tbuckley/cabot-search huggingface dataset:
AB0582 TOFACITINIB IS SAFE IN REPRODUCTIVELY ACTIVE WOMEN PLANNING FOR PREGNANCY: A REPORT OF 6 CASES
Authors: N. Prabu, V. Petchiappan, G. Anandh, J. Antony, A. Kumar, S. Ramachandiran
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Tofacitinib a targeted synthetic DMARDS is being increasingly used in the management of Rheumatoid arthritis. The literature regarding its safety in pregnancy is often limited with trial results showing favorable outcome but no real world data. <h3>Objectives:</h3> To assess the outcomes of rheumatoid arthritis patients treated with tofacitinib who become pregnant. <h3>Methods:</h3> All case records of rheumatoid arthritis patients who become pregnant after taking tofacitinib were identified and the details of pregnancy outcome were categorized as healthy newborn (Pre-term birth &amp; healthy new borns with low birth weight),Spontaneous abortions, Medical termination, Fetal demise,Congenital malformation, Neonatal death or Lost to follow up. <h3>Results:</h3> There were total of 6 patients who become pregnant with total of 8 pregnancies while on tofacitinib. The median age was 28years. There were five successful pregnancy outcomes with two still in gestation and one of them lost to follow-up. One patient delivered an extreme low birth weight infant(700 grams) while all others had normal kids. There were no reports of abortions, congenital malformations and neonatal deaths. <h3>Conclusion:</h3> Tofacitinib doesn't seem to have adverse pregnancy outcomes and is safe in reproductively active females who wish to become pregnant <h3>REFERENCES:</h3> [1] Mahadevan U, Dubinsky MC, Su C, Lawendy N, Jones TV, Marren A, Zhang H, Graham D, Clowse MEB, Feldman SR, Baumgart DC. Outcomes of Pregnancies With Maternal/Paternal Exposure in the Tofacitinib Safety Databases for Ulcerative Colitis. Inflamm Bowel Dis. 2018 Nov 29;24(12):2494-2500. doi: 10.1093/ibd/izy160. PMID: 29982686; PMCID: PMC6262193. <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> <b>None declared.</b>
AB0567 PREVALENCE OF CONCOMITANT SARCOPENIA AND FRAILTY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN A MULTICENTER, PROSPECTIVE, OBSERVATIONAL STUDY (PRESENT STUDY)
Authors: M. Tada, Y. Matsumoto, T. Koike, K. Mamoto, T. Nakamura, S. Anno, T. Iida, H. Goto, N. Hidaka
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Patients with rheumatoid arthritis (RA) have higher rates of sarcopenia and frailty than the general population because they have reduced muscle strength due to the disease. In RA patients, the relationship between and the prevalence of concomitant sarcopenia and frailty is unclear. <h3>Objectives:</h3> The characteristics of RA patients with sarcopenia and frailty were investigated to clarify their interrelationship. <h3>Methods:</h3> Background data from the multicenter, prospective, observational study, "The effect of biologics and JAK inhibitors on sarcopenia in RA (PRESENT Study)," were used. The Asian Working Group for Sarcopenia (AWGS) 2019 diagnostic criteria were used to diagnose sarcopenia and severe sarcopenia, and the Japanese-Cardiovascular Health Study (J-CHS) criteria were used for frailty and pre-frailty. Two hundred RA patients who required tight control were divided into those with or without sarcopenia or with or without frailty, and patients' background characteristics, disease activity, treatment, body composition, and muscle function were compared. The interrelationship between sarcopenia and frailty was also examined. <h3>Results:</h3> The incidences of sarcopenia and severe sarcopenia were 20% and 10%, respectively. Those with sarcopenia were significantly older, had longer disease duration, more advanced Stage and Class, higher RF positivity, higher C-reactive protein (CRP) level, higher methotrexate (MTX) use, lower muscle and fat mass, and weaker grip strength (Table 1). On the other hand, the incidences of frailty and pre-frailty