scholarly journals The Rethinking Clinical Trials (REaCT) Program. A Canadian-Led Pragmatic Trials Program: Strategies for Integrating Knowledge Users into Trial Design

2021 ◽  
Vol 28 (5) ◽  
pp. 3959-3977
Author(s):  
Deanna Saunders ◽  
Michelle Liu ◽  
Lisa Vandermeer ◽  
Mashari Jemaan Alzahrani ◽  
Brian Hutton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Response Rate ◽  
Median Response ◽  
Cancer Management ◽  
Patient Surveys ◽  
Grant Applications ◽  
Electronic Distribution ◽  
Breast Cancer Management ◽  
Median Response Rate ◽  
Alternative Means

We reviewed patient and health care provider (HCP) surveys performed through the REaCT program. The REaCT team has performed 15 patient surveys (2298 respondents) and 13 HCP surveys (1033 respondents) that have addressed a broad range of topics in breast cancer management. Over time, the proportion of surveys distributed by paper/regular mail has fallen, with electronic distribution now the norm. For the patient surveys, the median duration of the surveys was 3 months (IQR 2.5–7 months) and the median response rate was 84% (IQR 80–91.7%). For the HCP surveys, the median survey duration was 3 months (IQR 1.75–4 months), and the median response rate, where available, was 28% (IQR 21.2–49%). The survey data have so far led to: 10 systematic reviews, 6 peer-reviewed grant applications and 19 clinical trials. Knowledge users should be an essential component of clinical research. The REaCT program has integrated surveys as a standard step of their trials process. The COVID-19 pandemic and reduced face-to-face interactions with patients in the clinic as well as the continued importance of social media highlight the need for alternative means of distributing and responding to surveys.

scholarly journals Special considerations of breast cancer management in the elderly

2020 ◽  
pp. BMT46
Author(s):  
Lauren F Cornell ◽  
Sarah A Mclaughlin ◽  
Sandhya Pruthi ◽  
Dawn M Mussallem
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Elderly Patients ◽  
Management Strategies ◽  
The Elderly ◽  
Evidence Based ◽  
Limited Evidence ◽  
Cancer Management ◽  
Breast Cancer Management ◽  
Evidence Based Guidelines

There are increasing numbers of elderly patients diagnosed with breast cancer. These patients are under-represented in available clinical trials, and as such, there are limited evidence-based guidelines for treatment in this population. Elderly patients have unique needs and management strategies should be tailored accordingly. This article reviews available literature regarding breast cancer management and special considerations in elderly patients.

Radix Stephaniae Tetrandrine: An Emerging Role for Management of Breast Cancer

2020 ◽  
Vol 26 (1) ◽  
pp. 25-36 ◽  
Author(s):  
Yubo Guo ◽  
Beibei Chen ◽  
Xiaohua Pei ◽  
Dongwei Zhang
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Comprehensive Evaluation ◽  
Blood Stasis ◽  
In Vivo Studies ◽  
Cancer Management ◽  
Scientific Exploration ◽  
Breast Cancer Management

Background: Radix Stephaniae Tetrandrine (RST), known as FangJi (Pinyin name) in Chinese, is the dried root of Stephania tetrandra S.Moore, and has been prescribed in combination with other herbs to treat cardiovascular diseases and breast cancer in traditional Chinese medicine (TCM) clinical trials. Objective: The aim of the review is to provide a comprehensive evaluation about the application of RST in breast cancer management in TCM clinical trials, its ingredients, and its action on preventing the development of breast cancer in vitro and in vivo studies. Methods: Literature sources used were Pubmed, CNKI.net, Cqvip.com, and the Web of Science. For the inquiry, keywords such as Fangji, breast cancer, clinical trials, Radix Stephaniae Tetrandrine, tetrandrine, and fangchinoline were used in various combinations. About 150 research papers and reviews were consulted. Results: In TCM, RST exhibited the anti-tumor ability through its action on the bladder and lungs through dispersing phlegm and blood stasis. 10 clinical trials were identified which used RST in combination with other herbs to treat breast cancer. On average, the trials were characterized by high efficacy (>85%) and low toxicity. However, most of the clinical trials are characterized as small patient samples, poor design, and different combinations of herbs in prescriptions. To date, more and more compounds have been isolated from this plant. RST exhibited anti-tumor activities by targeting reversing multidrug resistance, inhibiting cell proliferation, inducing apoptosis, preventing tumor angiogenesis, anti-oxidation, anti-inflammation, and enhancing the sensitization and attenuating the toxicity of radiotherapy. Conclusion: The successful applications of RST in TCM clinical trials and preclinical experiments to beating breast cancer will provide potent lead compounds in the identification of novel anti-cancer drugs, which further contributes to the scientific exploration of functions of RST in TCM.

