tbuckley/cabot-search huggingface dataset:
An epidemiological study on chronic obstructive pulmonary disease in a rural area of Tianjin
Authors: 陈宝元, 单淑香, 陈哲, 冯靖, 李津娜, 李硕, 钟晓芃, 周伟, 郑立文, 赵丽红
Journal: BMJ (2006)

目的 了解天津市农村地区40岁以上人群慢性阻塞性肺疾病的流行病学特点.方法 将天津市宝坻区新开口乡5个自然村40岁以上1 508名村民作为调查对象,进行流行病学问卷、肺功能测定、体格检查.对确诊慢性阻塞性肺疾病者进行胸部X线及心电图检查.结果 该地区慢性阻塞性肺疾病患病率为9.4%,其中肺源性心脏病患病率为16.9%.随着年龄的增长,慢性阻塞性肺疾病患病率男性高于女性(13.5%与6.2%),吸烟者高于非吸烟者(12.2%与7.2%),有家族史者高于无家族史者(21.4%与8.5%),幼年前有咳嗽史者高于无咳嗽史者(75.0%与9.2%),P值均＜O.01.单因素回归分析显示,室外空气污染、下厨、使用柴草烹饪时间、吸烟、幼儿时咳嗽史、男性、年龄增长、家族史为慢性阻塞性肺疾病的易患因素.多因素分析显示,男性、年龄增长、家族史为慢性阻塞性肺疾病的独立易患因素.非慢性阻塞性肺疾病者生存质量优于慢性阻塞性肺疾病者,差异具有统计学意义.结论 天津市农村地区慢性阻塞性肺疾病患病率较高,主要危险因素为男性、年龄、家族史、吸烟及室外空气污染。
Minimal-Residual Disease Guided Treatment with Azacitidine in MDS/AML Patients at Imminent Risk of Relapse: Results of the Prospective RELAZA2 Trial
Authors: Uwe Platzbecker, Jan Moritz Middeke, Katja Sockel, Anke Mütherig, Regina Herbst, Mathias Hänel, Dominik Wolf, Claudia D. Baldus, Lars Fransecky, Richard Noppeney, Gesine Bug, Katharina S Götze, Alwin Krämer, Tilman Bochtler, Karsten Spiekermann, Marion Subklewe, Matthias Stelljes, Christoph Groth, Antje Schubert, Hubert Serve, Ulrich Duehrsen, Johannes Schetelig, Christoph Rollig, Michael Kramer, Gerhard Ehninger, Martin Bornhäuser, Christian Thiede
Journal: Blood (2017)
Is knowledge retained by healthcare providers after training? A pragmatic evaluation of drug-resistant tuberculosis management in China
Authors: 吴诗诗, 李仁忠, 苏伟, 阮云洲, 陈明亭, Khan Mishal
Journal: BMJ (2020)

目的
中国现阶段对于耐药性传染病的标准化管理迫切地需要相关培训，然而现有文献中缺乏关于培训长期影响的研究证据。因此本研究课题的目的是评估参加培训的学员有关耐多药结核病的知识是否在培训结束时和1年后得到改善。


研究方法和对象
选取了91名曾参加在中国辽宁省和江西省开展的耐多药结核病管理培训的医生、护士和疾病预防控制中心工作人员。


主要结局指标
在2016年，所有的培训学员均在培训当天参与了培训前及培训结束时关于耐多药结核病管理知识的测验。2017年7月，即培训后1年，通过电话访问，对调查对象的耐多药结核病管理知识进行了第三次测试。利用卡方检验比较了培训前、培训结束时以及培训1年后的知识测试成绩，并使用线性回归分析了影响培训学员在长期知识测试中表现的因素。


结果
在2个省中，对于耐药结核病的定义、耐多药结核病病例检测方案和实验室诊断等3题的学员正确回答比例在培训后1年比培训前提高了14.5%（P= 0.037）、32.4%（P<0.001）和31%（P<0.001）。然而，与培训结束时测试成绩相比，江西省的正确回答学员比例分别下降了26.5%（P= 0.003）、19.8%（P=0.018）和52.7%（P<0.001）。在辽宁省我们并没有观察到显著下降。此外，我们发现在培训1年后的测试中获得较高分数与较长的临床经验（系数= 0.51；95%可信区间，0.02~0.99；P=0.041）和参加辽宁省举办的培训有关（系数= 0.50；95%可信区间，0.14~0.85；P=0.007）。


