Fran Lowry

HOLLYWOOD, FLA. — All women with ductal carcinoma in situ should have the choice of foregoing radiation therapy, according to updated breast cancer guidelines announced at the annual conference of the National Comprehensive Cancer Network.

Previously, the guidelines distinguished between the majority of women who have a typical ductal carcinoma in situ (DCIS) and the few women who have a very small DCIS that is less than 0.5 centimeters, unicentric, and of low grade, said Dr. Stephen B. Edge.

For that small subset of women, the guidelines had stipulated treatment by lumpectomy alone with omission of radiation therapy. All other women with DCIS were to be treated with total mastectomy without lymph node dissection or by lumpectomy plus radiation therapy.

The updated guidelines incorporate lumpectomy without radiation therapy as an option of for all women with DCIS. “This is a major change,” said Dr. Edge, interim chair of the department of surgical oncology, and chair of the department of health services and outcomes research at Roswell Park Cancer Institute in Buffalo, N.Y.

The three treatment options for early stage DCIS with no nodal involvement now comprise:

▸ Lumpectomy without lymph node surgery, plus whole breast radiation therapy (offered as a category 1 recommendation).

▸ Total mastectomy with or without sentinel node biopsy, and with or without breast reconstruction.

▸ Lumpectomy alone, with no lymph node surgery and no radiation therapy (offered as a category 2b recommendation).

The new guidelines place the onus on the physician to have a discussion with the patient as to whether or not to choose radiation therapy for DCIS, said Dr. Edge, who is also a professor of surgery at the State University of New York at Buffalo.

They also make recommendations about postmastectomy radiation, an issue neglected in past years. The breast cancer guidelines committee now urges the use of radiation therapy for women who have 1–3 positive nodes, although it stopped short of making this a category 1 recommendation.

“Previously we said patients should consider this, now we've gone so far as to say women should strongly consider radiation therapy after mastectomy,” Dr. Edge said.

Also new are recommendations on the use of breast reconstruction. The guidelines now warn that reconstruction has the potential to affect delivery of radiation therapy. In one study, 52% of women who received radiation after reconstruction had some compromise in the application of radiation, either in terms of the field or the dosing to underlying structures (Int. J. Radiat. Oncol. Biol. Phys. 2006;66:76–82).

In general, women undergoing autologous tissue reconstruction should strongly consider delaying reconstruction until after radiation, because reconstruction before radiation may lead to a worse cosmetic outcome. The guidelines advise that reconstruction before radiation can spare expansion of nonirradiated skin, but they also caution that radiation may lead to capsular contraction.

Dr. Edge said he had no financial conflicts of interest to disclose.

HOLLYWOOD, FLA. — All women with ductal carcinoma in situ should have the choice of foregoing radiation therapy, according to updated breast cancer guidelines announced at the annual conference of the National Comprehensive Cancer Network.

Previously, the guidelines distinguished between the majority of women who have a typical ductal carcinoma in situ (DCIS) and the few women who have a very small DCIS that is less than 0.5 centimeters, unicentric, and of low grade, said Dr. Stephen B. Edge.

For that small subset of women, the guidelines had stipulated treatment by lumpectomy alone with omission of radiation therapy. All other women with DCIS were to be treated with total mastectomy without lymph node dissection or by lumpectomy plus radiation therapy.

The updated guidelines incorporate lumpectomy without radiation therapy as an option of for all women with DCIS. “This is a major change,” said Dr. Edge, interim chair of the department of surgical oncology, and chair of the department of health services and outcomes research at Roswell Park Cancer Institute in Buffalo, N.Y.

The three treatment options for early stage DCIS with no nodal involvement now comprise:

▸ Lumpectomy without lymph node surgery, plus whole breast radiation therapy (offered as a category 1 recommendation).

▸ Total mastectomy with or without sentinel node biopsy, and with or without breast reconstruction.

▸ Lumpectomy alone, with no lymph node surgery and no radiation therapy (offered as a category 2b recommendation).

The new guidelines place the onus on the physician to have a discussion with the patient as to whether or not to choose radiation therapy for DCIS, said Dr. Edge, who is also a professor of surgery at the State University of New York at Buffalo.

They also make recommendations about postmastectomy radiation, an issue neglected in past years. The breast cancer guidelines committee now urges the use of radiation therapy for women who have 1–3 positive nodes, although it stopped short of making this a category 1 recommendation.

“Previously we said patients should consider this, now we've gone so far as to say women should strongly consider radiation therapy after mastectomy,” Dr. Edge said.

Also new are recommendations on the use of breast reconstruction. The guidelines now warn that reconstruction has the potential to affect delivery of radiation therapy. In one study, 52% of women who received radiation after reconstruction had some compromise in the application of radiation, either in terms of the field or the dosing to underlying structures (Int. J. Radiat. Oncol. Biol. Phys. 2006;66:76–82).

In general, women undergoing autologous tissue reconstruction should strongly consider delaying reconstruction until after radiation, because reconstruction before radiation may lead to a worse cosmetic outcome. The guidelines advise that reconstruction before radiation can spare expansion of nonirradiated skin, but they also caution that radiation may lead to capsular contraction.

Dr. Edge said he had no financial conflicts of interest to disclose.

HOLLYWOOD, FLA. — All women with ductal carcinoma in situ should have the choice of foregoing radiation therapy, according to updated breast cancer guidelines announced at the annual conference of the National Comprehensive Cancer Network.

Previously, the guidelines distinguished between the majority of women who have a typical ductal carcinoma in situ (DCIS) and the few women who have a very small DCIS that is less than 0.5 centimeters, unicentric, and of low grade, said Dr. Stephen B. Edge.

For that small subset of women, the guidelines had stipulated treatment by lumpectomy alone with omission of radiation therapy. All other women with DCIS were to be treated with total mastectomy without lymph node dissection or by lumpectomy plus radiation therapy.

The updated guidelines incorporate lumpectomy without radiation therapy as an option of for all women with DCIS. “This is a major change,” said Dr. Edge, interim chair of the department of surgical oncology, and chair of the department of health services and outcomes research at Roswell Park Cancer Institute in Buffalo, N.Y.

The three treatment options for early stage DCIS with no nodal involvement now comprise:

▸ Lumpectomy without lymph node surgery, plus whole breast radiation therapy (offered as a category 1 recommendation).

▸ Total mastectomy with or without sentinel node biopsy, and with or without breast reconstruction.

▸ Lumpectomy alone, with no lymph node surgery and no radiation therapy (offered as a category 2b recommendation).

The new guidelines place the onus on the physician to have a discussion with the patient as to whether or not to choose radiation therapy for DCIS, said Dr. Edge, who is also a professor of surgery at the State University of New York at Buffalo.

They also make recommendations about postmastectomy radiation, an issue neglected in past years. The breast cancer guidelines committee now urges the use of radiation therapy for women who have 1–3 positive nodes, although it stopped short of making this a category 1 recommendation.

“Previously we said patients should consider this, now we've gone so far as to say women should strongly consider radiation therapy after mastectomy,” Dr. Edge said.

Also new are recommendations on the use of breast reconstruction. The guidelines now warn that reconstruction has the potential to affect delivery of radiation therapy. In one study, 52% of women who received radiation after reconstruction had some compromise in the application of radiation, either in terms of the field or the dosing to underlying structures (Int. J. Radiat. Oncol. Biol. Phys. 2006;66:76–82).

In general, women undergoing autologous tissue reconstruction should strongly consider delaying reconstruction until after radiation, because reconstruction before radiation may lead to a worse cosmetic outcome. The guidelines advise that reconstruction before radiation can spare expansion of nonirradiated skin, but they also caution that radiation may lead to capsular contraction.

Dr. Edge said he had no financial conflicts of interest to disclose.

ORLANDO – In a community sample of 205 adults with chronic pain of any type, neuropathic pain was documented in almost two-thirds of those who smoked, compared with one-third of those who did not smoke, Dr. Todd G. Call reported at the annual meeting of the American Academy of Pain Medicine.

“The results were a little bit of a surprise to us, but it appears that smoking seems to confer a greater risk of neuropathic pain. We're not quite sure why that is. It's too early to say. The study really wasn't designed to look at that, but it's worth looking into further,” Dr. Call of the Mayo Medical School, Rochester, Minn., said in an interview.

Dr. Call and his colleagues sought to validate a method of screening for neuropathic pain in adults with chronic pain living in the community.

They identified a subset of adults with self-reported nerve pain, and confirmed the diagnosis according to scores on the self-reported Leeds Assessment of Neuropathic Symptoms and Signs pain scale and select ICD-9-CM codes associated with neuropathic pain on chart review.

Neuropathic pain was confirmed in 75 of the 205 patients. The remaining 130 patients had chronic, nociceptive pain. Overall, 13% of the participants smoked, but among patients in the neuropathic pain subset, 21% were smokers.

In another study from the Mayo Clinic, Dr. Susan Moeschler reported that female smokers attending the clinic's pain center had higher pain intensity scores than female nonsmokers and smoking and nonsmoking males.

