Wednesday, November 25, 2015

Nivo/Opdivo approved as first line for melanoma!

Nivolumab/Opdivo (the drug I took in my trial) has gained FDA approval for use as a single agent, front line treatment for BRAF V600 wild type, unresectable or metastatic melanoma according to announcements put out today! FDA approves frontline opdivo for advanced melanoma
And here: FDA Approval of Opdivo in BRAF V600 WT Melanoma

Have to say, I don't like the limitation based on BRAF status...since we already know that such status doesn't matter in terms of a response to anti-PD1:  Nivo/Opdivo effective no matter BRAF status
The restriction in today's announcement is based on the way the data was attained from the study used to gain this approval, the CheckMate 066 trial.  (The narrow way in which trials are used when drug companies gain approval from the FDA is a HUGE problem.  Human brains are not so narrow as to only be able to interpret data in specific, grouped sets! We really are capable of putting two and two together and while Opdivo proved effective in the wild type ratties in the 066 study, we have simultaneously learned that other ratties respond as well.  Tunnel vision is NOT required!) But, this approval gives one more option for lots of melanoma peeps and as more and more Opdivo approvals are gained, the more latitude docs will have in the way they prescribe it.

Here's some more ways Opdivo has been approved and is helping others:
  • Advanced renal cell carcinoma (11/23/2015)
  • Advanced non-squamous non-small cell lung cancer - after platinum based chemo (10/9/2015)
  • In the Nivo/Opdivo with Ipililmumab/Yervoy combo for BRAF V600 advanced melanoma (10/1/2015)
  • Advanced non-small cell lung cancer - after platinum based chemo (3/4/2015)
  • For melanoma, after failing ipi, and if BRAF positive, BRAFi (12/22/14) 
Additionally, Nivo/Opdivo has shown high response rates (87%) for relapsed or refractory Hodgkin Lymphoma.  Studies are currently looking at Opdvo combined with the anti-CD27 antibody, Varlilumab as well as Opivo/Yervoy combined with GM CSF (sargramostim) for melanoma.

NOW!  Let's see Opdivo approved for BRAF positive folks....FIRST line!!!  We've got ipi, a more toxic, less effective drug in melanoma...though a huge boon for folks who need it...approved for NED melanoma folks.  Let's get Nivo/Opdivo approved for the NED melanoma patients.  My ratties have proven its worth!!  Tunnel vision with FDA approvals is silly, non-nonsensical, and patients with deadly illnesses die while bureaucrats fail to put 2 and 2 together!!

Hang in there, ratties!  Slowly but surely, you are changing the world! love, c

Tuesday, November 24, 2015

Fall hike in Cades Cove

I was able to whisk B away for his special day.  We had a lovely, restful time in Townsend, riding through and hiking in Cades Cove.  While warmer and a bit wetter than the weather had been recently, it was still fun.  The leaves had already peaked, but there was beauty to be had nonetheless.

 Thanks for the time, Bentie - and the bear!  Until spring....   les

Saturday, November 21, 2015

PCR testing for melanoma

Polymerase chain reaction (PCR) is a technique that is used to amplify trace amounts of DNA (and in some instances, RNA) located in or on almost any liquid or surface where DNA strands may be deposited.  It is an exceedingly sensitive technique to detect molecules.  In everyday medicine it can be used to check for the presence of a wide variety of substances - pertussis from a nasal swab, chlamydia and gc in urine, viral load of HIV patients from their blood sample, fungus in skin scrapings, and even genetic mutations.  It would be super cool if we could utilize this technique to accurately identify the presence and characteristics of melanoma cells....both for diagnosis as well as monitoring effects of treatment.  Here are some peeps who are working on it:

SNPase-ARMS qPCR:  Ultrasensitive Mutation-Based Detection of Cell-Free Tumor DNA in Melanoma Patients.  PLoS One. 2015 Nov 12.  Stadler, Eder, Pratscher, et al.

"Cell-free circulating tumor DNA in the plasma of cancer patients has become a common point of interest as indicator of therapy options and treatment response in clinical cancer research. Especially patient- and tumor-specific single nucleotide variants that accurately distinguish tumor DNA from wild type DNA are promising targets. The reliable detection and quantification of these single-base DNA variants is technically challenging. Currently, a variety of techniques is applied, with no apparent "gold standard". Here we present a novel qPCR protocol that meets the conditions of extreme sensitivity and specificity that are required for detection and quantification of tumor DNA. By consecutive application of two polymerases, one of them designed for extreme base-specificity, the method reaches unprecedented sensitivity and specificity. Three qPCR assays were tested with spike-in experiments, specific for point mutations BRAF V600E, PTEN T167A and NRAS Q61L of melanoma cell lines. It was possible to detect down to one copy of tumor DNA per reaction , at a background of up to 200 000 wild type DNAs. To prove its clinical applicability, the method was successfully tested on a small cohort of BRAF V600E positive melanoma patients."

Still needs to be tested on a greater scale...but sounds like progress. - c

Thursday, November 19, 2015

St. George - love - an artist's eye...

My cuties!!!

Bag ladies!  It was cold y'all!  And sunny!

Bag ladies with Mr. GQ!

No stopping a photog...even for a photog!!

Fisher menz.....

Beauty and the beach!


So much fun.  So lovely to have shared the time.  Great thanks to Irina's artistry.  (I don't get many pics of my resident photog!!!)  She's really awesome, y'all.  Check her out:
 Irina Popova - The artist - Art and Photography

Love, c