Thankful for PCORI & Patient-Centered Research

I recently had the opportunity to attend the annual meeting of  PCORI — Patient-Centered Outcomes Research Institute.

Three days of presentations and panel discussions all focused on one recurring theme:

Patient voices, preferences, values, experiences, and outcomes matter.

I felt like I was in patient advocate heaven.

Suzannah Fox, former Chief Technology Officer of the U.S. Department of Health and Human Services, led the audience through “The Natural History of a New Idea,” also known as Crazy. Crazy Crazy. Obvious.

  1. Outright wacko.
    “This is worthless nonsense.”
  2. Odd but unproven.
    “This is an interesting, but perverse, point of view.”
  3. True but trivial.
    “This may be correct, but it is quite unimportant.”
  4. Obvious.
    “What’s new? This is what we’ve said all along.”

I smiled… thinking about how this related to my personal experiences with DCIS.

In 2010, it was “crazy” to question the aggressive “standard-of-care” treatments for low-risk DCIS.

“Cancer is cancer!” women argued.

“Less is more” — even for low-risk DCIS — was often labeled “controversial” in the media.

But newer research began to tell a different story.

It became obvious that not all DCIS is the same — and maybe not all DCIS needed to be aggressively treated.

“Studies have shown 70-80% of DCIS may never become invasive breast cancer even when DCIS is left untreated.  Many breast cancer doctors and researchers now believe that low-risk DCIS is being over-treated. They also suggest that these women may have the same excellent outcomes with close monitoring, also known as “active surveillance.”

Fast forward to 2016…

PCORI awards $13.4 million in funding for  The Comet Study, the first randomized clinical trial in the U.S. to compare “active surveillance” to surgery for low-risk DCIS.

Some COMET Study Team members

This funding allows researchers, patients, physicians, and advocates to work together towards finding the scientific answers needed about low-risk DCIS.

PRECISION Team, London, 2018

COMET, along with LORIS in the UK and LORD in the Netherlands, is also part of a global research project called PRECISION (PREvent ductal Carcinoma In Situ Invasive Overtreatment Now).

Researchers are tackling the question…

“When is cancer not really cancer?

The goal is to find out whether bio-markers can accurately and reliably distinguish between women with DCIS who will likely develop breast cancer and should be treated, and those who can safely avoid treatment and life-long side effects.

Thank you PCORI for funding the COMET Study and so many more important research projects that are helping to change the culture of health-care!

(PCORI) is a nonprofit organization authorized by Congress to fund studies that help patients and those who care for them make better-informed healthcare choices.

Check out PCORI’s Research Done Differently

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What is “Low-risk” DCIS & Why is The COMET Study Urgently Needed?

comet new logoThe COMET Study is the nation’s first prospective, randomized clinical trial aimed at resolving an ongoing debate about the best way to manage “low-risk” DCIS (Ductal Carcinoma In Situ), also known as “stage zero” breast cancer.

otis-brawley-potraits-5x7-2016-e1504618558598.jpg“This is a trial whose time has come. Many of us have felt for two decades that this study needed to be done, but we needed to get doctors and patients to the right point emotionally where it could go forward.” – Otis Brawley, chief medical officer of the American Cancer Society. Waiting and watching with ‘Stage 0’ breast cancer put to nationwide test

comet_3

Some members of the COMET team

The COMET team hopes the study will show that active surveillance is equally as safe and effective as surgery for women with low-risk DCIS.

