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  • #22123
    Happy_girl
    Participant

    Hi! Well- for the past few months I was posting in the stage 1 and 2… But my surgeon just called and said they sent my lymph node to another pathologist who found 1 microscopic melanoma cell. I guess from here I get all other nodes removed will take interferon. I am terrified! I have a 6 month old baby and am afraid I won’t see her turn 5. Is there hope???? Please tell me stage 3a could survive.

    #65101
    alaskanmeg
    Participant

    I was diagnosed with stage IIIa in Feb 2011. I had a Wide Lesion Excision on my back. The first oncologist barely looked at my stats, but he took me to the infusion room and set me up for interferon a chemo.

    I had read about that particular chemo was like having the flu for a year. Overall survival doesn’t change. So I went to a different oncologist and she was just fine with me doing the “Wait and See” approach. My first year check up showed I was “clean”, but I found out that I had Multiple Myeloma, a cancer of the plasma cells. GREAT

    So I had a tandem Autologous Stem Cell Transplant in Dec20012 and Apr 2013. It’s been over a year now and my blood work is awesome.

    I noticed a lump on my back. It was itching, then I noticed another lump on my back closer to my WLE. Had the excised on 28 July. Now waiting for the pathology report. The lumps were near my first excision and they had their own blood supply. Suppose to know next week what the verdict is.

    So Ms. Terrified, I would look for an oncologist that does the “Wait and See” option. Oh yeah, i had a sentinel node with cancer, so they took out 11 more that were cancer free. (Lumpectomy”. Tell me more about your melanoma, where is it, how big is it, if it was ulcerated, what tests or procedures you’ve had done. With a five month old, I wouldn’t do interferon. It’s the Quality of Life aspect for me, but my daughter just turned 21.

    #65102
    Happy_girl
    Participant

    1.8mm on back

    mitotic rate-3

    not ulcerated

    did not show lymphatic or blood vessel involvment

    partial regression

    1 microscopic cell found in sln- so now I will get others taken out to see if they contain melanoma.

    I’ve already had a pet scan that came back clean. So far- that is all.

    #65103
    Catherine Poole
    Keymaster

    Take a deep breath and get another opinion. Interferon is an old therapy and not prescribed by many centers of excellence. We can help you find another opinion. Also, full node dissection for one micro met sounds like overkill. Where do you live? We can help with a scholarship to travel as well.

    #65104
    Happy_girl
    Participant

    Thanks Catherine. I am in ohio. I am going to university hospital. I believe it is considered a melanoma center of excellence- at least I thought that’s what I read. I also thought my oncologist was considered a melanoma specialist- dr koon. I appreciate advise- I’m just so afraid my dreams of seeing my 6 month old grow up are gone….

    #65105
    Anonymous
    Guest

    HG:

    Where in Ohio? I live in the greater Cincinnati area.

    Jeff

    #65106
    Anonymous
    Guest

    BTW, how’s your husband doing?

    #65107
    Catherine Poole
    Keymaster

    I would take a trip to NYC and see someone at Sloan Kettering, people travel from all over the world to get their opinion. I would see Dr. Coit for the surgery question and the team for adjuvant therapy (i.e. the Interferon question. Here is something we posted before about interferon.

    Scroll down for the whole contents:

    Articles by Hurley, K. E.

    Articles by Chapman, P. B.

    Search for Related Content

    PubMed

    PubMed Citation

    Articles by Hurley, K. E.

    Articles by Chapman, P. B.

    Helping Melanoma Patients Decide Whether to Choose Adjuvant High-Dose Interferon-2b

    Karen E. Hurley, Paul B. Chapman

    Department of Psychiatry and Behavioral Sciences, and Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA

    Key Words. Adjuvant treatment • Interferon • Melanoma • Risk–benefit • Survival

    Correspondence: Paul B. Chapman, M.D., Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, New York 10021, USA. Telephone: 212-639-5015; Fax: 212-704-4352; e-mail: chapmanp@mskcc.org

    Received May 31, 2005; accepted for publication August 1, 2005.