Compared with 131 female nonsmokers, the 14 female smokers were more likely to be unemployed and less likely to have completed high school. Smokers also reported greater pain intensity, which was more likely to interfere with their mood, personal relationships, sleep, and enjoyment of life. Among the 85 men in the study, 22 of whom were smokers, smoking status was not related to any demographic, pain intensity, or mood interference differences.

“These findings suggest that female smokers with painful conditions have greater affective distress than other male smokers and other subsets of patients,” Dr. Moeschler said.

Dr. Call's study was supported by an unrestricted grant from AstraZeneca Pharmaceuticals LP and the U.S. National Institutes of Health. Dr. Call said he had no financial conflicts of interest.

Dr. Moeschler's study was supported by the Mayo Clinic's department of anesthesia institutional funds.

ORLANDO – In a community sample of 205 adults with chronic pain of any type, neuropathic pain was documented in almost two-thirds of those who smoked, compared with one-third of those who did not smoke, Dr. Todd G. Call reported at the annual meeting of the American Academy of Pain Medicine.

“The results were a little bit of a surprise to us, but it appears that smoking seems to confer a greater risk of neuropathic pain. We're not quite sure why that is. It's too early to say. The study really wasn't designed to look at that, but it's worth looking into further,” Dr. Call of the Mayo Medical School, Rochester, Minn., said in an interview.

Dr. Call and his colleagues sought to validate a method of screening for neuropathic pain in adults with chronic pain living in the community.

They identified a subset of adults with self-reported nerve pain, and confirmed the diagnosis according to scores on the self-reported Leeds Assessment of Neuropathic Symptoms and Signs pain scale and select ICD-9-CM codes associated with neuropathic pain on chart review.

Neuropathic pain was confirmed in 75 of the 205 patients. The remaining 130 patients had chronic, nociceptive pain. Overall, 13% of the participants smoked, but among patients in the neuropathic pain subset, 21% were smokers.

In another study from the Mayo Clinic, Dr. Susan Moeschler reported that female smokers attending the clinic's pain center had higher pain intensity scores than female nonsmokers and smoking and nonsmoking males.

Compared with 131 female nonsmokers, the 14 female smokers were more likely to be unemployed and less likely to have completed high school. Smokers also reported greater pain intensity, which was more likely to interfere with their mood, personal relationships, sleep, and enjoyment of life. Among the 85 men in the study, 22 of whom were smokers, smoking status was not related to any demographic, pain intensity, or mood interference differences.

“These findings suggest that female smokers with painful conditions have greater affective distress than other male smokers and other subsets of patients,” Dr. Moeschler said.

Dr. Call's study was supported by an unrestricted grant from AstraZeneca Pharmaceuticals LP and the U.S. National Institutes of Health. Dr. Call said he had no financial conflicts of interest.

Dr. Moeschler's study was supported by the Mayo Clinic's department of anesthesia institutional funds.

ORLANDO – In a community sample of 205 adults with chronic pain of any type, neuropathic pain was documented in almost two-thirds of those who smoked, compared with one-third of those who did not smoke, Dr. Todd G. Call reported at the annual meeting of the American Academy of Pain Medicine.

“The results were a little bit of a surprise to us, but it appears that smoking seems to confer a greater risk of neuropathic pain. We're not quite sure why that is. It's too early to say. The study really wasn't designed to look at that, but it's worth looking into further,” Dr. Call of the Mayo Medical School, Rochester, Minn., said in an interview.

Dr. Call and his colleagues sought to validate a method of screening for neuropathic pain in adults with chronic pain living in the community.

They identified a subset of adults with self-reported nerve pain, and confirmed the diagnosis according to scores on the self-reported Leeds Assessment of Neuropathic Symptoms and Signs pain scale and select ICD-9-CM codes associated with neuropathic pain on chart review.

Neuropathic pain was confirmed in 75 of the 205 patients. The remaining 130 patients had chronic, nociceptive pain. Overall, 13% of the participants smoked, but among patients in the neuropathic pain subset, 21% were smokers.

In another study from the Mayo Clinic, Dr. Susan Moeschler reported that female smokers attending the clinic's pain center had higher pain intensity scores than female nonsmokers and smoking and nonsmoking males.

Compared with 131 female nonsmokers, the 14 female smokers were more likely to be unemployed and less likely to have completed high school. Smokers also reported greater pain intensity, which was more likely to interfere with their mood, personal relationships, sleep, and enjoyment of life. Among the 85 men in the study, 22 of whom were smokers, smoking status was not related to any demographic, pain intensity, or mood interference differences.

“These findings suggest that female smokers with painful conditions have greater affective distress than other male smokers and other subsets of patients,” Dr. Moeschler said.

Dr. Call's study was supported by an unrestricted grant from AstraZeneca Pharmaceuticals LP and the U.S. National Institutes of Health. Dr. Call said he had no financial conflicts of interest.

Dr. Moeschler's study was supported by the Mayo Clinic's department of anesthesia institutional funds.

HOLLYWOOD, FLA. — Inflammatory breast cancer, which used to be covered under the National Comprehensive Cancer Network's recommendations for locally advanced breast cancer, now has separate guidelines of its own.

“Inflammatory breast cancer is a distinct pathologic entity, and it's about time we formally recognized this,” Dr. Robert W. Carlson said, announcing the new category at the annual conference of the National Comprehensive Cancer Network.

Advocates have long criticized the inclusion of this very aggressive form of breast cancer in a general breast cancer treatment algorithm. “Giving it its own set of guidelines was the right thing to do. We should have done it with or without advocacy criticism,” said Dr. Carlson, professor of medicine at Stanford (California) University and chair of the NCCN breast cancer guidelines committee.

The classic criteria defining inflammatory breast cancer are dermal edema of a third or more of the breast, erythema of a third or more of the breast, and a palpable border to the erythema. These findings are usually, but not always, associated with dermal lymphatic involvement of the tumor, he said.

Historically, inflammatory breast cancer has carried a very unfavorable prognosis, Dr. Carlson said. He added that any cellulitis of the breast that occurs in a nongravid, nonlactating woman should be assumed to be inflammatory breast cancer until a biopsy proves differently.

The new guidelines say initial staging should include a determination of estrogen-receptor (ER), progesterone-receptor (PR), and human epidermal growth factor-receptor 2 (HER2) status; a bilateral diagnostic mammogram; and ultrasound, bone scan, and computed tomography (CT) scan of the chest, abdomen, and pelvis. Once staging is completed, the guidelines suggest treatment with preoperative anthracycline-based chemotherapy with or without a taxane.

HER2 is frequently overexpressed or positive in inflammatory breast cancers. In such cases, trastuzumab (Herceptin) or a trastuzumab-containing regimen should be used, Dr. Carlson said.

If the woman responds to neoadjuvant chemotherapy (“as the vast majority do” said Dr. Carlson), the new guidelines call for a total mastectomy with level one and two axillary dissection plus radiation to the chest wall and supraclavicular regions. Delayed breast reconstruction may also be considered at this time.

After surgery and radiation, the guidelines suggest that chemotherapy be resumed, if it was not completed preoperatively. They also call for endocrine treatment for ER-positive disease. If the tumor is HER2 positive, the guidelines recommend 1 year of trastuzumab.

Dr. Carlson disclosed that he is a consultant to AstraZeneca Pharmaceuticals LP, Genomic Health, and Pfizer Inc., and that he receives grant and research support from AstraZeneca and Genentech Inc.

HOLLYWOOD, FLA. — Inflammatory breast cancer, which used to be covered under the National Comprehensive Cancer Network's recommendations for locally advanced breast cancer, now has separate guidelines of its own.

“Inflammatory breast cancer is a distinct pathologic entity, and it's about time we formally recognized this,” Dr. Robert W. Carlson said, announcing the new category at the annual conference of the National Comprehensive Cancer Network.

Advocates have long criticized the inclusion of this very aggressive form of breast cancer in a general breast cancer treatment algorithm. “Giving it its own set of guidelines was the right thing to do. We should have done it with or without advocacy criticism,” said Dr. Carlson, professor of medicine at Stanford (California) University and chair of the NCCN breast cancer guidelines committee.

The classic criteria defining inflammatory breast cancer are dermal edema of a third or more of the breast, erythema of a third or more of the breast, and a palpable border to the erythema. These findings are usually, but not always, associated with dermal lymphatic involvement of the tumor, he said.

Historically, inflammatory breast cancer has carried a very unfavorable prognosis, Dr. Carlson said. He added that any cellulitis of the breast that occurs in a nongravid, nonlactating woman should be assumed to be inflammatory breast cancer until a biopsy proves differently.

The new guidelines say initial staging should include a determination of estrogen-receptor (ER), progesterone-receptor (PR), and human epidermal growth factor-receptor 2 (HER2) status; a bilateral diagnostic mammogram; and ultrasound, bone scan, and computed tomography (CT) scan of the chest, abdomen, and pelvis. Once staging is completed, the guidelines suggest treatment with preoperative anthracycline-based chemotherapy with or without a taxane.

HER2 is frequently overexpressed or positive in inflammatory breast cancers. In such cases, trastuzumab (Herceptin) or a trastuzumab-containing regimen should be used, Dr. Carlson said.

