Radiation Exposure and Vascular Access in Acute Coronary Syndromes: The RADMatrix Trial

MedicalResearch.com Interview with: Dr. Marco Valgimigli,

Dr. Marco Valgimigli

MedicalResearch.com Interview with:
Dr. Marco Valgimigli, MD, PhD

Interventional Cardiology
Sandro Pertini Hospital, ASL RM2, Rome, Italy

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Every year millions of people with coronary artery disease are treated worldwide with percutaneous coronary intervention (PCI). Radial access as compared to femoral access reduces bleeding and mortality in patients with acute coronary syndrome (ACS) undergoing invasive management. However, prior studies have raised concerns over the increased risk of radiation exposure for both patients and operators with radial instead of femoral access and it remains still unclear whether radial access increases the risk of operator or patient radiation exposure in contemporary practice when performed by expert operators.

The MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial is the largest randomized trial comparing radial versus femoral access in ACS patients undergoing invasive management. In this radiation sub-study (RAD-MATRIX), we collected fluoroscopy time and dose area product (DAP) and equipped radial operators consenting to participate with dedicated dosimeters, each wearing a thorax (primary endpoint), wrist and head (secondary endpoints) lithium fluoride thermo luminescent dosimeter, during study conduct to establish non-inferiority of radial versus femoral access.

Among eighteen operators, performing 777 procedures in 767 patients, the non-inferiority primary endpoint was not achieved. Operator equivalent dose at the thorax was significantly higher with radial than femoral access. After normalization of operator radiation dose by fluoroscopy time or DAP, the difference remained significant. Radiation dose at wrist or head did not differ between radial and femoral access. Thorax operator dose did not differ in the right radial compared to the left radial access. In the overall MATRIX population, fluoroscopy time and DAP were higher with radial as compared to femoral access.

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Shorter Term Precision Radiation Found Effective For Prostate Cancer

MedicalResearch.com Interview with:

Charles N Catton, MD, FRCPC Cancer Clinical Research Unit (CCRU) Princess Margaret Cancer Centre UHN

Dr. Catton

Charles N Catton, MD, FRCPC
Cancer Clinical Research Unit (CCRU)
Princess Margaret Cancer Centre
UHN 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Prostate cancer is a very common malignancy which is frequently treated with external beam radiotherapy. A typical standard treatment course can extend over 7.5-8.5 weeks.

The introduction of high-precision radiotherapy treatment techniques provided the opportunity to compress treatment courses by delivering fewer, but more intensive daily treatments. The concerns with giving fewer and larger daily treatments (hypofractionation) is that toxicity may increase and that cancer control may become worse.

This international randomized trial enrolled 1206 men with intermediate risk prostate cancer and compared a standard 8 week course of external beam radiation treatment with a novel hypofractionated treatment course that was given over 4 weeks. Cancer control as measured by PSA control and clinical evidence of failure, bowel and bladder toxicity and quality of life were compared.

At a median follow-up of 6 years the hypofractionated regimen was found to be non-inferior to the standard regimen for cancer control. There was no difference early or late bladder toxicity between the two treatments. There was slightly worse early bowel toxicity during and immediately after treatment with the hypofractionated regimen, but there was actually slightly less long-term bowel toxicity with this same regimen.

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Using a Spacer During Prostate Radiation May Help Preserve Sexual Function

MedicalResearch.com Interview with:

Daniel A. Hamstra, MD PhD The Texas Center for Proton Therapy Irving, TX

Dr. Hamstra

Daniel A. Hamstra, MD PhD
Radiation Oncologist
Beaumont Hospital
Dearborn Michigan

MedicalResearch.com: What is the background for the The SpaceOAR phase 3 trial study and the hydrogel spacer?

Response: External beam radiation therapy is commonly used to treat men with prostate cancer. As part of this treatment, side effects can occur involving bowel, urinary, and sexual symptoms.

This study was performed to test if an absorbable hydrogel placed between the prostate and rectum (using a simple outpatient procedure) could move the rectum away from the prostate and thus result in sparing of the rectum and decreased bowel toxicity. The study randomized 222 men and the three-year data were just published (The International Journal of Radiation Oncology Biology and Physics). With three years of follow-up, we saw that the spacer did improve the radiation plans and decreased both rectal toxicity and urinary toxicity.

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Reduction in Radiation Has Reduced Second Tumors in Pediatric Cancer Patients

MedicalResearch.com Interview with:

Lucie Turcotte, MD, MPH University of Minnesota Masonic Children's Hospital Division of Pediatric Hematology-Oncology Assistant Professor Minneapolis, MN 55455

Dr. Lucie Turcotte

Lucie Turcotte, MD, MPH
University of Minnesota Masonic Children’s Hospital
Division of Pediatric Hematology-Oncology
Assistant Professor
Minneapolis, MN 55455

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We have observed dramatic improvements in the number of survivors of childhood cancer over the last 60 years. As more children are surviving, we have identified many important late health consequences of cancer therapy. One of the most devastating of these late health consequences is the diagnosis of a second cancer. As we have identified late effects, such as second cancers, we have modified therapy in an effort to prevent long-term sequelae of therapy, while still maintaining superior survival rates.

For this study, we utilized data from the Childhood Cancer Survivor Study (CCSS), which is a cohort of more than 23,000 survivors of childhood cancer from multiple centers in North America, who were initially diagnosed between 1970 and 1999. Our analysis focused on elucidating whether survivors diagnosed more recently were experiencing fewer second cancers, and determining whether a reduction in second cancers could be associated with treatment modifications.

The most important finding from this study is that the reductions in therapeutic radiation exposure that occurred between 1970-1999 resulted in a significant reduction in the second cancers experienced by survivors of childhood cancer.

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Factors That Expose Cardiologists To More Radiation During Procedures Outlined

MedicalResearch.com Interview with:

Alessandro Sciahbasi, MD, PhD  Sandro Pertini Hospital Rome, Italy

Dr. Sciahbasi

Alessandro Sciahbasi, MD, PhD
Sandro Pertini Hospital
Rome, Italy

MedicalResearch.com: What is the background for this study?

Response: Radiation exposure is an important issue for interventional cardiologists due to the deterministic and stochastic risks for operators, staff and patients. Consequently, it is important to know which are the determinants of operator radiation exposure during percutaneous coronary procedures in order to reduce radiation exposure. Despite different studies have already evaluated the radiation dose during percutaneous coronary procedures, most data were obtained using an indirect measure of the operator dose expressed in term of fluoroscopy time or dose area product (DAP) and only in a minority of studies dedicated operator dosimeters were used. The aim of our study was to evaluate operator radiation exposure during percutaneous coronary procedures with dedicated electronic dosimeters in a high volume center for transradial procedures.

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Radiation Therapy Improves Pain and Quality of Life in Bone

MedicalResearch.com Interview with:
Rachel McDonald, MD(C)

Department of Radiation Oncology
Odette Cancer Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Radiation treatment has been demonstrated in numerous studies to provide effective and timely pain relief to those suffering from painful bone metastases. However, as a palliative treatment, the goal should be not only to reduce pain but also to maintain and even improve quality of life. To date, studies have not effectively demonstrated this; most of these have included either small sample sizes or utilize questionnaires that aren’t tailored to the palliative cancer population with bone metastases.

We aimed to determine how soon after radiation treatment one can expect an improvement in quality of life. Our results showed that patients who had a pain response to radiation also had significantly greater improvements in pain, pain characteristics, functional interference, and psychosocial aspects of well-being at day 10 post-treatment. Further improvements in most domains of quality of life were found for responders at day 42.

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Therapies That Target Accessory Cells in a Tumor May Enhance Standard Care

MedicalResearch.com Interview with:

Sudarshan Anand, PhD Department of Cell, Developmental and Cancer Biology Department of Radiation Medicine Oregon Health and Science University Portland, Oregon

Dr. Sudarshan Anand

Sudarshan Anand, PhD
Department of Cell, Developmental and Cancer Biology
Department of Radiation Medicine
Oregon Health and Science University
Portland, Oregon

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Almost half of all cancer patients receive radiation therapy during the course of their disease.

While the impact of radiation on the cancer cells has been well studied in experimental models, its effects on the accessory cells that are present in the tumor are not well known. One of the major interests of our lab is studying these accessory cells of the tumor aka “the tumor microenvironment”. These group of cells consists of blood vessel cells, fibroblasts and immune cells that are normal cells that have been recruited by the tumor and generally support tumor growth.

The goal of this study was to understand the impact of radiation (and broadly DNA damaging agents) on the blood vessel cells in the tumor. We focused on a specific type of molecule called microRNAs (miRs) in these cells. miRs are small RNA molecules that bind to dozens of messenger RNAs and the production of proteins.

We discovered a group of microRNAs that was induced in blood vessel cells by radiation, a chemotherapy agent cisplatin and peroxide an agent that mimics oxidative stress that is often present in cancers. We found that the top candidate on this list was a microRNA that mimicked radiation by inducing DNA damage and eventually killing the blood vessel cells. Administering this microRNA, either within a tumor or using a specific nanoparticle that delivers cargo to the tumor blood vessels, decreased tumor growth in mouse models of breast cancer, brain cancer and colorectal cancer. We found that the efficacy of this agent was a result of its ability to suppress a protein TREX1, that is often mutated in human lupus.

In other words, this microRNA was able to create some of the immune and inflammatory features of lupus within a tumor and induce proteins that triggered cell death on tumor cells. Overall, our work illustrates how the tumor accessory cells respond to radiation and highlights the cross-talk between different accessory cells and the tumor cells.

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Localized Prostate Cancer: Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy

MedicalResearch.com Interview with:

Professor Jenny Donovan  PhD   OBE FMedSci NIHR-SI AcSS FFPHM Director, NIHR CLAHRC West (National Institute for Health Research Collaboration for  Leadership in Applied Health Research and Care West) at University Hospitals Bristol NHS Trust Bristol, UK

Prof. Jenny Donovan

Professor Jenny Donovan  PhD
OBE FMedSci NIHR-SI AcSS FFPHM
Director, NIHR CLAHRC West
(National Institute for Health Research Collaboration for
Leadership in Applied Health Research and Care West)
at University Hospitals Bristol NHS Trust
Bristol, UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: PSA testing identifies many men with prostate cancer, but they do not all benefit from treatment. Surgery, radiation therapy and various programs of active monitoring/surveillance can be given as treatments for fit men with clinically localized prostate cancer. Previous studies have not compared the most commonly used treatments in terms of mortality, disease progression and patient-reported outcomes. In the ProtecT study, we used a comprehensive set of validated measures, completed by the men at baseline (before diagnosis), at six and 12 months and then annually for six years.

The main finding is that each treatment has a particular pattern of side-effects and recovery which needs to be balanced against the findings from the paper reporting the clinical outcomes (Hamdy et al).

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Knowledge of Risks From Imaging Radiation Has Room For Improvement

MedicalResearch.com Interview with:

David Leswick MD FRCPC Radiologist Saskatoon Health Region and the University of Saskatchewan

Dr. David Leswick

David Leswick MD FRCPC
Radiologist Saskatoon Health Region and the
University of Saskatchewan

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The background for this study is that the use of computed tomography (CT) is increasing, and there is a significant radiation dose imparted to the population through imaging. There have been multiple prior studies showing limited knowledge of both dose levels and its associated risk from medical imaging procedures, and we wanted to evaluate local knowledge in our Health Region. We surveyed a total of 308 health care providers, including 217 referring physicians, 32 radiologists and 59 technologists. Overall, most respondents were aware of the risk of malignancy from CT, with only 23% of physicians, 3% of radiologists, and 25% of technologists believing there was no increased risk of malignancy from a single CT scan. Underestimating radiation dose levels from a procedure is more concerning than overestimating as it may lead to minimization of the perceived risk. Although relatively few respondents (20%) selected the most appropriate dose estimate for an abdominal CT scan in chest x-ray equivalents, the majority (54%) correctly or overestimated dose, with better knowledge amongst radiologists and imaging technologists than referring physicians. In general, respondents were appropriately more concerned regarding radiation dose when imaging pregnant and pediatric patients as risks from radiation are higher in those groups of patients.