    LEARNING OBJECTIVES

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    Learning objectives

    Abstract

    Introduction

    The benefits and risks…

    How do we determine…

    Patient decision-making about hd…

    Subjective benefits of hd…

    Decision rules for discussing…

    Other options for adjuvant…

    Disclosure of potential…

    References

    After completing this course, the reader will be able to:

    Describe the benefits of adjuvant high-dose interferon- therapy to melanoma patients.

    List the toxicities most commonly associated with adjuvant high-dose interferon- therapy in melanoma patients.

    Assist patients with melanoma to decide whether to choose adjuvant high-dose interferon- therapy.

    Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com

    ABSTRACT

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    Learning objectives

    Abstract

    Introduction

    The benefits and risks…

    How do we determine…

    Patient decision-making about hd…

    Subjective benefits of hd…

    Decision rules for discussing…

    Other options for adjuvant…

    Disclosure of potential…

    References

    High-dose interferon-2b is a U.S. Food and Drug Administration–approved adjuvant treatment for stage III melanoma, and yet, because of its limited efficacy and well-known toxicity, it is not universally accepted by patients and oncologists. In this paper, we evaluate the benefits and risks of adjuvant high-dose interferon-2b and try to provide a framework to help oncologists guide patients trying to decide whether to undergo adjuvant high-dose interferon therapy.

    INTRODUCTION

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    Learning objectives

    Abstract

    Introduction

    The benefits and risks…

    How do we determine…

    Patient decision-making about hd…

    Subjective benefits of hd…

    Decision rules for discussing…

    Other options for adjuvant…

    Disclosure of potential…

    References

    The value of a year of high-dose interferon-2b (HD IFN) for the adjuvant treatment of stage III melanoma remains a source of controversy among oncologists and patients. Since it is a U.S. Food and Drug Administration–approved treatment and is administered on an outpatient basis, some oncologists recommend it to all stage III melanoma patients after complete surgical resection. However, a substantial proportion of oncologists feel that the benefits of adjuvant HD IFN treatment do not justify the toxicities. Initially, some of this controversy arose from the lack of mature results from the two randomized phase III trials comparing adjuvant HD IFN with observation [1, 2]. Over the past few years, however, these data have matured, and an updated pooled analysis has recently been published [3]. These data, which are reviewed below, can be considered to represent the final word on the value of HD IFN, and as a result, it seems timely to consider how oncologists can help patients weigh the risks and benefits of adjuvant HD IFN treatment and so come to an informed decision on whether to undergo this treatment.

    THE BENEFITS AND RISKS ASSOCIATED WITH ADJUVANT HD IFN

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    Learning objectives

    Abstract

    Introduction

    The benefits and risks…

    How do we determine…

    Patient decision-making about hd…

    Subjective benefits of hd…

    Decision rules for discussing…

    Other options for adjuvant…

    Disclosure of potential…

    References

    The two randomized trials, in which a total of 713 patients received either adjuvant HD IFN or observation, both showed similar results [1, 2]. To be eligible for these trials, melanoma patients had to have had either deep primaries (>4 mm) or regional lymph node involvement. They were started on the trials within 70 days after complete surgical excision. With follow-up now complete in the first trial (median of 12.6 years of follow-up of survivors) and a median follow-up of 6.6 years in the second trial, neither showed an overall survival benefit associated with adjuvant HD IFN treatment. This is reflected in the pooled analysis of these two studies, which was recently published [3]. This pooled analysis showed that the survival curves were virtually superimposable (p = .42). Both treatment arms show an approximately 50% survival rate at 5 years, and there was no effect on the “tail of the survival curve,” meaning that HD IFN did not increase the chance of cure. On the other hand, HD IFN was associated with longer recurrence-free survival in both trials. However, in the pooled analysis [3], the median time to relapse was longer in the HD IFN group by less than 1 year.

