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ACMS: High Risk for Secondary Malignancies after Melanoma
NEW YORK - The risk of developing a primary malignancy of the salivary gland, bone, prostate, and other areas is significantly--and in some cases dramatically--increased following a cutaneous melanoma diagnosis.
That's according to research by Dr. Joshua Spanogle, a resident in the department of dermatology at the Mayo Clinic in Rochester, Minn., presented during an abstract session at the American College of Mohs Surgery annual meeting.
Dr. Spanogle looked at data from the Surveillance, Epidemiology and End Results database (SEER) from 1973 to 2003, which included "over 1.3 million person years of observation," he said.
A total of 151,996 patients were found to have a cutaneous melanoma diagnosis during that period; 16,591 (11%) of these patients had a second documented primary malignancy sometime in the next 120 months. That observed rate was 32% higher than what would be expected among a healthy population in that time period, he said.
Further analysis of the results revealed that particular cancers carried a significantly higher risk than others.
The most striking, perhaps not surprisingly, is for a second primary cutaneous melanoma: there were 3,923 through 120 months of follow-up, for a standardized incidence ratio of 8.99. "This is the 600-pound elephant in the room," said Dr. Spanogle.
But other cancers have high standardized incidence ratios (SIRs) as well. Salivary gland malignancies following carcinoma had a SIR of 2.18 overall. Prostate cancer had a SIR of 1.13 following melanoma. Breast cancer showed a SIR of 1.07. And soft tissue cancers, including malignancies of the heart, had a SIR of 2.80.
On the other hand, "Quite a few cancers had a decreased incidence following melanoma," said Dr. Spanogle, including cancer of the liver (SIR 0.77), lungs (0.83), cervix (0.57), and pharynx (0.61).
That could be because risk factors for melanoma are associated with higher socioeconomic status, like fair skin and intermittent high intensity UV exposure (tanning), said Dr. Spanogle. In contrast, risk factors for lung cancer and liver cancer are associated with comorbidities commonly found in lower socioeconomic patients, like smoking and hepatitis.
Moreover, according to Dr. Spanogle, the risks of secondary cancers of the prostate gland, bone, soft tissue, and salivary gland remained elevated throughout the study period, "implying no surveillance bias."
Instead, he speculated that the link could be genetic, and said that future research into the possibility is warranted.
Dr. Spanogle reported having no disclosures relevant to his presentation. He added that this study has been accepted for publication in the Journal of the American Academy of Dermatology.
NEW YORK - The risk of developing a primary malignancy of the salivary gland, bone, prostate, and other areas is significantly--and in some cases dramatically--increased following a cutaneous melanoma diagnosis.
That's according to research by Dr. Joshua Spanogle, a resident in the department of dermatology at the Mayo Clinic in Rochester, Minn., presented during an abstract session at the American College of Mohs Surgery annual meeting.
Dr. Spanogle looked at data from the Surveillance, Epidemiology and End Results database (SEER) from 1973 to 2003, which included "over 1.3 million person years of observation," he said.
A total of 151,996 patients were found to have a cutaneous melanoma diagnosis during that period; 16,591 (11%) of these patients had a second documented primary malignancy sometime in the next 120 months. That observed rate was 32% higher than what would be expected among a healthy population in that time period, he said.
Further analysis of the results revealed that particular cancers carried a significantly higher risk than others.
The most striking, perhaps not surprisingly, is for a second primary cutaneous melanoma: there were 3,923 through 120 months of follow-up, for a standardized incidence ratio of 8.99. "This is the 600-pound elephant in the room," said Dr. Spanogle.
But other cancers have high standardized incidence ratios (SIRs) as well. Salivary gland malignancies following carcinoma had a SIR of 2.18 overall. Prostate cancer had a SIR of 1.13 following melanoma. Breast cancer showed a SIR of 1.07. And soft tissue cancers, including malignancies of the heart, had a SIR of 2.80.
On the other hand, "Quite a few cancers had a decreased incidence following melanoma," said Dr. Spanogle, including cancer of the liver (SIR 0.77), lungs (0.83), cervix (0.57), and pharynx (0.61).
That could be because risk factors for melanoma are associated with higher socioeconomic status, like fair skin and intermittent high intensity UV exposure (tanning), said Dr. Spanogle. In contrast, risk factors for lung cancer and liver cancer are associated with comorbidities commonly found in lower socioeconomic patients, like smoking and hepatitis.
Moreover, according to Dr. Spanogle, the risks of secondary cancers of the prostate gland, bone, soft tissue, and salivary gland remained elevated throughout the study period, "implying no surveillance bias."
Instead, he speculated that the link could be genetic, and said that future research into the possibility is warranted.
Dr. Spanogle reported having no disclosures relevant to his presentation. He added that this study has been accepted for publication in the Journal of the American Academy of Dermatology.
NEW YORK - The risk of developing a primary malignancy of the salivary gland, bone, prostate, and other areas is significantly--and in some cases dramatically--increased following a cutaneous melanoma diagnosis.
That's according to research by Dr. Joshua Spanogle, a resident in the department of dermatology at the Mayo Clinic in Rochester, Minn., presented during an abstract session at the American College of Mohs Surgery annual meeting.
Dr. Spanogle looked at data from the Surveillance, Epidemiology and End Results database (SEER) from 1973 to 2003, which included "over 1.3 million person years of observation," he said.
A total of 151,996 patients were found to have a cutaneous melanoma diagnosis during that period; 16,591 (11%) of these patients had a second documented primary malignancy sometime in the next 120 months. That observed rate was 32% higher than what would be expected among a healthy population in that time period, he said.
Further analysis of the results revealed that particular cancers carried a significantly higher risk than others.
The most striking, perhaps not surprisingly, is for a second primary cutaneous melanoma: there were 3,923 through 120 months of follow-up, for a standardized incidence ratio of 8.99. "This is the 600-pound elephant in the room," said Dr. Spanogle.
But other cancers have high standardized incidence ratios (SIRs) as well. Salivary gland malignancies following carcinoma had a SIR of 2.18 overall. Prostate cancer had a SIR of 1.13 following melanoma. Breast cancer showed a SIR of 1.07. And soft tissue cancers, including malignancies of the heart, had a SIR of 2.80.
On the other hand, "Quite a few cancers had a decreased incidence following melanoma," said Dr. Spanogle, including cancer of the liver (SIR 0.77), lungs (0.83), cervix (0.57), and pharynx (0.61).
That could be because risk factors for melanoma are associated with higher socioeconomic status, like fair skin and intermittent high intensity UV exposure (tanning), said Dr. Spanogle. In contrast, risk factors for lung cancer and liver cancer are associated with comorbidities commonly found in lower socioeconomic patients, like smoking and hepatitis.
Moreover, according to Dr. Spanogle, the risks of secondary cancers of the prostate gland, bone, soft tissue, and salivary gland remained elevated throughout the study period, "implying no surveillance bias."
Instead, he speculated that the link could be genetic, and said that future research into the possibility is warranted.
Dr. Spanogle reported having no disclosures relevant to his presentation. He added that this study has been accepted for publication in the Journal of the American Academy of Dermatology.
AAD: Digital Dermoscopy Device Detects Melanoma
MIAMI -- A computer-automated device detected melanoma and high-grade dysplastic nevi lesions with 98% sensitivity in a large, prospective, multicenter study.
The digital dermoscopy device "sees" at different skin depths using 10 spectral bands ranging from 430 nm to 950 nm. The technology, which was more than a decade in development, objectively assesses up to 75 factors to differentiate melanoma from low-grade and high-grade dysplastic nevi, Dr. Gary D. Monheit said.
Dr. Monheit was an investigator at one of seven sites that used the MelaFind (Electro-Optical Sciences) to assess a total of 1,632 evaluable lesions. Lesions included 70 invasive melanomas and 57 melanoma in situ. "This is the largest prospective, blinded study ever conducted in melanoma detection," he noted.
The noninvasive device has a handheld wand for image capture at the point of care. Because of these features and a proprietary algorithm that analyzes multiple spectrums, it is "totally objective with a yes or no algorithm for excision," said Dr. Monheit, a private practice dermatologist in Birmingham, Ala., and an associate clinical professor in the departments of dermatology and ophthalmology at the University of Alabama at Birmingham. Detection is automatic with immediate feedback, Dr. Monheit said. "If we don't get a clear image, the machine tells us the image is not possible." The technology was developed after assessment of more than 10,000 pigmented lesions from more than 7,000 patients.
The aim of this "pivotal study" was to establish safety of the device and sensitivity for melanoma detection. No adverse events were reported, Dr. Monheit said. Lesions had to be pigmented with melanin, keratin, and/or blood. Clinical management was biopsy, he added.
For melanoma and high-grade dysplastic nevi, the device had a 98% sensitivity. "These are the [lesions] you will want to take out," Dr. Monheit said.
"At same time we should look at specificity--we do not want to biopsy every lesion that comes into our office," Dr. Monheit said. The specificity of the device was 9.4%, statistically superior to the dermatologist evaluations at 3.7%.
The results with the device were compared with prebiopsy investigator diagnoses and with an objective pathologic review of lesions by a panel of three dermatopathologists. If two of the three dermatopathologists concurred on the diagnosis, their consensus was final. The device had a 98% sensitivity for biopsy detection.
Dr. Monheit and the other study investigators also collected patient data, including age, gender, ethnicity, patient in-house or referred, and any risk factors for melanoma. Anatomic locations of the lesions were also noted.
This study provides "evidence for safety and efficacy for aid in evaluating pigmented lesions," Dr. Monheit said.
Disclosures: Dr. Monheit is a consultant and researcher for Electro-Optical Sciences.
MIAMI -- A computer-automated device detected melanoma and high-grade dysplastic nevi lesions with 98% sensitivity in a large, prospective, multicenter study.
The digital dermoscopy device "sees" at different skin depths using 10 spectral bands ranging from 430 nm to 950 nm. The technology, which was more than a decade in development, objectively assesses up to 75 factors to differentiate melanoma from low-grade and high-grade dysplastic nevi, Dr. Gary D. Monheit said.
Dr. Monheit was an investigator at one of seven sites that used the MelaFind (Electro-Optical Sciences) to assess a total of 1,632 evaluable lesions. Lesions included 70 invasive melanomas and 57 melanoma in situ. "This is the largest prospective, blinded study ever conducted in melanoma detection," he noted.
The noninvasive device has a handheld wand for image capture at the point of care. Because of these features and a proprietary algorithm that analyzes multiple spectrums, it is "totally objective with a yes or no algorithm for excision," said Dr. Monheit, a private practice dermatologist in Birmingham, Ala., and an associate clinical professor in the departments of dermatology and ophthalmology at the University of Alabama at Birmingham. Detection is automatic with immediate feedback, Dr. Monheit said. "If we don't get a clear image, the machine tells us the image is not possible." The technology was developed after assessment of more than 10,000 pigmented lesions from more than 7,000 patients.
The aim of this "pivotal study" was to establish safety of the device and sensitivity for melanoma detection. No adverse events were reported, Dr. Monheit said. Lesions had to be pigmented with melanin, keratin, and/or blood. Clinical management was biopsy, he added.
For melanoma and high-grade dysplastic nevi, the device had a 98% sensitivity. "These are the [lesions] you will want to take out," Dr. Monheit said.
"At same time we should look at specificity--we do not want to biopsy every lesion that comes into our office," Dr. Monheit said. The specificity of the device was 9.4%, statistically superior to the dermatologist evaluations at 3.7%.
The results with the device were compared with prebiopsy investigator diagnoses and with an objective pathologic review of lesions by a panel of three dermatopathologists. If two of the three dermatopathologists concurred on the diagnosis, their consensus was final. The device had a 98% sensitivity for biopsy detection.
Dr. Monheit and the other study investigators also collected patient data, including age, gender, ethnicity, patient in-house or referred, and any risk factors for melanoma. Anatomic locations of the lesions were also noted.
