Michele G. Sullivan

A short course of preoperative radiotherapy before total mesorectal surgery significantly reduced the rate of local recurrence in patients with rectal cancer, particularly if the tumor was located in the midrectal region.

After 10 years of follow-up, however, the 50% reduction in local recurrence didn’t translate into better overall survival, Dr. Corrie Marijnen will report at the annual meeting of the American Society for Radiation Oncology. But these data from the Dutch TME (Total Mesorectal Excision) study have still been enough to change practice in the Netherlands, she said at a press briefing Oct. 25 before the meeting.

“The preoperative radiation, which we give over 5 days immediately before the surgery, is safe and typically painless,” said Dr. Marijnen, a radiation oncologist at the Leiden (the Netherlands) University Medical Center. “We have advised that in all our Nordic countries, patients with stage II and III rectal cancer will get this short course of preoperative radiotherapy before their TME surgery.”

She will report 11-year follow-up data on 1,861 patients who were enrolled in the randomized TME study. All patients had resectable stage II or III rectal cancer.

Surgeon training was a key point in the TME study, Dr. Marijnen stressed. Experts in the technique visited surgeons in all the participating centers, instructing them in how to best perform the surgery. After a level of expertise was established, patients were randomized to either TME surgery alone, or 5 days of 5-Gy radiotherapy immediately followed by TME. The primary end point was local disease control

The 10-year local recurrence rate was 6.4% in the combination therapy group and 13.3% in the surgery-only group, a significant difference (P = .001). Overall recurrence was also significantly lower in the combination therapy group, compared with the surgery-only group (28.8% vs. 33.3%; P = .042). Dr. Marijnen noted, however, that there was no difference in overall survival.

In a subgroup analysis, the benefit seemed to be confined to those patients who had negative circumferential resection margins, stage III tumors, and midrectal tumors greater than 5 cm.

“We showed that the local recurrence rate was reduced by about 50% when preoperative radiotherapy was given before surgery, with most of the benefit seen in patients with midrectal cancers,” Dr. Marijnen said at the briefing. “Also, to our surprise, we saw that the radiotherapy was even more beneficial for patients with a good surgical outcome – negative lateral margins – than it was for patients who had positive margins. This demonstrates that good surgical technique is also absolutely necessary.”

Neither Dr. Marijnen nor any of her coauthors disclosed any financial conflicts with regard to the study.

A short course of preoperative radiotherapy before total mesorectal surgery significantly reduced the rate of local recurrence in patients with rectal cancer, particularly if the tumor was located in the midrectal region.

After 10 years of follow-up, however, the 50% reduction in local recurrence didn’t translate into better overall survival, Dr. Corrie Marijnen will report at the annual meeting of the American Society for Radiation Oncology. But these data from the Dutch TME (Total Mesorectal Excision) study have still been enough to change practice in the Netherlands, she said at a press briefing Oct. 25 before the meeting.

“The preoperative radiation, which we give over 5 days immediately before the surgery, is safe and typically painless,” said Dr. Marijnen, a radiation oncologist at the Leiden (the Netherlands) University Medical Center. “We have advised that in all our Nordic countries, patients with stage II and III rectal cancer will get this short course of preoperative radiotherapy before their TME surgery.”

She will report 11-year follow-up data on 1,861 patients who were enrolled in the randomized TME study. All patients had resectable stage II or III rectal cancer.

Surgeon training was a key point in the TME study, Dr. Marijnen stressed. Experts in the technique visited surgeons in all the participating centers, instructing them in how to best perform the surgery. After a level of expertise was established, patients were randomized to either TME surgery alone, or 5 days of 5-Gy radiotherapy immediately followed by TME. The primary end point was local disease control

The 10-year local recurrence rate was 6.4% in the combination therapy group and 13.3% in the surgery-only group, a significant difference (P = .001). Overall recurrence was also significantly lower in the combination therapy group, compared with the surgery-only group (28.8% vs. 33.3%; P = .042). Dr. Marijnen noted, however, that there was no difference in overall survival.

In a subgroup analysis, the benefit seemed to be confined to those patients who had negative circumferential resection margins, stage III tumors, and midrectal tumors greater than 5 cm.

“We showed that the local recurrence rate was reduced by about 50% when preoperative radiotherapy was given before surgery, with most of the benefit seen in patients with midrectal cancers,” Dr. Marijnen said at the briefing. “Also, to our surprise, we saw that the radiotherapy was even more beneficial for patients with a good surgical outcome – negative lateral margins – than it was for patients who had positive margins. This demonstrates that good surgical technique is also absolutely necessary.”

Neither Dr. Marijnen nor any of her coauthors disclosed any financial conflicts with regard to the study.

A short course of preoperative radiotherapy before total mesorectal surgery significantly reduced the rate of local recurrence in patients with rectal cancer, particularly if the tumor was located in the midrectal region.

After 10 years of follow-up, however, the 50% reduction in local recurrence didn’t translate into better overall survival, Dr. Corrie Marijnen will report at the annual meeting of the American Society for Radiation Oncology. But these data from the Dutch TME (Total Mesorectal Excision) study have still been enough to change practice in the Netherlands, she said at a press briefing Oct. 25 before the meeting.

“The preoperative radiation, which we give over 5 days immediately before the surgery, is safe and typically painless,” said Dr. Marijnen, a radiation oncologist at the Leiden (the Netherlands) University Medical Center. “We have advised that in all our Nordic countries, patients with stage II and III rectal cancer will get this short course of preoperative radiotherapy before their TME surgery.”

She will report 11-year follow-up data on 1,861 patients who were enrolled in the randomized TME study. All patients had resectable stage II or III rectal cancer.

Surgeon training was a key point in the TME study, Dr. Marijnen stressed. Experts in the technique visited surgeons in all the participating centers, instructing them in how to best perform the surgery. After a level of expertise was established, patients were randomized to either TME surgery alone, or 5 days of 5-Gy radiotherapy immediately followed by TME. The primary end point was local disease control

The 10-year local recurrence rate was 6.4% in the combination therapy group and 13.3% in the surgery-only group, a significant difference (P = .001). Overall recurrence was also significantly lower in the combination therapy group, compared with the surgery-only group (28.8% vs. 33.3%; P = .042). Dr. Marijnen noted, however, that there was no difference in overall survival.

In a subgroup analysis, the benefit seemed to be confined to those patients who had negative circumferential resection margins, stage III tumors, and midrectal tumors greater than 5 cm.

“We showed that the local recurrence rate was reduced by about 50% when preoperative radiotherapy was given before surgery, with most of the benefit seen in patients with midrectal cancers,” Dr. Marijnen said at the briefing. “Also, to our surprise, we saw that the radiotherapy was even more beneficial for patients with a good surgical outcome – negative lateral margins – than it was for patients who had positive margins. This demonstrates that good surgical technique is also absolutely necessary.”

Neither Dr. Marijnen nor any of her coauthors disclosed any financial conflicts with regard to the study.

Routine screening for prostate cancer resulted in fewer cases of metastatic disease over the past 10 years even after controlling for disease severity, a new retrospective study suggests.

Men who developed prostate cancer before prostate specific antigen (PSA) testing became routine were 3.5 times more likely to progress to metastatic disease than were men diagnosed after PSA testing became the standard of care, Chandana Reddy, M.S., reported Oct. 25 during a press briefing sponsored by the American Society for Radiation Oncology in advance of its annual meeting.

“Our study showed that routine screening not only improves the patient’s quality of life by stopping metastatic disease but also decreases the burden of care for this advanced disease that must be provided by the health care system,” Ms. Reddy said. “This demonstrates that the prostate specific antigen [PSA] test is extremely valuable in catching the disease earlier and allowing men to live more productive lives after treatment.”

The impact of routine prostate cancer screening has been widely debated for years, Ms. Reddy said. “Because prostate cancer is generally a slow-growing disease, often diagnosed in older men with other medical conditions, the question has been [whether] they [should] be treated, since the treatment itself can have complications.”

Routine screening using the PSA was first implemented in 1992, and, she said, “Skeptics have argued that it has not resulted in any meaningful increase in survival. In fact, two recent trials showed no benefit.”

She cautioned that trial design could have skewed those results. “Those trials looked at overall survival as the primary end point, and since many of these men had other medical conditions, any prostate cancer–specific survival could have been masked by the likelihood of death from other illness.”

Ms. Reddy, a senior biostatistician at the Cleveland Clinic, Ohio, and her colleagues reported a retrospective study of 1,721 men with prostate cancer who were treated at the facility from 1986-1996. All men underwent radical prostatectomy or radiotherapy.

The investigators divided the group into two eras: a prescreening era (1986-1992; 575 patients) and a post-screening era (1993-1996; 1,146 patients). The median follow-up time for both groups was 10 years.

At baseline, according to the National Comprehensive Cancer Network risk classification, 44% of the prescreening era group were high risk, 21% were intermediate risk, and 28% low risk; no classification data were available for the remaining patients. For the post- screening era group, 36% were considered high risk, 27% intermediate risk, and 37% low risk. These differences between screening groups were statistically significant.

Within the 10 year post-treatment follow-up period, 13% (224) of all study patients developed metastatic disease. Significant differences (P less than .0001) in the rate of metastasis-free survival emerged when each risk level was compared between the prescreening and post-screening era groups: high risk (58% vs. 82%), intermediate risk (79% vs. 93%), and low risk (90% vs. 98%)

In a univariate analysis, screening era, age, T stage, pretreatment PSA value, and Gleason score on biopsy were significantly associated with the development of metastatic disease (P less than .05). In the multivariate analysis, screening era, T stage, and biopsy Gleason score remained statistically significant predictors of metastatic disease.

Neither Ms. Reddy nor any of her coauthors had any relevant financial disclosures.

Routine screening for prostate cancer resulted in fewer cases of metastatic disease over the past 10 years even after controlling for disease severity, a new retrospective study suggests.

Men who developed prostate cancer before prostate specific antigen (PSA) testing became routine were 3.5 times more likely to progress to metastatic disease than were men diagnosed after PSA testing became the standard of care, Chandana Reddy, M.S., reported Oct. 25 during a press briefing sponsored by the American Society for Radiation Oncology in advance of its annual meeting.

“Our study showed that routine screening not only improves the patient’s quality of life by stopping metastatic disease but also decreases the burden of care for this advanced disease that must be provided by the health care system,” Ms. Reddy said. “This demonstrates that the prostate specific antigen [PSA] test is extremely valuable in catching the disease earlier and allowing men to live more productive lives after treatment.”

The impact of routine prostate cancer screening has been widely debated for years, Ms. Reddy said. “Because prostate cancer is generally a slow-growing disease, often diagnosed in older men with other medical conditions, the question has been [whether] they [should] be treated, since the treatment itself can have complications.”

Routine screening using the PSA was first implemented in 1992, and, she said, “Skeptics have argued that it has not resulted in any meaningful increase in survival. In fact, two recent trials showed no benefit.”

She cautioned that trial design could have skewed those results. “Those trials looked at overall survival as the primary end point, and since many of these men had other medical conditions, any prostate cancer–specific survival could have been masked by the likelihood of death from other illness.”

Ms. Reddy, a senior biostatistician at the Cleveland Clinic, Ohio, and her colleagues reported a retrospective study of 1,721 men with prostate cancer who were treated at the facility from 1986-1996. All men underwent radical prostatectomy or radiotherapy.

The investigators divided the group into two eras: a prescreening era (1986-1992; 575 patients) and a post-screening era (1993-1996; 1,146 patients). The median follow-up time for both groups was 10 years.

At baseline, according to the National Comprehensive Cancer Network risk classification, 44% of the prescreening era group were high risk, 21% were intermediate risk, and 28% low risk; no classification data were available for the remaining patients. For the post- screening era group, 36% were considered high risk, 27% intermediate risk, and 37% low risk. These differences between screening groups were statistically significant.