Pomalidomide Therapy for Myelofibrosis: Analysis of Results From Three Consecutive Clinical Trials

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1759-1759 ◽  
Author(s):  
Kebede Begna ◽  
Animesh Pardanani ◽  
Ruben A. Mesa ◽  
William J Hogan ◽  
Mark R. Litzow ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Phase Ii ◽  
Response Rate ◽  
Single Agent ◽  
Costal Margin ◽  
Median Response ◽  
Long Term Treatment

Abstract Abstract 1759 Background: Pomalidomide is a second generation IMiDsÒ immunomodulatory drug that has been shown to be active in the treatment of myelofibrosis (MF)-associated anemia (J Clin Oncol 2009; 27: 4563; Leukemia 2011;25: 301). In the current sponsor-independent analysis, we report long-term follow up data on patients from the Mayo Clinic who had participated in three consecutive clinical trials using single agent pomalidomide for MF. Methods: From May 2007 to January 2010, 94 patients with MF (including primary and post-polycythemia/essential thrombocythemia) were enrolled in three consecutive phase I and II clinical trials involving pomalidomide with or without prednisone. Eight two patients who received only single agent pomalidomide constitute the study population for the current study. Follow up information was updated in July, 2011. Results: Among the 82 study patients, 19 were included in a phase I dose escalation study (2.5-3.5 mg/day), 58 in a phase II low-dose single agent pomalidomide study (0.5 mg/day), and 5 in a phase II randomized study (2 mg/day). Median age was 67 years and 63 (77 %) patients were red blood cell transfusion dependent at study entry. Forty-five (55%), 24 (29%), 7 (9%), and 2 (2%) patients remained on pomalidomide therapy for at least 6, 12, 24, and 36 months, respectively (Table 1). The overall anemia response rate per IWG-MRT criteria was 27% (22/82). Response occurred in the first 6 months in 21 (96%) of the 22 responders. The median time for response was 2.3 months (range, 1–10). The median response duration was 16.5 months (2–40). The anemia response rate in patients with spleen size palpable at less than 10 cm below the costal margin was 44 % (17/39) vs. 10 % (4/39) in those whose spleen was palpable at or above 10 cm (p=0.002). The anemia response rate was twice as likely in JAK2 mutated versus non-mutated cases (30% vs 15% p=0.2). Anemia response rate was also higher in patients with at least 50% increase in absolute basophil count during the first month of therapy: 39% (19/49) vs 6% (2/32) p=0.001). The anemia response rate was not significantly affected by karyotype, transfusion need or leukocyte count. Among the anemia responders (n=22), 3 (14%) relapsed in the first 12 months; relapse was more likely in the presence of baseline leukocytosis (p=0.006). Among the 24 patients who took pomalidomide for at lease 12 months, grade 1 sensory neuropathy developed in 4 (16%) patients. Conclusion: Anemia response to pomalidomide therapy in myelofibrosis often occurs in the first 6 months of treatment and is more likely to occur in the presence of JAK2V617F and absence of marked splenomegaly. Long-term treatment with pomalidomide might be associated with sensory peripheral neuropathy in a subset of treated patients. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Image and Imaging an Emergency Department: Expense and Benefit of Different Quality Assessment Methods

2013 ◽  
Vol 2013 ◽  
pp. 1-5
Author(s):  
Carmen Andrea Pfortmueller ◽  
Michael Keller ◽  
Urs Mueller ◽  
Heinz Zimmermann ◽  
Aristomenis Konstantinos Exadaktylos
Keyword(s):  
Emergency Department ◽  
Patient Satisfaction ◽  
Response Rate ◽  
High Tech ◽  
Median Response ◽  
Assess Patient Satisfaction ◽  
Number Of Patients ◽  
Median Response Rate ◽  
Ideal Method ◽  
Do So

Introduction. In this era of high-tech medicine, it is becoming increasingly important to assess patient satisfaction. There are several methods to do so, but these differ greatly in terms of cost, time, and labour and external validity. The aim of this study is to describe and compare the structure and implementation of different methods to assess the satisfaction of patients in an emergency department.Methods. The structure and implementation of the different methods to assess patient satisfaction were evaluated on the basis of a 90-minute standardised interview.Results. We identified a total of six different methods in six different hospitals. The average number of patients assessed was 5012, with a range from 230 (M5) to 20 000 patients (M2). In four methods (M1, M3, M5, and M6), the questionnaire was composed by a specialised external institute. In two methods, the questionnaire was created by the hospital itself (M2, M4).The median response rate was 58.4% (range 9–97.8%). With a reminder, the response rate increased by 60% (M3).Conclusion. The ideal method to assess patient satisfaction in the emergency department setting is to use a patient-based, in-emergency department-based assessment of patient satisfaction, planned and guided by expert personnel.

scholarly journals Lymphatic malformations in children: treatment outcomes of sclerotherapy in a large cohort

