Rubraca® (Rucaparib) FDA-Approved as Monotherapy for BRCA1/2, mCRPC patients

Rubraca® (Rucaparib) FDA-Approved as Monotherapy for BRCA1/2, mCRPC patients

Rucaparib has leapfrogged over olaparib to become the first PARP inhibitor approved for prostate cancer patients with either a germline (inherited) or somatic (tumor) BRCA1/2 mutation after analysis of the TRITON2, Phase 2 clinical trial for metastatic castrate resistant (mCRPC) patients who were previously treated with Androgen Receptor-Directed Therapy and a Taxane-Based Chemotherapy (docetaxel or cabazitaxel).  Continued FDA-approval will be dependent upon successful completion of the ongoing Phase 3 TRITON3 clinical trial.  This is an unusual development since most drugs are not approved until completion of Phase 3 data.

Rubraca’s accelerated approval was based on an overall response rate of 44% and duration of response exceeding 6 months, but not yet evaluable because the endpoint had not yet been met.

Adverse Effects

The most common adverse reactions (greater than or equal to 20% of patients Grade 1-4) occurring in the BRCA mutant population (n=115) were asthenia/fatigue, nausea, anemia, ALT/AST increased, decreased appetite, constipation, rash, thrombocytopenia, vomiting, and diarrhea. The most common laboratory abnormalities (greater than or equal to 35% of patients Grade 1-4) were increase in ALT, decrease in leukocytes, decrease in phosphate, decrease in absolute neutrophil count, decrease in hemoglobin, increase in alkaline phosphatase, increase in creatinine, increase in triglycerides, decrease in lymphocytes, decrease in platelets, and decrease in sodium.

The full BusinessWire press release can be found here: https://www.businesswire.com/news/home/20200515005527/en/Rubraca%C2%AE-Rucaparib-Approved-U.S.-Monotherapy-Treatment-Patients

Advisor Kudos to Howard Wolinsky!

Advisor Kudos to Howard Wolinsky!

Congrats to AnCan Advisor and  Active Surveillance Prostate Cancer Virtual Support Group Moderator, Howard Wolinsky, for receiving the Best In-depth Report or Series Lisagor Award from the Chicago Headline Club  for his article in Chicago Medicine on “The debate over gadolinium-based contrast agents

For those who attend this group, they are well aware that gadolinium contrast is a frequent topic of conversation. This may have even spurred Howard into his excellent in-depth report on the dangers associated with the use of this scanning contrast.

Onward & upwards, Howard ….. keep generating that social profit!

Rubraca® (Rucaparib) FDA-Approved as Monotherapy for BRCA1/2, mCRPC patients

Hi-Risk/Recurrent/Advanced PCa Men & Caregivers Recording – May 12, 2020

 

Pick of the Week: Do academic GU med oncs have a clinical trial conflict of interest?

Topics Discussed

Finding a quarterback GU med onc in Pennsylvania; do academic GU med oncs have a trial conflict of interest?; no prednisone with chemo; what mutation drives your PCa; gynecomastia remedies; is too much succes from a 2nd line HT a bad thing?; Dr. Daniel Petrylak @ Yale; how do you follow up your RT/SBRT?; painful Lupron shots; generic abiraterone co-pay assistance

Chat Log  

scott (to Everyone): 3:31 PM: could you spell that again…the gumedical oncologist?

Len (to Everyone): 3:31 PM: genitourinary

Len (to Everyone): 3:31 PM: genito-urinary medical oncologist

Peter K : 3:38 PM: Allentown to MSK in Bedminster, NJ is only 1 hour drive.  Same distance and time to Philly.

Peter K : 3:52 PM: Roswell Park is not far from Rochester

scott (to Everyone): 3:54 PM: how do you spell and what is something lilke “sabozitaxil” she is referring to?  anyone?

Len (to Everyone): 3:55 PM: cabazitaxel

Len (to Everyone): 3:55 PM: It’s a form of chemotherapy very similar to docetaxel

scott (to Everyone): 3:55 PM: how do you spell it? thanks

Len (to Everyone): 3:59 PM: cabazitaxel

Len (to Everyone): 4:00 PM: trade name is Jevtana

scott (to Everyone): 4:03 PM: my big question tonight, if I get to ask, is what is best foundation or group for financial assistance with Zytiga copays?

Len (to Everyone): 4:10 PM: Scott, go here: https://www.janssencarepath.com/patient/zytiga/cost-support

scott (to Everyone): 4:15 PM: Janssen won’t help if you have Medicare

Jake (to Everyone): 4:16 PM: https://www.youtube.com/channel/UCOX221U27DhVDCe3Ozz2rDg

Len (to Everyone): 4:18 PM: Jake, can you help Scott with Zytiga co-pay assistance?