Within the 10 year post-treatment follow-up period, 13% (224) of all study patients developed metastatic disease. Significant differences (P less than .0001) in the rate of metastasis-free survival emerged when each risk level was compared between the prescreening and post-screening era groups: high risk (58% vs. 82%), intermediate risk (79% vs. 93%), and low risk (90% vs. 98%)

In a univariate analysis, screening era, age, T stage, pretreatment PSA value, and Gleason score on biopsy were significantly associated with the development of metastatic disease (P less than .05). In the multivariate analysis, screening era, T stage, and biopsy Gleason score remained statistically significant predictors of metastatic disease.

Neither Ms. Reddy nor any of her coauthors had any relevant financial disclosures.

Routine screening for prostate cancer resulted in fewer cases of metastatic disease over the past 10 years even after controlling for disease severity, a new retrospective study suggests.

Men who developed prostate cancer before prostate specific antigen (PSA) testing became routine were 3.5 times more likely to progress to metastatic disease than were men diagnosed after PSA testing became the standard of care, Chandana Reddy, M.S., reported Oct. 25 during a press briefing sponsored by the American Society for Radiation Oncology in advance of its annual meeting.

“Our study showed that routine screening not only improves the patient’s quality of life by stopping metastatic disease but also decreases the burden of care for this advanced disease that must be provided by the health care system,” Ms. Reddy said. “This demonstrates that the prostate specific antigen [PSA] test is extremely valuable in catching the disease earlier and allowing men to live more productive lives after treatment.”

The impact of routine prostate cancer screening has been widely debated for years, Ms. Reddy said. “Because prostate cancer is generally a slow-growing disease, often diagnosed in older men with other medical conditions, the question has been [whether] they [should] be treated, since the treatment itself can have complications.”

Routine screening using the PSA was first implemented in 1992, and, she said, “Skeptics have argued that it has not resulted in any meaningful increase in survival. In fact, two recent trials showed no benefit.”

She cautioned that trial design could have skewed those results. “Those trials looked at overall survival as the primary end point, and since many of these men had other medical conditions, any prostate cancer–specific survival could have been masked by the likelihood of death from other illness.”

Ms. Reddy, a senior biostatistician at the Cleveland Clinic, Ohio, and her colleagues reported a retrospective study of 1,721 men with prostate cancer who were treated at the facility from 1986-1996. All men underwent radical prostatectomy or radiotherapy.

The investigators divided the group into two eras: a prescreening era (1986-1992; 575 patients) and a post-screening era (1993-1996; 1,146 patients). The median follow-up time for both groups was 10 years.

At baseline, according to the National Comprehensive Cancer Network risk classification, 44% of the prescreening era group were high risk, 21% were intermediate risk, and 28% low risk; no classification data were available for the remaining patients. For the post- screening era group, 36% were considered high risk, 27% intermediate risk, and 37% low risk. These differences between screening groups were statistically significant.

Within the 10 year post-treatment follow-up period, 13% (224) of all study patients developed metastatic disease. Significant differences (P less than .0001) in the rate of metastasis-free survival emerged when each risk level was compared between the prescreening and post-screening era groups: high risk (58% vs. 82%), intermediate risk (79% vs. 93%), and low risk (90% vs. 98%)

In a univariate analysis, screening era, age, T stage, pretreatment PSA value, and Gleason score on biopsy were significantly associated with the development of metastatic disease (P less than .05). In the multivariate analysis, screening era, T stage, and biopsy Gleason score remained statistically significant predictors of metastatic disease.

Neither Ms. Reddy nor any of her coauthors had any relevant financial disclosures.

Circulating cytokines appear to influence fetal growth in pregnant women who have rheumatoid arthritis, results of a Dutch study suggest.

High levels of interleukin-10, IL-6, and TNF-alpha might all play a role, each acting independently – and at different stages of pregnancy – to increase the risk of low birth weight among infants born to these mothers, Dr. Radboud Dolhain and colleagues wrote in the October online issue of the Journal of Reproductive Immunology (doi: 10.1016/j.jri.2010.08.010).

Dr. Dolhain of Erasmus University Medical Centre, Rotterdam, the Netherlands, and his coinvestigators examined circulating cytokines in 134 pregnant patients with rheumatoid arthritis during their first trimester, 168 in their third trimester, and 33 healthy controls. Birth weights were analyzed using standard deviation scores.

Disease activity in the women was based on the disease activity score for 28 joints (DAS28); the scale runs from 0-10, with higher numbers indicating greater disease activity.

Since IL-10, IL-6 and TNF-alpha generally decrease during pregnancy, the investigators sought to determine if any increasing gestational levels correlated with birth weight. Among the first trimester patients, 12 had detectable IL-10; all of these women had a higher disease activity score than did those with no IL-10 (mean DAS28 4.4 vs. 3.6). Birth weights were compared between the two groups, which were matched with regard to disease activity, parity, and prednisone use.

The mean birth weight standard deviation was significantly greater in the IL-10 positive group (0.92) than in the matched negative group (0.15). This association with IL-10 was not seen in the third trimester pregnancies.

The investigators then examined the effect of IL-6 by stratifying IL-6 levels and disease activity scores in the first and third trimester. In the two groups with high disease activity (DAS28 3.8 or higher), birth weight standard deviation was significantly lower in mothers with high IL-6. In the high IL-6 group, the birth weight standard deviation was –0.19, compared with 0.36 in the low IL-6 group. Again, the authors found no such association in the third trimester.

“In the first trimester, elevated IL-10 seems to protect against the negative influence of RA disease activity on birth weight, [while] IL-6 seems to amplify this negative influence,” the investigators wrote. “Both cytokines create a birth weight standard deviation of more than 0.50, which is considered clinically relevant. In the third trimester, there is no influence, suggesting an early critical window.”

TNF-alpha, however, did exert an influence in the third trimester of pregnancy, Dr. Dolhain and his colleagues noted. Stratifying TNF-alpha in the same way, they concluded that the birth weight standard deviation was lower in the group with low TNF-alpha (0.05) than in the group with high TNF-alpha (0.52). This association was not present in the first trimester.

The finding that increased TNF-alpha is associated with better birth weights may require a rethinking of anti–TNF-alpha therapy for pregnant women, they suggested. This implies that “TNF blockers, which are more and more prescribed during pregnancy to treat rheumatoid arthritis, should be used with caution.”

The study was funded by the Dutch Arthritis Association. Dr. Dolhain did not disclose any pertinent financial relationships.

Circulating cytokines appear to influence fetal growth in pregnant women who have rheumatoid arthritis, results of a Dutch study suggest.

High levels of interleukin-10, IL-6, and TNF-alpha might all play a role, each acting independently – and at different stages of pregnancy – to increase the risk of low birth weight among infants born to these mothers, Dr. Radboud Dolhain and colleagues wrote in the October online issue of the Journal of Reproductive Immunology (doi: 10.1016/j.jri.2010.08.010).

Dr. Dolhain of Erasmus University Medical Centre, Rotterdam, the Netherlands, and his coinvestigators examined circulating cytokines in 134 pregnant patients with rheumatoid arthritis during their first trimester, 168 in their third trimester, and 33 healthy controls. Birth weights were analyzed using standard deviation scores.

Disease activity in the women was based on the disease activity score for 28 joints (DAS28); the scale runs from 0-10, with higher numbers indicating greater disease activity.

Since IL-10, IL-6 and TNF-alpha generally decrease during pregnancy, the investigators sought to determine if any increasing gestational levels correlated with birth weight. Among the first trimester patients, 12 had detectable IL-10; all of these women had a higher disease activity score than did those with no IL-10 (mean DAS28 4.4 vs. 3.6). Birth weights were compared between the two groups, which were matched with regard to disease activity, parity, and prednisone use.

The mean birth weight standard deviation was significantly greater in the IL-10 positive group (0.92) than in the matched negative group (0.15). This association with IL-10 was not seen in the third trimester pregnancies.

The investigators then examined the effect of IL-6 by stratifying IL-6 levels and disease activity scores in the first and third trimester. In the two groups with high disease activity (DAS28 3.8 or higher), birth weight standard deviation was significantly lower in mothers with high IL-6. In the high IL-6 group, the birth weight standard deviation was –0.19, compared with 0.36 in the low IL-6 group. Again, the authors found no such association in the third trimester.

“In the first trimester, elevated IL-10 seems to protect against the negative influence of RA disease activity on birth weight, [while] IL-6 seems to amplify this negative influence,” the investigators wrote. “Both cytokines create a birth weight standard deviation of more than 0.50, which is considered clinically relevant. In the third trimester, there is no influence, suggesting an early critical window.”

TNF-alpha, however, did exert an influence in the third trimester of pregnancy, Dr. Dolhain and his colleagues noted. Stratifying TNF-alpha in the same way, they concluded that the birth weight standard deviation was lower in the group with low TNF-alpha (0.05) than in the group with high TNF-alpha (0.52). This association was not present in the first trimester.

The finding that increased TNF-alpha is associated with better birth weights may require a rethinking of anti–TNF-alpha therapy for pregnant women, they suggested. This implies that “TNF blockers, which are more and more prescribed during pregnancy to treat rheumatoid arthritis, should be used with caution.”

The study was funded by the Dutch Arthritis Association. Dr. Dolhain did not disclose any pertinent financial relationships.

Circulating cytokines appear to influence fetal growth in pregnant women who have rheumatoid arthritis, results of a Dutch study suggest.

High levels of interleukin-10, IL-6, and TNF-alpha might all play a role, each acting independently – and at different stages of pregnancy – to increase the risk of low birth weight among infants born to these mothers, Dr. Radboud Dolhain and colleagues wrote in the October online issue of the Journal of Reproductive Immunology (doi: 10.1016/j.jri.2010.08.010).

Dr. Dolhain of Erasmus University Medical Centre, Rotterdam, the Netherlands, and his coinvestigators examined circulating cytokines in 134 pregnant patients with rheumatoid arthritis during their first trimester, 168 in their third trimester, and 33 healthy controls. Birth weights were analyzed using standard deviation scores.

Disease activity in the women was based on the disease activity score for 28 joints (DAS28); the scale runs from 0-10, with higher numbers indicating greater disease activity.

Since IL-10, IL-6 and TNF-alpha generally decrease during pregnancy, the investigators sought to determine if any increasing gestational levels correlated with birth weight. Among the first trimester patients, 12 had detectable IL-10; all of these women had a higher disease activity score than did those with no IL-10 (mean DAS28 4.4 vs. 3.6). Birth weights were compared between the two groups, which were matched with regard to disease activity, parity, and prednisone use.

The mean birth weight standard deviation was significantly greater in the IL-10 positive group (0.92) than in the matched negative group (0.15). This association with IL-10 was not seen in the third trimester pregnancies.

The investigators then examined the effect of IL-6 by stratifying IL-6 levels and disease activity scores in the first and third trimester. In the two groups with high disease activity (DAS28 3.8 or higher), birth weight standard deviation was significantly lower in mothers with high IL-6. In the high IL-6 group, the birth weight standard deviation was –0.19, compared with 0.36 in the low IL-6 group. Again, the authors found no such association in the third trimester.

“In the first trimester, elevated IL-10 seems to protect against the negative influence of RA disease activity on birth weight, [while] IL-6 seems to amplify this negative influence,” the investigators wrote. “Both cytokines create a birth weight standard deviation of more than 0.50, which is considered clinically relevant. In the third trimester, there is no influence, suggesting an early critical window.”

TNF-alpha, however, did exert an influence in the third trimester of pregnancy, Dr. Dolhain and his colleagues noted. Stratifying TNF-alpha in the same way, they concluded that the birth weight standard deviation was lower in the group with low TNF-alpha (0.05) than in the group with high TNF-alpha (0.52). This association was not present in the first trimester.

The finding that increased TNF-alpha is associated with better birth weights may require a rethinking of anti–TNF-alpha therapy for pregnant women, they suggested. This implies that “TNF blockers, which are more and more prescribed during pregnancy to treat rheumatoid arthritis, should be used with caution.”

The study was funded by the Dutch Arthritis Association. Dr. Dolhain did not disclose any pertinent financial relationships.

A hand-held, computerized imaging device identified 98% of melanomas in a set of suspicious pigmented skin lesions, according to results published online in the Archives of Dermatology.

