Sharon Worcester

ATLANTA — A retrospective analysis of data from nearly 4,000 patients treated with intravenous bisphosphonates suggests that osteonecrosis of the jaw in patients with metastatic cancer is an important but rare event in these patients, Dr. Ana O. Hoff reported in a poster at the annual meeting of the American Society of Clinical Oncology.

Reports of an association between bisphosphonate treatment and osteonecrosis of the jaw (ONJ) in patients with metastatic bone disease prompted this study examining the frequency of and risk factors for ONJ, explained Dr. Hoff of the University of Texas M.D. Anderson Cancer Center, Houston.

The cohort that was studied included patients treated from September 1996 to February 2004. The most common diagnoses were breast cancer (in more than 1,300 patients) and multiple myeloma (in 550 patients), and the indications for intravenous bisphosphonate treatment included metastatic bone disease, hypercalcemia, and osteoporosis. ONJ, which developed in 29 patients (0.73% overall, including about 1% of breast cancer patients and 2% of multiple myeloma patients), was defined as exposed nonhealing bone of at least 3 months' duration.

Mean cumulative doses of the bisphosphonates used (pamidronate and zoledronate) were significantly higher, and duration of disease and follow-up were significantly longer, in ONJ patients than in those who didn't develop ONJ.

Dental extractions, estrogen-receptor-positive tumors, and treatment with pamidronate and zoledronate were shown to be significant risk factors for ONJ in breast cancer patients. In multiple myeloma patients, significant risk factors were dental extractions, periodontal disease, and osteoporosis.

About 70% of ONJ patients reported no pain with bone exposure, Dr. Hoff noted.

Management of patients with ONJ included aggressive oral hygiene, oral rinses, debridement of necrotic bone, and antibiotic therapy.

ONJ Rate Higher In White Patients

White cancer patients on intravenous bisphosphonate therapy for bone metastases may be at higher risk for osteonecrosis of the jaw (ONJ), Dr. Tamer Aiti reported in a poster at the ASCOmeeting. (See story above.)

A retrospective study by Dr. Aiti and colleagues at John H. Stroger Jr. Cook County Hospital, Chicago, found that 6 (3.7%) of 161 patients with metastatic breast cancer developed ONJ. Five of the six patients were white, yet whites accounted for less than a third of the population reviewed. All but 29 patients were nonwhite.

The investigators calculated that white patients had significantly more bisphosphonate infusions, 21 on average, compared with a mean of 13.5 infusions in nonwhite patients. Logistic regression analysis established that significantly more whites developed ONJ even after the study investigators controlled for dose (odds ratio 45.7).

The patients were treated with zoledronic acid and/or pamidronate between Jan. 1, 2001, and Oct. 30, 2005. None had prior glucocorticosteroid therapy.

As of Dec. 30, 2005, only two patients had resolution of their ONJ. Three patients had exposed bone—two with intermittent pain and one with chronic pain. The lone African American patient with the complication developed sepsis and died.

Dr. Aiti, of the department of surgical oncology at the University of Illinois at Chicago, called for larger studies to consider not only race but also confounding variables such as type of bisphosphonate therapy and cumulative dose, as well as other possible risk factors. Dr. Aiti and his colleagues also urged prospective imaging of high-risk patients, doing oral surgery before bisphosphonate treatment, and surveillance for ONJ.

— Jane Salodof MacNeil

ATLANTA — A retrospective analysis of data from nearly 4,000 patients treated with intravenous bisphosphonates suggests that osteonecrosis of the jaw in patients with metastatic cancer is an important but rare event in these patients, Dr. Ana O. Hoff reported in a poster at the annual meeting of the American Society of Clinical Oncology.

Reports of an association between bisphosphonate treatment and osteonecrosis of the jaw (ONJ) in patients with metastatic bone disease prompted this study examining the frequency of and risk factors for ONJ, explained Dr. Hoff of the University of Texas M.D. Anderson Cancer Center, Houston.

The cohort that was studied included patients treated from September 1996 to February 2004. The most common diagnoses were breast cancer (in more than 1,300 patients) and multiple myeloma (in 550 patients), and the indications for intravenous bisphosphonate treatment included metastatic bone disease, hypercalcemia, and osteoporosis. ONJ, which developed in 29 patients (0.73% overall, including about 1% of breast cancer patients and 2% of multiple myeloma patients), was defined as exposed nonhealing bone of at least 3 months' duration.