2020 ◽  
Author(s):  
Frédérique C. M. Bouwman ◽  
Silje S. Kooijman ◽  
Bas H. Verhoeven ◽  
Leo J. Schultze Kool ◽  
Carine J. M. van der Vleuten ◽  
...  
Keyword(s):  
Interventional Radiology ◽  
Retrospective Study ◽  
Clinical Response ◽  
Response Rate ◽  
Good Clinical Response ◽  
Lymphatic Malformations ◽  
Median Response ◽  
Patient Level ◽  
Median Response Rate ◽  
Good Improvement

Abstract This retrospective study examines the outcomes of sclerotherapy in children with (veno)lymphatic malformations who received sclerotherapy between 2011 and 2016 (116 children, 234 procedures). Complication severity was classified using the Society of Interventional Radiology classification. Clinical response was rated on a scale of 0 (no change) to 3 (good improvement). The sclerosants used were bleomycin (n = 132; 56%), lauromacrogol (n = 42; 18%), doxycycline (n = 15; 6%), ethanol (n = 12; 5%), or a combination (n = 33; 14%). Four major and 25 minor complications occurred without significant differences between the agents. The median response rate per procedure was 2—some improvement—for all sclerosants. However, in pure LMs (67%), bleomycin and a combination of agents resulted in the best clinical response. On patient level, all had some or good clinical response. Mixed macrocystic and microcystic lesions showed a significantly lower clinical response (median 2 versus 3; p = 0.023 and p = 0.036, respectively) and required significantly more procedures (median 2 versus 1; p = 0.043 and p = 0.044, respectively) compared with lesions with one component. Conclusion: Sclerotherapy for (V)LMs in children is safe and effective. Bleomycin is the most frequently used agent in this clinic and seemed most effective for pure LMs. Mixed macrocystic and microcystic lesions are most difficult to treat effectively. What is Known:• A variety of agents can be used for sclerotherapy of lymphatic malformations in children.• Macrocystic lesions have favorable outcomes compared with microcystic and mixed lesions. What is New:• Bleomycin and a combination of agents seem to be most effective to treat lymphatic malformations in children.• Mixed macrocystic and microcystic lesions are more difficult to treat effectively compared with lesions with either one of these components.

scholarly journals Pros and Cons of Intraoperative Radiotherapy: Comparison of Two Clinical Trials in Breast Cancer Management

2018 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Mohammad Esmaeil- Akbari ◽  
Nahid Nafissi ◽  
Seyed Rabie Mahdavi ◽  
Hamidreza Mirzaei ◽  
Fattaneh Ziyayi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Intraoperative Radiotherapy ◽  
Cancer Management ◽  
Breast Cancer Management ◽  
Pros And Cons

scholarly journals Relationship Between Response and Dose in Published, Contemporary Phase I Oncology Trials

2020 ◽  
Vol 18 (4) ◽  
pp. 428-433
Author(s):  
Antonious Hazim ◽  
Gordon Mills ◽  
Vinay Prasad ◽  
Alyson Haslam ◽  
Emerson Y. Chen
Keyword(s):  
Phase I ◽  
Dose Level ◽  
Response Rate ◽  
Dose Range ◽  
Drug Dose ◽  
Cancer Type ◽  
Drug Study ◽  
Median Response ◽  
Median Response Rate ◽  
The Relationship

Background: As progress continues in oncology drug development, this study aimed to examine whether the previously established association between drug dose and efficacy in the era of cytotoxic therapies remains true in today’s phase I dose-escalation oncology trials. Methods: A systematic review of early-phase dose-finding trials of single-agent oncology drugs from 2015 to 2018 was conducted to examine the relationship between drug dose and objective responses. Cancer-specific trials were included if they determined maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D). Data related to the study drug, study design, treatment response, cancer type, dose levels, MTD, and RP2D were all collected. Dose level was categorized into 4 categories (≤40%, 41%–80%, 81%–120%, and >120% of the RP2D) and was further analyzed by class of drug. Results: A total of 175 phase I studies were identified, with a total of 7,330 patients showing a median response rate of 5% (range, 0%–83%) across trials. A total of 93 trials with 2,506 participants had response data corresponding to drug dose level. In this subset, the median response rate was 5% (range, 0%–83%) across trials. Across all participants in this subset, the response rate was 12% (57 of 491) among those in the dose range of ≤40% of RP2D, 17% (95 of 562) among those in 41% to 80% of RP2D, 23% (272 of 1,206) among those in 81% to 120% of RP2D, and 29% (71 of 247) among those in >120% of RP2D (P<.001). The response rate at ≤40% of RP2D for targeted antibody was 5%, 4% for cellular therapy, 19% for immunotherapy, and 21% for small-molecule targeted inhibitors. Conclusions: Whereas our study of published phase I trials continued to show a low response rate consistent with earlier studies, the relationship between response and dose does not always peak at 81% to 120% of RP2D anymore, likely due to the use of novel immunotherapy and targeted agents with distinct efficacy and toxicity patterns.