结论
本次研究是第一个在培训1年后评估耐多药结核病医务人员知识保留情况的研究。研究结果显示了讲座式培训对学员专业知识有着长期的、积极的影响。然而，针对培训后1年的知识下降的情况，特别是在参加江西省培训的学员中，可以通过对临床经验不足的医务人员进行有针对性的后续辅导，以改善知识下降的情况。
End-of-life (EOL) trajectories among older adults dying with lung cancer (LC).
Authors: Amy J. Davidoff, Maureen Canavan, Shi-Yi Wang, Elizabeth Horn Prsic, Maureen Saphire, Carolyn J Presley
Journal: Journal of Clinical Oncology (2020)

e24008 Background: Medicare decedents often receive intensive care during the last month (mth) of life. There is little information on longer (6-mth) EOL trajectories of care intensity. Area hospice use rates may reflect supply and/or patient and physician preferences, and may influence patterns for individual decedents. Methods: Using SEER-Medicare linked registry and claims data, we selected decedents diagnosed with LC between 2008-2013 who survived ≥6-mths and died between 2008-2014. We linked Dartmouth Atlas data on hospital referral region (HRR) % cancer decedents with hospice use. Each mth we assessed claims to identify cancer-directed (CD) care (chemotherapy or radiation) and pharmacologic or other palliative care services (PCS) and assigned decedents to either CD only, PCS only, concurrent CD &amp; PCS, full-mth inpatient (IP) or full-mth hospice. We ordered monthly care intensity from high to low (IP &gt; CD only &gt; concurrent CD &amp; PCS &gt; PCS only &gt; hospice). Using the indicators arrayed by calendar mth, we assigned each decedent to 1 of 6 trajectories: stable (6-mth continuous) hospice, stable PCS only, stable CD only or concurrent CD &amp; PCS, decreasing intensity, increasing intensity, and mixed (multiple directional shifts). Multinomial logistic regression estimated associations between area hospice rates, socio-demographics, and comorbidity with EOL trajectory, controlling for 1 st line therapy, and diagnosis stage. Results: Our sample (N = 24,342) was predominantly male (53.7%), age ≥75 years (59.4%), and non-Hispanic white (80.5%); 19.1% lived in HRRs where ≤50% of cancer decedents received any hospice care. Trajectories were 7% stable hospice, 26% stable PCS only, 4% stable CD; 29% decreasing intensity, 9% increasing intensity, and 26% mixed. Relative to stable hospice, higher HRR-level hospice rates were associated with decreasing EOL intensity; higher age, female, and married were associated with increased probability of stable hospice enrollment); Black, non-Hispanic decedents had higher risk of increasing intensity (aRRR: 1.39, 95% confidence interval: 1.09-1.76, p &lt; .01) and mixed patterns. Conclusions: Among older decedents with LC, only 62% had 6-mth EOL trajectories indicating low- (stable hospice or PCS only) or decreasing intensity, but few received persistent CD care. Area hospice use patterns, demographic characteristics and health status were associated with EOL trajectory. Additional research is needed to identify subgroups at risk of high or increasing intensity trajectories, and interventions that may shift trajectories towards lower intensity at EOL.
Establishment and application of files of doctors′ work ability
Authors: Peichu Zhang, Junling Wang, Huali Wu
Journal: BMJ (2019)

The current status and major problems of doctors′ working ability archives were investigated. The qualitative interview method was used to explore the establishment of doctors′ working ability archives for secondary, tertiary hospitals and community health service centers, as well as for doctors of Chinese and Western medicine. The collection cycle of relevant data and measures to improve accuracy, application value and response were also explored. The aim of establishing the archives of doctors′ working ability is to provide reference for evaluation of clinicians accurately, developing a rational incentive system, improving data support and upgrading hospital management level.


Key words: 
Doctor; Ability files; Establish; Application
INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma (GBM): Interim results.
Authors: David A. Reardon, Steven Brem, Arati Suvas Desai, Stephen Joseph Bagley, Sylvia Christine Kurz, Macarena Ines De La Fuente, Seema Nagpal, Mary Roberta Welch, Adilia Hormigo, Nicholas Carroll, Sarah K Bartra, Patricia Campbell, Kamalnayan Bhatt, Israel Lowy, Jean Boyer, Kimberly Kraynyak, Matthew P Morrow, Trevor McMullan, David B. Weiner, Jeffrey Skolnik
Journal: Journal of Clinical Oncology (2020)

