March 14, 2011 (Hollywood, Florida) — The 2011 updated National Comprehensive Cancer Center (NCCN) guidelines for melanoma say that routine imaging is no longer required for stage IIa melanoma patients who have negative lymph nodes.
"We do not recommend a [computed tomography] scan for these patients. They don't have to have it. We have decided that there is no compromise in their care," committee chair Daniel G. Coit, MD, professor of medicine at Memorial Sloan-Kettering Cancer Center in New York City, told Medscape Medical News here at the NCCN 16th Annual Conference.
"It's a category 2a recommendation, meaning that there was general agreement among the committee but very little data in the form of prospective randomized trials."
Stage IIa melanoma patients are those with melanomas between 2 and 4 mm thick and no lymph node involvement.
Imaging should be undertaken only to evaluate specific signs or symptoms, he said.
"This is a unique category. The yield for imaging is extremely low in these patients, and the benefit has never been shown," Dr. Coit said in an interview.
The statement not to recommend is much stronger than the advice in the previous version of the guidelines, which left the decision of whether or not to image to the clinician's discretion.
"This time we are saying that we cannot recommend that the clinician do the imaging. That is an important message to get out. It tells the clinician that if you don't do it, you will not be sued, there will be no litigation, because we are standing here as a committee of experts behind you saying that what you have done is in accordance with best practice," he said.
Being able to guide clinical practice in this way is "one of the great potentials" of the NCCN, Dr. Coit noted.
"If we don't take charge of these recommendations for best practice, it will be totally random, or worse, it will be mandated by people who have absolutely no idea what they are doing," he said.
Biopsy Should Be Discussed With Patient
The updated guidelines also suggest that the possibility of a sentinel lymph node biopsy be discussed with patients with stage 1B or stage II disease.
"The committee recognized that there is no hard and fast rule about who should and who should not have one. There is no hard and fast rule about what the probability is of a positive lymph node that would trigger the recommendation for a sentinel node biopsy. This is something that should be discussed with the patient," he said.
Some patients, when told that they have a 5% chance of having a positive sentinel node, will opt for a sentinel node biopsy, and others will not.
"It's hard, but as a committee, we are starting to come to grips with some very low-risk groups (we consider 3% or less low risk). In these patients, we do not recommend a sentinel node biopsy," he said.
For patients with a positive sentinel node, the primary treatment should be enrolment in a clinical trial or lymph node dissection.
Adjuvant treatment should consist of enrolment in a clinical trial, observation, or high-dose interferon alfa. These are all category 2b recommendations, Dr. Coit said.
Who Needs Further Testing?
Another change in this year's update is the replacement of Clark level with mitotic index to define stage IB disease. The presence of a single incident of mitosis puts the patient into a higher-risk group, according to American Joint Committee on Cancer staging criteria.
Dr. Coit noted that refining who needs to go for further testing is extremely important in today's economic climate.
"The cost of finding a positive lymph node is very expensive. So the question is, when do we start this discussion about a sentinel lymph node biopsy and at what probability of a positive lymph node do we begin to think, yes, it is high enough to justify the cost of trying to find one. We don't have an effective treatment for that, and it costs $1.2 million to find a death we can't prevent and to identify 5 other people at risk, all of whom are worried and all of whom will live. This doesn't even include the additional expense of the imaging and follow-up. So we have to start taking cost into consideration in our work-ups," he said.
Dr. Coit also highlighted new drugs that are on the horizon for melanoma.
One drug that has shown promise in some patients with metastatic melanoma is the molecular agent ipilimumab (Bristol-Myers Squibb).
The US Food and Drug Administration will be deliberating whether to approve ipilimumab in 2 weeks. The NCCN committee is standing by and, if the drug is approved, it will add it as a treatment option immediately, Dr. Coit said.
"Ipilimumab in early trials has benefit and could be a significant advance," agreed Robert S. Kirsner, MD, PhD, professor and chief of dermatology at the University of Miami Miller School of Medicine and Sylvester Cancer Center, in Florida, who was invited to comment on the updated melanoma guidelines by Medscape Medical News.
"It certainly doesn't appear that it will be a cure-all, but it has the potential to become the first-line treatment for advanced melanoma," he said.
Dr. Kirsner added that, "if the guidelines are clear, they allow an easier path to care. In this case, where the guidelines specifically state that certain patients with stage I and IIa melanomas with negative nodes don't need imaging, I think this gives a clear message to clinicians what the expectations are, and I think that's important."
The guidelines also can alert the research community to new avenues of research, he said. "In this case, the recommendation not to image was made because there's really a lack of level 1 evidence. This might prompt investigators to do more research to support that recommendation. So there are 2 values to the NCCN guidelines. The obvious value is to the clinician and the second value is to the researcher."
Dr. Coit and Dr. Kirsner have disclosed no relevant financial relationships.
