Two new FDA approvals for the treatment of melanoma!

Vemurafenib (Zelboraf) with Cobimetinib (Cotellic):

This combo is only effective for patients who are positive for the BRAF mutation (V600E or K).  Vemufafenib is a BRAF inhibitor (initially approved in 2011). Cobimetinib is a new MEK inhibitor.  For sometime now we have known that BRAF inhibitors work better, with fewer side effects and longer duration of effectiveness when combined with a MEK inhibitor.  Sources are noting a median of 12.25 months of progression free survival with the combo vs 7.2 months on vemurafenib alone.  Here is an article from early trials with this combo as well as other intel on all things BRAFi:
BRAF/MEK combo - vemurafenib/cobimetinib

Ipilimumab/Yervoy as adjuvant:

Hanging around melanoma world for about ten minutes over the past....forever....will teach you that adjuvant therapy (treatment you can take if you are lucky enough to have all your tumors zapped with radiation and/or removed surgically....even though you are still Stage III or IV) has been pretty much nonexistent!!  Granted many things have been in and are continuing in clinical trials for these patients - my nivo/peptide vaccine trial is just one example, other vaccines, ipi, BRAFi, and all sorts of concoctions are still in process.  However, ipi has now been actually approved for use in Stage III/IV melanoma patients who have had all their tumor removed (or is not significantly measurable currently).  Here's some of the data leading up to this approval along with info about Nivo as adjuvant:
ipi vs-nivo trial as adjuvant for resected melanoma

Given the higher response rate in Stage IV patients treated with anti-PD1 (40%) vs the roughly 15% response rate of ipi as well as the evidence my trial is providing regarding the response rate of my Stage IV NED ratties treated with nivo, along with anti-PD1's lower side effect profile when compared to ipi, I can only hope that Nivolumab/Opdivo will be approved as an adjuvant treatment for melanoma very soon!!!  However, ipi's approval as an adjuvant treatment option is a good thing and will save many lives.  I certainly would have taken it in 2010 if I could have gotten it!!!!

Hang in there, ratties!  You are changing the world! - c

To Paris with love....

We had a beautiful visit to Paris in 2006.  Part of me remains there still...

Pour mes fre`res et soeurs France:  Mon coeur est brise` avec votre douleur.  Merci pour tout ce que vous partager avec le monde et la force de l`espirit, je sais que vous allez montrer.  Beaucoup d`amour. - c

(For my French brothers and sisters:  My heart is broken for your pain.  Thanks for all you share with the world and the strength of spirit I know you will show.  Much love.)

Pianist plays 'Imagine'.... outside Bataclan 

Merde! Again. With love to friends and family of Lori Murdock...

When you swim in melanoma soup for as long as I have...and as deeply...you meet some incredible people.  I just keep wondering why we have to lose so many.  I first mentioned Lori here:
A beautiful lady with eloquent though heartbreaking words

Lori was diagnosed with melanoma in 2009.  She, like myself and so many others, faced a horrible prognosis with no available melanoma treatments other than standard chemo, like Dacarbazine (DTIC), or the old school immunotherapies of  interferon or IL-2.  She researched and fought for clinical trial options.  Just after being diagnosed as Stage IV, ipilimumab/Yervoy was licensed in the UK, though patients had to try dacarbazine first.  She did.  Predictably, DTIC made her very ill and had no positive effects on her melanoma.  However, she was able to advance to ipi.  She tolerated ipi well and her tumors responded.  Yet, bad news and melanoma growth eventually returned and she was back to the search for treatment.  Her plea for a repeated round of ipi was denied.  Luckily, she found a nivo/Opdivo trial.  Unfortunately, it randomized participants to nivo OR dacarbazine.  Dacarbazine was the lot she drew.  She declined further participation.  Traumatizing as that was, she continued her fight for participation in another trial and reasonable trial protocols....and not just for herself...but for others:
In 2013 she sailed around the UK to spread melanoma awareness and raise money for cancer patients

Yet, her own struggles were far from over:
Asks strangers donate to help raise money to secure her own cancer treatment
Though she had been accepted in a TIL program, she was not allowed access to the treatment without 70,000 euro's in hand.  Folks helped her out, though why on earth this is the way so many folks across the globe are forced to find access to deserved medical care, I'll never know.
Her "go fund me" medical fundraiser - help lori murdock live

By June, having had a melanoma riddled kidney removed and those tumor cells prepped to grow TIL cells, there was good news - the needed cells for TIL treatment had grown.  I am not sure exactly what happened after that....but today....Lori Murdock left this earth due to melanoma.

