Damian McNamara

MIAMI BEACH — Acid-suppressive medication is associated with a 30% increased risk of hospital-acquired pneumonia compared with nonexposure, according to a recent report.

“These medications are potentially responsible for 180,000 excess cases of hospital-acquired pneumonia annually,” lead investigator Dr. Shoshana J. Herzig commented at the annual meeting of the Society of General Internal Medicine. “We believe these should be used more judiciously” than they are currently used in the non-ICU population.

Proton pump inhibitors were significantly associated with an increased risk of pneumonia, but histamine2 receptor blockers were not.

In U.S. hospitals, an estimated 40%-70% of inpatients receive acid-suppressive medication (ASM). In about half the cases, ASM therapy is prescribed for the first time while the patient is in the hospital (Ann. Pharmacother. 2006;40:1261-6; Am. J. Gastroenterol. 2000;95:3118–22). Prophylaxis of stress ulcers in low-risk patients is a common reason these agents are ordered (Am. J. Gastroenterol. 2006;101:2200–5).

In the current study, up to 70% of the indications for ASMs were not well investigated or supported by the literature, Dr. Herzig and her associates reported (JAMA 2009;301:2120–8).

Other studies have suggested that the risk of community-acquired pneumonia is increased among people taking ASMs in an outpatient setting (Ann. Intern. Med. 2008;149:391–8; Arch. Intern. Med. 2007;167:950–5).

Dr. Herzig and her associates found that more than half of 63,787 non-ICU admissions to Beth Israel Deaconess Medical Center in Boston from January 2004 to December 2007 had an order for a proton-pump inhibitor (PPI) and/or a histamine2 receptor blocker. Of these admissions, 2,219 (3.5%) later had an ICD-9 code for bacterial pneumonia as a secondary discharge diagnosis, said Dr. Herzig, chief medical resident and general medicine fellow at the hospital.

Inpatients who received an ASM had a higher rate of hospital-acquired pneumonia, 4.9%, compared with 2.0% of unexposed patients (unadjusted odds ratio, 2.6). The adjusted odds ratio was 1.3, indicating a 30% higher risk associated with this practice, based on a multivariable analysis that controlled for 50 possible confounders and comorbidities.

“We found PPIs, in particular, were associated with increased risk,” Dr. Herzig said. This association was significant (OR, 1.3), but an order for a histamine2 receptor blocker was not (OR, 1.1).

Why ASM agents, and especially PPIs, are associated with a higher risk of pneumonia is unknown. Dr. Herzig and her coworkers hypothesized that impairment of white blood cell function might play a role.

The mean age of the study population was 54 years; men comprised 37% of the cohort. Inpatients prescribed an ASM were more likely to be male, to be older, and to have heart disease or diabetes. Taking these factors into account, Dr. Herzig and her associates did a validation study and found the same higher risk of hospital-acquired pneumonia (adjusted OR, 1.3) in 16,396 patients with an ASM order, compared with 16,396 demographically similar unexposed patients.

The generalizability of the findings may be limited by the fact that the study was conducted at a single large urban medical center. Results should be validated at other institutions, she said.

Dr. Herzig and her associates did not disclose any conflicts of interest. The study was funded through a grant from the Department of Health and Human Services that supports the Fellowship in General Medicine and Primary Care at Harvard Medical School.

MIAMI BEACH — Acid-suppressive medication is associated with a 30% increased risk of hospital-acquired pneumonia compared with nonexposure, according to a recent report.

“These medications are potentially responsible for 180,000 excess cases of hospital-acquired pneumonia annually,” lead investigator Dr. Shoshana J. Herzig commented at the annual meeting of the Society of General Internal Medicine. “We believe these should be used more judiciously” than they are currently used in the non-ICU population.

Proton pump inhibitors were significantly associated with an increased risk of pneumonia, but histamine2 receptor blockers were not.

In U.S. hospitals, an estimated 40%-70% of inpatients receive acid-suppressive medication (ASM). In about half the cases, ASM therapy is prescribed for the first time while the patient is in the hospital (Ann. Pharmacother. 2006;40:1261-6; Am. J. Gastroenterol. 2000;95:3118–22). Prophylaxis of stress ulcers in low-risk patients is a common reason these agents are ordered (Am. J. Gastroenterol. 2006;101:2200–5).

In the current study, up to 70% of the indications for ASMs were not well investigated or supported by the literature, Dr. Herzig and her associates reported (JAMA 2009;301:2120–8).

Other studies have suggested that the risk of community-acquired pneumonia is increased among people taking ASMs in an outpatient setting (Ann. Intern. Med. 2008;149:391–8; Arch. Intern. Med. 2007;167:950–5).

Dr. Herzig and her associates found that more than half of 63,787 non-ICU admissions to Beth Israel Deaconess Medical Center in Boston from January 2004 to December 2007 had an order for a proton-pump inhibitor (PPI) and/or a histamine2 receptor blocker. Of these admissions, 2,219 (3.5%) later had an ICD-9 code for bacterial pneumonia as a secondary discharge diagnosis, said Dr. Herzig, chief medical resident and general medicine fellow at the hospital.

Inpatients who received an ASM had a higher rate of hospital-acquired pneumonia, 4.9%, compared with 2.0% of unexposed patients (unadjusted odds ratio, 2.6). The adjusted odds ratio was 1.3, indicating a 30% higher risk associated with this practice, based on a multivariable analysis that controlled for 50 possible confounders and comorbidities.

“We found PPIs, in particular, were associated with increased risk,” Dr. Herzig said. This association was significant (OR, 1.3), but an order for a histamine2 receptor blocker was not (OR, 1.1).

Why ASM agents, and especially PPIs, are associated with a higher risk of pneumonia is unknown. Dr. Herzig and her coworkers hypothesized that impairment of white blood cell function might play a role.

The mean age of the study population was 54 years; men comprised 37% of the cohort. Inpatients prescribed an ASM were more likely to be male, to be older, and to have heart disease or diabetes. Taking these factors into account, Dr. Herzig and her associates did a validation study and found the same higher risk of hospital-acquired pneumonia (adjusted OR, 1.3) in 16,396 patients with an ASM order, compared with 16,396 demographically similar unexposed patients.

The generalizability of the findings may be limited by the fact that the study was conducted at a single large urban medical center. Results should be validated at other institutions, she said.

Dr. Herzig and her associates did not disclose any conflicts of interest. The study was funded through a grant from the Department of Health and Human Services that supports the Fellowship in General Medicine and Primary Care at Harvard Medical School.

MIAMI BEACH — Acid-suppressive medication is associated with a 30% increased risk of hospital-acquired pneumonia compared with nonexposure, according to a recent report.

“These medications are potentially responsible for 180,000 excess cases of hospital-acquired pneumonia annually,” lead investigator Dr. Shoshana J. Herzig commented at the annual meeting of the Society of General Internal Medicine. “We believe these should be used more judiciously” than they are currently used in the non-ICU population.

Proton pump inhibitors were significantly associated with an increased risk of pneumonia, but histamine2 receptor blockers were not.

In U.S. hospitals, an estimated 40%-70% of inpatients receive acid-suppressive medication (ASM). In about half the cases, ASM therapy is prescribed for the first time while the patient is in the hospital (Ann. Pharmacother. 2006;40:1261-6; Am. J. Gastroenterol. 2000;95:3118–22). Prophylaxis of stress ulcers in low-risk patients is a common reason these agents are ordered (Am. J. Gastroenterol. 2006;101:2200–5).

In the current study, up to 70% of the indications for ASMs were not well investigated or supported by the literature, Dr. Herzig and her associates reported (JAMA 2009;301:2120–8).

Other studies have suggested that the risk of community-acquired pneumonia is increased among people taking ASMs in an outpatient setting (Ann. Intern. Med. 2008;149:391–8; Arch. Intern. Med. 2007;167:950–5).

Dr. Herzig and her associates found that more than half of 63,787 non-ICU admissions to Beth Israel Deaconess Medical Center in Boston from January 2004 to December 2007 had an order for a proton-pump inhibitor (PPI) and/or a histamine2 receptor blocker. Of these admissions, 2,219 (3.5%) later had an ICD-9 code for bacterial pneumonia as a secondary discharge diagnosis, said Dr. Herzig, chief medical resident and general medicine fellow at the hospital.

Inpatients who received an ASM had a higher rate of hospital-acquired pneumonia, 4.9%, compared with 2.0% of unexposed patients (unadjusted odds ratio, 2.6). The adjusted odds ratio was 1.3, indicating a 30% higher risk associated with this practice, based on a multivariable analysis that controlled for 50 possible confounders and comorbidities.

“We found PPIs, in particular, were associated with increased risk,” Dr. Herzig said. This association was significant (OR, 1.3), but an order for a histamine2 receptor blocker was not (OR, 1.1).

Why ASM agents, and especially PPIs, are associated with a higher risk of pneumonia is unknown. Dr. Herzig and her coworkers hypothesized that impairment of white blood cell function might play a role.

The mean age of the study population was 54 years; men comprised 37% of the cohort. Inpatients prescribed an ASM were more likely to be male, to be older, and to have heart disease or diabetes. Taking these factors into account, Dr. Herzig and her associates did a validation study and found the same higher risk of hospital-acquired pneumonia (adjusted OR, 1.3) in 16,396 patients with an ASM order, compared with 16,396 demographically similar unexposed patients.

The generalizability of the findings may be limited by the fact that the study was conducted at a single large urban medical center. Results should be validated at other institutions, she said.

Dr. Herzig and her associates did not disclose any conflicts of interest. The study was funded through a grant from the Department of Health and Human Services that supports the Fellowship in General Medicine and Primary Care at Harvard Medical School.

HOLLYWOOD, FLA. — New recommendations in breast cancer guidelines rank preferred adjuvant chemotherapy regimens and offer guidance on local therapy for women who present with stage IV breast cancer, according to an update presented at the annual conference of the National Comprehensive Cancer Network, an alliance of 21 leading cancer centers.

The revised guidelines also make optional a radiation boost after lumpectomy for early invasive disease, and call for a mammogram between surgery and radiotherapy for women with ductal carcinoma in situ (DCIS). Furthermore, they say that women with DCIS or early invasive disease should be referred for genetic counseling if they are at high risk for hereditary breast cancer.

For women who initially present with metastatic breast cancer, a new guideline says that local breast surgery and/or radiation therapy may beneficial. These “generally palliative” treatments should be considered after a patient responds to initial systemic treatment.

“There is some evidence for an impact on survival for stage IV disease in some large registries,” Dr. Stephen B. Edge said, noting that, historically, local therapy was reserved for palliation of patients with local tumor progression.

Partial mastectomy improved median survival for women with stage IV disease at initial diagnosis, according to a National Cancer Data Base study (Surgery 2002;132:620–6). With clear margins, these women lived a median of 23 months, compared with 12 months for women with no surgery.

However, the data to support surgery vs. systemic therapy in stage IV disease are all retrospective, Dr. Edge said. The surgery benefit may be best in the setting of minimal metastatic burden, he added. “This will be best addressed by a controlled trial, which has been proposed but not yet initiated” in the United States.

Exclusive locoregional radiation therapy improved survival among 581 women with synchronous metastasis at the time of diagnosis, and might be an alternative to surgery (J. Clin. Oncol. 2009;27:1375–81). Overall survival at 3 years was 43% with exclusive locoregional radiotherapy, compared with 27% without.

“Interestingly, [women with] visceral metastasis … fared better vs. those with bone metastasis,” said Dr. Edge, chair of breast surgery at Roswell Park Cancer Institute in Buffalo, N.Y.

Another new recommendation calls for mammography following surgery in women with DCIS. This is a “very important footnote,” Dr. Beryl McCormick said. “A postexcision mammogram should be performed when there is uncertainty about margins.” She copresented the updates with Dr. Edge; neither disclosed any relevant conflicts of interest.

The radiation boost was previously “recommended for all women having breast conservation therapy. This year, we changed the guidelines to say [the boost] could be omitted in older women,” as well as in some other scenarios, such as in a patient who has a reexcision—for example, in the case of close initial margins—and the specimen is large and contains no cancer, said Dr. McCormick, clinical director of the department of radiation oncology at the Memorial Sloan-Kettering Cancer Center in New York.

The boost is an option for women with stage I, IIA, IIB, or T3 N1 M0 cancer following lumpectomy with surgical axillary staging. Significantly less local recurrence at 5 years among women who received additional radiation to their tumor bed, compared with those who did not, was reported in a key study (N. Engl. J. Med. 2001;345:1378–87).

The data out to 8 years still support a significant benefit, particularly for younger women, Dr. McCormick said. The decrease in local recurrence was “highly significant” for women younger than 40 years who had the boost, compared with those who did not (P = .0019). The benefit remained significant, with P values of .0096 in women aged 41–50 years, .0012 in women aged 51–60, and .029 in women older than age 60. “The biological benefit was really insignificant for women over 60,” she noted.

The guideline panel also reorganized adjuvant chemotherapy regimens in invasive disease. “This year, we ranked the relative value of adjuvant chemotherapy—a list of 'preferred regimens' and 'other regimens' that have been used,” Dr. Edge said.

The NCCN identifies the following “preferred” trastuzumab-containing adjuvant regimens for invasive breast cancer:

▸ Doxorubicin (Adriamycin) and cyclophosphamide (AC) followed by paclitaxel plus trastuzumab (Herceptin).

▸ Docetaxel (Taxotere), carboplatin, trastuzumab (TCH).

