and side effects, and psychosocial factors. The EDS is completed by patients before a clinical encounter for early symptom identification and intervention. We conducted a retrospective data analysis of sexual health concerns (>5; scale 0-10) and evaluated patient characteristics and clinically relevant distress (>4; NCCN Distress Tool), depression risk (>3; PhQ2), and anxiety risk (>3; GAD2). Our primary aim was to identify the prevalence of sexual health concerns. The secondary aim was to examine the relationship between sexual health and emotional well-being. Results: 57,375 EDS screens were completed. 13,950 patients (24%) reported sexual concerns or lack of interest in sex (>5) within the last 2 weeks. The frequency of these concerns at specific clinics ranged from 12% to 48%, with the highest rates at Palliative care (39%) and Psycho-Oncology (48%) clinics. Genitourinary (30%), Gynecologic (27%) and Gastroenterology (26%) reported the highest frequency of sexual concerns from cancer site specific clinics. Males reported a higher rate of sexual problems compared to females (30% vs 21%, p < 0.001), but a lower rate of relationship concern distress (12% vs 13%, p < 0.05). Patients with a risk for depression (n = 9,126) or anxiety (n = 10,809) had higher rates of self-reported sexual concerns than those with a negative screen (44% vs 21% depression, p < 0.001; 40% vs 21% anxiety, p < 0.001). Conclusions: Sexual health is a concern for approximately one-quarter of patients presenting for cancer care. Sexual health concerns were prevalent across cancer sites. Patients with positive screens for anxiety and/or depression have nearly double the rates of reported sexual health concerns. Sexual health is a current unmet need that impacts cancer patients and warrants attention.
Family members’ attitudes towards disclosure of cancer diagnosis to patients in China.
Authors: Rao Xi , Zhang Yongshen , Kong Feng-Ming Spring 
Published: June 2021

12131 Background: Informed consent is very important aspect of treatment, in western countries, a diagnosis of malignancy should be delivered the paient directly. It was the decision of the patient for further disclosure. However, in China, people are always family centered decision making, a diagnosis of cancer is traditionally delivered to the family members, with a protective assumption. We used anonymized questionnaire to investigate the attitude of Chinese people towards to cancer diagnosis disclosure and correlated factors. Methods: This is a survey study conducted by a web system named “Wenjuan Xing”. The study questionnaires were designed in dual English and Chinese. answered by the same person. The regarding questions that answered by the same person are as following: “If your close family member is diagnosed with a malignant tumor, would you like to tell him the truth?”, “If yes/no, what’s your reason?”. Demographic information include gender, age, economic status, education level, health condition, residential region, occupation, nationality and major reasons. The survey link was placed on Wechat contact of these investigators, social media and also distributed in Oncology Center of a general hospital in Mainland China. The answers of the questions were captured directly online, data can also be exported into excel format for compiled analysis. Results: A total of 1470 people completed the survey questions from January to July 2020. The potential factors which influence disclosing diagnosis were registered, 1041 (70.8%) family members are in favor of informing the diagnosis to patients, 429 (29.2%) are not. The main reasons for disclosure diagnosis are ‘it is his or her life, he/she has to be in control’ (N=832) and she or he can plan his/her remaining life and leave the world with no regret (N=588). The famliy member who hide the diagnosis worry that paitents could not handle the stress would have poor quality of life (N=295) and die faster(N=323). 1425(96.9%) people want to know the diagnosis if they have a malignanti tumor, while 45 (3.1%) don’t want to know.The univariate analysis revealed educational level, health condition and residential region are correlated to disclosing diagnosis. The logistic regression anaylsis show a significant effort to disclosing diagnosis(OR= 1.9, 95% CI (1.4, 2.7) P<0.001).Interaction and stratified analyses were conducted according to education level and redidential region (P interaction= 0.0406). In the high education level group, people who live in other countries(America, Europe) (P=0.009 OR=29.7 CI 2.3-375.7) more likely to disclose the diagnosis compared to mainland in China. Conclusions: The majority of Chinese people want to know the diagnosis. People who have higher education level and live in western countries more likely prefer disclosure of diagnosis to patients.