USF Health: International Symposium on IGF-1, GH and Ghrelin/GHS

ORLANDO – When a woman with a suspicious ovarian mass presents to a primary care physician, the majority of these doctors would not refer the patients directly to a gynecologic oncologist, even though early management by such specialists is associated with improved outcome, Dr. Barbara A. Goff said.

In all, 52% of 414 internists and 40% of 591 family physicians who responded to a mailed survey indicated that they would refer a patient with a suspicious pelvic mass directly to a gynecologic oncologist. Overall, 98% indicated that they would refer or consult with another physician, but half would initially refer to an ob.gyn., Dr. Goff said at the annual meeting of the Society of Gynecologic Oncologists.

"It’s been shown in numerous studies that women who receive their care from gynecologic oncologists have a significantly higher likelihood of receiving NCCN guidelines [recommended] therapy, optimal cytoreduction, and better overall survival," Dr. Goff said. The National Comprehensive Cancer Network (NCCN) is a consortium of 21 leading cancer centers in the United States that regularly releases and updates clinical guidelines in oncology.

The survey findings suggest a need for greater awareness of the benefits of such direct referrals and, possibly, for incentives to get internists and family physicians to refer these women more often, said Dr. Goff, director of gynecologic oncology at the University of Washington, Seattle. "Promoting direct referral to gynecologic oncologists from primary care may be the best way to increase compliance."

A total of 596 ob.gyns. also responded to the vignette-based survey. Their answers differed from those of internists and family physicians when they were asked to consider how they would manage the same hypothetical patient. The scenario was a 57-year-old woman complaining of pelvic pain and bloating for 3 weeks, whose ultrasound reveals a 10-cm, complex, right adnexal mass with solid and cystic components and increased vascularity. Patient variables such as race and insurance status were changed in different versions of the survey.

About one-third of ob.gyns. (34%) indicated that they would perform surgery themselves. These ob.gyns. were significantly more likely to work in practices that were smaller and/or located in more remote places, according to a multivariate analysis. The other 66% responded that they would consult with or refer the woman to another physician, and 96% of these ob.gyns. would involve a gynecologic oncologist.

This combination of findings – that only about half of internists and family physicians would refer directly to a gynecologic oncologist, and about one-third of ob.gyns. would perform surgery themselves – may partially explain why many women with ovarian cancer in the United States do not receive comprehensive surgical care or get treated at a high-volume center, Dr. Goff said.

"Unfortunately, recent studies show that 30%-50% of women with ovarian cancer are not receiving care from gynecologic oncologists," Dr. Goff said. For example, 44% of 31,897 stage III/IV ovarian cancers were treated by a different type of physician (Gynecol. Oncol. 2010;117:18-22). Those women who were treated by a gynecologic oncologist had a 40% improvement in overall survival.

Dr. Goff also examined this phenomenon in her study that showed that 67% of 9,963 women with ovarian cancer who were admitted received comprehensive surgery (Cancer 2007;109:2031-42).

Dr. Goff and her associates looked for significant patient and physician factors that were associated with referral to a gynecologic oncologist. Private insurance was the only significant, unadjusted patient factor. Among the internists and family physicians, significant factors included female sex, internal medicine specialty, board certification, fewer years in practice, group practice, fewer patients seen per week on average, involvement in clinical teaching, and an urban practice location.

In a multivariate logistic regression, factors that were significantly associated with an internist or family physician’s not referring directly to a gynecologic oncologist included male sex, family physician specialty, Medicaid insurance, providers with a weekly average number of patients greater than 91, solo practice, and rural location.

The 12-page survey was mailed to 3,200 primary care physicians who were randomly sampled from the AMA master file. A $20 bill was included as an incentive. The response rate was 62%.

"This is an important and provocative paper," said invited study discussant Dr. Claes Trope, head of the national gynecologic oncology center at Oslo University Hospital.

The sample size is large, there seems to be no selection bias because a random sample of physicians was surveyed, and the "62% response rate is quite impressive," she said. An inability to judge whether physician responses completely reflected what the clinicians would actually do in practice, compared with a "politically correct" response, is a potential limitation, Dr. Trope added.

Does women’s "social, economic, or education status influence referral practice?" she asked.

"Definitely, socioeconomic factors have an influence on whether people go to a high-volume center or to a gynecologic oncologist," Dr. Goff replied. "I don’t know if that is patient or physician driven."