    What does all this mean to the patient? It means that, among patients destined to recur, a year’s worth of HD IFN treatment can delay the time of recurrence in a small subset, although for half of these patients this delay will be less than 1 year. However, the overall chance of recurrence and the overall survival is not improved. This means that, if the patient is destined to relapse and die of melanoma, HD IFN does not affect this nor does it significantly delay the time of death.

    HD IFN is associated with toxicities that result in decreased performance status in virtually all patients. In the most recent HD IFN trials, severe toxicities (grade 3–4) were frequently reported for fatigue, myalgias, and hepatotoxicity (Table 1). Although toxicities such as fatigue, fever, and flu-like symptoms are universal, they are under-reported in publications since generally only grade 3 or worse toxicities are reported. Depression appears to be very common, occurring in 40% of patients if patients are assessed carefully [4]. Patients reporting a depressed mood or insomnia before starting HD IFN have been shown to be at a higher risk for worsening of depression during treatment, particularly if they also have low levels of social support [5]. In some patients, serious cardiac, hepatic, and bone marrow toxicities are also seen, and because of the need to screen for and manage these toxicities, frequent follow-up and blood tests are necessary in patients on HD IFN. This represents both a financial cost as well as a further cost in quality of life (QoL).

    View this table:

    [in this window]

    [in a new window]

    Table 1. Benefits and risks of high-dose interferon-2b therapy

    Data on QoL during HD IFN therapy can be presented to patients as part of informed decision-making. Trask and colleagues [6] conducted a longitudinal study of QoL in stage III melanoma patients receiving HD IFN after surgical resection. Patients reported increased depression, fatigue, and somatic complaints and decreased physical well-being over the course of 6 months of HD IFN treatment. Similarly, data from the E1684 trial show that up to 70% of patients on HD IFN experienced grade 3 toxicities or higher and that the mean length of time spent experiencing these symptoms was 7.4 months out of the 12 months of treatment [7].

    In oncology, we often offer toxic, noncurative treatment to our patients with metastatic cancer. However, in the setting of evaluable metastatic disease, the oncologist and patient can frequently evaluate the risk–benefit ratio by weighing the antitumor effects in the patient against the side effects being experienced. Even if the treatment is not curative, individual patients could elect to continue treatment if the risk–benefit ratio is sufficiently high. For example, in the setting of stable disease and no toxicity, the patient might reasonably choose to continue treatment. Alternatively, some patients may experience tumor regression and, as a result, might tolerate more toxicity. If the risk–benefit ratio becomes too low, treatment would be stopped.

    In the adjuvant setting, it is impossible to assess the ongoing benefits in an individual patient because there is no tumor to evaluate. Although the toxicities are evident, the individual patient cannot gauge the benefit in an individual case; this must be inferred from previous phase III trials. For many adjuvant treatments, data are not available regarding the magnitude or likelihood of the potential benefits, and the risk–benefit ratio must be estimated based on scientific rationale. In the case of HD IFN, however, mature data defining the benefit are available (as noted above), and a more precise risk–benefit analysis is possible.

    HOW DO WE DETERMINE THE RISK–BENEFIT RATIO FOR HD IFN?

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    Learning objectives

    Abstract

    Introduction

    The benefits and risks…

    How do we determine…

    Patient decision-making about hd…

    Subjective benefits of hd…

    Decision rules for discussing…

    Other options for adjuvant…

    Disclosure of potential…

    References

    Now that the benefits and risks of HD IFN have been well defined (Table 1), it is possible to examine how oncologists and patients might weigh the risks against the benefit of longer relapse-free survival to decide on the advisability of adjuvant HD IFN.