The study findings were also published online on Skin & Allergy News Digital Network on May 6, 2010 (AAD: Digital Dermoscopy Device Detects Melanoma).

Results of the automated device – MelaFind from MELA Sciences Inc. – were compared with dermatologists who examined a subset of lesions from the same group, for a 78% identification rate. On lesions that had been previously biopsied to rule out melanoma, MelaFind's average specificity was 10%, significantly better than the 3.7% rate of dermatologists.

The device's 98% sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation, Dr. Gary Monheit and his colleagues reported (Arch. Dermatol. 2010 [doi:10.1001/archdermatol.2010.302]).

The study compared MelaFind's performance on a group of 1,632 lesions with a reading study of 50 lesions randomly extracted from the same set. All of the lesions had been biopsied by the patients’ attending dermatologists.

Lesion data, including the clinical overview and close-up and dermatoscopy images, were provided to 39 dermatologists, who were blinded to the biopsy results. The dermatologists evaluated which lesions they believed should be biopsied as probable melanoma and which should be followed clinically, wrote Dr. Monheit, a dermatologist in private practice in Birmingham, Ala., and his coauthors. The lesion samples came from a group of 1,257 patients whose mean age was 46 years. Most (98%) were white.

The MelaFind study's primary end point was the device’s sensitivity and specificity for lesions classified before biopsy as "melanoma cannot be ruled out" or as "not melanoma." After reviewing each lesion, MelaFind generated one of two conclusions: positive (biopsy) or negative (follow clinically).

Pigmented nevi made up the bulk of the lesion group (77%; 1,258), with 61% being low-grade dysplasia. Another 15% of the lesions were nonmelanocytic. Melanomas accounted for 8% of the group (127), with 57 in situ and 70 invasive; however, the invasive lesions were mostly thin, with a median thickness of 0.36 mm. Only two were relatively thick (1.0 mm and 1.2 mm). "Thus," the investigators noted, "almost all melanomas in this trial were early lesions that are difficult to differentiate from benign simulants."

Other components of the group included keratoses (119), lentigos (76), pigmented basal and squamous cell carcinomas (33), and other lesions (14).

In the reader study, the average biopsy sensitivity of the 39 dermatologists was 78%. However, the authors noted, the inter-reader variability was high. "Only 5 of the 25 melanomas would have been biopsied by all readers, and different readers missed different melanomas." Since all of the lesions had previously been biopsied, the paper did not compare clinician and MelaFind biopsy ratios. However, the authors noted, historical biopsy ratios among dermatologists are about 8:1 for the general population and up to 47:1 for high-risk patients.

The authors concluded that the device could be a valuable tool in accurately assessing pigmented lesions – an area that is largely dependent on clinicians’ individual observations and conclusions.

In a statement from MELA Sciences, coauthor Dr. Kenneth Gross stressed the need for an objective tool in the biopsy decision-making process.

"The pilot reader study found that dermatologists do miss early melanomas," said Dr. Gross, who practices surgical dermatology in San Diego. "Only 20% of the melanomas in the pilot reader study would have been biopsied by all readers and different readers missed different melanomas. Thus, even though all lesions in the clinical trial were biopsied by the examining dermatologists, many of the melanomas would not have been biopsied by other dermatologists, underscoring the need for an objective tool to aid in the decision to biopsy. We believe that the results of the pivotal trial and the pilot reader study underscore the clinical utility of MelaFind as an objective tool to aid clinicians in the detection of early melanoma."

The Food and Drug Administration will consider MelaFind on Nov. 18, during the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. The committee will make recommendations and vote on data related to the device's premarket approval.

According to the company Web site, MelaFind is a hand-held device that acquires and displays multispectral digital images from blue to near-infrared, for pigmented skin lesions. The computerized device uses automatic image analysis and statistical pattern recognition to help identify lesions that should be considered for biopsy to rule out melanoma. The device consists of an illuminator that produces light in 10 wavelengths, a lens system that creates the images, a light sensor, and an image processor that identifies discrete characteristics of each picture.

MELA Sciences sponsored the study. Dr. Monheit and 7 of the other 15 investigators are on the MELA Sciences Advisory Committee. Dr. Gross did not disclose any financial relationship with the company.

A hand-held, computerized imaging device identified 98% of melanomas in a set of suspicious pigmented skin lesions, according to results published online in the Archives of Dermatology.

The study findings were also published online on Skin & Allergy News Digital Network on May 6, 2010 (AAD: Digital Dermoscopy Device Detects Melanoma).

Results of the automated device – MelaFind from MELA Sciences Inc. – were compared with dermatologists who examined a subset of lesions from the same group, for a 78% identification rate. On lesions that had been previously biopsied to rule out melanoma, MelaFind's average specificity was 10%, significantly better than the 3.7% rate of dermatologists.

The device's 98% sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation, Dr. Gary Monheit and his colleagues reported (Arch. Dermatol. 2010 [doi:10.1001/archdermatol.2010.302]).

The study compared MelaFind's performance on a group of 1,632 lesions with a reading study of 50 lesions randomly extracted from the same set. All of the lesions had been biopsied by the patients’ attending dermatologists.

Lesion data, including the clinical overview and close-up and dermatoscopy images, were provided to 39 dermatologists, who were blinded to the biopsy results. The dermatologists evaluated which lesions they believed should be biopsied as probable melanoma and which should be followed clinically, wrote Dr. Monheit, a dermatologist in private practice in Birmingham, Ala., and his coauthors. The lesion samples came from a group of 1,257 patients whose mean age was 46 years. Most (98%) were white.

The MelaFind study's primary end point was the device’s sensitivity and specificity for lesions classified before biopsy as "melanoma cannot be ruled out" or as "not melanoma." After reviewing each lesion, MelaFind generated one of two conclusions: positive (biopsy) or negative (follow clinically).

Pigmented nevi made up the bulk of the lesion group (77%; 1,258), with 61% being low-grade dysplasia. Another 15% of the lesions were nonmelanocytic. Melanomas accounted for 8% of the group (127), with 57 in situ and 70 invasive; however, the invasive lesions were mostly thin, with a median thickness of 0.36 mm. Only two were relatively thick (1.0 mm and 1.2 mm). "Thus," the investigators noted, "almost all melanomas in this trial were early lesions that are difficult to differentiate from benign simulants."

Other components of the group included keratoses (119), lentigos (76), pigmented basal and squamous cell carcinomas (33), and other lesions (14).

In the reader study, the average biopsy sensitivity of the 39 dermatologists was 78%. However, the authors noted, the inter-reader variability was high. "Only 5 of the 25 melanomas would have been biopsied by all readers, and different readers missed different melanomas." Since all of the lesions had previously been biopsied, the paper did not compare clinician and MelaFind biopsy ratios. However, the authors noted, historical biopsy ratios among dermatologists are about 8:1 for the general population and up to 47:1 for high-risk patients.

The authors concluded that the device could be a valuable tool in accurately assessing pigmented lesions – an area that is largely dependent on clinicians’ individual observations and conclusions.

In a statement from MELA Sciences, coauthor Dr. Kenneth Gross stressed the need for an objective tool in the biopsy decision-making process.

"The pilot reader study found that dermatologists do miss early melanomas," said Dr. Gross, who practices surgical dermatology in San Diego. "Only 20% of the melanomas in the pilot reader study would have been biopsied by all readers and different readers missed different melanomas. Thus, even though all lesions in the clinical trial were biopsied by the examining dermatologists, many of the melanomas would not have been biopsied by other dermatologists, underscoring the need for an objective tool to aid in the decision to biopsy. We believe that the results of the pivotal trial and the pilot reader study underscore the clinical utility of MelaFind as an objective tool to aid clinicians in the detection of early melanoma."

The Food and Drug Administration will consider MelaFind on Nov. 18, during the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. The committee will make recommendations and vote on data related to the device's premarket approval.

According to the company Web site, MelaFind is a hand-held device that acquires and displays multispectral digital images from blue to near-infrared, for pigmented skin lesions. The computerized device uses automatic image analysis and statistical pattern recognition to help identify lesions that should be considered for biopsy to rule out melanoma. The device consists of an illuminator that produces light in 10 wavelengths, a lens system that creates the images, a light sensor, and an image processor that identifies discrete characteristics of each picture.

MELA Sciences sponsored the study. Dr. Monheit and 7 of the other 15 investigators are on the MELA Sciences Advisory Committee. Dr. Gross did not disclose any financial relationship with the company.

A hand-held, computerized imaging device identified 98% of melanomas in a set of suspicious pigmented skin lesions, according to results published online in the Archives of Dermatology.

The study findings were also published online on Skin & Allergy News Digital Network on May 6, 2010 (AAD: Digital Dermoscopy Device Detects Melanoma).

Results of the automated device – MelaFind from MELA Sciences Inc. – were compared with dermatologists who examined a subset of lesions from the same group, for a 78% identification rate. On lesions that had been previously biopsied to rule out melanoma, MelaFind's average specificity was 10%, significantly better than the 3.7% rate of dermatologists.

The device's 98% sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation, Dr. Gary Monheit and his colleagues reported (Arch. Dermatol. 2010 [doi:10.1001/archdermatol.2010.302]).

The study compared MelaFind's performance on a group of 1,632 lesions with a reading study of 50 lesions randomly extracted from the same set. All of the lesions had been biopsied by the patients’ attending dermatologists.

Lesion data, including the clinical overview and close-up and dermatoscopy images, were provided to 39 dermatologists, who were blinded to the biopsy results. The dermatologists evaluated which lesions they believed should be biopsied as probable melanoma and which should be followed clinically, wrote Dr. Monheit, a dermatologist in private practice in Birmingham, Ala., and his coauthors. The lesion samples came from a group of 1,257 patients whose mean age was 46 years. Most (98%) were white.

The MelaFind study's primary end point was the device’s sensitivity and specificity for lesions classified before biopsy as "melanoma cannot be ruled out" or as "not melanoma." After reviewing each lesion, MelaFind generated one of two conclusions: positive (biopsy) or negative (follow clinically).

Pigmented nevi made up the bulk of the lesion group (77%; 1,258), with 61% being low-grade dysplasia. Another 15% of the lesions were nonmelanocytic. Melanomas accounted for 8% of the group (127), with 57 in situ and 70 invasive; however, the invasive lesions were mostly thin, with a median thickness of 0.36 mm. Only two were relatively thick (1.0 mm and 1.2 mm). "Thus," the investigators noted, "almost all melanomas in this trial were early lesions that are difficult to differentiate from benign simulants."

Other components of the group included keratoses (119), lentigos (76), pigmented basal and squamous cell carcinomas (33), and other lesions (14).

In the reader study, the average biopsy sensitivity of the 39 dermatologists was 78%. However, the authors noted, the inter-reader variability was high. "Only 5 of the 25 melanomas would have been biopsied by all readers, and different readers missed different melanomas." Since all of the lesions had previously been biopsied, the paper did not compare clinician and MelaFind biopsy ratios. However, the authors noted, historical biopsy ratios among dermatologists are about 8:1 for the general population and up to 47:1 for high-risk patients.

The authors concluded that the device could be a valuable tool in accurately assessing pigmented lesions – an area that is largely dependent on clinicians’ individual observations and conclusions.

In a statement from MELA Sciences, coauthor Dr. Kenneth Gross stressed the need for an objective tool in the biopsy decision-making process.

"The pilot reader study found that dermatologists do miss early melanomas," said Dr. Gross, who practices surgical dermatology in San Diego. "Only 20% of the melanomas in the pilot reader study would have been biopsied by all readers and different readers missed different melanomas. Thus, even though all lesions in the clinical trial were biopsied by the examining dermatologists, many of the melanomas would not have been biopsied by other dermatologists, underscoring the need for an objective tool to aid in the decision to biopsy. We believe that the results of the pivotal trial and the pilot reader study underscore the clinical utility of MelaFind as an objective tool to aid clinicians in the detection of early melanoma."

The Food and Drug Administration will consider MelaFind on Nov. 18, during the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. The committee will make recommendations and vote on data related to the device's premarket approval.

