scholarly journals Extracting primary care records for prostate cancer patients in the CHHiP multicentre randomised control trial: A healthcare data linkage study

2018 ◽  
Vol 3 (4) ◽  
Author(s):  
Agnieszka Lemanska ◽  
Rachel C Byford ◽  
Clare Cruickshank ◽  
David P Dearnaley ◽  
Filipa Ferreira ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Primary Care ◽  
Clinical Trial ◽  
Side Effects ◽  
Cancer Patients ◽  
Data Linkage ◽  
Clinical Trial Data ◽  
Small Sample ◽  
Randomised Control Trial ◽  
The Impact

IntroductionThe aim is to investigate the effect of cardiovascular and diabetes comorbidities on radiotherapy-related side-effects in prostate cancer. Previous research suggests that comorbidities increase the risk of side-effects, but some cardiovascular medications may reduce symptoms by protecting against radiation damage. The evidence is inconclusive and mechanisms are not fully understood. ObjectiveTo explore whether routine primary care data can supplement clinical trial data in evaluating the impact of comorbidities and prescription medications on patient outcomes. ApproachThe CHHiP radiotherapy trial (CRUK/06/16) recruited 3,216 prostate cancer patients from 71 centres in UK, Ireland, Switzerland, and New Zealand between 2002 and 2011. Baseline comorbidity and radiotherapy-related side-effects over time were recorded. This was linked to computerised medical records (CMRs) from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) database. RCGP RSC is a network of 192 English general practices with over 2 million patients (2.8% of the population). ResultsThe English population of CHHiP patients (N=2811) was used. 120 CMRs were linked, which exceeded the estimation of 79 linked records. However, six CMRs showed no evidence of regular GP care and a further eight patients were not recruited into the CHHiP trial until after they had de-registered from an RCGP RSC practice. Information on cardiovascular and diabetes comorbidities was extracted for 106 patients. The mean age was 69±7 years, representative of the CHHiP population. From the CMRs, 23 (22%) patients had diabetes and 47 (44%) had hypertension including 37 (35%) who took angiotensin converting enzyme (ACE) inhibitors (medications lowering blood pressure). In addition, 44 (41%) patients took aspirin, 65 (61%) statins (lowering blood lipids) and 14 (13%) took metformin (lowering blood sugar levels).  Conclusion/ImplicationsThe small sample limits statistical analysis. However, a clinical trial was successfully linked to GP data to determine comorbidities and medications of patients. This will serve as a pilot for further research. The advantage of data linkage is that it may provide a mechanism for long-term follow-up of radiotherapy-related side-effects.

Analysis of PSA-Specific T-Cell Responses of Prostate Cancer Patients Given a PSA-Based Vaccine on a Clinical Trial

2003 ◽  
Author(s):  
James Gulley ◽  
William Dahut ◽  
Philip M. Arlen ◽  
Kwong Tsang ◽  
Jeffrey Schlom
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
T Cell ◽  
Cancer Patients ◽  
T Cell Responses ◽  
Cell Responses

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

scholarly journals FRI0612-HPR EFFECT OF THERMOFORMABLE ORTHOSES ON FOOT FUNCTION IN RHEUMATOID ARTHRITIS PATIENTS: PRELIMINARY RESULTS FROM AN OPEN CLINICAL TRIAL.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 911.2-912
Author(s):  
I. Aachari ◽  
H. Rkain ◽  
F. Safaa ◽  
L. Benzakour ◽  
T. Latifa ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Small Sample ◽  
Activity Limitation ◽  
Foot Orthoses ◽  
Functional Impact ◽  
Pain Disability ◽  
Before And After ◽  
Foot Function ◽  
The Impact

Background:Orthoses and footwear can play an important role in managing foot pathology in patients whose systemic disease is controlled. Foot orthoses are frequently prescribed in clinical practice as an intervention for people with rheumatoid arthritis (RA).Objectives:The aim of our study is to evaluate the impact of thermoformable orthoses on the functional index of the foot (FFI) in patients with rheumatoid arthritis.Methods:We conducted an open clinical trial, having consecutively included 14 patients (85.7% female, average age 54.8 ± 10 years) suffering from rheumatoid arthritis (median progression time of 9 years [5 - 12]). The average DAS28 was 2.7 ± 1.2 and the functional impact objectified by the Health Assessment Questionnaire (HAQ) was on average 0.9 ± 0.7.The median deadline from the start of RA and the onset of the foot problem was 3 years [0 – 7,75]. The foot problem was bilateral in 100% of the cases and inaugural in 85.7% of the cases.We evaluated the functional impact of foot injury for all our patients at baseline and 8 weeks after the use of thermoformable orthoses, based on the FFI (Foot function Index) measuring the impact of foot pathology on function in terms of pain, disability and activity limitation.The comparison of the FFI domains before and after the use of orthoses was carried out using parametric or nonparametric paired tests using The SPSS statistical software.Results:With the use of foot orthoses, FFI values decreased in all subscales (p=0,024) (pain, disability and activity limitation). This reduction was significant for disability (0,011) but not for pain and activity limitation.There were no significant correlations between the global FFI and the progression of RA, the duration of foot damage and the functional impact measured by the HAQ.Table 1. The comparison of the FFI domains before and after the use of orthoses.psignificatif if< 0,05; Test used: Non-parametric test for two linked samples.Conclusion:Foot orthoses were effective as an adjuvant in the management of rheumatoid foot. They significantly reduced disability as measured by the FFI. The absence of factors associated with pain and limitation of activity could possibly be related to the small sample size.Disclosure of Interests:None declared

