Monday, January 8, 2018

Sew Chaotically! - A Plethora of Christmas pillows!!!


I made a pile of pillows!!  Well, pillow cases...as Christmas gifts for all my peeps!


For The Hills

For Fred and Irina

For Rose and Jamie

For Ruth and Frankie
Each peep set got two sets of pillow cases and two pillows, all designed with their tastes and decor in mind!  I looked at lots of pillow case "patterns" on various blogs and videos.  I wanted to make it such that the opening made an envelope over the pillow...keeping it cute and contained.


Yes, it was hard to wrap my non spatial relation oriented brain around this, as I wanted the entire thing to have completely finished seams.  I should have taken pics of the many miniature FAILS I made before I got it straight!!  But, here's my recipe for one American Standard pillow case (20 X 26 inches):

  • Cut a long piece measuring 57 1/2 inches in length and 21 inches wide of your main fabric.
  • Cut a short piece, measuring 7 1/2 inches in length and 21 inches wide, of your border fabric.

(You can split these lengths up any way you want should you wish to add contrasting strips of fabric or ribbon to the border as I did for Fred and Irina's above.)

  • Hem one end of both your pieces by folding over 1/4 inch and 1/4 inch again and top stitch.
  • Sew the unfinished end of your border piece to the unfinished end of your main piece, using a 1/2 inch seam allowance.
  • Flat fell that seam, with top stitching on the main fabric's side or use a French seam.
  • Lay the now pieced fabric on flat surface right side up, with border to your right.
  • Fold fabric, bringing border side to your left, right sides together, until the edge of your border is 6 inches from the edge of the end of the piece.  The fold will be the bottom of your case.


  • Fold the left hand edge OVER the wrong side of the border, by those 6 inches.



  • Stitch both sides using a 1/2 inch seam and serge to finish.
  • Turn the whole ta-dah right side out and press!

Now you have neatly finished seams all around and an envelope for your pillow!!!

So much better than those flappy, open ended ones, isn't it????

I'll confess:  I had to make this one to get my head back around how I did this....even though I'd already made 8!  Still....
Certainly better than the robes, huh????  Sew Chaotically!!! - les

Sunday, January 7, 2018

Long term outcomes with Dabrafenib/Trametinib (BRAF/MEK combo)


While dabrafenib as a single agent for 4 months did not prove to be effective as an adjuvant, targeted therapy has saved lives of melanoma patients.  Now, there's this:

Long-Term Outcomes in Patients With BRAF V600-Mutant Metastatic Melanoma Who Received Dabrafenib Combined With Trametinib. Long, Eroglu, Infante...Daud...Hamid...Sznol...Weber, et al.  J Clin Oncol. 2017 Oct 9.

Purpose: To report 5-year landmark analysis efficacy and safety outcomes in patients with BRAF V600-mutant metastatic melanoma (MM) who received BRAF inhibitor dabrafenib (D) and MEK inhibitor trametinib (T) combination therapy versus D monotherapy in the randomized phase II BRF113220 study part C. 

Patients and Methods:   BRAF inhibitor-naive patients with BRAF V600-mutant MM were randomly assigned 1:1:1 to receive D 150 mg twice a day, D 150 mg twice a day plus T 1 mg once daily, or D 150 mg twice a day plus T 2 mg once daily (D + T 150/2). Patients who received D monotherapy could cross over to D + T 150/2 postprogression. Efficacy and safety were analyzed 4 and 5 years after initiation in patients with greater than/= to 5 years of follow-up. 

Results:   As of October 13, 2016, 18 patients who received D + T 150/2 remained in the study (13 [24%] of 54 enrolled at this dose plus five [11%] of 45 initially administered D who crossed over to D + T). With D + T 150/2, overall survival (OS; 4 years, 30%; 5 years, 28%) and progression-free survival (4 and 5 years, both 13%) appeared to stabilize with extended follow-up. Increased OS was observed in patients who received D + T with baseline normal lactate dehydrogenase (5 years, 45%) and normal lactate dehydrogenase with fewer than three organ sites with metastasis (5 years, 51%). With extended follow-up, one additional patient who received D + T 150/2 improved from a partial to a complete response. No new safety signals were observed.