In terms of nontrastuzumab-containing adjuvant regimens, the NCCN designates the following as “preferred”:

▸ Docetaxel, doxorubicin, cyclophosphamide (TAC).

▸ Dose-dense AC followed by paclitaxel every 2 weeks.

▸ AC followed by weekly paclitaxel.

▸ Docetaxel and cyclophosphamide (TC).

▸ AC.

Another guideline change, which has achieved the status of the rarely used category 3 recommendation (reflecting “major disagreement”) is the use of trastuzumab for systemic adjuvant therapy in HER2 (human epidermal growth factor 2)-positive disease for women with small tumors, Dr. Edge said. This option was added for women with tumors measuring 0.6–1.0 cm that are moderately or poorly differentiated, or have unfavorable features.

Although it was added to the guidelines, the recommendation is not as strong as the unanimous category 1 recommendation for use of trastuzumab in combination with adjuvant endocrine therapy and adjuvant chemotherapy for women with tumors larger than 1 cm or who have node-positive disease with one or more axillary node metastases larger than 2 mm.

Genetic counseling of women with DCIS “if they are at high risk for hereditary breast cancer or early invasive disease” is a new recommendation. “In high-risk women, genetic testing can often lead to a decision that leads to treatment of both the affected breast and the unaffected breast,” Dr. McCormick said, citing a study that notes the increase in prophylactic bilateral mastectomy rates from 4% in 1998 to 11% in 2003 (J. Clin. Oncol. 2007;25:5203–9). “And I suspect if we look again, it would be even higher.”

For the first time, the guidelines also feature a section on principles of breast reconstruction after surgery. Breast implants, autologous tissue, or a combination are identified as options.

These principles say that skin-sparing mastectomy is “probably equivalent” to standard mastectomy, and “should be performed by an experienced breast surgery team that works in a coordinated, multidisciplinary fashion.” Dr. McCormick said at the meeting that reconstruction “most importantly” should be “performed by an experienced team of breast surgeons and plastic surgeons.”

Reconstruction can be done at the same time or after completion of cancer treatment. When postmastectomy radiation is required, however, the general preference is to delay autologous-tissue reconstruction until after the completion of radiation therapy, Dr. McCormick said. This is a category 2B recommendation, which means it was not unanimous, she noted. “We have had great experience [with delayed reconstruction] at Memorial Sloan-Kettering, but other colleagues on the panel, especially at [the University of Texas M.D. Anderson Cancer Center in Houston], have not, so it remains 2B,” she said.

A postexcision mammogram should be performed when there is uncertainty about margins. DR. MCCORMICK

HOLLYWOOD, FLA. — New recommendations in breast cancer guidelines rank preferred adjuvant chemotherapy regimens and offer guidance on local therapy for women who present with stage IV breast cancer, according to an update presented at the annual conference of the National Comprehensive Cancer Network, an alliance of 21 leading cancer centers.

The revised guidelines also make optional a radiation boost after lumpectomy for early invasive disease, and call for a mammogram between surgery and radiotherapy for women with ductal carcinoma in situ (DCIS). Furthermore, they say that women with DCIS or early invasive disease should be referred for genetic counseling if they are at high risk for hereditary breast cancer.

For women who initially present with metastatic breast cancer, a new guideline says that local breast surgery and/or radiation therapy may beneficial. These “generally palliative” treatments should be considered after a patient responds to initial systemic treatment.

“There is some evidence for an impact on survival for stage IV disease in some large registries,” Dr. Stephen B. Edge said, noting that, historically, local therapy was reserved for palliation of patients with local tumor progression.

Partial mastectomy improved median survival for women with stage IV disease at initial diagnosis, according to a National Cancer Data Base study (Surgery 2002;132:620–6). With clear margins, these women lived a median of 23 months, compared with 12 months for women with no surgery.

However, the data to support surgery vs. systemic therapy in stage IV disease are all retrospective, Dr. Edge said. The surgery benefit may be best in the setting of minimal metastatic burden, he added. “This will be best addressed by a controlled trial, which has been proposed but not yet initiated” in the United States.

Exclusive locoregional radiation therapy improved survival among 581 women with synchronous metastasis at the time of diagnosis, and might be an alternative to surgery (J. Clin. Oncol. 2009;27:1375–81). Overall survival at 3 years was 43% with exclusive locoregional radiotherapy, compared with 27% without.

“Interestingly, [women with] visceral metastasis … fared better vs. those with bone metastasis,” said Dr. Edge, chair of breast surgery at Roswell Park Cancer Institute in Buffalo, N.Y.

Another new recommendation calls for mammography following surgery in women with DCIS. This is a “very important footnote,” Dr. Beryl McCormick said. “A postexcision mammogram should be performed when there is uncertainty about margins.” She copresented the updates with Dr. Edge; neither disclosed any relevant conflicts of interest.

The radiation boost was previously “recommended for all women having breast conservation therapy. This year, we changed the guidelines to say [the boost] could be omitted in older women,” as well as in some other scenarios, such as in a patient who has a reexcision—for example, in the case of close initial margins—and the specimen is large and contains no cancer, said Dr. McCormick, clinical director of the department of radiation oncology at the Memorial Sloan-Kettering Cancer Center in New York.

The boost is an option for women with stage I, IIA, IIB, or T3 N1 M0 cancer following lumpectomy with surgical axillary staging. Significantly less local recurrence at 5 years among women who received additional radiation to their tumor bed, compared with those who did not, was reported in a key study (N. Engl. J. Med. 2001;345:1378–87).

The data out to 8 years still support a significant benefit, particularly for younger women, Dr. McCormick said. The decrease in local recurrence was “highly significant” for women younger than 40 years who had the boost, compared with those who did not (P = .0019). The benefit remained significant, with P values of .0096 in women aged 41–50 years, .0012 in women aged 51–60, and .029 in women older than age 60. “The biological benefit was really insignificant for women over 60,” she noted.

The guideline panel also reorganized adjuvant chemotherapy regimens in invasive disease. “This year, we ranked the relative value of adjuvant chemotherapy—a list of 'preferred regimens' and 'other regimens' that have been used,” Dr. Edge said.

The NCCN identifies the following “preferred” trastuzumab-containing adjuvant regimens for invasive breast cancer:

▸ Doxorubicin (Adriamycin) and cyclophosphamide (AC) followed by paclitaxel plus trastuzumab (Herceptin).

▸ Docetaxel (Taxotere), carboplatin, trastuzumab (TCH).

In terms of nontrastuzumab-containing adjuvant regimens, the NCCN designates the following as “preferred”:

▸ Docetaxel, doxorubicin, cyclophosphamide (TAC).

▸ Dose-dense AC followed by paclitaxel every 2 weeks.

▸ AC followed by weekly paclitaxel.

▸ Docetaxel and cyclophosphamide (TC).

▸ AC.

Another guideline change, which has achieved the status of the rarely used category 3 recommendation (reflecting “major disagreement”) is the use of trastuzumab for systemic adjuvant therapy in HER2 (human epidermal growth factor 2)-positive disease for women with small tumors, Dr. Edge said. This option was added for women with tumors measuring 0.6–1.0 cm that are moderately or poorly differentiated, or have unfavorable features.

Although it was added to the guidelines, the recommendation is not as strong as the unanimous category 1 recommendation for use of trastuzumab in combination with adjuvant endocrine therapy and adjuvant chemotherapy for women with tumors larger than 1 cm or who have node-positive disease with one or more axillary node metastases larger than 2 mm.

Genetic counseling of women with DCIS “if they are at high risk for hereditary breast cancer or early invasive disease” is a new recommendation. “In high-risk women, genetic testing can often lead to a decision that leads to treatment of both the affected breast and the unaffected breast,” Dr. McCormick said, citing a study that notes the increase in prophylactic bilateral mastectomy rates from 4% in 1998 to 11% in 2003 (J. Clin. Oncol. 2007;25:5203–9). “And I suspect if we look again, it would be even higher.”

For the first time, the guidelines also feature a section on principles of breast reconstruction after surgery. Breast implants, autologous tissue, or a combination are identified as options.

These principles say that skin-sparing mastectomy is “probably equivalent” to standard mastectomy, and “should be performed by an experienced breast surgery team that works in a coordinated, multidisciplinary fashion.” Dr. McCormick said at the meeting that reconstruction “most importantly” should be “performed by an experienced team of breast surgeons and plastic surgeons.”

Reconstruction can be done at the same time or after completion of cancer treatment. When postmastectomy radiation is required, however, the general preference is to delay autologous-tissue reconstruction until after the completion of radiation therapy, Dr. McCormick said. This is a category 2B recommendation, which means it was not unanimous, she noted. “We have had great experience [with delayed reconstruction] at Memorial Sloan-Kettering, but other colleagues on the panel, especially at [the University of Texas M.D. Anderson Cancer Center in Houston], have not, so it remains 2B,” she said.

A postexcision mammogram should be performed when there is uncertainty about margins. DR. MCCORMICK

HOLLYWOOD, FLA. — New recommendations in breast cancer guidelines rank preferred adjuvant chemotherapy regimens and offer guidance on local therapy for women who present with stage IV breast cancer, according to an update presented at the annual conference of the National Comprehensive Cancer Network, an alliance of 21 leading cancer centers.

The revised guidelines also make optional a radiation boost after lumpectomy for early invasive disease, and call for a mammogram between surgery and radiotherapy for women with ductal carcinoma in situ (DCIS). Furthermore, they say that women with DCIS or early invasive disease should be referred for genetic counseling if they are at high risk for hereditary breast cancer.

For women who initially present with metastatic breast cancer, a new guideline says that local breast surgery and/or radiation therapy may beneficial. These “generally palliative” treatments should be considered after a patient responds to initial systemic treatment.

“There is some evidence for an impact on survival for stage IV disease in some large registries,” Dr. Stephen B. Edge said, noting that, historically, local therapy was reserved for palliation of patients with local tumor progression.

Partial mastectomy improved median survival for women with stage IV disease at initial diagnosis, according to a National Cancer Data Base study (Surgery 2002;132:620–6). With clear margins, these women lived a median of 23 months, compared with 12 months for women with no surgery.

However, the data to support surgery vs. systemic therapy in stage IV disease are all retrospective, Dr. Edge said. The surgery benefit may be best in the setting of minimal metastatic burden, he added. “This will be best addressed by a controlled trial, which has been proposed but not yet initiated” in the United States.

Exclusive locoregional radiation therapy improved survival among 581 women with synchronous metastasis at the time of diagnosis, and might be an alternative to surgery (J. Clin. Oncol. 2009;27:1375–81). Overall survival at 3 years was 43% with exclusive locoregional radiotherapy, compared with 27% without.

“Interestingly, [women with] visceral metastasis … fared better vs. those with bone metastasis,” said Dr. Edge, chair of breast surgery at Roswell Park Cancer Institute in Buffalo, N.Y.

Another new recommendation calls for mammography following surgery in women with DCIS. This is a “very important footnote,” Dr. Beryl McCormick said. “A postexcision mammogram should be performed when there is uncertainty about margins.” She copresented the updates with Dr. Edge; neither disclosed any relevant conflicts of interest.

The radiation boost was previously “recommended for all women having breast conservation therapy. This year, we changed the guidelines to say [the boost] could be omitted in older women,” as well as in some other scenarios, such as in a patient who has a reexcision—for example, in the case of close initial margins—and the specimen is large and contains no cancer, said Dr. McCormick, clinical director of the department of radiation oncology at the Memorial Sloan-Kettering Cancer Center in New York.

The boost is an option for women with stage I, IIA, IIB, or T3 N1 M0 cancer following lumpectomy with surgical axillary staging. Significantly less local recurrence at 5 years among women who received additional radiation to their tumor bed, compared with those who did not, was reported in a key study (N. Engl. J. Med. 2001;345:1378–87).

The data out to 8 years still support a significant benefit, particularly for younger women, Dr. McCormick said. The decrease in local recurrence was “highly significant” for women younger than 40 years who had the boost, compared with those who did not (P = .0019). The benefit remained significant, with P values of .0096 in women aged 41–50 years, .0012 in women aged 51–60, and .029 in women older than age 60. “The biological benefit was really insignificant for women over 60,” she noted.

The guideline panel also reorganized adjuvant chemotherapy regimens in invasive disease. “This year, we ranked the relative value of adjuvant chemotherapy—a list of 'preferred regimens' and 'other regimens' that have been used,” Dr. Edge said.

The NCCN identifies the following “preferred” trastuzumab-containing adjuvant regimens for invasive breast cancer:

▸ Doxorubicin (Adriamycin) and cyclophosphamide (AC) followed by paclitaxel plus trastuzumab (Herceptin).

▸ Docetaxel (Taxotere), carboplatin, trastuzumab (TCH).

In terms of nontrastuzumab-containing adjuvant regimens, the NCCN designates the following as “preferred”:

▸ Docetaxel, doxorubicin, cyclophosphamide (TAC).

▸ Dose-dense AC followed by paclitaxel every 2 weeks.

▸ AC followed by weekly paclitaxel.

▸ Docetaxel and cyclophosphamide (TC).

▸ AC.

Another guideline change, which has achieved the status of the rarely used category 3 recommendation (reflecting “major disagreement”) is the use of trastuzumab for systemic adjuvant therapy in HER2 (human epidermal growth factor 2)-positive disease for women with small tumors, Dr. Edge said. This option was added for women with tumors measuring 0.6–1.0 cm that are moderately or poorly differentiated, or have unfavorable features.