This study provides "evidence for safety and efficacy for aid in evaluating pigmented lesions," Dr. Monheit said.
Disclosures: Dr. Monheit is a consultant and researcher for Electro-Optical Sciences.
MIAMI -- A computer-automated device detected melanoma and high-grade dysplastic nevi lesions with 98% sensitivity in a large, prospective, multicenter study.
The digital dermoscopy device "sees" at different skin depths using 10 spectral bands ranging from 430 nm to 950 nm. The technology, which was more than a decade in development, objectively assesses up to 75 factors to differentiate melanoma from low-grade and high-grade dysplastic nevi, Dr. Gary D. Monheit said.
Dr. Monheit was an investigator at one of seven sites that used the MelaFind (Electro-Optical Sciences) to assess a total of 1,632 evaluable lesions. Lesions included 70 invasive melanomas and 57 melanoma in situ. "This is the largest prospective, blinded study ever conducted in melanoma detection," he noted.
The noninvasive device has a handheld wand for image capture at the point of care. Because of these features and a proprietary algorithm that analyzes multiple spectrums, it is "totally objective with a yes or no algorithm for excision," said Dr. Monheit, a private practice dermatologist in Birmingham, Ala., and an associate clinical professor in the departments of dermatology and ophthalmology at the University of Alabama at Birmingham. Detection is automatic with immediate feedback, Dr. Monheit said. "If we don't get a clear image, the machine tells us the image is not possible." The technology was developed after assessment of more than 10,000 pigmented lesions from more than 7,000 patients.
The aim of this "pivotal study" was to establish safety of the device and sensitivity for melanoma detection. No adverse events were reported, Dr. Monheit said. Lesions had to be pigmented with melanin, keratin, and/or blood. Clinical management was biopsy, he added.
For melanoma and high-grade dysplastic nevi, the device had a 98% sensitivity. "These are the [lesions] you will want to take out," Dr. Monheit said.
"At same time we should look at specificity--we do not want to biopsy every lesion that comes into our office," Dr. Monheit said. The specificity of the device was 9.4%, statistically superior to the dermatologist evaluations at 3.7%.
The results with the device were compared with prebiopsy investigator diagnoses and with an objective pathologic review of lesions by a panel of three dermatopathologists. If two of the three dermatopathologists concurred on the diagnosis, their consensus was final. The device had a 98% sensitivity for biopsy detection.
Dr. Monheit and the other study investigators also collected patient data, including age, gender, ethnicity, patient in-house or referred, and any risk factors for melanoma. Anatomic locations of the lesions were also noted.
This study provides "evidence for safety and efficacy for aid in evaluating pigmented lesions," Dr. Monheit said.
Disclosures: Dr. Monheit is a consultant and researcher for Electro-Optical Sciences.
Attorney: Proper Pathology Slide Storage Helps Mitigate Lawsuits
SAN DIEGO - Reliably tracking and storing pathology slides is key to avoiding the possibility of major liability, Robert A. Cosgrove said at a melanoma conference sponsored by the Scripps Clinic.
To illustrate his point, Dr. Cosgrove presented the personal injury case of a woman with advanced melanoma. About 1 year after she presented to the physician-defendant for evaluation of a lesion on her toe, she required lymph node resection and amputation of the toe.
The plaintiff claimed that the physician had negligently lost biopsy results, resulting in a delay in proper treatment.
The defendant claimed that the plaintiff's lesion had disintegrated at the time it was originally removed and left nothing for further testing.
The jury awarded the plaintiff a settlement in excess of $8 million.
"I've had this come up in a number of cases," said Mr. Cosgrove, a health care attorney based in Encinitas, Calif. "The problem with losing or misplacing pathology slides [is that] it raises questions about whether that was done intentionally or not. Plus, it puts you in a difficult position of being able to prove or disprove what your diagnosis is or your interpretation of the slides."
Another case he discussed underscored the importance of solid chart documentation. The case was brought to trial by the heirs of a 36-year-old woman who died of melanoma while under the defendant dermatologist's care. The heirs contended that the defendant failed to diagnose the decedent's shoulder mole, which was cancerous, in a timely manner.
The defendant denied liability and contended that the decedent was comparatively negligent and failed to make her appointments for yearly full skin exams.
"It is imperative to have documentation in your charts - photo documentation, and in this situation, documentation of yearly examinations. … You can rely on custom and practice, but it's better evidence for the jury when you present the case at trial to have documentation in the chart to that effect," Mr. Cosgrove said.
The defendant also contended that the cancerous mole was not the same as the one that she complained about, and that the decedent would have survived at the time of diagnosis because the lesion was thin.
"Many of these cases are presented at time of trial 2 and 3 years downstream," Mr. Cosgrove noted. "So it comes down to chart documentation. Was it adequately documented in terms of the location of where the lesion was when you evaluated the patient?"
In this case the jury ruled in favor of the defense.
During a question and answer session, a meeting attendee asked Mr. Cosgrove how long physicians should keep medical records on file. "I would find out what the legal policy is in your state on this and follow it accordingly," he advised. "It's important to keep good records and to not do anything after the fact to change your records. By changing the record, by altering the records, by falsifying information, or by destroying records you expose yourself to tremendous personal liability."
Mr. Cosgrove said he had no relevant financial conflicts to disclose.
SAN DIEGO - Reliably tracking and storing pathology slides is key to avoiding the possibility of major liability, Robert A. Cosgrove said at a melanoma conference sponsored by the Scripps Clinic.
To illustrate his point, Dr. Cosgrove presented the personal injury case of a woman with advanced melanoma. About 1 year after she presented to the physician-defendant for evaluation of a lesion on her toe, she required lymph node resection and amputation of the toe.
The plaintiff claimed that the physician had negligently lost biopsy results, resulting in a delay in proper treatment.
The defendant claimed that the plaintiff's lesion had disintegrated at the time it was originally removed and left nothing for further testing.
The jury awarded the plaintiff a settlement in excess of $8 million.
"I've had this come up in a number of cases," said Mr. Cosgrove, a health care attorney based in Encinitas, Calif. "The problem with losing or misplacing pathology slides [is that] it raises questions about whether that was done intentionally or not. Plus, it puts you in a difficult position of being able to prove or disprove what your diagnosis is or your interpretation of the slides."
Another case he discussed underscored the importance of solid chart documentation. The case was brought to trial by the heirs of a 36-year-old woman who died of melanoma while under the defendant dermatologist's care. The heirs contended that the defendant failed to diagnose the decedent's shoulder mole, which was cancerous, in a timely manner.
The defendant denied liability and contended that the decedent was comparatively negligent and failed to make her appointments for yearly full skin exams.
"It is imperative to have documentation in your charts - photo documentation, and in this situation, documentation of yearly examinations. … You can rely on custom and practice, but it's better evidence for the jury when you present the case at trial to have documentation in the chart to that effect," Mr. Cosgrove said.
The defendant also contended that the cancerous mole was not the same as the one that she complained about, and that the decedent would have survived at the time of diagnosis because the lesion was thin.
"Many of these cases are presented at time of trial 2 and 3 years downstream," Mr. Cosgrove noted. "So it comes down to chart documentation. Was it adequately documented in terms of the location of where the lesion was when you evaluated the patient?"
In this case the jury ruled in favor of the defense.
During a question and answer session, a meeting attendee asked Mr. Cosgrove how long physicians should keep medical records on file. "I would find out what the legal policy is in your state on this and follow it accordingly," he advised. "It's important to keep good records and to not do anything after the fact to change your records. By changing the record, by altering the records, by falsifying information, or by destroying records you expose yourself to tremendous personal liability."
Mr. Cosgrove said he had no relevant financial conflicts to disclose.
SAN DIEGO - Reliably tracking and storing pathology slides is key to avoiding the possibility of major liability, Robert A. Cosgrove said at a melanoma conference sponsored by the Scripps Clinic.
To illustrate his point, Dr. Cosgrove presented the personal injury case of a woman with advanced melanoma. About 1 year after she presented to the physician-defendant for evaluation of a lesion on her toe, she required lymph node resection and amputation of the toe.
The plaintiff claimed that the physician had negligently lost biopsy results, resulting in a delay in proper treatment.
The defendant claimed that the plaintiff's lesion had disintegrated at the time it was originally removed and left nothing for further testing.
The jury awarded the plaintiff a settlement in excess of $8 million.
"I've had this come up in a number of cases," said Mr. Cosgrove, a health care attorney based in Encinitas, Calif. "The problem with losing or misplacing pathology slides [is that] it raises questions about whether that was done intentionally or not. Plus, it puts you in a difficult position of being able to prove or disprove what your diagnosis is or your interpretation of the slides."
Another case he discussed underscored the importance of solid chart documentation. The case was brought to trial by the heirs of a 36-year-old woman who died of melanoma while under the defendant dermatologist's care. The heirs contended that the defendant failed to diagnose the decedent's shoulder mole, which was cancerous, in a timely manner.
The defendant denied liability and contended that the decedent was comparatively negligent and failed to make her appointments for yearly full skin exams.
"It is imperative to have documentation in your charts - photo documentation, and in this situation, documentation of yearly examinations. … You can rely on custom and practice, but it's better evidence for the jury when you present the case at trial to have documentation in the chart to that effect," Mr. Cosgrove said.
The defendant also contended that the cancerous mole was not the same as the one that she complained about, and that the decedent would have survived at the time of diagnosis because the lesion was thin.
"Many of these cases are presented at time of trial 2 and 3 years downstream," Mr. Cosgrove noted. "So it comes down to chart documentation. Was it adequately documented in terms of the location of where the lesion was when you evaluated the patient?"
In this case the jury ruled in favor of the defense.
During a question and answer session, a meeting attendee asked Mr. Cosgrove how long physicians should keep medical records on file. "I would find out what the legal policy is in your state on this and follow it accordingly," he advised. "It's important to keep good records and to not do anything after the fact to change your records. By changing the record, by altering the records, by falsifying information, or by destroying records you expose yourself to tremendous personal liability."
Mr. Cosgrove said he had no relevant financial conflicts to disclose.
Chest X-Ray May Be Unnecessary After Surgical Treatment of Melanoma
CHICAGO - A chest x-ray after the surgical treatment of melanoma, as suggested in the National Comprehensive Cancer Networks guidelines, does not detect recurrence at levels sufficient to justify its use, according to an analysis from the Sunbelt Melanoma Trial.
In the review of more than 1,200 patients who had yearly chest x-rays following surgical treatment for melanoma, fewer than 0.1% of the x-rays showed pulmonary metastases that were amenable to resection, Dr. Russell E. Brown said at the annual meeting of the Central Surgical Association.
This finding has implications for patients' exposure to radiation, and, according to one member of the audience, for health care costs as well. "I think in 2010, with health care reform, we all need to look very carefully at what these follow-up criteria are and what we're using resources for," said Dr. Thomas Howard, professor of surgery at Indiana University, Indianapolis. "These are powerful data, and they really speak to the inadvisability of having a chest x-ray for everyone."
The National Comprehensive Cancer Networks Medical Practice Guidelines in Oncology (v.2.2009) describes the "option" of a chest x-ray - as well as a CBC and a lactate dehydrogenase (LDH) measurement - every 6-12 months in patients with melanoma stage IB-IV and no evidence of disease.
However, physicians do not necessarily view such guidelines as optional, said Dr. Brown of the University of Louisville (Ky.). "Recommendations such as these lead physicians to feel obligated to use the chest x-ray during follow-up," he noted.
The Sunbelt Melanoma Trial was a prospective, randomized trial of 3,619 patients (aged 18-70 years) at 79 centers in the United States and Canada. The trial evaluated the role of completion lymph node dissection or high-dose interferon alpha-2b in patients with melanoma that was staged by sentinel lymph node biopsy. All patients were clinically node negative, with primary tumors at least 1 mm thick. Those who had positive nodes in sentinel lymph node biopsy underwent completion lymphadenectomy. All patients also had yearly follow-up chest x-rays.
