MPIP: Melanoma Patients Information Page

The MPIP is the oldest and largest community of people affected by melanoma hosted through the Melanoma Research Foundation. It is designed to provide support and information to caregivers, patients, family and friends. Once you have been touched by melanoma—either as a patient or as a family member or friend of a patient—you become part of a community. It is not a community anyone joins willingly. But if you must be part of this group, you will find no better place to find the tools you need in your journey with this cancer, and the friends who can make that journey more bearable.

The information on the bulletin board is open and accessible to everyone. To add a new topic or to post a reply, you must be a registered user. Please note that you will be able to post both topics and replies anonymously even though you are logged in. All posts must abide by MRF posting policies.

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ecc26's picture
Replies 16
Last reply 1/12/2014 - 1:40pm

Hello,

It's been a while since I've posted but I've got a question or two.

After winning a fight wiht my insurance company about coverage I was denied access to a PD-1 trial in December because the researchers realized during prescreening that I had not tried the BRAF inhibitors yet. Not that it would have mattered- I would have been denied anyway because after successfully treating 7+ mets in my brain last summer with WBR there were 4 new ones found at prescreening- just about a month after a clean scan. Following denial of enterance to the trial I was placed on the BRAF/MEK combo and have been on those drugs for about a month, give or take.

I had a follow up MRI on Friday and my results appointment yesterday locally. Unfortunately the images from my December MRI did not upload into their system so we were not able to make an acurate comparison (and the written report does not give measurements), but based on what I saw on this new scan I very much expect I will be referred back to a center for either SRS or gamma knife. Hopefully they can get the computer guys on it and be able to more acurately compare the scans later this week, but in the mean time...

I know a little about the basic differences between the two methods of targeted radiation, but I guess I'm soliciting opinions about which may be the better choice and other's experiences with this therapy particularly regarding side effects. 

Thanks

 

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Anonymous's picture
Replies 1
Last reply 1/9/2014 - 8:49am
Replies by: Tina D

Ok ladies, kind of an akward question here and it may be that no one has any answers or ideas, but here goes:

I started the BRAF/MEK combo about a month ago and have been on birth control pills for over a decade. Before starting I was told (by about 6 different doctors, nurses and pharmacists) that the new medications would make my birth control less effective and it was imperative that I use a barrier method as backup. OK. Fine.

I started the new meds about the same time as I started a new pack of birth control. I had some minor spotting mid way through the pack which I attributed to the "less effectiveness" but no other issues. Anyone who's ever been on birth control knows one of the perks is very predictable reliable menstuations. I was supposed to have my menstual period this past week and... nada. I've had nothing. I started a new pack this weekend, but I've never not had a period in the almost 20 years I've been on these pills. For those of you thinking I might be pregnant- unless it's an immaculate conception I'm not... trust me. I know exactly how long it's been and if I'm pregnant it's either because some magical baby fairy managed to outsmart biology, or the government is doing more than reading people's e-mails. 

Not sure if anyone out there has had any kind of experience with these drugs and birth control pills, but I thought I'd put it out there just in case.

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Maureen038's picture
Replies 14
Last reply 1/9/2014 - 5:38pm

My husband just had scans from the BMS CA209-004 study of 3mg/kg of yervoy and 1 mg/kg of nivolumbab. There is nothing new and his tumors have shrunk almost 50 percent!!! We are so thrilled, but we are still dealing with the side effect of hemolytic anemia after the third infusion. He has been on steroids for almost a month and while it's been tapered down from 100mg to 30 mg he can't get on the maintaince schedule of nivolumbab until his steroids are stopped. Yesterday, we were at UPMC with Dr. kirkwood and his glucose level went very high so they had to give him insulin twice. We are hoping to get all of this under control soon and he needs to see an endricologist now.

i wanted to post this to give people hope. This is the third trial he has been on, so please don't give up. He had HD interferon and he had the ACT at NIH this summer. The ACT stopped the alarmingly quick growth of lung mets, but unfortunately a few mets kept growing a few mm. Each of the trials have taken a toll on his body though so he is eating very healthy foods, exercising and enjoying each day! You truly learn what is important in life. We wish everyone here the best!!