2514 Background: Novel T cell-enabling therapies, in combination with checkpoint inhibition, may improve OS in GBM. INO-5401 (synthetic DNA plasmids encoding for hTERT, WT-1 and PSMA), plus INO-9012 (synthetic DNA plasmid encoding IL-12), with the PD-1 checkpoint inhibitor cemiplimab, is given to patients with newly-diagnosed GBM to evaluate tolerability, efficacy and immunogenicity of the combination. Methods: Phase I/II, single arm, 2 cohort study (A: MGMT unmethylated, B: MGMT methylated). The primary endpoint is safety; efficacy and immunogenicity are secondary. Nine mg INO-5401 plus 1 mg INO-9012 (every 3 weeks for 4 doses, then Q9W) is given with EP by CELLECTRA 2000 with cemiplimab (350 mg IV Q3W). RT is given as 40 Gy over 3 weeks. TMZ is given with radiation (all patients), followed by maintenance (Cohort B only). Results: Fifty two subjects were enrolled: 32 in Cohort A; 20 in Cohort B. 35% women and 90% white. Median age 60 years (range 19-78 years). Common Grade ≥3 AEs reported were: platelet count decreased (11.5%), tumor inflammation (7.7%), seizure (7.7%), ALT increased (7.7%), lymphocyte count decreased (7.7.%). One Grade 5 unrelated event of urosepsis was reported. Of 69 SAEs reported there was only 1 related to the combination therapy, Grade 1 pyrexia. 48% of subjects reported irAEs, most frequently ALT increased (9.6%), AST increased (7.7%), diarrhea (7.7%), pyrexia (7.7%) and tumor inflammation (7.7%). 71% of the reported SAEs and irAEs occurred within the first 12 weeks of treatment. OS at 12 months was 84.4% (95% CI 67.2, 94.7) in Cohort A; Cohort B will be presented at ASCO. ELISpot assessments demonstrated T cell responses to INO-5401. Flow cytometry demonstrated evidence of activated INO-5401-specific CD8+T cells with lytic potential (CD38+Prf+GrzA+) when compared with baseline, post-treatment in the majority of patients assayed. Conclusions: INO-5401 + INO-9012 in combination with cemiplimab and RT/TMZ has an acceptable safety profile, is immunogenic and may show a survival advantage in patients with newly-diagnosed GBM. OS18 data will be presented later this year. Clinical trial information: NCT03491683 .
Study of serum LOX-1 and lipids in patients with obstructive sleep apnea hypopnea syndrome
Authors: Yan Li, Xiu-hong Nie, Wei Zhang, Xiao-jun Fan, Kui Ren
Journal: BMJ (2013)

Objective
To explore the changes of serum lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) and the level of lipids in patients with obstructive sleep apnea hypopnea syndrome (OSAHS).


Methods
A total of 94 candidates with sleep disorders between January-July 2011 at outpatient department were monitored with polysomnography. According to apnea-hypopnea index (AHI), they were divided into mild-to-moderate OSAHS (5≤AHI≤30) (n=27), severe OSAHS (AHI>30) (n=37) and normal control groups (AHI<5) (n=30). After polysomnography, their blood samples were obtained to measure the levels of serum LOX-1, triglycerides (TG), cholesterol (TC), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C).


Results
The serum level of LOX-1 in severe OSAHS group was significantly higher than that in the mild-to-moderate and control groups (P 0.05).


Conclusions
Intermittent hypoxia caused by OSAHS increases the level of LOX-1 to further promote the formation and development of atherosclerotic in patients with OSAHS. The levels of lipid can not effectively predict the severity of lipid metabolism disorder in patients with OSAHS.


Key words: 
Sleep apnea, obstructive; Receptors LDL; Dyslipidemias
Tepotinib in patients (pts) with NSCLC with <i>MET</i> exon 14 (<i>MET</i>ex14) skipping: Health-related quality of life (HRQoL).
Authors: Paul K. Paik, Leora Horn, Dariusz M. Kowalski, Jyoti D. Patel, Frank Griesinger, Ji-Youn Han, Egbert F. Smit, Terufumi Kato, Xiuning Le, Jürgen Scheele, Rolf Bruns, Helene Vioix, Boris M Pfeiffer, Byoung Chul Cho
Journal: Journal of Clinical Oncology (2020)

