America's Highway to Health - An Op-ed

Want to get somewhere? To a friend down the block? A big city, states away? Need something delivered? Mail from your love? Amazon package? There it is! How? Our roads. A huge system of Roads, Freeways, Thoroughfares, Boulevards, Avenues, Lanes, Drives and Alleys. From sea to shining sea. Beyond your driveway, your block, city, county, state and country. By foot and by wheel there is local entry and universal access. Who needs it? Everybody. Who builds it? Everybody! And we use the government to do it. Local, State and Federal. Who pays for it? We all do. At the local, state and national level. Do we help pay for roads we’ll never use? You bet, the whole system is a mutual venture. That’s what makes it work. It wouldn’t if you only supported the route you drive to work on. We drive our cars where we wish. Yes, there are rules. And insurance is required to cover the risk. But overall, the highway system is an essential, beneficial, and shared project. It is a contract between the people and their government providing crucial infrastructure.

Want to be healthy? Want a productive life? Want to prevent disease, alleviate suffering, avoid unnecessary death? Want your loved ones, friends, neighbors to be able to pursue happiness? Want your employees to be productive? How are we as a nation to accomplish these goals? The answer - health care. We all need entry at a local primary care level and universal access. Who needs it? Everybody!! What do we use to attain health? Our health care system. We need health care from sea to shining sea. When do we need it? Our entire lives. From womb to old age! As individuals and communities. Who pays for it? We all do. Sometimes directly. Sometimes indirectly in order to prevent deaths of others, needless suffering, and loss of productivity. Do we pay for the care of others? You bet! But like our roads, our healthcare system is a mutual venture. That’s how it works best. If health care costs are not shared, the total price will go up and the system itself falls short for all of us. Just like drivers on roads, we all need insurance to navigate the healthcare system. That is how we share the risk of being alive. Our healthcare system is an essential, beneficial and shared project. It is a contract between the people and their government - to protect the lives of our most crucial infrastructure - our citizens. Brent and Celeste Morris

Something to think about, huh? - c

Happy 4th of July!!!

A bit of summery happiness I scavenged this morning...

Hope everyone is having a great day.  love, c

Pembro (Keytruda) and epacadostat - a promising combo for melanoma

While this year's ASCO didn't provide any new amazing drug or therapy promising a cure for melanoma...but rather offered data from the maturation of existing studies and additional supporting data for current accepted therapies...there was one combo that just may offer a possible change/better treatment option in the future.  Epacadostat, an IDO inhibitor, studied in combination with Pembrolizumab (anti-PD-1, also known as Keytruda) since the ECHO-204 trial started in 2015, has now morphed into the ECHO 301 study for melanoma patients.   I've been impressed by the data coming out on the combo for awhile, posting this in March of 2016: Immunology webinar update by Dr. Weber

While the webinar covered many topics, there was this on the combo:

Epacadostat (an IDO inhibitor) + Pembrolizumab:Preliminary Results

                61 patients were enrolled by September 2, 2015  Safety data on 46 patients (19 melanoma, 7 RCC, 7 NSCLC, 5 transitional cell carcinoma, 4 endometrial adenocarcinoma). Most common all-grade treatment-related AEs were rash (22%), fatigue (17%), nausea (11%), and pruritus (11%).   Grade 3/4 treatment-related AEs occurred in 13% of patients (rash, 7%).   One patient discontinued for a treatment-related AE.  IDO inhibitor did not seem to increase side effects.  Melanoma patients only (n - 18) - 56% ORR.  Melanoma treatment naive patients (n - 16) - 63% ORR.  Weber found these results very promising and comparable to the ipi/nivo combo in regard to response rates but with much milder side effects!!!

In December of last year, there was this:  The Future for Melanoma Treatment = Combo's! Dr. Weber breaks it down -

Now...we have this:  Weber's report: Pembro plus Epacadostat as frontline melanoma treatment

In the link above, Shannon Connelly's June 29, 2017 OncLive report, notes the following:

   'If mature data from the ongoing phase III trial of pembrolizumab (Keytruda) combined with epacadostat are positive, the combination could become the preferred frontline treatment regimen for patients with melanoma, says Jeffrey Weber, MD, PhD.

The ongoing KEYNOTE-252/ECHO-301 study is exploring the efficacy, safety, and tolerability of the PD-1 inhibitor pembrolizumab with the first-in-class IDO1 inhibitor epacadostat in patients with stage III/IV unresectable or metastatic melanoma (NCT02752074).

Findings of the multi-arm, open-label phase I/II ECHO-204 trial of pembrolizumab/epacadostat in patients with advanced solid tumors presented at the 2017 ASCO Annual Meeting showed the combination demonstrated an objective response rate (ORR) of 63% and a complete response (CR) rate of 5% for patients with treatment-naïve melanoma. Based on the projected 2-year survival data, the combination could represent a new, less toxic frontline standard of care for patients with melanoma, said Weber, a medical oncologist and deputy director of the Laura and Isaac Perlmutter Cancer Center at NYU Langone Medical Center.