Maureen

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mikvahnrose's picture
Replies 1
Last reply 1/7/2014 - 9:39am
Replies by: Janner

I got a shave biopsy of a suspicious mole about a month ago. December 2nd

The results came back that it was a Benign Compound Melanocytic Nevus. Read by a dermatopathologist so it makes me feel more confortable that it is not cancerous.

Well i now know that the mole wasnt cancerous, but within a month it has reappeared!!! Not the same size as it was before, it's smaller, but it came back. Is that normal?? Is that a concern that i should get it checked out again?

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Hstevens0072's picture
Replies 8
Last reply 1/9/2014 - 8:50am

I don't usually post but I do read the board.  I want to let you know that I am in the MK 3475 PD1 clinical trial and just had my third set of scans at the end of December.  I am very fortunate, my largest tumor is 82% smaller and the others have resolved.  No new disease.  I haven't had any trouble with side effects.

i know many people read these posts looking for hope so I wanted to share.

Holly

"The key is don't go to the funeral until the day of the funeral" ~ Valerie Harper

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Anonymous's picture
Anonymous
Replies 2
Last reply 1/6/2014 - 10:33pm
Replies by: POW, BrianP

My 34 year son was diagnosed two years ago

large mole on torso surgically removed with lymph nodes under arm, one of 12 nodes infected

radiation for 6 weeks then 12 months of interferon

july 2013 MRI showed small brain lesion and 3 new tumors on torso and back

radiation of total brain for 4 weeks plus 1 mega boost to exact spot

12 weeks of yervoy

good news brain MRI showed lesion gone

bad news tumors on torso 2mm larger and also on liver and spleen and new tumor on thigh and side torso

next step clinical trial - dr Laos at u of m has already closed his trial so have been recommended us to karmonas cancer at Wayne state

waiting now for appt date

Pat

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Anonymous's picture
Replies 11
Last reply 11/4/2014 - 5:00am

hi ... i'm a Danish guy looking to enter a Bristol Myers Sqiubb phase 3 trial of ipilumimab and/or nivolumab and I was wondering if anyone else in this forum is participating in this trial already and what your observations have been so far - both in terms of tumor effects as well as side effects ... looking forward to your comments !

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Anonymous's picture
Replies 7
Last reply 1/9/2014 - 12:14pm
Replies by: POW, Anonymous, Kim K, Momrn5
When Is a Completion ALND Necessary in the Presence of a Positive Sentinel Node?

 

Eur. J. Cancer 2013 Dec 10;[EPub Ahead of Print], A Suyoi, SK Bains, A Kothari, M Douek, O Agbaje, H Hamed, I Fentiman, S Pinder, AD Purushotham

Research · January 02, 2014
 
 

TAKE-HOME MESSAGE

  • This retrospective study from the UK examined 155 patients undergoing completion ALND after positive sentinel lymph node biopsy. Patients with macrometastasis (> 2 mm) in the sentinel node had a 35% likelihood of further axillary disease on completion surgery vs a 10% likelihood in those with micrometastasis (< 2 mm).
  • The authors suggest that this adds further evidence supporting the avoidance of completion ALND in patients with micrometastases.

- Richard Bambury, MD

ABSTRACT

Background

The management of the axilla in the presence of positive sentinel lymph node (SLN) remains controversial. Many centres forgo completion axillary lymph node dissection (cALND) in the presence of micrometastatic disease. The American College of Surgeons Oncology Group (ACOSOG) Z0011 trialists argue for extending this to macrometastasis. The aim of this study was to correlate tumour burden in SLNs with that in the residual lymph node basin to determine the likelihood of residual disease in patients with micro- and macrometastasis in the SLN.

Methods

Patients who underwent cALND following a positive SLN were analysed for histopathological features of the primary tumour and burden of axillary disease.

Results

Of 155 patients, 115 (74%) had macrometastases and 40 (26%) micrometastases in the SLNs. Residual axillary disease was detected in 55/155 (35%) patients with macrometastases and 4/40 (10%) with micrometastases. Generally, with increasing size of metastasis in the SLN there was an increasing risk of further disease in residual lymph nodes. Logistic regression analysis showed increased odds ratios for further disease for all groups when compared with the <2 mm (micrometastasis) SLN group.