Dr. Goff and Dr. Trope said that they had no relevant financial disclosures. The study coauthors included researchers at the Centers for Disease Control and Prevention, which provided funding for the survey.

ORLANDO – When a woman with a suspicious ovarian mass presents to a primary care physician, the majority of these doctors would not refer the patients directly to a gynecologic oncologist, even though early management by such specialists is associated with improved outcome, Dr. Barbara A. Goff said.

In all, 52% of 414 internists and 40% of 591 family physicians who responded to a mailed survey indicated that they would refer a patient with a suspicious pelvic mass directly to a gynecologic oncologist. Overall, 98% indicated that they would refer or consult with another physician, but half would initially refer to an ob.gyn., Dr. Goff said at the annual meeting of the Society of Gynecologic Oncologists.

"It’s been shown in numerous studies that women who receive their care from gynecologic oncologists have a significantly higher likelihood of receiving NCCN guidelines [recommended] therapy, optimal cytoreduction, and better overall survival," Dr. Goff said. The National Comprehensive Cancer Network (NCCN) is a consortium of 21 leading cancer centers in the United States that regularly releases and updates clinical guidelines in oncology.

The survey findings suggest a need for greater awareness of the benefits of such direct referrals and, possibly, for incentives to get internists and family physicians to refer these women more often, said Dr. Goff, director of gynecologic oncology at the University of Washington, Seattle. "Promoting direct referral to gynecologic oncologists from primary care may be the best way to increase compliance."

A total of 596 ob.gyns. also responded to the vignette-based survey. Their answers differed from those of internists and family physicians when they were asked to consider how they would manage the same hypothetical patient. The scenario was a 57-year-old woman complaining of pelvic pain and bloating for 3 weeks, whose ultrasound reveals a 10-cm, complex, right adnexal mass with solid and cystic components and increased vascularity. Patient variables such as race and insurance status were changed in different versions of the survey.

About one-third of ob.gyns. (34%) indicated that they would perform surgery themselves. These ob.gyns. were significantly more likely to work in practices that were smaller and/or located in more remote places, according to a multivariate analysis. The other 66% responded that they would consult with or refer the woman to another physician, and 96% of these ob.gyns. would involve a gynecologic oncologist.

This combination of findings – that only about half of internists and family physicians would refer directly to a gynecologic oncologist, and about one-third of ob.gyns. would perform surgery themselves – may partially explain why many women with ovarian cancer in the United States do not receive comprehensive surgical care or get treated at a high-volume center, Dr. Goff said.

"Unfortunately, recent studies show that 30%-50% of women with ovarian cancer are not receiving care from gynecologic oncologists," Dr. Goff said. For example, 44% of 31,897 stage III/IV ovarian cancers were treated by a different type of physician (Gynecol. Oncol. 2010;117:18-22). Those women who were treated by a gynecologic oncologist had a 40% improvement in overall survival.

Dr. Goff also examined this phenomenon in her study that showed that 67% of 9,963 women with ovarian cancer who were admitted received comprehensive surgery (Cancer 2007;109:2031-42).

Dr. Goff and her associates looked for significant patient and physician factors that were associated with referral to a gynecologic oncologist. Private insurance was the only significant, unadjusted patient factor. Among the internists and family physicians, significant factors included female sex, internal medicine specialty, board certification, fewer years in practice, group practice, fewer patients seen per week on average, involvement in clinical teaching, and an urban practice location.

In a multivariate logistic regression, factors that were significantly associated with an internist or family physician’s not referring directly to a gynecologic oncologist included male sex, family physician specialty, Medicaid insurance, providers with a weekly average number of patients greater than 91, solo practice, and rural location.

The 12-page survey was mailed to 3,200 primary care physicians who were randomly sampled from the AMA master file. A $20 bill was included as an incentive. The response rate was 62%.

"This is an important and provocative paper," said invited study discussant Dr. Claes Trope, head of the national gynecologic oncology center at Oslo University Hospital.

The sample size is large, there seems to be no selection bias because a random sample of physicians was surveyed, and the "62% response rate is quite impressive," she said. An inability to judge whether physician responses completely reflected what the clinicians would actually do in practice, compared with a "politically correct" response, is a potential limitation, Dr. Trope added.

Does women’s "social, economic, or education status influence referral practice?" she asked.

