Ulceration? Why is this an important factor?

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6/23/2011 3:02am
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Replies: 21

Hi Everyone,

I was just diagnosed with mm on June 2, 2011.  Surgery and sentinal lymph node removal on June 8, 2011.

Pathology report came back as follows. 

Nodular Malignant Melanoma

Surface measurement 2.7 x 2.7

Breslow Depth 14mm

Clarks level V

Sparse Lymphocytic infiltrate at periphery of Melanoma

Ulceration present

Mitoses 4/mm

Skin margins and deep margins negative for melanoma

Melanoma 1.5 cm to deep margin__________________________

My doctor said I was Stage IIC with high risk reoccurrence and wanted me to research diferent options for treatment.

I understand the clarks level V isn't good and the breslow depth was high but what does the ulceration mean and why is it bad?

If anyone understands what Mitoses 4/mm means let me know too!!  Thanks for your help!!

 

Denise 

Cancer Cannot cripple love, silence courage, destroy friendship, shatter hope or conquer the spirit.

hello Denise,

im so sorry about your news. the mitotic rate means how quick the cancer cells are breeding, a 4mm mititic rate is middle, the low is <2mm and hight more than 6mm.you can consider of the clark but most important is the brelsow. do you have the report of the biopsy of the sln?it was positive or negative?that is tha most important of all now.ulceration isnt a good sign cause  vessels and blood come in touch with the melanomatic mole and you have more chanches to reoccurance, but that isnt for sure that will happen!my mum had a malanoma at her back 1,9mm with clark iv, ulceration not full, 4/mm mitotic rate and an non-Brisk lymph vessel activity.she did the wide ext and the sln and one lymp came back positive with micrometastasis.after that she did a full axillary disection.the doctors told as to do inerferon for 1year but she hasnt decide it yet due to the many sife effects and the low rate of succefull.

i m sending you a lot of hope

be strong and everything is going to be ok

whatever you want you can ask me and if i know i will try to explain

ps:the bleslow was 14mm or 1.4mm?

DiRena

Hi DiRena,

The breslow was 14 mm.  It says negative for lymphvascular invasion.

I'm sorry to hear about your moms diagnosis.  This cancer is brutal and seriously messes with your head!

From what I understand about Interferon it is brutal side effects but it decreases your chances of reoccurrence 15-20%.  That seems better than a clinical trial that may give you a placebo. 

Thanks for your information.

Denise

Cancer Cannot cripple love, silence courage, destroy friendship, shatter hope or conquer the spirit.

Welcome to our forum. Thanks for filling in your profile, as doing this helps us to help
you better.

From: http://www.cancerhelp.org.uk/type/melanoma/treatment/stages-of-melanoma
"Ulcerated means that the covering layer of skin over the tumour is broken ... Ulcerated
melanomas have a higher risk of spreading than those which are not ulcerated".

From: http://www.melanomacenter.org/staging/stage1.html
"Mitoses: A condition of the cells being in a state of active division... It will be
defined as 'present or not present' and should include a number of mitoses per mm2".

Your profile mentions that you are due to have a PET scan soon. Have you had a CT scan
yet?

Best wishes

Frank from Australia

I urge everyone to thoroughly educate themselves about melanoma. No part of this post should be considered to constitute any form of medical advice. Please consult a competent oncologist. (I think that prayer can help in ways that we don't always expect).

I'm sorry you have been diagnosed with melanoma, but you've come to the right place.  I would be lost without the support and wealth of information from this great group!

I was also diagnosed earlier this year with a very deep primary, nodular melanoma (22mm) with ulceration.  I also had macro mets to one lymph node and it's now in my lungs.  My mitosis was less than 1, but since I had spread to a lymph node, my onc. didn't seem to think it mattered.  I think mitosis is more important in thin melanomas, but I could be wrong.

I was faced with the same problem as you when I was diagnosed - I had NED after surgery, so in essence, the melanoma was gone. I chose to get myself into a clinical trial with a placebo arm versus ipillumumab. I wanted to do something that was newer and showing more benefit over Interferon - especially considering my melanoma was deep and possibly already in my bloodstream. Everyone is different - it could take months or years to come back - nobody knows.

I wish you the best of luck and hope that you have many years of NED!