    In the case of HD IFN, the question is: How much risk is a median improvement in progression-free survival of less than a year worth to the patient, knowing that there is no improvement in overall survival? Each patient has a sense of what risk–benefit ratio is acceptable. In some cases, it may be reasonable to accept a higher risk–benefit ratio (e.g., when potential benefits are greater). No matter what risk–benefit ratio the patient feels comfortable with, the physician can help the patient come to a treat/no-treat decision by discussing both the benefits (longer progression-free survival but no improvement in survival) and the risks (toxicities, frequent injections, office visits, blood tests). As an example, we may consider a stage IIIB patient with a single, palpable regional lymph node involved with melanoma. This patient has an approximately 50% chance of dying from melanoma over 5 years [8], a risk that is not improved by HD IFN according to the published data [3]. This means that if the patient chooses to receive HD IFN, he runs a 50% risk that he will spend at least 20% of his remaining time (presumably the best 20%, because it is the year immediately after surgery) on HD IFN.

    PATIENT DECISION-MAKING ABOUT HD IFN

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    Introduction

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    How do we determine…

    Patient decision-making about hd…

    Subjective benefits of hd…

    Decision rules for discussing…

    Other options for adjuvant…

    Disclosure of potential…

    References

    Psychosocial studies of patient preferences for HDIFN show large standard deviations [7, 9], suggesting that patients may differ in their subjective valuation of the risk–benefit ratio and that factors other than outcome data are influencing patient decisions [10]. Research on decision making among patients with other types of cancer has shown that patients are less likely to experience regret when they feel the decision was their own rather than undergoing the specific treatment because the doctor told them to [11, 12]. In discussing HD IFN, the oncologist can facilitate this process by exploring the meaning of disease-free survival for the patient, as well as expectations about side effects, to reach a decision that addresses both the patient’s physical and mental well-being. This approach can help maintain the doctor–patient relationship in the long run and facilitate patient acceptance of recommendations in case of toxicities or recurrence.

    SUBJECTIVE BENEFITS OF HD IFN

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    Introduction

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    How do we determine…

    Patient decision-making about hd…

    Subjective benefits of hd…

    Decision rules for discussing…

    Other options for adjuvant…

    Disclosure of potential…

    References

    Some patients may be willing to risk the toxicity of HD IFN because they perceive the advent of recurrence as synonymous with death, whereas the disease-free period allows them to cling to hope that they might achieve long-term survival. For other patients, recurrence in the absence of action may trigger thoughts that they missed an opportunity to stave off death [7]. In this instance, taking HD IFN may represent a form of “regret management” in which patients seek to avoid the scenario that would trigger the most regret and self-blame. Feeling that one has done everything possible may make the possibility of recurrence more bearable; if the disease returns despite HD IFN, the patient may interpret this as meaning that it was meant to be and that he or she is blameless. Paradoxically, severe side effects can be construed as concrete evidence that one’s efforts to survive were sincere and that no stone was left unturned.

    DECISION RULES FOR DISCUSSING HD IFN

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    Introduction

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    How do we determine…

    Patient decision-making about hd…

    Subjective benefits of hd…

    Decision rules for discussing…

    Other options for adjuvant…

    Disclosure of potential…

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    Kilbridge and colleagues [9] developed a decision rule consisting of two screening questions that allow identification of patients who would clearly benefit from HD IFN. These questions were based on the assumption that adjuvant HD IFN is associated with an improvement in overall survival. However, since subsequent data no longer support the primary assumption that adjuvant HD IFN is associated with improved overall survival (as discussed above), these specific screening questions appear to be no longer valid. However, the findings do suggest that, for most patients, a discussion of expectations about HD IFN can be accomplished in a brief, focused fashion and that the key elements of assessing patient readiness for HD IFN include a realistic understanding of the probability and nature of the side effects, a clear willingness to tolerate side effects for the possibility of modifying the course of one’s disease, and a realistic understanding of the nature and probability of any benefits of HD IFN.