"Definitely, socioeconomic factors have an influence on whether people go to a high-volume center or to a gynecologic oncologist," Dr. Goff replied. "I don’t know if that is patient or physician driven."

Dr. Goff and Dr. Trope said that they had no relevant financial disclosures. The study coauthors included researchers at the Centers for Disease Control and Prevention, which provided funding for the survey.

ORLANDO – When a woman with a suspicious ovarian mass presents to a primary care physician, the majority of these doctors would not refer the patients directly to a gynecologic oncologist, even though early management by such specialists is associated with improved outcome, Dr. Barbara A. Goff said.

In all, 52% of 414 internists and 40% of 591 family physicians who responded to a mailed survey indicated that they would refer a patient with a suspicious pelvic mass directly to a gynecologic oncologist. Overall, 98% indicated that they would refer or consult with another physician, but half would initially refer to an ob.gyn., Dr. Goff said at the annual meeting of the Society of Gynecologic Oncologists.

"It’s been shown in numerous studies that women who receive their care from gynecologic oncologists have a significantly higher likelihood of receiving NCCN guidelines [recommended] therapy, optimal cytoreduction, and better overall survival," Dr. Goff said. The National Comprehensive Cancer Network (NCCN) is a consortium of 21 leading cancer centers in the United States that regularly releases and updates clinical guidelines in oncology.

The survey findings suggest a need for greater awareness of the benefits of such direct referrals and, possibly, for incentives to get internists and family physicians to refer these women more often, said Dr. Goff, director of gynecologic oncology at the University of Washington, Seattle. "Promoting direct referral to gynecologic oncologists from primary care may be the best way to increase compliance."

A total of 596 ob.gyns. also responded to the vignette-based survey. Their answers differed from those of internists and family physicians when they were asked to consider how they would manage the same hypothetical patient. The scenario was a 57-year-old woman complaining of pelvic pain and bloating for 3 weeks, whose ultrasound reveals a 10-cm, complex, right adnexal mass with solid and cystic components and increased vascularity. Patient variables such as race and insurance status were changed in different versions of the survey.

About one-third of ob.gyns. (34%) indicated that they would perform surgery themselves. These ob.gyns. were significantly more likely to work in practices that were smaller and/or located in more remote places, according to a multivariate analysis. The other 66% responded that they would consult with or refer the woman to another physician, and 96% of these ob.gyns. would involve a gynecologic oncologist.

This combination of findings – that only about half of internists and family physicians would refer directly to a gynecologic oncologist, and about one-third of ob.gyns. would perform surgery themselves – may partially explain why many women with ovarian cancer in the United States do not receive comprehensive surgical care or get treated at a high-volume center, Dr. Goff said.

"Unfortunately, recent studies show that 30%-50% of women with ovarian cancer are not receiving care from gynecologic oncologists," Dr. Goff said. For example, 44% of 31,897 stage III/IV ovarian cancers were treated by a different type of physician (Gynecol. Oncol. 2010;117:18-22). Those women who were treated by a gynecologic oncologist had a 40% improvement in overall survival.

Dr. Goff also examined this phenomenon in her study that showed that 67% of 9,963 women with ovarian cancer who were admitted received comprehensive surgery (Cancer 2007;109:2031-42).

Dr. Goff and her associates looked for significant patient and physician factors that were associated with referral to a gynecologic oncologist. Private insurance was the only significant, unadjusted patient factor. Among the internists and family physicians, significant factors included female sex, internal medicine specialty, board certification, fewer years in practice, group practice, fewer patients seen per week on average, involvement in clinical teaching, and an urban practice location.

In a multivariate logistic regression, factors that were significantly associated with an internist or family physician’s not referring directly to a gynecologic oncologist included male sex, family physician specialty, Medicaid insurance, providers with a weekly average number of patients greater than 91, solo practice, and rural location.

The 12-page survey was mailed to 3,200 primary care physicians who were randomly sampled from the AMA master file. A $20 bill was included as an incentive. The response rate was 62%.

"This is an important and provocative paper," said invited study discussant Dr. Claes Trope, head of the national gynecologic oncology center at Oslo University Hospital.

The sample size is large, there seems to be no selection bias because a random sample of physicians was surveyed, and the "62% response rate is quite impressive," she said. An inability to judge whether physician responses completely reflected what the clinicians would actually do in practice, compared with a "politically correct" response, is a potential limitation, Dr. Trope added.