Crizotinib Versus Chemotherapy on ALK-positive NSCLC: A Systematic Review of Efficacy and Safety

2018 ◽  
Vol 19 (1) ◽  
pp. 41-49 ◽  
Author(s):  
Mingxia Wang ◽  
Guanqi Wang ◽  
Haiyan Ma ◽  
Baoen Shan
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Objective Response Rate ◽  
Retrospective Studies ◽  
Response Rate ◽  
Objective Response ◽  
Treated Group ◽  
Efficacy And Safety ◽  
Alk Positive

Introduction: Crizotinib was approved to treat anaplastic lymphoma kinase (ALK)- positive non-small cell lung cancer (NSCLC) by the Food and Drug Administration in 2011.We conducted a systematic review of clinical trials and retrospective studies to compare the efficacy and safety of crizotinib with chemotherapy. </P><P> Methods: We searched electronic databases from inception to Dec. 2016. Clinical trials and retrospective studies regarding crizotinib and crizotinib versus chemotherapy in treatment of NSCLC were eligible. The primary outcomes were the objective response rate (ORR) and disease control rate (DCR). Results: Nine studies (five clinical trials and four retrospective studies) including 729 patients met the inclusion criteria. Crizotinib treatment revealed 1-year OS of 77.1% and PFS of 9.17 months. And crizotinib had a better performance than chemotherapy in ORR (OR: 4.97, 95%CI: 3.16 to 7.83, P<0.00001, I2=35%). DCR revealed superiority with crizotinib than chemotherapy (OR: 3.42, 95% CI: 2.33 to 5.01, P<0.00001, I2=0%). PR (partial response) were significant superior to that of chemotherapy through direct systematic review. No statistically significant difference in CR (complete response) was found between crizotinib-treated group and chemotherapy-treated group. Regarding SD (stable disease), chemotherapy-treated group had a better performance than crizotinib-treated group. Common adverse events associated with crizotinib were visual disorder, gastrointestinal side effects, and elevated liver aminotransferase levels, whereas common adverse events with chemotherapy were fatigue, nausea, and hematologic toxicity. This systematic review revealed improved objective response rate and increased disease control rate in crizotinib group comparing with chemotherapy group. Crizotinib treatment would be a favorable treatment option for patients with ALK-positive NSCLC. ALK inhibitors may have future potential applications in other cancers driven by ALK or c-MET gene mutations.

Potential Therapeutic Targets of Curcumin, Most Abundant Active Compound of Turmeric Spice: Role in the Management of Various Types of Cancer

2020 ◽  
Vol 15 ◽  
Author(s):  
Saleh A. Almatroodi ◽  
Mansoor Ali Syed ◽  
Arshad Husain Rahmani
Keyword(s):  
Clinical Trials ◽  
Cancer Cells ◽  
Active Compound ◽  
Molecular Mechanisms ◽  
Human Subjects ◽  
Cell Signalling ◽  
Chemopreventive Agents ◽  
Signalling Molecules ◽  
Cancer Management ◽  
Induced Apoptosis

Background:: Curcumin, an active compound of turmeric spice is one of the most-studies natural compounds and have been widely recognized as chemopreventive agents. Several molecular mechanisms have been proven, curcumin and its analogs play a role in cancer prevention through modulating various cell signaling pathways as well as inhibition of carcinogenesis process. Objective:: To study the potential role of curcumin in the management of various types of cancer through modulating cell signalling molecules based on available literature and recent patents. Methods:: A wide-ranging literature survey was performed based on Scopus, PubMed, PubMed central and Google scholar for the implication of curcumin in cancer management along with special emphasis on human clinical trials. Moreover, patents were searched through www.google.com/patents, www.freepatentsonline.com and www.freshpatents.com. Result:: Recent studies based on cancer cells have proven that curcumin have potential effects against cancer cells, prevent the growth of cancer and act as cancer therapeutic agents. Besides, curcumin exerted anticancer effects through inducing apoptosis, activating tumor suppressor genes, cell cycle arrest, inhibiting tumor angiogenesis, initiation, promotion and progression stages of tumor. It was established that co-treatment of curcumin and anti-cancer drugs could induce apoptosis and also play a significant role in the suppression of the invasion and metastasis of cancer cells. Conclusion:: Accumulating evidences suggest that curcumin has potentiality to inhibit cancer growth, induced apoptosis and modulate various cell signalling pathways molecules. Well-designed clinical trials of curcumin based on human subjects are still needed to establish the bioavailability, mechanism of action, efficacy and safe dose in the management of various cancers.

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