Mean cumulative doses of the bisphosphonates used (pamidronate and zoledronate) were significantly higher, and duration of disease and follow-up were significantly longer, in ONJ patients than in those who didn't develop ONJ.

Dental extractions, estrogen-receptor-positive tumors, and treatment with pamidronate and zoledronate were shown to be significant risk factors for ONJ in breast cancer patients. In multiple myeloma patients, significant risk factors were dental extractions, periodontal disease, and osteoporosis.

About 70% of ONJ patients reported no pain with bone exposure, Dr. Hoff noted.

Management of patients with ONJ included aggressive oral hygiene, oral rinses, debridement of necrotic bone, and antibiotic therapy.

ONJ Rate Higher In White Patients

White cancer patients on intravenous bisphosphonate therapy for bone metastases may be at higher risk for osteonecrosis of the jaw (ONJ), Dr. Tamer Aiti reported in a poster at the ASCOmeeting. (See story above.)

A retrospective study by Dr. Aiti and colleagues at John H. Stroger Jr. Cook County Hospital, Chicago, found that 6 (3.7%) of 161 patients with metastatic breast cancer developed ONJ. Five of the six patients were white, yet whites accounted for less than a third of the population reviewed. All but 29 patients were nonwhite.

The investigators calculated that white patients had significantly more bisphosphonate infusions, 21 on average, compared with a mean of 13.5 infusions in nonwhite patients. Logistic regression analysis established that significantly more whites developed ONJ even after the study investigators controlled for dose (odds ratio 45.7).

The patients were treated with zoledronic acid and/or pamidronate between Jan. 1, 2001, and Oct. 30, 2005. None had prior glucocorticosteroid therapy.

As of Dec. 30, 2005, only two patients had resolution of their ONJ. Three patients had exposed bone—two with intermittent pain and one with chronic pain. The lone African American patient with the complication developed sepsis and died.

Dr. Aiti, of the department of surgical oncology at the University of Illinois at Chicago, called for larger studies to consider not only race but also confounding variables such as type of bisphosphonate therapy and cumulative dose, as well as other possible risk factors. Dr. Aiti and his colleagues also urged prospective imaging of high-risk patients, doing oral surgery before bisphosphonate treatment, and surveillance for ONJ.

— Jane Salodof MacNeil

ATLANTA — A retrospective analysis of data from nearly 4,000 patients treated with intravenous bisphosphonates suggests that osteonecrosis of the jaw in patients with metastatic cancer is an important but rare event in these patients, Dr. Ana O. Hoff reported in a poster at the annual meeting of the American Society of Clinical Oncology.

Reports of an association between bisphosphonate treatment and osteonecrosis of the jaw (ONJ) in patients with metastatic bone disease prompted this study examining the frequency of and risk factors for ONJ, explained Dr. Hoff of the University of Texas M.D. Anderson Cancer Center, Houston.

The cohort that was studied included patients treated from September 1996 to February 2004. The most common diagnoses were breast cancer (in more than 1,300 patients) and multiple myeloma (in 550 patients), and the indications for intravenous bisphosphonate treatment included metastatic bone disease, hypercalcemia, and osteoporosis. ONJ, which developed in 29 patients (0.73% overall, including about 1% of breast cancer patients and 2% of multiple myeloma patients), was defined as exposed nonhealing bone of at least 3 months' duration.

Mean cumulative doses of the bisphosphonates used (pamidronate and zoledronate) were significantly higher, and duration of disease and follow-up were significantly longer, in ONJ patients than in those who didn't develop ONJ.

Dental extractions, estrogen-receptor-positive tumors, and treatment with pamidronate and zoledronate were shown to be significant risk factors for ONJ in breast cancer patients. In multiple myeloma patients, significant risk factors were dental extractions, periodontal disease, and osteoporosis.

About 70% of ONJ patients reported no pain with bone exposure, Dr. Hoff noted.

Management of patients with ONJ included aggressive oral hygiene, oral rinses, debridement of necrotic bone, and antibiotic therapy.

ONJ Rate Higher In White Patients

White cancer patients on intravenous bisphosphonate therapy for bone metastases may be at higher risk for osteonecrosis of the jaw (ONJ), Dr. Tamer Aiti reported in a poster at the ASCOmeeting. (See story above.)

A retrospective study by Dr. Aiti and colleagues at John H. Stroger Jr. Cook County Hospital, Chicago, found that 6 (3.7%) of 161 patients with metastatic breast cancer developed ONJ. Five of the six patients were white, yet whites accounted for less than a third of the population reviewed. All but 29 patients were nonwhite.