This analysis from the University of Louisville studied a subset of 1,235 patients whose follow-up comprised both a chest x-ray and other exams, including blood tests and evaluation of disease state and recurrence pattern. Within the subset, 1,025 patients (83%) had no recurrence, and 210 (17%) had recurrence. Sites of recurrence were locoregional in 108 patients (51%), distant in 74 (35%), and in the lung only in 28 (13%).
The subset of 1,235 patients had 4,218 chest x-rays, of which 38 (0.9%) were true positives and 3,593 (85.2%) were true negatives.
"An overwhelming 3,593 true negatives," said Dr. Brown. Of the 38 positives, 35 had widely disseminated metastases.
Only 3 (0.07%) of the 4,218 chest x-rays showed pulmonary metastases that were amenable to resection, said Dr. Brown. He invited the audience to extrapolate, pointing out that 1,406 chest x-rays were required to find a single resectable pulmonary metastasis. "Or conversely, 412 patients that you screen yearly for 74 months," he said.
Dr. Brown noted that the ideal screening test is noninvasive, low cost, and widely available, and has high sensitivity and specificity. It also must have potential for therapeutic benefit. A chest x-ray has "terrible" sensitivity and little therapeutic potential, he said.
Discussant Dr. Margo Shoup of Loyola University Medical Center in Maywood, Ill., asked Dr. Brown whether these findings have altered his practice in Louisville.
"Practice in multidisciplinary settings varies widely," said Dr. Brown. "Among our surgeons, we do not routinely perform chest x-ray imaging, LDH, or really anything other than physical exams. We rely heavily on patient education, and we see our patients about every 6 months for the first 1-5 years," he said. "Our medical colleagues use PET and CT liberally, without proven benefit, especially with the lack of effective systemic therapies."
Dr. Brown disclosed that the Sunbelt Melanoma Trial was supported by a grant from Schering Oncology/Biotech.
CHICAGO - A chest x-ray after the surgical treatment of melanoma, as suggested in the National Comprehensive Cancer Networks guidelines, does not detect recurrence at levels sufficient to justify its use, according to an analysis from the Sunbelt Melanoma Trial.
In the review of more than 1,200 patients who had yearly chest x-rays following surgical treatment for melanoma, fewer than 0.1% of the x-rays showed pulmonary metastases that were amenable to resection, Dr. Russell E. Brown said at the annual meeting of the Central Surgical Association.
This finding has implications for patients' exposure to radiation, and, according to one member of the audience, for health care costs as well. "I think in 2010, with health care reform, we all need to look very carefully at what these follow-up criteria are and what we're using resources for," said Dr. Thomas Howard, professor of surgery at Indiana University, Indianapolis. "These are powerful data, and they really speak to the inadvisability of having a chest x-ray for everyone."
The National Comprehensive Cancer Networks Medical Practice Guidelines in Oncology (v.2.2009) describes the "option" of a chest x-ray - as well as a CBC and a lactate dehydrogenase (LDH) measurement - every 6-12 months in patients with melanoma stage IB-IV and no evidence of disease.
However, physicians do not necessarily view such guidelines as optional, said Dr. Brown of the University of Louisville (Ky.). "Recommendations such as these lead physicians to feel obligated to use the chest x-ray during follow-up," he noted.
The Sunbelt Melanoma Trial was a prospective, randomized trial of 3,619 patients (aged 18-70 years) at 79 centers in the United States and Canada. The trial evaluated the role of completion lymph node dissection or high-dose interferon alpha-2b in patients with melanoma that was staged by sentinel lymph node biopsy. All patients were clinically node negative, with primary tumors at least 1 mm thick. Those who had positive nodes in sentinel lymph node biopsy underwent completion lymphadenectomy. All patients also had yearly follow-up chest x-rays.
This analysis from the University of Louisville studied a subset of 1,235 patients whose follow-up comprised both a chest x-ray and other exams, including blood tests and evaluation of disease state and recurrence pattern. Within the subset, 1,025 patients (83%) had no recurrence, and 210 (17%) had recurrence. Sites of recurrence were locoregional in 108 patients (51%), distant in 74 (35%), and in the lung only in 28 (13%).
The subset of 1,235 patients had 4,218 chest x-rays, of which 38 (0.9%) were true positives and 3,593 (85.2%) were true negatives.
"An overwhelming 3,593 true negatives," said Dr. Brown. Of the 38 positives, 35 had widely disseminated metastases.
Only 3 (0.07%) of the 4,218 chest x-rays showed pulmonary metastases that were amenable to resection, said Dr. Brown. He invited the audience to extrapolate, pointing out that 1,406 chest x-rays were required to find a single resectable pulmonary metastasis. "Or conversely, 412 patients that you screen yearly for 74 months," he said.
Dr. Brown noted that the ideal screening test is noninvasive, low cost, and widely available, and has high sensitivity and specificity. It also must have potential for therapeutic benefit. A chest x-ray has "terrible" sensitivity and little therapeutic potential, he said.
Discussant Dr. Margo Shoup of Loyola University Medical Center in Maywood, Ill., asked Dr. Brown whether these findings have altered his practice in Louisville.
"Practice in multidisciplinary settings varies widely," said Dr. Brown. "Among our surgeons, we do not routinely perform chest x-ray imaging, LDH, or really anything other than physical exams. We rely heavily on patient education, and we see our patients about every 6 months for the first 1-5 years," he said. "Our medical colleagues use PET and CT liberally, without proven benefit, especially with the lack of effective systemic therapies."
Dr. Brown disclosed that the Sunbelt Melanoma Trial was supported by a grant from Schering Oncology/Biotech.
CHICAGO - A chest x-ray after the surgical treatment of melanoma, as suggested in the National Comprehensive Cancer Networks guidelines, does not detect recurrence at levels sufficient to justify its use, according to an analysis from the Sunbelt Melanoma Trial.
In the review of more than 1,200 patients who had yearly chest x-rays following surgical treatment for melanoma, fewer than 0.1% of the x-rays showed pulmonary metastases that were amenable to resection, Dr. Russell E. Brown said at the annual meeting of the Central Surgical Association.
This finding has implications for patients' exposure to radiation, and, according to one member of the audience, for health care costs as well. "I think in 2010, with health care reform, we all need to look very carefully at what these follow-up criteria are and what we're using resources for," said Dr. Thomas Howard, professor of surgery at Indiana University, Indianapolis. "These are powerful data, and they really speak to the inadvisability of having a chest x-ray for everyone."
The National Comprehensive Cancer Networks Medical Practice Guidelines in Oncology (v.2.2009) describes the "option" of a chest x-ray - as well as a CBC and a lactate dehydrogenase (LDH) measurement - every 6-12 months in patients with melanoma stage IB-IV and no evidence of disease.
However, physicians do not necessarily view such guidelines as optional, said Dr. Brown of the University of Louisville (Ky.). "Recommendations such as these lead physicians to feel obligated to use the chest x-ray during follow-up," he noted.
The Sunbelt Melanoma Trial was a prospective, randomized trial of 3,619 patients (aged 18-70 years) at 79 centers in the United States and Canada. The trial evaluated the role of completion lymph node dissection or high-dose interferon alpha-2b in patients with melanoma that was staged by sentinel lymph node biopsy. All patients were clinically node negative, with primary tumors at least 1 mm thick. Those who had positive nodes in sentinel lymph node biopsy underwent completion lymphadenectomy. All patients also had yearly follow-up chest x-rays.
This analysis from the University of Louisville studied a subset of 1,235 patients whose follow-up comprised both a chest x-ray and other exams, including blood tests and evaluation of disease state and recurrence pattern. Within the subset, 1,025 patients (83%) had no recurrence, and 210 (17%) had recurrence. Sites of recurrence were locoregional in 108 patients (51%), distant in 74 (35%), and in the lung only in 28 (13%).
The subset of 1,235 patients had 4,218 chest x-rays, of which 38 (0.9%) were true positives and 3,593 (85.2%) were true negatives.
"An overwhelming 3,593 true negatives," said Dr. Brown. Of the 38 positives, 35 had widely disseminated metastases.
Only 3 (0.07%) of the 4,218 chest x-rays showed pulmonary metastases that were amenable to resection, said Dr. Brown. He invited the audience to extrapolate, pointing out that 1,406 chest x-rays were required to find a single resectable pulmonary metastasis. "Or conversely, 412 patients that you screen yearly for 74 months," he said.
Dr. Brown noted that the ideal screening test is noninvasive, low cost, and widely available, and has high sensitivity and specificity. It also must have potential for therapeutic benefit. A chest x-ray has "terrible" sensitivity and little therapeutic potential, he said.
Discussant Dr. Margo Shoup of Loyola University Medical Center in Maywood, Ill., asked Dr. Brown whether these findings have altered his practice in Louisville.
"Practice in multidisciplinary settings varies widely," said Dr. Brown. "Among our surgeons, we do not routinely perform chest x-ray imaging, LDH, or really anything other than physical exams. We rely heavily on patient education, and we see our patients about every 6 months for the first 1-5 years," he said. "Our medical colleagues use PET and CT liberally, without proven benefit, especially with the lack of effective systemic therapies."
Dr. Brown disclosed that the Sunbelt Melanoma Trial was supported by a grant from Schering Oncology/Biotech.
Indoor Tanning Addictive for Many Teens, Young Adults
Indoor tanning is an addictive behavior for a substantial portion of adolescents and young adults, findings in the April issue of the Archives of Dermatology suggest.
Any efforts to reduce skin cancer risk must address the addictive nature of indoor tanning for these members of the population, said Catherine E. Mosher, Ph.D., of the department of psychiatry and behavioral sciences, Memorial Sloan-Kettering Cancer Center, New York, and Sharon Danoff-Burg, Ph.D., of the department of psychology at the State University of New York, Albany.
They studied the self-reported indoor tanning habits of more than 400 students at a state university in the northeastern United States. The students completed anonymous questionnaires that also detailed their substance use. They also completed the Beck Depression Inventory and the Beck Anxiety Inventory, and addictive behavior was assessed using two measures to identify substance related disorders.
Nearly 40% of the 237 students who used indoor tanning met modified Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria for addiction to the behavior, they reported.
Students in this subgroup were more likely to report the recent use of two or more controlled substances (excluding alcohol), compared with those who occasionally or never used indoor tanning. A total of 42% of those who qualified as addicted to indoor tanning reported this level of substance use, compared with only 16% of the subjects who never used indoor tanning and 17% of those who occasionally did.
Students who met the criteria for addiction to indoor tanning also were approximately two times more likely to report symptoms of anxiety or depression than students who were not addicted to indoor tanning.
Taken together with the results of previous studies, these findings "suggest that individuals who use drugs may be more likely to develop dependence on indoor tanning because of a similar addictive process. In addition, tanning and drug use may be reinforced by peer group norms," the investigators wrote (Arch. Dermatol. 2010;146:412-7).
The study findings corroborate those of earlier research and extend "prior work by relating indoor tanning addiction to substance use and affective disturbance," Dr. Mosher and Dr. Danoff-Burg noted.
The results suggest that treating an underlying mood disorder "may be a necessary step in reducing skin cancer risk among those who frequently tan indoors.
"Researchers have hypothesized that those who tan regularly year round may require more intensive intervention efforts, such as motivational interviewing, relative to those who tan periodically in response to mood changes or special events," the investigators wrote.
Future studies "should evaluate the usefulness of incorporating a brief anxiety and depression screening for individuals who tan indoors," they wrote. Those found to have such symptoms can then be referred to mental health professionals for diagnosis and treatment.
This study was funded in part by the National Cancer Institute. No financial conflicts of interest were reported.
Indoor tanning is an addictive behavior for a substantial portion of adolescents and young adults, findings in the April issue of the Archives of Dermatology suggest.