Conclusion: This 5-year analysis represents the longest follow-up to date with BRAF + MEK inhibitor combination therapy in BRAF V600-mutant MM. Consistent with trends observed in landmark analyses with shorter follow-up, this therapy elicits durable plateaus of long-term OS and progression-free survival that last greater than/= to 5 years in some patients with MM.

SO....we already knew that BRAF/MEK combined was much better than BRAFi alone...again evidenced here.  With the combo there was 30% survival at 4 years, 28% at 5 years.  Also with the combo, progression free survival was 13% at both the 4 and 5 year mark.  Greater overall survival ocurred when patients started with a low baseline LDH level and fewer organ sites with mets (points that are true in immunotherapy as well).  

While only about 1/2 of melanoma patients are BRAF positive, and thereby have BRAF/MEK as a viable treatment option, this is still good news.  Melanoma's ability to mutate and work around the positive effects of BRAF treatment remains a fight.  As noted in this report:  Encorafenib/binimetinib, a BRAF/MEK combo = 14.9 month PFS  where:

Generally, prior studies of BRAF/MEK combos demonstrate about a 12 month PFS.  This combo showed a PFS of 14.9 months.  Objective response rate was 63% with the comb0.  There was an ORR of 51% to encorafenib alone.  Objective response rates to BRAF/MEK combo's in other studies have ranged from 48-70%, depending.  OS data for encorafenib/binimetinib has not yet been reported.  OS in most other BRAF/MEK combo's is around 2 years.  

It is heartening to see in this latest report that there are those among the BRAF positive melanoma patients who can maintain responses at 5 years.  Great thanks and admiration to Dick K and Stevie (among others) who pushed this envelope!!! - love, c

Thursday, January 4, 2018

Four months of Dabrafenib as adjuvant ~ not a good plan


As most of you are probably tired of hearing, I've been yelling about the need for adjuvant treatments for patients with Stage III and IV melanoma, rendered NED through surgery and/or radiation for years!  We know there are many options that work (ipi and nivo, to start) and some that don't (interferon).  There is excellent data showing the effectiveness of targeted therapy (Dabrafenib with Trametinib) as adjuvant as well.  Here's a link to a zillion articles addressing all those options:  Adjuvant treatments for melanoma  Now there's this:

Four-month course of adjuvant dabrafenib in patients with surgically resected stage IIIC melanoma characterized by a BRAFV600E/K mutation. Momtaz, Harding, Ariyan...Postow, Wolchok, Chapman. Oncotarget. eCollection 2017 Dec 1.

We tested the hypothesis that a 4-month course of adjuvant dabrafenib in stage IIIC BRAF-mutated melanoma would improve 2 year RFS from 24% to 51%, and that tumor-derived cell free DNA (cfDNA) in plasma would correlate with and predict recurrence.

Patients with stage IIIC BRAF V600E/K mutated melanoma who were free of disease after surgical resection received 4 months of adjuvant dabrafenib. Patients were evaluated with imaging at baseline, at the end of cycles 2, 4, 6, then every 3 months until disease relapse or 2 years, whichever came first. Serial blood samples were collected for evaluation of cfDNA at the same time.

21/23 patients enrolled were evaluable; 2 patients withdrew consent during the first week of treatment. The 2 year RFS was 28.6%. The estimated overall survival at 2 years was 78%. cfDNA detection had a 53% sensitivity in relapsing patients but cfDNA detection did not provide lead-time advantage over CT scanning.

A 4-month course of adjuvant dabrafenib did not result in a detectable improvement in 2-year RFS. cfDNA was less sensitive than standard CT imaging and did not provide a lead-time advantage in detecting relapse.

So, 23 peeps with Stage III, BRAF positive melanoma, were given the single agent dabrafenib for 4 months.  Unfortunately, it did not provide any "detectable improvement in 2-year recurrence free survival".  The thing that confuses me here is why researchers would even do this to patients!!!  We have known for many years now that when we COMBINE BRAF inhibitors WITH a MEK inhibitor patients have much fewer side effects (and therefore tolerate the treatment more easily) and simultaneously attain a much higher response rate with decreased rates of tumor work-around.  Why at this late date anyone would use Dabrafenib as a single agent is beyond me!!!  At any rate...now we 'know'!

Thanks ratties.  - c

Monday, January 1, 2018

Where I've been, where I'm going ~ Fractals!


I have always felt it is hard to know where I'm going if I disregard where I've been.  At the same time, I really dislike focusing on the past.  I find myself conflicted about all those 'remembrances' that show up on Facebook and other social media these days.  Yeah, it's kinda cool to see those old pics and remember those events, but if I spend all my time looking back on what I've already done....how will I have time to live my life today?  Even so, I do like to consider the past.  Why did THAT happen?  What role did I play in making things good?  Making them go badly?  Where exactly did this thing go off the rails?  How did I get it back on track?  Some things are unknowable.  But, I often learn important lessons that, hopefully, allow me to make a better garment, enjoy my travels in a different way, become a better person/partner/friend/mom.

So, today...I will take a moment ~

I tend to look at things in one of two ways...in the micro or the macro.  I am a firm believer in the "God of Small Things".  It is hard for me to suppose that anyone who adopts the adage, "Don't sweat the details!" ever made a decent garment, cooked a truly delectable dish, was a good diagnostician, or a very good friend.  Details are what transform a wearable shirt into one that is exquisite with a perfect fit.  The small additions of this spice (That would be fresh thyme, people!!!) or those extra moments taken to caramelize the onions, takes French onion soup from a good, basic, filling lunch ~ to an incredible, unctuous bowl of deliciousness.  Remembering the small moments you've shared with friends, the little random comments they made regarding their likes and dislikes, makes me a friend that I would like to have.  I don't always succeed in this, but I know I did well when my dear one exclaims, "I can't believe you knew I liked this!"  That one moment when getting the history of her baby's illness from a worried mom, a small detail in her report tells me, "Ah hah!!!" and goes on to make all the difference in my diagnosis and treatment.  I guess listening and paying attention figures largely in this business as well.

My faith in and passion for turtles (You can find more than you ever wanted to know about that here:  Turtles and me.) brings me to my macro view.  Driving to work the other day, I heard this fabulously well told and all around awesome story on NPR/Living on Earth about the preservation of Blanding Turtles in Massachusetts through the efforts of some really cool peeps and amazing school children.  Turtles and kids?  You can bet I'm in!!!  (Here's the link and it really is worth a listen if you have a minute:  Living on Earth: Blanding turtles in the Northeast.)  And for all that I loved every bit about the story, one part I keep thinking about is how long turtles have been on the planet.  Over 200 million years!!!!  Listening to any story about how humans have clearly gummed up the works for all the species on our planet...including our own!!!...worries me intensely.  I mean for Pete's sake!  The sex of turtles is determined by temperature!  (Yeah, I didn't know that until I heard the story.)  Too hot or too cold and we've got ALL Sallies or ALL Sams.  That ain't gonna work out!  But, knowing that turtles have survived, despite gigantic volcanic eruptions, ice ages, and horrifying world leaders (ones with strange mustaches and orange complexions come to mind) brings me down from my tree.  Not that it makes me sanguine about all this.  It makes me want to work harder!  Do better!  These turtles and our kids deserve it!!  But...the big picture...in life, in turtle survival, in melanoma, allows me to focus on the small things. I am certain my clinical trial saved my life.  But now, the approval of the drug I took, Nivolumab/Opdivo for folks like me, may finally...save the lives of many more.  (Yes, you know I was yelling about it.  Check it here:  About DAMN time!!! Opdivo approved as adjuvant for resected melanoma with lymph node involvement or metastatic disease!!!!)

