tbuckley/cabot-search huggingface dataset:
Sex differences in efficacy and toxicity of first-line treatment of metastatic colorectal cancer (CRC): An analysis of 18,399 patients in the ARCAD database.
Authors: Anna Dorothea Wagner, Manel Rakez, Benoist Chibaudel, Richard Adams, John Raymond Zalcberg, Leonard B. Saltz, Alan P. Venook, Hans-Joachim Schmoll, Jean-Yves Douillard, Christophe Tournigand, Volker Heinemann, Richard M. Goldberg, J. Randolph Hecht, Chiara Cremolini, Eduardo Diaz-Rubio, Axel Grothey, Qian Shi, Aimery De Gramont
Journal: Journal of Clinical Oncology (2020)

4029 Background: The clearance of 5-FU differs significantly between men (M) and women (W). Adjuvant chemotherapy (CT) for CRC has a higher toxicity in W. The impact of sex on efficacy and toxicity in first-line trials of metastatic CRC (mCRC) is unknown. Methods: We analyzed patient (pt) and tumor characteristics, toxicities (nausea (AE1), vomiting (AE2), diarrhea, neutropenia (AE3)) and efficacy (overall survival (OS), progression-free survival (PFS)) according to sex in the following treatment groups: A: CT alone, B: CT + bevacizumab, C: CT + EGFR-antibodies, with subgroup analyses in the CT alone group for single-agent, doublets and triplets, as well as irinotecan- and oxaliplatin-based regimens. Pts from trials with treatments still used today and all relevant data available were eligible. OS and PFS were assessed using Kaplan-Meier and Cox models adjusted for primary tumor location and performance status (PS). Results: We included 28 trials with 18.399 pts (11.352 M and 7.047 W). W were younger (61 vs. 63 years), had more often a PS of 1 (49 vs 45%), BRAF mutations (10 vs. 7%), right-sided tumors (42 vs. 35%) and less often rectal tumors (26 vs. 32%). Significant differences in toxicity are reported in table. Rates of diarrhea were similar. There was no sex disparity in OS in the predefined subgroups except for pts receiving triplets where OS was better in M (HR adj =1.39 (1.05 - 1.85)). Median (interquartile range) OS in months for M and W was 16.7 (9.2-27.4) and 16.2 (8.9-27.2) in group 1, 21.9 (12.7-37.5) and 22.3 (12.9 – 39.0) in group 2, and 26.8 (14.6-45.3) and 24.8 (12.3-49.2) in group 3. HRs adj (W vs M) (95% CI), p values for OS were 1.02 (0.96-1.09), .557, 0.92 (0.83-1.03), .142, 0.99 (0.85-1.14), .866. Conclusions: M and W with mCRC differ significantly regarding patient and tumor characteristics. The significant higher toxicity in W does not translate in a higher treatment efficacy. Apart from known sex differences in pharmacokinetics of 5-FU, differences in pharmacodynamics must be postulated. [Table: see text]
A phase II multicenter study of stereotactic radiotherapy (SRT) for oligoprogression in metastatic renal cell cancer (mRCC) patients receiving tyrosine kinase inhibitor (TKI) therapy.
Authors: Patrick Cheung, Samir Patel, Scott A. North, Arjun Sahgal, William Chu, Hany Soliman, Belal Ahmad, Eric Winquist, Francois Patenaude, Tamim Niazi, Daniel Yick Chin Heng, Gerald Lim, Arbind Dubey, Piotr Czaykowski, Rebecca Wong, Anand Swaminath, Scott Carlyle Morgan, Justin White, Sareh Keshavarzi, Georg A. Bjarnason
Journal: Journal of Clinical Oncology (2020)