According to the company Web site, MelaFind is a hand-held device that acquires and displays multispectral digital images from blue to near-infrared, for pigmented skin lesions. The computerized device uses automatic image analysis and statistical pattern recognition to help identify lesions that should be considered for biopsy to rule out melanoma. The device consists of an illuminator that produces light in 10 wavelengths, a lens system that creates the images, a light sensor, and an image processor that identifies discrete characteristics of each picture.

MELA Sciences sponsored the study. Dr. Monheit and 7 of the other 15 investigators are on the MELA Sciences Advisory Committee. Dr. Gross did not disclose any financial relationship with the company.

A hand-held, computerized imaging device identified 98% of melanomas in a set of suspicious pigmented skin lesions, according to results published online in the Archives of Dermatology.

The study findings were also published online on Skin & Allergy News Digital Network on May 6, 2010 (AAD: Digital Dermoscopy Device Detects Melanoma).

Results of the automated device – MelaFind from MELA Sciences Inc. – were compared with dermatologists who examined a subset of lesions from the same group, for a 78% identification rate. On lesions that had been previously biopsied to rule out melanoma, MelaFind's average specificity was 10%, significantly better than the 3.7% rate of dermatologists.

The device's 98% sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation, Dr. Gary Monheit and his colleagues reported (Arch. Dermatol. 2010 [doi:10.1001/archdermatol.2010.302]).

The study compared MelaFind's performance on a group of 1,632 lesions with a reading study of 50 lesions randomly extracted from the same set. All of the lesions had been biopsied by the patients’ attending dermatologists.

Lesion data, including the clinical overview and close-up and dermatoscopy images, were provided to 39 dermatologists, who were blinded to the biopsy results. The dermatologists evaluated which lesions they believed should be biopsied as probable melanoma and which should be followed clinically, wrote Dr. Monheit, a dermatologist in private practice in Birmingham, Ala., and his coauthors. The lesion samples came from a group of 1,257 patients whose mean age was 46 years. Most (98%) were white.

The MelaFind study's primary end point was the device’s sensitivity and specificity for lesions classified before biopsy as "melanoma cannot be ruled out" or as "not melanoma." After reviewing each lesion, MelaFind generated one of two conclusions: positive (biopsy) or negative (follow clinically).

Pigmented nevi made up the bulk of the lesion group (77%; 1,258), with 61% being low-grade dysplasia. Another 15% of the lesions were nonmelanocytic. Melanomas accounted for 8% of the group (127), with 57 in situ and 70 invasive; however, the invasive lesions were mostly thin, with a median thickness of 0.36 mm. Only two were relatively thick (1.0 mm and 1.2 mm). "Thus," the investigators noted, "almost all melanomas in this trial were early lesions that are difficult to differentiate from benign simulants."

Other components of the group included keratoses (119), lentigos (76), pigmented basal and squamous cell carcinomas (33), and other lesions (14).

In the reader study, the average biopsy sensitivity of the 39 dermatologists was 78%. However, the authors noted, the inter-reader variability was high. "Only 5 of the 25 melanomas would have been biopsied by all readers, and different readers missed different melanomas." Since all of the lesions had previously been biopsied, the paper did not compare clinician and MelaFind biopsy ratios. However, the authors noted, historical biopsy ratios among dermatologists are about 8:1 for the general population and up to 47:1 for high-risk patients.

The authors concluded that the device could be a valuable tool in accurately assessing pigmented lesions – an area that is largely dependent on clinicians’ individual observations and conclusions.

In a press release from MELA Sciences, coauthor Dr. Kenneth Gross stressed the need for an objective tool in the biopsy decision-making process.

"The pilot reader study found that dermatologists do miss early melanomas," said Dr. Gross, who practices surgical dermatology in San Diego. "Only 20% of the melanomas in the pilot reader study would have been biopsied by all readers and different readers missed different melanomas. Thus, even though all lesions in the clinical trial were biopsied by the examining dermatologists, many of the melanomas would not have been biopsied by other dermatologists, underscoring the need for an objective tool to aid in the decision to biopsy. We believe that the results of the pivotal trial and the pilot reader study underscore the clinical utility of MelaFind as an objective tool to aid clinicians in the detection of early melanoma."

The Food and Drug Administration will consider MelaFind on Nov. 18, during the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. The committee will make recommendations and vote on data related to the device's premarket approval.

According to the company Web site, MelaFind is a hand-held device that acquires and displays multispectral digital images from blue to near-infrared, for pigmented skin lesions. The computerized device uses automatic image analysis and statistical pattern recognition to help identify lesions that should be considered for biopsy to rule out melanoma. The device consists of an illuminator that produces light in 10 wavelengths, a lens system that creates the images, a light sensor, and an image processor that identifies discrete characteristics of each picture.

MELA Sciences sponsored the study. Dr. Monheit and 7 of the other 15 investigators are on the MELA Sciences Advisory Committee. Dr. Gross did not disclose any financial relationship with the company.

A hand-held, computerized imaging device identified 98% of melanomas in a set of suspicious pigmented skin lesions, according to results published online in the Archives of Dermatology.

The study findings were also published online on Skin & Allergy News Digital Network on May 6, 2010 (AAD: Digital Dermoscopy Device Detects Melanoma).

Results of the automated device – MelaFind from MELA Sciences Inc. – were compared with dermatologists who examined a subset of lesions from the same group, for a 78% identification rate. On lesions that had been previously biopsied to rule out melanoma, MelaFind's average specificity was 10%, significantly better than the 3.7% rate of dermatologists.

The device's 98% sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation, Dr. Gary Monheit and his colleagues reported (Arch. Dermatol. 2010 [doi:10.1001/archdermatol.2010.302]).

The study compared MelaFind's performance on a group of 1,632 lesions with a reading study of 50 lesions randomly extracted from the same set. All of the lesions had been biopsied by the patients’ attending dermatologists.

Lesion data, including the clinical overview and close-up and dermatoscopy images, were provided to 39 dermatologists, who were blinded to the biopsy results. The dermatologists evaluated which lesions they believed should be biopsied as probable melanoma and which should be followed clinically, wrote Dr. Monheit, a dermatologist in private practice in Birmingham, Ala., and his coauthors. The lesion samples came from a group of 1,257 patients whose mean age was 46 years. Most (98%) were white.

The MelaFind study's primary end point was the device’s sensitivity and specificity for lesions classified before biopsy as "melanoma cannot be ruled out" or as "not melanoma." After reviewing each lesion, MelaFind generated one of two conclusions: positive (biopsy) or negative (follow clinically).

Pigmented nevi made up the bulk of the lesion group (77%; 1,258), with 61% being low-grade dysplasia. Another 15% of the lesions were nonmelanocytic. Melanomas accounted for 8% of the group (127), with 57 in situ and 70 invasive; however, the invasive lesions were mostly thin, with a median thickness of 0.36 mm. Only two were relatively thick (1.0 mm and 1.2 mm). "Thus," the investigators noted, "almost all melanomas in this trial were early lesions that are difficult to differentiate from benign simulants."

Other components of the group included keratoses (119), lentigos (76), pigmented basal and squamous cell carcinomas (33), and other lesions (14).

In the reader study, the average biopsy sensitivity of the 39 dermatologists was 78%. However, the authors noted, the inter-reader variability was high. "Only 5 of the 25 melanomas would have been biopsied by all readers, and different readers missed different melanomas." Since all of the lesions had previously been biopsied, the paper did not compare clinician and MelaFind biopsy ratios. However, the authors noted, historical biopsy ratios among dermatologists are about 8:1 for the general population and up to 47:1 for high-risk patients.

The authors concluded that the device could be a valuable tool in accurately assessing pigmented lesions – an area that is largely dependent on clinicians’ individual observations and conclusions.

In a press release from MELA Sciences, coauthor Dr. Kenneth Gross stressed the need for an objective tool in the biopsy decision-making process.

"The pilot reader study found that dermatologists do miss early melanomas," said Dr. Gross, who practices surgical dermatology in San Diego. "Only 20% of the melanomas in the pilot reader study would have been biopsied by all readers and different readers missed different melanomas. Thus, even though all lesions in the clinical trial were biopsied by the examining dermatologists, many of the melanomas would not have been biopsied by other dermatologists, underscoring the need for an objective tool to aid in the decision to biopsy. We believe that the results of the pivotal trial and the pilot reader study underscore the clinical utility of MelaFind as an objective tool to aid clinicians in the detection of early melanoma."

The Food and Drug Administration will consider MelaFind on Nov. 18, during the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. The committee will make recommendations and vote on data related to the device's premarket approval.

According to the company Web site, MelaFind is a hand-held device that acquires and displays multispectral digital images from blue to near-infrared, for pigmented skin lesions. The computerized device uses automatic image analysis and statistical pattern recognition to help identify lesions that should be considered for biopsy to rule out melanoma. The device consists of an illuminator that produces light in 10 wavelengths, a lens system that creates the images, a light sensor, and an image processor that identifies discrete characteristics of each picture.

MELA Sciences sponsored the study. Dr. Monheit and 7 of the other 15 investigators are on the MELA Sciences Advisory Committee. Dr. Gross did not disclose any financial relationship with the company.

A hand-held, computerized imaging device identified 98% of melanomas in a set of suspicious pigmented skin lesions, according to results published online in the Archives of Dermatology.

The study findings were also published online on Skin & Allergy News Digital Network on May 6, 2010 (AAD: Digital Dermoscopy Device Detects Melanoma).

Results of the automated device – MelaFind from MELA Sciences Inc. – were compared with dermatologists who examined a subset of lesions from the same group, for a 78% identification rate. On lesions that had been previously biopsied to rule out melanoma, MelaFind's average specificity was 10%, significantly better than the 3.7% rate of dermatologists.

The device's 98% sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation, Dr. Gary Monheit and his colleagues reported (Arch. Dermatol. 2010 [doi:10.1001/archdermatol.2010.302]).

The study compared MelaFind's performance on a group of 1,632 lesions with a reading study of 50 lesions randomly extracted from the same set. All of the lesions had been biopsied by the patients’ attending dermatologists.

Lesion data, including the clinical overview and close-up and dermatoscopy images, were provided to 39 dermatologists, who were blinded to the biopsy results. The dermatologists evaluated which lesions they believed should be biopsied as probable melanoma and which should be followed clinically, wrote Dr. Monheit, a dermatologist in private practice in Birmingham, Ala., and his coauthors. The lesion samples came from a group of 1,257 patients whose mean age was 46 years. Most (98%) were white.

The MelaFind study's primary end point was the device’s sensitivity and specificity for lesions classified before biopsy as "melanoma cannot be ruled out" or as "not melanoma." After reviewing each lesion, MelaFind generated one of two conclusions: positive (biopsy) or negative (follow clinically).

Pigmented nevi made up the bulk of the lesion group (77%; 1,258), with 61% being low-grade dysplasia. Another 15% of the lesions were nonmelanocytic. Melanomas accounted for 8% of the group (127), with 57 in situ and 70 invasive; however, the invasive lesions were mostly thin, with a median thickness of 0.36 mm. Only two were relatively thick (1.0 mm and 1.2 mm). "Thus," the investigators noted, "almost all melanomas in this trial were early lesions that are difficult to differentiate from benign simulants."

Other components of the group included keratoses (119), lentigos (76), pigmented basal and squamous cell carcinomas (33), and other lesions (14).

In the reader study, the average biopsy sensitivity of the 39 dermatologists was 78%. However, the authors noted, the inter-reader variability was high. "Only 5 of the 25 melanomas would have been biopsied by all readers, and different readers missed different melanomas." Since all of the lesions had previously been biopsied, the paper did not compare clinician and MelaFind biopsy ratios. However, the authors noted, historical biopsy ratios among dermatologists are about 8:1 for the general population and up to 47:1 for high-risk patients.

The authors concluded that the device could be a valuable tool in accurately assessing pigmented lesions – an area that is largely dependent on clinicians’ individual observations and conclusions.

In a press release from MELA Sciences, coauthor Dr. Kenneth Gross stressed the need for an objective tool in the biopsy decision-making process.