were 40% and 54%, respectively. The frailty group was significantly older, had more advanced Stage and Class, higher DAS28-ESR, higher mHAQ, higher CRP level, higher glucocorticoid usage rate, lower muscle mass, weaker grip strength, and slower walking speed (Table 2). Sarcopenia and frailty were combined in 10% of patients (50% of sarcopenia and 25% of frailty patients). A significant positive correlation was found between severe sarcopenia and frailty (correlation coefficient 0.31, p&lt;0.001). <h3>Conclusion:</h3> In RA patients requiring enhanced therapy, the incidences of sarcopenia and frailty were 20% and 40%, respectively, and both were present in 10% of patients. In particular, patients with frailty had high disease activity and a marked decline in muscle function. <h3>REFERENCES:</h3> <b>NIL.</b> <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> <b>None declared.</b>
AB0576 PERCUTANEOUS CORONARY INTERVENTION (PCI) IN PATIENTS WITH RHEUMATOID ARTHRITIS(RA): A SYSTEMATIC REVIEW AND META-ANALYSIS
Authors: S. Piplani, A. Kostojchin, S. Kong, A. Sharma, D. Brown, V. Jelic, S. Chaturvedi, V. R. Bejugam, T. Simpson, W. Xiao, A. Sharma, M. Radulovic
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Rheumatoid Arthritis (RA) is an inflammatory arthritis linked to an elevated risk of cardiovascular disease (CVD), including heart failure, myocardial infarction, stroke, and coronary revascularization. Recognized as an independent CVD risk factor, RA's accelerated inflammation contributes to premature ischemic disease. Percutaneous coronary intervention (PCI) is a common revascularization method, yet research on its outcomes in autoimmune rheumatic diseases like RA is sparse and often involves small sample sizes. This Meta-Analysis aims to comprehensively assess PCI outcomes in RA patients compared to non-RA counterparts, delving into parameters such as MACE, revascularization rates, mortality, infarction, and complications to enhance management and mitigate adverse cardiac events. <h3>Objectives:</h3> We aim to assess the outcomes of Percutaneous coronary intervention (PCI) in patients with Rheumatoid arthritis (RA). <h3>Methods:</h3> A systemic search was conducted from electronic databases from inception to 15<sup>th</sup> September 2023. All statistical analyses were conducted using Review Manager 5.4.1. Studies meeting inclusion criteria were selected. A random-effect model was used when heterogeneity was seen to pool the studies, and the result was reported in the Odds Ratio (OR) and the corresponding 95% confidence interval (CI). <h3>Results:</h3> Eight observational studies were used to conduct our analysis. Quantitative analysis on eleven factors was done. A statistically significant increase in major adverse cardiovascular event (MACE) was seen in RA patients after undergoing PCI as compared to the control group (SMD = 1.18 (1.16, 1.21); p &lt; 0.00001; I2 = 0%). There no significant difference in the long-term revascularization outcome between the RA and non-RA patients (SMD = 1.18 (0.81, 1.71); p = 0.39; I2 = 93%). Survival rates of all-cause mortality in the long-term outcome were statistically insignificant among the two groups (SMD = 1.21 (0.84, 1.74); p = 0.31; I2 = 99%). <h3>Conclusion:</h3> Percutaneous Coronary Intervention is an important intervention to reduce morbidity and mortality but special precautions and attention should be made when it comes to patients with Rheumatoid Arthritis. <h3>REFERENCES:</h3> <b>NIL.</b> <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> <b>None declared.</b>
AB0590 CORRELATION BETWEEN CUMULATIVE METHOTREXATE DOSE, METABOLIC SYNDROME AND HEPATIC FIBROSIS DETECTED BY FIBROSCAN IN PATIENTS RECEIVING METHOTREXATE IN RHEUMATOID ARTHRITIS IN COMPARISON WITH PSORIATIC ARTHRITIS
Authors: R. Lertnawapan, S. Chonprasertsuk, S. Siramolpiwat, K. Jatuworapruk