Any efforts to reduce skin cancer risk must address the addictive nature of indoor tanning for these members of the population, said Catherine E. Mosher, Ph.D., of the department of psychiatry and behavioral sciences, Memorial Sloan-Kettering Cancer Center, New York, and Sharon Danoff-Burg, Ph.D., of the department of psychology at the State University of New York, Albany.
They studied the self-reported indoor tanning habits of more than 400 students at a state university in the northeastern United States. The students completed anonymous questionnaires that also detailed their substance use. They also completed the Beck Depression Inventory and the Beck Anxiety Inventory, and addictive behavior was assessed using two measures to identify substance related disorders.
Nearly 40% of the 237 students who used indoor tanning met modified Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria for addiction to the behavior, they reported.
Students in this subgroup were more likely to report the recent use of two or more controlled substances (excluding alcohol), compared with those who occasionally or never used indoor tanning. A total of 42% of those who qualified as addicted to indoor tanning reported this level of substance use, compared with only 16% of the subjects who never used indoor tanning and 17% of those who occasionally did.
Students who met the criteria for addiction to indoor tanning also were approximately two times more likely to report symptoms of anxiety or depression than students who were not addicted to indoor tanning.
Taken together with the results of previous studies, these findings "suggest that individuals who use drugs may be more likely to develop dependence on indoor tanning because of a similar addictive process. In addition, tanning and drug use may be reinforced by peer group norms," the investigators wrote (Arch. Dermatol. 2010;146:412-7).
The study findings corroborate those of earlier research and extend "prior work by relating indoor tanning addiction to substance use and affective disturbance," Dr. Mosher and Dr. Danoff-Burg noted.
The results suggest that treating an underlying mood disorder "may be a necessary step in reducing skin cancer risk among those who frequently tan indoors.
"Researchers have hypothesized that those who tan regularly year round may require more intensive intervention efforts, such as motivational interviewing, relative to those who tan periodically in response to mood changes or special events," the investigators wrote.
Future studies "should evaluate the usefulness of incorporating a brief anxiety and depression screening for individuals who tan indoors," they wrote. Those found to have such symptoms can then be referred to mental health professionals for diagnosis and treatment.
This study was funded in part by the National Cancer Institute. No financial conflicts of interest were reported.
Indoor tanning is an addictive behavior for a substantial portion of adolescents and young adults, findings in the April issue of the Archives of Dermatology suggest.
Any efforts to reduce skin cancer risk must address the addictive nature of indoor tanning for these members of the population, said Catherine E. Mosher, Ph.D., of the department of psychiatry and behavioral sciences, Memorial Sloan-Kettering Cancer Center, New York, and Sharon Danoff-Burg, Ph.D., of the department of psychology at the State University of New York, Albany.
They studied the self-reported indoor tanning habits of more than 400 students at a state university in the northeastern United States. The students completed anonymous questionnaires that also detailed their substance use. They also completed the Beck Depression Inventory and the Beck Anxiety Inventory, and addictive behavior was assessed using two measures to identify substance related disorders.
Nearly 40% of the 237 students who used indoor tanning met modified Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria for addiction to the behavior, they reported.
Students in this subgroup were more likely to report the recent use of two or more controlled substances (excluding alcohol), compared with those who occasionally or never used indoor tanning. A total of 42% of those who qualified as addicted to indoor tanning reported this level of substance use, compared with only 16% of the subjects who never used indoor tanning and 17% of those who occasionally did.
Students who met the criteria for addiction to indoor tanning also were approximately two times more likely to report symptoms of anxiety or depression than students who were not addicted to indoor tanning.
Taken together with the results of previous studies, these findings "suggest that individuals who use drugs may be more likely to develop dependence on indoor tanning because of a similar addictive process. In addition, tanning and drug use may be reinforced by peer group norms," the investigators wrote (Arch. Dermatol. 2010;146:412-7).
The study findings corroborate those of earlier research and extend "prior work by relating indoor tanning addiction to substance use and affective disturbance," Dr. Mosher and Dr. Danoff-Burg noted.
The results suggest that treating an underlying mood disorder "may be a necessary step in reducing skin cancer risk among those who frequently tan indoors.
"Researchers have hypothesized that those who tan regularly year round may require more intensive intervention efforts, such as motivational interviewing, relative to those who tan periodically in response to mood changes or special events," the investigators wrote.
Future studies "should evaluate the usefulness of incorporating a brief anxiety and depression screening for individuals who tan indoors," they wrote. Those found to have such symptoms can then be referred to mental health professionals for diagnosis and treatment.
This study was funded in part by the National Cancer Institute. No financial conflicts of interest were reported.
Non–Sentinel Node Metastasis Important Prognostic Factor in Melanoma
ST. LOUIS - Non–sentinel node status is an independent prognostic factor for disease-free survival and overall survival in patients with melanoma, results from a large study with long-term follow-up demonstrated.
“This effect is not simply a result of greater numbers of positive nodes,” Dr. Russell E. Brown said at a symposium sponsored by the Society of Surgical Oncology.
The findings support the notion that the sentinel lymph node (SLN) acts as the first line of defense against metastasis in melanoma and that metastasis past the SLN predicts a poorer prognosis.
“Status of sentinel lymph nodes is the most powerful predictor of outcomes for early-stage melanoma,” said Dr. Brown, a surgical oncology fellow at the University of Louisville, Kentucky. “Non–sentinel nodes (NSN) are evaluated at completion of lymph node dissection and are found in 8%-33% of complete lymph node dissection specimens.”
Multiple factors are used to predict NSN metastases, he said, including include age, tumor thickness, number of sentinel lymph nodes, SLN tumor burden, ulceration, male gender, perinodal intralymphatic tumor, and extranodal extension. While single-institution studies have shown a survival disadvantage for NSN-positive patients, Dr. Brown and his associates hypothesized that metastasis beyond the SLN to the non–sentinel nodes is an important predictor of survival.
To test their hypothesis, the researchers performed a post hoc analysis of data from 2,335 patients in the Sunbelt Melanoma Trial, a prospective, randomized study of patients aged 18-70 years at 79 centers in the United States and Canada. The Sunbelt Melanoma Trial was the world’s largest prospective study of melanoma, led by Dr. Kelly McMasters, chair of the department of surgery at the University of Louisville. Patients were treated between 1997 and 2003 and were clinically node negative, with primary tumors at least 1 mm thick. All subjects underwent SLN biopsy and were followed for a median of 68 months.
The researchers used Kaplan-Meier analysis and univariate and multivariate analysis to compare disease-free survival and overall survival in three groups of patients: 1,988 who were SLN negative (group 1), 296 who were SLN-only positive (group 2), and 51 who were SLN and NSN positive (group 3). Dr. Brown reported that the 5-year disease-free survival rates for groups 1, 2, and 3 were 86%, 65%, and 43%, respectively, while the 5-year overall survival rates were 86%, 65%, and 49%, respectively.
Univariate analysis revealed the following significant independent predictors of decreased disease-free survival: SLN positivity (hazard ratio of 2.4), NSN positivity (HR 4.57), increased total number of positive lymph nodes (HR 1.18), increased ratio of positive lymph node count to total lymph node count (HR 1.03), increased Breslow thickness (HR 3.28), presence of ulceration (HR 2.76), Clark level of 4 or greater (HR 1.65), axial primary (HR 1.45), and male gender (1.31).
When the total number of positive lymph nodes and NSN status were evaluated in a multivariate Cox model with other univariate predictors of decreased disease-free survival, NSN status remained statistically significant (HR 3.95), while the total number of positive lymph nodes and lymph node ratio did not (both were an HR of 1.01).
Univariate analysis also revealed the following significant predictors of decreased overall survival: SLN positivity (HR 2.29), NSN positivity (HR 3.6), increased total number of positive lymph nodes (HR 1.16), increased ratio of positive lymph node count to total lymph node count (HR 1.03), increased Breslow thickness (HR 2.96), presence of ulceration (HR 2.92), Clark level of 4 or greater (HR 1.41), axial primary (HR 1.71), male gender (1.68), and increased age (HR 1.24).
“The results of Dr. Brown’s study are important and suggest that there is a biological significance to the sentinel nodes as the first line of defense against metastasis in melanoma,” said Dr. McMasters, a melanoma specialist.
When the total number of positive lymph nodes and NSN status were evaluated in a multivariate Cox model with other univariate predictors of decreased overall survival, NSN status remained statistically significant (HR 2.81) while the total number of positive lymph nodes and lymph node ratio did not (HR of 1.03 and 1.11, respectively).
Dr. Brown noted that lymphovascular invasion, the number of involved nodal basins, the presence of a vertical growth phase, and evidence of regression were not significant predictors of overall survival.
Dr. McMasters has received grant support for the study from Schering Oncology/Biotech and has been on the company’s speakers bureau.
Dr. Brown had no relevant financial disclosures.
ST. LOUIS - Non–sentinel node status is an independent prognostic factor for disease-free survival and overall survival in patients with melanoma, results from a large study with long-term follow-up demonstrated.
“This effect is not simply a result of greater numbers of positive nodes,” Dr. Russell E. Brown said at a symposium sponsored by the Society of Surgical Oncology.
The findings support the notion that the sentinel lymph node (SLN) acts as the first line of defense against metastasis in melanoma and that metastasis past the SLN predicts a poorer prognosis.
“Status of sentinel lymph nodes is the most powerful predictor of outcomes for early-stage melanoma,” said Dr. Brown, a surgical oncology fellow at the University of Louisville, Kentucky. “Non–sentinel nodes (NSN) are evaluated at completion of lymph node dissection and are found in 8%-33% of complete lymph node dissection specimens.”
Multiple factors are used to predict NSN metastases, he said, including include age, tumor thickness, number of sentinel lymph nodes, SLN tumor burden, ulceration, male gender, perinodal intralymphatic tumor, and extranodal extension. While single-institution studies have shown a survival disadvantage for NSN-positive patients, Dr. Brown and his associates hypothesized that metastasis beyond the SLN to the non–sentinel nodes is an important predictor of survival.
To test their hypothesis, the researchers performed a post hoc analysis of data from 2,335 patients in the Sunbelt Melanoma Trial, a prospective, randomized study of patients aged 18-70 years at 79 centers in the United States and Canada. The Sunbelt Melanoma Trial was the world’s largest prospective study of melanoma, led by Dr. Kelly McMasters, chair of the department of surgery at the University of Louisville. Patients were treated between 1997 and 2003 and were clinically node negative, with primary tumors at least 1 mm thick. All subjects underwent SLN biopsy and were followed for a median of 68 months.
The researchers used Kaplan-Meier analysis and univariate and multivariate analysis to compare disease-free survival and overall survival in three groups of patients: 1,988 who were SLN negative (group 1), 296 who were SLN-only positive (group 2), and 51 who were SLN and NSN positive (group 3). Dr. Brown reported that the 5-year disease-free survival rates for groups 1, 2, and 3 were 86%, 65%, and 43%, respectively, while the 5-year overall survival rates were 86%, 65%, and 49%, respectively.
Univariate analysis revealed the following significant independent predictors of decreased disease-free survival: SLN positivity (hazard ratio of 2.4), NSN positivity (HR 4.57), increased total number of positive lymph nodes (HR 1.18), increased ratio of positive lymph node count to total lymph node count (HR 1.03), increased Breslow thickness (HR 3.28), presence of ulceration (HR 2.76), Clark level of 4 or greater (HR 1.65), axial primary (HR 1.45), and male gender (1.31).
When the total number of positive lymph nodes and NSN status were evaluated in a multivariate Cox model with other univariate predictors of decreased disease-free survival, NSN status remained statistically significant (HR 3.95), while the total number of positive lymph nodes and lymph node ratio did not (both were an HR of 1.01).
Univariate analysis also revealed the following significant predictors of decreased overall survival: SLN positivity (HR 2.29), NSN positivity (HR 3.6), increased total number of positive lymph nodes (HR 1.16), increased ratio of positive lymph node count to total lymph node count (HR 1.03), increased Breslow thickness (HR 2.96), presence of ulceration (HR 2.92), Clark level of 4 or greater (HR 1.41), axial primary (HR 1.71), male gender (1.68), and increased age (HR 1.24).
“The results of Dr. Brown’s study are important and suggest that there is a biological significance to the sentinel nodes as the first line of defense against metastasis in melanoma,” said Dr. McMasters, a melanoma specialist.
When the total number of positive lymph nodes and NSN status were evaluated in a multivariate Cox model with other univariate predictors of decreased overall survival, NSN status remained statistically significant (HR 2.81) while the total number of positive lymph nodes and lymph node ratio did not (HR of 1.03 and 1.11, respectively).
Dr. Brown noted that lymphovascular invasion, the number of involved nodal basins, the presence of a vertical growth phase, and evidence of regression were not significant predictors of overall survival.
Dr. McMasters has received grant support for the study from Schering Oncology/Biotech and has been on the company’s speakers bureau.
Dr. Brown had no relevant financial disclosures.
ST. LOUIS - Non–sentinel node status is an independent prognostic factor for disease-free survival and overall survival in patients with melanoma, results from a large study with long-term follow-up demonstrated.
“This effect is not simply a result of greater numbers of positive nodes,” Dr. Russell E. Brown said at a symposium sponsored by the Society of Surgical Oncology.
The findings support the notion that the sentinel lymph node (SLN) acts as the first line of defense against metastasis in melanoma and that metastasis past the SLN predicts a poorer prognosis.
“Status of sentinel lymph nodes is the most powerful predictor of outcomes for early-stage melanoma,” said Dr. Brown, a surgical oncology fellow at the University of Louisville, Kentucky. “Non–sentinel nodes (NSN) are evaluated at completion of lymph node dissection and are found in 8%-33% of complete lymph node dissection specimens.”
Multiple factors are used to predict NSN metastases, he said, including include age, tumor thickness, number of sentinel lymph nodes, SLN tumor burden, ulceration, male gender, perinodal intralymphatic tumor, and extranodal extension. While single-institution studies have shown a survival disadvantage for NSN-positive patients, Dr. Brown and his associates hypothesized that metastasis beyond the SLN to the non–sentinel nodes is an important predictor of survival.
To test their hypothesis, the researchers performed a post hoc analysis of data from 2,335 patients in the Sunbelt Melanoma Trial, a prospective, randomized study of patients aged 18-70 years at 79 centers in the United States and Canada. The Sunbelt Melanoma Trial was the world’s largest prospective study of melanoma, led by Dr. Kelly McMasters, chair of the department of surgery at the University of Louisville. Patients were treated between 1997 and 2003 and were clinically node negative, with primary tumors at least 1 mm thick. All subjects underwent SLN biopsy and were followed for a median of 68 months.
The researchers used Kaplan-Meier analysis and univariate and multivariate analysis to compare disease-free survival and overall survival in three groups of patients: 1,988 who were SLN negative (group 1), 296 who were SLN-only positive (group 2), and 51 who were SLN and NSN positive (group 3). Dr. Brown reported that the 5-year disease-free survival rates for groups 1, 2, and 3 were 86%, 65%, and 43%, respectively, while the 5-year overall survival rates were 86%, 65%, and 49%, respectively.
Univariate analysis revealed the following significant independent predictors of decreased disease-free survival: SLN positivity (hazard ratio of 2.4), NSN positivity (HR 4.57), increased total number of positive lymph nodes (HR 1.18), increased ratio of positive lymph node count to total lymph node count (HR 1.03), increased Breslow thickness (HR 3.28), presence of ulceration (HR 2.76), Clark level of 4 or greater (HR 1.65), axial primary (HR 1.45), and male gender (1.31).
When the total number of positive lymph nodes and NSN status were evaluated in a multivariate Cox model with other univariate predictors of decreased disease-free survival, NSN status remained statistically significant (HR 3.95), while the total number of positive lymph nodes and lymph node ratio did not (both were an HR of 1.01).
Univariate analysis also revealed the following significant predictors of decreased overall survival: SLN positivity (HR 2.29), NSN positivity (HR 3.6), increased total number of positive lymph nodes (HR 1.16), increased ratio of positive lymph node count to total lymph node count (HR 1.03), increased Breslow thickness (HR 2.96), presence of ulceration (HR 2.92), Clark level of 4 or greater (HR 1.41), axial primary (HR 1.71), male gender (1.68), and increased age (HR 1.24).
“The results of Dr. Brown’s study are important and suggest that there is a biological significance to the sentinel nodes as the first line of defense against metastasis in melanoma,” said Dr. McMasters, a melanoma specialist.
When the total number of positive lymph nodes and NSN status were evaluated in a multivariate Cox model with other univariate predictors of decreased overall survival, NSN status remained statistically significant (HR 2.81) while the total number of positive lymph nodes and lymph node ratio did not (HR of 1.03 and 1.11, respectively).
Dr. Brown noted that lymphovascular invasion, the number of involved nodal basins, the presence of a vertical growth phase, and evidence of regression were not significant predictors of overall survival.
Dr. McMasters has received grant support for the study from Schering Oncology/Biotech and has been on the company’s speakers bureau.
Dr. Brown had no relevant financial disclosures.
Merkel Cell Cancer Virus Discovery May Yield New Treatments
MADRID – The discovery of a new virus that appears to play a causative role in most cases of Merkel cell carcinoma has brought a new sense of optimism regarding this most aggressive of all cutaneous neoplasms.
"The discovery of the Merkel cell polyomavirus could be a major breakthrough. It could hopefully lead to new, more successful treatments," Dr. Ingrid Wolf said at the 13th World Congress on Cancers of the Skin.
Among the therapeutic possibilities opened up by the discovery of the new Merkel cell polyomavirus, known as MCPyV for short, are a preventive vaccine, interferon therapy, and serologic screening of individuals at increased risk for Merkel cell carcinoma to identify those infected by MCPyV and thus in need of close surveillance, added Dr. Wolf, a dermatologist at the University of Graz (Austria).
She provided an encouraging case report involving a patient with multiple nodular lesions on the arm. The largest lesion was excised, while the rest were treated with daily injections of interferon-beta for 5 weeks with no adjuvant radiation or chemotherapy. The lesions have regressed, and the patient has since gone 8 years without relapse or recurrence. The discovery of MCPyV provides a mechanistic basis for this success story.
MCPyV was discovered by the same team of investigators that found a new oncogenic herpesvirus that is the cause of Kaposi’s sarcoma, both HIV-related and non-HIV-related (N. Engl. J. Med. 2005;332:1,181-5).
The researchers surmised that MCPyV is far more likely to play an etiologic role in Merkel cell carcinoma than to be a bystander based on their demonstration that the virus is clonally integrated in the tumor genome (Science 2008;319:1,096-100). This observation suggests MCPyV is involved in clonal expansion of the tumor.
The group’s findings have subsequently been confirmed and expanded upon in other laboratories. It is now apparent that MCPyV is present in 70%-80% of Merkel cell carcinomas.
This trend is consistent with two broad population trends: the graying of society, and the steadily increasing population of immunosuppressed individuals. The risk of Merkel cell carcinoma has been estimated to be increased 8-fold in HIV-positive patients, 10-fold in organ transplant recipients, and at least 20-fold in patients living with chronic lymphocytic leukemia. The other major risk factor for Merkel cell carcinoma is age greater than 60. The most common site is the head and neck, reflecting the tumor’s predilection for UV-damaged skin. Sixty-two percent of patients in the SEER analysis were men. Nearly 97% of cases occurred in Caucasians.
MCPyV, like other polyomaviruses, is a small double-helix DNA virus. Infection by the virus is widespread: Serum antibodies are present in 80% of individuals over age 50 and 50% of those less than 15 years old.
The virus appears to be involved in the pathogenesis of other malignancies apart from Merkel cell carcinoma. It has been reported to be present in 6% of Kaposi’s sarcoma specimens and two-thirds of basal cell carcinomas. The basal cell carcinomas linked to MCPyV tend to have more necrosis and less palisading, according to Dr. Fernandez-Figueras of the Autonomous University of Barcelona.
The overall 5-year mortality of Merkel cell carcinoma is 33%. Tumor stage at diagnosis is the chief determinant of prognosis. The 5-year survival rate ranges from 79% for patients with tumors 2 cm or less and no lymph node involvement to 26%-42% with regional nodal involvement to 10%-18% for stage IV disease marked by distant metastasis.
Merkel cell carcinoma is a rapidly growing small cell neuroendocrine tumor of the skin. The Merkel cells present in the tumor are thought to originate from epidermal cells in the basal layer or adnexa, or perhaps from a primitive cutaneous epithelial precursor, Dr. Fernandez-Figueras observed.
It’s important to note that the biologic behavior of Merkel cell carcinoma is the same regardless of whether or not a tumor is associated with MCPyV, she stressed.
Dr. Wolf said the diagnostic challenge is to distinguish Merkel cell carcinoma from metastatic small cell carcinoma of the lung, melanoma, and lymphoblastic lymphoma. This can be done immunohistologically on the basis of positive staining for cytokeratin 20 and neurofilament, which is unique to Merkel cell carcinoma among these cancers. Also, most Merkel cell carcinomas will stain positive for CM2B4, which recognizes MCPyV, while the other malignancies will not.
Current guidelines recommend surgery with wide margins along with routine sentinel lymph node biopsy. Radiation therapy to the tumor bed and regional lymph nodes is recommended when nodes are positive.
“Surgery is the best and I would say the only good treatment for Merkel cell carcinoma,” according to Dr. Fernandez-Figueras.
Chemotherapy is palliative. The agents used are similar to those employed in small cell lung carcinoma, including cyclophosphamide, doxorubicin, vincristine, and cisplatin with or without etoposide.
Dr. Wolf said there is considerable interest in trying targeted therapy for Merkel cell carcinoma. A Phase II study of the bcl-2 antisense agent oblimersen (Genasense) disappointingly showed no objective responses in patients with advanced disease (Am. J. Clin. Oncol. 2009;32:174-9). However, there is a case report of an excellent result with pazopanib (Votrient) in a patient with metastatic Merkel cell carcinoma (J. Clin. Oncol. 2009;27:e97-100; PMID 19564526).
Drs. Wolf and Fernandez-Figueras reported they had no financial conflicts.
MADRID – The discovery of a new virus that appears to play a causative role in most cases of Merkel cell carcinoma has brought a new sense of optimism regarding this most aggressive of all cutaneous neoplasms.
"The discovery of the Merkel cell polyomavirus could be a major breakthrough. It could hopefully lead to new, more successful treatments," Dr. Ingrid Wolf said at the 13th World Congress on Cancers of the Skin.
Among the therapeutic possibilities opened up by the discovery of the new Merkel cell polyomavirus, known as MCPyV for short, are a preventive vaccine, interferon therapy, and serologic screening of individuals at increased risk for Merkel cell carcinoma to identify those infected by MCPyV and thus in need of close surveillance, added Dr. Wolf, a dermatologist at the University of Graz (Austria).
She provided an encouraging case report involving a patient with multiple nodular lesions on the arm. The largest lesion was excised, while the rest were treated with daily injections of interferon-beta for 5 weeks with no adjuvant radiation or chemotherapy. The lesions have regressed, and the patient has since gone 8 years without relapse or recurrence. The discovery of MCPyV provides a mechanistic basis for this success story.
MCPyV was discovered by the same team of investigators that found a new oncogenic herpesvirus that is the cause of Kaposi’s sarcoma, both HIV-related and non-HIV-related (N. Engl. J. Med. 2005;332:1,181-5).
The researchers surmised that MCPyV is far more likely to play an etiologic role in Merkel cell carcinoma than to be a bystander based on their demonstration that the virus is clonally integrated in the tumor genome (Science 2008;319:1,096-100). This observation suggests MCPyV is involved in clonal expansion of the tumor.
The group’s findings have subsequently been confirmed and expanded upon in other laboratories. It is now apparent that MCPyV is present in 70%-80% of Merkel cell carcinomas.
This trend is consistent with two broad population trends: the graying of society, and the steadily increasing population of immunosuppressed individuals. The risk of Merkel cell carcinoma has been estimated to be increased 8-fold in HIV-positive patients, 10-fold in organ transplant recipients, and at least 20-fold in patients living with chronic lymphocytic leukemia. The other major risk factor for Merkel cell carcinoma is age greater than 60. The most common site is the head and neck, reflecting the tumor’s predilection for UV-damaged skin. Sixty-two percent of patients in the SEER analysis were men. Nearly 97% of cases occurred in Caucasians.
MCPyV, like other polyomaviruses, is a small double-helix DNA virus. Infection by the virus is widespread: Serum antibodies are present in 80% of individuals over age 50 and 50% of those less than 15 years old.
The virus appears to be involved in the pathogenesis of other malignancies apart from Merkel cell carcinoma. It has been reported to be present in 6% of Kaposi’s sarcoma specimens and two-thirds of basal cell carcinomas. The basal cell carcinomas linked to MCPyV tend to have more necrosis and less palisading, according to Dr. Fernandez-Figueras of the Autonomous University of Barcelona.
The overall 5-year mortality of Merkel cell carcinoma is 33%. Tumor stage at diagnosis is the chief determinant of prognosis. The 5-year survival rate ranges from 79% for patients with tumors 2 cm or less and no lymph node involvement to 26%-42% with regional nodal involvement to 10%-18% for stage IV disease marked by distant metastasis.
Merkel cell carcinoma is a rapidly growing small cell neuroendocrine tumor of the skin. The Merkel cells present in the tumor are thought to originate from epidermal cells in the basal layer or adnexa, or perhaps from a primitive cutaneous epithelial precursor, Dr. Fernandez-Figueras observed.
It’s important to note that the biologic behavior of Merkel cell carcinoma is the same regardless of whether or not a tumor is associated with MCPyV, she stressed.
Dr. Wolf said the diagnostic challenge is to distinguish Merkel cell carcinoma from metastatic small cell carcinoma of the lung, melanoma, and lymphoblastic lymphoma. This can be done immunohistologically on the basis of positive staining for cytokeratin 20 and neurofilament, which is unique to Merkel cell carcinoma among these cancers. Also, most Merkel cell carcinomas will stain positive for CM2B4, which recognizes MCPyV, while the other malignancies will not.
Current guidelines recommend surgery with wide margins along with routine sentinel lymph node biopsy. Radiation therapy to the tumor bed and regional lymph nodes is recommended when nodes are positive.
“Surgery is the best and I would say the only good treatment for Merkel cell carcinoma,” according to Dr. Fernandez-Figueras.
Chemotherapy is palliative. The agents used are similar to those employed in small cell lung carcinoma, including cyclophosphamide, doxorubicin, vincristine, and cisplatin with or without etoposide.
Dr. Wolf said there is considerable interest in trying targeted therapy for Merkel cell carcinoma. A Phase II study of the bcl-2 antisense agent oblimersen (Genasense) disappointingly showed no objective responses in patients with advanced disease (Am. J. Clin. Oncol. 2009;32:174-9). However, there is a case report of an excellent result with pazopanib (Votrient) in a patient with metastatic Merkel cell carcinoma (J. Clin. Oncol. 2009;27:e97-100; PMID 19564526).
Drs. Wolf and Fernandez-Figueras reported they had no financial conflicts.
MADRID – The discovery of a new virus that appears to play a causative role in most cases of Merkel cell carcinoma has brought a new sense of optimism regarding this most aggressive of all cutaneous neoplasms.
"The discovery of the Merkel cell polyomavirus could be a major breakthrough. It could hopefully lead to new, more successful treatments," Dr. Ingrid Wolf said at the 13th World Congress on Cancers of the Skin.
Among the therapeutic possibilities opened up by the discovery of the new Merkel cell polyomavirus, known as MCPyV for short, are a preventive vaccine, interferon therapy, and serologic screening of individuals at increased risk for Merkel cell carcinoma to identify those infected by MCPyV and thus in need of close surveillance, added Dr. Wolf, a dermatologist at the University of Graz (Austria).
She provided an encouraging case report involving a patient with multiple nodular lesions on the arm. The largest lesion was excised, while the rest were treated with daily injections of interferon-beta for 5 weeks with no adjuvant radiation or chemotherapy. The lesions have regressed, and the patient has since gone 8 years without relapse or recurrence. The discovery of MCPyV provides a mechanistic basis for this success story.
MCPyV was discovered by the same team of investigators that found a new oncogenic herpesvirus that is the cause of Kaposi’s sarcoma, both HIV-related and non-HIV-related (N. Engl. J. Med. 2005;332:1,181-5).
The researchers surmised that MCPyV is far more likely to play an etiologic role in Merkel cell carcinoma than to be a bystander based on their demonstration that the virus is clonally integrated in the tumor genome (Science 2008;319:1,096-100). This observation suggests MCPyV is involved in clonal expansion of the tumor.
The group’s findings have subsequently been confirmed and expanded upon in other laboratories. It is now apparent that MCPyV is present in 70%-80% of Merkel cell carcinomas.
This trend is consistent with two broad population trends: the graying of society, and the steadily increasing population of immunosuppressed individuals. The risk of Merkel cell carcinoma has been estimated to be increased 8-fold in HIV-positive patients, 10-fold in organ transplant recipients, and at least 20-fold in patients living with chronic lymphocytic leukemia. The other major risk factor for Merkel cell carcinoma is age greater than 60. The most common site is the head and neck, reflecting the tumor’s predilection for UV-damaged skin. Sixty-two percent of patients in the SEER analysis were men. Nearly 97% of cases occurred in Caucasians.
MCPyV, like other polyomaviruses, is a small double-helix DNA virus. Infection by the virus is widespread: Serum antibodies are present in 80% of individuals over age 50 and 50% of those less than 15 years old.
The virus appears to be involved in the pathogenesis of other malignancies apart from Merkel cell carcinoma. It has been reported to be present in 6% of Kaposi’s sarcoma specimens and two-thirds of basal cell carcinomas. The basal cell carcinomas linked to MCPyV tend to have more necrosis and less palisading, according to Dr. Fernandez-Figueras of the Autonomous University of Barcelona.
The overall 5-year mortality of Merkel cell carcinoma is 33%. Tumor stage at diagnosis is the chief determinant of prognosis. The 5-year survival rate ranges from 79% for patients with tumors 2 cm or less and no lymph node involvement to 26%-42% with regional nodal involvement to 10%-18% for stage IV disease marked by distant metastasis.
Merkel cell carcinoma is a rapidly growing small cell neuroendocrine tumor of the skin. The Merkel cells present in the tumor are thought to originate from epidermal cells in the basal layer or adnexa, or perhaps from a primitive cutaneous epithelial precursor, Dr. Fernandez-Figueras observed.
It’s important to note that the biologic behavior of Merkel cell carcinoma is the same regardless of whether or not a tumor is associated with MCPyV, she stressed.
Dr. Wolf said the diagnostic challenge is to distinguish Merkel cell carcinoma from metastatic small cell carcinoma of the lung, melanoma, and lymphoblastic lymphoma. This can be done immunohistologically on the basis of positive staining for cytokeratin 20 and neurofilament, which is unique to Merkel cell carcinoma among these cancers. Also, most Merkel cell carcinomas will stain positive for CM2B4, which recognizes MCPyV, while the other malignancies will not.
Current guidelines recommend surgery with wide margins along with routine sentinel lymph node biopsy. Radiation therapy to the tumor bed and regional lymph nodes is recommended when nodes are positive.
“Surgery is the best and I would say the only good treatment for Merkel cell carcinoma,” according to Dr. Fernandez-Figueras.
Chemotherapy is palliative. The agents used are similar to those employed in small cell lung carcinoma, including cyclophosphamide, doxorubicin, vincristine, and cisplatin with or without etoposide.
Dr. Wolf said there is considerable interest in trying targeted therapy for Merkel cell carcinoma. A Phase II study of the bcl-2 antisense agent oblimersen (Genasense) disappointingly showed no objective responses in patients with advanced disease (Am. J. Clin. Oncol. 2009;32:174-9). However, there is a case report of an excellent result with pazopanib (Votrient) in a patient with metastatic Merkel cell carcinoma (J. Clin. Oncol. 2009;27:e97-100; PMID 19564526).
Drs. Wolf and Fernandez-Figueras reported they had no financial conflicts.
Private Practice Melanoma Screenings Reap Stellar Cure Rate
MADRID – A novel program of recalls for twice-yearly full skin examinations in patients at increased risk for melanoma has uniformly resulted in very early detection and cure of melanomas over a 17-year period in a private-practice dermatologist’s office.
This extensive experience refutes the recent controversial U.S. Preventive Health Services Task Force statement that screening for melanoma hasn’t been shown to be of value.
“It is my belief that it is now possible to protect patients at increased risk or at high risk of melanoma with extraordinary efficacy. What is needed is to identify such individuals and to offer them the opportunity to participate in a serial screening program,” explained Dr. Shore, a Rockville, Md., dermatologist who is also on the clinical faculty at Johns Hopkins University, Baltimore.
“When patients present with recognized risk factors for melanoma, dermatologists should seriously consider recommending and performing such serial screening procedures,” he added. “The skill that is required when examining patients is not to know what lesions are melanomas, but what lesions could be melanomas, so that such lesions are biopsied or at least monitored. Dermatologists, who are familiar with the numerous benign entities that occur in human skin, are almost uniquely prepared to perform this function so that large numbers of biopsies are not necessary.”
The genesis for Dr. Shore’s screening program lay in the teachings of the well-known dermatopathologist Dr. Wallace Clark, who asserted that melanomas in their early developmental radial growth phase almost never metastasize, and that this phase lasts for at least 6 months.
Building upon this principle, Dr. Shore fashioned a screening program founded on what he considered to be five key elements: performing thorough skin exams, biopsying all suspicious lesions, recalling patients every 6 months, carefully educating patients regarding the importance of returning when called, and encouraging self-screening through teaching the classical features of melanoma.
In retrospect, however, he has concluded that the self-examination component wasn’t particularly useful. For example, during a recent 5-year period in which 10 new cases of melanoma were detected through the screening program, all were in the radial growth phase, the greatest Breslow depth was only 0.15 mm, and seven melanomas were in men over age 50—but only one cancer was detected by a patient.
“This was particularly surprising to us, as all patients had been familiarized with the features of melanoma. It appears that in very early cases of melanoma, where lesions are asymptomatic and flat, most patients are not particularly adept at recognizing them,” the dermatologist continued. “Based on our extensive experience, particularly with older patients, we do not believe self-examination by patients compares at all well to what can be achieved by trained professionals. If our experience is at all reflective of the larger community, we believe there should be a much greater emphasis on dermatologists’ examinations and less on self-screening by patients themselves.”
Median time between skin examinations in the series was 9 months rather than the sought-after 6 months. Despite this indication of slight foot-dragging, patients have enthusiastically embraced the serial screening program, according to Dr. Shore.
“Most patients feel wonderful coming in for exams because they know what our experience has been and they feel reassured that they will not die of melanoma,” he observed in response to an audience question.
In an interview, the dermatologist explained that he didn’t incorporate routine total body photography in his repetitive follow-up program because the technology wasn’t available when he started out. It’s still not part of his screening system because he wants the program to be readily generalizable for other dermatologists, relatively few of whom use whole body photographs.
Dr. Shore noted that two prior studies have also reported 100% survival of screened patients at increased risk for melanoma: one led by Dr. Darrell S. Rigel (Cancer 1989; 63:386-9), and another more recent study led by investigators at the University of Minnesota (J. Am. Acad. Dermatol. Jan. 2004; 50:15-20).