5065 Background: SRT is increasingly considered to delay the need to change systemic therapy in metastatic cancer patients who develop oligoprogression. This prospective phase II study evaluated the use of SRT in the setting of mRCC patients who developed oligoprogression while on 1st or 2nd line TKI therapy. Methods: IMDC favourable or intermediate risk mRCC patients (pts) who had previous stability or response on ≥ 3 months of TKI therapy were eligible if they developed radiographic progression of ≤ 5 metastases. The oligoprogressive tumours were treated with SRT while other metastases which were stable or responding to TKI therapy were left alone. TKI therapy was temporarily stopped during SRT, and the same TKI drug then resumed. Endpoints included local control of the irradiated lesions, progression free survival (PFS), overall survival (OS), and cumulative incidence of changing systemic therapy after study entry. Results: 37 pts (median age 63, IMDC favourable 12, intermediate 25) with 57 oligoprogressive tumours were enrolled. 35 pts were on sunitinib and 2 on pazopanib. Median duration of TKI therapy prior to study entry was 18.6 months. 4 pts had IL-2 therapy prior to a 2 nd line TKI. 21 pts had a solitary oligoprogressive tumour, while 17 pts had 2-3 oligoprogressive tumours treated with SRT. Median biological effective dose (BED 10 ) was 72 Gy, corresponding to an SRT dose of 40 Gy in 5 fractions. Irradiated tumour sites were the following: 21 lung/pleural, 15 bone, 7 lymph node, 4 adrenal, 4 liver, 3 brain, 2 spleen, and 1 pancreas. At a median followup of 11.6 (1.8-53.5) months the median PFS from study entry was 9.6 months (95%CI 7.4-20.5) with the vast majority of progression occurring outside of the irradiated areas. The 2-year local control of the irradiated tumours was 96%. The 2-year OS from study entry was 77%. The cumulative incidence of changing systemic therapy was 47% at 1 year and 75% at 2 years, with a median time to a change in systemic therapy of 12.6 months. There were no grade 3-5 SRT related toxicities. Conclusions: To our knowledge, this is the first prospective evaluation of the use of SRT for oligoprogressive metastatic cancer. Local control of irradiated oligoprogressive mRCC tumours was high. After delivering SRT, mRCC patients did not need a change in their systemic therapy for a median of 1 year, effectively increasing the PFS of their TKI therapy. This novel approach should be studied in patients with oligoprogression on immunotherapy. Clinical trial information: NCT02019576 .
对门诊核医学检查患者做详细护理指导效果分析
Authors: 李芳, 张福芝, 周凤飞
Journal: BMJ (2011)

核医学检查对临床诊断起着越来越重要的作用,近年来,由于核素显像检查人数增多,尤其是在门诊,单纯依靠护士的常规护理指导已经远远不够.为使患者能够积极配合检查,做好有效的护理指导十分重要.本研究是2009年11月至2010年2月间对我院门诊核素检查患者及陪同家属进行详细护理指导后的效果分析。
中医治疗肝豆状核变性一例
Authors: 杨占华, 何玲
Journal: BMJ (2005)

肝豆状核变性是一种常染色体隐性遗传疾病,发病机理目前尚不清楚,与铜代谢障碍有关.主要治疗手段为排铜疗法,青霉胺为首选药物,但临床见效慢,且必须持续甚至终生服药.中药对本病的早期治疗有良好疗效,但如何掌握辨证,科学合理用药,成为治疗成败的关键.作者曾遇到1例,现报告如下。
Prevalence of diabetic retinopathy among 13 473 patients with diabetes mellitus in China: a cross-sectional epidemiological survey in six provinces
Authors: 刘嫣, 宋一帆, 陶立元, 邱伟强, 吕会斌, 江晓丹, 张明洲, 李学民
Journal: BMJ (2017)

目的
本研究旨在探究中国糖尿病患者中糖尿病视网膜病变（DR）和视力威胁性糖尿病视网膜病变（STDR）的患病率和严重程度。


研究设计、设置与参与者
本研究为横断面流行病学调查，研究对象为中国内地地区的糖尿病患者（N=13 473）。研究对象为被内科医师诊断为糖尿病，并转诊到筛查门诊的糖尿病患者（其中住院患者占1/3，城市居民占1/3，农村居民占1/3）。研究对象的每只眼睛应用彩色、免散瞳和非立体眼底照相机拍摄2张眼底照片，并根据英国DR分级指南进行分级。