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Methotrexate (MTX) has been recommended as the first-line treatment in the American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) guidelines for rheumatoid arthritis (RA) and psoriatic arthritis (PsA). Long-term MTX usage possesses a known side-effect of hepatic fibrosis, which is associated with high cumulative MTX dosage and metabolic syndrome. Both RA and PsA patients have a higher incidence of metabolic syndrome. <h3>Objectives:</h3> We try to compare the correlation between hepatic fibrosis, cumulative MTX dosage, metabolic syndrome, and clinical parameters between RA and PsA patients. <h3>Methods:</h3> RA and PsA prescribed MTX patients were evaluated for hepatic fibrosis by using transient elastography (TE). The two subgroups were compared. Linear regression analysis was performed to determine clinical factors correlated with hepatic fibrosis. <h3>Results:</h3> Two hundred and ninety-five patients were recruited. There were one hundred and eighty-five patients in the RA group. The PsA group had one hundred and ten patients. TE was used as an investigation tool for hepatic fibrosis detection, which was found in 28.6% and 45.5% of RA and PsA, respectively. There were higher body mass index (BMI), metabolic syndrome, duration of disease, and hepatic fibrosis in the PsA group. Whereas cumulative MTX dosage and MTX dose per weight were comparable between the two groups. The linear regression analysis demonstrated statistical significance only in the association of hepatic fibrosis with metabolic syndrome (regression coefficient 3.677; 95% CI 2.748-4.605; <i>P</i>&lt;0.001) and psoriatic arthritis (regression coefficient 0.62; 95% CI 0.051-1.189; <i>P</i>=0.033). Notably, MTX dosage was not associated with hepatic fibrosis (regression coefficient 0.03; 95% CI -0.008-0.013; <i>P</i>=0.616). <h3>Conclusion:</h3> Hepatic fibrosis measured with Fibroscan was correlated with metabolic syndrome and psoriatic arthritis. PsA also had a higher incidence of metabolic syndrome, which emphasized the occurrence of hepatitis fibrosis in this group of patients. MTX-prescribed patients with risk factors (i.e. metabolic syndrome and psoriatic arthritis) should be vigilantly monitored for hepatitis fibrosis. <h3>REFERENCES:</h3> <b>NIL.</b> <h3>REFERENCES:</h3> <b>NIL.</b> <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> <b>None declared.</b>
A multicenter, retrospective study analysis: Evaluating the efficacy and safety of pembrolizumab in the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma.
Authors: Man Hu, Shichuan Zhang, Yaqian Han, Hui Wu, Jin Gao, Haijun Wu, Qin Lin, Wei Shang, Xia Li, Hong Feng, Qiao Qiao, Guangyuan Hu, Kunyu Yang, Xicheng Song, Yuandong Cao, Min Kang, Ruozheng Wang, Jinming Yu
Journal: Journal of Clinical Oncology (2024)

e18013 Background: PD-1-based therapy has become the first-line standard treatment for R/M HNSCC, but KN-048 lacked data on the mainland Chinese population. This study aims to conduct a pooled analysis of the efficacy and safety of first-line pembrolizumab-based therapy in patients (pts) with R/M HNSCC from different regions in China. Methods: Data comes from 17 hospitals. R/M HNSCC pts who received pembrolizumab alone or in combination with chemotherapy/targeted therapy from July 2020 to Jan 2023 were reviewed by searching the hospital HIS/medical record system. The primary endpoint of was OS, and secondary endpoints include time of pembrolizumab treatment (TOPT), safety, etc. Investigators also explored the impact of different biomarkers on survival. This study used SPSS 29 to analyze the data. Results: Total 160 pts were included. Median age was 60 yrs. 81.2% of pts was male, 95% of pts had an ECOG 0-1 . Main primary tumor site showed: oral cavity (60.6%), larynx (12.5%), oropharynx (10.6%). 88.8% of pts had undergone surgery in the past, and 65% received RT. The proportion of pts with only recurrence reached 75.6%. 79 (90.8%) had CPS of 1 or more and 44 (50.6%) had CPS of 20 or more. Other baseline information could be seen in the table. The median follow-up time was 18.5 mos. 70.6% of pts received pembrolizumab combined with chemotherapy, 17.5% received pembrolizumab alone. 48 pts subsequently received second-line treatment, more than half of which were target-based treatments. The median OS of all pts was not reach, among which the mono group vs. combination chemotherapy group (p=0.254). 18mo-OS of monotherapy was 69%, while 61% in combination. No statistical difference was seen in mTOPT (6.0 vs 4.7 mos, p=0.644). The results of the Cox Proportional Hazards Model suggest that ECOG score, smoking history, previous RT and distant metastatic of tumors were related to OS. Primary tumor location, T stage, EGFR mutation related to TOPT. Studies have not found a significant correlation between CPS and survival prognosis. 28.1% of pts experienced TRAEs, the most common of which was G1-4 myelosuppression (33.3%). The main TRAEs of G3-4 were pneumonia (11.1%), bone marrow suppression (8.9%) and abnormal liver function (4.4%). No patient died due to TRAEs. Conclusions: The data reflects that the real-world mOS with local recurrence as the main population was significantly higher than KN-048, and some clinical indicators related to prognosis were also found. In the future, the data of pembrolizumab in R/M HNSCC will be further explored to find more valuable biomarkers. [Table: see text]
Screening failure in clinical trials for patients with head and neck squamous cell carcinoma: A retrospective analysis.
Authors: Pablo Jiménez Labaig, Sandra Llop, Antonio Rullan, Ben O'Leary, Kate Newbold, Kee Howe Wong, Shreerang Bhide, Christopher Nutting, Kevin Joseph Harrington
Journal: Journal of Clinical Oncology (2024)

e18009 Background: Clinical trials drive improvements in patient care with head and neck squamous cell carcinoma (HNSCC), presenting opportunities for optimizing clinical outcomes. However, a significant number of patients (pts) miss out on new therapeutic opportunities due to screen failure (SF) after signing the informed consent form. Understanding the circumstances leading to SF might improve enrollment processes. Methods: Retrospective cohort analysis of pts with HNSCC intended for treatment within a clinical trial at the Royal Marsden Cancer Centre but who experienced SF between Jan 2016 and Jan 2024. Demographic and cancer-related characteristics, comorbidities, consent and SF dates, SF causes, and subsequent outcomes after SF were analyzed. Results: 76 pts who experienced SF were identified across 33 different trials. Cohort characteristics and type of trials offered are described in the table. The largest number of SFs was due to exclusion criteria being met in screening tests in 37 pts (49%): Pathology sample did not meet the quality standards in 11 pts (14%); abnormal laboratory tests in 5pts (6%); abnormal echocardiogram/reduced ejection fraction in 5 pts (6%); vessel invasion/ encasement in 4 pts (5%); non-measurable disease in 2 pts (3%); abnormal audiometry in 1pt (1%) among other reasons. The next commonest cause of SF was rapid progression during screening in 28 pts (37%): 11% compromised airway; 11% active bleeding; 5% central nervous system progression and 7% other rapid progression causes. Other causes of SF included: withdrawn consent in 7 pts (9%), comorbidity-related complication in 3 pts (5%) and study termination by sponsor in 2 pts (3%). The median time between consenting and SF was 20 days (range 4-42). After SF, 8% reconsented for the same trial, 56% received standard therapy, and 36% received best supportive care. Conclusions: This study reveals abnormal screening tests and rapid progression as primary causes for SF in patients with HNSCC. Timely referral , airway assessments and improved tissue acquisition could improve enrollment and minimize SF. [Table: see text]
Precision medicine for papillary thyroid carcinoma (PTC) variants: A machine learning approach to prognosis and treatment guidance.