"The pilot reader study found that dermatologists do miss early melanomas," said Dr. Gross, who practices surgical dermatology in San Diego. "Only 20% of the melanomas in the pilot reader study would have been biopsied by all readers and different readers missed different melanomas. Thus, even though all lesions in the clinical trial were biopsied by the examining dermatologists, many of the melanomas would not have been biopsied by other dermatologists, underscoring the need for an objective tool to aid in the decision to biopsy. We believe that the results of the pivotal trial and the pilot reader study underscore the clinical utility of MelaFind as an objective tool to aid clinicians in the detection of early melanoma."

The Food and Drug Administration will consider MelaFind on Nov. 18, during the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. The committee will make recommendations and vote on data related to the device's premarket approval.

According to the company Web site, MelaFind is a hand-held device that acquires and displays multispectral digital images from blue to near-infrared, for pigmented skin lesions. The computerized device uses automatic image analysis and statistical pattern recognition to help identify lesions that should be considered for biopsy to rule out melanoma. The device consists of an illuminator that produces light in 10 wavelengths, a lens system that creates the images, a light sensor, and an image processor that identifies discrete characteristics of each picture.

MELA Sciences sponsored the study. Dr. Monheit and 7 of the other 15 investigators are on the MELA Sciences Advisory Committee. Dr. Gross did not disclose any financial relationship with the company.

PARIS – Rituximab seemed to be safe and effective for six patients with severe Graves’ orbitopathy that was refractory to steroid therapy, Dr. Anna Mitchell reported at the International Thyroid Congress.

But reports of the drug’s use in this application are just beginning to emerge, she cautioned. “This is an off-label indication and we must have randomized, controlled trial data to support this as an intervention.”

Rituximab is used in treating rheumatoid arthritis and has recently been examined for possible benefit in other autoimmune disorders, including Graves’ orbitopathy. The drug depletes circulating B cells, but does not interfere with precursor B cells or differentiated plasma cells, said Dr. Mitchell of Newcastle University, Newcastle upon Tyne, England.

She and her colleagues have used rituximab to treat six patients with refractory Graves’ orbitopathy (one man, five women; aged 37-73 years). Two patients had dysthyroid optic neuropathy; one proved refractory to intravenous methylprednisolone and the other worsened despite orbital decompression surgery. The other four patients had been treated for severe Graves’ orbitopathy that was refractory to multiple doses of methylprednisolone (4.5 g in three patients) or a combination regimen of methylprednisolone and mycophenolate mofetil (one patient).

All six patients received rituximab; the first three received two intravenous infusions of 1 g; the last three, infusions of 0.5 g. Infusions were scheduled 2 weeks apart; patients had to have absolute B-cell depletion confirmed before the second infusion could be administered.

At baseline, the patients’ mean Graves’ clinical activity score was 5.5 on a 10-point scale (range, 3-9). Within the first 3 months after the initial infusion, all patients saw an improvement in the CAS of at least 2 points.

One patient with dysthyroid optic neuropathy experienced an almost immediate, significant improvement in visual acuity; within 10 days of the first infusion, this patient’s vision went from perception of light only to 6/18, a metric rating that corresponds to 20/60 on the visual acuity scale.

The other patient with dysthyroid optic neuropathy did not experience any improvement in visual acuity within 12 days of her first infusion, and so opted for an emergency orbital decompression.

Dr. Mitchell added that there was no difference in efficacy between the 1-g and 0.5-g doses, but did mention the cost savings associated with the lower dose.

Last January, researchers from the University of California, Los Angeles, published another case series of six patients who had refractory Graves’ orbitopathy and underwent rituximab treatment. Dr. Dinesh Khanna and colleagues administered rituximab in two infusions of 1 g each, given 2 weeks apart.

In their series, all patients had a significant improvement in the CAS. The four patients with dysthyroid optic neuropathy experienced significant improvements in visual acuity within 4 weeks of the initial infusion and stabilized at preneuropathy levels by 2 months (Ophthalmology 2010;117:133-9).

However, proptosis remained unchanged in all, and no patient showed improvement in extraocular motility.

Dr. Mitchell did not present specific adverse event data, but the California study noted that one patient developed a urinary tract infection, one had an exacerbation of preexisting hypertension, and one died of sudden cardiac arrest at 3 months after the final infusion.

Dr. Mitchell and Dr. Khanna had no relevant financial disclosures.

PARIS – Rituximab seemed to be safe and effective for six patients with severe Graves’ orbitopathy that was refractory to steroid therapy, Dr. Anna Mitchell reported at the International Thyroid Congress.

But reports of the drug’s use in this application are just beginning to emerge, she cautioned. “This is an off-label indication and we must have randomized, controlled trial data to support this as an intervention.”

Rituximab is used in treating rheumatoid arthritis and has recently been examined for possible benefit in other autoimmune disorders, including Graves’ orbitopathy. The drug depletes circulating B cells, but does not interfere with precursor B cells or differentiated plasma cells, said Dr. Mitchell of Newcastle University, Newcastle upon Tyne, England.

She and her colleagues have used rituximab to treat six patients with refractory Graves’ orbitopathy (one man, five women; aged 37-73 years). Two patients had dysthyroid optic neuropathy; one proved refractory to intravenous methylprednisolone and the other worsened despite orbital decompression surgery. The other four patients had been treated for severe Graves’ orbitopathy that was refractory to multiple doses of methylprednisolone (4.5 g in three patients) or a combination regimen of methylprednisolone and mycophenolate mofetil (one patient).

All six patients received rituximab; the first three received two intravenous infusions of 1 g; the last three, infusions of 0.5 g. Infusions were scheduled 2 weeks apart; patients had to have absolute B-cell depletion confirmed before the second infusion could be administered.

At baseline, the patients’ mean Graves’ clinical activity score was 5.5 on a 10-point scale (range, 3-9). Within the first 3 months after the initial infusion, all patients saw an improvement in the CAS of at least 2 points.

One patient with dysthyroid optic neuropathy experienced an almost immediate, significant improvement in visual acuity; within 10 days of the first infusion, this patient’s vision went from perception of light only to 6/18, a metric rating that corresponds to 20/60 on the visual acuity scale.

The other patient with dysthyroid optic neuropathy did not experience any improvement in visual acuity within 12 days of her first infusion, and so opted for an emergency orbital decompression.

Dr. Mitchell added that there was no difference in efficacy between the 1-g and 0.5-g doses, but did mention the cost savings associated with the lower dose.

Last January, researchers from the University of California, Los Angeles, published another case series of six patients who had refractory Graves’ orbitopathy and underwent rituximab treatment. Dr. Dinesh Khanna and colleagues administered rituximab in two infusions of 1 g each, given 2 weeks apart.

In their series, all patients had a significant improvement in the CAS. The four patients with dysthyroid optic neuropathy experienced significant improvements in visual acuity within 4 weeks of the initial infusion and stabilized at preneuropathy levels by 2 months (Ophthalmology 2010;117:133-9).

However, proptosis remained unchanged in all, and no patient showed improvement in extraocular motility.

Dr. Mitchell did not present specific adverse event data, but the California study noted that one patient developed a urinary tract infection, one had an exacerbation of preexisting hypertension, and one died of sudden cardiac arrest at 3 months after the final infusion.

Dr. Mitchell and Dr. Khanna had no relevant financial disclosures.

PARIS – Rituximab seemed to be safe and effective for six patients with severe Graves’ orbitopathy that was refractory to steroid therapy, Dr. Anna Mitchell reported at the International Thyroid Congress.

But reports of the drug’s use in this application are just beginning to emerge, she cautioned. “This is an off-label indication and we must have randomized, controlled trial data to support this as an intervention.”

Rituximab is used in treating rheumatoid arthritis and has recently been examined for possible benefit in other autoimmune disorders, including Graves’ orbitopathy. The drug depletes circulating B cells, but does not interfere with precursor B cells or differentiated plasma cells, said Dr. Mitchell of Newcastle University, Newcastle upon Tyne, England.

She and her colleagues have used rituximab to treat six patients with refractory Graves’ orbitopathy (one man, five women; aged 37-73 years). Two patients had dysthyroid optic neuropathy; one proved refractory to intravenous methylprednisolone and the other worsened despite orbital decompression surgery. The other four patients had been treated for severe Graves’ orbitopathy that was refractory to multiple doses of methylprednisolone (4.5 g in three patients) or a combination regimen of methylprednisolone and mycophenolate mofetil (one patient).

All six patients received rituximab; the first three received two intravenous infusions of 1 g; the last three, infusions of 0.5 g. Infusions were scheduled 2 weeks apart; patients had to have absolute B-cell depletion confirmed before the second infusion could be administered.

At baseline, the patients’ mean Graves’ clinical activity score was 5.5 on a 10-point scale (range, 3-9). Within the first 3 months after the initial infusion, all patients saw an improvement in the CAS of at least 2 points.

One patient with dysthyroid optic neuropathy experienced an almost immediate, significant improvement in visual acuity; within 10 days of the first infusion, this patient’s vision went from perception of light only to 6/18, a metric rating that corresponds to 20/60 on the visual acuity scale.

The other patient with dysthyroid optic neuropathy did not experience any improvement in visual acuity within 12 days of her first infusion, and so opted for an emergency orbital decompression.

Dr. Mitchell added that there was no difference in efficacy between the 1-g and 0.5-g doses, but did mention the cost savings associated with the lower dose.

Last January, researchers from the University of California, Los Angeles, published another case series of six patients who had refractory Graves’ orbitopathy and underwent rituximab treatment. Dr. Dinesh Khanna and colleagues administered rituximab in two infusions of 1 g each, given 2 weeks apart.

In their series, all patients had a significant improvement in the CAS. The four patients with dysthyroid optic neuropathy experienced significant improvements in visual acuity within 4 weeks of the initial infusion and stabilized at preneuropathy levels by 2 months (Ophthalmology 2010;117:133-9).

However, proptosis remained unchanged in all, and no patient showed improvement in extraocular motility.

Dr. Mitchell did not present specific adverse event data, but the California study noted that one patient developed a urinary tract infection, one had an exacerbation of preexisting hypertension, and one died of sudden cardiac arrest at 3 months after the final infusion.

Dr. Mitchell and Dr. Khanna had no relevant financial disclosures.

PARIS – An ultrasensitive chemoluminescent thyroglobulin assay can identify which differentiated thyroid cancer patients may require more intense follow-up after surgery, as well as those with a low risk of persistent or recurrent disease.

“In patients with a low basal thyroglobulin (less than 0.15 ng/mL), follow-up can be simplified, while in patients with a higher basal level, periodic examination and regulation are probably required,” Dr. Pasqualino Malandrino said at the International Thyroid Congress.

Dr. Malandrino of the Garibaldi-Nesima Hospital in Catania, Italy, and his colleagues employed the ultrasensitive assay in 425 consecutive patients who had been treated for differentiated thyroid cancer in 2006-2010. All had undergone a total thyroidectomy followed by radioiodine ablation. No patient had any evidence of residual disease, and all had a basal thyroglobulin level of less than 1 ng/mL.

Of the cohort, 337 were women; their mean age at diagnosis was 44 years. There were 406 papillary and 19 follicular cancers among them. All patients were negative for antithyroid antibodies and all were receiving recombinant TSH as scheduled.

All of the patients had their thyroglobulin measured with the ultrasensitive chemoluminescent assay before and after receiving recombinant TSH. The investigators defined persistent disease as a stimulated thyroglobulin value exceeding 2 ng/mL.

Most of the patients (331) had a baseline thyroglobulin level of less than 0.10 ng/mL and a median TSH level of 0.21 microIU/mL. The thyroglobulin level was 0.11-0.50 ng/mL in 80 patients, with a median TSH of 0.15 microIU/mL; 14 had a thyroglobulin level of 0.50-1 ng/mL with a median TSH of 0.19 microIU/mL.

After the patients underwent TSH stimulation, the ultrasensitive assay determined that thyroglobulin levels were 2 ng/mL or higher in 1% of those in the lowest tertile of basal thyroglobulin levels, in 29% of those in middle tertile, and in 71% of those in the highest tertile.