Advisor Kudos to Howard Wolinsky!

Palliative Care Meets Telehealth!

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

A female healthcare worker helps a bed ridden elderly female patient use a tablet

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.”

Rubraca® (Rucaparib) FDA-Approved as Monotherapy for BRCA1/2, mCRPC patients

Hi-Risk/Recurrent/Advanced PCa Men & Caregivers Recording – May 4, 2020

Pick of the Week – not too exciting folks, but an important discussion on radiation procitis that we rarely have! rd

Topics Discussed

Treatment choice for hi-risk Dx; when is oligometastatic no longer?; risks of Keytruda + Xtandi trial vs cabazitaxel; clinical trial conflict of interest; success with dutasteride; radiation proctitis – pentoxifylline, argo laser, hyperbaric Tx?; Intermittent Hormone Therapy – risks and rewards; abscopal effect from spot RT;

Chat Log

Jake (to Everyone): 5:10 PM: https://ancan.org/

Jake (to Everyone): 5:10 PM: https://www.youtube.com/channel/UCOX221U27DhVDCe3Ozz2rDg

Bill Franklin (to Everyone): 5:17 PM: Highly recommend the nexverse.org COVID-19 Summit @  https://www.crowdcast.io/e/nextopic-future-of-pandemics.  Lots of interesting things about viruses, vaccines, and future treatments.

Ken Anderson (to Everyone): 5:18 PM: thanks Bill…

Ken Anderson (to Everyone): 5:18 PM: will have a look!

Bill Franklin (to Everyone): 5:19 PM: Just above the video window is a small drop down menu where you can select the different presentations.  It’s kind of hard to see.

AnCan – Rick (to Everyone): 5:21 PM: prostatecancerinfolink.net/2015/03/12/ebrt-ldrbt-boost-provides-superior-cancer-control-compared-to-ebrt-alone/#comment-152149

AnCan – Rick (to Everyone): 5:34 PM: http://urology.ucsf.edu/sites/urology.ucsf.edu/files/uploaded-files/attachments/hormone_therapy_for_prostate_cancer_a_patient_guide_2.pdf

AnCan – Rick (to Everyone): 5:35 PM: https://smile.amazon.com/Androgen-Deprivation-Therapy-Second-Essential/dp/0826183913/ref=dp_ob_title_bk

Len (to Everyone): 5:36 PM: http://www.lifeonadt.com/

Len (to Everyone): 6:44 PM: Pentoxifylline

scott (to Everyone): 6:55 PM: does this group generally meet 1st and 3rd Mondays or other times as well?

AnCan – Rick (to Everyone): 6:59 PM: 1st & 3rd Mondays @ 8 pm    2nd & 4th Tuesdays @ 6 pm

scott (to Everyone): 7:00 PM: will we get invites to each group or do we go online and find the link for each meeting?

AnCan – Rick (to Everyone): 7:01 PM: info@ancan.org

AnCan – Rick (to Everyone): 6:55 PM: https://medicalxpress.com/news/2020-03-intense-disease-men-prostate-cancer.html

 

Rubraca® (Rucaparib) FDA-Approved as Monotherapy for BRCA1/2, mCRPC patients

Hi-Risk/Recurrent/Advanced PCa Men & Caregivers Recording – Apr 28, 2020

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

Chat Log 

Len (to Everyone): 3:21 PM: Xgeva patients:  Patient Interview Eligibility Questionnaire

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.

Advisor Kudos to Howard Wolinsky!

ASKING FOR HELP …… & that includes the male gender!!

Peter Kafka, our Board Chair, is currently in the midst of chemo. He relates first hand why men must to get off their high horse and ask for help – it can solve many medical problems simply!  (rd)
ASKING FOR HELP

Why is it so difficult for men to ask for help?  Perhaps many men view it as a sign of weakness if we can’t handle a challenge on our own.  I have had plenty of occasions to ask myself this question over the past number of years.  In terms of changes in my body and internal mechanisms I have noticed that I can “put up” with many things for long periods of time under the belief that whatever it is that is going on will go away or I will adapt to the changes.  When I think about it now, I realize that this is a pretty stupid approach.  An independent nature can get one in big and unnecessary trouble.

For many months before I was diagnosed with Prostate Cancer, I was symptomatic with urinary retention.  In simple terms, I could not piss.  This is not a normal condition which I knew, but somehow, I talked myself into believing that it was a sign of aging and probably nothing more than an enlarged prostate.  It did not help that my urologist was not very attentive and did not give much more than a passing thought and a prescription for Flowmax for my condition.