Conclusion

Patients may be advised to forgo cALND where the SLN contains isolated tumour cells or micrometastasis. Recommendations for proceeding to cALND can be based on the size of metastasis in the SLN, which relates to the risk of further disease in the residual axillary lymph nodes and subsequent regional recurrence.

European Journal of Cancer
When Is a Completion Axillary Lymph Node Dissection Necessary in the Presence of a Positive Sentinel Lymph Node?
Eur. J. Cancer 2013 Dec 10;[EPub Ahead of Print], A Suyoi, SK Bains, A Kothari, M Douek, O Agbaje, H Hamed, I Fentiman, S Pinder, AD Purushotham

 

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Single vs Multiple Fractions of Repeat Radiation for Painful Bone Metastases

 

Lancet Oncol 2013 Dec 23;[EPub Ahead of Print], E Chow, YM van der Linden, D Roos, WF Hartsell, P Hoskin, JSY Wu, MD Brundage, A Nabid, CJA Tissing-Tan, B Oei, S Babington, WF Demas, CF Wilson, RM Meyer, BE Chen, RKS Wong

Research · January 02, 2014
 
 

TAKE-HOME MESSAGE

  • In an attempt to determine the benefit of repeat palliative radiotherapy to previously radiated painful bone metastasis, investigators randomized patients to 8 Gy in a single fraction or 20 Gy in multiple fractions and evaluated pain response at 2 months. Although the results are confounded by a high rate of not assessable patients in both arms, single-fraction radiation therapy appeared to be non-inferior and less toxic to multiple fractions.
  • While this trial appears to support a less intensive palliative radiation treatment, improved trial adherence in future explorations will help in firmly defining future treatment protocols.

- Chris Tully, MD

 

Commentary by
Lee S. Schwartzberg MD, FACP

Painful bone metastases remain one of the most feared and difficult consequences of advanced cancer. Radiation therapy provides relief of pain, and evidence has accumulated that a single fraction of 8 Gy can yield similar results to multiple smaller fractions over 1 to 2 weeks designed to deliver 20 Gy. Less is known about the benefit of single fraction vs multiple fractions when re-radiating lesions that either failed to respond to the first radiation or became painful again. Chow and colleagues performed a multicenter trial over several years designed to answer that question. They found that, in general, a single 8 Gy fraction yielded a noninferior result in terms of the primary endpoint of pain reduction compared with multiple fractions. However, the study was hampered by a high dropout rate and large number of patients who did not complete the pain assessment at the appropriate time. These complications were not unexpected as the trial dealt with a very advanced population. It was, therefore, gratifying to see that quality of life improved for the majority of patients in both arms after re-irradiation.

These results support the use of a convenient, single day/dose of 8 Gy when a bony lesion requires re-irradiation for pain control. Such an approach could be useful for palliation even in patients not receiving active cancer therapy and those on hospice care, given the significant improvement in pain, symptoms, and quality of life seen in many patients.

ABSTRACT

Background

Although repeat radiation treatment has been shown to palliate pain in patients with bone metastases from multiple primary origin sites, data for the best possible dose fractionation schedules are lacking. We aimed to assess two dose fractionation schedules in patients with painful bone metastases needing repeat radiation therapy.

Methods

We did a multicentre, non-blinded, randomised, controlled trial in nine countries worldwide. We enrolled patients 18 years or older who had radiologically confirmed, painful (ie, pain measured as ≥2 points using the Brief Pain Inventory) bone metastases, had received previous radiation therapy, and were taking a stable dose and schedule of pain-relieving drugs (if prescribed). Patients were randomly assigned (1:1) to receive either 8 Gy in a single fraction or 20 Gy in multiple fractions by a central computer-generated allocation sequence using dynamic minimisation to conceal assignment, stratified by previous radiation fraction schedule, response to initial radiation, and treatment centre. Patients, caregivers, and investigators were not masked to treatment allocation. The primary endpoint was overall pain response at 2 months, which was defined as the sum of complete and partial pain responses to treatment, assessed using both Brief Pain Inventory scores and changes in analgesic consumption. Analysis was done by intention to treat.