National Comprehensive Cancer Network (NCCN) 16th Annual Conference. Presented March 12, 2011.
"We do not recommend a [computed tomography] scan for these patients. They don't have to have it. We have decided that there is no compromise in their care," committee chair Daniel G. Coit, MD, professor of medicine at Memorial Sloan-Kettering Cancer Center in New York City, told Medscape Medical News here at the NCCN 16th Annual Conference.
"It's a category 2a recommendation, meaning that there was general agreement among the committee but very little data in the form of prospective randomized trials."
Stage IIa melanoma patients are those with melanomas between 2 and 4 mm thick and no lymph node involvement.
Imaging should be undertaken only to evaluate specific signs or symptoms, he said.
"This is a unique category. The yield for imaging is extremely low in these patients, and the benefit has never been shown," Dr. Coit said in an interview.
The statement not to recommend is much stronger than the advice in the previous version of the guidelines, which left the decision of whether or not to image to the clinician's discretion.
"This time we are saying that we cannot recommend that the clinician do the imaging. That is an important message to get out. It tells the clinician that if you don't do it, you will not be sued, there will be no litigation, because we are standing here as a committee of experts behind you saying that what you have done is in accordance with best practice," he said.
Being able to guide clinical practice in this way is "one of the great potentials" of the NCCN, Dr. Coit noted.
"If we don't take charge of these recommendations for best practice, it will be totally random, or worse, it will be mandated by people who have absolutely no idea what they are doing," he said.
Biopsy Should Be Discussed With Patient
The updated guidelines also suggest that the possibility of a sentinel lymph node biopsy be discussed with patients with stage 1B or stage II disease.
"The committee recognized that there is no hard and fast rule about who should and who should not have one. There is no hard and fast rule about what the probability is of a positive lymph node that would trigger the recommendation for a sentinel node biopsy. This is something that should be discussed with the patient," he said.
Some patients, when told that they have a 5% chance of having a positive sentinel node, will opt for a sentinel node biopsy, and others will not.
"It's hard, but as a committee, we are starting to come to grips with some very low-risk groups (we consider 3% or less low risk). In these patients, we do not recommend a sentinel node biopsy," he said.
For patients with a positive sentinel node, the primary treatment should be enrolment in a clinical trial or lymph node dissection.
Adjuvant treatment should consist of enrolment in a clinical trial, observation, or high-dose interferon alfa. These are all category 2b recommendations, Dr. Coit said.
Who Needs Further Testing?
Another change in this year's update is the replacement of Clark level with mitotic index to define stage IB disease. The presence of a single incident of mitosis puts the patient into a higher-risk group, according to American Joint Committee on Cancer staging criteria.
Dr. Coit noted that refining who needs to go for further testing is extremely important in today's economic climate.
"The cost of finding a positive lymph node is very expensive. So the question is, when do we start this discussion about a sentinel lymph node biopsy and at what probability of a positive lymph node do we begin to think, yes, it is high enough to justify the cost of trying to find one. We don't have an effective treatment for that, and it costs $1.2 million to find a death we can't prevent and to identify 5 other people at risk, all of whom are worried and all of whom will live. This doesn't even include the additional expense of the imaging and follow-up. So we have to start taking cost into consideration in our work-ups," he said.
Dr. Coit also highlighted new drugs that are on the horizon for melanoma.
One drug that has shown promise in some patients with metastatic melanoma is the molecular agent ipilimumab (Bristol-Myers Squibb).
The US Food and Drug Administration will be deliberating whether to approve ipilimumab in 2 weeks. The NCCN committee is standing by and, if the drug is approved, it will add it as a treatment option immediately, Dr. Coit said.
"Ipilimumab in early trials has benefit and could be a significant advance," agreed Robert S. Kirsner, MD, PhD, professor and chief of dermatology at the University of Miami Miller School of Medicine and Sylvester Cancer Center, in Florida, who was invited to comment on the updated melanoma guidelines by Medscape Medical News.
"It certainly doesn't appear that it will be a cure-all, but it has the potential to become the first-line treatment for advanced melanoma," he said.
Dr. Kirsner added that, "if the guidelines are clear, they allow an easier path to care. In this case, where the guidelines specifically state that certain patients with stage I and IIa melanomas with negative nodes don't need imaging, I think this gives a clear message to clinicians what the expectations are, and I think that's important."
The guidelines also can alert the research community to new avenues of research, he said. "In this case, the recommendation not to image was made because there's really a lack of level 1 evidence. This might prompt investigators to do more research to support that recommendation. So there are 2 values to the NCCN guidelines. The obvious value is to the clinician and the second value is to the researcher."
Dr. Coit and Dr. Kirsner have disclosed no relevant financial relationships.
National Comprehensive Cancer Network (NCCN) 16th Annual Conference. Presented March 12, 2011.
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου