More info from ASCO....PV-10...Rose Bengal for melanoma....

I think PV10 (a 10% Rose Bengal solution) is a very interesting approach for melanoma patients with dermal and subcutaneous tumors.  I've been reporting on it for the past couple of years as data has become available and will list my prior posts at the bottom of this one so you can follow the history of it yourself if interested.

Here's a synopsis of the latest out of ASCO:

Efficacy of intralesional Rose Bengal in patients receiving injection of all existing melanoma in phase II study PV-10-MM-02

2014 ASCO abstract No: 9027, Authors:  Agarwala, Thomplson, Smithers, et al....St. Lukes in Easton, PA;  University of Sydney, Sydney, Australia; Brisbane Hospital, Brisbane, Australia; MD Anderson, Houston, TX; University of Louisville, Lousiville, KY; California Pacific, San Fran, CA; Provectus Pharm, Knoxville, TN.

Safety and efficacy of intralesional treatment of cutaneous melanoma with rose bengal (PV-10) was evaluated in an 80 patient international, multicenter, single arm phase II trial. Patients with a median of 6 previous interventions and a 6.3 cm median sum lesion diameter in biopsy confirmed melanoma, were given PV-10 into up to 20 cutaneous and subcutaneous lesions up to 4 times over a 16-week period and were followed for 52 weeks.  RESULTS:  In the subgroup of 28 patients who received PV-10 into all existing melanoma lesions (therefore had NO un-injected lesions) the overall response rate was 71% with 50% experiencing a complete response.  In these patients with all disease injected plus 26 other patients with uninjected disease limited to by-stander lesions - complete response was achieved in 232 of 363 injected lesions.  121 lesions required a single injection for complete response, 84 required 2 injections, 22 required 3, and 5 required 4 injections.  Additionally, 10 of 28 UN-INJECTED bystander lesions achieved complete response.  CONCLUSIONS:  The high rate of symptom control in refractory patients, manifested in a complete response of injected lesions after minimal intervention, is the basis for a breakthrough therapy application based on the 28 patient "all treated" subgroup.  Although the primary ablative effect is responsible for complete response in injected tumors, durability of response and bystander response implicate an immunologic mechanism of action secondary to ablation.

Assessment of immune and clinical efficacy after intralesional PV-10 in injected and uninjected metastatic melanoma patients.

2014 ASCO abstract No:  9028, Authors:  Sarnaik, Crago, Weber, et al...of Moffitt, Tampa, FL

Intralesional therapy is under investigation to treat dermal and subq mets in melanoma. In mice...injection of PV-10 (10% rose bengal) induced regression of injected and uninjected "bystander" lesions.  We observed a consistent increase in anti-tumor T cell responses following injection of PV-10 in the mouse model....so:  A pilot clinical trial enrolled 8 patients.  Two study lesions in each patient were sampled by biopsy pre-treatment; one of the two lesions was injected with PV-10, then both residual sites were completely excised.  We compared tumors before and after treatment with staining and MelanA immunohistochemistry.  Blood samples were studied before and after injections were done.  RESULTS:  Treatment with injected PV-10 led to a complete response when the removed tumors were examined as a pathology sample for both the injected AND uninjected (bystander) lesions in 4 of the 8 patients.  In all 8 patients...examination of both of their removed tumors....showed at least partial regression of the injected lesion.

SO...in HALF the patients, both of their tumors (injected and noninjected) had a complete response.  In all 8 of the patients, the injected lesions had at least a partial response.

NOTES: Blood work demonstrated a statistically significant increase in circulating cytotoxic T cells.  Patient history = 6 of 8 patients treated with PV-10 had metastatic disease refractory to prior ipi, anti-PD1 and/or vemurafenib therapy.  4 of these 6 patients demonstrated complete response in both their injected and uninjected tumors on the pathology exam. 

Hmmmm....wonder (not that it really matters) how long the injected tumors were left in place, before both tumors were removed??  Though these are clearly small numbers....and change from patient data to tumor by tumor data in the first report can be confusing...it seems to me that this approach could provide significant relief if not eradication of disease in some.  Best - c

Rose Bengal/PV 10 - 2012

Rose Bengal/PV 10 - 2013

Rose Bengal/PV 10 - 2014

Vemurafenib really does work on melanoma brain mets for BRAF V600E patients!!!

The latest and greatest is coming in from ASCO 2014 (the annual meeting of the American Society of Clinical Oncology) so here we go!!!!

Treatment patterns and outcomes in BRAF V600E mutant melanoma patients with brain metastases receiving vemurafenib in the real-world setting.

2014 ASCO abstract 
By:  Gibney, Marynchenko, Galebach, et al....with info from Moffit, Boston, Montreal, and San Fran

Synopsis:
Metastatic melanoma patients with brain mets have a poor prognosis and median survival of less than 6 months.  Clinical data for 283 BRAF V600E melanoma patients with active brain mets treated with vem after 8/2011 (and their diagnosis of brain mets) were analyzed.  Prior to vem, 109 had received local treatment and 23 had received systemic treatment.  Median vem treatment duration among patients who stopped vem was 5 months. 21 patients required a dose reduction.  Reasons for discontinuation of vem = systemic disease progression (42.9%), intracranial progression (18.1%), death (16.4%), and patient decision (5.6%).  136/283 patients (48.1%) were reported to achieve overall intracranial response.  Survival at 6 months was 85.7%.  Patients with >/= 5 brain mets, progressive extracranial mets, and >/= 2 sites of extracranial mets were found to be significant prognostic factors for death.
CONCLUSION:  In the real world setting, the use of vem treatment is associated with clinical benefit in BRAF V600E melanoma patients with active brain mets.

For a break down on BRAF and what V600E means you can look at:
The low down on BRAF!

More intel to come.  C

For melanoma....I've said it before..."Go where they KNOW!!!"

In everything, really.  Get yourself a specialist!!!!  And, perhaps just as importantly, a specialist who does a lot of the thing you need them to do for you.  Wouldn't you rather hire the plumber who puts in lots of bathroom toilets to fix yours, rather than the one who predominantly puts in septic systems????

Hospital Case Volume is Associated with Improved Survival for Patients with Metastatic Melanoma.
Huo, et al.  American Journal of Clinical Oncology.  April 2014

Linked databases were used to identify patients aged 65 and older diagnosed with metastatic melanoma between 2000 and 2009.  Claims data was used to determine cancer treatment variation by hospital case volume. Of 1,438 patients, 42.6% were treated in low-volume hospitals, and 33.3% were treated in high volume hospitals.  "For patients diagnosed with metastatic melanoma, being treated in a high-volume hospital was associated with an improvement in survival and lower utilization of chemotherapy, immunotherapy, surgery, and radiation therapy."

So what this tells me is that at high volume facilities....they know better how to treat melanoma...with fewer unneeded scans, less use of ineffective radiation and chemo treatments, and better outcomes!  Please!!! If at all possible, get yourself a melanoma specialist who works at a facility that treats lots of patients with melanoma. - c

22 for Roo...the keeper of the dragonfly....

So proud of the work you've done, the amazing woman you've become.  You've stood up for those in need.  You've brought smiles when they were needed most.  You've reached out to others, near and far, in honesty and hope.  I really can't say it any better than this:

Jeanne and Kidlet.....

As Jeanne points out, they say that when Pandora opened her box, releasing all the world's horrors of suffering, work, and illness, the last thing to flutter out was not terrible at all.  It was hope....in the shape of a dragonfly.

You have made the story real...for many. The integrity, pain, joy, and beauty your writing carries are gifts worthy of the dragonfly indeed.  I cannot wait to see where such truth and generosity of spirit takes you in the coming years.  The world is lucky to have you, my girl.  And, I?  Beyond blessed, as you "keep ever burning before my vagrant steps, the kindly light of HOPE."

Happy birthday, baby.  I love you. (With just a few happy birthday night time pictures...this time, colored by daddy!) - mommy

May = Melanoma Awareness Month!

Melanoma is a type of cancer, most often of the skin. It occurs in melanocytes, the cells that give your skin color. Melanoma is the most serious type of skin cancer because it can spread to lymph nodes and distant organs. In 2014, it is expected that approximately 77,000 Americans will be diagnosed with melanoma, resulting in nearly 10,000 deaths.

#GETNAKED....and check your skin.  The life you save may be your own....or of someone you love.  Got moles, funny lumps or bumps...Get Naked.  Get checked.  Take care. - c

Across Four Aprils...a melanoma perspective....

April is one of the most softly beautiful months of all 12 here on the mountain.  But, in 2010, April was crazy!  SRS to my brain met on April 27th was followed by removal of the right upper lobe of my lung on April 30.  Four Aprils later, I'm still here to feel the breeze gently warming, with spring's most tender greens and beautiful flowers.  I came home from work yesterday to find this handpicked spring bouquet, in which not a single bud from my yard was hurt in the slightest, thanks to a wonderful photographer and the sweetest man.  Enjoy....

And if you've never...please!!!!....read...Across Five Aprils....one of the most poignant, hauntingly beautiful books...poetry really...ever written, by Irene Hunt.  Tell you what!  We'll discuss...a year from today...at our annual book club gathering.  Hey, if I can be there!!!???  You can too!  To spring! - c

Is that prom tan worth wrinkles, age spots, and melanoma by the time you're 30????

While melanoma can certainly appear in someone with no history of significant tanning or use of sun beds, the link to those behaviors and melanoma is no longer speculation.

Indoor Tanning:  The Link to Melanoma is No Longer Deniable
Hwryluk, et al.  Skin Cancer Foundation, The Melanoma Letter, Winter 2013

Some studies in the 1990's pointed to the carcinogenic effects of indoor tanning,but "with advances in scientific scrutiny and the results of multiple investigations, the weight of evidence has become virtually irrefutable."  "Tanning beds darken the skin through a process that requires UV-induced DNA damage; this damage activates transcription of cellular repair signals that ultimately increase skin pigmentation as a partial barrier against further damage. Unfortunately, some damage has already been done, and the repairs are probably never complete, the remaining damage is what produces genetic mutations that can lead to skin cancers." 

"A recent report linked indoor tanning to 170,000 nonmelanoma skin cancer cases per year in the US. The impact of indoor tanning on an individual's total UV exposure can be substantial...UV emission of sunbeds exceed the UV index of the noontime summer sun at intermediate latititudes.  While the sunbed emission spectra of UVB are similar to the noon sun, UVA emissions are 10-15 times higher...with frequent tanners attaining 12 times the annual UV exposure of sun tanners."

Use is widespread, the "FDA estimates that more than 30 million Americans use tanning devices annually" with the "highest prevalence among individuals 18-29 years of age."   "The 2011 National Youth Risk Behavior Surveillance System found the 13% of high school students engaged in indoor tanning."

Studies linking indoor tanning to melanoma go back to 1994.  Numerous well-done studies demonstrating the link are noted in the article.  Studies in 2011 and 2012 found that the "earlier age at first exposure, as well as increased frequency of use, was associated with earlier onset melanoma" and that..."the risk for developing melanoma was especially increased for individuals who started indoor tanning before age 25."  Sad, but very clear statistics like these fill the report.

Due to continuing, overwhelming data like that above, in 2012, "11 countries had legislation that restricts indoor tanning for individuals under age 18."  In the US, California became the first state to ban indoor tanning for anyone under 18, in 2011.  Gradually, bans were developed in Vermont, Illinois, Nevada, Texas, Oregon for those under 18.  Connecticut, NY, NJ ban use for those under 17, Wisconsin for those under 16, and many other states ban those under 14, or require parental accompaniment/consent.  Unfortunately, a study in 2011 found that this access limiting legislation was NOT decreasing indoor tanning use in teens...ie such bans were probably not being enforced.

Now that the association between melanoma and indoor tanning has been definitively PROVEN, the World Health Organization, the American Medical Association, the American Academy of Dermatology, and the Academy of Pediatrics have "all issued strong statements about the dangers of tanning....It is time for the FDA to revisit the safety data, and to move forward with raising the classification of tanning devices to Class II, requiring increased legislation.  It is time, in fact, to pass nationwide laws banning all minors under age 18 from indoor tanning."
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Adolescent Indoor Tanning Use and Unhealthy Weight Control Behaviors
Amrock and Weitzman. Journal of Developmental/Behavioral Pediatrics.  April 2014.

Pooled data from high school students from 2009 = 2011 (n=26,951) showed 23.3% of females and 6.5% of males reported indoor tanning within the past year.  Additionally, those same teens were likely to have also utilized fasting, taken a pill, powder, or liquid and vomited or taken a laxative to lose weight within the past 30 days than those who did not.  CONCLUSION:  "Significant associations between indoor tanning use and unhealthy weight control behaviors exist for both male and female adolescents, with a stronger association observed among males."
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What can we say or do to prove to our teens that there are plenty of ways to be their best, most healthy and beautiful selves without fad diets or changing the color of their skin?  And why would parents, in light of all the current data, continue to take their children (too young to drive themselves!!!) to tanning beds????  Why do adult women I know, continue to participate themselves?  Is leathery wrinkled skin really that beautiful?  Why, as a nation, do we allow a business to make money from a population they are known to be harming...sometimes in life threatening ways? 

As usual, I fail to have the answers I need.  But, I will keep preaching the true dangers of tanning to every beautiful teen who has their physical with me....to every nurse who has the courage (insanity?????) to continue to go to tanning beds and work in my presence. (Sorry guys...[not really]....but I just can't stop myself!!!!)  Guess I figured it was time to preach a little here.

To beauty...in all colors, shapes and sizes. - c