After months of pushing on my gut in order to force out small amounts of urine to take the pressure off my bladder, it was a close friend who pushed me to seek medical help.  I did, and as they say; “The rest is history”.  But I went through many months of needless discomfort and agony before I humbled myself enough to seek help.  Was it embarrassment? Arrogance? Independence? Perhaps a bit of all of these that kept me from asking for help.

I mention this because I am still learning thIS great lesson.  In my current regimen of chemotherapy, I have noticed marked changes to my vision.  My first thought (self-diagnosis again) was that it must be cataracts.  Perhaps the chemo was accelerating this “natural” phenomenon that comes with aging for many of us in our 70’s.   But the changes in my vision were substantial and rapid enough that I thought it would be worth mentioning to my medical oncologist during a recent telephone consult.  I included this item in my list of “talking points” which I put together for each and every one of my medical appointments.  It is too easy to forget stuff.  I have learned this the hard way.

The answer came quick.  It was not the chemo; it was the Prednisone.  Sure enough, when I searched out the side effects of Prednisone, the blurry and cloudy vision I experienced was one of them and even at the low dose I was taking.  I inquired about why I needed this steroid, I was told that for some it helped stimulate appetite and energy levels.  With my doctor’s approval I weaned myself off the prednisone and decided that I would try and continue my chemo regimen with out it. 

So, I guess I am still learning the great lesson:  Be your own best advocate and ask for help!

Join SUPER HealtheVoices Live this Saturday, April 25 – all invited!!!

Some of you may already be aware of Janssen/J&J’s annual patient advocate conference, HealtheVoices, that is usually by invitation only based on a competitive application process. This year’s pandemic has sent the Conference virtual, and it is open to ALL! The conference covers the spectrum of conditions from mental to physical, and from cancer to rare diseases.
#HealtheVoicesLIVE 2020 is this Saturday, April 25 starting from 11 am – 8.30 pm Eastern. You can find the full agenda and link to join HERE. Feel free to pop in and out during the day and tune in to presentations and events of interest to each of you.There are presentations, interviews and even small group breakouts allowing you to interact with leading national advocates for differing conditions.
Please note the links to join change for the morning and afternoon sessions:

To join the broadcast between 11 a.m. and 3:30 p.m. ET, click this link.

To join the broadcast between 3:30 p.m. and 8:30 p.m. ET, click this link.

For the best experience, join the meeting via Google Chrome

I will be presenting in the 3rd Hour; the session starts at 1.30 pm Eastern and I am due up first as part of 4 flash sessions followed by a Q&A. I will be offering tips on virtual moderation – a skill many patient advocates have had to quickly familiarize themselves with in the past few weeks. But as you all know, we’ve been at this game for many years!!
Please join me and HeV, enjoy the conference, learn a little, and above all – stay safe, well and have fun!
Onward & upwards, rd
AnCan is more than prostate cancer – two articles for our other groups!

AnCan is more than prostate cancer – two articles for our other groups!

Admittedly AnCan has a bias to prostate cancer …. after all that’s where we proved our concept –  and why one virtual meeting a month has blossomed into 22! Articles cross our transom that pertain our other groups, and here are a couple that caught our eye in the past few days:

For our Male Breast Cancer particpants – and please note you have to register for MedPage Today … it’s free!

ASCO’s New Guidelines for Male Breast Cancer | MedPage Today

For our Ovarian Cancer readers:

Breastfeeding May be Associated with Reduced Risk of Ovarian Cancer | Cancer Network

Sign up for our Blog in the right panel and watch this space!

 

 

 

Focal treatment for Urologic Cancer .. and perhaps other cancers???

Focal treatment for Urologic Cancer .. and perhaps other cancers???

https://www.urotoday.com/recent-abstracts/urologic-oncology/prostate-cancer/120402-12th-international-symposium-on-focal-therapy-and-imaging-in-prostate-and-kidney-cancer.html

In the context of prostate cancer, newly diagnosed men with low and intermediate disease often consider focal therapy modes such as cryotherapy, HIFU or targeted radiation for intial treatment. And more frequently, we are seeing some of these modes employed for adjuvant and salvage therapy.

AnCan’s good friend, John Fortin, just published a short report on UroToday summarizing the findings from a Febraury 2020 Conference that considered focal therapy. This may well be of interest to other cancers, like ovarian and breast, where focal modes are also employed. John’s report linked above does not address follow-up treatment in the case of recurrent disease after intial treatment.