Lisa

Many impossible things have been accomplished for those who refuse to quit

Hi Lisa,

Where was your tumor located?  That's very deep!!  Are you in the trial now?  So are you considered stage IV now? 

There's so many factors in being diagnosed it gets confusing.  Some say Breslow depth is the most important then ulceration or not, clarks level, lymph nodes, etc...I guess your right everyone is different and in considering options it would depend on the individuals particular case.  Nodular melanoma is supposed to be the most invasive.  

Keep in touch

Denise 

Cancer Cannot cripple love, silence courage, destroy friendship, shatter hope or conquer the spirit.

Hi Frank,

Thanks for the information.  It seems like I can't get enough lately!  I'm trying to understand this and look at my options for treatment that will have the best results. 

I haven't had any scans as of yet.  This happened really fast.  One day I was at the doctors getting a biopsy the next week was diagnosed and 6 days later having surgery.  It's been 2 weeks since surgery and doctor wants me to heal more before the PET scan. 

He didn't say anything about a CT scan just the PET and LDH levels tested. 

Thanks,

Denise

Cancer Cannot cripple love, silence courage, destroy friendship, shatter hope or conquer the spirit.

Hi, and welcome to the forum that no one wants to be a member of by choice.

Ulceration is where the melanoma tumor invades through the overlying epidermis rather than pushing it upwards, manifesting as an absent epidermis overlying the major portion of the tumor. It carries a worse prognosis because the tumor has invaded the surrounding tissue. Since a small amount of melanoma cells were found in one of your nodes, perhaps you should now concentrate on your treatment options, as even though your melanoma is ulcerated it has already been found in your node anyway.

Mitosis is the rate of cell division. It may be stated as an amount based on per HPF-high power fields or per mm squared (mm2)

You may wish to go to clinicaltrials.gov and check some of the trials there.

Here is a list of trials for stage 2 and 3. You can narrow it down with more specific criteria by putting terms in the search box.

http://clinicaltrials.gov/ct2/results?term=melanoma+stage+II&recr=Open&no_unk=Y

There is one ray of light in this. Some studies have shown that a ulcerated melanoma may have a better chance of response to adjuvant interferon therapy. This and several trials is what you should discuss with your doctor.

From ASCO 2009:

Ulceration of primary melanoma and responsiveness to adjuvant interferon therapy. This was presented by Dr. Lex Eggermont of the EORTC. It was chock full of data and I couldn’t get it all down fast enough (as Dr. Eggermont said, “fasten your seat belts”). However, the data were very consistent. Basically, in reviewing the recent EORTC experience with adjuvant interferon, either standard Intron or the newer long-acting PEG-Intron (not yet approved in USA), they found that primary melanoma ulceration is very strongly associated with clinical benefit from either interferon therapy. In fact, patients whose melanoma lacked ulceration apparently derived NO benefit from interferon therapy. The numbers: in 2644 combined patients from two most recent trials, ulcerated melanoma patients had a 25% reduction in recurrence risk which was statistically significant. This benefit was even greater for patients with minimal lymph node disease, ie 0-1 lymph nodes involved, with a 31% reduction in recurrence and a 42% reduction in death rate. This is very impressive, since usually the RFS improvement dwarfs the impact on OS! This benefit almost disappeared for ulcerated melanomas with multiple lymph node involvement (N2) and completely disappeared for non-ulcerated melanomas.

Here are a few more you may wish to read:

http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=32368

http://www.ncbi.nlm.nih.gov/pubmed/20739846

Good luck, and keep the board posted.

Michael 1B

This information is for general patient educational & information purposes only. It should not be used for diagnosing/treating a health problem or disease. If you have or suspect you may have a health problem, you should consult your healthcare provider.

Hi Michael,

Wow!  That's pretty impressive statistics for the Interferon!  Great information!!

Thank you so much!  It pretty much seals the deal for my decision for Interferon.  I'm afraid of clinical trials and possibly getting a placebo.  I don't think I want to gamble with my life unless I'm left with no other options.

Thanks again

Denise

Cancer Cannot cripple love, silence courage, destroy friendship, shatter hope or conquer the spirit.

Denise, do not let this information be the sole basis your decision, as the numbers are not impressive for interferon. (then again, what is when it comes to melanoma?) This information merely states that since your melanoma is ulcerated, you may have a better chance in a delay of recurrence than if it was not ulcerated.