The investigators calculated that white patients had significantly more bisphosphonate infusions, 21 on average, compared with a mean of 13.5 infusions in nonwhite patients. Logistic regression analysis established that significantly more whites developed ONJ even after the study investigators controlled for dose (odds ratio 45.7).

The patients were treated with zoledronic acid and/or pamidronate between Jan. 1, 2001, and Oct. 30, 2005. None had prior glucocorticosteroid therapy.

As of Dec. 30, 2005, only two patients had resolution of their ONJ. Three patients had exposed bone—two with intermittent pain and one with chronic pain. The lone African American patient with the complication developed sepsis and died.

Dr. Aiti, of the department of surgical oncology at the University of Illinois at Chicago, called for larger studies to consider not only race but also confounding variables such as type of bisphosphonate therapy and cumulative dose, as well as other possible risk factors. Dr. Aiti and his colleagues also urged prospective imaging of high-risk patients, doing oral surgery before bisphosphonate treatment, and surveillance for ONJ.

— Jane Salodof MacNeil

ATLANTA — Herpes simplex virus-2 does not appear to be a cofactor of human papillomavirus in the development of cervical cancer, Dr. Manuela Zereu reported at the annual meeting of the American Society of Clinical Oncology.

Human papillomavirus (HPV) is well established as an infection that is central to the pathogenesis of invasive cervical cancer, but because many women with HPV do not develop this cancer, it is believed certain cofactors play a role in disease development.

Some studies have suggested HSV-2 is one such cofactor, and in vitro experiments have shown a synergistic interaction between HSV-2 and HPV, but the findings of the current study did not bear this out, Dr. Zereu of the Santa Casa Cancer Center in Porto Alegre, Brazil, said in a poster presentation.

For the study, paraffin-embedded tissue samples from 229 patients diagnosed with adenocarcinoma of the uterine cervix between 1995 and 2003 were tested. DNA extraction showed that HPV was present in 79% of specimens, including HPV-18 in 51% of cases and HPV-16 in 34% of cases. However, all samples were negative for HSV-2 DNA.

ATLANTA — Herpes simplex virus-2 does not appear to be a cofactor of human papillomavirus in the development of cervical cancer, Dr. Manuela Zereu reported at the annual meeting of the American Society of Clinical Oncology.

Human papillomavirus (HPV) is well established as an infection that is central to the pathogenesis of invasive cervical cancer, but because many women with HPV do not develop this cancer, it is believed certain cofactors play a role in disease development.

Some studies have suggested HSV-2 is one such cofactor, and in vitro experiments have shown a synergistic interaction between HSV-2 and HPV, but the findings of the current study did not bear this out, Dr. Zereu of the Santa Casa Cancer Center in Porto Alegre, Brazil, said in a poster presentation.

For the study, paraffin-embedded tissue samples from 229 patients diagnosed with adenocarcinoma of the uterine cervix between 1995 and 2003 were tested. DNA extraction showed that HPV was present in 79% of specimens, including HPV-18 in 51% of cases and HPV-16 in 34% of cases. However, all samples were negative for HSV-2 DNA.

ATLANTA — Herpes simplex virus-2 does not appear to be a cofactor of human papillomavirus in the development of cervical cancer, Dr. Manuela Zereu reported at the annual meeting of the American Society of Clinical Oncology.

Human papillomavirus (HPV) is well established as an infection that is central to the pathogenesis of invasive cervical cancer, but because many women with HPV do not develop this cancer, it is believed certain cofactors play a role in disease development.

Some studies have suggested HSV-2 is one such cofactor, and in vitro experiments have shown a synergistic interaction between HSV-2 and HPV, but the findings of the current study did not bear this out, Dr. Zereu of the Santa Casa Cancer Center in Porto Alegre, Brazil, said in a poster presentation.

For the study, paraffin-embedded tissue samples from 229 patients diagnosed with adenocarcinoma of the uterine cervix between 1995 and 2003 were tested. DNA extraction showed that HPV was present in 79% of specimens, including HPV-18 in 51% of cases and HPV-16 in 34% of cases. However, all samples were negative for HSV-2 DNA.

ATLANTA — High-grade anogenital intraepithelial neoplasia has remarkably high recurrence and malignancy potential despite repeated treatments; thus long-term surveillance is mandatory, according to Dr. Mathias K. Fehr of University Hospital, Zurich, Switzerland.

