Monday, May 26, 2014

A bouquet and diversion for Jonathan and Francoise!!!

Big hugs (and a special bug!!!) from all of us!  Love, C

Thursday, May 22, 2014

Octopussy, Htapothi, Pulpo...a culinary break from melanoma

Bent LOVES octopus.  Whether the Greek flame grilled versions that have been beaten on rocks by the fishermen, then hung on a rope stretched over the doorway of the dining establishment, in the sun, for unknown hours...or the Pulpo de gallego that we had in Madrid.  Yes, we had an amazing trip to Spain after the Tampa trip in September!!! I like octopus...ok.  Not enough to order it from the menu.  But, well enough to taste Bentie's. It is not at all slime-y, as might be imagined.  Instead, if not prepared carefully, it is very tough....rubber it has been dubbed by Fred-o.  At any rate...this is what I found in my freezer a couple of weeks ago!!!!  Sorry for the upside-down pic...but octopus...almost three pounds....for 21 bucks...packed in Spain...AND IN MY FREEZER!!!!!!

Many Spanish and Greek Cook books were read.  Web sites perused. These are the aromatics that made it into the initial broth.

And there you have...Octopussy.  Much was studied beforehand about the removal of the eyes and "beak"!

Poor thing.  They are supposedly very intelligent.  I once saw one unlatch his cage on a Jacques Cousteau special!

Very wasteful and Queen of Hearts of with the head!  Hungry people eat that.  But, having never been served that in restaurants and with the necessity of digging out the eyes....well....there's only so much a girl can take!!!

Yes, there is a very hard ring of cartilage (??) just here...called the "beak" that must be removed.


ALL the recipes tell you to dunk the octopus up and down in boiling water/broth for 3-5 times.  Some say it is to prevent 'scarring'...but we decided it was so that the tentacles wouldn't be all stuck together.
So there she boiled for about ten minutes.

Then for the braising...with no added water...per multiple the octopus has so much water that it will exude enough on it own.  How long?  You might ask.  Per the door to forever is none too soon.

After braising for about 4 hours...which was minimal per the recipes...the tentacles were removed and sliced for the pulpo de gallega.  Ours must have been smaller or more tender than most...because we may have actually cooked it overlong!!

Sliced potatoes that were boiled in the broth from the initial octopus dunking.

Pan con tomate that Brent put together while I was all octopussy!
Sliced octopus tops the potatoes.
Sprinkle with a mixture of smoked and sweet paprika (pimenton) with a bit of cayenne, since I had no hot Spanish Paprika and a dusting of sea salt.

And there you have it!  A Spanish tapas dinner Madrilenos would be proud of....pan con tomate, marinated olives, chorizo, and YES!!!  Pulpo de Gallego!!! with Cava!!!   Buen provecho!!
Love, C

Wednesday, May 21, 2014

Expanded access program for BMS anti- PD1 (nivolumab) for Stage III/IV melanoma!!!!

OK...BMS can't let the competition get ahead (aka...the EAP for the Merck 3475)!!!  BMS is technically ahead in the anti-PD1 race to FDA approval in that they have more patients in Phase II studies.  However, it is clear that they felt the pressure when MERCK "opened" their expanded access program.  You can find some data that shows an ever so slightly greater response rate with Merck than with BMS...but the powers that whom I have spoken...seem to think that they are going to pan out at about the same, with approximately 30% of melanoma patients attaining either a complete or partial response.

Here's the deal:

Expanded access program with Nivolumab for subjects with histologically confirmed Stage III (unresectable) or Stage IV  advanced melanoma progressing post prior systemic treatment containing an anti_CTLA-4 monoclonal antibody.

NCT02142218        Sponsor:  Bristol-Myers Squibb        Date received:  May 16, 2014

  • 18 years of age or more
  • Histologically confirmed malignant melanoma, including mucosal
  • Previously treated unresectable med stage III or stage IV
  • Progressed on or after prior treatment with an anti-CTLA4 containing therapy and, for subjects with known BRAF mutation, also progressed on or after treatment with a BRAF inhibitor
Exclusion Criteria:
  • Active brain mets or leptomeningeal mets
  • Life expectancy less than 6 weeks
  • Subjects with active, known or suspected autoimmune disease
  • Subjects with known history of anti-CTLA4 therapy related adverse reactions
  • Any treatment in a Nivolumab clinical trial 
My Thoughts:

  • Pretty much the same inclusions and restrictions as the Merck must have failed ipi already and if you are BRAF positive, BRAF inhibitors as well.
  • This EAP does state specifically that mucosal melanoma is allowed...the Merck EAP doesn't say one way or another.
  • The Merck EAP has been frustratingly slow in its rollout...with its posting to March 7 and actually treating the first patients at Mayo clinics just a little over 1 week ago...though things are starting to move at other facilities this week.
  • Hopefully, the BMS EAP will get things moving a little more quickly.
  • My fear:  Since both the Merck and BMS EAP are requiring failure of ipi and BRAFi when the patient is positive, I fear that these requirements may be included in the final FDA approval.  I don't KNOW is just what I am worried about and would view that requirement as a waste of time, money and effort for patients.  If anti-PD1 is more effective for more patients....wouldn't it make sense to use that first...knowing that ipi and BRAFi could be used later if needed????  But....maybe that will not be what happens.
Wishing you all my best! - c

    Sunday, May 18, 2014

    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  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. 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 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

    Friday, May 16, 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

    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

    Saturday, May 10, 2014

    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

    Wednesday, May 7, 2014

    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 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

    Saturday, May 3, 2014

    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