There have been many times in my life when looking further than a day or two ahead was a huge challenge for me ~ Looking forward..... Pondering what my future holds is still a bit tricky.  I figure that's true for all of us. So, with a conscious review of where I've been and one slightly squinted eye, I am looking forward.  Forward to more silliness with Rosie as I attempt 40 more seconds of push-ups, ("You can do anything for 40 seconds," our least preferred instructor shouts!) and crap out entirely, lying prone on my mat giggling uncontrollably.  Forward to more hikes and meals and love and laughter with my Bentie.  Forward to more stories from Fredo, the best yarn spinner among us, and perhaps to writing a few of my own.  Forward to immersing myself in the smiles and even tears of my little critters, making the most of those moments and hopefully impacting them and their families in a positive way.  Being creative in my small garden patch, at my sewing machine, at my cook top...everywhere.

I certainly do not wish to fail to see the forest as I examine the beauty in a leaf, or the overarching theme in the mosaic by limiting myself to a single tile.  The fractals that compose my life and the world around me allow me to see the whole.  I know where I've been, let's see where I go...


Wishing a vibrant 2018 to each of you.  May your days and moments be filled with beauty in things large and small.  - love, les

Sunday, December 31, 2017

Durable responses to pembro. The 'C' word (CURE!!!!!!!!!!) used by melanoma researchers. And....HAPPY NEW YEAR!!!!


This is how to leave 2017 with a bang!!!!! We know that among melanoma patients there is a roughly 15% response rate to ipi and about a 40% response rate to anti-PD-1.  But, if you are a responder...how long will the response last?  I've been talking about "durable benefit" and melanoma treatments for years.  Being disease free for 10 minutes doesn't mean that much, now does it?  Here are some previous posts on durable responses ~
2016:  Nivolumab Shows Impressive OS in melanoma
2015:  Ipi for melanoma...the data keeps pouring in...and it's pretty good!
2014:  Review of immunotherapy and durable benefit in melanoma!!!

The authors in the 2016 Nivo paper above looked at overall and progression free survival and note: 

“These data represent the longest survival follow-up of patients who received anti–PD-1 therapy in a clinical study, and suggest durable, long-term survival with nivolumab monotherapy,” said lead investigator F. Stephen Hodi,

“In all patients, there is a plateauing, a so called tail on the curve, and it’s lasting many months to years, and about a third of patients have this long-term survival,” said Hodi. “Those who make it to 48 months, have a very good chance of surviving their disease.”

“What distinguishes immunotherapy from other forms of cancer treatment is the durability of the benefit. Those who have complete responses seem to be protected from that disease recurring,” said Louis M. Weiner, MD, director of the Georgetown Lombardi Comprehensive Cancer Center, who moderated a press conference. “The memory and the adaptability of the immune response to pick off resistant variables is an important take-home here. These are very compelling data to suggest that this is the case.”

This article looks at the staying power of COMPLETE responses...a bit different from "response rate" which includes those with complete and partial responses...

Durable Complete Response After Discontinuation of Pembrolizumab in Patients With Metastatic Melanoma. Robert, Ribas, Hamid, Daud, Wolchok...Weber...Hodi. J Clin Oncol. 2017 Dec 28.  

Purpose: Pembrolizumab provides durable antitumor activity in metastatic melanoma, including complete response (CR) in about 15% of patients. Data are limited on potential predictors of CR and patient disposition after pembrolizumab discontinuation after CR. We describe baseline characteristics and long-term follow-up in patients who experienced CR with pembrolizumab in the KEYNOTE-001 study ( ClinicalTrials.gov identifier: NCT01295827).