Findings

Between Jan 7, 2004, and May 24, 2012, we randomly assigned 425 patients to each treatment group. 19 (4%) patients in the 8 Gy group and 12 (3%) in the 20 Gy group were found to be ineligible after randomisation, and 140 (33%) and 132 (31%) patients, respectively, were not assessable at 2 months and were counted as missing data in the intention-to-treat analysis. In the intention-to-treat population, 118 (28%) patients allocated to 8 Gy treatment and 135 (32%) allocated to 20 Gy treatment had an overall pain response to treatment (p=0·21; response difference of 4·00% [upper limit of the 95% CI 9·2, less than the prespecified non-inferiority margin of 10%]). In the per-protocol population, 116 (45%) of 258 patients and 134 (51%) of 263 patients, respectively, had an overall pain response to treatment (p=0·17; response difference 6·00% [upper limit of the 95% CI 13·2, greater than the prespecified non-inferiority margin of 10%]). The most frequently reported acute radiation-related toxicities at 14 days were lack of appetite (201 [56%] of 358 assessable patients who received 8 Gy vs 229 [66%] of 349 assessable patients who received 20 Gy; p=0·011) and diarrhoea (81 [23%] of 357 vs 108 [31%] of 349; p=0·018). Pathological fractures occurred in 30 (7%) of 425 patients assigned to 8 Gy and 20 (5%) of 425 assigned to 20 Gy (odds ratio [OR] 1·54, 95% CI 0·85–2·75; p=0·15), and spinal cord or cauda equina compressions were reported in seven (2%) of 425 versus two (<1%) of 425, respectively (OR 3·54, 95% CI 0·73–17·15; p=0·094).

Interpretation

In patients with painful bone metastases requiring repeat radiation therapy, treatment with 8 Gy in a single fraction seems to be non-inferior and less toxic than 20 Gy in multiple fractions; however, as findings were not robust in a per-protocol analysis, trade-offs between efficacy and toxicity might exist.

The Lancet Oncology
Single Versus Multiple Fractions of Repeat Radiation for Painful Bone Metastases: A Randomised, Controlled, Non-Inferiority Trial
Lancet Oncol 2013 Dec 23;[EPub Ahead of Print], E Chow, YM van der Linden, D Roos, WF Hartsell, P Hoskin, JSY Wu, MD Brundage, A Nabid, CJA Tissing-Tan, B Oei, S Babington, WF Demas, CF Wilson, RM Meyer, BE Chen, RKS Wong

 

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High-Dose Interferon With Maintenance Treatment in High-Risk Melanoma

 

J. Clin. Oncol 2013 Dec 16;[EPub Ahead of Print], MJ Payne, K Argyropoulou, P Lorigan, JJ McAleer, D Farrugia, N Davidson, C Kelly, D Chao, E Marshall, C Han, S Wellman, MR Middleton

Research · January 02, 2014
 
 
 

TAKE-HOME MESSAGE

  • In this phase II study, 194 patients with stage IIB, IIC, IIIB, or IIIC melanoma were randomly assigned to receive adjuvant high-dose intravenous interferon alfa-2b for 4 weeks +/− maintenance low-dose subcutaneous interferon alpha-2b for 48 weeks. Improved outcomes seen with maintenance therapy in terms of relapse-free survival were not significant (2-year RFS, 54% vs 50%; P = .569). Improvement of overall survival was of borderline significance (median OS, not reached vs 41 months; P = .05).
  • Results did not support the initiation of a phase III trial. More data are needed to determine the optimal duration of adjuvant interferon alpha-2b therapy.

- Richard Bambury, MD

 

ABSTRACT

 

PURPOSE

High-dose interferon alfa-2b (HDI) has emerged as a potentially effective adjuvant therapy in patients with resected melanoma at high risk of recurrence. Evidence suggests it may be the early, very-high-dose part of the regimen that is critical. This pilot study sought to provide an early indication of whether the same effects can be achieved with the intravenous component of HDI alone and inform the feasibility and design of a phase III trial.

 
PATIENTS AND METHODS

Patients with stage 2B, 2C, 3B, and 3C melanoma were randomly assigned to receive interferon alfa-2b (IFN-α-2b) 20 MIU/m(2) intravenously (IV) daily 5 days per week for 4 weeks (arm A) versus the same regimen followed by IFN-α-2b 10 MIU/m(2) administered subcutaneously three times per week for 48 weeks (arm B) and observed for relapse-free survival (RFS) and overall survival.