Although it was added to the guidelines, the recommendation is not as strong as the unanimous category 1 recommendation for use of trastuzumab in combination with adjuvant endocrine therapy and adjuvant chemotherapy for women with tumors larger than 1 cm or who have node-positive disease with one or more axillary node metastases larger than 2 mm.

Genetic counseling of women with DCIS “if they are at high risk for hereditary breast cancer or early invasive disease” is a new recommendation. “In high-risk women, genetic testing can often lead to a decision that leads to treatment of both the affected breast and the unaffected breast,” Dr. McCormick said, citing a study that notes the increase in prophylactic bilateral mastectomy rates from 4% in 1998 to 11% in 2003 (J. Clin. Oncol. 2007;25:5203–9). “And I suspect if we look again, it would be even higher.”

For the first time, the guidelines also feature a section on principles of breast reconstruction after surgery. Breast implants, autologous tissue, or a combination are identified as options.

These principles say that skin-sparing mastectomy is “probably equivalent” to standard mastectomy, and “should be performed by an experienced breast surgery team that works in a coordinated, multidisciplinary fashion.” Dr. McCormick said at the meeting that reconstruction “most importantly” should be “performed by an experienced team of breast surgeons and plastic surgeons.”

Reconstruction can be done at the same time or after completion of cancer treatment. When postmastectomy radiation is required, however, the general preference is to delay autologous-tissue reconstruction until after the completion of radiation therapy, Dr. McCormick said. This is a category 2B recommendation, which means it was not unanimous, she noted. “We have had great experience [with delayed reconstruction] at Memorial Sloan-Kettering, but other colleagues on the panel, especially at [the University of Texas M.D. Anderson Cancer Center in Houston], have not, so it remains 2B,” she said.

A postexcision mammogram should be performed when there is uncertainty about margins. DR. MCCORMICK

HOLLYWOOD, FLA. — The National Comprehensive Cancer Network has updated its thyroid carcinoma guidelines to add consideration of small molecule kinase inhibitors in metastatic disease treatment, refine diagnosis and treatment strategies based on fine-needle aspiration, and provide new information on thyroid-stimulating hormone suppression.

The panel of 26 physicians noted increasing off-label use of small molecule kinase inhibitors in patients with thyroid carcinoma. They said these agents can be considered to treat papillary, follicular, Hürthle cell, or medullary carcinoma, if a clinical trial is unavailable or inappropriate.

Although it's a drug class recommendation, “we specifically mention sorafenib and sunitinib as options,” Dr. Steven I. Sherman said at the annual conference of the National Comprehensive Cancer Network (NCCN). Best supportive care also remains a consideration for these patients with clinically progressive or symptomatic disease.

Neither kinase inhibitor is indicated for thyroid cancer. The Food and Drug Administration has approved sorafenib (Nexavar) in advanced renal cell carcinoma and hepatocellular carcinoma, and sunitinib (Sutent) in gastrointestinal stromal tumors and metastatic renal cell carcinoma. Both are under investigation in other tumors.

The NCCN revised procedures for evaluating thyroid nodules, especially follicular or Hürthle cell neoplasms and follicular lesions of undetermined significance that cannot be diagnosed by fine-needle aspiration (FNA). For an undetermined lesion, if the thyroid-stimulating hormone level is high or normal, repeat FNA and consider surgery based on clinical findings concerning growth or suspicious findings on ultrasound. If the TSH is low, perform a thyroid scan, and repeat FNA based on the same factors if the scan is cold; if it is hot, evaluate and treat for thyrotoxicosis. A follicular lesion of undetermined significance still carries a 5%–10% risk of cancer, Dr. Sherman said.

Diagnostic categories based on FNA findings have been updated. One category, for example, is patients who have or are suspected of having papillary, medullary, or anaplastic thyroid carcinoma. These patients have a 99% risk of cancer, and should go directly to primary treatment, said Dr. Sherman, department chair and professor of endocrine neoplasia and hormonal disorders at the University of Texas M.D. Anderson Cancer Center, Houston.

If the FNA indicates thyroid lymphoma, refer to NCCN Non-Hodgkin's Lymphoma Guidelines. If the FNA comes back as an insufficient biopsy or as nondiagnostic, treatment is dictated by whether it is cystic or solid. “An insufficient biopsy still carries a 1%–7% risk of cancer,” Dr. Sherman said.

For a benign thyroid nodule, the risk of cancer is 1% or less, Dr. Sherman said, and observation is recommended. However, if there is nodule growth, repeat the FNA or consider surgery.

Patient age over 45 years is no longer a factor that should raise clinical suspicion with a solitary thyroid nodule greater than 1 cm in diameter in the setting of an unknown TSH level, according to the new guidelines.

For patients with a positive FNA finding, the panel provides a less stringent recommendation for a chest radiograph: “Consider chest x-ray” instead of “chest x-ray, if not recently done.” There is greater consensus now behind the panel's recommendation to perform a lateral neck ultrasound in this group of patients.

The NCCN also added recommendations for the use of levothyroxine for TSH suppression in papillary, follicular, and Hürthle cell carcinomas. The use of levothyroxine is considered optimal to maintain low TSH levels and minimize risk of stimulating the growth of cells derived from thyroid follicular epithelium, but there are insufficient data to recommend serum TSH targets. Instead, the guidelines say, “in general, patients with known residual carcinoma or at high risk for recurrence should have TSH levels maintained below 0.1 mU/L, whereas disease-free patients at low risk for recurrence should have TSH levels maintained either slightly below or slightly above the lower limit of the reference range.” Patients who remain disease free for several years can probably have TSH levels maintained within the reference range.

The guidelines advise balancing risks and benefits of suppressive levothyroxine therapy for each patient. There is potential for cardiac tachyarrhythmias, bone demineralization, and thyrotoxicosis caused by TSH-suppressive doses. Also, patients on long-term suppression need an adequate intake of calcium (1,200 mg/day) and vitamin D (800 U/day).

Dr. Sherman is a consultant for and receives grant and research support from several pharmaceutical companies and the National Cancer Institute, and is on the speakers bureau for Genzyme.

Radioiodine Recommendations Refined

The National Comprehensive Cancer Network changed its recommendations for management of patients with thyroid carcinoma post thyroidectomy, especially concerning the use of radioiodine therapy.

Radioactive iodine (RAI) therapy is now an option for patients with no gross residual disease in the neck after surgery. “Postoperative RAI therapy is to destroy any remaining normal thyroid tissue as a source of thyroglobulin production, to improve accuracy of follow-up testing,” Dr. Sherman said.

The guidelines now list RAI as an alternative at 1–12 weeks post thyroidectomy to a total body radioiodine scan.

Clinical indications for RAI are based on pathology, postoperative thyroglobulin, and intraoperative findings.

The recommendations are specific by cancer stage. For example, radioiodine therapy for stage II disease “for the first time is associated with a survival advantage … with total or near-total thyroidectomy,” Dr. Sherman said. “Stage I is the problem. This is the largest group of patients, but overall survival is worse with radioactive iodine therapy.

“Clearly there is no evidence of a benefit among stage I patients. This is a very important pullback in terms of the recommendations,” he said.

“It is our particular opinion at M.D. Anderson that a total body radioiodine scan should be performed prior to treatment because of its diagnostic usefulness,” he added.

HOLLYWOOD, FLA. — The National Comprehensive Cancer Network has updated its thyroid carcinoma guidelines to add consideration of small molecule kinase inhibitors in metastatic disease treatment, refine diagnosis and treatment strategies based on fine-needle aspiration, and provide new information on thyroid-stimulating hormone suppression.

The panel of 26 physicians noted increasing off-label use of small molecule kinase inhibitors in patients with thyroid carcinoma. They said these agents can be considered to treat papillary, follicular, Hürthle cell, or medullary carcinoma, if a clinical trial is unavailable or inappropriate.

Although it's a drug class recommendation, “we specifically mention sorafenib and sunitinib as options,” Dr. Steven I. Sherman said at the annual conference of the National Comprehensive Cancer Network (NCCN). Best supportive care also remains a consideration for these patients with clinically progressive or symptomatic disease.

Neither kinase inhibitor is indicated for thyroid cancer. The Food and Drug Administration has approved sorafenib (Nexavar) in advanced renal cell carcinoma and hepatocellular carcinoma, and sunitinib (Sutent) in gastrointestinal stromal tumors and metastatic renal cell carcinoma. Both are under investigation in other tumors.

The NCCN revised procedures for evaluating thyroid nodules, especially follicular or Hürthle cell neoplasms and follicular lesions of undetermined significance that cannot be diagnosed by fine-needle aspiration (FNA). For an undetermined lesion, if the thyroid-stimulating hormone level is high or normal, repeat FNA and consider surgery based on clinical findings concerning growth or suspicious findings on ultrasound. If the TSH is low, perform a thyroid scan, and repeat FNA based on the same factors if the scan is cold; if it is hot, evaluate and treat for thyrotoxicosis. A follicular lesion of undetermined significance still carries a 5%–10% risk of cancer, Dr. Sherman said.

Diagnostic categories based on FNA findings have been updated. One category, for example, is patients who have or are suspected of having papillary, medullary, or anaplastic thyroid carcinoma. These patients have a 99% risk of cancer, and should go directly to primary treatment, said Dr. Sherman, department chair and professor of endocrine neoplasia and hormonal disorders at the University of Texas M.D. Anderson Cancer Center, Houston.

If the FNA indicates thyroid lymphoma, refer to NCCN Non-Hodgkin's Lymphoma Guidelines. If the FNA comes back as an insufficient biopsy or as nondiagnostic, treatment is dictated by whether it is cystic or solid. “An insufficient biopsy still carries a 1%–7% risk of cancer,” Dr. Sherman said.

For a benign thyroid nodule, the risk of cancer is 1% or less, Dr. Sherman said, and observation is recommended. However, if there is nodule growth, repeat the FNA or consider surgery.

Patient age over 45 years is no longer a factor that should raise clinical suspicion with a solitary thyroid nodule greater than 1 cm in diameter in the setting of an unknown TSH level, according to the new guidelines.

For patients with a positive FNA finding, the panel provides a less stringent recommendation for a chest radiograph: “Consider chest x-ray” instead of “chest x-ray, if not recently done.” There is greater consensus now behind the panel's recommendation to perform a lateral neck ultrasound in this group of patients.

The NCCN also added recommendations for the use of levothyroxine for TSH suppression in papillary, follicular, and Hürthle cell carcinomas. The use of levothyroxine is considered optimal to maintain low TSH levels and minimize risk of stimulating the growth of cells derived from thyroid follicular epithelium, but there are insufficient data to recommend serum TSH targets. Instead, the guidelines say, “in general, patients with known residual carcinoma or at high risk for recurrence should have TSH levels maintained below 0.1 mU/L, whereas disease-free patients at low risk for recurrence should have TSH levels maintained either slightly below or slightly above the lower limit of the reference range.” Patients who remain disease free for several years can probably have TSH levels maintained within the reference range.

The guidelines advise balancing risks and benefits of suppressive levothyroxine therapy for each patient. There is potential for cardiac tachyarrhythmias, bone demineralization, and thyrotoxicosis caused by TSH-suppressive doses. Also, patients on long-term suppression need an adequate intake of calcium (1,200 mg/day) and vitamin D (800 U/day).

Dr. Sherman is a consultant for and receives grant and research support from several pharmaceutical companies and the National Cancer Institute, and is on the speakers bureau for Genzyme.

Radioiodine Recommendations Refined

The National Comprehensive Cancer Network changed its recommendations for management of patients with thyroid carcinoma post thyroidectomy, especially concerning the use of radioiodine therapy.

Radioactive iodine (RAI) therapy is now an option for patients with no gross residual disease in the neck after surgery. “Postoperative RAI therapy is to destroy any remaining normal thyroid tissue as a source of thyroglobulin production, to improve accuracy of follow-up testing,” Dr. Sherman said.

The guidelines now list RAI as an alternative at 1–12 weeks post thyroidectomy to a total body radioiodine scan.

Clinical indications for RAI are based on pathology, postoperative thyroglobulin, and intraoperative findings.

The recommendations are specific by cancer stage. For example, radioiodine therapy for stage II disease “for the first time is associated with a survival advantage … with total or near-total thyroidectomy,” Dr. Sherman said. “Stage I is the problem. This is the largest group of patients, but overall survival is worse with radioactive iodine therapy.

“Clearly there is no evidence of a benefit among stage I patients. This is a very important pullback in terms of the recommendations,” he said.

“It is our particular opinion at M.D. Anderson that a total body radioiodine scan should be performed prior to treatment because of its diagnostic usefulness,” he added.

HOLLYWOOD, FLA. — The National Comprehensive Cancer Network has updated its thyroid carcinoma guidelines to add consideration of small molecule kinase inhibitors in metastatic disease treatment, refine diagnosis and treatment strategies based on fine-needle aspiration, and provide new information on thyroid-stimulating hormone suppression.

The panel of 26 physicians noted increasing off-label use of small molecule kinase inhibitors in patients with thyroid carcinoma. They said these agents can be considered to treat papillary, follicular, Hürthle cell, or medullary carcinoma, if a clinical trial is unavailable or inappropriate.

Although it's a drug class recommendation, “we specifically mention sorafenib and sunitinib as options,” Dr. Steven I. Sherman said at the annual conference of the National Comprehensive Cancer Network (NCCN). Best supportive care also remains a consideration for these patients with clinically progressive or symptomatic disease.

