Pick of the Week …. long term monotherapy bicalutamide (Casodex)
Topic discussed
Mayo Clinic & Medicare reimbursement; PSMA scans vs starting ADT and salvage radiation on recurrence; USPSTF PSA recommndations result in advanced Dx and death; long-term monotherapy bicalutamide (Casodex); olaparib & CDK12; diet during salvage RT; novel abiraterone protocol; intervention after surgery; compassionate vs off label use; drug pricing after FDA approval; Richard Foody RIP
Chat Log
Peter Kafka : 3:41 PM: DR. Felix Feng at UCSF rad onc is amonst the best in the nation. Hard to get to him. He came from Michigan and is well known for his research in prostate cancer.
AnCan – Rick (to Peter Kafka): 3:55 PM: You are right – forgot about Felix. Best to let Borno direct him ….
Richard Stanton (to Everyone): 4:02 PM: Anyone who wants to chat offline please contact me. Thanks. (Ed. If you wish to discuss bicalutamide monotherapy, please contact info@ancan.org for Richard Stanton’s email address)
Not before time, researchers are looking closely at the impact of the USPSTF advisories to stop (2012) or limit (2016) PSA screening. Back in the day, PCa advocates submitted our comments warning exactly of the morbid findings you can read below. It ain’t brain surgery to work out that:
“These data illustrate the trade-off between higher screening rates and more early-stage disease diagnoses (possibly overdiagnosis and overtreatment) and lower screening rates and more late-stage (possibly fatal) disease,”
Problem was, there were no brain surgeons on the USPSTF Panel in 2012… neither were there any urologists if my memory serves me right,. The Chair was a pediatrician!
These stats upset the PCa advocay community greatly. We are the ones working with younger men, often with kids in their tweens and teens, who wonder if they will see them graduate high school, never mind college. Some of you know that AnCan (https://ancan.org) suports a virtual group specifically for men under 60 with advanced PCa in respnse to the need we have identified.
What good does “We told you so” do as we see PCa specific deaths mount. What USPSTF did was criminal – it has resulted in a significant uptick in PCa specific deaths estimated by ACS as increasing 25% in number over the past 4 years. If nothing more, USPSTF should apologize and take responsibility. They were forewarned!
Advanced Prostate Cancer Cases Continue to Rise in U.S.
— Lasting effect of USPSTF’s 2012 recommendation against PSA testing
Coinciding with declines in prostate-specific antigen (PSA) screening over the last decade, the incidence of intermediate- and high-risk prostate cancer has continued to increase across the U.S. in men 50 and older, a nationwide, population-based analysis has shown.
From 2008 to 2012, ahead of the United States Preventive Services Task Force (USPSTF) recommendations against PSA testing for prostate cancer, incidence of distant-stage disease was increasing by 2.4% per year for men 50 to 74 years. But this more than doubled to 5.6% per year from 2012 to 2015, reported Ahmedin Jemal, DVM, PhD, of the American Cancer Society in Atlanta, and colleagues.
Their analysis in the Journal of the National Cancer Institute also found that in men 75 and older, incidence of distant-stage prostate cancer increased by 5.2% per year from 2010 and 2016.
In contrast, incidence of local-stage disease decreased by 6.4% per year in men 50 to 74, from 2007 to 2016. And in men 75 and older, declined by 10.7% per year from 2007 to 2013, and then stabilized.
From 2009 to 2016, the researchers estimated that 11,387 more men were diagnosed with distant disease than would have been diagnosed had the incidence rates remained at their 2008 nadir. But 633,111 additional local cancers would have been diagnosed from 2008 to 2016, had rates for local disease remained at their 2007 peak.
“These data illustrate the trade-off between higher screening rates and more early-stage disease diagnoses (possibly overdiagnosis and overtreatment) and lower screening rates and more late-stage (possibly fatal) disease,” the investigators wrote. “The persistently increasing regional- and distant-stage prostate cancer incidence during the past 5 years has public health implications given the substantial morbidity and premature mortality associated with it.”