Does women’s "social, economic, or education status influence referral practice?" she asked.

"Definitely, socioeconomic factors have an influence on whether people go to a high-volume center or to a gynecologic oncologist," Dr. Goff replied. "I don’t know if that is patient or physician driven."

Dr. Goff and Dr. Trope said that they had no relevant financial disclosures. The study coauthors included researchers at the Centers for Disease Control and Prevention, which provided funding for the survey.

ORLANDO – When a woman with a suspicious ovarian mass presents to a primary care physician, the majority of these doctors would not refer the patients directly to a gynecologic oncologist, even though early management by such specialists is associated with improved outcome, Dr. Barbara A. Goff said.

In all, 52% of 414 internists and 40% of 591 family physicians who responded to a mailed survey indicated that they would refer a patient with a suspicious pelvic mass directly to a gynecologic oncologist. Overall, 98% indicated that they would refer or consult with another physician, but half would initially refer to an ob.gyn., Dr. Goff said at the annual meeting of the Society of Gynecologic Oncologists.

"It’s been shown in numerous studies that women who receive their care from gynecologic oncologists have a significantly higher likelihood of receiving NCCN guidelines [recommended] therapy, optimal cytoreduction, and better overall survival," Dr. Goff said. The National Comprehensive Cancer Network (NCCN) is a consortium of 21 leading cancer centers in the United States that regularly releases and updates clinical guidelines in oncology.

The survey findings suggest a need for greater awareness of the benefits of such direct referrals and, possibly, for incentives to get internists and family physicians to refer these women more often, said Dr. Goff, director of gynecologic oncology at the University of Washington, Seattle. "Promoting direct referral to gynecologic oncologists from primary care may be the best way to increase compliance."

A total of 596 ob.gyns. also responded to the vignette-based survey. Their answers differed from those of internists and family physicians when they were asked to consider how they would manage the same hypothetical patient. The scenario was a 57-year-old woman complaining of pelvic pain and bloating for 3 weeks, whose ultrasound reveals a 10-cm, complex, right adnexal mass with solid and cystic components and increased vascularity. Patient variables such as race and insurance status were changed in different versions of the survey.

About one-third of ob.gyns. (34%) indicated that they would perform surgery themselves. These ob.gyns. were significantly more likely to work in practices that were smaller and/or located in more remote places, according to a multivariate analysis. The other 66% responded that they would consult with or refer the woman to another physician, and 96% of these ob.gyns. would involve a gynecologic oncologist.

This combination of findings – that only about half of internists and family physicians would refer directly to a gynecologic oncologist, and about one-third of ob.gyns. would perform surgery themselves – may partially explain why many women with ovarian cancer in the United States do not receive comprehensive surgical care or get treated at a high-volume center, Dr. Goff said.

"Unfortunately, recent studies show that 30%-50% of women with ovarian cancer are not receiving care from gynecologic oncologists," Dr. Goff said. For example, 44% of 31,897 stage III/IV ovarian cancers were treated by a different type of physician (Gynecol. Oncol. 2010;117:18-22). Those women who were treated by a gynecologic oncologist had a 40% improvement in overall survival.

Dr. Goff also examined this phenomenon in her study that showed that 67% of 9,963 women with ovarian cancer who were admitted received comprehensive surgery (Cancer 2007;109:2031-42).

Dr. Goff and her associates looked for significant patient and physician factors that were associated with referral to a gynecologic oncologist. Private insurance was the only significant, unadjusted patient factor. Among the internists and family physicians, significant factors included female sex, internal medicine specialty, board certification, fewer years in practice, group practice, fewer patients seen per week on average, involvement in clinical teaching, and an urban practice location.

In a multivariate logistic regression, factors that were significantly associated with an internist or family physician’s not referring directly to a gynecologic oncologist included male sex, family physician specialty, Medicaid insurance, providers with a weekly average number of patients greater than 91, solo practice, and rural location.

The 12-page survey was mailed to 3,200 primary care physicians who were randomly sampled from the AMA master file. A $20 bill was included as an incentive. The response rate was 62%.

"This is an important and provocative paper," said invited study discussant Dr. Claes Trope, head of the national gynecologic oncology center at Oslo University Hospital.