“The same kind of active surveillance approach is taken in prostate, thyroid, and other slow-growing, non-invasive cancer types.” – Ann Partridge, COMET co-principal investigator, MD, MPH, Medical Oncologist, Dana-Farber Cancer Institute

70349_thompson“Our study is designed to answer: Does every woman need an operation for a condition that’s non-fatal? What are the patient concerns, outcomes, and issues that arise from having DCIS? And finally how do women make their decisions for treatment?” – Alastair M. Thompson, COMET co-principal investigator , MD, Professor, Breast Surgical Oncology, University of Texas MD Anderson

“Without evidence from the COMET Study, physicians and patients will never learn if Active Surveillance is a reasonable and safe option. Given that low-risk DCIS is not life-threatening, we believe this study will help women make confident, informed treatment decisions that align with their personal preferences.” –  COMET Patient Leadership Team (PLT): Desiree Basila, Donna Pinto, Deborah Collyar, Liz Frank

deanna“It is important to recognize that lack of surgery does not mean no care – ‘active surveillance’ is now an accepted management strategy for some cases of low grade prostate cancer. Our treatments come with real long term side effects and toxicity. The COMET study is a step in the right direction to help determine which patients may safely avoid aggressive treatment.” – Deanna J. Attai, M.D., Assistant Clinical Professor of Surgery at the David Geffen School of Medicine at UCLA and COMET Stakeholder Advisory Board member.

In this video, Dr. Shelley Hwang and patient advocate Donna Pinto discuss physician and patient perspectives about DCIS and why the COMET Study is important:

What is COMET?

The COMET Study was awarded $13.4 million in funding from the Patient-Centered Outcomes Research Institute (PCORI), an independent, nonprofit organization authorized by Congress in 2010 to support research that enlightens health care decisions.

COMET stands for Comparison of Operative to Monitoring and Endocrine Therapy for low-risk ductal carcinoma in situ (DCIS).

The study is currently enrolling patients newly diagnosed with low-risk DCIS at 100 cancer centers throughout the U.S. Nine hundred women will be randomized to receive one of two treatment approaches:

  1. Current standard of care (surgery, radiation and/or endocrine therapy)
  2. Careful monitoring (Active Surveillance) with mammograms every 6 months and physical exams every 12 months. Endocrine therapy is optional.

Why is the COMET Study urgently needed?

  • There is a growing concern that low-risk DCIS is being over-treated.
  • Retrospective trials indicate that 70-80% of DCIS cases may be low-risk and may never develop to invasive cancer or a future DCIS if left untreated and carefully monitored.
  • Current uncertainty and disagreement in the medical community about DCIS contributes to patient confusion, fear, and anxiety.
  • Results of this study may help more physicians feel confident in offering patients active surveillance as a safe treatment choice for low-risk DCIS.
  • Patients may experience a better quality of life knowing that they are being monitored carefully while avoiding potentially unnecessary physical, emotional and financial burdens.

What is “low-risk” DCIS?

DCIS that may have the lowest chance of becoming invasive cancer is called low-risk DCIS. Low-risk DCIS is generally thought to be DCIS that is grade I or grade II, sensitive to hormones, and does not cause symptoms.

There is growing evidence suggesting that low-risk DCIS grows so slowly that it would never cause health problems during a woman’s lifetime. For this type of DCIS, surgery and radiation may have very little or no benefit. – Read more about Risk and Making Decisions.

“This study will provide so many answers to questions about DCIS that are critical to resolve.” — Principal Investigator E. Shelley Hwang, M.D., Chief of Breast Surgery, Duke Cancer Institute

Who is a candidate for COMET?

  • Women 40 years or older with low-risk DCIS (low-intermediate grade)
  • No personal history of breast cancer or prior treatment of DCIS
  • For more information on eligibility, contact Tom Lynch, COMET Project Manager: thomas.lynch2@duke.edu , or visit DCISoptions.org

Where is COMET being offered?

Liang_Wen_web“This study is very exciting, the next big frontier in breast cancer treatment with no surgery. We’re trying to change our care and perception of care with less aggressive treatment.” — Dr. Wen Liang,  Seeking less aggressive breast cancer treatment, Anne Arundel Medical Center takes part in clinical trial

Are their similar studies in other countries?