    OTHER OPTIONS FOR ADJUVANT THERAPY

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    Learning objectives

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    Introduction

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    How do we determine…

    Patient decision-making about hd…

    Subjective benefits of hd…

    Decision rules for discussing…

    Other options for adjuvant…

    Disclosure of potential…

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    If the patient (or oncologist) is convinced that the risks of HD IFN are not reasonable for the potential benefits, it is rational to explore alternative options. In the past, adjuvant chemotherapy has been explored, but, aside from one trial assessing the role of adjuvant dacarbazine (DTIC-Dome®; BayerPharmaceuticals Corporation, WestHaven, CT, http://www.bayerpharma-na.com/), all the other randomized trials were either significantly underpowered or tested drugs that we no longer believe are active in melanoma. As a result, the question of the role of adjuvant chemotherapy in melanoma remains an open one. Currently, an intercooperative group study is testing the efficacy of biochemotherapy as an adjuvant treatment compared with HD IFN, a trial in which both treatment arms are associated with significant toxicity and a high risk–benefit ratio. The European Organization for Research and Treatment of Cancer is evaluating the role of prolonged (5-year) treatment with low-dose pegylated interferon- as an adjuvant treatment. Other adjuvant strategies focus on vaccine approaches. Although the benefits are not yet defined, the risks are generally minimal, and patients may view these as having lower risk–benefit ratios.

    In most situations in melanoma, patients are faced with trying to make a rational decision in the setting of incomplete information. For the issue of adjuvant HD IFN, however, the information is remarkably complete, and oncologists can help patients to quantitate the risks and benefits that will help them come to a decision.

    DISCLOSURE OF POTENTIAL CONFLICTS OF INTEREST

    #65108
    TreeFrog
    Participant

    Hi Happy_girl,

    I agree with Catherine – especially the part about taking a deep breath!

    First off, of course many, many people with Stage III survive. Some never have another recurrence at all. And I’d say you are just barely Stage III if at all. Yes, get the second opinion from the best in the field. They will be able to tell you the significance – or insignificance – of the finding of one melanoma cell in a node.

    As Catherine said, Interferon is no longer used by the experts. I also have doubts that they would recommend a dissection. You are NED right now and may remain that way forever. :) See what the experts say about early detection and preventative options. You’ll feel a lot better.

    Best wishes,

    ~Wendy

    #65109
    Happy_girl
    Participant

    I wonder if they could get me in relatively quickly? I’m a teacher and school starts soon- although I know my health/life comes first.

    Jeff- my husband has been amazing. I know it is hard on him and he is scared- but he believes I’ll be ok. He is my rock- no way around that! I am blessed!!!!

    #65110
    Catherine Poole
    Keymaster

    Here is their number for SLoan’s melanoma center: Call 800-525-2225. You might see if you can get into see Dan Coit (the surgeon) first and he will consult with the rest of the team. They take a team approach and are excellent.

    #65111
    Happy_girl
    Participant

    Also- I’m hoping there is a chance it might not be melanoma in my lymph node- but I’m guessing they aren’t wrong in this diagnosis. I’m assuming it either is or isn’t – very clearly.

    #65112
    Catherine Poole
    Keymaster

    Your slides will be reviewed at Sloan Kettering, and yes, there is a chance that they may find something different. Always a good idea to have two opinions at least. You can send the slides ahead of your visit.

    #65113
    Happy_girl
    Participant

    Thank you for your help. I have called and am waiting for a call back.

    #65114
    alaskanmeg
    Participant

    Yes,take a deep breath, now hold it…hold it, okay let it out.

    First, I am unclear how it was decided that you are Stage III.

    However, did you get a Wide Lesion Excision?

    Don’t know Dr. Coit, but he seems to be very popular. I hope he tells you to “Wait and See”.

    Then you just become an expert on exploring your body looking for the tiniest of changes.

    What grade do you teach? I’m a K-8 Special Education teacher that doesn’t know what age I’ll be teaching this year. Last I taught it was Kindergarten, which was a hoot. I’m told I looked like a deer in the headlights when I first started with those Rugrats.

Viewing 15 posts - 1 through 15 (of 27 total)
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