Neither kinase inhibitor is indicated for thyroid cancer. The Food and Drug Administration has approved sorafenib (Nexavar) in advanced renal cell carcinoma and hepatocellular carcinoma, and sunitinib (Sutent) in gastrointestinal stromal tumors and metastatic renal cell carcinoma. Both are under investigation in other tumors.

The NCCN revised procedures for evaluating thyroid nodules, especially follicular or Hürthle cell neoplasms and follicular lesions of undetermined significance that cannot be diagnosed by fine-needle aspiration (FNA). For an undetermined lesion, if the thyroid-stimulating hormone level is high or normal, repeat FNA and consider surgery based on clinical findings concerning growth or suspicious findings on ultrasound. If the TSH is low, perform a thyroid scan, and repeat FNA based on the same factors if the scan is cold; if it is hot, evaluate and treat for thyrotoxicosis. A follicular lesion of undetermined significance still carries a 5%–10% risk of cancer, Dr. Sherman said.

Diagnostic categories based on FNA findings have been updated. One category, for example, is patients who have or are suspected of having papillary, medullary, or anaplastic thyroid carcinoma. These patients have a 99% risk of cancer, and should go directly to primary treatment, said Dr. Sherman, department chair and professor of endocrine neoplasia and hormonal disorders at the University of Texas M.D. Anderson Cancer Center, Houston.

If the FNA indicates thyroid lymphoma, refer to NCCN Non-Hodgkin's Lymphoma Guidelines. If the FNA comes back as an insufficient biopsy or as nondiagnostic, treatment is dictated by whether it is cystic or solid. “An insufficient biopsy still carries a 1%–7% risk of cancer,” Dr. Sherman said.

For a benign thyroid nodule, the risk of cancer is 1% or less, Dr. Sherman said, and observation is recommended. However, if there is nodule growth, repeat the FNA or consider surgery.

Patient age over 45 years is no longer a factor that should raise clinical suspicion with a solitary thyroid nodule greater than 1 cm in diameter in the setting of an unknown TSH level, according to the new guidelines.

For patients with a positive FNA finding, the panel provides a less stringent recommendation for a chest radiograph: “Consider chest x-ray” instead of “chest x-ray, if not recently done.” There is greater consensus now behind the panel's recommendation to perform a lateral neck ultrasound in this group of patients.

The NCCN also added recommendations for the use of levothyroxine for TSH suppression in papillary, follicular, and Hürthle cell carcinomas. The use of levothyroxine is considered optimal to maintain low TSH levels and minimize risk of stimulating the growth of cells derived from thyroid follicular epithelium, but there are insufficient data to recommend serum TSH targets. Instead, the guidelines say, “in general, patients with known residual carcinoma or at high risk for recurrence should have TSH levels maintained below 0.1 mU/L, whereas disease-free patients at low risk for recurrence should have TSH levels maintained either slightly below or slightly above the lower limit of the reference range.” Patients who remain disease free for several years can probably have TSH levels maintained within the reference range.

The guidelines advise balancing risks and benefits of suppressive levothyroxine therapy for each patient. There is potential for cardiac tachyarrhythmias, bone demineralization, and thyrotoxicosis caused by TSH-suppressive doses. Also, patients on long-term suppression need an adequate intake of calcium (1,200 mg/day) and vitamin D (800 U/day).

Dr. Sherman is a consultant for and receives grant and research support from several pharmaceutical companies and the National Cancer Institute, and is on the speakers bureau for Genzyme.

Radioiodine Recommendations Refined

The National Comprehensive Cancer Network changed its recommendations for management of patients with thyroid carcinoma post thyroidectomy, especially concerning the use of radioiodine therapy.

Radioactive iodine (RAI) therapy is now an option for patients with no gross residual disease in the neck after surgery. “Postoperative RAI therapy is to destroy any remaining normal thyroid tissue as a source of thyroglobulin production, to improve accuracy of follow-up testing,” Dr. Sherman said.

The guidelines now list RAI as an alternative at 1–12 weeks post thyroidectomy to a total body radioiodine scan.

Clinical indications for RAI are based on pathology, postoperative thyroglobulin, and intraoperative findings.

The recommendations are specific by cancer stage. For example, radioiodine therapy for stage II disease “for the first time is associated with a survival advantage … with total or near-total thyroidectomy,” Dr. Sherman said. “Stage I is the problem. This is the largest group of patients, but overall survival is worse with radioactive iodine therapy.

“Clearly there is no evidence of a benefit among stage I patients. This is a very important pullback in terms of the recommendations,” he said.

“It is our particular opinion at M.D. Anderson that a total body radioiodine scan should be performed prior to treatment because of its diagnostic usefulness,” he added.

MIAMI BEACH — Less pain on injection, less postprocedure swelling, and greater convenience are among the advantages of hyaluronic acid and lidocaine combination products, according to two studies and a live patient demonstration at the South Beach Symposium.

Prevelle (Mentor Corp.) and Dermal Gel Extra (Genzyme Corp.) come premixed with lidocaine, thus saving preparation time for physicians who might otherwise mix in their own anesthetic. Prevelle is approved for correction of moderate-to-severe facial wrinkles and folds via injection into the mid- to deep dermis. Dermal Gel Extra (DGE) is under FDA review.

Prevelle and DGE are fully hydrated, unlike existing hyaluronic acid fillers that absorb water and increase in volume after injection. "Prevelle is like Captique with lidocaine, versus Restylane [Medicis Pharmaceutical Corp.] and Juvéderm [Allergan Inc.], which are underhydrated," said Dr. Stephen H. Mandy of the department of dermatology at the University of Miami. His disclosures include Allergan, Bioform Medical Inc., Galderma Laboratories LP, OrthoNeutrogena, Procter & Gamble, Sanofi-Aventis, and Stiefel Laboratories Inc.

Dr. Mandy and his associates assessed 45 patients in a randomized, controlled, patient-blinded comparison between Captique and Prevelle. Although participants reported pain with both fillers, there was no swelling and very little erythema. "Pain at injection was lower with Prevelle, greater than 50% less, and improves over 45 minutes."

Dr. Mandy also participated in a multicenter safety and efficacy study. The split-face comparison between DGE and Restylane included 140 patients at six U.S. centers. Although he was unable to share data, he said, "I can tell you there is less volume and less pain with [DGE], with volume filling as great as Restylane at 9 months." He added that it takes much less volume to get maximum effect, "so we should fill very conservatively."

DGE is a "very robust" filler material, Dr. Mandy said. "You can feel the difference as you inject it."

"The nice thing about the Prevelle product is the price point," said Dr. Susan H. Weinkle, a dermatologist in private practice in Bradenton, Fla. Her disclosures include Allergan, Bioform, DermAvance Pharmaceuticals Inc., Medicis, Procter & Gamble, and Stiefel.

"This is a great product for a first-time patient, [one who may be] needle-phobic or concerned about pain," said Dr. Gary D. Monheit of the department of dermatology and ophthalmology at the University of Alabama at Birmingham. Dr. Monheit's disclosures include Allergan, Dermik Laboratories, Genzyme, Medicis, Mentor Corp., Merz Pharma, and Stiefel.

Dr. Monheit injected the first patient volunteer at the meeting, a woman with asymmetrical lips and a history of lip correction. "She could benefit from a lift to the malar crease," he noted.

Use a fanning technique for volume effect on the mid-face, Dr. Monheit said. Start with injections along the nasolabial fold. "Then I like to advance to the modiolus to see the commissures go up."

As lidocaine takes effect, subsequent injections become easier, Dr. Monheit said. Prevelle "requires very little manipulation afterward—it has an even flow."

"It is important to stop [during the procedure], get a frontal look, and make sure you get same volume on both sides," Dr. Monheit said. Remember this filler is not hydrophilic, "so what you see at the end is what you will get."

Patient follow-up is important, Dr. Weinkle said. Ask patients to come back in 2 weeks to check the results, including symmetry. "Don't charge them if you use another small amount. It's all about patient retention." n

MIAMI BEACH — Less pain on injection, less postprocedure swelling, and greater convenience are among the advantages of hyaluronic acid and lidocaine combination products, according to two studies and a live patient demonstration at the South Beach Symposium.

Prevelle (Mentor Corp.) and Dermal Gel Extra (Genzyme Corp.) come premixed with lidocaine, thus saving preparation time for physicians who might otherwise mix in their own anesthetic. Prevelle is approved for correction of moderate-to-severe facial wrinkles and folds via injection into the mid- to deep dermis. Dermal Gel Extra (DGE) is under FDA review.

Prevelle and DGE are fully hydrated, unlike existing hyaluronic acid fillers that absorb water and increase in volume after injection. "Prevelle is like Captique with lidocaine, versus Restylane [Medicis Pharmaceutical Corp.] and Juvéderm [Allergan Inc.], which are underhydrated," said Dr. Stephen H. Mandy of the department of dermatology at the University of Miami. His disclosures include Allergan, Bioform Medical Inc., Galderma Laboratories LP, OrthoNeutrogena, Procter & Gamble, Sanofi-Aventis, and Stiefel Laboratories Inc.

Dr. Mandy and his associates assessed 45 patients in a randomized, controlled, patient-blinded comparison between Captique and Prevelle. Although participants reported pain with both fillers, there was no swelling and very little erythema. "Pain at injection was lower with Prevelle, greater than 50% less, and improves over 45 minutes."

Dr. Mandy also participated in a multicenter safety and efficacy study. The split-face comparison between DGE and Restylane included 140 patients at six U.S. centers. Although he was unable to share data, he said, "I can tell you there is less volume and less pain with [DGE], with volume filling as great as Restylane at 9 months." He added that it takes much less volume to get maximum effect, "so we should fill very conservatively."

DGE is a "very robust" filler material, Dr. Mandy said. "You can feel the difference as you inject it."

"The nice thing about the Prevelle product is the price point," said Dr. Susan H. Weinkle, a dermatologist in private practice in Bradenton, Fla. Her disclosures include Allergan, Bioform, DermAvance Pharmaceuticals Inc., Medicis, Procter & Gamble, and Stiefel.

"This is a great product for a first-time patient, [one who may be] needle-phobic or concerned about pain," said Dr. Gary D. Monheit of the department of dermatology and ophthalmology at the University of Alabama at Birmingham. Dr. Monheit's disclosures include Allergan, Dermik Laboratories, Genzyme, Medicis, Mentor Corp., Merz Pharma, and Stiefel.

Dr. Monheit injected the first patient volunteer at the meeting, a woman with asymmetrical lips and a history of lip correction. "She could benefit from a lift to the malar crease," he noted.

Use a fanning technique for volume effect on the mid-face, Dr. Monheit said. Start with injections along the nasolabial fold. "Then I like to advance to the modiolus to see the commissures go up."

As lidocaine takes effect, subsequent injections become easier, Dr. Monheit said. Prevelle "requires very little manipulation afterward—it has an even flow."

"It is important to stop [during the procedure], get a frontal look, and make sure you get same volume on both sides," Dr. Monheit said. Remember this filler is not hydrophilic, "so what you see at the end is what you will get."

Patient follow-up is important, Dr. Weinkle said. Ask patients to come back in 2 weeks to check the results, including symmetry. "Don't charge them if you use another small amount. It's all about patient retention." n

MIAMI BEACH — Less pain on injection, less postprocedure swelling, and greater convenience are among the advantages of hyaluronic acid and lidocaine combination products, according to two studies and a live patient demonstration at the South Beach Symposium.

Prevelle (Mentor Corp.) and Dermal Gel Extra (Genzyme Corp.) come premixed with lidocaine, thus saving preparation time for physicians who might otherwise mix in their own anesthetic. Prevelle is approved for correction of moderate-to-severe facial wrinkles and folds via injection into the mid- to deep dermis. Dermal Gel Extra (DGE) is under FDA review.

Prevelle and DGE are fully hydrated, unlike existing hyaluronic acid fillers that absorb water and increase in volume after injection. "Prevelle is like Captique with lidocaine, versus Restylane [Medicis Pharmaceutical Corp.] and Juvéderm [Allergan Inc.], which are underhydrated," said Dr. Stephen H. Mandy of the department of dermatology at the University of Miami. His disclosures include Allergan, Bioform Medical Inc., Galderma Laboratories LP, OrthoNeutrogena, Procter & Gamble, Sanofi-Aventis, and Stiefel Laboratories Inc.

Dr. Mandy and his associates assessed 45 patients in a randomized, controlled, patient-blinded comparison between Captique and Prevelle. Although participants reported pain with both fillers, there was no swelling and very little erythema. "Pain at injection was lower with Prevelle, greater than 50% less, and improves over 45 minutes."

Dr. Mandy also participated in a multicenter safety and efficacy study. The split-face comparison between DGE and Restylane included 140 patients at six U.S. centers. Although he was unable to share data, he said, "I can tell you there is less volume and less pain with [DGE], with volume filling as great as Restylane at 9 months." He added that it takes much less volume to get maximum effect, "so we should fill very conservatively."

DGE is a "very robust" filler material, Dr. Mandy said. "You can feel the difference as you inject it."

"The nice thing about the Prevelle product is the price point," said Dr. Susan H. Weinkle, a dermatologist in private practice in Bradenton, Fla. Her disclosures include Allergan, Bioform, DermAvance Pharmaceuticals Inc., Medicis, Procter & Gamble, and Stiefel.