Starting about 5 years ago, investigators including Daniel Barocas, MD, MPH, of Vanderbilt University in Nashville, began documenting a decline in the incidence of localized prostate cancer and hinted at a rise in the incidence of non-localized disease in the wake of the 2012 USPSTF recommendations against PSA-based screening.
“The study by Jemal et al actually quantifies the trade-offs associated with this policy,” Barocas told MedPage Today. By 2016, localized cases — representing a combination of “overdiagnosed” low-risk cases and higher-risk localized cases that are destined to progress — had declined by over 115,000 per year.
At the same time, “non-localized (lethal) cases had increased by over 3,500,” Barocas wrote in an email. Although the USPSTF updated the recommendations for PSA screening in 2018, suggesting that decision-making for PSA-based screening should be “individualized” for men ages 55 to 69, “decoupling” the diagnosis of localized disease and treatment did not seem to reduce the survival benefit associated with screening, he added.
Furthermore, “urologists, all reputable guideline bodies, and increasingly the public, have embraced the concept of observing low-risk prostate cancer. And continued efforts to improve the specificity of screening and to increase the use of observation for low-risk disease will preserve the survival benefit and reduce metastatic disease associated with screening while minimizing the harms associated with overdiagnosis,” Barocas continued.
For the new study, all prostate cancer cases diagnosed from 2005 to 2016 were obtained from the U.S. Cancer Statistics 2001 to 2016 Public Use Research Database, which covers 100% of the U.S. population. Men were stratified by disease stage, age, and race/ethnicity.
Incidence of local-stage disease in men 50 and over increased from 456.4 to 506.1 per 100,000 from 2005 to 2007, and then plummeted to 279.2 per 100,000 by 2016, Jemal and co-authors reported.
In contrast, incidence of regional-stage disease generally increased across the same study interval, from 5.7 to to 9.0 per 100,000 men from 2005 to 2016. For distant-stage disease, incidence rates declined from 23.1 to 22.4 per 100,000 from 2005 to 2008, but then increased to 29.7 per 100,000 men by 2016.
“For all races/ethnicities combined, the incidence patterns for age 50-74 and ≥75 years are generally similar to those of age ≥50 years, with the incidence rates after the late 2000s declining for local-stage disease but increasing for regional- and distant-stage disease” — the one exception being for men 75 years of age and older, among whom the incidence of local-stage disease stabilized from 2013 to 2016, Jemal and co-authors noted.
Jemal and co-authors also noted a “substantial decline” in the racial disparity in the incidence of distant disease in black and white men age 50 to 74. But this coincided with a steeper increase in the incidence of distant disease in non-Hispanic white men over the study period, and the incidence of distant disease in non-Hispanic black men still remains two to three times higher than in non-Hispanic white men among those under 75, and is 65% higher in men 75 and older, the researchers noted.
“The harms associated with high PSA screening rates can be mitigated while preserving the benefit of screening through PSA-stratified strategies including longer screening interval based on baseline PSA, higher PSA threshold for biopsy referral in older men, and restricting routine testing to men age ≤70 years,” the team wrote. “And future studies are needed to elucidate the reasons for the rising incidence trends for regional- and distant-stage disease and for the disproportionately high burden of the disease in black men.”
Asked for his perspective, Thomas Ahlering, MD, of the University of California (UC) Irvine, noted that he and his colleagues have documented a similar pattern of prostate cancer incidence rates as an unintended consequence of decreased PSA-based prostate cancer screening. In a 2018 study, the team found that the proportion of low-grade prostate cancers decreased significantly from a pre-recommendation average of 30.2% in 2012 to an average of 17.1% in 2016.
In contrast, the incidence of high-grade cancers with Gleason scores of 8 and over increased from a pre-recommendation low of 8.34% to a post-recommendation high of 13.5%. There was also a 24% increase in absolute numbers of Gleason 8 and above cancers in the post-recommendation interval.
“The major difference between this study and our own is that their study is clinical and ours was pathological, meaning it used a surgical database,” Ahlering told MedPage Today. “We were picking up much more regional disease with metastatic potential.”