主要结果和测量指标
DR与STDR的患病率和严重程度。


结果
在参与本研究的13 473例糖尿病患者中，共发现4 591例DR和1 769例STDR患者，DR的总体患病率为34.08%[95%可信区间（CI）33.28%~34.88%]，其中STDR的总体患病率为13.13%（95%CI 12.56%~13.70%）。在所有研究对象中，12 780例参与了眼底照片分级（94.86%）。年龄大于65岁的研究对象患DR或STDR的可能性较低（P 0.05）。STDR患者与非STDR患者相比，视力损伤更为严重（P<0.001）。中国北方DR和STDR的患病率高于南方（P<0.001）。DR的患病率与糖尿病患病时间[比值比（OR）2.63; 95%CI 2.42~2.86; P<0.001]以及糖尿病发病年龄（OR 0.38; 95% CI为0.35~0.41; P<0.001）密切相关。


结论
DR和STDR在中国内地地区的患病率偏高，并且不同地区患病率存在差异。在DR中，非增殖性DR更常见，但STDR更需要及时的诊断和治疗，特别是在经济欠发达地区。本研究强调了中国内地地区DR筛查和治疗的重要性。
Clinical pathway management for patients with acute exacerbation of chronic obstructive pulmonary disease undergoing antimicrobial medication
Authors: Lijuan Wei, Ping Zheng, Jing Wang
Journal: BMJ (2019)

Objective
To evaluate the application of clinical pathway for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) undergoing antibiotic administration.


Methods
One hundred and twenty six patients with AECOPD admitted from April 2017 to December 2018 were randomly divided into two groups: 63 patients in study group (63) received antibiotics treatment according to the clinical pathway and other 63 patients in control group received antibiotics according to clinical experience. The rates of sample submission and positive sputum pathogens, the rates of antibiotic use and its intensity, course of treatment, drug cost and combined medication, length of stay and costs of hospitalization were analyzed and compared between two groups.


Results
The sample submission rate and the positive rate of sputum pathogens in study group were significantly higher than those in control group [100.0% (63/63) vs. 90.5% (57/63), χ2=6.300; 44.4% (28/63) vs. 22.8% (13/57), χ2=6.229, P 0.05]. Types and rate of antibiotic usage in study group were lower than those in control group [9 vs. 12; 85.7% (54/63) vs. 96.8% (61/63), χ2=4.881, P 0.05). In study group, the combined antibiotics use rate was lower than that in control group [(41.3% (28/63) vs. (63.5% (40/63) , P=0.03]; the length [(7.63±3.95)d vs. (12.84±4.45) d, t=-6.939, P<0.01] and costs of antibiotics use [1 157 (745,2 002) Yuan vs. 2 063 (1 534, 2 811)Yuan, Z=-4.480, P<0.01], length of hospital stay [(11.43±3.53)d vs. (16.65±3.99)d, t=-7.785, P<0.01] and hospitalization expenses [(13 020±5 511) Yuan vs. (19 621±4 824) Yuan, t=-7.121, P<0.01] in study group were all significantly lower than those in control group. Acute exacerbation rate within 30 days in study group was not different from that in control group [9.5% (4/63) vs.6.3% (6/63), χ2=0.434, P=0.51].


Conclusion
Application of clinical pathway management provides basis for rational use of antimicrobial drugs and for control of medical expenses for COPD patients with acute exacerbation.


Key words: 
Clinical pathway; Pulmonary disease, chronic obstructive; Anti-bacterial agents; Evaluation studies
重度有机磷农药中毒后早期进食对反跳发生的影响
Authors: 李瑞梅, 和立
Journal: BMJ (2011)

急性有机磷乐果和马拉硫磷口服中毒经急救后临床症状好转,可在数日或1周后病情突然恶化,重新出现有机磷急性中毒症状,甚至发生肺水肿或突然死亡,称为反跳[1]963.一旦反跳发生,死亡率极高.本研究探讨乐果中毒后早期进食对反跳发生的影响.
Open label, phase II study of axitinib, a selective inhibitor of vascular endothelial growth factor receptors, in patients with stage III malignant melanoma.
Authors: Eric Zhuang, James G. Jakowatz, Maki Yamamoto, John P. Fruehauf
Journal: Journal of Clinical Oncology (2020)