"This is a great product for a first-time patient, [one who may be] needle-phobic or concerned about pain," said Dr. Gary D. Monheit of the department of dermatology and ophthalmology at the University of Alabama at Birmingham. Dr. Monheit's disclosures include Allergan, Dermik Laboratories, Genzyme, Medicis, Mentor Corp., Merz Pharma, and Stiefel.

Dr. Monheit injected the first patient volunteer at the meeting, a woman with asymmetrical lips and a history of lip correction. "She could benefit from a lift to the malar crease," he noted.

Use a fanning technique for volume effect on the mid-face, Dr. Monheit said. Start with injections along the nasolabial fold. "Then I like to advance to the modiolus to see the commissures go up."

As lidocaine takes effect, subsequent injections become easier, Dr. Monheit said. Prevelle "requires very little manipulation afterward—it has an even flow."

"It is important to stop [during the procedure], get a frontal look, and make sure you get same volume on both sides," Dr. Monheit said. Remember this filler is not hydrophilic, "so what you see at the end is what you will get."

Patient follow-up is important, Dr. Weinkle said. Ask patients to come back in 2 weeks to check the results, including symmetry. "Don't charge them if you use another small amount. It's all about patient retention." n

MIAMI BEACH — Remember the three P's of perfect lip enhancement—proportion, profile, and plumping—and you are more likely to get a satisfied patient who will use their new lips to refer other patients to your office.

Always keep proportion in mind—the ideal lip size ratio is about 40% for the top lip to 60% bottom lip, Dr. Glynis R. Ablon said at the South Beach Symposium.

The main goal of augmentation is to give patients natural-looking lips versus an overdone or "trout" lip appearance. "Don't completely change their look," she said, because no one should be able to tell the lips were enhanced.

For guidance, look at very young women or men, depending on what you're doing, "and see what looks natural to you," she said.

Look at each patient in profile and keep in mind you are sculpting the appearance of their lips from all sides, Dr. Ablon said.

Err on the side of injecting less filler material versus too much. "Less is more," Dr. Ablon said.

Start with a small amount and have the patient return for additional enhancement if desired. "Make sure you don't create lips that enter the door before the patient does. Not everyone will look normal with large lips, especially in Hollywood, where I work," commented Dr. Ablon, who is in private practice in Manhattan Beach, Calif., and on the dermatology faculty at the University of California in Los Angeles.

The actress Demi Moore, for example, has thin lips and "might look strange with enhanced lips."

When injecting filler, pay particular attention to the philtrum and cupid's bow on the upper lip, she said. You can also enhance or recreate the Glogau-Klein point, the dimple in the lower lip.

A general rule for the lower lips is to only inject in the central two-thirds. "Don't go too lateral. It will look like sausage otherwise," Dr. Ablon said. One exception, she said, is a patient with significant facial wrinkles who might get improvement to the side of the mouth (below the nasolabial fold).

Always have patients seated upright to allow for normal gravity. Another tip is to start with a nonpermanent filler, something you can dissolve, Dr. Ablon said.

Juvederm (hyaluronic acid, Allergan) is her lip filler product of choice, which she also injects above the vermillion border in some patients to provide additional enhancement. "It is a softer filler, and very moldable and malleable. Patients cannot notice there is anything inside their lips." Collagen and calcium hydroxylapatite are other lip filler choices.

Surgical options include lifts and advanced flaps. "The only surgical approach I typically use is the butterfly lip lift," Dr. Ablon said at the meeting.

The technique is best suited for patients with an elongated philtrum.

The lips are very sensitive and Dr. Ablon recommends use of topical and injected analgesics, such as lidocaine, before augmentation. She also uses the ArTek cooling device (ThermoTek Inc.) to increase patient comfort during the procedure. "If the patient is miserable, they will not return."

Tips to minimize bruising include avoidance of aspirin, nonsteroidal anti-inflammatory drugs, and vitamin E, and addition of bromelain supplements (a compound from pineapple). Also, consider antiviral treatment if the patient has a history of herpes outbreaks.

Dr. Ablon disclosed that she is a member of the Medicis advisory board (makers of Restylane and Perlane fillers).

'Don't create lips that enter the door before the patient does. Not everyone will look normal with large lips.' DR. ABLON

MIAMI BEACH — Remember the three P's of perfect lip enhancement—proportion, profile, and plumping—and you are more likely to get a satisfied patient who will use their new lips to refer other patients to your office.

Always keep proportion in mind—the ideal lip size ratio is about 40% for the top lip to 60% bottom lip, Dr. Glynis R. Ablon said at the South Beach Symposium.

The main goal of augmentation is to give patients natural-looking lips versus an overdone or "trout" lip appearance. "Don't completely change their look," she said, because no one should be able to tell the lips were enhanced.

For guidance, look at very young women or men, depending on what you're doing, "and see what looks natural to you," she said.

Look at each patient in profile and keep in mind you are sculpting the appearance of their lips from all sides, Dr. Ablon said.

Err on the side of injecting less filler material versus too much. "Less is more," Dr. Ablon said.

Start with a small amount and have the patient return for additional enhancement if desired. "Make sure you don't create lips that enter the door before the patient does. Not everyone will look normal with large lips, especially in Hollywood, where I work," commented Dr. Ablon, who is in private practice in Manhattan Beach, Calif., and on the dermatology faculty at the University of California in Los Angeles.

The actress Demi Moore, for example, has thin lips and "might look strange with enhanced lips."

When injecting filler, pay particular attention to the philtrum and cupid's bow on the upper lip, she said. You can also enhance or recreate the Glogau-Klein point, the dimple in the lower lip.

A general rule for the lower lips is to only inject in the central two-thirds. "Don't go too lateral. It will look like sausage otherwise," Dr. Ablon said. One exception, she said, is a patient with significant facial wrinkles who might get improvement to the side of the mouth (below the nasolabial fold).

Always have patients seated upright to allow for normal gravity. Another tip is to start with a nonpermanent filler, something you can dissolve, Dr. Ablon said.

Juvederm (hyaluronic acid, Allergan) is her lip filler product of choice, which she also injects above the vermillion border in some patients to provide additional enhancement. "It is a softer filler, and very moldable and malleable. Patients cannot notice there is anything inside their lips." Collagen and calcium hydroxylapatite are other lip filler choices.

Surgical options include lifts and advanced flaps. "The only surgical approach I typically use is the butterfly lip lift," Dr. Ablon said at the meeting.

The technique is best suited for patients with an elongated philtrum.

The lips are very sensitive and Dr. Ablon recommends use of topical and injected analgesics, such as lidocaine, before augmentation. She also uses the ArTek cooling device (ThermoTek Inc.) to increase patient comfort during the procedure. "If the patient is miserable, they will not return."

Tips to minimize bruising include avoidance of aspirin, nonsteroidal anti-inflammatory drugs, and vitamin E, and addition of bromelain supplements (a compound from pineapple). Also, consider antiviral treatment if the patient has a history of herpes outbreaks.

Dr. Ablon disclosed that she is a member of the Medicis advisory board (makers of Restylane and Perlane fillers).

'Don't create lips that enter the door before the patient does. Not everyone will look normal with large lips.' DR. ABLON

MIAMI BEACH — Remember the three P's of perfect lip enhancement—proportion, profile, and plumping—and you are more likely to get a satisfied patient who will use their new lips to refer other patients to your office.

Always keep proportion in mind—the ideal lip size ratio is about 40% for the top lip to 60% bottom lip, Dr. Glynis R. Ablon said at the South Beach Symposium.

The main goal of augmentation is to give patients natural-looking lips versus an overdone or "trout" lip appearance. "Don't completely change their look," she said, because no one should be able to tell the lips were enhanced.

For guidance, look at very young women or men, depending on what you're doing, "and see what looks natural to you," she said.

Look at each patient in profile and keep in mind you are sculpting the appearance of their lips from all sides, Dr. Ablon said.

Err on the side of injecting less filler material versus too much. "Less is more," Dr. Ablon said.

Start with a small amount and have the patient return for additional enhancement if desired. "Make sure you don't create lips that enter the door before the patient does. Not everyone will look normal with large lips, especially in Hollywood, where I work," commented Dr. Ablon, who is in private practice in Manhattan Beach, Calif., and on the dermatology faculty at the University of California in Los Angeles.

The actress Demi Moore, for example, has thin lips and "might look strange with enhanced lips."

When injecting filler, pay particular attention to the philtrum and cupid's bow on the upper lip, she said. You can also enhance or recreate the Glogau-Klein point, the dimple in the lower lip.

A general rule for the lower lips is to only inject in the central two-thirds. "Don't go too lateral. It will look like sausage otherwise," Dr. Ablon said. One exception, she said, is a patient with significant facial wrinkles who might get improvement to the side of the mouth (below the nasolabial fold).

Always have patients seated upright to allow for normal gravity. Another tip is to start with a nonpermanent filler, something you can dissolve, Dr. Ablon said.

Juvederm (hyaluronic acid, Allergan) is her lip filler product of choice, which she also injects above the vermillion border in some patients to provide additional enhancement. "It is a softer filler, and very moldable and malleable. Patients cannot notice there is anything inside their lips." Collagen and calcium hydroxylapatite are other lip filler choices.

Surgical options include lifts and advanced flaps. "The only surgical approach I typically use is the butterfly lip lift," Dr. Ablon said at the meeting.

The technique is best suited for patients with an elongated philtrum.

The lips are very sensitive and Dr. Ablon recommends use of topical and injected analgesics, such as lidocaine, before augmentation. She also uses the ArTek cooling device (ThermoTek Inc.) to increase patient comfort during the procedure. "If the patient is miserable, they will not return."

Tips to minimize bruising include avoidance of aspirin, nonsteroidal anti-inflammatory drugs, and vitamin E, and addition of bromelain supplements (a compound from pineapple). Also, consider antiviral treatment if the patient has a history of herpes outbreaks.

Dr. Ablon disclosed that she is a member of the Medicis advisory board (makers of Restylane and Perlane fillers).

'Don't create lips that enter the door before the patient does. Not everyone will look normal with large lips.' DR. ABLON

MIAMI BEACH — Minimizing bleeding during and after Mohs surgery can be a challenge, according to Dr. Susan H. Weinkle.

"In Bradenton [Fla.] where I practice, almost everyone is taking an anticoagulant," Dr. Weinkle said. As a Mohs surgeon "we realize that the risk of a thrombotic event is much worse for the patient than the risk of bleeding." She recommended that patients with a history of a transient ischemic attack or thrombotic event, in particular, be allowed to continue their anticoagulant therapy.

Ask patients to provide a comprehensive list of all the medications and supplements they take, Dr. Weinkle said at the South Beach Symposium. "Sometimes patients do not tell you the whole story, so you need a complete history." Patients may be taking ginkgo biloba or consuming a lot of cinnamon, which can thin the blood.

Meticulous hemostasis is important; do your best to maintain a dry field intraoperatively during Mohs surgery, said Dr. Weinkle, a private practice dermatologist in Bradenton. Epidermal sutures often can halt superficial bleeding along the edge of a wound. If excessive bleeding occurs intraoperatively, you may need to tie off a larger vessel. Also, avoid placing a patient in the Trendelenburg position.

How you bandage is also important to minimize the risk of postoperative bleeding. Provide pressure with a large bandage because "as the anesthetic goes away, you can get rebound vasodilatation," Dr. Weinkle said. Consider using flesh-colored bandages, and provide written instructions to leave bandages in place for 48 hours and to restrict activities.

Other strategies to prevent or manage postoperative bleeding include the application of ice, direct pressure for 15 minutes, and the use of Surgicel Absorbable Hemostat (Ethicon Inc.).

Surgicel looks like a little piece of gauze, Dr. Weinkle said. "One of my patients [who lives] 2 hours away went to the ED. They laid this on top of his sutured wound and it stopped" bleeding.

"One thing I want you to take home today—Surgicel is absolutely magical stuff," Dr. Weinkle said. (She stated that she had no relevant disclosures.) It is particularly helpful for controlling bleeding on more challenging wound sites.

Consider using flesh-colored bandages, and provide written instructions to leave them on for 48 hours. DR. WEINKLE

MIAMI BEACH — Minimizing bleeding during and after Mohs surgery can be a challenge, according to Dr. Susan H. Weinkle.

"In Bradenton [Fla.] where I practice, almost everyone is taking an anticoagulant," Dr. Weinkle said. As a Mohs surgeon "we realize that the risk of a thrombotic event is much worse for the patient than the risk of bleeding." She recommended that patients with a history of a transient ischemic attack or thrombotic event, in particular, be allowed to continue their anticoagulant therapy.

Ask patients to provide a comprehensive list of all the medications and supplements they take, Dr. Weinkle said at the South Beach Symposium. "Sometimes patients do not tell you the whole story, so you need a complete history." Patients may be taking ginkgo biloba or consuming a lot of cinnamon, which can thin the blood.

Meticulous hemostasis is important; do your best to maintain a dry field intraoperatively during Mohs surgery, said Dr. Weinkle, a private practice dermatologist in Bradenton. Epidermal sutures often can halt superficial bleeding along the edge of a wound. If excessive bleeding occurs intraoperatively, you may need to tie off a larger vessel. Also, avoid placing a patient in the Trendelenburg position.

How you bandage is also important to minimize the risk of postoperative bleeding. Provide pressure with a large bandage because "as the anesthetic goes away, you can get rebound vasodilatation," Dr. Weinkle said. Consider using flesh-colored bandages, and provide written instructions to leave bandages in place for 48 hours and to restrict activities.