This regional disease — which can be thought of as intermediate risk, he said — is much more burdensome for patients and especially for the healthcare system, because it usually necessitates some form of secondary intervention. And that secondary intervention likely costs about the same as the first intervention cost — i.e., around $40,000 per year.
Linda Huynh, MSc, also of UC Irvine, noted that research from Ruth Etzioni and colleagues has shown that if PSA screening were continued, but only for men younger than 70, more than half of avoidable cancer deaths could be prevented, while at the same time the strategy would dramatically reduce overdiagnoses compared with continued PSA screening for all ages.
“Etzioni has said, and we applaud it: ‘Discontinued screening for all men eliminated 100% of overdiagnoses but failed to prevent 100% of avoidable cancer deaths,'” Huynh said. “So it really is a matter of systematically screening first, and then you can worry about overtreatment and complications from treatment after the cancer is diagnosed.”
Ahlering also noted that screening recommendations may be “tinkered” with as much as anyone might like, but what is really needed are centers of excellence where prostate cancer is expertly treated: “The initial intervention for a man with prostate cancer needs to last 22 years or more,” he said. “So how a patient gets treated is as important or more important than anything else — that is what we are pushing for at least — you just can’t pull the plug and stop doing PSA screening.”
Disclosures
The study was funded by the American Cancer Society (ACS), and the authors, ACS employees, noted the ACS receives grants from private and corporate foundations, including foundations associated with companies in the health sector for research outside of the study, and that the authors are not funded by any of these grants and their salary is solely funded through ACS funds.
Neither Ahlering nor Huynh had any conflicts of interest to declare
Barocas disclosed relevant relationships with Astellas, MDxHealth, Janssen, and Tolmar.
Editor’s Pick – Low PSA with high volume metastasis (rd) + successful treatment for ‘young’ man with de novo metastatic disease
Topics Discussed
de novo Mx with low PSA; clinical trial conflicts; biopsy sample from primary vs. Mx tumor; relevance of bone density tests; young de novo Mx man finds successful treatment; debulking the primary; when the end may not be the end!; bone biopsies; testing for PSMA avidity; PSMA scan availability in Covid times; testosterone swings; shipping delays for abiraterone; specialty pharmacies; what is the ‘doughnut’ hole?; abscopal/immuno effect from RT
Chat Log
scott (to Everyone): 5:05 PM: is this link the same link for all meetings?
Ken Anderson (to Everyone): 5:06 PM: scott yes this is the same meeting room
scott (to Everyone): 5:07 PM: 100 degrees isn’t fun…
Dell Jensen (to Everyone): 5:38 PM: Both Lupron and Docataxel
Dell Jensen (to Everyone): 5:43 PM: Rick is correct, treating the primary is critical
scott (to Everyone): 5:48 PM: is docetaxyl an infusion or a pill?
Dell Jensen (to Everyone): 5:48 PM: infusion
Ken Anderson (to Everyone): 5:49 PM: infusion once every three weeks
scott (to Everyone): 5:49 PM: do you do docetaxyl if the Zytiga I am on isn’t working?”
Ken Anderson (to Everyone): 5:49 PM: you can for sure do both at the same time…
scott (to Everyone): 5:51 PM: does the docetaxil have hard side effects?
Dell Jensen (to Everyone): 5:51 PM: osteoporosis is a result of ADT treatment
Dell Jensen (to Everyone): 5:51 PM: I definitely concur
Dell Jensen (to Everyone): 5:52 PM: my side effects were minimal, infections were my problems.
Ken Anderson (to Everyone): 5:52 PM: all chemo has side effects.. doce has some for sure and all are post on the web.
scott (to Everyone): 5:53 PM: thanks ken
Peter Kafka (to Everyone): 5:54 PM: I had a specialized genetic test from MIRA labs that gave me a risk assessment for developing a grade 2 or greater adverse reaction to PD1/PDL1 agent therapy.
Russ Smith (to Everyone): 6:28 PM: Good night all. It’s been a long day.
scott (to Everyone): 6:31 PM: is david muslin head of answer cancer foundation?