Interferon is not very effective in the majority of patients. IFN treatment may delay the time to a potential recurrence, but is now known that the overall chance of survival time is not improved.

You may wish to research further the one month high dose vs. the 11 month low dose, and the potential side effects as well, such as depression.

Good luck,

Michael

This information is for general patient educational & information purposes only. It should not be used for diagnosing/treating a health problem or disease. If you have or suspect you may have a health problem, you should consult your healthcare provider.

Hi Michael,

Thanks so much for the information.  I'm continuing to weigh the benefits vs the side effects.  I was leaning towards Interferon because I'm not thrilled with the idea of possibly getting a placebo with a clinical trial.  With the Interferon it decreases your risk of reoccurrence with a significant percentage based on an overall average.  I've been living with this cancer for 2 years causing me to be susceptable to colds, flus, and chronic fatigue so the side effects don't scare me!  I thought the treatment was 1 month high dose as well as 11 months low dose??  Can you choose the 11 months low dose without the 1 month high dose?

Denise

Cancer Cannot cripple love, silence courage, destroy friendship, shatter hope or conquer the spirit.

Sorry, I should have been more clear. Sometimes it is lost in typing translation.

Also, please be aware that I am not trying to push interferon on you in any way, but just to help inform you instead. Whatever you do, the decision is yours to make.

What I meant was to read up on the one month studies vs. the 11 months after. Some studies show that the one month high dose may be as effective as the 11 months low dose.

Here is something you may wish to read as well:

http://www.melanomacenter.org/treatment/lowdoseinterferon.html

Similar info here:

http://www.aimatmelanoma.org/aim-for-answers/treatment-of-melanoma/immunotherapy/interferons.html

Michael

This information is for general patient educational & information purposes only. It should not be used for diagnosing/treating a health problem or disease. If you have or suspect you may have a health problem, you should consult your healthcare provider.

Oh, and not all trails have a placebo:

http://clinicaltrials.gov/ct2/info/understand

From WIKI:

http://en.wikipedia.org/wiki/Clinical_trial

Phase I

Phase I trials are the first stage of testing in human subjects. Normally, a small (20-100) group of healthy volunteers will be selected. This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials also normally include dose-ranging, also called dose escalation, studies so that the appropriate dose for therapeutic use can be found. The tested range of doses will usually be a fraction of the dose that causes harm in animal testing. Phase I trials most often include healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have terminal cancer or HIV and lack other treatment options. "The reason for conducting the trial is to discover the point at which a compound is too poisonous to administer."[21] Volunteers are paid an inconvenience fee for their time spent in the volunteer centre. Pay ranges from a small amount of money for a short period of residence, to a larger amount of up to approx $6000 depending on length of participation.

There are different kinds of Phase I trial:

Single Ascending Dose studies are those in which small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time. If they do not exhibit any adverse side effects, and the pharmacokinetic data is roughly in line with predicted safe values, the dose is escalated, and a new group of subjects is then given a higher dose. This is continued until pre-calculated pharmacokinetic safety levels are reached, or intolerable side effects start showing up (at which point the drug is said to have reached the Maximum tolerated dose (MTD)).
SAD
Multiple Ascending Dose studies are conducted to better understand the pharmacokinetics & pharmacodynamics of multiple doses of the drug. In these studies, a group of patients receives multiple low doses of the drug, while samples (of blood, and other fluids) are collected at various time points and analyzed to acquire information on how the drug is processed within the body. The dose is subsequently escalated for further groups, up to a predetermined level.
MAD
A short trial designed to investigate any differences in absorption of the drug by the body, caused by eating before the drug is given. These studies are usually run as a crossover study, with volunteers being given two identical doses of the drug while fasted, and after being fed.
Food effect

Phase II

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.

Phase II studies are sometimes divided into Phase IIA and Phase IIB.

  • Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).
  • Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).

Some trials combine Phase I and Phase II, and test both efficacy and toxicity.

Some Phase II trials are designed as case series, demonstrating a drug's safety and activity in a selected group of patients. Other Phase II trials are designed as randomized clinical trials, where some patients receive the drug/device and others receive placebo/standard treatment. Randomized Phase II trials have far fewer patients than randomized Phase III trials.
Trial design

Phase III

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.

It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug. Studies in this phase are by some companies categorised as "Phase IIIB studies."[22][23]

While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as FDA (USA), or the EMA (European Union), for example.

Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life. This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities[3] in different countries. They will review the submission, and, it is hoped, give the sponsor approval to market the drug.

Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines, but in case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market.[24]

Phase IV

Phase IV trial is also known as Post-Marketing Surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

Phase V

Phase V is a growing term used in the literature of translational research to refer to comparative effectiveness research and community-based research; it is used to signify the integration of a new clinical treatment into widespread public health practice. [1]

This information is for general patient educational & information purposes only. It should not be used for diagnosing/treating a health problem or disease. If you have or suspect you may have a health problem, you should consult your healthcare provider.

Denise,

I'm so sorry that you've had to join us.  Like your cousin my spread has also been in the blood vessels. That's why we all have to be vigilent.

Your profile says that there was a small amount found in the node. Is this a melanoma specialist your going to? I'm asking because I've always heard that even microscopic amounts found in the node is stage 3A.  Staging is just a word but it does make a difference when looking for treatments. When I was first staged my oncology surgeon refused to tell me my stage. My oncologist side tracked my asking telling me, but the trial I was put on was for recurrent mel and stage IV.  An intern is the one that told me I was stage IV. When I cornered the oncologist he admitted I was but then tried to tell me it was just a word. My derm tried to tell me I was stage 3B.   I got to a melanoma specialist and he explained to me why I was stage IV. It was because it was so deep in the tissue under the original scar line.  All a mute point because now it has spread to further places.

My point is, there are Doctors out there that will tell you what you want to hear. Please get this checked out before you spend the time researching a trial that you might not be eligible for.

Wishing you the best,

Linda

Stage IV since 06

I agree with Linda.  Even one cell in the lymph nodes says that melanoma has traveled away from the original site through the lymph channels.  I'm not sure how your doctor can say you aren't stage III.  You'll find an easier time looking at clinical trials when you do it at stage III also. 

Stage IIIB: T4bN1aM0: The melanoma can be of any thickness and is ulcerated. It has spread to 1 to 3 lymph nodes near the affected skin area, but the nodes are not enlarged and the melanoma is found only when they are viewed under the microscope. There is no distant spread.

I do have another link I ran across that discusses a total lymph node dissection in people with minimal metastasis to the sentinal node.  It seems to apply to your minimal mets in the sentinel node.  http://www.gmmm.com.ve/lectura/00000658-200906000-00021.pdf

I know another warrior from Reno area traveled to CA to do treatment.  Are there any melanoma specialists in Reno?  I know Las Vegas has Dr. Samlowski (previously from Utah where I live), but not sure about Reno.

Good luck in your treatment research!

Janner

Hi Linda,

I basically staged myself when he read me the results.  My doctor is a surgeon theres an M.D., F.A.C.S. but not sure what that means.  He's really skilled in surgery and said he's done hundreds of lymph node removals.  I really like him.  He's going to a tumor board the end of the month and said he was going to discuss my case with everyone so it would be like getting 4-5 or more second opinions.  He's supposed to be referring me to an oncologist on June 30th my next appt. 

The pathology said the lymph node infiltration was sparse less than .2mm so they called it negative. 

What kind of treatments are you doing or have you done.  Stage IV since 06 sounds like you've been dealing with this a very long time.  I take my hat off to you Linda!!  Your a fighter!!

Thanks so much for the advice and information.

Denise

Cancer Cannot cripple love, silence courage, destroy friendship, shatter hope or conquer the spirit.

Denise

Hi I'm stage 3a and live just down the road from you, Washoe Valley.  Just to let you knowI fly down to L.A. for specialist.  Choices are really S.F., L.A. or now Las Vegas.  I didn't want to have to drive over the hill in Jan. when I was dx.  I go to the Angeles Clinic.  Very happy with Dr Hamid there.  There is also UCLA and John Wayne Cancer Center all in LA.  SF has DR O'Day who is one of the leading Mel Specialists. 

P.S.  I chose to have all my lymoh node removed then just watch and wait.  That too is a vaible option.

Good Luck

Mary

Life is too short to be anything but happy. Falling down is a part of life, getting back up is living.

Hi Mary,

We're actually looking for homes in Washoe Valley!  I love that area plus I work in Carson and my fiance works in Reno so it's a perfect location! 