Patients and Methods: Patients with ipilimumab-naive or -treated advanced/metastatic melanoma received one of three dose regimens of pembrolizumab. Eligible patients who received pembrolizumab for greater than/= to 6 months and at least two treatments beyond confirmed CR could discontinue therapy. Response was assessed every 12 weeks by central Response Evaluation Criteria in Solid Tumors version 1.1. For this analysis, CR was defined per investigator assessment, immune-related response criteria, and potential predictors of CR were evaluated using univariate and multivariate analyses.

Results:  Of 655 treated patients, 105 (16.0%) achieved CR after median follow-up of 43 months. At data cutoff, 92 patients (87.6%) had CR, with median follow-up of 30 months from first CR. Fourteen (13.3%) patients continued to receive treatment for a median of greater than/ = to 40 months. Pembrolizumab was discontinued by 91 patients (86.7%), including 67 (63.8%) who proceeded to observation without additional anticancer therapy. The 24-month disease-free survival rate from time of CR was 90.9% in all 105 patients with CR and 89.9% in the 67 patients who discontinued pembrolizumab after CR for observation. Tumor size and programmed death-ligand 1 status were among the baseline factors independently associated with CR by univariate analysis.

Conclusion: Patients with metastatic melanoma can have durable complete remission after discontinuation of pembrolizumab, and the low incidence of relapse after median follow-up of approximately 2 years from discontinuation provides hope for a cure for some patients. The mechanisms underlying durable CR require further investigation.

Basically, this report looks at folks treated with pembro who had a complete response (CR). A complete response was noted in 105 (of 655) patients treated, which turned out to be 16%.  There are a few other details, but ultimately of the 105 patients with a complete response, their disease free survival rate at 2 years was 91%.  67 of those 105 patients with a complete response opted to discontinue pembro (and have no further treatment - only observation) after they attained their complete response, and 90% of them remained disease free at 2 years.  In other words, there was little difference between the complete responders' 2 year survival, no matter if they continued their treatment beyond their CR or not.

While this durability, combined with the promise of nivo as adjuvant for Stage III and IV NED patients, as well as BRAF/MEK, nivo, pembro, and the ipi/nivo combo for folks with advanced melanoma is an excellent note on which to end 2017 ~ I am looking forward to a 2018 filled with improvements in melanoma care that include more responses overall and an even greater number of complete responses!!!

Bless you one and all!  Cheers! - love, c

Saturday, December 30, 2017

SLN biopsy. Delay of 40 days = WHAT???? (Plus some general guidelines)


While there is controversy around whether or not to do a complete lymph node dissection - with newer research indicating little to no increase in overall survival with the procedure - sentinel lymph node biopsy remains an essential part of diagnosis and thereby treatment!!!  How would you know you were Stage III (or not) if no sentinel node(s) evaluation was done after a cutaneous lesion is removed?????  How would you know what treatment and course of observation you would need to pursue????  Furthermore, insurance companies balk at covering anything!  When you don't have the argument of proof of metastasis to a node very few, if any, will cover important follow-up scans.
Here's a post covering a great deal of recent research on both SNL biopsy and CLND:

CLND - Complete lymph node dissection in melanoma - the whole shmegegge!!!!!!!!!!!

Now...there's this:

The intriguing effect of delay time to sentinel lymph node biopsy on survival: a propensity score matching study on a cohort of melanoma patients. Tejera-Vaquerizo, Descalzo-Gallego, Traves, et al. Eur J Dermatol. 2017 Sep 23. 

Time between primary melanoma excision and sentinel lymph node biopsy (SLNB) has not been sufficiently studied as an independent predictor of survival in cutaneous melanoma.

We used propensity score matching to evaluate whether early SLNB (performed  less than/= to 40 days from excisional biopsy) is associated with higher mortality in patients with cutaneous melanoma.


A retrospective cohort study at a tertiary melanoma referral centre. We included 787 consecutive patients from the melanoma database of the Instituto Valenciano de OncologĂ­a who underwent a SLNB between 1st January 2000 and 31st December 2015, of whom 350 were matched into pairs using propensity score matching. The variable of interest was the time between primary melanoma excision and SLNB (less than/= to 40 days vs greater than 40 days). The study outcomes were disease-free survival (DFS), melanoma-specific survival (MSS), and overall survival (OS).  


A delay time of 40 days or less was associated with worse DFS, and OS. Other variables associated with shorter MSS were age, tumour location and thickness, mitotic rate, and SLN status.  Early SLNB was associated with worse survival in patients with cutaneous melanoma after adjusting for classic prognostic factors. A delay time of over 40 days was not associated with higher mortality.

While this sounds a bit counter intuitive....in that leaving the positive node in place for 40 plus days...garners BETTER responses than removing the same node in 40 or fewer days in regard to disease free survival and overall survival.  However, the rational for this phenomenon is the idea that those positive lymph nodes are needed for the body to process the antigens in the melanoma cells that are present in the node(s) in order to facilitate the body's immune response.  If the immune response is never launched, the chance of persistent disease is greater.

Sentinel Lymph Node Biopsy and Management of Regional Lymph Nodes in Melanoma: American Society of Clinical Oncology and Society of Surgical Oncology Clinical Practice Guideline Update. Wong, Fariers, Kennedy, Agarawala, et al. Ann Surg Oncol, 2017 Dec 13.

To update the American Society of Clinical Oncology (ASCO)-Society of Surgical Oncology (SSO) guideline for sentinel lymph node (SLN) biopsy in melanoma.  An ASCO-SSO panel was formed, and a systematic review of the literature was conducted regarding SLN biopsy and completion lymph node dissection (CLND) after a positive sentinel node in patients with melanoma.


Nine new observational studies, two systematic reviews and an updated randomized controlled trial (RCT) of SLN biopsy, as well as two randomized controlled trials of CLND after positive SLN biopsy, were included.
Routine SLN biopsy is not recommended for patients with thin melanomas that are T1a (non-ulcerated lesions less than 0.8 mm in Breslow thickness). SLN biopsy may be considered for thin melanomas that are T1b (0.8 to 1.0 mm Breslow thickness or less than 0.8 mm Breslow thickness with ulceration) after a thorough discussion with the patient of the potential benefits and risk of harms associated with the procedure. SLN biopsy is recommended for patients with intermediate-thickness melanomas (T2 or T3; Breslow thickness of greater than1.0 to 4.0 mm). SLN biopsy may be recommended for patients with thick melanomas (T4; greater than 4.0 mm in Breslow thickness), after a discussion of the potential benefits and risks of harm. In the case of a positive SLN biopsy, CLND or careful observation are options for patients with low-risk micrometastatic disease, with due consideration of clinicopathological factors. For higher risk patients, careful observation may be considered only after a thorough discussion with patients about the potential risks and benefits of foregoing CLND. Important qualifying statements outlining relevant clinicopathological factors, and details of the reference patient populations are included within the guideline.

So...not really much new here...but might be edifying for folks looking at making this decision.

Hang in there, peeps.  Melanoma-land is a crazy place.  - c

LATE ADDENDUM!
Sometimes I get tired, or lazy, or weary of beating the same old drum over and over.  But, sometimes...important topics NEED repeating, re-visiting, and re-evaluating.  Plus....2 heads are certainly better than one!  That being said, for those of you who don't follow the forum on MPIP, I am adding a discussion of this post that developed there thanks to my dear Edster. I think his points are worth bringing here, as are my thoughts about the "new" guidelines for SNLB which, though I have railed about them on this blog before, are perhaps even more pertinent at this time given the possibility of effective adjuvant care with minimal side effects.  That said, here you go:

Hi Celeste, does that journal article come in English or is it published in spainish? I have a thought about the time frame of the data, starting in 2000 and running to 2015. My thought is if they are looking at overall survival and progression free survival, you would think that the effect of adjuvant therapies and stage 4 therapies that would be available to the group in that time frame(2000-2013) were not very good and would make it hard to transfer finding to what is such a drastic land scape change, even in the last year and a half. Now, if they had data from say, MD Anderson from 2014-2016, with the better stage 4 drugs available to patients and Ipi approved in the adjuvant setting. If these observation held up then I could see the value of their study. I think that I am becoming to critical of research studies and wonder too much about alternative motives of researcher's. I had treatment on Friday #100 and there wasn't even a cake or candles or a marching band!!! I love the way that your blog makes me think and ask questions and how important it has been to so many of us,on our melanoma journey's!!! Hugs from a very cold Canadian!!!Ed


Hey Edster!
I think the questions you pose are good ones.  And as I noted in my comments...the data of better outcomes by delaying SLNB by 40+ days...is certainly counter intuitive.  Alternatively, there has been a good deal of data noting that a delay of 1-2 months before SLNB has not adversely affected outcomes.  I had BOTH my SLNB's within 2-3 weeks of my cutaneous biopsy results back in 2003 and 2007. (Maybe that's why I progressed to Stage IV!!  Ha!  Who knows?)   In theory, one would assume that researchers took the time frame of the patient's diagnosis and treatment changes into account.  However, I can't be sure about that.  One other factor to be considered is that adjuvant treatment for NED Stage III or IV patients is a relatively new thing...and many of these peeps would not have had treatment unless they had active disease.  But....it is still an important point to think about when we know the landscape of melanoma treatment has changed so radically just since 2011.  The complete article is in English if you have a mere $39.95!  Hee hee!  https://link.springer.com/article/10.1684/ejd.2017.3065  
I don't think that this article is enough to change current practice...though it is something researchers should think about.  Mostly, it should be very reassuring to those who find themselves...for whatever reason...going longer than they like before having their SNLB.  I know I wanted the suckers out of there!  I  have worked with many here on this forum and via my blog going nutters about any delay, so this should help provide a bit of prospective.
For another point relative to that post...I don't really agree with the new guidelines for SNLB.  For instance, I would still not technically qualify...as my first primary was only 0.61mm with no ulceration.  Yet, I had a positive node, developed a second primary 4 years later, and developed brain and lung mets 3 years after that.  NOT THAT EVERYONE DOES THIS!!!!!!!!!!!!!!!!   But, the more important point is that the positive node, took me from Stage 1b to Stage IIIa in one fell swoop.  Back then - it didn't matter very much.  There was no treatment.  TODAY, it makes a world of difference, because as you pointed out - ADJUVANT care!!!  Soooooo important and now thankfully exists and is FDA approved.
Additionally, the factors that make a difference for a thin melanoma are younger age (less than 40), mitotic rate (which folks don't really look at any more), higher Clark level, and sex.  Ultimately, guidelines are JUST guidelines.  A framework for a starting point...not the end all be all.  It remains very rare for thin melanomas to have lymph node involvement.  However, with a 5% chance of that positive node, now that we have various adjuvant treatment options...finding out if you are in that 5% makes a bigger difference.  
And as to the most important part of your comment - HAPPY 100th TREATMENT day, to you!!!!  I would totally have baked you a cake and had a Timmy with you!!  Salud!! You rock!!  Love you bunches...from a fairly cold Chatt town.  (Do I get to claim being cold if it's 34 degrees????) - c
Thanks, Edster.  This is important stuff and your attention to it makes the world a much better place for melanoma peeps!  love, c

To read more of this thread with really thought provoking comments from Janner, here's the link:  Discussion of SLNB post on MPIP

Sunday, December 24, 2017

About DAMN time!!! Opdivo approved as adjuvant for resected melanoma with lymph node involvement or metastatic disease!!!!