e22062 Background: This open-label, phase II study investigated the clinical activity and safety profile of axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors (VEGFR) in patients with stage III melanoma. Methods: Eligible patients had histology proven stage III melanoma, at least 1 target lesion as defined by RECIST, and no prior systemic therapy. Primary end point was objective response rate (ORR) according to RECIST v1.1; response was also considered if there was a ≥ 25% reduction in the involved nodal basin specific uptake value (SUV) on PET/CT. Secondary endpoints included duration of response (DOR), progression free survival (PFS), and overall survival (OS). Axitinib 5mg was given orally twice each day; treatment continued until tumor progression, unmanageable toxicity, or if the patient withdrew consent. After two months of therapy, patients then underwent definitive surgical resection of their involved nodal basins; one month after surgery patients would restart axitinib. In the 1 st stage, 18 patients were to be enrolled; if there was ≥ 1 response, then the study would proceed to the 2 nd stage with enrollment of additional 14 patients. At the end of the study, if there were at least 4 confirmed responses, then axitinib would be recommended for further studies in this patient population. Results: Fifteen patients were screened, and eleven patients were initiated on protocol therapy. Median age was 63 years (range 37-88). Three patients (27%) had BRAF mutations. Objective response rate was 45.5% [95% confidence interval (CI), 16.7-76.6], comprised of one complete and four partial responses, with two patients ongoing. Median duration of response was 8 months (95% CI, 3.5-13.3). Stable disease was observed in one patient, with an overall disease control rate of 54.5% (95% CI, 23.3-83.2]. Median progression free survival was 4 months [95% CI, 2.8-8.5]. Median overall survival was 59 months [95% CI, 29.6-67.5]. The most frequently reported ( &gt; 15%) nonhematologic, treatment-related adverse effects were hypertension, fatigue, and diarrhea. Conclusions: Axitinib showed single-agent activity among patients with stage III melanoma and had favorable effect as a neoadjuvant therapy. Axitinib was well tolerated and safety profiles were consistent with previous reports from previous studies in patients with melanoma. Axitinib alone or combined with other therapies merits further research. Clinical trial information: NCT01321437.
Diagnosis and treatment of uterine carcinosarcoma.
Authors: Anna Beliaeva, Elena Bakhidze
Journal: Journal of Clinical Oncology (2020)

e18111 Background: Uterine carcinosarcoma (UCS) is rare and highly aggressive malignant tumor belonging to mixed epithelial and mesenchymal tumors and classified as high-grade endometrial carcinoma. UCS is more prone to metastasis, especially in the lymph nodes, and 35% of the diagnostics show advanced process and worse treatment results. High UCS aggressiveness, unsatisfactory treatment results and the lack of standard approaches to its treatment require more researches. Methods: Clinical and morphological data of 72 patients from N.N. Petrov National Medical Research Center of Oncology treated from 2004 to 2014 were analysed. 28 patients were included with the UCS I – III stages based on clinical and morphological data. The average age of the patients was 61.5 years (43 to 82). Results: 15 patients had stage I (53.6%), 3 - stage II (10.7%), 10 – stage III (35.7%) with ovarian metastases 14.3% and omental - 18.2%. 5 patients received only surgical treatment; 21 received combined treatment, including surgery and radiation therapy (RT). Postoperative remote RT in combination with brachytherapy was applied in 18 patients, only brachytherapy - 5. Chemotherapy (CT) was used in 6 patients. Metastatic lesion of the iliac lymph was morphologically proven in 6 of 18 patients (31.6%). No correlation between frequency of regional metastasis and depth of tumor invasion to the myometrium was found. Overall survival was 52%, relapse-free - 32%, for stage I – II it reached 72.2%. Five-year survival for stage III was 44.4%. Recurrence rate after total hysterectomy with pelvic lymphadenectomy was 2 times lower compared to that without lymphadenectomy (30 and 62.5%, respectively). The relapse rate in patients with UCS I – II stages after surgical treatment without adjuvant RT reached 33.3%, with brachytherapy - 40%, with remote RT in combination with brachytherapy - 20%. Systemic treatment was applied to 6 patients, 2 of them did not undergo RT (relapses in these 2 patients were noted during the first year of observation). Conclusions: The overall 5-year survival and relapse-free survival of patients with UCS I – III stages is quite low: about 50% and 30%, respectively. Optimal surgical staging (which involves performing pelvic lymphadenectomy) and the use of adjuvant RT, can reduce the frequency of relapses. The use of systemic CT as an adjunct to surgical and radiation treatment is justified for patients with UCS from the standpoint of the same frequency of both local relapses and distant metastases.
Initial experience of the adjuvant treatments to the local tumor for metastatic prostate cancer: Assessment of novel treatment algorithms, a multicenter, phase II randomized controlled trial (IP2-ATLANTA).
Authors: Martin John Connor, Taimur T Shah, Johanna Sukumar, Olivia Frances Naismith, Emily Day, Francesca Fiorentino, Alison Falconer, Naveed Sarwar, Michael Gonzalez, Shiva Gayadeen, Kamalram Thippu Jayaprakash, John McGrath, Gail Horan, Catherine Heath, Stephen Mangar, Vincent Khoo, Tim Dudderidge, John Nicholas Staffurth, Mathias Winkler, Hashim Uddin Ahmed
Journal: Journal of Clinical Oncology (2020)