“The 1- and 2-year survivals are projected to be as good as ipilimumab (Yervoy)/nivolumab (Opdivo), which means a 64% 2-year survival rate,” Weber said. “Let's say it's around a 62% 2-year survival rate. Given the very favorable toxicity profile, a lot of doctors will want to use pembrolizumab/epacadostat in the frontline setting.”'

So...as has been proven out in other studies...it may be that naive patients do the best...and they are the only folks in this trial.  But, even so - an ORR of 63% and CR of 5% is just as good as the ipi/nivo combo while epacadostat has far fewer side effects than those produced by ipi.  If these numbers hold...The Wizard Weber may be on to something here!! Thanks, ratties!!  Happy 4th! -c

Sew Chaotically! - The Demi Pant from Tessuti

Remember when I said I had another pair of Funky Pants in my future??? They're here!

I saw the pants above in a Sundance catalog and thought..."Those would be fun and easy for summer!"  Then, I saw the Tessuti pattern and there they were, but with an even better funky vibe!!! Then, I saw these little shorts with an embroidered edge in a shop in Atlanta with Ruthie! The wheels started turning...but I'll get to that in a minute!

Though I admit it took a minute to get my non-spatial brain around some of the pattern details....once it clicked, they were amazing and perfect!!! The pocket is simply one piece applied to the front leg after you make a little placket on the side seam.  Genius!!! I finished all seams with my serger.  No. Ugly. Insides!!!

The bottom of the legs are cut just so....MAGICALLY making the cutest little pleat ever!

Here's how my second brain wave came to fruition!!!   I LOVE Bernie!!!

See the neat little pocket up top?  This linen from Gail K Fabrics in Atlanta is really pretty with a faint blue thread woven through! (Yes, Bentie found it!)  It holds up well in the wash and dryer!  Wrinkles are inherent, but the drape is perfect for these pants!

How cute is that????

The elastic insertion and treatment for the waist made me nervous....because I had never done it this way...but it was awesome!  The pattern instructions have you stitch the elastic within the tunnel as you make it.  THEN you stitch through the center of the tunnel, OVER and through the elastic to keep it in place and the waistband smooth!!  It worked perfectly!!!  Certainly a technique I will employ again. Initially, I was a little worried that these pants would be too voluminous around the bootie and tummy!!  They're not!  

Don't you love that shape?  Yes, my family has already dubbed me Princess Jasmine when I wear them...but I don't care!  I like being an exotic princess!!!  Sew Chaotically!!! - les

Outcomes for melanoma patients ~ clinical trials vs standard of care

I thought this was an interesting outcome to look at:

Outcomes in Melanoma Patients Treated with BRAF/MEK-Directed Therapy or Immune Checkpoint Inhibition Stratified by Clinical Trial versus Standard of Care. Goldman, Tchack, Robinson...Pavick, et al.  Oncology. 2017 Jun 10.

Since 2011, metastatic melanoma treatment has evolved with commercial approval of BRAF- and MEK-targeted therapy and CTLA-4- and PD-1-blocking antibodies (immune checkpoint inhibitors, ICI). While novel therapies have demonstrated improved prognosis in clinical trials, few studies have examined the evolution of prognosis and toxicity of these drugs among an unselected population. We assess whether survival and toxicity reported in trials, which typically exclude most patients with brain metastases and poor performance status, are recapitulated within a commercial access population.

182 patients diagnosed with stage IV melanoma from July 2006 to December 2013 and treated with BRAF- and/or MEK-targeted therapy or ICI were prospectively studied. Outcomes and clinicopathologic differences between trial and commercial cohorts were assessed

Patients receiving commercial therapy (vs. on trial) had poorer prognostic features (i.e., brain metastases) and lower median overall survival (mOS) when assessed across all treatments (9.2 vs. 17.5 months). While toxicity within trial and commercial cohorts did not differ, patients who experienced toxicity had increased mOS, irrespective of stratification by trial status or therapy.

Metastatic melanoma patients receiving commercial treatment may represent a different clinical population with poor prognostic features compared to trial patients. Toxicity may prognosticate treatment benefit.

So...in this report it is noted that folks who were NOT in a clinical trial, no matter if they were being treated with immunotherapy OR targeted therapy, did less well.  The researchers acknowledge that it is likely that folks who were in poorer health were the peeps who made up more of the population in the standard of care group.  Heaven knows....I have yelled and yelled about the exclusions that are so very often baked into clinical trials...and my firm belief that Big Pharma's (and even some researcher's) desire to make their outcomes look good drives much of this.  For far too long, folks who are in dire straits with significant tumor burden, prior treatments, and certainly CNS disease have been automatically excluded from clinical trials.  Consequently, when those folks finally get treatment from their local doc, outside of a clinical trial, they do less well when compared to the cream of the crop patients that the trials deign to include.