Even before I wrote this little story, as I was getting my last dose of Nivolumab in June of 2013, Love Potion...or Patient...#9!!!!!  which includes this history of Opdivo's development ~

Once upon a time (2005), in a land far, far away...(Japan), ONO Pharmaceutical generated ONO4538, an anti-PD1 monoclonal antibody, in research collaboration with Medarex (who called the product, MDX1106).  In 2009, the big, getting ever bigger, (? benevolent) King of the World, Bristol-Myers Squibb (BMS) acquired the rights to develop ONO4538/MDX1106/BMS936558  in North America.   In an additional agreement in 2011, BMS attained the rights to the product in the rest of the world...except Japan, Korea, and Taiwan...where ONO retained exclusive development rights and is conducting Phase II studies with ONO4538 in non small cell lung cancer and melanoma and Phase III studies in renal cell carcinoma currently.  However, no results of either of those studies can be found.  Thus began the exploration of BMS 936558 in the Americas! 

~ to as recently as this past November when I put together this post (which covers the results of the CheckMate-238 trial):  Review of adjuvant treatment in Stage III melanoma and "death knell" for ipi and interferon in that role!!!!  I have NEVER stopped SCREAMING about the obvious need to approve anti-PD-1 for the adjuvant treatment of melanoma in Stage III AND IV patients!!

Thanks to all the ratties and researchers who kept pushing....as of 4 days ago - it's finally done:  FDA Approves Adjuvant Nivolumab for Melanoma

The OncLive link above notes:  "The FDA has approved nivolumab (Opdivo) as an adjuvant treatment for patients with completely resected melanoma with lymph node involvement or metastatic disease, based on findings from the phase III CheckMate-238 trial."

Here's a synopsis of Opdivo's approvals by the FDA:  History of Opdivo from Drugs.com

Development History and FDA Approval Process for Opdivo

DateArticle
Sep 22, 2017Approval  Opdivo gets Approval for  Hepatocellular Carcinoma Previously Treated with Sorafenib
Aug  1, 2017Approval Opdivo approved in MSI-H or dMMR Metastatic Colorectal Cancer That Progressed after Treatment
Feb  2, 2017Approval Opdivo  approved in urothelial cancer Previously Treated then Locally Advanced or Metastatic 
Nov 10, 2016Approval Opdivo is the First Immuno therapy Approved in Head and Neck Cancer
May 17, 2016Approval Opdivo Approved for the Treatment of Hodgkin Lymphoma
Jan 23, 2016Approval Opdivo + Yervoy Approved in Unresectable or Metastatic Melanoma Across BRAF Status
Nov 23, 2015Approval Approves Opdivo to Treat Metastatic Renal Cell Carcinoma
Oct  9, 2015Approval Expands Approved Use of Opdivo (nivolumab) in Advanced Lung Cancer
Oct  1, 2015Approval Approval for Opdivo + Yervoy in BRAF V600 Wild-Type Melanoma
Mar  4, 2015Approval Expanded use of Opdivo to Treat Lung Cancer approved
Dec 22, 2014Approval Opdivo Approved for Advanced Melanoma
Dec  6, 2014Opdivo Demonstrates High Overall Response Rate of 87% for Treatment of Relapsed or Refractory Hodgkin Lymphoma
Nov 16, 2014Study Comparing Opdivo to Chemotherapy Demonstrates Survival Benefit
Oct 30, 2014Phase 2 Objective Response Rate and Survival Data for Opdivo in NSCLC to be Presented
Oct  6, 2014BMS Announces Collaboration to Evaluate Opdivo in Combination to Treat Non-Small Cell Lung Cancer
Sep 26, 2014Bristol-Myers Squibb Announces Multiple Regulatory Milestones for Opdivo 
Ratties are truly and for certain (along with at least one special mouse, my dear Edster!) amazing peeps.  And while one of us changes little alone.........together......The Rats of NIMH                                    (No Idiotic/Injurious/Insulting/Intensely awful Melanoma Here!!!)  HAVE CHANGED THE WORLD!!!!!Thanks and much love to each and every one of you.  Merry Christmas!!! - love, c