Authors: Sakhr Abdulsalam Alshwayyat, Abdalwahab Alenezy, Wafa Asha, Mustafa Alshwayyat, Haya Kamal, Owais Ghammaz, Tala Abdulsalam Alshwayyat
Journal: Journal of Clinical Oncology (2024)

e18072 Background: PTC is a common endocrine cancer with a good prognosis, but aggressive subtypes, such as Hürthle cell (HCC) and columnar cell variants (CCV), pose challenges due to their higher recurrence and metastasis rates. To provide personalized care, we applied machine learning to evaluate the treatment effectiveness and develop precise prognostic models for PTC variants. Methods: The Surveillance, Epidemiology, and End Results (SEER) database provided the data used for this study’s analysis (2000–2019). Patients who met any of the following criteria were excluded: diagnosis not confirmed by histology, previous history of cancer or with other concurrent malignancies, and unknown data. To identify prognostic variables, we conducted Cox regression analysis and constructed prognostic models using machine learning (ML) algorithms to predict the 5-year survival. Patient records were randomly divided into training (70 %) and validation (30 %) sets. A validation method incorporating the area under the curve (AUC) of the receiver operating characteristic curve was used to validate the accuracy and reliability of the ML models. Results: The study population comprised 3690 patients. Among them 3180 patients with CCV and 510 patients with HCC, respectively. Most patients (62.8%) were 45 years or older, with a median age of 52 years. A total of 56.9% of patients had a tumor size greater than 2 cm, with a median tumor size of 3.1 cm. The largest racial group was white, comprising 83.8% of the cases, and 11.8% of the cases were Asian. Most cases were regional (53.4%, n=1969), followed by localized (38.3%, n= 1413). Multivariate Cox regression analysis revealed that N1 negatively affected the survival of HCC patients. CCV has a favorable prognosis after surgery, radiotherapy, or total thyroidectomy. Poor prognosis in CCV is associated with black race, large tumor size, and T4 stage. Improved survival in the localized/regional stage and decreased survival with male sex, older age, distant metastasis, and advanced AJCC stage in both PTC subtypes. ML models revealed that the random forest classifier (RFC) and K-Nearest Neighbors (KNN) accurately predicted outcomes, followed by Logistic Regression (LR) models. The highest contributing factors were AJCC staging, tumor size, and T aspect of TNM staging. Conclusions: Our study offers a method for evaluating and treating patients with PTC variants. The machine learning model that we created serves as a useful and personalized resource to aid in clinical decision-making processes.[Table: see text]
A random forest model to predict the efficacy of KL-A167 in previously treated recurrent or metastatic nasopharyngeal carcinoma based on the data from the KL167-II-05-CTP study.