If the woman responds to neoadjuvant chemotherapy (“as the vast majority do” said Dr. Carlson), the new guidelines call for a total mastectomy with level one and two axillary dissection plus radiation to the chest wall and supraclavicular regions. Delayed breast reconstruction may also be considered at this time.

After surgery and radiation, the guidelines suggest that chemotherapy be resumed, if it was not completed preoperatively. They also call for endocrine treatment for ER-positive disease. If the tumor is HER2 positive, the guidelines recommend 1 year of trastuzumab.

Dr. Carlson disclosed that he is a consultant to AstraZeneca Pharmaceuticals LP, Genomic Health, and Pfizer Inc., and that he receives grant and research support from AstraZeneca and Genentech Inc.

HOLLYWOOD, FLA. — Inflammatory breast cancer, which used to be covered under the National Comprehensive Cancer Network's recommendations for locally advanced breast cancer, now has separate guidelines of its own.

“Inflammatory breast cancer is a distinct pathologic entity, and it's about time we formally recognized this,” Dr. Robert W. Carlson said, announcing the new category at the annual conference of the National Comprehensive Cancer Network.

Advocates have long criticized the inclusion of this very aggressive form of breast cancer in a general breast cancer treatment algorithm. “Giving it its own set of guidelines was the right thing to do. We should have done it with or without advocacy criticism,” said Dr. Carlson, professor of medicine at Stanford (California) University and chair of the NCCN breast cancer guidelines committee.

The classic criteria defining inflammatory breast cancer are dermal edema of a third or more of the breast, erythema of a third or more of the breast, and a palpable border to the erythema. These findings are usually, but not always, associated with dermal lymphatic involvement of the tumor, he said.

Historically, inflammatory breast cancer has carried a very unfavorable prognosis, Dr. Carlson said. He added that any cellulitis of the breast that occurs in a nongravid, nonlactating woman should be assumed to be inflammatory breast cancer until a biopsy proves differently.

The new guidelines say initial staging should include a determination of estrogen-receptor (ER), progesterone-receptor (PR), and human epidermal growth factor-receptor 2 (HER2) status; a bilateral diagnostic mammogram; and ultrasound, bone scan, and computed tomography (CT) scan of the chest, abdomen, and pelvis. Once staging is completed, the guidelines suggest treatment with preoperative anthracycline-based chemotherapy with or without a taxane.

HER2 is frequently overexpressed or positive in inflammatory breast cancers. In such cases, trastuzumab (Herceptin) or a trastuzumab-containing regimen should be used, Dr. Carlson said.

If the woman responds to neoadjuvant chemotherapy (“as the vast majority do” said Dr. Carlson), the new guidelines call for a total mastectomy with level one and two axillary dissection plus radiation to the chest wall and supraclavicular regions. Delayed breast reconstruction may also be considered at this time.

After surgery and radiation, the guidelines suggest that chemotherapy be resumed, if it was not completed preoperatively. They also call for endocrine treatment for ER-positive disease. If the tumor is HER2 positive, the guidelines recommend 1 year of trastuzumab.

Dr. Carlson disclosed that he is a consultant to AstraZeneca Pharmaceuticals LP, Genomic Health, and Pfizer Inc., and that he receives grant and research support from AstraZeneca and Genentech Inc.

ORLANDO — Epidurally administered glucocorticosteroids produce a transient increase in fasting blood glucose levels in patients with diabetes, according to results from a study presented at the annual meeting of the American Academy of Pain Medicine.

In a small trial of 40 patients, fasting blood glucose levels rose significantly—about 30% above baseline—the first morning after the epidural, and remained elevated for an average of 7 days in one subset of patients, Dr. Adam Stoller of Beth Israel Deaconess Medical Center, Boston, said.

“Diabetic patients can have quite high rises in their blood sugar after such procedures. It's important to know that there is this potential for bad outcomes, especially since epidural steroid injections are the most common pain clinic procedure and there is an increasing number of diabetics in our patient population,” Dr. Stoller said in an interview.

He and his associates at Beth Israel Deaconess were prompted to study the effect of epidural steroid injections on blood sugar after one of their diabetic patients went into a ketoacidosis coma following the procedure.

“We looked in the literature to see what evidence there was about epidural steroids causing any sort of derangements in glucose, but we couldn't find any, so we decided to start this study,” he explained.

Patients were randomized to receive epidural administration of 40 mg or 80 mg of methylprednisolone acetate (Depo-Medrol). Hemoglobin A1c (HbA_1c) levels were drawn on the day of the epidural, and baseline blood sugars were obtained from the patients' glucose log, or from a glucose monitoring device. Fasting blood sugars were monitored for 2 weeks following the epidural.

Fasting blood glucose levels remained elevated for an average of 7 days in the patients who received the 80-mg dose of Depo-Medrol, and for an average of 2 days in patients who received the 40-mg dose.

The magnitude of the rise in blood sugar was correlated with HbA_1c levels at the time the injection was given, Dr. Stoller said. “The higher the hemoglobin A1c, the greater the derangement in fasting blood glucose. Hemoglobin A1c of 7[%] or greater predicted a more significant increase in blood glucose.”

Baseline fasting blood sugars did not correlate with the subsequent rise that occurred after the epidural steroids, a finding that surprised the investigators, Dr. Stoller said.

“We often use a fasting blood sugar as an indication of whether we should or should not give epidural steroids. But in this study, we found that fasting sugars had no correlation with what their rise after the epidural steroids would be. The thing that most correlated with a rise in blood sugar was the hemoglobin A1c, and levels that started at 7 were linked to the greatest rise.”

He added that there was no correlation between the change in fasting blood glucose levels and body mass index or years with diabetes.

Dr. Stoller reported no conflicts of interest.

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Epidurally administered glucocorticosteroids produce a transient increase in fasting blood glucose levels in patients with diabetes, according to results from a study presented at the annual meeting of the American Academy of Pain Medicine.

In a small trial of 40 patients, fasting blood glucose levels rose significantly—about 30% above baseline—the first morning after the epidural, and remained elevated for an average of 7 days in one subset of patients, Dr. Adam Stoller of Beth Israel Deaconess Medical Center, Boston, said.

“Diabetic patients can have quite high rises in their blood sugar after such procedures. It's important to know that there is this potential for bad outcomes, especially since epidural steroid injections are the most common pain clinic procedure and there is an increasing number of diabetics in our patient population,” Dr. Stoller said in an interview.

He and his associates at Beth Israel Deaconess were prompted to study the effect of epidural steroid injections on blood sugar after one of their diabetic patients went into a ketoacidosis coma following the procedure.

“We looked in the literature to see what evidence there was about epidural steroids causing any sort of derangements in glucose, but we couldn't find any, so we decided to start this study,” he explained.

Patients were randomized to receive epidural administration of 40 mg or 80 mg of methylprednisolone acetate (Depo-Medrol). Hemoglobin A1c (HbA_1c) levels were drawn on the day of the epidural, and baseline blood sugars were obtained from the patients' glucose log, or from a glucose monitoring device. Fasting blood sugars were monitored for 2 weeks following the epidural.

Fasting blood glucose levels remained elevated for an average of 7 days in the patients who received the 80-mg dose of Depo-Medrol, and for an average of 2 days in patients who received the 40-mg dose.

The magnitude of the rise in blood sugar was correlated with HbA_1c levels at the time the injection was given, Dr. Stoller said. “The higher the hemoglobin A1c, the greater the derangement in fasting blood glucose. Hemoglobin A1c of 7[%] or greater predicted a more significant increase in blood glucose.”

Baseline fasting blood sugars did not correlate with the subsequent rise that occurred after the epidural steroids, a finding that surprised the investigators, Dr. Stoller said.

“We often use a fasting blood sugar as an indication of whether we should or should not give epidural steroids. But in this study, we found that fasting sugars had no correlation with what their rise after the epidural steroids would be. The thing that most correlated with a rise in blood sugar was the hemoglobin A1c, and levels that started at 7 were linked to the greatest rise.”

He added that there was no correlation between the change in fasting blood glucose levels and body mass index or years with diabetes.

Dr. Stoller reported no conflicts of interest.

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Epidurally administered glucocorticosteroids produce a transient increase in fasting blood glucose levels in patients with diabetes, according to results from a study presented at the annual meeting of the American Academy of Pain Medicine.

In a small trial of 40 patients, fasting blood glucose levels rose significantly—about 30% above baseline—the first morning after the epidural, and remained elevated for an average of 7 days in one subset of patients, Dr. Adam Stoller of Beth Israel Deaconess Medical Center, Boston, said.

“Diabetic patients can have quite high rises in their blood sugar after such procedures. It's important to know that there is this potential for bad outcomes, especially since epidural steroid injections are the most common pain clinic procedure and there is an increasing number of diabetics in our patient population,” Dr. Stoller said in an interview.

He and his associates at Beth Israel Deaconess were prompted to study the effect of epidural steroid injections on blood sugar after one of their diabetic patients went into a ketoacidosis coma following the procedure.