However, I feel there may be one other component relevant to this outcome ~ expertise. Participating in a clinical trial comes with some significant risks, expense, chaos and craziness inherent to the process. But, much of the time, it also comes with state of the art facilities, research labs, and renowned experts in the field in question who are at the top of their game and on top of the latest data and intel.  I fear that local oncs are not always well versed and experienced in the treatments they are providing.  They may fail to recognize symptoms of both progression and side effects as rapidly as a more expert clinician would.  Equally importantly, they may not allow the time needed for a response when dealing with immunotherapy, leading to the abandonment of a potentially good treatment outcome before the patient can attain the response needed, thus causing an unnecessary bad outcome.

As the article notes, these therapies have now been on the market, and therefore in the arsenal of melanoma treatments available for use by local oncologists, for 6 years.  Hopefully, local learning curves have been climbed and trial requirements will soon be adjusted in ways that make standard of care what it really should be for all melanoma patients. - c

Sew Chaotically! - Hollyburn skirt

I have loved Provençal fabrics, food, colors, the people, the place since we visited France, driving from Nice to Antibes, in 2006. Such a lovely trip.  So when I saw this fabric in Paris last year, I knew EXACTLY what I wanted to do with it!!!  A full, but shaped skirt!  Yes, this print and fabric is more commonly used for tablecloths and other household linens...but....that's just how I roll!!!

The Hollyburn skirt from Sewaholic has gotten rave reviews by many sewists and its shape was perfect for what I envisioned.  But, some had mentioned the need to contour the waistband and having had that experience on a pair of pants I made, I bit the bullet and did it!  I was taught every step in this amazing Tutorial by A Fashionable Stitch 

While the waistband may not lay perfectly on mannie.....

It's a great fit on me!!!

I finished the back with a button and embroidered loop.

The construction of this pattern is perfect and the pockets are awesome!!!

While I purchased this fabric and created a skirt with it on a bit of a whim, I think it will end up being more flexible, utilized in more styles and through more seasons than I had even hoped! Sew Chaotically! - les

Sew Chaotically! - Jean Jacket B5616 - May's Magnum Opus!!!

Though it has been finished for a bit, this jacket was certainly my magnum opus of Me Made May...if not my entire sewing career!!!  I began this project in May and it was slow going...on purpose!  I looked at tons of sew-a-longs  Like Alina's for her Hampton Jean Jacket  and found them very helpful.  I ended up using B5616, cropped with a mandarin collar.  For fabric, I used a stretch, but substantial denim from JoAnn's.  I considered distressing along the seams...but in the end, left it as it was.  It will wear, with wear.  And...at 53 it may be wiser to keep things classic!!!  I considered doing a double row of top stitching...and did on the side seams...but for the most part, I kept that clean and super simple as well.

BUT!!!!!  I did go nutters in one area!!!  The buttons!  (I know.  It seems to be a thing with me lately!!!) I got the buttons (minus one) visible in this picture when we visited Maiwa in Vancouver, having no idea about what I would do with them!  Once I decided they would be perfect on this jacket...I didn't have enough!  No worries. B sent them a pic of the buttons in question and ordered some more right up with help from a super sweet and tolerant lady!!!! 

I worked slowly, finishing every seam.  Pinning and pressing and basting and pressing AGAIN all the flat felled seams before top stitching with a thicker classic thread used with denim....which Bernie was not terribly fond of having in his bobbin!!!  (Since then, I've learned that lots of sewists keep a more normal thread in the bobbin and just use the thicker thread on top...but...then my insides wouldn't have been quite as fab!  Though Bernie may have been a bit happier!)  Yes, there was threading and re-threading the machine!!!  And..when you are going to that much trouble....those basted, top stitched seams better match up.  But not surprisingly...as per the rule of life (and sewing) - the first sleeve went in like a charm, matching the back yoke seam perfectly....ON THE FIRST TRY!!!!  The next sleeve - 4!....FOUR!!!!....F@#king tries later...and all was right with the world!

NO puckers, baby!!  Not one!!!

Yes.  I am inordinately proud of that back yoke!!!  Hee hee!

Since I was going for a jean jacket with a classic, crazy button twist....I used two buttons to both sleeves, creating a Faux French cuff!  How cute are these buttons????

No ugly insides!!!

And I mean ~ NONE!!!!  The pattern, oddly, didn't include a facing to the back yoke...but it was easy peasy.  I just used a bit of left over chambray for the job.

It even got a label B had made special for me...using my mantra and his dragonfly pic!!!

I am Scott-Boy-Stoked about this one!!!  I really enjoyed taking my time and doing it right.  (Though I did have to interject a super fast Silly button Sorbetto and a  quick and flirty double knit skirt  as well as a crazy chair recovery project in order to continue to feel I was being true to my chaotic self!!!!)

Just to prove how much I love it....

It's style...

...and shape...

...makes anything look good!  (Even when your ancient dog is leaving you behind!)

In spite of having no idea what your photog is wanting you to do....

...a jacket like this goes with anything and keeps you looking GOOD!

Sew chaotically! - les