9575 Background: In the phase II VISION study (NCT02864992) tepotinib had promising efficacy (response rate of 40–50% &amp; median duration of response &gt;1 y) and tolerable safety in pts with advanced NSCLC with METex14 skipping (3–4% of NSCLC), who are typically elderly with poor prognosis. Pt reported outcomes (PROs) of HRQoL are described here. Methods: Pts with advanced NSCLC positive for METex14 skipping by tissue or liquid biopsy received oral tepotinib 500 mg once daily; PROs were assessed using QLQ-LC13 (lung cancer symptoms), EORTC QLQ-C30 (Global health status [GHS] &amp; 5 functional scales), and EQ-5D-5L (VAS). Questionnaires were completed at baseline (BL) and every 6 weeks (Wk); results were scored from 0–100 (minimal clinically important difference [MCID] ≥10 points). Mean change from BL was analyzed at Wk 12 (predefined analyses). Results: By 19 Jul 19 cut-off, 130 pts across treatment lines were enrolled (median age 74.2 y), with PROs available for 129. Questionnaire completion rates were 90.1% at Wk 12. Symptom burden at BL was moderate for advanced NSCLC; mean change from BL for PROs are shown in the table (better functioning: lower QLQ-LC13 or higher QLQ-C30 scores). For the QLQ-LC13 symptoms, mean changes from BL indicated a meaningful improvement in coughing, with a median time to improvement (2.8 months) paralleling the onset of objective response (within first 3 months), and a numerical improvement in dyspnea (–2.3 at Wk 12) and chest pain (–4.2 at Wk 12). QLQ-C30 values remained stable over treatment as did EQ-5D-5L scores (higher=better): mean (standard deviation, SD) change from BL score (60 [20.4]) was 6 (18.6) at Wk 6 and 5 (20.9) at Wk 12. Conclusions: In this first analysis of PROs in pts with advanced NSCLC with METex14 skipping with a moderate symptom burden, treatment with tepotinib led to a clinically meaningful improvement in coughing symptoms, while maintaining HRQoL. Coupled with the efficacy and safety profile, the predefined HRQoL analysis from the VISION study supports tepotinib as a promising treatment option for this elderly population with METex14+ NSCLC. Clinical trial information: NCT02864992 . [Table: see text]
高龄老人重症有机磷中毒抢救成功一例
Authors: 范秀芝, 赵增平, 赵娜
Journal: BMJ (2007)

患者男,81岁,农民.既往有高血压、冠心病、心房纤颤病史20年.因自服敌敌畏(约100 ml)0.5 h于2006年6月24日9:00就诊于我院急救中心.查体:血压170/90 mm Hg(1 mm Hg=0.133 kPa);患者呈浅昏迷状,呼吸急促,面色灰暗,多汗,双瞳孔直径1 mm,胸廓肌束颤动;双肺可闻及较多干、湿啰音;心率80次/min,律不齐,心音强弱不一;腹平软,肝脾无肿大.心电图表现:P波消失,代之以f波,QRS波群振幅、频率不等,心室率为80次/min;Ⅱ、Ⅲ、aVF及V4-5导联ST段压低3 mm。
气管导管辅助插入胃管在吸入性损伤中的应用
Authors: 陈军, 王静, 张劲光, 史海涛, 尹艳, 王立荣, 侯贺宪
Journal: BMJ (2009)

重度吸入性损伤患者因张口困难,往往合并有喉头水肿或昏迷,用常规胃管插入法通常插入困难,且不能保证一次成功.为预防应急性溃疡发生,应当尽早进行鼻饲,胃肠营养.2005年2月至2009年1月,我院收治烧伤后合并中、重度吸入性损伤患者29例,应用气管导管辅助插入胃管29次,均为一次成功,取得了良好效果。
Efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor in the prevention of chemotherapy-induced neutropenia in patients with breast cancer.
Authors: Xiaoyu Chong, Xiaoli Zhu, Xuejuan Li, Lingna Gao, Hongfang Ma, Baogui Chong
Journal: Journal of Clinical Oncology (2020)