“We looked in the literature to see what evidence there was about epidural steroids causing any sort of derangements in glucose, but we couldn't find any, so we decided to start this study,” he explained.

Patients were randomized to receive epidural administration of 40 mg or 80 mg of methylprednisolone acetate (Depo-Medrol). Hemoglobin A1c (HbA_1c) levels were drawn on the day of the epidural, and baseline blood sugars were obtained from the patients' glucose log, or from a glucose monitoring device. Fasting blood sugars were monitored for 2 weeks following the epidural.

Fasting blood glucose levels remained elevated for an average of 7 days in the patients who received the 80-mg dose of Depo-Medrol, and for an average of 2 days in patients who received the 40-mg dose.

The magnitude of the rise in blood sugar was correlated with HbA_1c levels at the time the injection was given, Dr. Stoller said. “The higher the hemoglobin A1c, the greater the derangement in fasting blood glucose. Hemoglobin A1c of 7[%] or greater predicted a more significant increase in blood glucose.”

Baseline fasting blood sugars did not correlate with the subsequent rise that occurred after the epidural steroids, a finding that surprised the investigators, Dr. Stoller said.

“We often use a fasting blood sugar as an indication of whether we should or should not give epidural steroids. But in this study, we found that fasting sugars had no correlation with what their rise after the epidural steroids would be. The thing that most correlated with a rise in blood sugar was the hemoglobin A1c, and levels that started at 7 were linked to the greatest rise.”

He added that there was no correlation between the change in fasting blood glucose levels and body mass index or years with diabetes.

Dr. Stoller reported no conflicts of interest.

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Botulinum toxin injected at the plantar fascia insertion and at the gastrocnemius-soleus complex relieved chronic plantar fasciitis pain better than did standard treatment, according to the findings of a small, randomized controlled trial.

Dr. Mehul J. Desai of George Washington University Hospital in Washington and associates randomly assigned 10 patients with chronic unilateral plantar fasciitis and a mean age of 35 years into two groups. The five patients in the experimental treatment group received 50 U of botulinum toxin type A at the plantar fascia insertion, 50 U at the motor point of the soleus muscle, and 25 U at both the medial and lateral gastrocnemius motor points. Patients in the standard treatment group received 50 U of botulinum toxin type A at the plantar fascia insertion and saline at the 3 other sites.

The patients were assessed before the injections, and at 4, 8, and 12 weeks following treatment.

At study completion, patients in the experimental treatment group went from 7.9 points on a 10-point visual analog scale to 1.9 points. By comparison, patients who received the standard treatment went from 4.4 points to 2.4 points. The difference between the two groups was significant, Dr. Desai reported at the annual meeting of the American Academy of Pain Medicine.

Gait also was substantially improved from baseline in the experimental treatment group, as shown by significant improvement in ankle and hip ranges of motion.

Limited ankle dorsiflexion, secondary to a tight gastrocnemius-soleus complex, is the most important risk factor for the development of plantar fasciitis, according to Dr. Desai. “Our hope is that instead of just treating the symptom, which is at the plantar fascia, we are also treating the tight medial and lateral gastrocnemius and soleus muscles and thereby correcting the underlying biomechanical problem.”

Dr. Desai disclosed no conflicts of interest. Funding for the study was provided by Allergan Inc., a producer of botulinum toxin type A.

Botulinum toxin type A is injected locally, at the plantar fascia insertion site (shown), and distally. Courtesy Dr. Mehul J. Desai

ORLANDO — Botulinum toxin injected at the plantar fascia insertion and at the gastrocnemius-soleus complex relieved chronic plantar fasciitis pain better than did standard treatment, according to the findings of a small, randomized controlled trial.

Dr. Mehul J. Desai of George Washington University Hospital in Washington and associates randomly assigned 10 patients with chronic unilateral plantar fasciitis and a mean age of 35 years into two groups. The five patients in the experimental treatment group received 50 U of botulinum toxin type A at the plantar fascia insertion, 50 U at the motor point of the soleus muscle, and 25 U at both the medial and lateral gastrocnemius motor points. Patients in the standard treatment group received 50 U of botulinum toxin type A at the plantar fascia insertion and saline at the 3 other sites.

The patients were assessed before the injections, and at 4, 8, and 12 weeks following treatment.

At study completion, patients in the experimental treatment group went from 7.9 points on a 10-point visual analog scale to 1.9 points. By comparison, patients who received the standard treatment went from 4.4 points to 2.4 points. The difference between the two groups was significant, Dr. Desai reported at the annual meeting of the American Academy of Pain Medicine.

Gait also was substantially improved from baseline in the experimental treatment group, as shown by significant improvement in ankle and hip ranges of motion.

Limited ankle dorsiflexion, secondary to a tight gastrocnemius-soleus complex, is the most important risk factor for the development of plantar fasciitis, according to Dr. Desai. “Our hope is that instead of just treating the symptom, which is at the plantar fascia, we are also treating the tight medial and lateral gastrocnemius and soleus muscles and thereby correcting the underlying biomechanical problem.”

Dr. Desai disclosed no conflicts of interest. Funding for the study was provided by Allergan Inc., a producer of botulinum toxin type A.

Botulinum toxin type A is injected locally, at the plantar fascia insertion site (shown), and distally. Courtesy Dr. Mehul J. Desai

ORLANDO — Botulinum toxin injected at the plantar fascia insertion and at the gastrocnemius-soleus complex relieved chronic plantar fasciitis pain better than did standard treatment, according to the findings of a small, randomized controlled trial.

Dr. Mehul J. Desai of George Washington University Hospital in Washington and associates randomly assigned 10 patients with chronic unilateral plantar fasciitis and a mean age of 35 years into two groups. The five patients in the experimental treatment group received 50 U of botulinum toxin type A at the plantar fascia insertion, 50 U at the motor point of the soleus muscle, and 25 U at both the medial and lateral gastrocnemius motor points. Patients in the standard treatment group received 50 U of botulinum toxin type A at the plantar fascia insertion and saline at the 3 other sites.

The patients were assessed before the injections, and at 4, 8, and 12 weeks following treatment.

At study completion, patients in the experimental treatment group went from 7.9 points on a 10-point visual analog scale to 1.9 points. By comparison, patients who received the standard treatment went from 4.4 points to 2.4 points. The difference between the two groups was significant, Dr. Desai reported at the annual meeting of the American Academy of Pain Medicine.

Gait also was substantially improved from baseline in the experimental treatment group, as shown by significant improvement in ankle and hip ranges of motion.

Limited ankle dorsiflexion, secondary to a tight gastrocnemius-soleus complex, is the most important risk factor for the development of plantar fasciitis, according to Dr. Desai. “Our hope is that instead of just treating the symptom, which is at the plantar fascia, we are also treating the tight medial and lateral gastrocnemius and soleus muscles and thereby correcting the underlying biomechanical problem.”

Dr. Desai disclosed no conflicts of interest. Funding for the study was provided by Allergan Inc., a producer of botulinum toxin type A.

Botulinum toxin type A is injected locally, at the plantar fascia insertion site (shown), and distally. Courtesy Dr. Mehul J. Desai

ORLANDO — Glucocorticosteroids that are epidurally administered produce a transient increase in fasting blood glucose levels in patients with diabetes, according to data presented at the annual meeting of the American Academy of Pain Medicine.

In a trial of 40 patients, fasting blood glucose levels rose significantly—about 30% above baseline—the first morning after the epidural and stayed elevated for an average of 7 days in one subset of patients, said Dr. Adam Stoller of Beth Israel Deaconess Medical Center, Boston.

“It's important to know that there is this potential for bad outcomes, especially since epidural steroid injections are the most common pain clinic procedure and there is an increasing number of diabetics,” Dr. Stoller said in an interview.

He and his associates at Beth Israel Deaconess were prompted to study the effect of epidural steroid injections on blood sugar after a diabetic patient went into a ketoacidosis coma following the procedure.

The patients were randomized to receive epidural administration of 40 mg or 80 mg of methylprednisolone acetate (Depo-Medrol). Hemoglobin A_1c (HbA_1c) levels were drawn on the day of the epidural, and baseline blood sugars were obtained from the patients' glucose log, or from a glucose monitoring device. Fasting blood sugars were monitored for 2 weeks after the epidural.

Fasting blood glucose levels were elevated for an average of 7 days in the patients who received the 80-mg dose of Depo- Medrol and for an average of 2 days in those on the 40-mg dose.

The magnitude of the rise in blood sugar was correlated with HbA_1c levels at the time of the injection, Dr. Stoller said. “The higher the hemoglobin A_1c, the greater the derangement in fasting blood glucose. Hemoglobin A_1c of 7[%] or greater predicted a more significant increase in blood glucose.”

Baseline fasting blood sugars did not correlate with the subsequent rise that occurred after the epidural steroids, which surprised the investigators.

“We often use fasting blood sugar as an indication of whether we should or should not give epidural steroids. In this study, we found fasting sugars had no correlation with what their rise after the epidural steroids would be. The thing that most correlated with a rise in blood sugar was the [HbA_1c], and levels that started at 7 were linked to the greatest rise.” Dr. Stoller said he had no conflicts of interest to report.

