Saturday, January 23, 2010

Help Get Medicaid Coverage for Triple Negative Breast Cancer Patients

Kay Mobley is a TNBC survivor.  She discovered, the hard way, that Medicaid does not consider follow-ups, oncology appointments and scans "treatment" whereas they consider receiving endocrine therapy and the doctor appointments that requires as treatment and they cover it.


She didn't take it lying down and has a bill that is scheduled to be heard in her state legislature. However, now they are telling her that the bill may not be read, which means, uninsured women with triple negative breast cancer cannot get coverage to see their oncologists after their chemotherapy ends.


You can help- no matter where you live.


Call and leave the following message:

MY NAME IS ____________ CALLING FROM  CITY, STATE.   I am a member of a breast cancer support group along with Kay Mobley.  I am requesting that Senate Bill SB0279 be called and heard in committee.  This is Medicaid coverage for Triple Negative Breast Cancer, a life threatening illness.

The number to call is 317-232-9489.

Friday, January 22, 2010

MAJOR BREAKTHROUGH IN THE TREATMENT OF TRIPLE NEGATIVE BREAST CANCER

The No Surrender Breast Cancer Foundation is blessed to have Constantine Kaniklidis to report to us from the front lines of breast cancer research and treatment advances.


For all women who have triple negative breast cancer, this is the hope we have been waiting for.








Major Breakthrough in the Treatment of Triple Negative Breast Cancer

  1. A recent updated analysis of the original BS-201 PARP Inhibitor (PARPi) Trial continues to show an exceptional outcome benefit to the addition of the PARP inhibitor (PARPi) BSI-201 to the gemcitabine-carboplatin chemotherapy backbone, and although these are interim and not final results which could change in either direction, at this time the interim findings support the provisional conclusion that the PARP inhibitor essentially - and amazingly - doubles overall survival (OS) - not just PFS (progression-free survival), also improved, meaning reduction in the risk of recurrence - in the triple negative breast cancer population, and at this time sustains a 50% reduction in the risk of death.
    [Disclaimer: we must wait the final results  of the trial to see if these dramatic, first-ever results, are sustained at the same or reasonably comparable levels as now seen with the interim findings].




  2. These rather stunning survival outcomes were furthermore accompanied by highly impressive response rates: the  overall response rate (ORR) was high, at 48% of patients achieving complete response (CR) or partial response (PR) which is  three times as high as that obtained with chemotherapy alone, and with another 14% achieving stable disease  (SD, for  6 month or greater), yielding a clinical benefit rate (CBR) of 62% (CBR = CR + PR + SD), and with no significant additional adverse effects from the addition of BSI-201 to  the chemotherapy backbone (impressive, remembering that non-toxic agents are notoriously hard to come by in oncology).



  3. The accrual and progress of the trial has proceeded at extremely rapid pace, well beyond expectations, and the best estimation, based on feedback from investigators, is  that this Phase III trial given the pace, will come to completion as early as this (First) Quarter of 2010. Interview statements - but not officially posted NCI protocol data - suggests that there are just 40 patients remaining requiring trial accounting, 20 in the PARP inhibitor arm, and another 20 in the chemotherapy only arm, confirming that completion is very close, and  that a First Quarter 2010 estimate is plausible on the progress to date.



  4. Finally, on the regulatory front it also appears there is accelerated progress: the PARP inhibitor BSI-201 has been granted on Fast Track Designation by the FDA, very good news for patients: FDA Fast Track means that, against standard requirements, the agency will accept initial late-stage data instead of waiting for entire Phase III clinical trial results, something that is done when (1) a  proposed agent is intended for treatment of a serious or life-threatening disease -  a status now accepted by the FDA for mTNBC (metastatic TNBC) - and (2) demonstrates the potential to address unmet needs for such a condition. Based on this status and on a review of documents filed in the FDA regulatory pipeline process, it is now estimated that  BSI-201 may actually become commercially available - and hence available to all mTNBC  patients in clinical practice without being on any clinical trial - at year's end (mid November to mid December, best estimate).

Commentary:  Missed, and New, Opportunities
My own sense of the ASCO BSI-201 PARP trial is that on the contrary that it may have  underestimated the true benefit; this perspective stems from my own TNBC review and  research which on the cumulative evidence suggests that maximal benefit of PARP inhibition is accrued when it is concurrent with a strongly  genotoxic (DNA-damaging) regimen, and although carboplatin is genotoxic, as are all platinum agents, gemcitabine (Gemzar) is not, and I believe this represents a lost opportunity.  Indeed, I have on several  occasions advocated in this context the omission of gemcitabine (Gemzar)  altogether in the  PARP  context, in favor either of (1) a more optimal dose of carboplatin - I consider carboplatin AUC=2 as  substantially sub-optimal, and would have deployed at least AUC=6 even up to AUC=7.5, or (2) substituting another genotoxic agent  instead of gemcitabine (Gemzar), my choice being an anthracycline (preferably the pegylated liposomal Doxil or Caelyx.  Given this limitation - which in all fairness the principal investigator Joyce O'Shaughnessy has acknowledged (due to expediency, not oversight) - of the  failure to maximize the potential synergy of genotoxicity and PARP inhibition, in my mind therefore the trial's  findings are actually therefore even more impressive by extrapolation, ad I would predict that an all-genotoxic chemotherapy + PARP inhibitor (BSI-201) will achieve significantly greater outcome benefit than even doubling of survival and halving of mortality for metastatic TNBC patients.