A basal thyroglobulin cutoff value of 0.15 ng/mL was the most accurate predictor of residual disease. Using this cutoff, a stimulated thyroglobulin of 2 ng/mL or greater was found in 1% of those with a basal thyroglobulin of 0.15 ng/mL or less, compared with 45% of those with a baseline level of more than 0.15 ng/mL.

The marker had a sensitivity of 87% and a specificity of 91%, a negative predictive value of 99% and a positive predictive value of 48%.

However, Dr. Malandrino added, “the low positive predictive value of the 0.15 ng/mL cutoff means that we require additional investigation to be able to identify very-high-risk patients.”

Dr. Malandrino did not disclose any financial conflicts.

PARIS – An ultrasensitive chemoluminescent thyroglobulin assay can identify which differentiated thyroid cancer patients may require more intense follow-up after surgery, as well as those with a low risk of persistent or recurrent disease.

“In patients with a low basal thyroglobulin (less than 0.15 ng/mL), follow-up can be simplified, while in patients with a higher basal level, periodic examination and regulation are probably required,” Dr. Pasqualino Malandrino said at the International Thyroid Congress.

Dr. Malandrino of the Garibaldi-Nesima Hospital in Catania, Italy, and his colleagues employed the ultrasensitive assay in 425 consecutive patients who had been treated for differentiated thyroid cancer in 2006-2010. All had undergone a total thyroidectomy followed by radioiodine ablation. No patient had any evidence of residual disease, and all had a basal thyroglobulin level of less than 1 ng/mL.

Of the cohort, 337 were women; their mean age at diagnosis was 44 years. There were 406 papillary and 19 follicular cancers among them. All patients were negative for antithyroid antibodies and all were receiving recombinant TSH as scheduled.

All of the patients had their thyroglobulin measured with the ultrasensitive chemoluminescent assay before and after receiving recombinant TSH. The investigators defined persistent disease as a stimulated thyroglobulin value exceeding 2 ng/mL.

Most of the patients (331) had a baseline thyroglobulin level of less than 0.10 ng/mL and a median TSH level of 0.21 microIU/mL. The thyroglobulin level was 0.11-0.50 ng/mL in 80 patients, with a median TSH of 0.15 microIU/mL; 14 had a thyroglobulin level of 0.50-1 ng/mL with a median TSH of 0.19 microIU/mL.

After the patients underwent TSH stimulation, the ultrasensitive assay determined that thyroglobulin levels were 2 ng/mL or higher in 1% of those in the lowest tertile of basal thyroglobulin levels, in 29% of those in middle tertile, and in 71% of those in the highest tertile.

A basal thyroglobulin cutoff value of 0.15 ng/mL was the most accurate predictor of residual disease. Using this cutoff, a stimulated thyroglobulin of 2 ng/mL or greater was found in 1% of those with a basal thyroglobulin of 0.15 ng/mL or less, compared with 45% of those with a baseline level of more than 0.15 ng/mL.

The marker had a sensitivity of 87% and a specificity of 91%, a negative predictive value of 99% and a positive predictive value of 48%.

However, Dr. Malandrino added, “the low positive predictive value of the 0.15 ng/mL cutoff means that we require additional investigation to be able to identify very-high-risk patients.”

Dr. Malandrino did not disclose any financial conflicts.

PARIS – An ultrasensitive chemoluminescent thyroglobulin assay can identify which differentiated thyroid cancer patients may require more intense follow-up after surgery, as well as those with a low risk of persistent or recurrent disease.

“In patients with a low basal thyroglobulin (less than 0.15 ng/mL), follow-up can be simplified, while in patients with a higher basal level, periodic examination and regulation are probably required,” Dr. Pasqualino Malandrino said at the International Thyroid Congress.

Dr. Malandrino of the Garibaldi-Nesima Hospital in Catania, Italy, and his colleagues employed the ultrasensitive assay in 425 consecutive patients who had been treated for differentiated thyroid cancer in 2006-2010. All had undergone a total thyroidectomy followed by radioiodine ablation. No patient had any evidence of residual disease, and all had a basal thyroglobulin level of less than 1 ng/mL.

Of the cohort, 337 were women; their mean age at diagnosis was 44 years. There were 406 papillary and 19 follicular cancers among them. All patients were negative for antithyroid antibodies and all were receiving recombinant TSH as scheduled.

All of the patients had their thyroglobulin measured with the ultrasensitive chemoluminescent assay before and after receiving recombinant TSH. The investigators defined persistent disease as a stimulated thyroglobulin value exceeding 2 ng/mL.

Most of the patients (331) had a baseline thyroglobulin level of less than 0.10 ng/mL and a median TSH level of 0.21 microIU/mL. The thyroglobulin level was 0.11-0.50 ng/mL in 80 patients, with a median TSH of 0.15 microIU/mL; 14 had a thyroglobulin level of 0.50-1 ng/mL with a median TSH of 0.19 microIU/mL.

After the patients underwent TSH stimulation, the ultrasensitive assay determined that thyroglobulin levels were 2 ng/mL or higher in 1% of those in the lowest tertile of basal thyroglobulin levels, in 29% of those in middle tertile, and in 71% of those in the highest tertile.

A basal thyroglobulin cutoff value of 0.15 ng/mL was the most accurate predictor of residual disease. Using this cutoff, a stimulated thyroglobulin of 2 ng/mL or greater was found in 1% of those with a basal thyroglobulin of 0.15 ng/mL or less, compared with 45% of those with a baseline level of more than 0.15 ng/mL.

The marker had a sensitivity of 87% and a specificity of 91%, a negative predictive value of 99% and a positive predictive value of 48%.

However, Dr. Malandrino added, “the low positive predictive value of the 0.15 ng/mL cutoff means that we require additional investigation to be able to identify very-high-risk patients.”

Dr. Malandrino did not disclose any financial conflicts.

PARIS – Smokers who have recently kicked the habit could face a significant increase in the risk of developing new-onset hypothyroidism.

The risk is greatest within the first 2 years of quitting, when it can run as high as 5 times the risk of someone who has never smoked, or who has been tobacco-free for more than 2 years.

© PhotoDisc

There’s no obvious explanation for the phenomenon, Dr. Allan Carle said at the International Thyroid Meeting. However, he said, a 2007 study suggests that current smokers actually have a significantly lower risk of developing hypothyroidism but an increased risk of hyperthyroidism (Arch. Intern. Med. 2007;167:1428-32).

“Perhaps quitting causes come kind of rebound effect, with changes in antithyroid antibodies,” said Dr. Carle of the Aalborg Hospital, Denmark. But his case-control study could only observe the phenomenon – not uncover its possible cause.

He and his associates compared 140 patients with incident autoimmune overt hypothyroidism, extracted from a population-based study, to 560 age- and sex-matched controls from the same population.

All the subjects provided information on their smoking status, including daily and overall tobacco intake, years of smoking, pack/years of smoking, and – if they were past smokers – the time since quitting. Clinical measurements included autoantibodies to thyroid peroxidase (TPOAb) and thyroglobulin (TgAb); thyroid function; and a thyroid ultrasound exam. Possible relationships were examined in both univariate and multivariate models that controlled for confounding.

The investigators used the group of never-smokers as the reference group. The risk of hypothyroidism among current smokers and those who had quit more than 2 years before the study was not significantly different from the risk among never-smokers. There were also no significant relationships between new hypothyroidism and the duration or magnitude of smoking.

However, among subjects who had quit within the past 2 years, the risk of new hypothyroidism was significantly increased. Those who had quit within the past 1 year were 5.6 times as likely as never-smokers to develop the disorder; those who had quit 1-2 years before were 5 times as likely to develop it.

The risk of new-onset hypothyroidism dropped back to the reference range for those who had quit smoking 3-10 years before the study (odds ratio 0.85).

“Recent quitters were also more hypothyroid than other study subjects who had hypothyroidism,” Dr. Carle said. Those who had quit within the past 2 years had a median total T4 level of 20 nmol/L, compared with 40 nmol/L in never-smokers with the disorder, and a median thyroid-stimulating hormone level of 82 mU/L compared with 49 mU/L.

“Looking at these data, we can say that in this series, 13% of new-onset hypothyroidism was associated with smoking withdrawal,” Dr. Carle said. Because of this association, he recommended thyroid testing for all patients who report recent smoking cessation, “especially in those who have any complaints of symptoms.”

Dr. Carle said that he had no potential financial conflicts.

PARIS – Smokers who have recently kicked the habit could face a significant increase in the risk of developing new-onset hypothyroidism.

The risk is greatest within the first 2 years of quitting, when it can run as high as 5 times the risk of someone who has never smoked, or who has been tobacco-free for more than 2 years.

© PhotoDisc

There’s no obvious explanation for the phenomenon, Dr. Allan Carle said at the International Thyroid Meeting. However, he said, a 2007 study suggests that current smokers actually have a significantly lower risk of developing hypothyroidism but an increased risk of hyperthyroidism (Arch. Intern. Med. 2007;167:1428-32).

“Perhaps quitting causes come kind of rebound effect, with changes in antithyroid antibodies,” said Dr. Carle of the Aalborg Hospital, Denmark. But his case-control study could only observe the phenomenon – not uncover its possible cause.

He and his associates compared 140 patients with incident autoimmune overt hypothyroidism, extracted from a population-based study, to 560 age- and sex-matched controls from the same population.

All the subjects provided information on their smoking status, including daily and overall tobacco intake, years of smoking, pack/years of smoking, and – if they were past smokers – the time since quitting. Clinical measurements included autoantibodies to thyroid peroxidase (TPOAb) and thyroglobulin (TgAb); thyroid function; and a thyroid ultrasound exam. Possible relationships were examined in both univariate and multivariate models that controlled for confounding.

The investigators used the group of never-smokers as the reference group. The risk of hypothyroidism among current smokers and those who had quit more than 2 years before the study was not significantly different from the risk among never-smokers. There were also no significant relationships between new hypothyroidism and the duration or magnitude of smoking.

However, among subjects who had quit within the past 2 years, the risk of new hypothyroidism was significantly increased. Those who had quit within the past 1 year were 5.6 times as likely as never-smokers to develop the disorder; those who had quit 1-2 years before were 5 times as likely to develop it.

The risk of new-onset hypothyroidism dropped back to the reference range for those who had quit smoking 3-10 years before the study (odds ratio 0.85).

“Recent quitters were also more hypothyroid than other study subjects who had hypothyroidism,” Dr. Carle said. Those who had quit within the past 2 years had a median total T4 level of 20 nmol/L, compared with 40 nmol/L in never-smokers with the disorder, and a median thyroid-stimulating hormone level of 82 mU/L compared with 49 mU/L.

“Looking at these data, we can say that in this series, 13% of new-onset hypothyroidism was associated with smoking withdrawal,” Dr. Carle said. Because of this association, he recommended thyroid testing for all patients who report recent smoking cessation, “especially in those who have any complaints of symptoms.”

Dr. Carle said that he had no potential financial conflicts.

PARIS – Smokers who have recently kicked the habit could face a significant increase in the risk of developing new-onset hypothyroidism.

The risk is greatest within the first 2 years of quitting, when it can run as high as 5 times the risk of someone who has never smoked, or who has been tobacco-free for more than 2 years.

© PhotoDisc

There’s no obvious explanation for the phenomenon, Dr. Allan Carle said at the International Thyroid Meeting. However, he said, a 2007 study suggests that current smokers actually have a significantly lower risk of developing hypothyroidism but an increased risk of hyperthyroidism (Arch. Intern. Med. 2007;167:1428-32).

“Perhaps quitting causes come kind of rebound effect, with changes in antithyroid antibodies,” said Dr. Carle of the Aalborg Hospital, Denmark. But his case-control study could only observe the phenomenon – not uncover its possible cause.

He and his associates compared 140 patients with incident autoimmune overt hypothyroidism, extracted from a population-based study, to 560 age- and sex-matched controls from the same population.