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Glucocorticosteroids that are epidurally administered produce a transient increase in fasting blood glucose levels in patients with diabetes, according to data presented at the annual meeting of the American Academy of Pain Medicine.

In a trial of 40 patients, fasting blood glucose levels rose significantly—about 30% above baseline—the first morning after the epidural and stayed elevated for an average of 7 days in one subset of patients, said Dr. Adam Stoller of Beth Israel Deaconess Medical Center, Boston.

“It's important to know that there is this potential for bad outcomes, especially since epidural steroid injections are the most common pain clinic procedure and there is an increasing number of diabetics,” Dr. Stoller said in an interview.

He and his associates at Beth Israel Deaconess were prompted to study the effect of epidural steroid injections on blood sugar after a diabetic patient went into a ketoacidosis coma following the procedure.

The patients were randomized to receive epidural administration of 40 mg or 80 mg of methylprednisolone acetate (Depo-Medrol). Hemoglobin A_1c (HbA_1c) levels were drawn on the day of the epidural, and baseline blood sugars were obtained from the patients' glucose log, or from a glucose monitoring device. Fasting blood sugars were monitored for 2 weeks after the epidural.

Fasting blood glucose levels were elevated for an average of 7 days in the patients who received the 80-mg dose of Depo- Medrol and for an average of 2 days in those on the 40-mg dose.

The magnitude of the rise in blood sugar was correlated with HbA_1c levels at the time of the injection, Dr. Stoller said. “The higher the hemoglobin A_1c, the greater the derangement in fasting blood glucose. Hemoglobin A_1c of 7[%] or greater predicted a more significant increase in blood glucose.”

Baseline fasting blood sugars did not correlate with the subsequent rise that occurred after the epidural steroids, which surprised the investigators.

“We often use fasting blood sugar as an indication of whether we should or should not give epidural steroids. In this study, we found fasting sugars had no correlation with what their rise after the epidural steroids would be. The thing that most correlated with a rise in blood sugar was the [HbA_1c], and levels that started at 7 were linked to the greatest rise.” Dr. Stoller said he had no conflicts of interest to report.

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Glucocorticosteroids that are epidurally administered produce a transient increase in fasting blood glucose levels in patients with diabetes, according to data presented at the annual meeting of the American Academy of Pain Medicine.

In a trial of 40 patients, fasting blood glucose levels rose significantly—about 30% above baseline—the first morning after the epidural and stayed elevated for an average of 7 days in one subset of patients, said Dr. Adam Stoller of Beth Israel Deaconess Medical Center, Boston.

“It's important to know that there is this potential for bad outcomes, especially since epidural steroid injections are the most common pain clinic procedure and there is an increasing number of diabetics,” Dr. Stoller said in an interview.

He and his associates at Beth Israel Deaconess were prompted to study the effect of epidural steroid injections on blood sugar after a diabetic patient went into a ketoacidosis coma following the procedure.

The patients were randomized to receive epidural administration of 40 mg or 80 mg of methylprednisolone acetate (Depo-Medrol). Hemoglobin A_1c (HbA_1c) levels were drawn on the day of the epidural, and baseline blood sugars were obtained from the patients' glucose log, or from a glucose monitoring device. Fasting blood sugars were monitored for 2 weeks after the epidural.

Fasting blood glucose levels were elevated for an average of 7 days in the patients who received the 80-mg dose of Depo- Medrol and for an average of 2 days in those on the 40-mg dose.

The magnitude of the rise in blood sugar was correlated with HbA_1c levels at the time of the injection, Dr. Stoller said. “The higher the hemoglobin A_1c, the greater the derangement in fasting blood glucose. Hemoglobin A_1c of 7[%] or greater predicted a more significant increase in blood glucose.”

Baseline fasting blood sugars did not correlate with the subsequent rise that occurred after the epidural steroids, which surprised the investigators.

“We often use fasting blood sugar as an indication of whether we should or should not give epidural steroids. In this study, we found fasting sugars had no correlation with what their rise after the epidural steroids would be. The thing that most correlated with a rise in blood sugar was the [HbA_1c], and levels that started at 7 were linked to the greatest rise.” Dr. Stoller said he had no conflicts of interest to report.

ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA — Women who opt for hormone therapy to ease their discomfort from hot flashes and other menopausal symptoms often do so without knowing their risk of developing adverse effects.

Now, data from the Women's Health Initiative trials of hormone therapy (HT) may help women make more informed decisions about their risk for venous thromboembolism, should they choose to resume or start hormones.

A nested case-control study from the WHI presented at the annual meeting of the American Society of Hematology has found that excessively high levels of the coagulation factor D-dimer, in the presence of HT, significantly increases a woman's risk of developing venous thrombosis.

“If your D-dimer was in the top quarter of population distribution and you were assigned to HT, your relative risk of deep vein thrombosis was increased sixfold, compared to women whose D-dimer was low and who were assigned placebo,” principal investigator Dr. Mary Cushman, professor of medicine at the University of Vermont, Burlington, said. “This means that you go from a one or two per thousand annual risk to about a 6–12 per thousand annual risk. This type of information might be helpful to women deciding for or against HT.”

Other factors that were found to be associated with an elevated venous thrombosis risk in the presence of HT included lower free protein S and plasmin-antiplasmin complex (PAP), a research-based test.

Dr. Cushman and her colleagues measured baseline levels of potential coagulation risk factors to see if they could pinpoint women at higher risk of venous thrombosis with hormones. They did a nested case-control study that measured baseline levels of these factors in 215 participants of the WHI who developed venous thrombosis, and 867 age-matched controls.

The women were all participants of two placebo-controlled double-blind randomized WHI trials evaluating the following regimens: conjugated equine estrogens alone, or estrogen plus medroxyproges-terone acetate. The mean age of the women in the analysis was 66 and ranged from 50 to 79 years.

The investigators studied procoagulant, anticoagulant, and fibrinolytic markers in blood samples that were taken at the time the women entered the WHI studies.

They found that women who had low levels of protein C, free protein S, and antithrombin, and high levels of D-dimer, PAP, and prothrombin fragment 1–2 had an elevated risk of venous thromboembolism. The highest risk was associated with women who had D-dimer in the top quartile and who were taking HT.

In an interview, Dr. Cushman cautioned that testing for D-dimer is not yet ready for prime time because there are currently no standardized tests specifically designed to gauge venous thrombosis risk.

“There are various D-dimer assays commercially available, but choosing a proper threshold and so forth among all the different commercially available assays is a challenge,” she said. “We used a particular assay in our analysis, and studies would be needed assessing other assays before using this in clinical practice.”

Nevertheless, D-dimer is a biomarker with the potential to identify 25% of women at risk for venous thromboembolism. Being able to tell those women their risk should they choose to go on HT would be very useful in helping them think carefully about the treatment, Dr. Cushman said.

She is doubtful that her results will be replicated in other studies. “In terms of confirming the findings, it's difficult because there's probably not going to be another large study like this. But this is definitely something that could be tested further. The most important take home is the translation about what we are beginning to understand about the pathophysiology and the additive nature of these coagulation factor abnormalities. The potential for clinical applicability is potentially there.”

'This type of information might be helpful to women deciding for or against' hormone therapy. DR. CUSHMAN

ATLANTA — Women who opt for hormone therapy to ease their discomfort from hot flashes and other menopausal symptoms often do so without knowing their risk of developing adverse effects.

Now, data from the Women's Health Initiative trials of hormone therapy (HT) may help women make more informed decisions about their risk for venous thromboembolism, should they choose to resume or start hormones.

A nested case-control study from the WHI presented at the annual meeting of the American Society of Hematology has found that excessively high levels of the coagulation factor D-dimer, in the presence of HT, significantly increases a woman's risk of developing venous thrombosis.

“If your D-dimer was in the top quarter of population distribution and you were assigned to HT, your relative risk of deep vein thrombosis was increased sixfold, compared to women whose D-dimer was low and who were assigned placebo,” principal investigator Dr. Mary Cushman, professor of medicine at the University of Vermont, Burlington, said. “This means that you go from a one or two per thousand annual risk to about a 6–12 per thousand annual risk. This type of information might be helpful to women deciding for or against HT.”

Other factors that were found to be associated with an elevated venous thrombosis risk in the presence of HT included lower free protein S and plasmin-antiplasmin complex (PAP), a research-based test.

Dr. Cushman and her colleagues measured baseline levels of potential coagulation risk factors to see if they could pinpoint women at higher risk of venous thrombosis with hormones. They did a nested case-control study that measured baseline levels of these factors in 215 participants of the WHI who developed venous thrombosis, and 867 age-matched controls.

The women were all participants of two placebo-controlled double-blind randomized WHI trials evaluating the following regimens: conjugated equine estrogens alone, or estrogen plus medroxyproges-terone acetate. The mean age of the women in the analysis was 66 and ranged from 50 to 79 years.

The investigators studied procoagulant, anticoagulant, and fibrinolytic markers in blood samples that were taken at the time the women entered the WHI studies.