  • Yes —LORIS (UK) and LORD (Netherlands)
  • PRECISION is an international initiative which will combine data from three trials

“The COMET Study is long over due for women like me (diagnosed with low-risk DCIS). This trial will help thousands of women for years to come make difficult treatment decisions based in research and reassurance rather than uncertainty, fear and concerns of potential over-treatment.” — Donna Pinto, DCIS 411

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A New Bio-marker Test for DCIS = Peace of Mind for Thousands of Women

peace-of-mindIf you are one of the 60,000 + women diagnosed with DCIS this year, you now have a way to gain more peace of mind about what to think and do about it.

A company called PreludeDx has scientifically validated a bio-marker test which evaluates a woman’s breast tissue sample and provides a “personalized” risk assessment based on her unique biology.

The test is called DCISionRT.

Had this test been available in 2010 when I was diagnosed with DCIS, I would have learned extremely valuable information that would have given me, my family AND my team of physicians great confidence in MY decisions.

Instead I found myself in a very lonely place. I was continually scared and pressured by physicians as well as women in online DCIS forums to succumb to aggressive cancer treatments — procedures and drugs that felt more toxic, scary and harmful than the actual DCIS diagnosis.

Fast forward 8.5 years.

The PreludeDx team discovered my story and arranged to test my original DCIS biopsy tissue from 2010.

Troy-Bremer
According to Troy Bremer, co-founder and Chief Scientific Officer at PreludeDx, “You have very clean biology for DCIS.”

He personally went over the results of my DCISionRT test with me which you can see below.

My Score was less than 1 out of 10 (0.8 / 10), with 9% risk of total 10-year recurrence and no expected benefit from radiation therapy.

Prelued Risk Results_DonnaIs this the picture of a woman in need of a mastectomy or weeks of daily radiation?

Is this someone who deserved to be told by a breast cancer physician, “Don’t be stupid Donna… at least do 3 weeks of radiation.

Unfortunately, DCISionRT was not available in 2010.

While I am thankful I had my strong intuition and a number of articles and studies on suspected overdiagnosis and overtreatment of DCIS, I now have the scientific proof that I  made the right choices and said NO to weeks of radiation or mastectomy.

Hopefully thousands of women today can be spared the frightening feeling that comes with uncertainty and can instead have more personalized information to support their decisions for active surveillance if they are low-risk rather than be continually pressured towards a one-size-fits-all highly aggressive treatment protocol.

In the past, studies have shown 97% of women end up doing aggressive treatments for DCIS. confusedLack of knowledge about the biological nature of DCIS coupled with fear and anxiety have been strong motivators.

Not only does DCISionRT give a woman and her family tremendous peace of mind, it can provide physicians the scientific evidence to feel more confident in supporting both someone like me — with a low-risk DCIS — to someone who is at a more elevated risk.

I believe DCISionRT will help shift the paradigm away from needless emotional trauma, (worry, overwhelm, confusion, uncertainty, intimidation and fear),  as well as help stop the problem known as “over-treatment” of DCIS.

I hope all health-care providers and organizations concerned with “early detection” of breast cancer embrace this important test.

When it comes to DCIS, there is no price tag for peace of mind.

PreludeDx_Tyler_Donna_Jenn

Jennifer Cohrs, PreludeDx Marketing Manager, Donna Pinto, DCIS411.com, Tyler H. Kibbee
Vice President, Strategic Marketing

If your doctor is unaware or unsupportive of DCISionRT, please contact Jennifer Cohrs for assistance:

I recently enjoyed a lab tour and meeting with the PreludeDx team at their office in Laguna, California.

Thank you Prelude Dx for advancing the science of DCIS and for treating me like a VIP!

To learn more about DCISionRT, click here.

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DCIS — Beyond “One-Size Fits-All”

Today, women newly diagnosed with DCIS have more support, options, and resources than ever before.