Other strategies to prevent or manage postoperative bleeding include the application of ice, direct pressure for 15 minutes, and the use of Surgicel Absorbable Hemostat (Ethicon Inc.).

Surgicel looks like a little piece of gauze, Dr. Weinkle said. "One of my patients [who lives] 2 hours away went to the ED. They laid this on top of his sutured wound and it stopped" bleeding.

"One thing I want you to take home today—Surgicel is absolutely magical stuff," Dr. Weinkle said. (She stated that she had no relevant disclosures.) It is particularly helpful for controlling bleeding on more challenging wound sites.

Consider using flesh-colored bandages, and provide written instructions to leave them on for 48 hours. DR. WEINKLE

MIAMI BEACH — Minimizing bleeding during and after Mohs surgery can be a challenge, according to Dr. Susan H. Weinkle.

"In Bradenton [Fla.] where I practice, almost everyone is taking an anticoagulant," Dr. Weinkle said. As a Mohs surgeon "we realize that the risk of a thrombotic event is much worse for the patient than the risk of bleeding." She recommended that patients with a history of a transient ischemic attack or thrombotic event, in particular, be allowed to continue their anticoagulant therapy.

Ask patients to provide a comprehensive list of all the medications and supplements they take, Dr. Weinkle said at the South Beach Symposium. "Sometimes patients do not tell you the whole story, so you need a complete history." Patients may be taking ginkgo biloba or consuming a lot of cinnamon, which can thin the blood.

Meticulous hemostasis is important; do your best to maintain a dry field intraoperatively during Mohs surgery, said Dr. Weinkle, a private practice dermatologist in Bradenton. Epidermal sutures often can halt superficial bleeding along the edge of a wound. If excessive bleeding occurs intraoperatively, you may need to tie off a larger vessel. Also, avoid placing a patient in the Trendelenburg position.

How you bandage is also important to minimize the risk of postoperative bleeding. Provide pressure with a large bandage because "as the anesthetic goes away, you can get rebound vasodilatation," Dr. Weinkle said. Consider using flesh-colored bandages, and provide written instructions to leave bandages in place for 48 hours and to restrict activities.

Other strategies to prevent or manage postoperative bleeding include the application of ice, direct pressure for 15 minutes, and the use of Surgicel Absorbable Hemostat (Ethicon Inc.).

Surgicel looks like a little piece of gauze, Dr. Weinkle said. "One of my patients [who lives] 2 hours away went to the ED. They laid this on top of his sutured wound and it stopped" bleeding.

"One thing I want you to take home today—Surgicel is absolutely magical stuff," Dr. Weinkle said. (She stated that she had no relevant disclosures.) It is particularly helpful for controlling bleeding on more challenging wound sites.

Consider using flesh-colored bandages, and provide written instructions to leave them on for 48 hours. DR. WEINKLE

SINT MAARTEN, NETHERLANDS ANTILLES — New formulations of established oral agents and new combination products are available to treat acne, according to Dr. Hilary Baldwin.

The new oral formulations include extended-release minocycline tablets and delayed-release, enteric-coated doxycycline, she said.

Long-term, yet-to-be published data on extended-release (ER) minocycline tablets (Solodyn) show a low number of adverse events over a 2-year period, Dr. Baldwin said at the Caribbean Dermatology Symposium. The agent does not appear to increase the risk of lupuslike syndrome, a concern some have with minocycline.

No cases of hyperpigmentation occurred among the 136 patients who completed the 2-year study. A total of 13 patients reported nausea and 8 had dizziness or vertigo.

ER minocycline is dosed to 1 mg/kg per day and maintains efficacy despite its lower dose, compared with other minocycline formulations, Dr. Baldwin said. “And food has no impact on absorption of the drug, which is important in our teenage boys who never stop eating.”

Both ER minocycline and delayed-release, enteric-coated doxycycline (Doryx) feature once-a-day dosing that should improve compliance, said Dr. Baldwin of the department of dermatology, State University of New York at Brooklyn.

DR doxycycline is slowly dissolved in the small intestine and features a lower potential for gastrointestinal upset, compared with other formulations of oral doxycycline, Dr. Baldwin said. The agent can be dosed once daily from 37.5 to 200 mg, she added.

In addition to the new oral agents, there is a new topical formulation—solubilized benzoyl peroxide. Solubilization is a chemical process that makes the benzoyl peroxide particle sizes smaller than even currently available micronized formulations. The tiny size and lipophilic and hydrophilic properties of solubilized benzoyl peroxide facilitate increased penetration into the follicle, Dr. Baldwin said. “Other forms of benzoyl peroxide have larger molecules, and you get clumps of [the drug] sitting on the skin.”

Solubilized benzoyl peroxide gel significantly reduced noninflammatory acne lesion counts, compared with a combination of 1% clindamycin and 5% benzoyl peroxide gel, according to a 12-week study by other investigators. There was no significant difference in inflammatory lesion counts between the two groups. The solubilized gel was slightly more irritating, Dr. Baldwin said, with significantly more stinging and burning in the first 4 weeks of treatment.

“The acne toolbox is so darn full the top won't close in 2009,” Dr. Baldwin said. She is a consultant, is an advisory board member, or is on the speakers bureau for Allergan, Galderma, GlaxoSmithKline, Graceway, Medicis, Ortho Neutrogena, Ranbaxy, Sanofi-Aventis, and Stiefel.

The new fixed-dose combination products for combatting acne include clindamycin 1.2%/benzoyl peroxide 2.5% (Acanya) gel, which provides a statistically significant improvement in noninflammatory lesions, compared with placebo, Dr. Baldwin said. This formulation, approved by the Food and Drug Administration in October 2008, allows for a lower strength of the active ingredients, but there are no head-to-head comparisons yet, she said. The “benzoyl peroxide and clindamycin combination prevents an increase in resistance versus clindamycin alone, which did well up to 8 weeks but then resistance increased exponentially.”

According to a 12-month study presented as a poster at the meeting, a fixed-dose combination of adapalene gel 0.1% and benzoyl peroxide 2.5% is a safe and effective topical treatment for acne vulgaris. Dr. David M. Pariser, professor of dermatology at Eastern Virginia Medical School in Norfolk, was the lead author. He reported no relevant disclosures.

In December 2008, the FDA approved the retinoid adapalene and benzoyl peroxide combination (Epiduo gel) for the treatment of acne vulgaris in patients 12 years and older.

SINT MAARTEN, NETHERLANDS ANTILLES — New formulations of established oral agents and new combination products are available to treat acne, according to Dr. Hilary Baldwin.

The new oral formulations include extended-release minocycline tablets and delayed-release, enteric-coated doxycycline, she said.

Long-term, yet-to-be published data on extended-release (ER) minocycline tablets (Solodyn) show a low number of adverse events over a 2-year period, Dr. Baldwin said at the Caribbean Dermatology Symposium. The agent does not appear to increase the risk of lupuslike syndrome, a concern some have with minocycline.

No cases of hyperpigmentation occurred among the 136 patients who completed the 2-year study. A total of 13 patients reported nausea and 8 had dizziness or vertigo.

ER minocycline is dosed to 1 mg/kg per day and maintains efficacy despite its lower dose, compared with other minocycline formulations, Dr. Baldwin said. “And food has no impact on absorption of the drug, which is important in our teenage boys who never stop eating.”

Both ER minocycline and delayed-release, enteric-coated doxycycline (Doryx) feature once-a-day dosing that should improve compliance, said Dr. Baldwin of the department of dermatology, State University of New York at Brooklyn.

DR doxycycline is slowly dissolved in the small intestine and features a lower potential for gastrointestinal upset, compared with other formulations of oral doxycycline, Dr. Baldwin said. The agent can be dosed once daily from 37.5 to 200 mg, she added.

In addition to the new oral agents, there is a new topical formulation—solubilized benzoyl peroxide. Solubilization is a chemical process that makes the benzoyl peroxide particle sizes smaller than even currently available micronized formulations. The tiny size and lipophilic and hydrophilic properties of solubilized benzoyl peroxide facilitate increased penetration into the follicle, Dr. Baldwin said. “Other forms of benzoyl peroxide have larger molecules, and you get clumps of [the drug] sitting on the skin.”

Solubilized benzoyl peroxide gel significantly reduced noninflammatory acne lesion counts, compared with a combination of 1% clindamycin and 5% benzoyl peroxide gel, according to a 12-week study by other investigators. There was no significant difference in inflammatory lesion counts between the two groups. The solubilized gel was slightly more irritating, Dr. Baldwin said, with significantly more stinging and burning in the first 4 weeks of treatment.

“The acne toolbox is so darn full the top won't close in 2009,” Dr. Baldwin said. She is a consultant, is an advisory board member, or is on the speakers bureau for Allergan, Galderma, GlaxoSmithKline, Graceway, Medicis, Ortho Neutrogena, Ranbaxy, Sanofi-Aventis, and Stiefel.

The new fixed-dose combination products for combatting acne include clindamycin 1.2%/benzoyl peroxide 2.5% (Acanya) gel, which provides a statistically significant improvement in noninflammatory lesions, compared with placebo, Dr. Baldwin said. This formulation, approved by the Food and Drug Administration in October 2008, allows for a lower strength of the active ingredients, but there are no head-to-head comparisons yet, she said. The “benzoyl peroxide and clindamycin combination prevents an increase in resistance versus clindamycin alone, which did well up to 8 weeks but then resistance increased exponentially.”

According to a 12-month study presented as a poster at the meeting, a fixed-dose combination of adapalene gel 0.1% and benzoyl peroxide 2.5% is a safe and effective topical treatment for acne vulgaris. Dr. David M. Pariser, professor of dermatology at Eastern Virginia Medical School in Norfolk, was the lead author. He reported no relevant disclosures.

In December 2008, the FDA approved the retinoid adapalene and benzoyl peroxide combination (Epiduo gel) for the treatment of acne vulgaris in patients 12 years and older.

SINT MAARTEN, NETHERLANDS ANTILLES — New formulations of established oral agents and new combination products are available to treat acne, according to Dr. Hilary Baldwin.

The new oral formulations include extended-release minocycline tablets and delayed-release, enteric-coated doxycycline, she said.

Long-term, yet-to-be published data on extended-release (ER) minocycline tablets (Solodyn) show a low number of adverse events over a 2-year period, Dr. Baldwin said at the Caribbean Dermatology Symposium. The agent does not appear to increase the risk of lupuslike syndrome, a concern some have with minocycline.

No cases of hyperpigmentation occurred among the 136 patients who completed the 2-year study. A total of 13 patients reported nausea and 8 had dizziness or vertigo.

ER minocycline is dosed to 1 mg/kg per day and maintains efficacy despite its lower dose, compared with other minocycline formulations, Dr. Baldwin said. “And food has no impact on absorption of the drug, which is important in our teenage boys who never stop eating.”

Both ER minocycline and delayed-release, enteric-coated doxycycline (Doryx) feature once-a-day dosing that should improve compliance, said Dr. Baldwin of the department of dermatology, State University of New York at Brooklyn.

DR doxycycline is slowly dissolved in the small intestine and features a lower potential for gastrointestinal upset, compared with other formulations of oral doxycycline, Dr. Baldwin said. The agent can be dosed once daily from 37.5 to 200 mg, she added.

In addition to the new oral agents, there is a new topical formulation—solubilized benzoyl peroxide. Solubilization is a chemical process that makes the benzoyl peroxide particle sizes smaller than even currently available micronized formulations. The tiny size and lipophilic and hydrophilic properties of solubilized benzoyl peroxide facilitate increased penetration into the follicle, Dr. Baldwin said. “Other forms of benzoyl peroxide have larger molecules, and you get clumps of [the drug] sitting on the skin.”

Solubilized benzoyl peroxide gel significantly reduced noninflammatory acne lesion counts, compared with a combination of 1% clindamycin and 5% benzoyl peroxide gel, according to a 12-week study by other investigators. There was no significant difference in inflammatory lesion counts between the two groups. The solubilized gel was slightly more irritating, Dr. Baldwin said, with significantly more stinging and burning in the first 4 weeks of treatment.

“The acne toolbox is so darn full the top won't close in 2009,” Dr. Baldwin said. She is a consultant, is an advisory board member, or is on the speakers bureau for Allergan, Galderma, GlaxoSmithKline, Graceway, Medicis, Ortho Neutrogena, Ranbaxy, Sanofi-Aventis, and Stiefel.

The new fixed-dose combination products for combatting acne include clindamycin 1.2%/benzoyl peroxide 2.5% (Acanya) gel, which provides a statistically significant improvement in noninflammatory lesions, compared with placebo, Dr. Baldwin said. This formulation, approved by the Food and Drug Administration in October 2008, allows for a lower strength of the active ingredients, but there are no head-to-head comparisons yet, she said. The “benzoyl peroxide and clindamycin combination prevents an increase in resistance versus clindamycin alone, which did well up to 8 weeks but then resistance increased exponentially.”

According to a 12-month study presented as a poster at the meeting, a fixed-dose combination of adapalene gel 0.1% and benzoyl peroxide 2.5% is a safe and effective topical treatment for acne vulgaris. Dr. David M. Pariser, professor of dermatology at Eastern Virginia Medical School in Norfolk, was the lead author. He reported no relevant disclosures.

In December 2008, the FDA approved the retinoid adapalene and benzoyl peroxide combination (Epiduo gel) for the treatment of acne vulgaris in patients 12 years and older.

SINT MAARTEN, NETHERLANDS ANTILLES — Physicians can use a “2-minute drill” that combines questions and a physical exam to screen psoriasis patients for psoriatic arthritis.