All the subjects provided information on their smoking status, including daily and overall tobacco intake, years of smoking, pack/years of smoking, and – if they were past smokers – the time since quitting. Clinical measurements included autoantibodies to thyroid peroxidase (TPOAb) and thyroglobulin (TgAb); thyroid function; and a thyroid ultrasound exam. Possible relationships were examined in both univariate and multivariate models that controlled for confounding.

The investigators used the group of never-smokers as the reference group. The risk of hypothyroidism among current smokers and those who had quit more than 2 years before the study was not significantly different from the risk among never-smokers. There were also no significant relationships between new hypothyroidism and the duration or magnitude of smoking.

However, among subjects who had quit within the past 2 years, the risk of new hypothyroidism was significantly increased. Those who had quit within the past 1 year were 5.6 times as likely as never-smokers to develop the disorder; those who had quit 1-2 years before were 5 times as likely to develop it.

The risk of new-onset hypothyroidism dropped back to the reference range for those who had quit smoking 3-10 years before the study (odds ratio 0.85).

“Recent quitters were also more hypothyroid than other study subjects who had hypothyroidism,” Dr. Carle said. Those who had quit within the past 2 years had a median total T4 level of 20 nmol/L, compared with 40 nmol/L in never-smokers with the disorder, and a median thyroid-stimulating hormone level of 82 mU/L compared with 49 mU/L.

“Looking at these data, we can say that in this series, 13% of new-onset hypothyroidism was associated with smoking withdrawal,” Dr. Carle said. Because of this association, he recommended thyroid testing for all patients who report recent smoking cessation, “especially in those who have any complaints of symptoms.”

Dr. Carle said that he had no potential financial conflicts.

PARIS – Patients with a nondecisive fine-needle aspiration for large nondiagnostic thyroid nodules or lesions of undetermined significance should be considered for surgery because more than half of these large nodules can be malignant.

In a review of 156 patients with nondecisive fine-needle aspirations (FNAs), nodule size was a major determinant in surgical referral, Dr. Susana Mascarell said at the International Thyroid Congress. “Nodules of this size were associated with a malignancy rate of up to 60%,” said Dr. Mascarell of the John H. Stroger Jr. Hospital of Cook County, Chicago.

FNA is considered the main diagnostic tool in deciding which patient to refer to surgery. “However,” Dr. Mascarell said, “the FNA results may not be helpful when the cytology specimen is nondiagnostic or qualifies as a follicular lesion of undetermined significance – both classifications that are part of the new six-level FNA classification system suggested by the National Cancer Institute.”

When an FNA comes back as nondecisive on such specimens, the clinician must choose between surgery and clinical follow-up as the next step. Unfortunately, said Dr. Mascarell, there are no hard-and-fast rules about which management path to choose.

Molecular markers are becoming more important in the decision, but can’t be relied upon in every patient, she said. “When these markers are present in high concentrations, they are up to 99% accurate in identifying malignant nodules and so are a very helpful tool. But only 40% of nodules are positive for these risk markers, so we still have an unmet need of what to do with many other patients.”

Dr. Mascarell and her colleagues reviewed all thyroid FNAs performed at the hospital from 2004 to 2007. Out of nearly 500 tests, 156 were nondecisive. Of these specimens, 90 (58%) were classified as follicular lesions of undetermined significance (FLUS) and 66 (42%) as nondiagnostic.

Overall, 104 patients had a thyroidectomy (77% of the FLUS group and 52% of the nondiagnostic group). The rest were followed clinically. The rate of malignancy was 41% in the FLUS patients and 32% in the nondiagnostic patients.

Among those with FLUS who had surgery, 50% had no other clinical indication for surgery except the nondecisive FNA, Dr. Mascarell said. “The most common documented indication was a nodule size of 3 cm or larger in 29%.” Other indications – each of which accounted for less than 5% – were male gender, a family history of thyroid cancer, exposure to radiation, and a suspicious ultrasound exam.

“In the nondiagnostic group, all of those who went for surgery had other indications [besides the FNA result]. The most common one was a cold thyroid scan in 31%. Other indications were nodule size (20%), microcalcifications on ultrasound (16%), and a history of radiation exposure (15%).” Indications that Dr. Mascarell did not specify accounted for the remaining 18%.

Half of all patients for whom nodule size was the documented surgical indication had clinically significant thyroid cancer. “When we compared the surgical and clinical follow-up groups, we found that 60% of the surgical group had a lesion 3 cm or larger, compared with 29% of the follow-up group, so clearly, when clinicians found a large lesion, most of them referred to surgery,” Dr. Mascarell said.

Dr. Mascarell said she had no potential conflicts of interest.

PARIS – Patients with a nondecisive fine-needle aspiration for large nondiagnostic thyroid nodules or lesions of undetermined significance should be considered for surgery because more than half of these large nodules can be malignant.

In a review of 156 patients with nondecisive fine-needle aspirations (FNAs), nodule size was a major determinant in surgical referral, Dr. Susana Mascarell said at the International Thyroid Congress. “Nodules of this size were associated with a malignancy rate of up to 60%,” said Dr. Mascarell of the John H. Stroger Jr. Hospital of Cook County, Chicago.

FNA is considered the main diagnostic tool in deciding which patient to refer to surgery. “However,” Dr. Mascarell said, “the FNA results may not be helpful when the cytology specimen is nondiagnostic or qualifies as a follicular lesion of undetermined significance – both classifications that are part of the new six-level FNA classification system suggested by the National Cancer Institute.”

When an FNA comes back as nondecisive on such specimens, the clinician must choose between surgery and clinical follow-up as the next step. Unfortunately, said Dr. Mascarell, there are no hard-and-fast rules about which management path to choose.

Molecular markers are becoming more important in the decision, but can’t be relied upon in every patient, she said. “When these markers are present in high concentrations, they are up to 99% accurate in identifying malignant nodules and so are a very helpful tool. But only 40% of nodules are positive for these risk markers, so we still have an unmet need of what to do with many other patients.”

Dr. Mascarell and her colleagues reviewed all thyroid FNAs performed at the hospital from 2004 to 2007. Out of nearly 500 tests, 156 were nondecisive. Of these specimens, 90 (58%) were classified as follicular lesions of undetermined significance (FLUS) and 66 (42%) as nondiagnostic.

Overall, 104 patients had a thyroidectomy (77% of the FLUS group and 52% of the nondiagnostic group). The rest were followed clinically. The rate of malignancy was 41% in the FLUS patients and 32% in the nondiagnostic patients.

Among those with FLUS who had surgery, 50% had no other clinical indication for surgery except the nondecisive FNA, Dr. Mascarell said. “The most common documented indication was a nodule size of 3 cm or larger in 29%.” Other indications – each of which accounted for less than 5% – were male gender, a family history of thyroid cancer, exposure to radiation, and a suspicious ultrasound exam.

“In the nondiagnostic group, all of those who went for surgery had other indications [besides the FNA result]. The most common one was a cold thyroid scan in 31%. Other indications were nodule size (20%), microcalcifications on ultrasound (16%), and a history of radiation exposure (15%).” Indications that Dr. Mascarell did not specify accounted for the remaining 18%.

Half of all patients for whom nodule size was the documented surgical indication had clinically significant thyroid cancer. “When we compared the surgical and clinical follow-up groups, we found that 60% of the surgical group had a lesion 3 cm or larger, compared with 29% of the follow-up group, so clearly, when clinicians found a large lesion, most of them referred to surgery,” Dr. Mascarell said.

Dr. Mascarell said she had no potential conflicts of interest.

PARIS – Patients with a nondecisive fine-needle aspiration for large nondiagnostic thyroid nodules or lesions of undetermined significance should be considered for surgery because more than half of these large nodules can be malignant.

In a review of 156 patients with nondecisive fine-needle aspirations (FNAs), nodule size was a major determinant in surgical referral, Dr. Susana Mascarell said at the International Thyroid Congress. “Nodules of this size were associated with a malignancy rate of up to 60%,” said Dr. Mascarell of the John H. Stroger Jr. Hospital of Cook County, Chicago.

FNA is considered the main diagnostic tool in deciding which patient to refer to surgery. “However,” Dr. Mascarell said, “the FNA results may not be helpful when the cytology specimen is nondiagnostic or qualifies as a follicular lesion of undetermined significance – both classifications that are part of the new six-level FNA classification system suggested by the National Cancer Institute.”

When an FNA comes back as nondecisive on such specimens, the clinician must choose between surgery and clinical follow-up as the next step. Unfortunately, said Dr. Mascarell, there are no hard-and-fast rules about which management path to choose.

Molecular markers are becoming more important in the decision, but can’t be relied upon in every patient, she said. “When these markers are present in high concentrations, they are up to 99% accurate in identifying malignant nodules and so are a very helpful tool. But only 40% of nodules are positive for these risk markers, so we still have an unmet need of what to do with many other patients.”

Dr. Mascarell and her colleagues reviewed all thyroid FNAs performed at the hospital from 2004 to 2007. Out of nearly 500 tests, 156 were nondecisive. Of these specimens, 90 (58%) were classified as follicular lesions of undetermined significance (FLUS) and 66 (42%) as nondiagnostic.

Overall, 104 patients had a thyroidectomy (77% of the FLUS group and 52% of the nondiagnostic group). The rest were followed clinically. The rate of malignancy was 41% in the FLUS patients and 32% in the nondiagnostic patients.

Among those with FLUS who had surgery, 50% had no other clinical indication for surgery except the nondecisive FNA, Dr. Mascarell said. “The most common documented indication was a nodule size of 3 cm or larger in 29%.” Other indications – each of which accounted for less than 5% – were male gender, a family history of thyroid cancer, exposure to radiation, and a suspicious ultrasound exam.

“In the nondiagnostic group, all of those who went for surgery had other indications [besides the FNA result]. The most common one was a cold thyroid scan in 31%. Other indications were nodule size (20%), microcalcifications on ultrasound (16%), and a history of radiation exposure (15%).” Indications that Dr. Mascarell did not specify accounted for the remaining 18%.

Half of all patients for whom nodule size was the documented surgical indication had clinically significant thyroid cancer. “When we compared the surgical and clinical follow-up groups, we found that 60% of the surgical group had a lesion 3 cm or larger, compared with 29% of the follow-up group, so clearly, when clinicians found a large lesion, most of them referred to surgery,” Dr. Mascarell said.

Dr. Mascarell said she had no potential conflicts of interest.

An updated guideline for emergency cardiovascular care has changed the A-B-C mnemonic of cardiopulmonary resuscitation to C-A-B, emphasizing the need to start chest compressions as quickly as possible and worry about the airway second.

It’s the biggest – and most important – change in the 2010 update of the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, said coauthor Dr. Michael Sayre, chairman of the American Heart Association’s Emergency Cardiovascular Care (ECC) Committee.

“For more than 40 years, CPR training has emphasized the ABCs of CPR, which instructed people to open a victim’s airway by tilting their head back, pinching the nose and breathing into the victim’s mouth, and only then giving chest compressions,” Dr. Sayre said in a press statement. “This approach was causing significant delays in starting chest compressions, which are essential for keeping oxygen-rich blood circulating through the body. Changing the sequence from A-B-C to C-A-B for adults and children allows all rescuers to begin chest compressions right away.”

Any delay in chest compression, either by bystanders squeamish about mouth-to-mouth or clinicians searching for ventilation equipment, increases the risk of death, the statement noted. This change correlates with a British study published recently in Lancet, which found that nonprofessional rescuers are most effective when they use compression-only CPR (Lancet 2010 [doi:10.1016/S0140-6736(10)61454-7]).

The AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care were last updated in 2005, the authors said. Since then, a plethora of evidence has changed the clinical approach to emergency cardiovascular care. The committee, which included 356 resuscitation experts from 29 countries, produced 411 new evidence-based reviews, from which the updates were drawn.

The new recommendations also call for an increase in the rate of chest compressions, to at least 100/minute. “Rescuers should push deeper on the chest, compressing at least two inches in adults and children and 1.5 inches in infants,” the statement notes. “Between each compression, rescuers should avoid leaning on the chest to allow it to return to its starting position.”