And this is where the opportunity can be regained, in the earlier availability of BSI-201 by this year's end, since at that point clinicians are no longer constrained to conform to the trial protocol's chemotherapy regimen, and I would advocated for them to instead adopt a more optimal all-genotoxic regimen which should translate to even more dramatic outcome gains.  I am also of the opinion for molecular and other reasons that the failure of response of the PARP inhibitor regimen for some patients may be due in part to the absence of  pure genotoxicity in the combination regimen, which therefore I am hoping innovative oncologists will recognize and overcome through appropriate DNA-damaging agent substitutions for the non-genotoxic gemcitabine (Gemzar) component, allowing more patients to be responsive to this breakthrough for metastatic TNBC disease.

Come The Revolution
Finally, remember the last time we heard of a 50% gain in breast cancer survival?  That was with the revolutionary, practice-changing (virtually overnight) findings from Dennis Slamon's trial on trastuzumab (Herceptin) for HER2-positive disease, heralded correctly as the greatest breakthrough in breast cancer treatment since tamoxifen 30+ years ago.  I believe an optimally genotoxic PARP inhibitor therapy can do for triple negative disease what Herceptin did for HER2+ patients, and the provisional results of the  Phase III PARP Inhibitor to date appear to support and imply that contention.  

These are the kind of times that researchers like me - and dedicated and brilliant investigators, and soon also patients - live to see as their reward for their commitment.

-
Constantine Kaniklidis



Saturday, January 9, 2010

It's not cute or pretty...and it is not a game.

I have a facebook account.  Most of my time I spend there I am trying to figure out what in hell most people are talking about and why am I being asked to milk a cow for someone's farm or join another's mafia family...

I don't do the games. I don't send drinks, hugs, kisses, snowballs or any other application they can think of.

Why? I don't have time. 

I do like to check in on friends and see how and what everyone is doing. That is enjoyable.
This week was particularly busy for me so I only had time for a glance here and there.
I noticed many of my friends had put a color on their "status" section. 
"Pink"
"Black"
"None"
I see it is still going on even today. This morning I asked someone what is it all about.
According to this friend, 
"We are posting what color bra we are wearing to raise breast cancer awareness. It is a game that was started last week! You should do it!"

You have got to be kidding. Posting the color of your bra on a social networking site is going to raise awareness of breast cancer?  What does the color of your bra have to do with breast cancer? Everyone is aware of breast cancer. The people who haven't been touched by it think it is pink and pretty and frilly and now a cute Facebook game. People who have had breast cancer know it is far from cute. But wait, I am seeing my friends who are survivors posting their bra colors too. Is it an escape from the reality of the disease? Are they longing to just have some fun with it for a change?


Could be.


As for myself, I won't be posting any colors on my Facebook page. I have to finish researching a clinical trial for a friend who is end-stage and needs a last ditch chemo to prolong her life. I will be adding a section on Male Breast Cancer to the website in honor of a friend who died this week. I will be sending more grant requests out for the Foundation to raise money so we can raise awareness of something that is not so well known: how young, African American women need to be screened in their 30s because they are at a higher risk of developing Triple Negative Breast Cancer. If they find it in their 30s they have a fighting chance. If they wait for their first mammogram at age 40, it could be too late. It is our Before Forty Initiative. It will save lives. I wish I had started it years ago. My friend Ferne may have been screened before her TNBC tumor had grown too large and spread to her nodes. 


Ferne is gone now. But she is not forgotten. Either are all the other women we have lost to this disease while we were busy painting the town pink.


My Facebook status today?
"Ferne"
Tomorrow?
"Deb"
Monday?
"Lori"
.... and so on, until the list is done.


That is what Breast Cancer really is. That is where awareness games get you.

For me, I am aware. Now I am doing something about it.

Saturday, January 2, 2010

Men Get Breast Cancer Too


Here is another thing the pink ribbon can't wrap up into a pretty bow: Men get breast cancer too.
And they have to endure the same things we women do. They get mastectomies, undergo brutal chemotherapy and even hormonal treatments. They cannot escape any of the Beast's ugliness.

In many ways it is harder for them because of how PINK it has become. Cancer is cancer. There should be one color- camouflage- to represent its awareness. Because it hides under cover and it is hard to see coming... it is a terrorist inside our bodies, male or female. If we are lucky, the terrorist is caught early. But for many, especially men, it is caught too late, because they don't think it is possible for them to ever get breast cancer.

This year, how about spreading awareness for Male Breast Cancer? Let the men in your life know that if they find a lump, get it checked out.

We lost a beloved member of No Surrender yesterday. Mike Eanes fought a long, courageous battle.
In his honor, we are starting the Camouflage Campaign for Male Breast Cancer.

Mike, you will be dearly missed. May God bless you.