Session cochair Dr. Fernando Stengel, chief of dermatology at the Clinicas Hospital in Buenos Aires, commented that Dr. Shore’s experience seems unusual in that he didn’t encounter any of the feared nodular melanomas that are so fast growing they’ve defied efforts to improve outcome through early detection.
Dr. Shore replied that some of the early melanomas detected in his series showed nodular-like histology. This leads him to suspect that “we basically catch them before they evolve into rapidly expanding lesions.”
He said that he has no financial interests relevant to his study.
MADRID – A novel program of recalls for twice-yearly full skin examinations in patients at increased risk for melanoma has uniformly resulted in very early detection and cure of melanomas over a 17-year period in a private-practice dermatologist’s office.
This extensive experience refutes the recent controversial U.S. Preventive Health Services Task Force statement that screening for melanoma hasn’t been shown to be of value.
“It is my belief that it is now possible to protect patients at increased risk or at high risk of melanoma with extraordinary efficacy. What is needed is to identify such individuals and to offer them the opportunity to participate in a serial screening program,” explained Dr. Shore, a Rockville, Md., dermatologist who is also on the clinical faculty at Johns Hopkins University, Baltimore.
“When patients present with recognized risk factors for melanoma, dermatologists should seriously consider recommending and performing such serial screening procedures,” he added. “The skill that is required when examining patients is not to know what lesions are melanomas, but what lesions could be melanomas, so that such lesions are biopsied or at least monitored. Dermatologists, who are familiar with the numerous benign entities that occur in human skin, are almost uniquely prepared to perform this function so that large numbers of biopsies are not necessary.”
The genesis for Dr. Shore’s screening program lay in the teachings of the well-known dermatopathologist Dr. Wallace Clark, who asserted that melanomas in their early developmental radial growth phase almost never metastasize, and that this phase lasts for at least 6 months.
Building upon this principle, Dr. Shore fashioned a screening program founded on what he considered to be five key elements: performing thorough skin exams, biopsying all suspicious lesions, recalling patients every 6 months, carefully educating patients regarding the importance of returning when called, and encouraging self-screening through teaching the classical features of melanoma.
In retrospect, however, he has concluded that the self-examination component wasn’t particularly useful. For example, during a recent 5-year period in which 10 new cases of melanoma were detected through the screening program, all were in the radial growth phase, the greatest Breslow depth was only 0.15 mm, and seven melanomas were in men over age 50—but only one cancer was detected by a patient.
“This was particularly surprising to us, as all patients had been familiarized with the features of melanoma. It appears that in very early cases of melanoma, where lesions are asymptomatic and flat, most patients are not particularly adept at recognizing them,” the dermatologist continued. “Based on our extensive experience, particularly with older patients, we do not believe self-examination by patients compares at all well to what can be achieved by trained professionals. If our experience is at all reflective of the larger community, we believe there should be a much greater emphasis on dermatologists’ examinations and less on self-screening by patients themselves.”
Median time between skin examinations in the series was 9 months rather than the sought-after 6 months. Despite this indication of slight foot-dragging, patients have enthusiastically embraced the serial screening program, according to Dr. Shore.
“Most patients feel wonderful coming in for exams because they know what our experience has been and they feel reassured that they will not die of melanoma,” he observed in response to an audience question.
In an interview, the dermatologist explained that he didn’t incorporate routine total body photography in his repetitive follow-up program because the technology wasn’t available when he started out. It’s still not part of his screening system because he wants the program to be readily generalizable for other dermatologists, relatively few of whom use whole body photographs.
Dr. Shore noted that two prior studies have also reported 100% survival of screened patients at increased risk for melanoma: one led by Dr. Darrell S. Rigel (Cancer 1989; 63:386-9), and another more recent study led by investigators at the University of Minnesota (J. Am. Acad. Dermatol. Jan. 2004; 50:15-20).
Session cochair Dr. Fernando Stengel, chief of dermatology at the Clinicas Hospital in Buenos Aires, commented that Dr. Shore’s experience seems unusual in that he didn’t encounter any of the feared nodular melanomas that are so fast growing they’ve defied efforts to improve outcome through early detection.
Dr. Shore replied that some of the early melanomas detected in his series showed nodular-like histology. This leads him to suspect that “we basically catch them before they evolve into rapidly expanding lesions.”
He said that he has no financial interests relevant to his study.
MADRID – A novel program of recalls for twice-yearly full skin examinations in patients at increased risk for melanoma has uniformly resulted in very early detection and cure of melanomas over a 17-year period in a private-practice dermatologist’s office.
This extensive experience refutes the recent controversial U.S. Preventive Health Services Task Force statement that screening for melanoma hasn’t been shown to be of value.
“It is my belief that it is now possible to protect patients at increased risk or at high risk of melanoma with extraordinary efficacy. What is needed is to identify such individuals and to offer them the opportunity to participate in a serial screening program,” explained Dr. Shore, a Rockville, Md., dermatologist who is also on the clinical faculty at Johns Hopkins University, Baltimore.
“When patients present with recognized risk factors for melanoma, dermatologists should seriously consider recommending and performing such serial screening procedures,” he added. “The skill that is required when examining patients is not to know what lesions are melanomas, but what lesions could be melanomas, so that such lesions are biopsied or at least monitored. Dermatologists, who are familiar with the numerous benign entities that occur in human skin, are almost uniquely prepared to perform this function so that large numbers of biopsies are not necessary.”
The genesis for Dr. Shore’s screening program lay in the teachings of the well-known dermatopathologist Dr. Wallace Clark, who asserted that melanomas in their early developmental radial growth phase almost never metastasize, and that this phase lasts for at least 6 months.
Building upon this principle, Dr. Shore fashioned a screening program founded on what he considered to be five key elements: performing thorough skin exams, biopsying all suspicious lesions, recalling patients every 6 months, carefully educating patients regarding the importance of returning when called, and encouraging self-screening through teaching the classical features of melanoma.
In retrospect, however, he has concluded that the self-examination component wasn’t particularly useful. For example, during a recent 5-year period in which 10 new cases of melanoma were detected through the screening program, all were in the radial growth phase, the greatest Breslow depth was only 0.15 mm, and seven melanomas were in men over age 50—but only one cancer was detected by a patient.
“This was particularly surprising to us, as all patients had been familiarized with the features of melanoma. It appears that in very early cases of melanoma, where lesions are asymptomatic and flat, most patients are not particularly adept at recognizing them,” the dermatologist continued. “Based on our extensive experience, particularly with older patients, we do not believe self-examination by patients compares at all well to what can be achieved by trained professionals. If our experience is at all reflective of the larger community, we believe there should be a much greater emphasis on dermatologists’ examinations and less on self-screening by patients themselves.”
Median time between skin examinations in the series was 9 months rather than the sought-after 6 months. Despite this indication of slight foot-dragging, patients have enthusiastically embraced the serial screening program, according to Dr. Shore.
“Most patients feel wonderful coming in for exams because they know what our experience has been and they feel reassured that they will not die of melanoma,” he observed in response to an audience question.
In an interview, the dermatologist explained that he didn’t incorporate routine total body photography in his repetitive follow-up program because the technology wasn’t available when he started out. It’s still not part of his screening system because he wants the program to be readily generalizable for other dermatologists, relatively few of whom use whole body photographs.
Dr. Shore noted that two prior studies have also reported 100% survival of screened patients at increased risk for melanoma: one led by Dr. Darrell S. Rigel (Cancer 1989; 63:386-9), and another more recent study led by investigators at the University of Minnesota (J. Am. Acad. Dermatol. Jan. 2004; 50:15-20).
Session cochair Dr. Fernando Stengel, chief of dermatology at the Clinicas Hospital in Buenos Aires, commented that Dr. Shore’s experience seems unusual in that he didn’t encounter any of the feared nodular melanomas that are so fast growing they’ve defied efforts to improve outcome through early detection.
Dr. Shore replied that some of the early melanomas detected in his series showed nodular-like histology. This leads him to suspect that “we basically catch them before they evolve into rapidly expanding lesions.”
He said that he has no financial interests relevant to his study.
FDA: Mycosis Fungoides Drug in Short Supply
An extended shortage of mechlorethamine hydrochloride, a nitrogen mustard used in chemotherapy for hematologic cancers - and for treating mycosis fungoides - is expected to begin this month, the Food and Drug Administration announced today.
The limited supply of mechlorethamine hydrochloride (Mustargen) will be allocated to patients already being treated with the chemotherapy drug, the agency said in a statement advising that "alternative treatment plans should be made for new patients to avoid interruption to a treatment program that would normally include Mustargen."
Once the current supply of Mustargen is depleted in mid to late April, the shortage of the drug is expected to last until "early 2011," according to the FDA. The existing supply will be distributed by Lundbeck Inc., the only manufacturer of the agent in the world, "to meet current patient needs, with priority given to sites with patients currently receiving Mustargen." No other supplies could be found.
Mustargen, the first chemotherapy drug approved by the FDA in 1949, is a component of the MOPP (Mustargen, Oncovin, procarbazine, and prednisone) regimen pioneered in the mid 1960s for advanced Hodgkin's disease. It is still used as a treatment for Hodgkin's disease, alone or in combination with radiation, as well as for polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.
In an April 1 letter to healthcare professionals, Dr. Mark Weinberg, vice president of U.S. medical affairs at Lundbeck, said the remaining supply of Mustargen is "very limited in terms of quality and dating." The company will make the product available until the inventory is depleted, and is encouraging physicians to "consider alternative therapy rather than starting a new course of therapy with Mustargen," he added.
The shortage is related to unsuccessful attempts to transfer the manufacturing of Mustargen to a new manufacturer over the past several years, and the recent decision by a new contractor not to pursue commercial manufacturing, according to the letter. The company is transferring the manufacturing to another site, and is "confident" that the new manufacturer will produce a "high quality product." That is not expected to be approved before 2011, however.
An extended shortage of mechlorethamine hydrochloride, a nitrogen mustard used in chemotherapy for hematologic cancers - and for treating mycosis fungoides - is expected to begin this month, the Food and Drug Administration announced today.
The limited supply of mechlorethamine hydrochloride (Mustargen) will be allocated to patients already being treated with the chemotherapy drug, the agency said in a statement advising that "alternative treatment plans should be made for new patients to avoid interruption to a treatment program that would normally include Mustargen."
Once the current supply of Mustargen is depleted in mid to late April, the shortage of the drug is expected to last until "early 2011," according to the FDA. The existing supply will be distributed by Lundbeck Inc., the only manufacturer of the agent in the world, "to meet current patient needs, with priority given to sites with patients currently receiving Mustargen." No other supplies could be found.
Mustargen, the first chemotherapy drug approved by the FDA in 1949, is a component of the MOPP (Mustargen, Oncovin, procarbazine, and prednisone) regimen pioneered in the mid 1960s for advanced Hodgkin's disease. It is still used as a treatment for Hodgkin's disease, alone or in combination with radiation, as well as for polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.
In an April 1 letter to healthcare professionals, Dr. Mark Weinberg, vice president of U.S. medical affairs at Lundbeck, said the remaining supply of Mustargen is "very limited in terms of quality and dating." The company will make the product available until the inventory is depleted, and is encouraging physicians to "consider alternative therapy rather than starting a new course of therapy with Mustargen," he added.
The shortage is related to unsuccessful attempts to transfer the manufacturing of Mustargen to a new manufacturer over the past several years, and the recent decision by a new contractor not to pursue commercial manufacturing, according to the letter. The company is transferring the manufacturing to another site, and is "confident" that the new manufacturer will produce a "high quality product." That is not expected to be approved before 2011, however.
An extended shortage of mechlorethamine hydrochloride, a nitrogen mustard used in chemotherapy for hematologic cancers - and for treating mycosis fungoides - is expected to begin this month, the Food and Drug Administration announced today.