 

RESULTS

Between 2003 and 2009, 194 patients were enrolled (arm A, 96; arm B, 98). After median follow-up of 39.5 months, RFS was 22.7 months (95% CI, 14.1 to 38.1 months) in arm A versus 33.3 months (95% CI, 18.2 to not reached) in arm B (P = .28). The proportions of patients free of relapse at 2 years were 50% and 54.1% (P = .569; hazard ratio, 0.89), respectively. Overall survival favored arm B (median, 41.5 months v not reached; P = .05).

 

CONCLUSION

Clinical outcomes were better in patients who had the longer regimen. Our results do not support either the use of a month of IV HDI alone in place of the year-long regimen or the initiation of a larger trial on this question.

Journal of Clinical Oncology
Phase II Pilot Study of Intravenous High-Dose Interferon With or Without Maintenance Treatment in Melanoma at High Risk of Recurrence
J. Clin. Oncol 2013 Dec 16;[EPub Ahead of Print], MJ Payne, K Argyropoulou, P Lorigan, JJ McAleer, D Farrugia, N Davidson, C Kelly, D Chao, E Marshall, C Han, S Wellman, MR Middleton

 

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DNA sequencer raises doctors' hopes for personalized medicine

The device could accelerate the use of genetic information in everyday medical care, physicians hope, improving diagnoses and treatments.

By Melissa Healy

January 3, 2014, 11:02 p.m.

Among the many stents, surgical clamps, pumps and other medical devices that have recently come before the Food and Drug Administration for clearance, none has excited the widespread hopes of physicians and researchers like a machine called the Illumina MiSeqDx.

This compact DNA sequencer has the potential to change the way doctors care for patients by making personalized medicine a reality, experts say.

"It's about time," said Michael Snyder, director of the Stanford Center for Genomics and Personalized Medicine.

Physicians who rely on genetic tests to guide their patients' treatment have had to order scans that reveal only small parts of a patient's genome, as if peeking through a keyhole, Snyder said: "Why would you study just a few genes when you can see the whole thing?"

Back in 2000, when the Human Genome Project completed its first draft of the 3 billion base pairs that make up a person's DNA, the effort took a full decade and cost close to $100 million. The Illumina MiSeqDx can pull off the same feat in about a day for less than $5,000 — and the results will be more accurate, two of the nation's top physicians gushed in the New England Journal of Medicine.

That confluence of "faster, cheaper and better" is likely to accelerate the use of genetic information in everyday medical care, Dr. Francis Collins, director of the National Institutes of Health, and Dr. Margaret Hamburg, commissioner of the FDA, wrote last month. DNA sequencing should guide physicians in choosing the best drug to treat a specific patient for a specific disease while risking the fewest side effects.

The Illumina MiSeqDx platform works by breaking down, rebuilding and recording the entire sequence of a person's DNA in a massively parallel fashion, completing the job in a matter of hours. The company intends to market the machine to diagnostic labs, medical centers and private practices, at a price slightly more than $125,000.

Now that MiSeqDx has been approved, several other whole-genome sequencers are likely to seek the FDA's blessing in the coming months, agency officials say.

Right away, the technology is poised to improve the diagnosis and treatment of cystic fibrosis. Two new assays for the chronic lung condition — both developed by Illumina for use on the MiSeqDx — were approved in November by the FDA. Instead of checking for the six mutations most commonly linked to the disease, the new tests are able to discern a total of 139 genetic variations that give rise to cystic fibrosis. They will also tell doctors whether a patient is among the 4% who has a mutation that's targeted by a specific, costly drug.

Whole-genome sequencing has begun to reshape the way physicians diagnose and treat cancer as well. For a growing number of patients, treatment is guided by a DNA scan that reveals which mutation gave rise to the malignancy, not the organ in which the cancer manifests itself.

Having a fuller, clearer picture of patients' complete genomes will also allow biomedical researchers to expand their understanding of how DNA variants work together to influence disease risk, said Dr. Robert Green, a medical geneticist at Harvard Medical School and Brigham and Women's Hospital in Boston.

In current practice, physicians use genetic tests to look for known mutations that show up in the "exome" — the 1.5% of the genome that dictates the composition and timing of how proteins are produced. When inherited in identifiable patterns, these mutations give rise to conditions like Huntington's disease and certain kinds of hearing loss.