Below are eight ways to help you create an “individualized” and empowered plan-of-action…

#1.  CONFIRM YOUR PATHOLOGY

#2.  ASK YOUR DOCTOR TO ORDER A BIOLOGICAL RISK ASSESSMENT TEST

#3.  JOIN A PEER SUPPORT GROUP

#4.  REVIEW PATIENT WEBSITES

 

#5. CONSIDER A CLINICAL TRIAL COMPARING ACTIVE SURVEILLANCE TO SURGERY

#6.  INCORPORATE LIFESTYLE STRATEGIES

 

#7.  UNDERSTAND LIMITATIONS OF MAMMOGRAMS

#8. STAY “IN THE KNOW” OF EMERGING RESEARCH

  • PRECISION is an international research project aimed at distinguishing indolent from aggressive DCIS in order to reduce overtreatment and life-long side effects.
  • Set up a Google Alert for “DCIS”

 

 

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Evaluating DCIS treatments — do you know your “survival” statistics?

facts not fear“There is strong evidence that treatment of DCIS in most women has no clear effect on mortality reduction.” – Finding the balance between over- and under-treatment of ductal carcinoma in situ (DCIS)

“Risk of development of metastases and/or death in a patient diagnosed with pure DCIS is very low (<1%).Ductal Carcinoma-In-Situ of the Breast with Subsequent Distant Metastasis and Death

SURGERY

RADIATION

TAMOXIFEN

  • While tamoxifen after local excision for DCIS (with or without adjuvant radiotherapy) reduced the risk of recurrent DCIS (in the ipsi- and contralateral breast), it did not reduce the risk of overall mortality. – Postoperative tamoxifen for ductal carcinoma in situ.
  • Warrick and Allred in their editorial piece conclude that tamoxifen is probably overused, and advocate more selective use. They particularly note that the major benefit would be seen in patients who are younger (premenopausal) with extensive high grade disease and/or narrow margins, and clearly only those that are ER positive.In conclusion, the clinical benefit of tamoxifen intervention based on the randomized trials is meager at best. There appears to be no benefit, at least in the UK/ANZ trial for tamoxifen amongst irradiated patients, and the benefits when claimed are very small. – Tamoxifen as an Adjuvant Agent for Ductal Carcinoma In Situ (DCIS)

 

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Namaste — My 4-11 Blessing to All

Today is 4-11 — a perfect day for a quick check-in… and “namaste” blessing to all!

On April 1, I celebrated my birthday with a visit to the Self Realization Fellowship Mediation Gardens in Encinitas.

I said a prayer of gratitude and wished for everyone to have the blessings of  love, truth, light, (health) and peace — the meaning of my word for the year — “namaste.”

One friend who is in my heart and soul is Sandie Walters.

I was so shocked and sad to learn that Sandie died suddenly from pneumonia in January. Sandie’s spirit will live on forever through DCIS Redefined, a website we created together in 2013.

I am so thankful for the meaningful work I am involved with along with my health, my family and all my dear friends near and far!

Wishing everyone peace, love, light, health and truth.

~ NAMASTE ~

Donna Pinto, 4-11-18

 

 

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Keeping Patient Perspectives at the Forefront of DCIS Research

COMET PLTPatient Advocates from across the US and around the world came together to share insights about DCIS at the 2017 San Antonio Breast Cancer Symposium.

The COMET Study Patient Leadership Team presented “Changing the DCIS Conversation: Development of an Alternative Discourse by Patient Advocate Stakeholders in the COMET Study.”

PLT POSTER

Ellen Jelle Deb DonnaAdvocates from the US, UK and the Netherlands highlighted their role as “partners” on PRECISION — “PREvent ductal Carcinoma In Situ Invasive Overtreatment Now.”

This international initiative was awarded Cancer Research UK’s Grand Challenge. Led by Dr. Jelle Wesseling of the Netherlands Cancer Institute, PRECISION aims to distinguish between lethal cancers that need treating, and non-lethal cancers that don’t.

 

Help keep patient perspectives at the forefront of DCIS research!  Join the conversation by commenting below or on social media!

 

 

 

 

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