The limited supply of mechlorethamine hydrochloride (Mustargen) will be allocated to patients already being treated with the chemotherapy drug, the agency said in a statement advising that "alternative treatment plans should be made for new patients to avoid interruption to a treatment program that would normally include Mustargen."
Once the current supply of Mustargen is depleted in mid to late April, the shortage of the drug is expected to last until "early 2011," according to the FDA. The existing supply will be distributed by Lundbeck Inc., the only manufacturer of the agent in the world, "to meet current patient needs, with priority given to sites with patients currently receiving Mustargen." No other supplies could be found.
Mustargen, the first chemotherapy drug approved by the FDA in 1949, is a component of the MOPP (Mustargen, Oncovin, procarbazine, and prednisone) regimen pioneered in the mid 1960s for advanced Hodgkin's disease. It is still used as a treatment for Hodgkin's disease, alone or in combination with radiation, as well as for polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.
In an April 1 letter to healthcare professionals, Dr. Mark Weinberg, vice president of U.S. medical affairs at Lundbeck, said the remaining supply of Mustargen is "very limited in terms of quality and dating." The company will make the product available until the inventory is depleted, and is encouraging physicians to "consider alternative therapy rather than starting a new course of therapy with Mustargen," he added.
The shortage is related to unsuccessful attempts to transfer the manufacturing of Mustargen to a new manufacturer over the past several years, and the recent decision by a new contractor not to pursue commercial manufacturing, according to the letter. The company is transferring the manufacturing to another site, and is "confident" that the new manufacturer will produce a "high quality product." That is not expected to be approved before 2011, however.
Sentinel Lymph Node Biopsies in Cutaneous Melanomas
MIAMI – The decision to perform sentinel lymph node biopsy in cutaneous melanomas with a Breslow depth of less than 1.0 mm should be based on histopathologic factors, findings from a series of 472 patients suggest.
Sentinel lymph node biopsy (SLNB) is important for staging and determining prognosis in thicker melanomas, but its role in thinner melanomas is more controversial. There is no clear consensus in the literature regarding which prognostic factors predict sentinel lymph node metastases in thin melanomas, Dr. Suzanne Berkman and her colleagues at the Washington (D.C.) Cancer Institute reported in a poster at the annual meeting of the American Academy of Dermatology.
In their series of patients who underwent SLNB between 1997 and 2008 at the institute, the investigators found Breslow depth, Clark level, and nodular subtype to be positively associated with SLNB positivity. Ulceration status was also associated with SLNB positivity, but this association did not reach statistical significance.
The mean Breslow depth of the melanomas in the study’s 472 patients was 2.11 mm. In all, 330 patients had a Breslow depth greater than 1.0 mm, and 142 had a Breslow depth of 1.0 mm or less (thin melanomas).
The American Joint Committee on Cancer recommends performing SLNB only on melanomas with a Breslow depth of 1.0 mm or greater with clinically uninvolved lymph nodes. The recommendation for thin melanomas is that SLNB be performed in those measuring less than 1.0 mm if there is ulceration and at least 1 mitosis per mm2 – particularly if Breslow depth is at least 0.75 mm.
The practice at the Washington Cancer Institute is to perform SLNB for all melanomas of a Breslow depth of at least 0.76 mm, and to biopsy those thinner than 0.76 mm that have adverse histopathologic factors, such as Clark level IV/V, ulceration, and high mitotic rate, the investigators reported. In their series, 55 patients with a mean Breslow depth of 3.26 mm had a positive SLNB.
Of the 330 patients with a Breslow depth greater than 1.0 mm, 16% had a positive SLNB, compared with only 2% of the 142 patients with thin melanomas. Mean Breslow depth in the patients in those groups with positive SLNB was 3.4 mm and 0.81 mm, respectively.
The rate of SLNB positivity in the study increased with increasing depth of invasion: In all, 2% of those with Breslow depth of 1.0 mm or less had a positive SLNB, compared with 10% of those with a depth of 1.01-2.0 mm, 23% of those with a depth of 2.01-4.00 mm, and 23% of those with a depth greater than 4.0 mm, the investigators noted.
Not only was positivity a function of Breslow depth, but Breslow depth correlated with disease progression and survival, as did SLNB positivity, the investigators found.
Local or distant recurrence occurred in 43 patients (9%) overall. Those with recurrence had a mean Breslow depth of 4.19 mm and a mean follow-up of 45 months. Only 17 of the 43 survived; they had a mean Breslow depth of 3.76 mm and a mean follow up of 58 months.
Of the 417 patients with a negative biopsy, 29 (7%) developed recurrence – including 1 with a thin melanoma – and 12 (3%) developed distant metastases. Of the 55 patients with a positive biopsy, 14 (25%) developed recurrence – including 1 with a thin melanoma – and 7 (13%) developed distant metastases. Death occurred in 4% of patients with a negative biopsy, compared with 16% of those with a positive biopsy.
“The results from our institution confirm the importance of SLNB on staging and prognosis in patients with cutaneous melanomas. We continue to perform SLNB in patients with thin melanomas and ulceration and high mitotic rate,” the investigators concluded.
The investigators reported no relevant disclosures related to the study.
MIAMI – The decision to perform sentinel lymph node biopsy in cutaneous melanomas with a Breslow depth of less than 1.0 mm should be based on histopathologic factors, findings from a series of 472 patients suggest.
Sentinel lymph node biopsy (SLNB) is important for staging and determining prognosis in thicker melanomas, but its role in thinner melanomas is more controversial. There is no clear consensus in the literature regarding which prognostic factors predict sentinel lymph node metastases in thin melanomas, Dr. Suzanne Berkman and her colleagues at the Washington (D.C.) Cancer Institute reported in a poster at the annual meeting of the American Academy of Dermatology.
In their series of patients who underwent SLNB between 1997 and 2008 at the institute, the investigators found Breslow depth, Clark level, and nodular subtype to be positively associated with SLNB positivity. Ulceration status was also associated with SLNB positivity, but this association did not reach statistical significance.
The mean Breslow depth of the melanomas in the study’s 472 patients was 2.11 mm. In all, 330 patients had a Breslow depth greater than 1.0 mm, and 142 had a Breslow depth of 1.0 mm or less (thin melanomas).
The American Joint Committee on Cancer recommends performing SLNB only on melanomas with a Breslow depth of 1.0 mm or greater with clinically uninvolved lymph nodes. The recommendation for thin melanomas is that SLNB be performed in those measuring less than 1.0 mm if there is ulceration and at least 1 mitosis per mm2 – particularly if Breslow depth is at least 0.75 mm.
The practice at the Washington Cancer Institute is to perform SLNB for all melanomas of a Breslow depth of at least 0.76 mm, and to biopsy those thinner than 0.76 mm that have adverse histopathologic factors, such as Clark level IV/V, ulceration, and high mitotic rate, the investigators reported. In their series, 55 patients with a mean Breslow depth of 3.26 mm had a positive SLNB.
Of the 330 patients with a Breslow depth greater than 1.0 mm, 16% had a positive SLNB, compared with only 2% of the 142 patients with thin melanomas. Mean Breslow depth in the patients in those groups with positive SLNB was 3.4 mm and 0.81 mm, respectively.
The rate of SLNB positivity in the study increased with increasing depth of invasion: In all, 2% of those with Breslow depth of 1.0 mm or less had a positive SLNB, compared with 10% of those with a depth of 1.01-2.0 mm, 23% of those with a depth of 2.01-4.00 mm, and 23% of those with a depth greater than 4.0 mm, the investigators noted.
Not only was positivity a function of Breslow depth, but Breslow depth correlated with disease progression and survival, as did SLNB positivity, the investigators found.
Local or distant recurrence occurred in 43 patients (9%) overall. Those with recurrence had a mean Breslow depth of 4.19 mm and a mean follow-up of 45 months. Only 17 of the 43 survived; they had a mean Breslow depth of 3.76 mm and a mean follow up of 58 months.
Of the 417 patients with a negative biopsy, 29 (7%) developed recurrence – including 1 with a thin melanoma – and 12 (3%) developed distant metastases. Of the 55 patients with a positive biopsy, 14 (25%) developed recurrence – including 1 with a thin melanoma – and 7 (13%) developed distant metastases. Death occurred in 4% of patients with a negative biopsy, compared with 16% of those with a positive biopsy.
“The results from our institution confirm the importance of SLNB on staging and prognosis in patients with cutaneous melanomas. We continue to perform SLNB in patients with thin melanomas and ulceration and high mitotic rate,” the investigators concluded.
The investigators reported no relevant disclosures related to the study.
MIAMI – The decision to perform sentinel lymph node biopsy in cutaneous melanomas with a Breslow depth of less than 1.0 mm should be based on histopathologic factors, findings from a series of 472 patients suggest.
Sentinel lymph node biopsy (SLNB) is important for staging and determining prognosis in thicker melanomas, but its role in thinner melanomas is more controversial. There is no clear consensus in the literature regarding which prognostic factors predict sentinel lymph node metastases in thin melanomas, Dr. Suzanne Berkman and her colleagues at the Washington (D.C.) Cancer Institute reported in a poster at the annual meeting of the American Academy of Dermatology.
In their series of patients who underwent SLNB between 1997 and 2008 at the institute, the investigators found Breslow depth, Clark level, and nodular subtype to be positively associated with SLNB positivity. Ulceration status was also associated with SLNB positivity, but this association did not reach statistical significance.
The mean Breslow depth of the melanomas in the study’s 472 patients was 2.11 mm. In all, 330 patients had a Breslow depth greater than 1.0 mm, and 142 had a Breslow depth of 1.0 mm or less (thin melanomas).
The American Joint Committee on Cancer recommends performing SLNB only on melanomas with a Breslow depth of 1.0 mm or greater with clinically uninvolved lymph nodes. The recommendation for thin melanomas is that SLNB be performed in those measuring less than 1.0 mm if there is ulceration and at least 1 mitosis per mm2 – particularly if Breslow depth is at least 0.75 mm.
The practice at the Washington Cancer Institute is to perform SLNB for all melanomas of a Breslow depth of at least 0.76 mm, and to biopsy those thinner than 0.76 mm that have adverse histopathologic factors, such as Clark level IV/V, ulceration, and high mitotic rate, the investigators reported. In their series, 55 patients with a mean Breslow depth of 3.26 mm had a positive SLNB.
Of the 330 patients with a Breslow depth greater than 1.0 mm, 16% had a positive SLNB, compared with only 2% of the 142 patients with thin melanomas. Mean Breslow depth in the patients in those groups with positive SLNB was 3.4 mm and 0.81 mm, respectively.
The rate of SLNB positivity in the study increased with increasing depth of invasion: In all, 2% of those with Breslow depth of 1.0 mm or less had a positive SLNB, compared with 10% of those with a depth of 1.01-2.0 mm, 23% of those with a depth of 2.01-4.00 mm, and 23% of those with a depth greater than 4.0 mm, the investigators noted.
Not only was positivity a function of Breslow depth, but Breslow depth correlated with disease progression and survival, as did SLNB positivity, the investigators found.
Local or distant recurrence occurred in 43 patients (9%) overall. Those with recurrence had a mean Breslow depth of 4.19 mm and a mean follow-up of 45 months. Only 17 of the 43 survived; they had a mean Breslow depth of 3.76 mm and a mean follow up of 58 months.
Of the 417 patients with a negative biopsy, 29 (7%) developed recurrence – including 1 with a thin melanoma – and 12 (3%) developed distant metastases. Of the 55 patients with a positive biopsy, 14 (25%) developed recurrence – including 1 with a thin melanoma – and 7 (13%) developed distant metastases. Death occurred in 4% of patients with a negative biopsy, compared with 16% of those with a positive biopsy.
“The results from our institution confirm the importance of SLNB on staging and prognosis in patients with cutaneous melanomas. We continue to perform SLNB in patients with thin melanomas and ulceration and high mitotic rate,” the investigators concluded.
The investigators reported no relevant disclosures related to the study.