ATLANTA—Six months follow up of the Select-D randomized open label multicenter pilot study with 406 patients has confirmed that therapy with the direct oral anticoagulant (DOAC) rivaroxaban was a safe and effective alternative strategy to standard treatment with the low molecular weight heparin dalteparin for avoiding recurrences of venous thromboembolism (VTE) in selected patients with cancer. The findings were reported at the 2017 meeting of the American Society of Hematology. Abstract 625: Anticoagulation Therapy in Selected Cancer Patients at Risk of Recurrence of Venous Thromboembolism: Results of the Select-D Pilot Trial
“We found recurrence rates with dalteparin at six months were 11 per cent. With rivaroxaban the recurrence rates were four per cent,” said lead author Annie Young PhD, Professor of Nursing at Warwick Clinical Trials Unit in Warwick University Medical School’s Cancer Research Centre, UK. “Definitely we found that the rivaroxaban recurrence rates at six months were lower than dalteparin.”
READ MORE IN ONCOLOGY TIMES
ATLANTA— In patients with a variety of cancers oral therapy with edoxaban—a direct oral anticoagulant (DOAC)—was just as effective and safe in terms of the risks of recurrent venous thromboembolism (VTE) and bleeding as injections with the low molecular weight heparin (LMWH) dalteparin in the multinational randomized Hokusai VTE-Cancer Study reported at the 2017 American Society of Hematology annual meeting.
LBA-6 A Randomized, Open-Label, Blinded Outcome Assessment Trial Evaluating the Efficacy and Safety of LMWH/Edoxaban Versus Dalteparin for Venous Thromboembolism Associated with Cancer: Hokusai VTE-Cancer Study
“[The] findings show that the edoxaban treatment is non-inferior to the low molecular weight heparin therapy,” said lead author Gary E. Raskob PhD, Dean of the College of Public Health and Professor of Medicine and Epidemiology at the University of Oklahoma in Oklahoma City.
READ MORE from the American Society of Hematology Meeting in Oncology Times.
GARY RASKOB Mono INTERVIEW Productdion MASTER
ATLANTA—Adding anti-BCL-2 therapy with the small-molecule drug venetoclax (VEN) to standard low-dose cytarabine (LDAC) chemotherapy tripled response rates over historical comparators and extended survival in older patients with acute myeloid leukemia (AML) who were ineligible for intensification of their chemotherapy in a phase 1/2 study reported at the 2017 American Society of Hematology annual meeting.
“With this new combination we seem to achieve very high complete response rates. We achieve response quickly—which means that patients have better quality of life, potentially, and less risk of fatal infections and also less need for blood transfusions and supportive care,” said lead study author Andrew Wei MBBS PhD FRACP FRCPA, a clinical hematologist and head of leukemia research at the Alfred Hospital in Melbourne, Australia.
READ THE ARTICLE IN ONCOLOGY TIMESAndrew Wei INTEVIEW PRODUCTION MASTER
ATLANTA—Subcutaneous administration of the anti-CD 38 monoclonal antibody daratumumab could help more patients get this emerging therapy more easily for their advanced or recently-diagnosed multiple myeloma according to research reported from the Pavo study at the 2017 American Society of Hematology annual meeting.
Study author Ajai Chari MD, Associate Professor of Medicine and Director of Clinical Research in the Multiple Myeloma Program, at Mount Sinai Hospital in New York tells the Audio Journal of Oncology “These are really exciting results. This would be extremely practice changing. Daratumumab has moved from monotherapy in advanced disease to first relapse. And now—at this year’s ASH—we have newly diagnosed [myeloma]. That’s a lot of dara[tumumab] being used globally. And to be giving a more convenient, potentially safer, form of administration is really going to be very practice changing.”