Unfortunately I can't afford to go to LA at this time.  I've been going to Auburn, CA.  I started off in Sacramento but got sent from a nurse practioner to get a mammogram to being told I needed to see a dermatologist!  My friends doctor referred me to the surgeon I went to now.  He saw the mole/tumor and got me an appt 3 days later.  I think that if I find I need more help or have no choice then I'll figure out a way to get to a better doctor.  Like I said in an above post this all has happened so fast and besides from healing my head is spinning with all the information I'm trying to absorb. 

Maybe we could meet for some iced tea and chat about our unfortunate commonality! 

I'm waiting for June 30th when I get my PET and LDH levels tested.  I've been having a horrible headache for the last 2 weeks so my doctor is gonna order a Brain scan/MRI as well.  I think I'll know more and feel better once I get the results back and know exactly what I'm dealing with.

Do you know if Interferon is administered by IV for the first month?  I read somewhere that it's IV for the first month mon-friday everyday!  I don't know if I could do that!

Thanks, Denise

Cancer Cannot cripple love, silence courage, destroy friendship, shatter hope or conquer the spirit.

I have been to both....a really good oncologist....and then an oncologist who specialized in the treatment of melanoma.  Trust me no matter how much I liked the first guy it was such a world of difference.  RUN!  It is great that your doc wants to take your case to a tumor board and get more opinions but unless they are docs who speicailize in melanoma you are no better off.  Listen, I have been in your shoes....they did find "something" in my lymph node and it took a TON of specialist across the country to figure out what it was.  It was 2 cells...just 2, and even if it had been just one cell it was going to be a stage III.  Yes, just one teny-tiny microscopic cell.  Luckily mine ended up just being mole cells.  BUT anything that is positive for melanoma in your lymph node moves your staging.  Maybe it is not that way with other cancers-I really have no clue. 

I love your additude about things and getting the bottom of the best treatment options for your case is the best thing.  People on this board know more about diagnoising melanoma then my orginal doctor who removed my mole did.  Listen to them, they are an amazaing vast of knowledge, hope, and friendship.

Shoot one more thing to add....it is the pathologist who looks at the slides that really sees what is going on normally the guy that you in the office doesn't even ever look under the microscope to see the results.  I found it very important to get a second opinion on the pathology of it, or even better a pathologist who is really a Histopathologist.  I have 4 different lab reports and when my slides were sent to a David E Elder of the Univ of Penn.  the report was more detailed and ended up being triple the length of the other ones.  Amazing difference.  The original Pathologist who checked out the slides couldn't even make out what was in the lymph node.....

I did Interferon for two days in April of 2010.

They put a "picc" in my arm and taped it into place. This is like a more permanent IV.  The picc is like an IV needle but has a foot or so of very narrow tubing that is threaded into your vein and stops very near your heart. This means you don't have to stick your veins every day and also the interferon ends up close to your heart.

I lasted two days. The first day I developed a headache after the interferon injection. The second day I got the chills, fever, and crying spells. By the morning of the day of my third injection, I was a basket case. I almost ran into the clinic crying and repeating "I can't do this, I can't do this". First the social worker and nurse spoke with me and tried to calm me down. Then the onc came.  My onc said she would not allow me to continue the interferon. 

Now I am normally a pretty tough person (8 surgeries in my life) but this was out of control. I now realize it was a psychotic experience.

In the first place my onc said she didn't think the interferon would do much, certainly not affect my survival rate. She said I might try it if I want.

I don't recommend Interferon. Some do it and are in remission for years. Some do it and get a recurrence soon after. There is simply no way of knowing if it works. Who knows if those in remission for years would have been in remission without interferon? Who knows if those with recurrences would have had recurrences even if they did Interferon. No one knows.

Nicki, Stage 3b

 

Be strong and take heart, all you who HOPE in the Lord. Ps. 31:24

Hi,

I am doing a research on interferon side effects and i was wondering if any of you would participate in my research.

I went through INTRON A therapy, 30 MIU induction 4 weeks,  and 18MIU maintenance 48 weeks. I had really bad side effects. 

Now my goal is to collect all the experiences from people who underwent any kind of treatment with Interferons regardless of their health condition. Intron A, Roferon A, Pegasys.. and so on.

With this information i mean to help others, offer them support whether they are about to undergo this therapy or are currently going throug.  Let me know if you are interested.

May you all be well.

Claude