e12515 Background: To explore the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF, brand name: Jinyouli) in the prevention of neutropenia in breast cancer patients receiving adjuvant chemotherapy with EC regimen (epirubicin combined with cyclophosphamide). Methods: Retrospective analysis was conducted on breast cancer patients receiving adjuvant chemotherapy with EC regimen in Hengshui People's Hospital between January 2018 to October 2019. In cycle 1, all patients developed grade 3/4 neutropenia and PEG-rhG-CSF was used prophylactically in the subsequent cycles. The incidence of grade 3/4 neutropenia, febrile neutropenia (FN), chemotherapy delay and dose adjustment were observed as well as relative dose intensity (RDI), antibiotics application and adverse events. Results: 96 breast cancer patients were enrolled and all of them developed grade 3/4 neutropenia (100%) in cycle 1. After secondary prophylactic use of PEG-rhG-CSF, the incidence of grade 3/4 neutropenia decreased to 26.32% (25/95), 12.50% (10/80) and 13.63% (9/66) in cycle 2-4, respectively, with a statistically significant difference with cycle 1 ( P&lt;0.001); The incidence of FN decreased from 2.08% (2/96) in cycle 1 to 0% (0/95), 1.25% (1/80) and 0% (0/66) in the subsequent cycles ( P&gt;0.05). The incidence of chemotherapy delay was 2.08% (2/96), 2.50% (2/80) and 1.52% (1/66) in cycle 2-4, respectively, and the incidence of dose adjustment was 9.38% (9/96) in cycle 2. There was no dose adjustment in cycle 3-4. The average RDI was 92%, 92% and 94% in cycle 2-4, respectively. The most common treatment-related adverse events were fever (2.08%), muscle pain (1.04%) and fatigue (1.04%). Conclusions: PEG-rhG-CSF secondary prevention can effectively reduce the incidence of neutropenia in breast cancer patients receiving adjuvant chemotherapy with EC regimen, which ensures the implementation of standard-dose chemotherapy with good safety.
Phase II study of lower-dose pracinostat plus azacitidine safety and efficacy in patients with high/very high-risk myelodysplastic syndromes.
Authors: Ehab L. Atallah, Samer K. Khaled, Brenda W. Cooper, Erica D. Warlick, David A. Ramies, Joanne Li, Riccardo Spezia, Silvia Mappa, Michael Kenneth Keng
Journal: Journal of Clinical Oncology (2020)

7556 Background: Hypomethylating agents (HMA), such as azacitidine (AZA), are the standard of care for patients (pts) with higher-risk myelodysplastic syndromes (MDS). However, overall response rate (ORR=CR+PR) with HMA alone is approximately 30%, with a 2-year overall survival (OS) rate of 50.8%. Preclinical studies show that pracinostat (PRAN), an oral histone deacetylase inhibitor, synergizes with HMA. A study in pts with untreated IPSS intermediate-2/high-risk MDS receiving 60 mg PRAN plus AZA resulted in early discontinuations, mainly due to adverse events (AE), potentially leading to diminished clinical benefit. This follow-up phase II study evaluates a lower dose of PRAN (25% reduction) in combination with AZA in order to reduce toxicity, decrease early discontinuations, and improve outcomes. An interim analysis showed low discontinuation rate and promising efficacy, allowing trial expansion. Herein, we report preliminary safety and efficacy in the overall population. Methods: Open-label, II-stage, phase II trial (NCT03151304) in pts (≥18 years) naive to HMA therapy and with IPSS-R of high/very high-risk MDS. Planned enrollment was 60 pts. Pts received 45 mg PRAN 3 days/week for 3 consecutive weeks plus standard AZA dose for 7 days of each 28-day cycle. Primary objectives were to define the safety/tolerability of the combination and to assess the ORR (CR+PR). OS was a secondary endpoint. Results: Sixty-four pts were enrolled and received ≥1 dose of treatment. Most pts were male (67%), median age was 68 years (range 47–89), and the proportion of pts with high/very high-risk MDS was similar. After 17.6 months’ median follow-up, 31% of pts remain on treatment; 69% of pts discontinued treatment due to stem cell transplant (25%), disease progression (17%), AEs (11%), consent withdrawal (3%), pt noncompliance (3%), death (3%), lost to follow-up (2%), and other (5%). Most common nonhematologic AEs were constipation (55%), nausea (52%), fatigue (45%), decreased appetite (39%), peripheral edema (36%), diarrhea, and dyspnea (31% each). Frequent hematologic AEs were decreased neutrophil count (50%), anemia (39%), decreased platelet count (38%), febrile neutropenia (36%), and thrombocytopenia (30%). ORR was 33% (95% CI 22-46), with 33% achieving CR; 34% of pts had marrow CR. Median OS was 23.5 months (95% CI 16.4-nc), with an estimated 1-year OS of 77%. Conclusions: In pts with high/very high-risk MDS, a lower dose of pracinostat in combination with AZA demonstrated a tolerable safety profile and promising efficacy. Clinical trial information: NCT03151304 .
A phase II study of olaparib in combination with pembrolizumab in patients with previously treated advanced solid tumors with homologous recombination repair mutation (HRRm) and/or homologous recombination repair deficiency (HRD): KEYLYNK-007.
Authors: Timothy A Yap, Mallika Sachdev Dhawan, Andrew Eugene Hendifar, Michele Maio, Taofeek Kunle Owonikoko, Miguel Quintela-Fandino, Roni Shapira, Sanatan Saraf, Ping Qiu, Fan Jin, Alexander Gozman, Douglas A Levine
Journal: Journal of Clinical Oncology (2020)