Routinely ask patients with psoriasis about musculoskeletal complaints, and then determine whether their symptoms are inflammatory, Dr. Gary L. Crump advised at the Caribbean Dermatology Symposium. Examine them for soft tissue joint swelling, joint tenderness, nail pitting, dactylitis, and pain on motion.

The final question is about morning stiffness that lasts longer than 30 minutes, which affects more than 50% of people with psoriatic arthritis (PsA), he said. “It's important how you ask patients,” because some will have chronic back stiffness, for example. He recommended asking: “How long does it take you to get as loose as you are going to get?”

Patients with PsA also can present with erythroderma, psoriasis, onycholysis, conjunctivitis/iritis, and valvular heart disease. “Psoriatic arthritis is a true systemic inflammatory disease,” Dr. Crump said.

Clinical judgment and physical examination remain superior to laboratory tests, which can vary and are not very predictive. If acute PsA is suspected, erythrocyte sedimentation rate and rheumatoid factor assays are better than a C-reactive protein test, he said.

“If you are not sure, refer and let the rheumatologist figure it out,” said Dr. Crump, a private practice rheumatologist in Louisville, Ky. The ideal approach is multidisciplinary, he added.

A clinical tip is to examine the patient's feet. “If you see someone with 'sausage toes' or dactylitis, you're done. They have psoriatic arthritis,” Dr. Crump said. Nail dystrophy is also very strongly associated with PsA, even if only one distal joint is affected.

Although not part of the 2-minute screen, Dr. Crump also recommends quality of life assessment for patients with PsA. The Classification Criteria for Psoriatic Arthritis (CASPAR) for diagnosis (Arthritis Rheum. 2006;54:2665–73) are widely used.

After initial confirmation of articular joint disease, the criteria stipulate 3 or more points, using a scoring system. Assign 2 points for current psoriasis, and 1 point for each of the following: dactylitis, nail dystrophy, juxta-articular bone formation, and negative rheumatoid factor assay. Patients without current psoriasis also score 1 point if they have either a personal or family history of psoriasis. “So you cannot diagnose PsA with just psoriasis and arthritis alone—you need something else,” Dr. Crump said.

A differential diagnosis includes exclusion of other forms of inflammatory arthritis. Some patients with psoriasis also have rheumatoid arthritis, gout, or osteoarthritis, for example. Asymmetry of affected joints is one tip that a patient does not have rheumatoid arthritis, he said.

An estimated 40% of patients have a family history in first-degree relatives, Dr. Crump said. Even so, “the epidemiology has been hard to pin down.” Researchers have confirmed genetic polymorphisms related to tumor necrosis factor (TNF)-α promoters in patients with PsA (Pharmacogenomics 2008;9:195–205). Immunologic studies point to T-cell activation in the skin and increases in proinflammatory cytokines, including TNF-α, interleukin-1, IL-6, and IL-8.

Features of the five subtypes of PsA often overlap, further confounding diagnosis, Dr. Crump said. And although the distal pattern of PsA affects less than 20% of patients, “it is pretty diagnostic.”

In terms of treatment, NSAIDs can control PsA symptoms, including pain, but they do not prevent structural damage, Dr. Crump said. Methotrexate 7.5–20 mg/week can slow radiographic progression, but it is not effective for axial disease.

TNF inhibitors can slow or halt radiographic progression, including axial disease. “These are our 'go-to' class of drugs now.” This class includes etanercept, adalimumab, and infliximab. “My impression of these agents is they all work well for the joints,” said Dr. Crump, who is on the speakers bureau for Centocor, Novartis, Bristol-Myers Squibb, Roche, and Abbott.

SINT MAARTEN, NETHERLANDS ANTILLES — Physicians can use a “2-minute drill” that combines questions and a physical exam to screen psoriasis patients for psoriatic arthritis.

Routinely ask patients with psoriasis about musculoskeletal complaints, and then determine whether their symptoms are inflammatory, Dr. Gary L. Crump advised at the Caribbean Dermatology Symposium. Examine them for soft tissue joint swelling, joint tenderness, nail pitting, dactylitis, and pain on motion.

The final question is about morning stiffness that lasts longer than 30 minutes, which affects more than 50% of people with psoriatic arthritis (PsA), he said. “It's important how you ask patients,” because some will have chronic back stiffness, for example. He recommended asking: “How long does it take you to get as loose as you are going to get?”

Patients with PsA also can present with erythroderma, psoriasis, onycholysis, conjunctivitis/iritis, and valvular heart disease. “Psoriatic arthritis is a true systemic inflammatory disease,” Dr. Crump said.

Clinical judgment and physical examination remain superior to laboratory tests, which can vary and are not very predictive. If acute PsA is suspected, erythrocyte sedimentation rate and rheumatoid factor assays are better than a C-reactive protein test, he said.

“If you are not sure, refer and let the rheumatologist figure it out,” said Dr. Crump, a private practice rheumatologist in Louisville, Ky. The ideal approach is multidisciplinary, he added.

A clinical tip is to examine the patient's feet. “If you see someone with 'sausage toes' or dactylitis, you're done. They have psoriatic arthritis,” Dr. Crump said. Nail dystrophy is also very strongly associated with PsA, even if only one distal joint is affected.

Although not part of the 2-minute screen, Dr. Crump also recommends quality of life assessment for patients with PsA. The Classification Criteria for Psoriatic Arthritis (CASPAR) for diagnosis (Arthritis Rheum. 2006;54:2665–73) are widely used.

After initial confirmation of articular joint disease, the criteria stipulate 3 or more points, using a scoring system. Assign 2 points for current psoriasis, and 1 point for each of the following: dactylitis, nail dystrophy, juxta-articular bone formation, and negative rheumatoid factor assay. Patients without current psoriasis also score 1 point if they have either a personal or family history of psoriasis. “So you cannot diagnose PsA with just psoriasis and arthritis alone—you need something else,” Dr. Crump said.

A differential diagnosis includes exclusion of other forms of inflammatory arthritis. Some patients with psoriasis also have rheumatoid arthritis, gout, or osteoarthritis, for example. Asymmetry of affected joints is one tip that a patient does not have rheumatoid arthritis, he said.

An estimated 40% of patients have a family history in first-degree relatives, Dr. Crump said. Even so, “the epidemiology has been hard to pin down.” Researchers have confirmed genetic polymorphisms related to tumor necrosis factor (TNF)-α promoters in patients with PsA (Pharmacogenomics 2008;9:195–205). Immunologic studies point to T-cell activation in the skin and increases in proinflammatory cytokines, including TNF-α, interleukin-1, IL-6, and IL-8.

Features of the five subtypes of PsA often overlap, further confounding diagnosis, Dr. Crump said. And although the distal pattern of PsA affects less than 20% of patients, “it is pretty diagnostic.”

In terms of treatment, NSAIDs can control PsA symptoms, including pain, but they do not prevent structural damage, Dr. Crump said. Methotrexate 7.5–20 mg/week can slow radiographic progression, but it is not effective for axial disease.

TNF inhibitors can slow or halt radiographic progression, including axial disease. “These are our 'go-to' class of drugs now.” This class includes etanercept, adalimumab, and infliximab. “My impression of these agents is they all work well for the joints,” said Dr. Crump, who is on the speakers bureau for Centocor, Novartis, Bristol-Myers Squibb, Roche, and Abbott.

SINT MAARTEN, NETHERLANDS ANTILLES — Physicians can use a “2-minute drill” that combines questions and a physical exam to screen psoriasis patients for psoriatic arthritis.

Routinely ask patients with psoriasis about musculoskeletal complaints, and then determine whether their symptoms are inflammatory, Dr. Gary L. Crump advised at the Caribbean Dermatology Symposium. Examine them for soft tissue joint swelling, joint tenderness, nail pitting, dactylitis, and pain on motion.

The final question is about morning stiffness that lasts longer than 30 minutes, which affects more than 50% of people with psoriatic arthritis (PsA), he said. “It's important how you ask patients,” because some will have chronic back stiffness, for example. He recommended asking: “How long does it take you to get as loose as you are going to get?”

Patients with PsA also can present with erythroderma, psoriasis, onycholysis, conjunctivitis/iritis, and valvular heart disease. “Psoriatic arthritis is a true systemic inflammatory disease,” Dr. Crump said.

Clinical judgment and physical examination remain superior to laboratory tests, which can vary and are not very predictive. If acute PsA is suspected, erythrocyte sedimentation rate and rheumatoid factor assays are better than a C-reactive protein test, he said.

“If you are not sure, refer and let the rheumatologist figure it out,” said Dr. Crump, a private practice rheumatologist in Louisville, Ky. The ideal approach is multidisciplinary, he added.

A clinical tip is to examine the patient's feet. “If you see someone with 'sausage toes' or dactylitis, you're done. They have psoriatic arthritis,” Dr. Crump said. Nail dystrophy is also very strongly associated with PsA, even if only one distal joint is affected.

Although not part of the 2-minute screen, Dr. Crump also recommends quality of life assessment for patients with PsA. The Classification Criteria for Psoriatic Arthritis (CASPAR) for diagnosis (Arthritis Rheum. 2006;54:2665–73) are widely used.

After initial confirmation of articular joint disease, the criteria stipulate 3 or more points, using a scoring system. Assign 2 points for current psoriasis, and 1 point for each of the following: dactylitis, nail dystrophy, juxta-articular bone formation, and negative rheumatoid factor assay. Patients without current psoriasis also score 1 point if they have either a personal or family history of psoriasis. “So you cannot diagnose PsA with just psoriasis and arthritis alone—you need something else,” Dr. Crump said.

A differential diagnosis includes exclusion of other forms of inflammatory arthritis. Some patients with psoriasis also have rheumatoid arthritis, gout, or osteoarthritis, for example. Asymmetry of affected joints is one tip that a patient does not have rheumatoid arthritis, he said.

An estimated 40% of patients have a family history in first-degree relatives, Dr. Crump said. Even so, “the epidemiology has been hard to pin down.” Researchers have confirmed genetic polymorphisms related to tumor necrosis factor (TNF)-α promoters in patients with PsA (Pharmacogenomics 2008;9:195–205). Immunologic studies point to T-cell activation in the skin and increases in proinflammatory cytokines, including TNF-α, interleukin-1, IL-6, and IL-8.

Features of the five subtypes of PsA often overlap, further confounding diagnosis, Dr. Crump said. And although the distal pattern of PsA affects less than 20% of patients, “it is pretty diagnostic.”

In terms of treatment, NSAIDs can control PsA symptoms, including pain, but they do not prevent structural damage, Dr. Crump said. Methotrexate 7.5–20 mg/week can slow radiographic progression, but it is not effective for axial disease.

TNF inhibitors can slow or halt radiographic progression, including axial disease. “These are our 'go-to' class of drugs now.” This class includes etanercept, adalimumab, and infliximab. “My impression of these agents is they all work well for the joints,” said Dr. Crump, who is on the speakers bureau for Centocor, Novartis, Bristol-Myers Squibb, Roche, and Abbott.

HOLLYWOOD, FLA. — A cautious footnote about the use of magnetic resonance imaging to stage breast cancer or to gauge response to breast cancer therapy was added to guidelines from an alliance of 21 leading cancer centers.

“The value of MRI is uncertain, practice varies, and the potential downsides are real,” Dr. Stephen B. Edge said at the annual conference of the National Comprehensive Cancer Network.

“This is a rapidly evolving area in practice. This is an area where there is no consensus,” he said.

To guide clinicians on the utility of MRI in breast cancer, NCCN added six new recommendations to the Principles of Dedicated Breast MRI Testing section of the guidelines. (Unless noted, all are grade 2A recommendations, reflecting uniform consensus from NCCN panel members.)

This section said that MRI may be useful to stage the extent of cancer or to detect multifocal or multicentric disease in the ipsilateral breast, or to screen the contralateral breast at time of diagnosis (a category 2B recommendation, which has the same level of evidence as a 2A recommendation, but with nonuniform NCCN consensus).

“The impact of identification of contralateral cancers is unclear,” Dr. Edge said. MRI leads to frequent biopsies, 75%–80% of which are benign, he added. For example, in an MRI screening study of 969 women with a normal mammogram, 121 had a biopsy-based on MRI lesion detection, and 30 (3%) of the 969 women had a diagnosis of contralateral cancer (N. Engl. J. Med. 2007;356:1295–303).

MRI may also be useful before and after neoadjuvant therapy to define the extent of disease or response to therapy. In addition, “MRI can help assess candidacy for surgery after adjuvant therapy,” said Dr. Edge, chair of the department of breast surgery and medical director of the Breast Center at Roswell Park Cancer Institute in Buffalo, N.Y.

However, MRI findings may underestimate residual disease, he said. In one study, “unfortunately, half of women cleared by MRI still had residual tumor at time of surgery” (Br. J. Cancer 2004;90:1349–60). “So, complete clearance on MRI does not mean complete clinical clearance. There is clearly a need for prospective data in this field.”

In addition, MRI may be useful to identify primary cancer in women with axillary node adenocarcinoma or with Paget's disease of the nipple when primary breast disease is not identified on mammography, ultrasound, or physical exam.

Also, because of a high rate of false-positive findings, the panel concluded that surgical decisions should not be based solely on MRI findings.

For example, a multicenter study of 426 women with a suspicious mammogram and proven cancer revealed a 24% incidental lesion false-positive rate with MRI, compared with 10% false-positive rate with mammography (J. Surg. Oncol. 2005;92:32–8). “But MRI also detected some additional lesions,” Dr. Edge said.