The sample size is large, there seems to be no selection bias because a random sample of physicians was surveyed, and the "62% response rate is quite impressive," she said. An inability to judge whether physician responses completely reflected what the clinicians would actually do in practice, compared with a "politically correct" response, is a potential limitation, Dr. Trope added.

Does women’s "social, economic, or education status influence referral practice?" she asked.

"Definitely, socioeconomic factors have an influence on whether people go to a high-volume center or to a gynecologic oncologist," Dr. Goff replied. "I don’t know if that is patient or physician driven."

Dr. Goff and Dr. Trope said that they had no relevant financial disclosures. The study coauthors included researchers at the Centers for Disease Control and Prevention, which provided funding for the survey.

ORLANDO – When a woman with a suspicious ovarian mass presents to a primary care physician, the majority of these doctors would not refer the patients directly to a gynecologic oncologist, even though early management by such specialists is associated with improved outcome, Dr. Barbara A. Goff said.

In all, 52% of 414 internists and 40% of 591 family physicians who responded to a mailed survey indicated that they would refer a patient with a suspicious pelvic mass directly to a gynecologic oncologist. Overall, 98% indicated that they would refer or consult with another physician, but half would initially refer to an ob.gyn., Dr. Goff said at the annual meeting of the Society of Gynecologic Oncologists.

"It’s been shown in numerous studies that women who receive their care from gynecologic oncologists have a significantly higher likelihood of receiving NCCN guidelines [recommended] therapy, optimal cytoreduction, and better overall survival," Dr. Goff said. The National Comprehensive Cancer Network (NCCN) is a consortium of 21 leading cancer centers in the United States that regularly releases and updates clinical guidelines in oncology.

The survey findings suggest a need for greater awareness of the benefits of such direct referrals and, possibly, for incentives to get internists and family physicians to refer these women more often, said Dr. Goff, director of gynecologic oncology at the University of Washington, Seattle. "Promoting direct referral to gynecologic oncologists from primary care may be the best way to increase compliance."

A total of 596 ob.gyns. also responded to the vignette-based survey. Their answers differed from those of internists and family physicians when they were asked to consider how they would manage the same hypothetical patient. The scenario was a 57-year-old woman complaining of pelvic pain and bloating for 3 weeks, whose ultrasound reveals a 10-cm, complex, right adnexal mass with solid and cystic components and increased vascularity. Patient variables such as race and insurance status were changed in different versions of the survey.

About one-third of ob.gyns. (34%) indicated that they would perform surgery themselves. These ob.gyns. were significantly more likely to work in practices that were smaller and/or located in more remote places, according to a multivariate analysis. The other 66% responded that they would consult with or refer the woman to another physician, and 96% of these ob.gyns. would involve a gynecologic oncologist.

This combination of findings – that only about half of internists and family physicians would refer directly to a gynecologic oncologist, and about one-third of ob.gyns. would perform surgery themselves – may partially explain why many women with ovarian cancer in the United States do not receive comprehensive surgical care or get treated at a high-volume center, Dr. Goff said.

"Unfortunately, recent studies show that 30%-50% of women with ovarian cancer are not receiving care from gynecologic oncologists," Dr. Goff said. For example, 44% of 31,897 stage III/IV ovarian cancers were treated by a different type of physician (Gynecol. Oncol. 2010;117:18-22). Those women who were treated by a gynecologic oncologist had a 40% improvement in overall survival.

Dr. Goff also examined this phenomenon in her study that showed that 67% of 9,963 women with ovarian cancer who were admitted received comprehensive surgery (Cancer 2007;109:2031-42).

Dr. Goff and her associates looked for significant patient and physician factors that were associated with referral to a gynecologic oncologist. Private insurance was the only significant, unadjusted patient factor. Among the internists and family physicians, significant factors included female sex, internal medicine specialty, board certification, fewer years in practice, group practice, fewer patients seen per week on average, involvement in clinical teaching, and an urban practice location.

In a multivariate logistic regression, factors that were significantly associated with an internist or family physician’s not referring directly to a gynecologic oncologist included male sex, family physician specialty, Medicaid insurance, providers with a weekly average number of patients greater than 91, solo practice, and rural location.

The 12-page survey was mailed to 3,200 primary care physicians who were randomly sampled from the AMA master file. A $20 bill was included as an incentive. The response rate was 62%.

"This is an important and provocative paper," said invited study discussant Dr. Claes Trope, head of the national gynecologic oncology center at Oslo University Hospital.