TPS5600 Background: Local cytoreductive and metastasis-directed interventions are hypothesised to confer additional survival benefit beyond standard systemic therapy in patients with de novo synchronous metastatic prostate cancer. There is accumulating prospective evidence for local cytoreductive therapy. In particular, the phase III study STAMPEDE which demonstrated improved overall survival in a low burden subgroup of men following cytoreductive radiotherapy. Cytoreductive prostatectomy and minimally invasive ablative therapies (MIAT) are now subject to similar trial evaluation. IP2-ATLANTA will evaluate progression-free and overall survival outcomes with the addition of sequential multi-modal local and metastasis-directed treatments in patients with newly diagnosed metastatic prostate cancer compared to standard care alone. Methods: Phase II, multicentre, three-arm randomised controlled trial using a positive comparator arm ( n=918 ). An internal pilot ( n=80) feasibility phase is incorporated. All men with new histologically diagnosed, hormone sensitive, metastatic prostate cancer, within three months of commencing ADT and of PS 0-2 are eligible. Patients are randomised (1:1:1) to: Control (Standard of Care) OR Intervention 1 (Minimally invasive ablative therapy to the prostate +/- pelvic lymph node dissection [PLND]) OR Intervention 2 (prostate radiotherapy +/- lymph nodes OR Radical prostatectomy +/- PLND). Metastatic burden pre-specified by CHAARTED definition. Men with low-burden disease in intervention arms are eligible for metastasis-directed therapy (stereotactic ablative radiotherapy [SABR] or surgery). Standard systemic therapy given in all arms (incl. docetaxel). Follow-up: min. 2-years; max. 4 years. Primary outcome: progression-free survival (PFS). Secondary outcomes: Overall survival; urinary, sexual &amp; rectal side-effects; patient reported outcome measures. HRA ethical approval (Ref: 19/WA0005). To date, 28/80 (35%) patients have been recruited and randomised across 9 open sites in the internal pilot. Median recruitment rate is 85.7% (IQR 55–86). Internal pilot recruitment expected to be complete by April 2020. IP2-ATLANTA addresses an important research gap in the role of local and metastasis-directed therapy in men with newly diagnosed metastatic prostate cancer. Clinical trial information: NCT03763253 .
肝脏血管瘤的CT及MRI影像诊断
Authors: 唐业欢, 柴瑞新, 叶慧义
Journal: BMJ (2012)

肝血管瘤是肝脏最为常见的良性肿瘤,是一种血管的先天性畸形.血管瘤检出的敏感性和诊断的准确性一直是临床关注的问题之一.诊断肝血管瘤的影像手段多种多样,包括超声、CT、肝血管造影、MRI等,本文阐述CT及MRI诊断肝脏血管瘤的价值。
Trends of colorectal cancer incidence in Xuhui District of Shanghai (2001–2011)
Authors: Qi Yang, Zhi-hua Gu, Chun-min Liu, Hai-yan Gu
Journal: BMJ (2013)

Objective
To investigate the trends of colorectal cancer incidence in Shanghai Xuhui District from 2001 to 2011.


Methods
Total 3042 cases of colon cancer and 1958 cases of rectal cancer were collected from the Shanghai Cancer Reporting System. The results were age-adjusted according the census data of 2000 as the standardized incidence.