This world has lost yet another amazing human to melanoma.  Ironically, to me....I have encountered a recent spate of:  'Poor me'...'I am so stressed'....'I think I have PTSD after all I have been through'....by melanoma patients on various boards and forums...and I fear I am not handling it very well.  I mean...up until this moment...I have done/said absolutely nothing...other than think about those proffered sentiments in my own strange brain.

Of course, everyone has the right to say what they like.  Additionally, I feel strongly that all patients deserve a safe place to speak and caring people to listen to what they are experiencing....whatever it may be.  Yet, really?  Those of us lucky enough to attain treatment and then actually respond positively to it....you think you are stressed?  That treatment made you cranky????  Yes, being told you have melanoma is frightening, gut wrenching, horrible.  To have to endure pain and infusion after infusion, surgeries, time consuming crap finding, understanding and working out care, the anxiety of paying for that care, seeing the suffering on the faces of those who care about us...is....pretty much....hellish.  But, we are here.  Our cars still break down.  Our faucets still leak.  Work still has moments that suck.  Surgical incision sites, though healed, never feel the same.  Yes, we are tired and stressed and cranky.  But....so are lots of other folks....in Syria, in refugee camps, in hospitals, in hospice, in melanoma never-land where treatments are not attainable....or are not working.  So....seriously?  Do we need to focus on our stress?  Or do we need to choose to be thankful that we are here at all?  Miraculously having been given another go at all of this?  I bet I know which Lori Murdock would be choosing tonight.

May you rest in peace, Lori.  You have been a beacon of light for us all. - c

Sew Chaotically! - Tops for Rosie -McCall's 6896

I first made this top for Roo in the spring of 2014:

A life les ordinary

I made a straight 12 and it fits her really well.  She likes to wear it alone in warmer weather and with a sweater when it's cooler.  It is not difficult though the princess seams were rather daunting when I first started!!!  It has a nifty way (if not intuitive for some of us) of finishing off the neck and arm facings so that they are all neat and tidy.  Here is a history of the sewing:

The first rendition, pictured in the post above.  My dress form is a little smaller than Roo, so the fit is not perfect in these pics.

With contrasting colors...

...and an exposed zip for fun!  Super easy to do.  There are many tutorials to peek at on youtube.

A year later, proof that practice does make perfect....or at least a lot better!!!

Right proud of dealing with this print!!!

Proof of the neat facings.

And since we're at it....

No ugly insides!!!  With label B had made for me!!!  Silly boy!  Don't you love it?

 Sew chaotically!!!!  love, c

Cooties in our gut keep us skinny, smart and cure cancer!?????

The cooties in our gut have been the hottest thing in research, and news about research, of late.  It is not as new as some folks would like to have you believe.  We have known for some time now, that a little dirt don't hurt.  Kids have become less immune to disease and more susceptible to various immune problems like asthma and allergies since the world got cleaner around them.  Concomitantly, they do die less from pneumonia and dysentery!!!  Just say'n!  On the other hand, as humans become more willing to take, and docs to prescribe, antibiotics for a cold (That's a virus people!!!  Antibiotics kill bacteria....not a virus!) and allow farmers to feed them in large quantities to animals that end up on our grills, we haven't cured a single virus, but we have killed a lot of important bacteria that should be living in our guts. 

Additionally, the diet most Americans consume...one low in fiber, fruits and vegetables....but filled with processed, "fast" food....does us no favors.  Rats fed more fiber eat less than their fiber-free counterparts, are thinner, faster and live longer.  Studies in real live people show that the fiber does that in an obvious way, but also changes the microbes in our gut as the "good" germs like to eat the fiber!!!  If there's no fiber there for them to eat, they aren't there!!!  So, along with obesity prevention, scientists are now touting the benefit of good germs in our gut to promote brain development, improved cognitive behaviors, and prevent neurologic disorders.  The latest reports also seem to show that good bacteria in our intestines can promote the beneficial effects of immunotherapy....