The sample size is large, there seems to be no selection bias because a random sample of physicians was surveyed, and the "62% response rate is quite impressive," she said. An inability to judge whether physician responses completely reflected what the clinicians would actually do in practice, compared with a "politically correct" response, is a potential limitation, Dr. Trope added.

Does women’s "social, economic, or education status influence referral practice?" she asked.

"Definitely, socioeconomic factors have an influence on whether people go to a high-volume center or to a gynecologic oncologist," Dr. Goff replied. "I don’t know if that is patient or physician driven."

Dr. Goff and Dr. Trope said that they had no relevant financial disclosures. The study coauthors included researchers at the Centers for Disease Control and Prevention, which provided funding for the survey.

ORLANDO – When a woman with a suspicious ovarian mass presents to a primary care physician, the majority of these doctors would not refer the patients directly to a gynecologic oncologist, even though early management by such specialists is associated with improved outcome, Dr. Barbara A. Goff said.

In all, 52% of 414 internists and 40% of 591 family physicians who responded to a mailed survey indicated that they would refer a patient with a suspicious pelvic mass directly to a gynecologic oncologist. Overall, 98% indicated that they would refer or consult with another physician, but half would initially refer to an ob.gyn., Dr. Goff said at the annual meeting of the Society of Gynecologic Oncologists.

"It’s been shown in numerous studies that women who receive their care from gynecologic oncologists have a significantly higher likelihood of receiving NCCN guidelines [recommended] therapy, optimal cytoreduction, and better overall survival," Dr. Goff said. The National Comprehensive Cancer Network (NCCN) is a consortium of 21 leading cancer centers in the United States that regularly releases and updates clinical guidelines in oncology.

The survey findings suggest a need for greater awareness of the benefits of such direct referrals and, possibly, for incentives to get internists and family physicians to refer these women more often, said Dr. Goff, director of gynecologic oncology at the University of Washington, Seattle. "Promoting direct referral to gynecologic oncologists from primary care may be the best way to increase compliance."

A total of 596 ob.gyns. also responded to the vignette-based survey. Their answers differed from those of internists and family physicians when they were asked to consider how they would manage the same hypothetical patient. The scenario was a 57-year-old woman complaining of pelvic pain and bloating for 3 weeks, whose ultrasound reveals a 10-cm, complex, right adnexal mass with solid and cystic components and increased vascularity. Patient variables such as race and insurance status were changed in different versions of the survey.

About one-third of ob.gyns. (34%) indicated that they would perform surgery themselves. These ob.gyns. were significantly more likely to work in practices that were smaller and/or located in more remote places, according to a multivariate analysis. The other 66% responded that they would consult with or refer the woman to another physician, and 96% of these ob.gyns. would involve a gynecologic oncologist.

This combination of findings – that only about half of internists and family physicians would refer directly to a gynecologic oncologist, and about one-third of ob.gyns. would perform surgery themselves – may partially explain why many women with ovarian cancer in the United States do not receive comprehensive surgical care or get treated at a high-volume center, Dr. Goff said.

"Unfortunately, recent studies show that 30%-50% of women with ovarian cancer are not receiving care from gynecologic oncologists," Dr. Goff said. For example, 44% of 31,897 stage III/IV ovarian cancers were treated by a different type of physician (Gynecol. Oncol. 2010;117:18-22). Those women who were treated by a gynecologic oncologist had a 40% improvement in overall survival.

Dr. Goff also examined this phenomenon in her study that showed that 67% of 9,963 women with ovarian cancer who were admitted received comprehensive surgery (Cancer 2007;109:2031-42).

Dr. Goff and her associates looked for significant patient and physician factors that were associated with referral to a gynecologic oncologist. Private insurance was the only significant, unadjusted patient factor. Among the internists and family physicians, significant factors included female sex, internal medicine specialty, board certification, fewer years in practice, group practice, fewer patients seen per week on average, involvement in clinical teaching, and an urban practice location.

In a multivariate logistic regression, factors that were significantly associated with an internist or family physician’s not referring directly to a gynecologic oncologist included male sex, family physician specialty, Medicaid insurance, providers with a weekly average number of patients greater than 91, solo practice, and rural location.

The 12-page survey was mailed to 3,200 primary care physicians who were randomly sampled from the AMA master file. A $20 bill was included as an incentive. The response rate was 62%.