Len (to Everyone): 6:35 PM: No, Rick is head of AnCan
scott (to Everyone): 6:36 PM: I sent a donation to ancan fdn in honor of rick and have heard nothing
Len (to Everyone): 6:36 PM: It will be acknowledged soon, if in fact they received it properly.
scott (to Everyone): 6:37 PM: thanks…just want to make sure rick is honored by donation
scott (to Everyone): 6:39 PM: is speaking freely 8 pm az time?
Rich Jackson (to Everyone): 6:43 PM: Speaking Freely starts at 8pm EST.
scott (to Everyone): 6:43 PM: thanks
Rich Jackson (to Everyone): 6:43 PM: Same connection as this call.
scott (to Everyone): 6:53 PM: who is the gentleman now speaking?
Dell Jensen (to Everyone): 6:53 PM: Correia
Dell Jensen (to Everyone): 6:55 PM: Are there other compounding pharmacy?
Dell Jensen (to Everyone): 6:57 PM: I have local one that is in Rock Island, IL
Regulars to our Advanced Prostate Cancer Virtual Support Group know the value AnCan places on the importance of palliative care, and having a palliative doc on your treating team. And NO – paliiative care is NOT the same as hospice; it is not end of life, nor anywhere near it. What it is, is the best way to treat comorbiditiies or what commonfolk call side effects. And it can be a lot more than that – like help dealing with mental health and social challenges surrounbding serious and chronic disease.
Just last night, our Advanced Cancer Caregivers Virtual Support Group was faced with an overwhelming issue that our moderators felt could be cut down to size with the help of a paliiative care or symptom management service, perhaps with telehealth involved in this current environment. Then today as if on demand, Medpage Today published this article! Since readers are required to register for Medpage Today, albeit free, it is reprinted below.
AnCan is proud to have Dr. B.J. Miller on our Advisory Board. BJ is a colleague of Dr. Mike Rabow, a friend of ours too, who is named in the article. If you want to learn a little more about palliative medicine and enjoy a wonderful TED Talk viewed by more than 10 million, watch BJ here!
Palliative Care Takes to Telemedicine in COVID Crisis
— Specialty built on personal contact finds telemedicine a boon to their profession
by Larry BeresfordMay 5, 2020
Before COVID-19, Mollie Biewald, MD, was skeptical about using telemedicine for palliative care visits. But now, she has found herself holding iPads or iPhones at the patient bedside, helping families make difficult decisions.
Over the past few weeks, some of her patients — whether hospitalized for COVID or another disease — have received daily family visits via Zoom or FaceTime. When a patient is actively dying, with the family present remotely, Biewald or another clinician will often stay at the bedside, holding the device.
“It is amazing,” said Biewald, a palliative care physician at Mount Sinai Hospital in New York City. “We mostly use it to bring the family to the bedsides of patients who are otherwise totally separated from everyone they know.”
While she initially thought it would be “nothing like the real thing,” she has changed her mind, as it has enabled family members to see their loved one and be present virtually while the patient is dying.
“It’s not ideal, but the best we can do, and much better than the alternative,” Biewald told MedPage Today.
Other palliative care teams across the country similarly have taken to telemedicine to conduct advance care planning and goals-of-care conversations with patients without having to enter their hospital room or increase the number of personal contacts by providers. Professional volunteers from around the country have also helped with palliative care consults and virtual office hours in support of providers in New York City.
More than other medical specialties, palliative care is built on personal contact, conversation, and relationship-building — supporting patients and families to clarify their values and define their treatment preferences in the face of serious illness, whether they are in the hospital or the community.
Michael Rabow, MD, of the University of California San Francisco, heads a busy outpatient palliative care clinic that was an early adopter of telemedicine, providing about half of its visits remotely.
“After this crisis ends, whatever new normal looks like, the numbers for tele-visits may go down, but not to where they were before,” Rabow said. “I think a lot of providers have recognized that telemedicine can work in palliative care, but the ideal balance between remote and in-person visits is not yet known.”