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Synergy Between Radiation and Chemotherapy Enhances Melanoma Treatment

MedicalResearch.com Interview with:

James S. Welsh, MS, MD, FACRO President, American College of Radiation Oncology Professor and Medical Director Director of Clinical & Translational Research Department of Radiation Oncology Stritch School of Medicine Loyola University- Chicago Cardinal Bernardin Cancer Center Maguire Center, Rm 2932 Maywood, IL 60153 Chief of Radiation Oncology Hines VA Medical Center

Dr. James Welsh

James S. Welsh, MS, MD, FACRO
President, American College of Radiation Oncology
Professor and Medical Director
Director of Clinical & Translational Research
Department of Radiation Oncology
Stritch School of Medicine Loyola University- Chicago
Cardinal Bernardin Cancer Center
Maywood, IL 60153
Chief of Radiation Oncology
Hines VA Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Welsh: Cancer immunotherapy could represent a truly powerful means of addressing cancer. Although immunotherapy itself is not new, there are new agents and combinations of older agents (including radiation therapy) that could prove more successful than anything we have seen in many years. The data in melanoma thus far is quite encouraging and this preliminary success could possibly extend to many other malignancies as well.

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Intra-operative Radiation For Breast Cancer Better For Patients and Environment

MedicalResearch.com Interview with:
Jayant S Vaidya MBBS MS DNB FRCS PhD  Professor of Surgery and Oncology,  Scientific Director, Clinical Trials Group, Division of Surgery and Interventional Science, University College London Whittington Health - Clinical Lead for Breast Cancer Royal Free Hospital University College London Hospital
Jayant S Vaidya MBBS MS DNB FRCS PhD 
Professor of Surgery and Oncology,
Scientific Director, Clinical Trials Group,
Division of Surgery and Interventional Science,
University College London
Whittington Health – Clinical Lead for Breast Cancer
Royal Free Hospital
University College London Hospital

 MedicalResearch.com: What is the background for this study? What are the main findings?

Prof. Vaidya: TARGIT-A randomised clinical trial (ISRCTN34086741) compared giving TARGIT IORT during lumpectomy vs. traditional EBRT given over several weeks after lumpectomy for breast cancer; local-recurrence-free-survival was similar in the two arms of the trial, particularly when TARGIT was given simultaneously with lumpectomy. Also, there were significantly fewer deaths from other causes with TARGIT IORT.

This study calculated journeys made by patients with breast cancer to receive their radiotherapy, using the geographic and treatment data from a large randomised trial.

The study then assessed the same outcomes (travel distances, travel time and CO2emissions) in two semi-rural breast cancers—the results of this assessment confirm and reinforce the original results: the benefit of the use of TARGIT for patients from two semi=rural breast centres was even larger (753 miles (1212 km), 30 h, 215 kg CO2 per patient).

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Chemotherapy Plus Radiation Demonstrated Control of Liver Metastases in Colon Cancer

MedicalResearch.com Interview with:

Dr Guy van Hazel Clinical Professor of Medicine, School of Medicine and Pharmacology, University of Western Australia

Dr. Guy van Hazel

Dr Guy van Hazel
Clinical Professor of Medicine,
School of Medicine and Pharmacology,
University of Western Australia 

Medical Research: What is the background for this study? What are the main findings?

Dr. van Hazel: The SIRFLOX study is based on original work by Dr Bruce Gray and myself almost two decades ago, when we studied the combination of Selective Internal Radiation Therapy (SIRT) with Y-90 resin microspheres – which was absolutely new at the time – with hepatic artery chemotherapy. This study showed an increase in liver control with the addition of SIRT [Gray B et al. Ann Oncol 2001; 12: 1711–1720.].

We then proceeded to initiate a trial comparing systemic SIRT plus 5-FU/LV according to the Mayo Clinic regimen compared to the Mayo Clinic regimen alone, but unfortunately this had to be abandoned because new chemotherapy became available which made it unethical to offer the control arm. However, in those patients who were treated up to that point with SIRT plus 5-FU/LV [van Hazel G et al. J Surg Oncol 2004; 88: 78–85.] we did see a very high response rates compared to the control arm, with an impressive survival of 29 months. We subsequently did a phase l/ll study of modified FOLFOX6 with or without SIRT and again found very high response rates [Sharma R et al. J Clin Oncol 2007; 25: 1099–1106.].  This led us to launch the SIRFLOX study in 2007.

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