Results
The standardized incidence rate of colorectal cancer in Xuhui District rose from the 21.83/100 000 in 2001 to 27.35/100 000 in 2006 and increased by 25.29%; from 2009 to 2011 the incidence rate was stabilized. The ratio of colon to rectal cancer was 1.55∶1, and the incidence of colon cancer was significantly higher than rectal cancer. The incidence rate of male and female colorectal cancer increased with age, especially at >45 y group accounting for 98.70% and 98.37% of total incidence rate respectively. The ratio of male to female in colon cancer incidence rate was 0.98∶1, while that of rectal cancer was1.25∶1.


Conclusion
The incidence of colorectal cancer in Xuhui District from the last 11 years is significantly higher than of national level. More effective preventive measures should be taken.


Key words: 
Colorectal neoplasms; Incidence; Data collection
Predictive and prognostic value of <i>HER2</i> gene expression and <i>HER2</i> amplification in patients with metastatic colorectal cancer (mCRC) enrolled in CALGB/SWOG 80405 (Alliance).
Authors: Francesca Battaglin, Fang-Shu Ou, Xueping Qu, Monica M. Bertagnolli, Howard S. Hochster, Donna Niedzwiecki, Richard M. Goldberg, Robert J. Mayer, Tyler J. Zemla, Charles David Blanke, Alan P. Venook, Omar Kabbarah, Heinz-Josef Lenz, Federico Innocenti
Journal: Journal of Clinical Oncology (2020)

4086 Background: The randomized phase III CALGB/SWOG 80405 trial found no difference in overall survival (OS) in first-line mCRC pts treated with either bevacizumab (Bev) or cetuximab (Cet) combined with the same chemotherapy. We investigated the potential prognostic and predictive value of HER2 amplification and HER2 gene expression using NGS and Nanostring data. Methods: Primary tumor DNA from 559 patients (pts) was profiled for HER2 amplification by NGS (Foundation One). Tumor tissue from 925 pts was tested for Nanostring gene expression using an 800 gene panel. OS and progression free survival (PFS) were the endpoints as time-to-event variables. Cox proportional hazard models with gene expression fitted with linear spline (one internal knot at median) were used, adjusting for pts baseline characteristics, treatment assignment, and molecular features (microsatellite instability, BRAF, all RAS). Results: Of 505 tumors with both NGS and Nanostring data, 16 harbored HER2 amplification (copy number variation &gt; 6), limited to microsatellite stable tumors and significantly associated with HER2 expression ( P &lt; 0.001) and wild-type RAS ( P = 0.036). HER2 amplification was neither prognostic nor predictive for OS or PFS. Conversely, HER2 expression higher than median was associated with longer PFS ( P = 0.018) but not OS ( P = 0.13). Among pts with HER2 not amplified, higher HER2 expression was associated with better OS (hazard ratio [HR], 0.83; 95%CI, 0.72-0.97; P = 0.016) and PFS (HR, 0.85; 95%CI, 0.74-0.98; P = 0.027) when the expression was less than median. Additionally, in pts with no HER2 amplification and HER2 expression lower than median, treatment with Cet was associated with worse PFS compared to Bev (HR, 1.46; 95%CI, 1.12-1.90; P = 0.005). This effect was not observed with expression higher than median regardless of HER2 amplification status. Conclusions: To our knowledge, this is the largest analysis of HER2 amplification and gene expression in mCRC pts treated with standard therapy. Our results provide novel insight on the predictive and prognostic value of HER2 gene expression in pts treated with Cet- and Bev-based regimens. Upon validation, these findings could inform pts selection and the design of more effective treatment options for pts with low HER2 expression. Clinical trial information: NCT00265850.
糖尿病足及其高危患者418例临床分析
Authors: 劳国娟, 陈黎红, 严励, 杨川, 肖辉盛
Journal: BMJ (2006)

为了解糖尿病足(DF)及其高危患者的临床特点,对 418例DF及其高危患者的生化指标、并发症、足病特点进行分析.结果 DF及其高危者空腹血糖、餐后血糖、糖化血红蛋白较非DF者高,高密度脂蛋白胆固醇显著降低;并发高血压、冠心病、脑血管意外、肾病变、视网膜病变发生率高.DF病变部位依次为右侧、左侧及双侧;截肢63例,局部感染88例.提示 DF及其高危患者血糖、血脂代谢紊乱明显,并发其他糖尿病并发症率与截肢、局部感染发生率高。