They found that women who had low levels of protein C, free protein S, and antithrombin, and high levels of D-dimer, PAP, and prothrombin fragment 1–2 had an elevated risk of venous thromboembolism. The highest risk was associated with women who had D-dimer in the top quartile and who were taking HT.

In an interview, Dr. Cushman cautioned that testing for D-dimer is not yet ready for prime time because there are currently no standardized tests specifically designed to gauge venous thrombosis risk.

“There are various D-dimer assays commercially available, but choosing a proper threshold and so forth among all the different commercially available assays is a challenge,” she said. “We used a particular assay in our analysis, and studies would be needed assessing other assays before using this in clinical practice.”

Nevertheless, D-dimer is a biomarker with the potential to identify 25% of women at risk for venous thromboembolism. Being able to tell those women their risk should they choose to go on HT would be very useful in helping them think carefully about the treatment, Dr. Cushman said.

She is doubtful that her results will be replicated in other studies. “In terms of confirming the findings, it's difficult because there's probably not going to be another large study like this. But this is definitely something that could be tested further. The most important take home is the translation about what we are beginning to understand about the pathophysiology and the additive nature of these coagulation factor abnormalities. The potential for clinical applicability is potentially there.”

'This type of information might be helpful to women deciding for or against' hormone therapy. DR. CUSHMAN

ATLANTA — Women who opt for hormone therapy to ease their discomfort from hot flashes and other menopausal symptoms often do so without knowing their risk of developing adverse effects.

Now, data from the Women's Health Initiative trials of hormone therapy (HT) may help women make more informed decisions about their risk for venous thromboembolism, should they choose to resume or start hormones.

A nested case-control study from the WHI presented at the annual meeting of the American Society of Hematology has found that excessively high levels of the coagulation factor D-dimer, in the presence of HT, significantly increases a woman's risk of developing venous thrombosis.

“If your D-dimer was in the top quarter of population distribution and you were assigned to HT, your relative risk of deep vein thrombosis was increased sixfold, compared to women whose D-dimer was low and who were assigned placebo,” principal investigator Dr. Mary Cushman, professor of medicine at the University of Vermont, Burlington, said. “This means that you go from a one or two per thousand annual risk to about a 6–12 per thousand annual risk. This type of information might be helpful to women deciding for or against HT.”

Other factors that were found to be associated with an elevated venous thrombosis risk in the presence of HT included lower free protein S and plasmin-antiplasmin complex (PAP), a research-based test.

Dr. Cushman and her colleagues measured baseline levels of potential coagulation risk factors to see if they could pinpoint women at higher risk of venous thrombosis with hormones. They did a nested case-control study that measured baseline levels of these factors in 215 participants of the WHI who developed venous thrombosis, and 867 age-matched controls.

The women were all participants of two placebo-controlled double-blind randomized WHI trials evaluating the following regimens: conjugated equine estrogens alone, or estrogen plus medroxyproges-terone acetate. The mean age of the women in the analysis was 66 and ranged from 50 to 79 years.

The investigators studied procoagulant, anticoagulant, and fibrinolytic markers in blood samples that were taken at the time the women entered the WHI studies.

They found that women who had low levels of protein C, free protein S, and antithrombin, and high levels of D-dimer, PAP, and prothrombin fragment 1–2 had an elevated risk of venous thromboembolism. The highest risk was associated with women who had D-dimer in the top quartile and who were taking HT.

In an interview, Dr. Cushman cautioned that testing for D-dimer is not yet ready for prime time because there are currently no standardized tests specifically designed to gauge venous thrombosis risk.

“There are various D-dimer assays commercially available, but choosing a proper threshold and so forth among all the different commercially available assays is a challenge,” she said. “We used a particular assay in our analysis, and studies would be needed assessing other assays before using this in clinical practice.”

Nevertheless, D-dimer is a biomarker with the potential to identify 25% of women at risk for venous thromboembolism. Being able to tell those women their risk should they choose to go on HT would be very useful in helping them think carefully about the treatment, Dr. Cushman said.

She is doubtful that her results will be replicated in other studies. “In terms of confirming the findings, it's difficult because there's probably not going to be another large study like this. But this is definitely something that could be tested further. The most important take home is the translation about what we are beginning to understand about the pathophysiology and the additive nature of these coagulation factor abnormalities. The potential for clinical applicability is potentially there.”

'This type of information might be helpful to women deciding for or against' hormone therapy. DR. CUSHMAN

ORLANDO — Early findings from the Aspirin Esomeprazole Chemoprevention Trial indicate that therapy with aspirin and esomeprazole is safe and well tolerated for preventing the progression of Barrett's esophagus to adenocarcinoma.

Since the start of the randomized Aspirin Esomeprazole Chemoprevention Trial (AspECT) in September 2005, 1,192 (83%) of the 1,436 patients have remained on their medication, and just 33 adverse events have been reported, said the study's lead investigator Dr. Janusz Jankowski, professor of medicine, Oxford University (England), at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

AspECT is an ambitious, 10-year clinical trial being conducted in the United Kingdom. The investigators are still recruiting to meet their goal of 3,000 patients. The trial's primary aim is to determine whether treatment with the proton pump inhibitor esomeprazole (Nexium, AstraZeneca) and aspirin can stop Barrett's metaplasia from progressing to adenocarcinoma.

The investigators are also trying to determine whether this therapy will prevent or reduce myocardial infarction.

The United Kingdom is fertile ground for such a study, Dr. Jankowski said at the symposium, also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

“The U.K. has the highest incidence of esophageal adenocarcinoma in the world—up to four times greater than that of other countries in Europe. Barrett's metaplasia is twice as common in the U.K. as it is in the United States,” he said in an interview.

Being able to show that aspirin “is incredibly well tolerated” is very gratifying, Dr. Jankowski said, because many people were skeptical that it could be done.

“One of the major criticisms of the study when we tried to get it funded in the first place was that people thought we were mad and dangerous, and that we would kill patients with low-dose aspirin. But about 90% of our patients are still on low-dose aspirin and esomeprazole 2 years into the study with hardly any adverse events, showing the drug combination is very well tolerated.”

So far, 12% of patients randomized to 20 mg esomeprazole have required an increase to 40 mg for symptom control, Dr. Jankowski said.

Besides conversion to high-grade dysplasia or cancer, the other primary end point of the study is all-cause mortality.

Additionally, it will look at the pharmacokinetics of aspirin resistance, genetic markers as potential risk factors for esophageal cancer, and quality of life.

The first planned efficacy analysis is scheduled for 2010, a second interim analysis is due in 2012, and the final analysis is due in 2016.

The trial is funded by Cancer Research UK, Oxford University, and AstraZeneca.

Dr. Jankowski disclosed that he is a consultant to and receives research funding from AstraZeneca.

Being able to show that aspirin 'is incredibly well tolerated' is very gratifying because many people were skeptical. DR. JANKOWSKI

ORLANDO — Early findings from the Aspirin Esomeprazole Chemoprevention Trial indicate that therapy with aspirin and esomeprazole is safe and well tolerated for preventing the progression of Barrett's esophagus to adenocarcinoma.

Since the start of the randomized Aspirin Esomeprazole Chemoprevention Trial (AspECT) in September 2005, 1,192 (83%) of the 1,436 patients have remained on their medication, and just 33 adverse events have been reported, said the study's lead investigator Dr. Janusz Jankowski, professor of medicine, Oxford University (England), at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

AspECT is an ambitious, 10-year clinical trial being conducted in the United Kingdom. The investigators are still recruiting to meet their goal of 3,000 patients. The trial's primary aim is to determine whether treatment with the proton pump inhibitor esomeprazole (Nexium, AstraZeneca) and aspirin can stop Barrett's metaplasia from progressing to adenocarcinoma.

The investigators are also trying to determine whether this therapy will prevent or reduce myocardial infarction.

The United Kingdom is fertile ground for such a study, Dr. Jankowski said at the symposium, also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

“The U.K. has the highest incidence of esophageal adenocarcinoma in the world—up to four times greater than that of other countries in Europe. Barrett's metaplasia is twice as common in the U.K. as it is in the United States,” he said in an interview.

Being able to show that aspirin “is incredibly well tolerated” is very gratifying, Dr. Jankowski said, because many people were skeptical that it could be done.

“One of the major criticisms of the study when we tried to get it funded in the first place was that people thought we were mad and dangerous, and that we would kill patients with low-dose aspirin. But about 90% of our patients are still on low-dose aspirin and esomeprazole 2 years into the study with hardly any adverse events, showing the drug combination is very well tolerated.”

So far, 12% of patients randomized to 20 mg esomeprazole have required an increase to 40 mg for symptom control, Dr. Jankowski said.

Besides conversion to high-grade dysplasia or cancer, the other primary end point of the study is all-cause mortality.

Additionally, it will look at the pharmacokinetics of aspirin resistance, genetic markers as potential risk factors for esophageal cancer, and quality of life.

The first planned efficacy analysis is scheduled for 2010, a second interim analysis is due in 2012, and the final analysis is due in 2016.

The trial is funded by Cancer Research UK, Oxford University, and AstraZeneca.