READ MORE about the Pavo study in Oncology TimesAjai Chari MONO INTERVIEW for AJO Production MASTER
Childhood Obesity—Whose Business Is It?12 Jan 2018
SOURCE: Pediatric Physical Therapy journal
ARTICLE “Trends in Attitudes and Practice Patterns of Physical Therapists in Addressing Childhood Obesity in Schools”[url=http://journals.lww.com/pedpt/pages/d…]
PLYMOUTH, New Hampshire USA—School-based physical therapists are well positioned (among a range of health care professionals and educators) to deliver guidance and training to help children cope with or avoid obesity—according to original research findings published in Pediatric Physical Therapy journal (Pediatr Phys Ther 2017;00:1–9). Author Eydie Kendall PT, PhD, PCS Assistant Professor at Plymouth State University’s Doctor of Physical Therapy Program talks about findings from her investigation of attitudes to childhood obesity among physical therapists in American schools and describes the pivotal position they occupy for providing interventions to combat this looming health threat. Sanjay Kinra MBBS MD MRCP MSc PhD FFPH, Professor of Clinical Epidemiology at the London School of Hygiene & Tropical Medicine, and Consultant Paediatrician (Childhood Obesity) at University College London adds comments from the perspective of his global research in pediatric obesity. Dylan Thompson PhD, Chair of Human Physiology and Research Director at the Department for Health, University of Bath, England, discusses his research findings about the science connecting physical activity with weight control. SOURCE: Pediatric Physical Therapy Volume 30 Number 1 (January 1st, 2018) REFERENCE: Pediatr Phys Ther 2017;00:1–9 TITLE: “Trends in attitudes and practice patterns of physical therapists in addressing childhood obesity in schools” AUTHOR: Eydie Kendall, PT, PhD, PCS, Assistant Professor, Plymouth State University Doctor of Physical Therapy Program [url=http://journals.lww.com/pedpt/pages/d…] TRANSCRIPT: Not only are there more kids who are affected by obesity, but those who are: are more obese then we seen before—even more obese. And so when you have greater levels of obesity you have many more problems with orthopedic development cardiovascular issues—that now we are starting to see not only in adulthood but we’re seeing in childhood as well. So: One of the major findings of this study is that we are really not at a consensus! We can’t agree as to whether or not it’s our role to intervene with childhood obesity as far as physical therapy within the schools. In a nutshell: what was the attitude you found among physical therapists? One of the really interesting findings is that the younger therapists—those with less experienced—tend to embrace that role in intervention in the childhood obesity more so than those older therapists who have already had clinical experience working with kids. And so it—sort of—hints that there might be some changes coming down the pike with our profession. It takes a whole team to address the issue of childhood obesity. And physical therapy is uniquely positioned to play a role—especially for those kids who are profoundly affected by the problem. The question that I aimed to the answer was: What is physical therapy’s role—and specifically for school-district physical therapy? A child spends a good part of their day—five days a week—in schools. So it’s an opportunity to influence that lifestyle for that child. And so working on being healthy and being active is a very important piece. What did you find out in your survey? Did you find that physical therapists regard it as part of the job? I think we’re all over the place. But I also think it’s (kind of) changing. When we see these kids who are profoundly overweight they’re going to have developmental impact. So the skeletal systems are not going to form because of the forces put upon them. Physical therapy looks at pathology. And then pediatric physical therapy has to have a crystal ball and predict the future based on what you are seeing at the time. And so I think we have a huge role that we can play that goes along with our typical practice because we can see what’s going on bio-mechanically with these kids, and then try to project what problems they may have as adults. So: I think the take-home message to physical therapist is that: We pretty much need to decide for ourselves what our treatment philosophy is—and what our role is—in embracing this problem. I think: maybe our focus needs to be on working with those kids who really need more help then just signing up for soccer, not drinking as much soda, and staying away from the TV. There are kids who really are in trouble. And I think we are uniquely positioned to help those kids.
Uptake of the Congenital Muscular Torticollis Guidelines
Survey findings about the effectiveness of a recently-introduced clinical practice guideline for congenital muscular torticollis therapy are reported in Pediatric Physical Therapy journal by Sandra Kaplan PT DPT PhD, Director, Post Professional Education at the Stuart D. Cook MD Guild and the Department of Rehabilitation and Movement Science at Rutgers, The State University of New Jersey. (“Uptake of the Congenital Muscular Torticollis Clinical Practice Guideline Into Pediatric Practice”)
Pediatr Phys Ther 2017;00:1–7
Research Demonstrates Effectiveness of PT Guideline
A case series of two children with benign paroxysmal positional vertigo (BPPV) is reported in Pediatric Physical Therapy journal by Jennifer L. Fay, PT, DPT, NCS, Neurologic Clinical Specialist, Vestibular Rehabiliation at New York University’s Langone Medical Center in New York City, who demonstrates the successful implementation of the Dix-Hallpike test and therapeutic correction of the condition. (Pediatr Phys Ther 2016;00:1–6)
Prostate Genomics—Which Patients Will Die?20 Apr 2017
MILAN, Italy—Genomic profiling could help reduce the risk of over-treatment in primary prostate cancer (PC) by identifying patients and healthy individuals whose genes put them at greatest risk of developing dangerous disseminated disease said Norman J Maitland PhD, Professor of Molecular Biology and Director of the Cancer Research Unit at York University, UK. He was speaking at the 2016 European Multidisciplinary Meeting on Urological Cancers (EMUC).
He interpreted data from several recent studies—investigating the influence gene mutations had on prostate tumor development—that infer gene arrays could soon distinguish patients with dangerous tumors from those whose disease does not need aggressive management.
He discusses his findings n the Audio Journal of Oncology Interview with Peter Goodwin: “We don’t know which [patients] are going to die of prostate cancer and which ones can be left untreated for the rest of their lives,” he said. “Genetics is one tool to allow us to understand that.”Norman Maitland AJO PRODUCTION Master
MILAN, Italy—The first choice of therapy for patients with metastatic kidney cancer who have failed VEGF therapy has changed according to experts at the 2016 European Multidisciplinary Meeting on Urological Cancers (EMUC) who assessed phase 3 study data on two different agents—each of which showed clinically meaningful improvements to outcomes.
“There is a new treatment algorithm for individuals who have failed VEGF-targeted therapy,” said Thomas Powles, MBBS MRCP MD, Director of Barts Cancer Centre at St Bartholemews Hospital in London, UK.