An unanswered question is whether MRI affects long-term breast cancer outcome and survival, Dr. Edge said. “The only available evidence—retrospective data—shows no impact of MRI on local recurrence or survival.”

Another updated NCCN guideline, this one on breast cancer screening and diagnosis, states that physicians can consider MRI as an adjunct to screening high-risk women in addition to annual mammography and breast exam. New definitions of high-risk patients include women aged 25 years and older with a history of thoracic radiotherapy, and those with a lifetime risk of breast cancer exceeding 20%. MRI is not recommended for screening average-risk women.

The NCCN guidelines panel also included MRI expertise recommendations. For example, an expert breast-imaging team should perform and interpret breast MRI examinations, working in concert with a multidisciplinary treatment team.

In addition, breast MRI should be done by a radiologist with expertise in breast imaging using a dedicated coil. Also, an imaging center should have the ability to perform MRI-guided needle sampling and/or wire localization of relevant findings.

HOLLYWOOD, FLA. — A cautious footnote about the use of magnetic resonance imaging to stage breast cancer or to gauge response to breast cancer therapy was added to guidelines from an alliance of 21 leading cancer centers.

“The value of MRI is uncertain, practice varies, and the potential downsides are real,” Dr. Stephen B. Edge said at the annual conference of the National Comprehensive Cancer Network.

“This is a rapidly evolving area in practice. This is an area where there is no consensus,” he said.

To guide clinicians on the utility of MRI in breast cancer, NCCN added six new recommendations to the Principles of Dedicated Breast MRI Testing section of the guidelines. (Unless noted, all are grade 2A recommendations, reflecting uniform consensus from NCCN panel members.)

This section said that MRI may be useful to stage the extent of cancer or to detect multifocal or multicentric disease in the ipsilateral breast, or to screen the contralateral breast at time of diagnosis (a category 2B recommendation, which has the same level of evidence as a 2A recommendation, but with nonuniform NCCN consensus).

“The impact of identification of contralateral cancers is unclear,” Dr. Edge said. MRI leads to frequent biopsies, 75%–80% of which are benign, he added. For example, in an MRI screening study of 969 women with a normal mammogram, 121 had a biopsy-based on MRI lesion detection, and 30 (3%) of the 969 women had a diagnosis of contralateral cancer (N. Engl. J. Med. 2007;356:1295–303).

MRI may also be useful before and after neoadjuvant therapy to define the extent of disease or response to therapy. In addition, “MRI can help assess candidacy for surgery after adjuvant therapy,” said Dr. Edge, chair of the department of breast surgery and medical director of the Breast Center at Roswell Park Cancer Institute in Buffalo, N.Y.

However, MRI findings may underestimate residual disease, he said. In one study, “unfortunately, half of women cleared by MRI still had residual tumor at time of surgery” (Br. J. Cancer 2004;90:1349–60). “So, complete clearance on MRI does not mean complete clinical clearance. There is clearly a need for prospective data in this field.”

In addition, MRI may be useful to identify primary cancer in women with axillary node adenocarcinoma or with Paget's disease of the nipple when primary breast disease is not identified on mammography, ultrasound, or physical exam.

Also, because of a high rate of false-positive findings, the panel concluded that surgical decisions should not be based solely on MRI findings.

For example, a multicenter study of 426 women with a suspicious mammogram and proven cancer revealed a 24% incidental lesion false-positive rate with MRI, compared with 10% false-positive rate with mammography (J. Surg. Oncol. 2005;92:32–8). “But MRI also detected some additional lesions,” Dr. Edge said.

An unanswered question is whether MRI affects long-term breast cancer outcome and survival, Dr. Edge said. “The only available evidence—retrospective data—shows no impact of MRI on local recurrence or survival.”

Another updated NCCN guideline, this one on breast cancer screening and diagnosis, states that physicians can consider MRI as an adjunct to screening high-risk women in addition to annual mammography and breast exam. New definitions of high-risk patients include women aged 25 years and older with a history of thoracic radiotherapy, and those with a lifetime risk of breast cancer exceeding 20%. MRI is not recommended for screening average-risk women.

The NCCN guidelines panel also included MRI expertise recommendations. For example, an expert breast-imaging team should perform and interpret breast MRI examinations, working in concert with a multidisciplinary treatment team.

In addition, breast MRI should be done by a radiologist with expertise in breast imaging using a dedicated coil. Also, an imaging center should have the ability to perform MRI-guided needle sampling and/or wire localization of relevant findings.

HOLLYWOOD, FLA. — A cautious footnote about the use of magnetic resonance imaging to stage breast cancer or to gauge response to breast cancer therapy was added to guidelines from an alliance of 21 leading cancer centers.

“The value of MRI is uncertain, practice varies, and the potential downsides are real,” Dr. Stephen B. Edge said at the annual conference of the National Comprehensive Cancer Network.

“This is a rapidly evolving area in practice. This is an area where there is no consensus,” he said.

To guide clinicians on the utility of MRI in breast cancer, NCCN added six new recommendations to the Principles of Dedicated Breast MRI Testing section of the guidelines. (Unless noted, all are grade 2A recommendations, reflecting uniform consensus from NCCN panel members.)

This section said that MRI may be useful to stage the extent of cancer or to detect multifocal or multicentric disease in the ipsilateral breast, or to screen the contralateral breast at time of diagnosis (a category 2B recommendation, which has the same level of evidence as a 2A recommendation, but with nonuniform NCCN consensus).

“The impact of identification of contralateral cancers is unclear,” Dr. Edge said. MRI leads to frequent biopsies, 75%–80% of which are benign, he added. For example, in an MRI screening study of 969 women with a normal mammogram, 121 had a biopsy-based on MRI lesion detection, and 30 (3%) of the 969 women had a diagnosis of contralateral cancer (N. Engl. J. Med. 2007;356:1295–303).

MRI may also be useful before and after neoadjuvant therapy to define the extent of disease or response to therapy. In addition, “MRI can help assess candidacy for surgery after adjuvant therapy,” said Dr. Edge, chair of the department of breast surgery and medical director of the Breast Center at Roswell Park Cancer Institute in Buffalo, N.Y.

However, MRI findings may underestimate residual disease, he said. In one study, “unfortunately, half of women cleared by MRI still had residual tumor at time of surgery” (Br. J. Cancer 2004;90:1349–60). “So, complete clearance on MRI does not mean complete clinical clearance. There is clearly a need for prospective data in this field.”

In addition, MRI may be useful to identify primary cancer in women with axillary node adenocarcinoma or with Paget's disease of the nipple when primary breast disease is not identified on mammography, ultrasound, or physical exam.

Also, because of a high rate of false-positive findings, the panel concluded that surgical decisions should not be based solely on MRI findings.

For example, a multicenter study of 426 women with a suspicious mammogram and proven cancer revealed a 24% incidental lesion false-positive rate with MRI, compared with 10% false-positive rate with mammography (J. Surg. Oncol. 2005;92:32–8). “But MRI also detected some additional lesions,” Dr. Edge said.

An unanswered question is whether MRI affects long-term breast cancer outcome and survival, Dr. Edge said. “The only available evidence—retrospective data—shows no impact of MRI on local recurrence or survival.”

Another updated NCCN guideline, this one on breast cancer screening and diagnosis, states that physicians can consider MRI as an adjunct to screening high-risk women in addition to annual mammography and breast exam. New definitions of high-risk patients include women aged 25 years and older with a history of thoracic radiotherapy, and those with a lifetime risk of breast cancer exceeding 20%. MRI is not recommended for screening average-risk women.

The NCCN guidelines panel also included MRI expertise recommendations. For example, an expert breast-imaging team should perform and interpret breast MRI examinations, working in concert with a multidisciplinary treatment team.

In addition, breast MRI should be done by a radiologist with expertise in breast imaging using a dedicated coil. Also, an imaging center should have the ability to perform MRI-guided needle sampling and/or wire localization of relevant findings.

The first head lice treatment with benzyl alcohol as the active ingredient has received Food and Drug Administration approval for use in adults and children aged 6 months and older.

The newly approved agent (not yet named) is the first prescription product to kill head lice by suffocation. While the agent lacks pesticides contained in other FDA-approved products, the approval carries a strongly worded warning not to use the agent in premature infants, citing the risk of serious respiratory and heart- or brain-related adverse events such as seizure, coma, or death.

The gestational age of the participants was not known when the clinical study data were submitted to the FDA, Jesse Fishman, Pharm.D., medical information officer for Sciele Pharma Inc. (manufacturer of benzyl alcohol lotion, 5%), said in an interview. The company recommends only using the product on babies of normal gestation age plus 6 months. Therefore, based on an average full gestation of 40 weeks, a baby born prematurely at 35 weeks could be treated when they reach 6 months plus 5 weeks of age, for example.

The approval was based on data from two safety and efficacy trials with a total of 628 children with active infestations of Pediculosis capitis; the children's average age was 7 years in one trial and 10 years in the other. The study participants underwent two 10-minute applications (1 week apart) of benzyl alcohol lotion, 5% or topical placebo. Scalp examination conducted 14 days after completion of treatment showed that active infestation was resolved in 75% of the participants on active treatment and 26% of those on placebo.

The warning about not using [the drug] in premature infants is strong,” Dr. Seth J. Orlow said in an interview. “Parents and prescribers will want to know how premature an infant must be to fall under the warning, and when an ex-preemie is no longer considered 'a premature infant,'” he said.

The potential for treatment resistance might be lower with benzyl alcohol lotion, 5%, compared with traditional pediculocides, said Dr. Orlow, chairman of dermatology and professor of pediatric dermatology at New York University, New York.

He had no relevant disclosures.

The new agent is the first prescription product to kill lice by suffocation. CDC/Dr. Dennis D. Juranek

The first head lice treatment with benzyl alcohol as the active ingredient has received Food and Drug Administration approval for use in adults and children aged 6 months and older.

The newly approved agent (not yet named) is the first prescription product to kill head lice by suffocation. While the agent lacks pesticides contained in other FDA-approved products, the approval carries a strongly worded warning not to use the agent in premature infants, citing the risk of serious respiratory and heart- or brain-related adverse events such as seizure, coma, or death.

The gestational age of the participants was not known when the clinical study data were submitted to the FDA, Jesse Fishman, Pharm.D., medical information officer for Sciele Pharma Inc. (manufacturer of benzyl alcohol lotion, 5%), said in an interview. The company recommends only using the product on babies of normal gestation age plus 6 months. Therefore, based on an average full gestation of 40 weeks, a baby born prematurely at 35 weeks could be treated when they reach 6 months plus 5 weeks of age, for example.

The approval was based on data from two safety and efficacy trials with a total of 628 children with active infestations of Pediculosis capitis; the children's average age was 7 years in one trial and 10 years in the other. The study participants underwent two 10-minute applications (1 week apart) of benzyl alcohol lotion, 5% or topical placebo. Scalp examination conducted 14 days after completion of treatment showed that active infestation was resolved in 75% of the participants on active treatment and 26% of those on placebo.

The warning about not using [the drug] in premature infants is strong,” Dr. Seth J. Orlow said in an interview. “Parents and prescribers will want to know how premature an infant must be to fall under the warning, and when an ex-preemie is no longer considered 'a premature infant,'” he said.

The potential for treatment resistance might be lower with benzyl alcohol lotion, 5%, compared with traditional pediculocides, said Dr. Orlow, chairman of dermatology and professor of pediatric dermatology at New York University, New York.

He had no relevant disclosures.

The new agent is the first prescription product to kill lice by suffocation. CDC/Dr. Dennis D. Juranek

The first head lice treatment with benzyl alcohol as the active ingredient has received Food and Drug Administration approval for use in adults and children aged 6 months and older.

The newly approved agent (not yet named) is the first prescription product to kill head lice by suffocation. While the agent lacks pesticides contained in other FDA-approved products, the approval carries a strongly worded warning not to use the agent in premature infants, citing the risk of serious respiratory and heart- or brain-related adverse events such as seizure, coma, or death.

The gestational age of the participants was not known when the clinical study data were submitted to the FDA, Jesse Fishman, Pharm.D., medical information officer for Sciele Pharma Inc. (manufacturer of benzyl alcohol lotion, 5%), said in an interview. The company recommends only using the product on babies of normal gestation age plus 6 months. Therefore, based on an average full gestation of 40 weeks, a baby born prematurely at 35 weeks could be treated when they reach 6 months plus 5 weeks of age, for example.

The approval was based on data from two safety and efficacy trials with a total of 628 children with active infestations of Pediculosis capitis; the children's average age was 7 years in one trial and 10 years in the other. The study participants underwent two 10-minute applications (1 week apart) of benzyl alcohol lotion, 5% or topical placebo. Scalp examination conducted 14 days after completion of treatment showed that active infestation was resolved in 75% of the participants on active treatment and 26% of those on placebo.

The warning about not using [the drug] in premature infants is strong,” Dr. Seth J. Orlow said in an interview. “Parents and prescribers will want to know how premature an infant must be to fall under the warning, and when an ex-preemie is no longer considered 'a premature infant,'” he said.

The potential for treatment resistance might be lower with benzyl alcohol lotion, 5%, compared with traditional pediculocides, said Dr. Orlow, chairman of dermatology and professor of pediatric dermatology at New York University, New York.

He had no relevant disclosures.

The new agent is the first prescription product to kill lice by suffocation. CDC/Dr. Dennis D. Juranek