Palliative care professionals in some cases could be brought in virtually to assist other clinicians in discussions about whether a COVID patient with comorbidities whose condition is getting worse would want to go on a ventilator, given the poor outcomes. Might they consider the alternative of dying without the vent, perhaps in a private hospital room or at home, supported by hospice care?
“The biggest benefits of palliative care consultations are further upstream, when people can consider in advance what would be important to them in a situation like that,” Rabow said. If they understand the ramifications and don’t want to die of COVID in the hospital, alone and on a ventilator, then they may want to express other choices now, through an advance directive.
For Michael Fratkin, MD, founder and CEO of ResolutionCare Network, a community palliative care service headquartered in Eureka, California, telemedicine is not only essential to delivering palliative care services to seriously ill patients in the current crisis, he thinks it provides a better medium, in many cases, than in-person visits, given the nature of the conversations.
Prior to March 16, when California shut down in response to COVID-19, ResolutionCare Network was conducting 30% to 40% of its local patient encounters by video on a computer, iPad, or smart phone, and the rest in person. Since then, its team of four physicians, nurses, social workers, and a chaplain, mostly working from their own homes, has provided 100% of visits remotely to a caseload of 200 patients.
What happens in these virtual meetings with seriously ill patients and their caregivers? Trust building, goal setting, shared decision making, advance care planning, symptom management, and the identification of social determinants of health, caregiver adequacy, and available community resources, Fratkin said. What makes it better is the relational quality of the encounter.
“We haven’t had a single situation that required an exception to our no-home-visit policy,” he added. Some patients have been referred to their primary care physician, to urgent care, or to the hospital for more acute needs. Precautions are practiced even though Eureka to date has had few COVID-infected patients. “We are prepared to go to the home, dressed in personal protective equipment (PPE), but we just haven’t needed to.”
Satisfaction with this approach among staff, clients, and referral sources is almost universal, Fratkin said. “Even for the resisters. They got over it quickly.” Advantages include the pragmatic — such as reduced risk of exposure to the virus. People don’t have to get up, get dressed, drive to the doctor’s office, and sit in a crowded waiting room; staff don’t have to drive on back roads to the patient’s home, he said.
“And it prevents a feeling of ‘home invasion’ by our staff. Everything we wish to see in the home has to be shared by consent of the patient. It’s a more balanced power relationship, without giving up anything in terms of trust-building or the intimacy of the interaction.”
Most of the patients Fratkin’s company serves are Medicaid-covered, often buffeted by housing and food insecurities, substance abuse, mental health issues, and trauma-informed losses, he said. “Because of our experience in telemedicine, we are being asked to be part of conversations aimed at getting patients out of the hospital and keeping them out.”
“Telemedicine is providing insights into all the ways to improve healthcare,” Fratkin said. It took the virus to change the game. “This experience with COVID will take us past the tipping point, to where the public better understands what palliative care is all about.”
Pick of the Week: First and last this week ….. prednisone may have optical side effects; and, using Lu177 very early in the metastatic disease cycle.(rd)
Prednisone side efects on eyes and more; Covid19 making you stir crazy?; Doctor/lab visits during Covid19; Getting treated home and away; Xgeva users survey pays well; getting used to ADT; starting salvage radiation; should a GU med onc lead your team?; very early Lu177 vs hormone therapy
AnCan – Rick (to Everyone): 4:17 PM: len@ancan.org
AnCan – Rick (to Paul Freda): 4:58 PM: We see ya …. looking v. good w/o a moustache!!
Paul Freda (Private): 4:59 PM: Oh gosh I have not had a mustache for years. Maybe when I was living in Bangkok 5 yrs ago. ??
Paul Freda (Private): 5:02 PM: My blood test came back in one day. Cheers … still in remission.
AnCan – Rick (to Paul Freda): 5:05 PM: Yeah …….
AnCan – Rick (to Paul Freda): 5:07 PM: We’ll get to you next week -promise
Paul Freda (Private): 5:08 PM: No problem. I was just going to mention a great documentary on Jim Allison, the Nobel Prize winner who is now at MD Anderson. He is responsible for many CURES with Ipilimumab. Really interesting guy.