"This is an important and provocative paper," said invited study discussant Dr. Claes Trope, head of the national gynecologic oncology center at Oslo University Hospital.

The sample size is large, there seems to be no selection bias because a random sample of physicians was surveyed, and the "62% response rate is quite impressive," she said. An inability to judge whether physician responses completely reflected what the clinicians would actually do in practice, compared with a "politically correct" response, is a potential limitation, Dr. Trope added.

Does women’s "social, economic, or education status influence referral practice?" she asked.

"Definitely, socioeconomic factors have an influence on whether people go to a high-volume center or to a gynecologic oncologist," Dr. Goff replied. "I don’t know if that is patient or physician driven."

Dr. Goff and Dr. Trope said that they had no relevant financial disclosures. The study coauthors included researchers at the Centers for Disease Control and Prevention, which provided funding for the survey.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – The dosing of growth hormone based on insulinlike growth factor–I levels is an effective strategy to help children with idiopathic short stature, based on a study that revealed significant gains in height velocity compared with controls.

"The most rational, cost-effective, and easy approach is to dial up the growth hormone [dosage] to achieve IGF-I to the upper 1 standard deviation of normal," Dr. Pinchas Cohen said. "This represents the optimal approach to this population at this time, in my mind."

The latest news regarding growth hormone is not about new agents or formulations, but about dosing strategies that more effectively deliver existing therapies, Dr. Cohen said at a symposium on IGF-I, growth hormone, and ghrelin/GHS sponsored by the University of South Florida.

Dr. Cohen and his colleagues randomized 114 children with varying levels of IGF-I deficiency to either treatment or observation. Participants were aged 3-15 years and were prepubertal; 70% were boys. The treatment group had their growth hormone dosage increased to target 1 standard deviation above the norm for IGF-I at 30, 90, 180, and 270 days, and at 1 year.

The growth hormone dosage was titrated up at each visit, unless patients were in the 66th- to 99th-percentile range. "The dose we achieved at the end of the study was quite moderate," Dr. Cohen said, "somewhat less than 60 mcg/kg per day." It was higher than the Food and Drug Administration–recommended dosage at the time, he added, although the current FDA-approved dose for idiopathic short stature (ISS) is 67 mcg/kg per day.

That resulted in a decrease in the IGF-I standard deviation score from a mean at the low range of normal (or sometimes even lower than that) to just above the mean at the end of the study. In contrast, "IGF-I essentially stays the same over time" in controls, Dr. Cohen said.

With treatment, the height velocity increased at each visit. By 90 days, the treated group of children had a growth velocity of about 10 cm/yr, and "they pretty much maintained that throughout the first year," compared with essentially no change in the control group, Dr. Cohen said. The difference was statistically significant.

In general, a dramatic rise in growth velocity at 3 months with conventional growth hormone treatment decreases somewhat at 1 year, Dr. Cohen said, but that was not the case in the current study. "Based on IGF-I dosing, we are preventing that expected small decline in the growth velocity by accelerating the dose to meet the IGF target requirement. This may be an interesting, unexpected advantage of this dosing strategy," said Dr. Cohen, professor of pediatrics at the University of California, Los Angeles, and chief of endocrinology at the Mattel Children’s Hospital UCLA.

Dr. Cohen also expressed the data in terms of gains in standard deviations of height.

"Patients start out at a mean height just below –2.5 [standard deviations], with no change at all in the untreated group and a nice rise in the growth in the treated group," Dr. Cohen said.

If patients are divided into subgroups based on their basal IGF-I –those with substantial IGF-I deficiency vs. those with normal IGF-I deficiency – "you can see [that] the degree of height gain during the study is essentially identical." Thus, in ISS patients with variable degrees of IGF deficiency, "the baseline IGF-I does not influence the response to growth hormone therapy," said Dr. Cohen, who is also the codirector of the diabetes and endocrinology research center at the University of California, San Diego/UCLA.

The study (NN2147) will be submitted for journal publication in 2011, Dr. Cohen said. He added that the findings validate and confirm his previous studies on IGF-based dosing (J. Clin. Endocrinol. Metabl. 2010;95:2089-98; J. Clin. Endocrdinol. Metab. 2007;92:2480-6).

Dr. Cohen disclosed that he is an adviser to Novo Nordisk and the Ipsen Group; is a consultant to Theratechnologies Inc. and Teva Pharmaceuticals; and receives research grants and support from Amgen, Eli Lilly, and Genentech.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.