TPS3156 Background: The anti-PD-1 antibody pembrolizumab (pembro) has improved clinical outcomes in multiple previously treated advanced solid tumors. The poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (ola) has shown antitumor activity as monotherapy in previously treated advanced cancers with BRCA1/ BRCA2 mutations (BRCAm), other HRRm, and ovarian cancer with HRD phenotype. Antitumor activity of PD-(L)1 plus PARP inhibition was reportedly higher than expected with either agent alone in patients (pts) with recurrent ovarian cancer regardless of BRCAm or HRD status and in pts with BRCAm breast cancer. KEYLYNK-007 (NCT04123366) evaluates antitumor activity and safety of ola plus pembro in pts with advanced solid tumors with HRRm and/or HRD. Methods: This phase 2, nonrandomized, multicenter, open-label study plans to enroll ~300 pts aged ≥18 y with histologically/cytologically confirmed, previously treated, advanced solid tumors with HRRm and/or HRD per Lynparza HRR-HRD assay (Foundation Medicine, Inc., Cambridge, MA, USA) and ECOG PS 0-1. Pts will be grouped by biomarker status: (1) BRCAm; (2) HRRm without BRCAm; (3) HRD positive without HRRm (loss of heterozygosity score ≥16 per Lynparza HRR-HRD assay). Pts will receive ola 300 mg BID + pembro 200 mg IV Q3W (35 cycles) until PD, unacceptable AEs, intercurrent illness, investigator decision, withdrawal, or pregnancy. Tumor imaging assessment by blinded independent central review (BICR) per RECIST v1.1 or Prostate Cancer Working Group (PCWG)-modified RECIST v1.1 for prostate cancer will occur Q9W for 12 mo, then Q12W until PD, start of new anticancer treatment, withdrawal, pregnancy, or death. AEs will be monitored throughout the study and for 30 days after final dose (90 days for serious AEs) and graded by NCI CTCAE v5. The primary endpoint is ORR (RECIST v1.1 or PCWG-modified RECIST v1.1 by BICR). Secondary endpoints include DOR, PFS (RECIST v1.1 or PCWG-modified RECIST v1.1 by BICR), OS, and safety. ORR will be analyzed by the Clopper-Pearson method; and DOR, PFS, and OS by the Kaplan-Meier method. Clinical trial information: NCT04123366 .
Cardiac complications of CDK4/6 inhibitors for breast cancer.
Authors: Samip R. Master
Journal: Journal of Clinical Oncology (2020)

e13038 Background: Cardiac toxicity has largely been underestimated toxicity of CDK4/6 inhibitors. We did a retrospective analysis of data made available to public by the FDA regarding the cardiac adverse effects of CDK 4/6 inhibitors. We used data from trastuumab for comparison purpose. Methods: The FDA has made the data on adverse effects of various treatments available to general public through the FDA Adverse Events Reports System (FAERS) public dashboard. We investigated the cardiac toxicities of CDK 4/6 inhibitor therapies available at FDERS for the years 2018-2019. Results: A total of 27,079 advere events(AE) from CDK4/6 inhibitors namely, ribociclib, palbociclib and abemaciclib were reported during the year 2018-2019. Out the total, 805 i.e. 2.9% were cardiac AEs. The most common reported cardiac AE were atrial fibrillation (121), myocardial infarction (190), cardiac failure (85) and pericardial effusion (70). As shown in the table, percentage of cardiac AE compared to total AE reported were 2.2%, 5.4%, 7.9% and 7.2% respectively for Palbociclib, Abemaciclib, Ribociclib and trastuzumab. Conclusions: Out of the reported cases of adverse reaction to CDK4/6 inhibitors, 2.9 % were cardio toxicities. The incidence of cardiac complications was higher in ribociclib, compared to Palbociclib and Abemaciclib. [Table: see text]