Dr. Jankowski disclosed that he is a consultant to and receives research funding from AstraZeneca.

Being able to show that aspirin 'is incredibly well tolerated' is very gratifying because many people were skeptical. DR. JANKOWSKI

ORLANDO — Early findings from the Aspirin Esomeprazole Chemoprevention Trial indicate that therapy with aspirin and esomeprazole is safe and well tolerated for preventing the progression of Barrett's esophagus to adenocarcinoma.

Since the start of the randomized Aspirin Esomeprazole Chemoprevention Trial (AspECT) in September 2005, 1,192 (83%) of the 1,436 patients have remained on their medication, and just 33 adverse events have been reported, said the study's lead investigator Dr. Janusz Jankowski, professor of medicine, Oxford University (England), at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

AspECT is an ambitious, 10-year clinical trial being conducted in the United Kingdom. The investigators are still recruiting to meet their goal of 3,000 patients. The trial's primary aim is to determine whether treatment with the proton pump inhibitor esomeprazole (Nexium, AstraZeneca) and aspirin can stop Barrett's metaplasia from progressing to adenocarcinoma.

The investigators are also trying to determine whether this therapy will prevent or reduce myocardial infarction.

The United Kingdom is fertile ground for such a study, Dr. Jankowski said at the symposium, also sponsored by the AGA Institute, the American Society for Therapeutic Radiology and Oncology, and the Society of Surgical Oncology.

“The U.K. has the highest incidence of esophageal adenocarcinoma in the world—up to four times greater than that of other countries in Europe. Barrett's metaplasia is twice as common in the U.K. as it is in the United States,” he said in an interview.

Being able to show that aspirin “is incredibly well tolerated” is very gratifying, Dr. Jankowski said, because many people were skeptical that it could be done.

“One of the major criticisms of the study when we tried to get it funded in the first place was that people thought we were mad and dangerous, and that we would kill patients with low-dose aspirin. But about 90% of our patients are still on low-dose aspirin and esomeprazole 2 years into the study with hardly any adverse events, showing the drug combination is very well tolerated.”

So far, 12% of patients randomized to 20 mg esomeprazole have required an increase to 40 mg for symptom control, Dr. Jankowski said.

Besides conversion to high-grade dysplasia or cancer, the other primary end point of the study is all-cause mortality.

Additionally, it will look at the pharmacokinetics of aspirin resistance, genetic markers as potential risk factors for esophageal cancer, and quality of life.

The first planned efficacy analysis is scheduled for 2010, a second interim analysis is due in 2012, and the final analysis is due in 2016.

The trial is funded by Cancer Research UK, Oxford University, and AstraZeneca.

Dr. Jankowski disclosed that he is a consultant to and receives research funding from AstraZeneca.

Being able to show that aspirin 'is incredibly well tolerated' is very gratifying because many people were skeptical. DR. JANKOWSKI

ORLANDO — Most colorectal cancer patients who undergo potentially curative resection of their tumors after age 65 do not receive the follow-up care that is recommended in clinical practice guidelines, according to the results of a large, population-based study.

Follow-up fell short in 74% of survivors, with the greatest lapse seen in carcinoembryonic antigen (CEA) testing, which is done to detect recurrent colon cancer.

Just 30% of survivors had their CEA concentrations measured twice a year, Dr. Gregory S. Cooper reported at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

Dr. Cooper of University Hospitals Case Medical Center, Cleveland, mined the linked Surveillance Epidemiology and End Results (SEER)-Medicare database to obtain the information used in the study.

He and his colleagues analyzed data on a total of 9,246 patients older than 65 years with local or regional colorectal cancer that was diagnosed in 2000 and 2001. All of the patients had their cancer resected with curative intent. The mean age of the patients was 77 years; 55% were female, and 87% were white.

About 76% of the tumors were located in the colon, and the remainder were located in the rectum. Likewise, 60% of cancers were local and the rest were regional. Patients who died within 3.5 years of diagnosis were excluded, as were those diagnosed with carcinoma in situ.

Medicare claims identified procedures performed between 6 and 42 months after diagnosis. These included office visits, colonoscopy, CT or PET scans, and CEA testing.

Patients were deemed to have been treated according to American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines if they had at least two office visits per year, at least two CEA tests per year, at least one colonoscopy within 3 years of their resection, and a yearly CT scan for any poorly differentiated cancer.

Patients were judged to be treated in excess of the guidelines if they had CT scans for tumors that were not poorly differentiated and if they had PET scans, which are not routinely recommended.

Dr. Cooper and his colleagues found just 30% of patients had the requisite testing for CEA; 74% had a colonoscopy within 3 years, and 90% had office visits according to the recommended schedule. Forty-eight percent had CT scans, only half of which were done for poorly differentiated cancer. Seven percent had PET scans.

In all, 74% of patients failed to get the follow-up care that the guidelines recommended, 16% received care that exceeded the guidelines, and only 10% received care that met the guidelines. Patients tended to get appropriate care if they were younger, female, and had lymph node involvement at diagnosis. Older patients were less likely to receive follow-up care in accordance with the guidelines.

“This bias might have been physician driven, where the physician feels that the patient is very [elderly], and so what are they going to do with the information if they find a recurrence,” Dr. Cooper suggested in an interview at the symposium.

There also was some geographic variation in adherence to the guidelines, with the West coast being less compliant than the East coast, he said.

The study was supported by the American Cancer Society. Dr. Cooper said he had no conflicts of interest to disclose.

Just 30% of patients had the requisite testing for CEA, and only 74% had a colonoscopy within 3 years. DR. COOPER

ORLANDO — Most colorectal cancer patients who undergo potentially curative resection of their tumors after age 65 do not receive the follow-up care that is recommended in clinical practice guidelines, according to the results of a large, population-based study.

Follow-up fell short in 74% of survivors, with the greatest lapse seen in carcinoembryonic antigen (CEA) testing, which is done to detect recurrent colon cancer.

Just 30% of survivors had their CEA concentrations measured twice a year, Dr. Gregory S. Cooper reported at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

Dr. Cooper of University Hospitals Case Medical Center, Cleveland, mined the linked Surveillance Epidemiology and End Results (SEER)-Medicare database to obtain the information used in the study.

He and his colleagues analyzed data on a total of 9,246 patients older than 65 years with local or regional colorectal cancer that was diagnosed in 2000 and 2001. All of the patients had their cancer resected with curative intent. The mean age of the patients was 77 years; 55% were female, and 87% were white.

About 76% of the tumors were located in the colon, and the remainder were located in the rectum. Likewise, 60% of cancers were local and the rest were regional. Patients who died within 3.5 years of diagnosis were excluded, as were those diagnosed with carcinoma in situ.

Medicare claims identified procedures performed between 6 and 42 months after diagnosis. These included office visits, colonoscopy, CT or PET scans, and CEA testing.

Patients were deemed to have been treated according to American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines if they had at least two office visits per year, at least two CEA tests per year, at least one colonoscopy within 3 years of their resection, and a yearly CT scan for any poorly differentiated cancer.

Patients were judged to be treated in excess of the guidelines if they had CT scans for tumors that were not poorly differentiated and if they had PET scans, which are not routinely recommended.

Dr. Cooper and his colleagues found just 30% of patients had the requisite testing for CEA; 74% had a colonoscopy within 3 years, and 90% had office visits according to the recommended schedule. Forty-eight percent had CT scans, only half of which were done for poorly differentiated cancer. Seven percent had PET scans.

In all, 74% of patients failed to get the follow-up care that the guidelines recommended, 16% received care that exceeded the guidelines, and only 10% received care that met the guidelines. Patients tended to get appropriate care if they were younger, female, and had lymph node involvement at diagnosis. Older patients were less likely to receive follow-up care in accordance with the guidelines.

“This bias might have been physician driven, where the physician feels that the patient is very [elderly], and so what are they going to do with the information if they find a recurrence,” Dr. Cooper suggested in an interview at the symposium.

There also was some geographic variation in adherence to the guidelines, with the West coast being less compliant than the East coast, he said.

The study was supported by the American Cancer Society. Dr. Cooper said he had no conflicts of interest to disclose.

Just 30% of patients had the requisite testing for CEA, and only 74% had a colonoscopy within 3 years. DR. COOPER

ORLANDO — Most colorectal cancer patients who undergo potentially curative resection of their tumors after age 65 do not receive the follow-up care that is recommended in clinical practice guidelines, according to the results of a large, population-based study.

Follow-up fell short in 74% of survivors, with the greatest lapse seen in carcinoembryonic antigen (CEA) testing, which is done to detect recurrent colon cancer.

Just 30% of survivors had their CEA concentrations measured twice a year, Dr. Gregory S. Cooper reported at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

Dr. Cooper of University Hospitals Case Medical Center, Cleveland, mined the linked Surveillance Epidemiology and End Results (SEER)-Medicare database to obtain the information used in the study.

He and his colleagues analyzed data on a total of 9,246 patients older than 65 years with local or regional colorectal cancer that was diagnosed in 2000 and 2001. All of the patients had their cancer resected with curative intent. The mean age of the patients was 77 years; 55% were female, and 87% were white.