The Atlantic: 11/2015 - Immunotherapy cancer drugs depend on gut microbes

Commensal Bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy.

Sivan, Corrales, Hubert, et al.  Science. 2015 Nov 5.

"T cell infiltration of solid tumors is associated with favorable patient outcomes, yet the mechanisms underlying variable immune responses between individuals are not well understood. One possible modulator could be the intestinal microbiota. We compared melanoma growth in mice harboring distinct commensal microbiota and observed differences in spontaneous antitumor immunity, which were eliminated upon cohousing or following fecal transfer. 16S ribosomal RNA sequencing identified Bifidobacterium as associated with the antitumor effects. Oral administration of Bifidobacterium alone improved tumor control to the same degree as anti-PD-L1 therapy (checkpoint blockade), and combination treatment nearly abolished tumor outgrowth. Augmented dendritic cell function leading to enhanced CD8⁺ T cell priming and accumulation in the tumor microenvironment mediated the effect. Our data suggest that manipulating the microbiota may modulate cancer immunotherapy."

None of this is really surprising.  We already knew how much difference the microbes within our intestines made in the presence of allergies and immunologic based diseases. And, yes, in some medical cases, like the treatment of c. difficile, we have even found that fecal transplants are needed!!! Of course it makes sense that this "background note" would affect drugs and treatments that work by stimulating the immune system!!!  However, once again....it is important to remember that this is not the end all, be all, to cancer and all sorts of diseases.  It goes back to the same old song.  There is no miracle drug or diet.  Doing something extreme or bizarre with your diet is not going to change your world or your cancer.  But....if you will exercise, eat your fruits and veggies....you will set yourself up to be the healthiest you can.  Want to increase the bifidobacterium in your gut?  No problem.  Eat yogurt with live cultures.  Drink kefir or buttermilk.  Enjoy kimchi (Korean fermented cabbage), sauerkraut, miso, and other fermented fruits and veg.  And after that...take a walk...preferably while holding hands with a good friend.
Love and luck - c

Vitiligo...again associated with response to anti-PD1 in melanoma patients

Here is some research and previous posts I made on vitiligo and a concomitant response to melanoma...the latest being in Jan of 2015:  Vitiligo: a good prognostic indicator for melanoma

Now there's this:
Association of vitiligo with tumor response in patients with metastatic melanoma treated with pembrolizumab.  Hua, Boussemart, Mateus, et al.  JAMA Dermatol.  Oct 2015.

Vitiligo is an autoimmune skin disorder that reacts against melanocytes.  The association of vitiligo with tumor response in patients with melanoma who undergo immunotherapy has been reported but is still controversial. ... This prospective observational study was conducted from 1/1/12 - 9/24/13... 67 patients with metastatic melanoma who were given pembro in a phase 1 study were included and screened for the emergence of vitiligo...  Of the 67 pts, 17 (25%) developed vitiligo during pembro treatment and 50 (67%) did not.  An objective (complete or partial) response to treatment was associated with a higher occurrence of vitiligo (12 of 17 {71%} vs 14 of 50 {28%}).  The time of onset of vitiligo ranged from 52 to 453 days (median = 126) from start of treatment.  Of the 17 patients with vitiligo, 3 had a complete response, 9 had a partial response, and 3 had stable disease, and 2 had progressive disease at final f/u.  Vitiligo, a clinically visible immune-related event could be associated with clinical benefit of pembro treatment.

Interesting.  Clearly, in terms of response, the presence of vitiligo doesn't equal a sure thing, as 2 of these patients with vitiligo had progressive disease.  However, overall it remains a good sign.  Also....when looking back on the development of my vitiligo...as best as I can figure, it began around 52 days after my first dose of nivo/Opdivo....which is in keeping with what was found in this study as well.  Again...time will tell....but it still seems to me....we need to find what in immunotherapy (be it ipi, IL2, Nivo or Pembro) triggers vitiligo and I think we will be closer to finding answers about what triggers a response to melanoma.
Hang in there, ratties! - c

My little mutant babies...

Awwwwwe.....  Love my punkins!!!