The guidelines recommend the new C-A-B approach for adults, teens, and children who suddenly collapse and stop breathing, or display ineffective respiration during collapse. For neonates with no known cardiac etiology, however, the A-B-Cs remain in effect. Ventilation with room air is best for term babies in arrest; to avoid the negative impact of pure oxygen on newborns, the statement calls for a blend of room air and oxygen for infants who need supplemental oxygen. For these babies, the recommendation for a 3:1 chest compression-ventilation ratio remains in effect, because ventilation is critical to reversing neonatal asphyxia arrest.

Advanced Life Support. In addition to providing information for bystander rescue attempts, the guidelines suggest some changes in the way cardiac arrest and stroke patients are treated by emergency medical services, emergency room physicians, and those involved with postincident care.

In keeping with the new C-A-B format, the document urges EMS personnel to minimize interruptions in chest compression any longer than needed for rescue ventilation. Even taking time for pulse checks is no longer advised, since pulse is not an effective indicator of cardiac status when blood pressure is low or absent.

Electrical therapy should be employed as soon as possible after CPR begins, but CPR should not cease while readying the defibrillator, the guidelines say. “Rescuers should minimize the interval between stopping compressions and delivering shocks, and should resume CPR immediately after shock delivery.”

The statement recommends an initial biphasic energy dose of 120-200 joules for atrial fibrillation and 50-100 joules for atrial flutter or other supraventricular tachycardias. If the initial shock fails, providers should increase the dose in a stepwise fashion.

For patients with symptomatic arrhythmias, the updates now recommend adenosine for diagnosing and treating stable undifferentiated wide-complex tachycardia when the rhythm is regular and the QRS wave is monomorphic. For symptomatic or unstable bradycardia, intravenous chronotropic agents can be an effective alternative to external pacing if adenosine is ineffective.

The guidelines include a major new Class I recommendation for adult airway management: the use of quantitative waveform capnography for confirmation and monitoring endotracheal tube placement. Additionally, they no longer endorse the routine use of cricoid pressure during airway management.

After the Cardiac Arrest. The recommendations don’t stop when the patient regains spontaneous circulation. An entire section of the document is devoted to post–cardiac arrest care, pushing for an integrated, multidisciplinary approach. “Patients with suspected acute coronary syndrome should be triaged to a facility with reperfusion capabilities and a multidisciplinary team prepared to monitor patients for multi-organ dysfunction and initiate appropriate post–cardiac arrest therapy, including hypothermia.”

The guidelines deal with stroke separately, summarizing what should occur during out-of-hospital care through the first hours of therapy. One new recommendation is that acute stroke patients be triaged to a stroke center or dedicated stroke unit within 3 hours of presentation. The guidelines also expand the time window for administration of recombinant tissue plasminogen activator, and recommend it also be used in patients with acute ischemic stroke.

Many of the 33 writing members of the guidelines committee disclosed financial relationships, which are listed on the last page of the executive summary (Circulation 2010;122:S640-56).

An updated guideline for emergency cardiovascular care has changed the A-B-C mnemonic of cardiopulmonary resuscitation to C-A-B, emphasizing the need to start chest compressions as quickly as possible and worry about the airway second.

It’s the biggest – and most important – change in the 2010 update of the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, said coauthor Dr. Michael Sayre, chairman of the American Heart Association’s Emergency Cardiovascular Care (ECC) Committee.

“For more than 40 years, CPR training has emphasized the ABCs of CPR, which instructed people to open a victim’s airway by tilting their head back, pinching the nose and breathing into the victim’s mouth, and only then giving chest compressions,” Dr. Sayre said in a press statement. “This approach was causing significant delays in starting chest compressions, which are essential for keeping oxygen-rich blood circulating through the body. Changing the sequence from A-B-C to C-A-B for adults and children allows all rescuers to begin chest compressions right away.”

Any delay in chest compression, either by bystanders squeamish about mouth-to-mouth or clinicians searching for ventilation equipment, increases the risk of death, the statement noted. This change correlates with a British study published recently in Lancet, which found that nonprofessional rescuers are most effective when they use compression-only CPR (Lancet 2010 [doi:10.1016/S0140-6736(10)61454-7]).

The AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care were last updated in 2005, the authors said. Since then, a plethora of evidence has changed the clinical approach to emergency cardiovascular care. The committee, which included 356 resuscitation experts from 29 countries, produced 411 new evidence-based reviews, from which the updates were drawn.

The new recommendations also call for an increase in the rate of chest compressions, to at least 100/minute. “Rescuers should push deeper on the chest, compressing at least two inches in adults and children and 1.5 inches in infants,” the statement notes. “Between each compression, rescuers should avoid leaning on the chest to allow it to return to its starting position.”

The guidelines recommend the new C-A-B approach for adults, teens, and children who suddenly collapse and stop breathing, or display ineffective respiration during collapse. For neonates with no known cardiac etiology, however, the A-B-Cs remain in effect. Ventilation with room air is best for term babies in arrest; to avoid the negative impact of pure oxygen on newborns, the statement calls for a blend of room air and oxygen for infants who need supplemental oxygen. For these babies, the recommendation for a 3:1 chest compression-ventilation ratio remains in effect, because ventilation is critical to reversing neonatal asphyxia arrest.

Advanced Life Support. In addition to providing information for bystander rescue attempts, the guidelines suggest some changes in the way cardiac arrest and stroke patients are treated by emergency medical services, emergency room physicians, and those involved with postincident care.

In keeping with the new C-A-B format, the document urges EMS personnel to minimize interruptions in chest compression any longer than needed for rescue ventilation. Even taking time for pulse checks is no longer advised, since pulse is not an effective indicator of cardiac status when blood pressure is low or absent.

Electrical therapy should be employed as soon as possible after CPR begins, but CPR should not cease while readying the defibrillator, the guidelines say. “Rescuers should minimize the interval between stopping compressions and delivering shocks, and should resume CPR immediately after shock delivery.”

The statement recommends an initial biphasic energy dose of 120-200 joules for atrial fibrillation and 50-100 joules for atrial flutter or other supraventricular tachycardias. If the initial shock fails, providers should increase the dose in a stepwise fashion.

For patients with symptomatic arrhythmias, the updates now recommend adenosine for diagnosing and treating stable undifferentiated wide-complex tachycardia when the rhythm is regular and the QRS wave is monomorphic. For symptomatic or unstable bradycardia, intravenous chronotropic agents can be an effective alternative to external pacing if adenosine is ineffective.

The guidelines include a major new Class I recommendation for adult airway management: the use of quantitative waveform capnography for confirmation and monitoring endotracheal tube placement. Additionally, they no longer endorse the routine use of cricoid pressure during airway management.

After the Cardiac Arrest. The recommendations don’t stop when the patient regains spontaneous circulation. An entire section of the document is devoted to post–cardiac arrest care, pushing for an integrated, multidisciplinary approach. “Patients with suspected acute coronary syndrome should be triaged to a facility with reperfusion capabilities and a multidisciplinary team prepared to monitor patients for multi-organ dysfunction and initiate appropriate post–cardiac arrest therapy, including hypothermia.”

The guidelines deal with stroke separately, summarizing what should occur during out-of-hospital care through the first hours of therapy. One new recommendation is that acute stroke patients be triaged to a stroke center or dedicated stroke unit within 3 hours of presentation. The guidelines also expand the time window for administration of recombinant tissue plasminogen activator, and recommend it also be used in patients with acute ischemic stroke.

Many of the 33 writing members of the guidelines committee disclosed financial relationships, which are listed on the last page of the executive summary (Circulation 2010;122:S640-56).

An updated guideline for emergency cardiovascular care has changed the A-B-C mnemonic of cardiopulmonary resuscitation to C-A-B, emphasizing the need to start chest compressions as quickly as possible and worry about the airway second.

It’s the biggest – and most important – change in the 2010 update of the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, said coauthor Dr. Michael Sayre, chairman of the American Heart Association’s Emergency Cardiovascular Care (ECC) Committee.

“For more than 40 years, CPR training has emphasized the ABCs of CPR, which instructed people to open a victim’s airway by tilting their head back, pinching the nose and breathing into the victim’s mouth, and only then giving chest compressions,” Dr. Sayre said in a press statement. “This approach was causing significant delays in starting chest compressions, which are essential for keeping oxygen-rich blood circulating through the body. Changing the sequence from A-B-C to C-A-B for adults and children allows all rescuers to begin chest compressions right away.”

Any delay in chest compression, either by bystanders squeamish about mouth-to-mouth or clinicians searching for ventilation equipment, increases the risk of death, the statement noted. This change correlates with a British study published recently in Lancet, which found that nonprofessional rescuers are most effective when they use compression-only CPR (Lancet 2010 [doi:10.1016/S0140-6736(10)61454-7]).

The AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care were last updated in 2005, the authors said. Since then, a plethora of evidence has changed the clinical approach to emergency cardiovascular care. The committee, which included 356 resuscitation experts from 29 countries, produced 411 new evidence-based reviews, from which the updates were drawn.

The new recommendations also call for an increase in the rate of chest compressions, to at least 100/minute. “Rescuers should push deeper on the chest, compressing at least two inches in adults and children and 1.5 inches in infants,” the statement notes. “Between each compression, rescuers should avoid leaning on the chest to allow it to return to its starting position.”

The guidelines recommend the new C-A-B approach for adults, teens, and children who suddenly collapse and stop breathing, or display ineffective respiration during collapse. For neonates with no known cardiac etiology, however, the A-B-Cs remain in effect. Ventilation with room air is best for term babies in arrest; to avoid the negative impact of pure oxygen on newborns, the statement calls for a blend of room air and oxygen for infants who need supplemental oxygen. For these babies, the recommendation for a 3:1 chest compression-ventilation ratio remains in effect, because ventilation is critical to reversing neonatal asphyxia arrest.

Advanced Life Support. In addition to providing information for bystander rescue attempts, the guidelines suggest some changes in the way cardiac arrest and stroke patients are treated by emergency medical services, emergency room physicians, and those involved with postincident care.

In keeping with the new C-A-B format, the document urges EMS personnel to minimize interruptions in chest compression any longer than needed for rescue ventilation. Even taking time for pulse checks is no longer advised, since pulse is not an effective indicator of cardiac status when blood pressure is low or absent.

Electrical therapy should be employed as soon as possible after CPR begins, but CPR should not cease while readying the defibrillator, the guidelines say. “Rescuers should minimize the interval between stopping compressions and delivering shocks, and should resume CPR immediately after shock delivery.”

The statement recommends an initial biphasic energy dose of 120-200 joules for atrial fibrillation and 50-100 joules for atrial flutter or other supraventricular tachycardias. If the initial shock fails, providers should increase the dose in a stepwise fashion.

For patients with symptomatic arrhythmias, the updates now recommend adenosine for diagnosing and treating stable undifferentiated wide-complex tachycardia when the rhythm is regular and the QRS wave is monomorphic. For symptomatic or unstable bradycardia, intravenous chronotropic agents can be an effective alternative to external pacing if adenosine is ineffective.

The guidelines include a major new Class I recommendation for adult airway management: the use of quantitative waveform capnography for confirmation and monitoring endotracheal tube placement. Additionally, they no longer endorse the routine use of cricoid pressure during airway management.

After the Cardiac Arrest. The recommendations don’t stop when the patient regains spontaneous circulation. An entire section of the document is devoted to post–cardiac arrest care, pushing for an integrated, multidisciplinary approach. “Patients with suspected acute coronary syndrome should be triaged to a facility with reperfusion capabilities and a multidisciplinary team prepared to monitor patients for multi-organ dysfunction and initiate appropriate post–cardiac arrest therapy, including hypothermia.”

The guidelines deal with stroke separately, summarizing what should occur during out-of-hospital care through the first hours of therapy. One new recommendation is that acute stroke patients be triaged to a stroke center or dedicated stroke unit within 3 hours of presentation. The guidelines also expand the time window for administration of recombinant tissue plasminogen activator, and recommend it also be used in patients with acute ischemic stroke.

Many of the 33 writing members of the guidelines committee disclosed financial relationships, which are listed on the last page of the executive summary (Circulation 2010;122:S640-56).