About 76% of the tumors were located in the colon, and the remainder were located in the rectum. Likewise, 60% of cancers were local and the rest were regional. Patients who died within 3.5 years of diagnosis were excluded, as were those diagnosed with carcinoma in situ.

Medicare claims identified procedures performed between 6 and 42 months after diagnosis. These included office visits, colonoscopy, CT or PET scans, and CEA testing.

Patients were deemed to have been treated according to American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines if they had at least two office visits per year, at least two CEA tests per year, at least one colonoscopy within 3 years of their resection, and a yearly CT scan for any poorly differentiated cancer.

Patients were judged to be treated in excess of the guidelines if they had CT scans for tumors that were not poorly differentiated and if they had PET scans, which are not routinely recommended.

Dr. Cooper and his colleagues found just 30% of patients had the requisite testing for CEA; 74% had a colonoscopy within 3 years, and 90% had office visits according to the recommended schedule. Forty-eight percent had CT scans, only half of which were done for poorly differentiated cancer. Seven percent had PET scans.

In all, 74% of patients failed to get the follow-up care that the guidelines recommended, 16% received care that exceeded the guidelines, and only 10% received care that met the guidelines. Patients tended to get appropriate care if they were younger, female, and had lymph node involvement at diagnosis. Older patients were less likely to receive follow-up care in accordance with the guidelines.

“This bias might have been physician driven, where the physician feels that the patient is very [elderly], and so what are they going to do with the information if they find a recurrence,” Dr. Cooper suggested in an interview at the symposium.

There also was some geographic variation in adherence to the guidelines, with the West coast being less compliant than the East coast, he said.

The study was supported by the American Cancer Society. Dr. Cooper said he had no conflicts of interest to disclose.

Just 30% of patients had the requisite testing for CEA, and only 74% had a colonoscopy within 3 years. DR. COOPER

ORLANDO — Resection of colorectal cancer metastases in the liver was associated with good long-term survival among patients over age 70 years in an analysis based on 20 years of data from an international registry.

Five-year survival after surgery was 37% in a cohort of 729 patients aged 70 years and older and 44% in patients younger than 70 years. The variations in survival, however, appeared to be associated primarily with the type of disease present rather than solely attributable to patient age, according to lead author Dr. René Adam of Hôpital Paul Brousse, Villejuif, France. Further, 5-year survival rates after resection were not different between patients aged 70–75 years, 76–80 years, and 81 years or older.

Perioperative mortality was 4% in the older group and 2% in the younger group, but selecting candidates for resection based on predictive risk factors would balance some of the risks of surgery, according to Dr. Adam, who presented the data as a poster at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

Further, given the slightly higher rate of curative hepatectomy in the elderly group, “doing liver resection in these patients is definitely worthwhile,” Dr. Adam concluded.

He and his colleagues analyzed the LiverMetSurvey registry of patients undergoing surgery for colorectal liver metastases from January 1986 to July 2006. The registry prospectively collected data on 3,662 patients who had resections at 36 centers in 11 countries. Of the 729 patients who were 70 years or older, 463 were 70–75 years; 194 were 75–80 years, and 72 were 80 years or more.

The cohort of elderly patients was compared with the younger population. A multivariate analysis was performed to determine which factors were predictive of survival after resection. Tumor size exceeded 50 cm in 204 (28%) of the elderly patients, compared with 675 (23%) of younger patients. Multinodular disease (at least 3 hepatic nodules) was present in 675 (23%) of the younger patients and 80 (11%) of the older patients. Rates of concomitant extrahepatic disease were similar, 5% in the elderly group and 7% in the younger patients.

Elderly patients had a slightly higher rate of curative hepatectomy, 94%, vs. 91% for younger patients. Further, recurrent disease was less common in the elderly patients; 34% of elderly patients and 43% of the younger group had recurrent disease after a mean follow-up of 32 months.

Factors that predicted poor survival in the elderly cohort were synchronous metastases (relative risk 1.5, 95% confidence interval 1.1 to 2.0, P = .01); bilateral distribution (RR 1.5, 95% CI 1.1 to 2.0, P = .01) and extrahepatic disease (RR 2.1, 95% CI 1.2 to 3.8, P = .009).

Dr. Adam disclosed that he had no relevant conflicts of interest to declare.

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Resection of colorectal cancer metastases in the liver was associated with good long-term survival among patients over age 70 years in an analysis based on 20 years of data from an international registry.

Five-year survival after surgery was 37% in a cohort of 729 patients aged 70 years and older and 44% in patients younger than 70 years. The variations in survival, however, appeared to be associated primarily with the type of disease present rather than solely attributable to patient age, according to lead author Dr. René Adam of Hôpital Paul Brousse, Villejuif, France. Further, 5-year survival rates after resection were not different between patients aged 70–75 years, 76–80 years, and 81 years or older.

Perioperative mortality was 4% in the older group and 2% in the younger group, but selecting candidates for resection based on predictive risk factors would balance some of the risks of surgery, according to Dr. Adam, who presented the data as a poster at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

Further, given the slightly higher rate of curative hepatectomy in the elderly group, “doing liver resection in these patients is definitely worthwhile,” Dr. Adam concluded.

He and his colleagues analyzed the LiverMetSurvey registry of patients undergoing surgery for colorectal liver metastases from January 1986 to July 2006. The registry prospectively collected data on 3,662 patients who had resections at 36 centers in 11 countries. Of the 729 patients who were 70 years or older, 463 were 70–75 years; 194 were 75–80 years, and 72 were 80 years or more.

The cohort of elderly patients was compared with the younger population. A multivariate analysis was performed to determine which factors were predictive of survival after resection. Tumor size exceeded 50 cm in 204 (28%) of the elderly patients, compared with 675 (23%) of younger patients. Multinodular disease (at least 3 hepatic nodules) was present in 675 (23%) of the younger patients and 80 (11%) of the older patients. Rates of concomitant extrahepatic disease were similar, 5% in the elderly group and 7% in the younger patients.

Elderly patients had a slightly higher rate of curative hepatectomy, 94%, vs. 91% for younger patients. Further, recurrent disease was less common in the elderly patients; 34% of elderly patients and 43% of the younger group had recurrent disease after a mean follow-up of 32 months.

Factors that predicted poor survival in the elderly cohort were synchronous metastases (relative risk 1.5, 95% confidence interval 1.1 to 2.0, P = .01); bilateral distribution (RR 1.5, 95% CI 1.1 to 2.0, P = .01) and extrahepatic disease (RR 2.1, 95% CI 1.2 to 3.8, P = .009).

Dr. Adam disclosed that he had no relevant conflicts of interest to declare.

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Resection of colorectal cancer metastases in the liver was associated with good long-term survival among patients over age 70 years in an analysis based on 20 years of data from an international registry.

Five-year survival after surgery was 37% in a cohort of 729 patients aged 70 years and older and 44% in patients younger than 70 years. The variations in survival, however, appeared to be associated primarily with the type of disease present rather than solely attributable to patient age, according to lead author Dr. René Adam of Hôpital Paul Brousse, Villejuif, France. Further, 5-year survival rates after resection were not different between patients aged 70–75 years, 76–80 years, and 81 years or older.

Perioperative mortality was 4% in the older group and 2% in the younger group, but selecting candidates for resection based on predictive risk factors would balance some of the risks of surgery, according to Dr. Adam, who presented the data as a poster at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology.

Further, given the slightly higher rate of curative hepatectomy in the elderly group, “doing liver resection in these patients is definitely worthwhile,” Dr. Adam concluded.

He and his colleagues analyzed the LiverMetSurvey registry of patients undergoing surgery for colorectal liver metastases from January 1986 to July 2006. The registry prospectively collected data on 3,662 patients who had resections at 36 centers in 11 countries. Of the 729 patients who were 70 years or older, 463 were 70–75 years; 194 were 75–80 years, and 72 were 80 years or more.

The cohort of elderly patients was compared with the younger population. A multivariate analysis was performed to determine which factors were predictive of survival after resection. Tumor size exceeded 50 cm in 204 (28%) of the elderly patients, compared with 675 (23%) of younger patients. Multinodular disease (at least 3 hepatic nodules) was present in 675 (23%) of the younger patients and 80 (11%) of the older patients. Rates of concomitant extrahepatic disease were similar, 5% in the elderly group and 7% in the younger patients.

Elderly patients had a slightly higher rate of curative hepatectomy, 94%, vs. 91% for younger patients. Further, recurrent disease was less common in the elderly patients; 34% of elderly patients and 43% of the younger group had recurrent disease after a mean follow-up of 32 months.

Factors that predicted poor survival in the elderly cohort were synchronous metastases (relative risk 1.5, 95% confidence interval 1.1 to 2.0, P = .01); bilateral distribution (RR 1.5, 95% CI 1.1 to 2.0, P = .01) and extrahepatic disease (RR 2.1, 95% CI 1.2 to 3.8, P = .009).

Dr. Adam disclosed that he had no relevant conflicts of interest to declare.

ELSEVIER GLOBAL MEDICAL NEWS