But with machines such as MiSeqDx, researchers will be able to look for subtle variations and disease-causing patterns anywhere in DNA, including the long stretches that until recently were regarded as "junk." What they learn will enable doctors to warn their patients of their genetic vulnerabilities, allowing patients, in turn, to take steps to reduce their risk.

It may take a while for physicians to become proficient in conveying such information, and for patients to grasp its meaning, Green said.

"We know that people get state-of-the-art genetic counseling and still walk out of that office confused," he said.

Scientists promised that the age of personalized medicine had arrived when the Human Genome Project published our DNA blueprint. In the years since, that promise has proved elusive.

It was all very well to imagine that a single genetic scan would alert a patient to disease risks and — should he or she become ill — identify which treatments would work best.

In reality, the painstaking process of sequencing every patient's entire genome was a distant dream. Each expensive scan would take months to complete, making it a poor guide to treatment. Results were unreliable. And large stretches of the genome came out fuzzy, yielding a picture of a person's genetic makeup too uncertain to base medical decisions on.

And then there was the question of what it all meant. Where in the genome's 3 billion base pairs should doctors look for clues to a patient's future illness? Which genetic variations should prompt immediate action and which could be safely ignored? How should all of these genetic risks and their inherent uncertainties be explained to a patient?

Lawmakers and bioethicists began to lay the groundwork for this new world, wrestling with issues such as whether companies could refuse to hire someone or health insurers could deny them coverage on the basis of their DNA. The Genetic Information Nondiscrimination Act made these actions illegal in 2008.

Last month, the Presidential Committee for the Study of Bioethical Issues urged doctors to come up with guidelines for dealing with the incidental findings that are bound to come up when a patient's genome receives such thorough scrutiny. Physicians ordering such tests — and the patients receiving their results — should decide in advance how much of that incidental information they want to know, the panel recommended.

In approving the MiSeqDx, the FDA declared that it would regulate the complex and fast-evolving industry of genomic sequencing services. The agency has already flexed its muscles by ordering 23andMe — a high-profile Silicon Valley company that encourages consumers to examine their own DNA by sending in vials of saliva — to stop marketing its $99 tests to the public until it had demonstrated to the FDA that its findings were accurate and reliable.

Elizabeth Mansfield, who directs the personalized-medicine office in the FDA's Center for Devices and Radiological Health, acknowledged the skepticism about the agency's ability to regulate this emerging industry. But standards have been developed and conveyed to companies, she said.

"We certainly hope to see more" devices like MiSeqDx in the coming year, Mansfield said. "Bring it on."

melissa.healy@latimes.com

http://www.latimes.com/science/la-sci-personalized-medicine-20140104,0,436970.story#ixzz2pZsOAMZF

 

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Anonymous's picture
Anonymous
Replies 5
Last reply 1/16/2014 - 9:09am
Replies by: Tina D, Ty, BrianP

Hi,    (third attempt to get posted past the scam filter!)

My wife is 5 months into the Ipi/nivo trial and has yet to see a positive response... though has had some of the nastier side effects.   Has anyone been on this trial and seen a response this late into the treatments?

Thanks, 

Ty

Ty

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Pink's picture
Replies 3
Last reply 1/6/2014 - 10:40pm
Replies by: Bubbles, Pink

tomorriow going for another brain scan then Wed. meet with radiologist and neurp at Moffit. Initial MRI showed 3 small mets to brain. i am also going to start Ipi as soon as insurance approves it. if SRS does not work can they do it again  and does IPI cross the blood brain barrier.

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G-Samsa's picture
Replies 2
Last reply 1/6/2014 - 12:22pm
Replies by: lucy3, Jahendry12

I noticed in today's Wall Street Journal that the immunological center at Memorial Sloan Kettering was the recipient of a 90 million dollar grant from shipping magnate Daniel Ludwig.   Dr Wolchok is quoted as saying the magnitude of the grant will be "transformative"-- and that it will support trials of new immunological agents.  It's not quite the cavalry to the rescue--too slow for that --but terrific news, regardless.

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bj63's picture
Replies 3
Last reply 1/6/2014 - 12:30pm
Replies by: POW, Jahendry12, ecc26

I just tried to post a reply in another thread and was blocked by the spam filter?  What gives?

Sometimes no news is the best news!

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