ORLANDO – A once-weekly formulation of growth hormone was found to be noninferior to a once-daily product in a phase III study, with no significant differences in annualized height velocity at 12 months.

A total of 86 children with growth hormone deficiency were randomized to 0.5 mg/kg per week injections of long-acting growth hormone (LB03002, LG LifeSciences/Biopartners). Another 83 deficient children were randomized to injections of 0.03 mg/kg per day of somatropin (Genotropin, Pharmacia and Upjohn). All participants were prepubertal, treatment-naive, and diagnosed with idiopathic (about 90%) or organic growth hormone deficiency.

"Noninferiority to Genotropin was demonstrated," Dr. Paul Saenger said at a symposium on IGF-1, growth hormone and ghrelin/GHS, sponsored by the University of South Florida, St. Petersburg.

Annualized height velocity was the primary outcome of this open-label, parallel-group multicenter study. Mean increases at 12 months were 11.7 cm in the weekly injection group and 12.2 cm in the daily injection group.

All participants were offered a rollover into the LB03002 treatment arm for up to 24 months, and all but nine of the once-daily patients opted to continue this study extension. In the second year, annual height velocity slowed to a mean 8.3 cm increase in the once-weekly group vs. 7.3 cm in the once-daily group. There was "some attenuation as usual" after higher initial gains, as observed in most pediatric growth hormone studies, Dr. Saenger said.

Twelve-month growth rates were similar in both groups, Dr. Saenger said. A secondary parameter, gain in height standard deviations (SDs) at 1 year, was the same in each group, a mean 1.3 SDs.

"Also, we paid particular attention to bone age maturation, because it should not be faster," said Dr. Saenger, pediatric endocrinologist at Albert Einstein College of Medicine, New York. There was no difference between the two modalities so the height prediction was not affected.

Thirty patients in the LB03002 group tested positive for potentially biologically relevant anti-hGH antibodies, compared with three patients in the somatropin group. "So, while we recognize that there were antibodies, they did not seem to have an effect on growth rate or pharmacodynamic changes such as IGF-1 [insulinlike growth factor–1]," Dr. Saenger said.

Both groups showed increases in IGF-1 and IGF binding protein–3 to the normal range by 12 months, Dr. Saenger said. Also, no significant differences were observed in hemoglobin A^1c or glucose levels at 12 months between treatment arms. One patient in each group had impaired glucose tolerance.

LB03002 was "considered ultimately safe and well tolerated," Dr. Saenger said.

Local tolerability was "overall good to very good" with the once-weekly subcutaneous injection, Dr. Saenger said. Incidence of injection site reactions (for example, pain, tenderness, erythema, warmth, and swelling) was higher in patients treated with LB03002. The most common local adverse event was injection site swelling that was "often mild and transient," he said.

All five serious adverse events were considered unrelated to treatment, Dr. Saenger said. There was one report of neoplasm progression in the LB03002 arm, one report of dengue fever, and one upper respiratory tract infection in the somatropin arm, and one case of tonsillitis in each group.

Dr. Saenger said the once-weekly formulation might improve long-term adherence to growth hormone therapy. "We have ample data that daily growth hormone compliance declines, and that may affect the efficacy of this drug."

LB03002 is a sustained-release formulation of growth hormone incorporated in a matrix of sodium hyaluronate and lecithin, which are reconstituted in an oil base of medium-chain triglycerides prior to injection. The primary structure is identical to endogenous 22 kD pituitary growth hormone, Dr. Saenger said.

A long-acting growth hormone approved by the Food and Drug Administration in 1999 (Nutropin Depot, Genentech) and intended for use once every 2 weeks or once per month was withdrawn from the market in 2004. This was a business decision based on an inability of this formulation to match the clinical efficacy of once-daily growth hormone products, Dr. Saenger said.

A meeting attendee asked about bioavailability with LB03002. "The bioavailability of all the long-acting compounds is not as good as the daily [formulations]," Dr. Saenger replied. "At a dose of 0.5 mg/kg per week the bioavailability would be 67%."

Early phase II trials are currently underway to assess additional formulations of growth hormone that could be administered once every 2 weeks or monthly, Dr. Saenger said.

Dr. Saenger said that he is a consultant to LG Life Sciences/Biopartners.