Authors: Guangyu Fan, Tongji Xie, Le Tang, Lin Gui, Yuankai Shi
Journal: Journal of Clinical Oncology (2024)

e18012 Background: KL-A167 is a fully humanized monoclonal antibody targeting programmed cell death-ligand 1. KL167-Ⅱ-05-CTP study had evaluated the efficacy and safety of KL-A167 in Chinese patients with previously treated recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC). The results of KL167-Ⅱ-05-CTP study showed that not all patients with R/M NPC could benefit from KL-A167 therapy, and an effective model to predict the efficacy of KL-A167 is necessary. Methods: The baseline data of clinical characteristics, laboratory examination and imaging of patients with R/M NPC in KL167-Ⅱ-05-CTP study were collected, who received KL-A167 therapy. The progression-free survival (PFS) was selected as the predicted variable. Patients were randomly divided into training cohort (70%) and test cohort (30%). In the training cohort, uni-Cox regression was used to estimate the value in predicting PFS, and least absolute shrinkage and selection operator (LASSO)-Cox regression was performed to screen clinical, laboratory and imaging indexes to build random forest model. The accuracy of this random forest model was validated in the test cohort. Results: In this study, 137 patients with R/M NPC were enrolled, and the median PFS of them was 2.689 (95% confidence interval [ CI]: 1.475-4.098) months. A total of 14 indexes with P &lt; 0.05 were selected to perform LASSO-Cox regression, and 10 indexes (blood lactate dehydrogenase, blood creatinine, left ventricular ejection fraction, body temperature, weight, blood lymphocyte count, blood chloride ion concentration, Eastern Cooperative Oncology Group performance status, blood triglyceride and blood alanine aminotransferase) were used to build prediction model. The C-index of risk score from this model was 0.820 and 0.790 in the training and test cohort, respectively. Patients were divided into the high and low risk groups according to the median risk score, and the median PFS of the high risk group was shorter than that of the low risk group (training cohort: 1.377 vs. 4.197 months, P &lt; 0.001, hazard ratio [ HR] = 1.142, 95% CI: 1.111-1.175; test cohort: 3.475 vs. 10.984 months, P &lt; 0.001, HR = 1.100, 95% CI: 1.060-1.142). Conclusions: In this study, a random forest model based on 10 clinical, laboratory and imaging indexes was constructed and showed a potential value in predicting the PFS of KL-A167 therapy in Chinese patients with previously treated R/M NPC, which could help to guide clinical trials and practices.
Immunotherapy for local/regional control of locally advanced orbital and periocular squamous cell carcinoma.
Authors: Bita Esmaeli, Janet Fan, Hila Goldberg, Tracy Lu, Neal Akhave, Luana Guimaraes de Sousa, Renata Ferrarotto
Journal: Journal of Clinical Oncology (2024)

e18034 Background: Periocular squamous cell carcinoma can be of eyelid skin, ocular surface (bulbar) or palpebral conjunctival, or of lacrimal sac/nasolacrimal duct mucosal origin, is relatively rare, and presents unique anatomic considerations due to proximity to the eye and inherent risk to ocular structures associated with high dose radiation therapy. We herein report on 17 patients with orbital or periocular SCC who were treated with immunotherapy (IO) to decrease surgical morbidity or to avoid high dose radiation therapy. Methods: Retrospective review of all previously unreported patients with orbital, conjunctival, or periocular SCC who were treated with IO either in the neoadjuvant setting prior to surgery or for treatment of periocular SCC with perineural spread into the orbit and skull base. Results: 17 patients, 12 men and 5 women (Age range: 44-92; median=70 years old) with orbital (n=6), conjunctival (n=5), or lacrimal sac/duct (n=2) squamous cell carcinoma (SCC), or periocular SCC with perineural spread into the orbit and skull base (n=4) who were treated with IO either as single drug (n= 11) or in combination with chemotherapy (n= 6 ). In all patients either cemiplimab or pembolizumab was used. In 13 patients IO was used in the neoadjuvant setting prior to planned surgery. In 4 patients with perineural spread as they had non surgically resectable disease, IO was used to avoid high dose radiation therapy with its inherent significant risk of ocular toxicity. Overall, 3 patients achieved complete response, 10 patients achieved partial response, and 4 patients had stable disease, using RECIST criteria. One of 5 patients with conjunctival SCC also had nodal metastasis at presentation and achieved a dramatic complete response of both the conjunctival tumor and the nodal metastasis and managed to avoid surgery altogether. This patient had a very high tumor mutation burden (TMB). One patient developed diabetic ketoacidosis as a side effect of IO; otherwise the adverse effects were low grade. Conclusions: IO either as single drug or in combination with chemotherapy has a fairly high response rate in patients with ocular adnexal, conjunctival or orbital SCC and in patients with periocular SCC with perineural spread in the orbit and skull base. Future prospective trails using IO for orbital and ocular adnexal SCC should be planned and should aim to correlate molecular data such as TMB with response.