91 poster: Investigating the Impact of the Highly Variable Lymphatic Drainage Pattern in Prostate Cancer Patients

2010 ◽  
Vol 94 ◽  
pp. S35
Author(s):  
L. Van den Bergh ◽  
C. Deroose ◽  
S. Joniau ◽  
T. Budiharto ◽  
F. Mottaghy ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Patients ◽  
Lymphatic Drainage ◽  
Drainage Pattern ◽  
The Impact ◽  
Lymphatic Drainage Pattern

scholarly journals Setting the IMPACT (IMProve Access to Clinical Trial data) Observatory baseline

2018 ◽  
Vol 28 (1) ◽  
Author(s):  
Mersiha Mahmić-Kaknjo ◽  
Josip Šimić ◽  
Karmela Krleža-Jerić
Keyword(s):  
Clinical Trial ◽  
Clinical Trial Data ◽  
Trial Data ◽  
The Impact ◽  
Improve Access

POD-01.03: The impact of first repeated biopsy in predicting progression in a cohort of prostate cancer patients managed with active surveillance

Urology ◽  
2007 ◽  
Vol 70 (3) ◽  
pp. 1-2
Author(s):  
M.F. Al Otaibi ◽  
N. Fahmy ◽  
P. Ross ◽  
W. Kassouf ◽  
S. Jeyaganth ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Patients ◽  
Active Surveillance ◽  
The Impact

Outcomes of older men receiving docetaxel for metastatic hormone-sensitive prostate cancer.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 82-82
Author(s):  
Daniel E Lage ◽  
M Dror Michaelson ◽  
Richard J. Lee ◽  
Joseph A. Greer ◽  
Jennifer S. Temel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Adverse Events ◽  
Older Men ◽  
Similar Proportion ◽  
Androgen Ablation ◽  
Younger Men ◽  
Hormone Sensitive ◽  
The Impact ◽  
Docetaxel Chemotherapy

82 Background: Most men who die of prostate cancer are older than 70 years, and the impact of therapy in this population is poorly defined. The ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) randomized men of all ages with metastatic hormone-sensitive prostate cancer (mHSPC) to receive androgen deprivation therapy (ADT) with or without docetaxel. Methods: The results of CHAARTED showed an overall survival (OS) benefit for the addition of docetaxel to ADT in men with mHSPC. In a secondary analysis of this trial, we assessed patient characteristics and OS in patients ≥70 years (“older men”) versus <70 years (“younger men”) with Cox proportional hazards models. Additionally, we compared adverse events, therapy completion rate, and subsequent treatment patterns between these two groups using Chi-squared tests. Results: Of the 790 patients enrolled, 177 (22.4%) were ≥70 years. A greater proportion of older men had an impaired performance status (Eastern Cooperative Oncology Group 1-2: 36.7% vs. 28.6%, p=0.038) and prior local therapy (31.7% vs. 25.9%, p<0.001) compared to younger men. Docetaxel + ADT resulted in improved OS in both older and younger men (Hazard Ratio [HR] 0.45, 95%CI: 0.25-0.80 for older men; HR 0.71, 95%CI: 0.53-0.95 for younger men). This treatment benefit was seen for subgroups of older men with high volume disease (HR 0.43, 95%CI 0.23-0.79) and de novo metastatic disease (HR 0.36, 95%CI 0.19-0.69). A similar proportion of older and younger men completed all six cycles of docetaxel (82.6% vs. 87.1%, p=0.28). Rates of grade 3-5 adverse events were similar between older and younger men (36.8% of older men vs. 26.8% of younger men, p=0.69). The rate of any Grade 4-5 adverse events did not differ significantly between older and younger men (14.9% vs. 11.9%, respectively, p=0.46). In the control arm, a smaller proportion of older men received subsequent cancer treatments (34.4% vs. 51.5%, p=0.017) or subsequent docetaxel (25.6% vs. 37.6%, p=0.035) compared to younger men. Conclusions: In summary, older men with mHSPC who were eligible to participate in a clinical trial had similar OS benefit and clinical outcomes compared to younger men when receiving docetaxel chemotherapy + ADT. Oncologists should consider docetaxel chemotherapy as a favorable treatment option for older men with mHSPC who are fit for chemotherapy. Clinical trial information: NCT00309985.

Sign in / Sign up

Export Citation Format

Share Document