“Both the ESMO and EAU guidelines are [now] supporting nivolumab and cabozantinib rather than—[as] previously—supporting axitinib and everolimus.”
He based his comments on observations from the METEOR and CheckMate 025 studies which found that therapy with cabozantinib or nivolumab improved overall survival compared to everolimus.
Peter Goodwin discusses the details of the METEOR findings with him.Thomas Powles 1 EMUC PRODUCTION Master
Karim Touijer, MD MPh, Sidney Kimmel Center for Prostate & Urologic Cancers, Memorial Sloan-Kettering Cancer Center, New York.
MILAN, Italy—Patients with node-positive prostate cancer being treated with prostatectomy could derive benefit from early multimodality therapy combining androgen deprivation therapy (ADT) with radiotherapy (RT)—on top of surgery—if they have pathological features indicating high risk, according to findings reported at the European Multidisciplinary Meeting on Urological Cancers (EMUC).
Combining ADT with RT soon after prostatectomy improved overall survival as much as 40 per cent in the highest-risk patients according to analysis of data from studies conducted at three institutions—Memorial Sloan-Kettering Cancer Center in New York, the Mayo Clinic in Rochester MN and San Raffaele Hospital in Milan.
“It is the patients who are supposed—technically—to have the worst mortality from the disease that have the best survival when they receive the treatment,” said co-investigator Karim Touijer MD MPh, Attending Physician at the Department of Urology in the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan-Kettering Cancer Center in New York City.
He said that while the most common approach to node-positive disease after prostatectomy was observation—followed by treatment only if there was progression—his analysis suggested a potential net benefit from combining RT and ADT in patients who had additional risk factors on top of nodal spread.
He said studies were urgently needed to confirm any benefit since the natural history of patients with nodal disease after radical prostatectomy indicated that even—without further treatment—30 per cent of all patients were free from recurrence by 10 years. And this figure rose to 45 per cent among patients with only one or two nodes.
Pathological features can discriminate the 80 per cent of patients with nodal disease who had favorable characteristics and would be candidates for observation, he said. But it was important to identify those at the high risk because they could benefit from a multimodality approach, he said.
In his research from the three institutions patients with node-positive prostate cancer were divided into three groups after prostatectomy—those who had additional treatment with external beam RT, those who received the same RT combined with ADT, and patients assigned to no further treatment until relapse.
“We looked at a combined data set of nearly 1400 patients [who] received one of three strategies: Observed until they failed biochemically then treatment started, or: Automatically received hormonal therapy for life, or: Received the combination of hormonal and radiation therapy,” he said, adding that patients who received the combination of ADT and external beam RT started with the worst disease yet had the best overall survival.
Local Treatment Benefit
Touijer said they concluded there was great value in local control of the disease, despite the belief that if a patient had lymph-node metastases after radical prostatectomy the disease was already distant and systemic.
“What this data shows us is that maybe some patients are like that but not all of them, and not the majority, [and] that if we still focus—with all the treatments that we have available—to control the disease locally and regionally we can improve survival,” he said.
Not all Nodal Disease the Same
And analysis of the National Cancer Database (including 70 percent of all patients treated at US cancer centers) had given “external validation of these findings”.
“Close to 5 000 patients were treated by observation followed by treatment after failure, radiation alone, hormonal therapy alone, or a combination of hormonal and radiation therapy,” he said, noting that subcategories of patients with nodal disease clearly needed different treatment since there was a wide spectrum of risk and patients with the worst pathological features benefited the most from combining surgery, ADT and RT.
“We did statistical risk groups based on Gleason grade, clinical stage, invasion of the seminal vesicles, T4 disease, positive surgical margins—all the elements which have been shown to be predictive in most prostate cancers in many series. And the worse these features are the better the separation and the advantage in overall survival if we added radiation and hormone therapy,” he said.
The three-institutional data set revealed no difference in overall survival between patients who were observed and those treated with lifetime ADT.
“When we tried to look in detail at cancer-specific survival we saw that there was an advantage to androgen deprivation therapy. But when we looked at death from other causes—not cancer causes—we saw that there was [also] a detriment,” he said.
Node-positive patients assigned after prostatectomy to RT alone lived longer than patients allocated to ADT alone.
“The assumption is that thorough surgery followed by radiation therapy is controlling the source of the disease and seems to make a difference in terms of survival. [But] the combination of both [ADT and RT] seems to give the best result.”
But Touijer repeated that prospective clinical trials were needed to remove potentially confounding variables in these retrospective data, warning that these therapies could also have deleterious effects.
“One always has to balance the risk and benefit. But in terms of survival it looks like multimodality therapy has a clear advantage,” he said.
“A prudent way forward is for surgeons to reach out to radiation therapists and medical oncologists when they are dealing with patients [who] have lymph node metastases after radical prostatectomy and happen to have a Gleason 8, 9 or 10, pathological stage T3b or T4, positive surgical margins, and a higher nodal count and really carefully look at the value a multimodality approach for these patients—because it may alter their survival.”
Karim Touijer EMUC AJO PRODUCTION Master
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