A retrospective study of 442 patients with biopsy-proven grade 2–3 intraepithelial neoplasia of the vulva (VIN), vagina (VAIN), or perianal skin (PAIN) showed that progression to invasive disease occurred in 4% of the 433 treated patients within a mean of 8 years, Dr. Fehr reported in a poster at the annual meeting of the American Society of Clinical Oncology.

Recurrent disease, defined as VIN, VAIN, or PAIN diagnosed at least 1 year after the initial diagnosis, occurred in 32% of the treated patients, and among treated patients with a follow-up of longer than 5 years, 14% continued to experience recurrences. On multivariate analysis, immunosuppression was shown to be associated with recurrence (odds ratio 2.33), and immunosuppression and smoking were shown to be independent risk factors for disease progression (odds ratios 3.31 and 3.12, respectively).

Patients had a mean age of 47 years at initial diagnosis, and were treated with biopsy and laser evaporation in 62% of cases, surgical excision in 33% of cases, and other local destructive methods in 3% of cases. Nine patients (2%) refused treatment, Dr. Fehr noted.

Particular attention should be paid to long-term surveillance of VIN, VAIN, and PAIN in immunosuppressed patients and in patients who smoke, he concluded.

ATLANTA — High-grade anogenital intraepithelial neoplasia has remarkably high recurrence and malignancy potential despite repeated treatments; thus long-term surveillance is mandatory, according to Dr. Mathias K. Fehr of University Hospital, Zurich, Switzerland.

A retrospective study of 442 patients with biopsy-proven grade 2–3 intraepithelial neoplasia of the vulva (VIN), vagina (VAIN), or perianal skin (PAIN) showed that progression to invasive disease occurred in 4% of the 433 treated patients within a mean of 8 years, Dr. Fehr reported in a poster at the annual meeting of the American Society of Clinical Oncology.

Recurrent disease, defined as VIN, VAIN, or PAIN diagnosed at least 1 year after the initial diagnosis, occurred in 32% of the treated patients, and among treated patients with a follow-up of longer than 5 years, 14% continued to experience recurrences. On multivariate analysis, immunosuppression was shown to be associated with recurrence (odds ratio 2.33), and immunosuppression and smoking were shown to be independent risk factors for disease progression (odds ratios 3.31 and 3.12, respectively).

Patients had a mean age of 47 years at initial diagnosis, and were treated with biopsy and laser evaporation in 62% of cases, surgical excision in 33% of cases, and other local destructive methods in 3% of cases. Nine patients (2%) refused treatment, Dr. Fehr noted.

Particular attention should be paid to long-term surveillance of VIN, VAIN, and PAIN in immunosuppressed patients and in patients who smoke, he concluded.

ATLANTA — High-grade anogenital intraepithelial neoplasia has remarkably high recurrence and malignancy potential despite repeated treatments; thus long-term surveillance is mandatory, according to Dr. Mathias K. Fehr of University Hospital, Zurich, Switzerland.

A retrospective study of 442 patients with biopsy-proven grade 2–3 intraepithelial neoplasia of the vulva (VIN), vagina (VAIN), or perianal skin (PAIN) showed that progression to invasive disease occurred in 4% of the 433 treated patients within a mean of 8 years, Dr. Fehr reported in a poster at the annual meeting of the American Society of Clinical Oncology.

Recurrent disease, defined as VIN, VAIN, or PAIN diagnosed at least 1 year after the initial diagnosis, occurred in 32% of the treated patients, and among treated patients with a follow-up of longer than 5 years, 14% continued to experience recurrences. On multivariate analysis, immunosuppression was shown to be associated with recurrence (odds ratio 2.33), and immunosuppression and smoking were shown to be independent risk factors for disease progression (odds ratios 3.31 and 3.12, respectively).

Patients had a mean age of 47 years at initial diagnosis, and were treated with biopsy and laser evaporation in 62% of cases, surgical excision in 33% of cases, and other local destructive methods in 3% of cases. Nine patients (2%) refused treatment, Dr. Fehr noted.

Particular attention should be paid to long-term surveillance of VIN, VAIN, and PAIN in immunosuppressed patients and in patients who smoke, he concluded.

HOLLYWOOD, FLA. — The addition of spinal analgesia to a routine walking epidural patient-controlled analgesia regimen shortened the time to pain relief in a randomized study.

In the study of 136 patients who were randomized to receive a combined spinal-epidural (CSE) regimen or a routine epidural regimen, the CSE group achieved full analgesia satisfaction in a mean of 8 minutes, compared with 16 minutes in the epidural group.

Moreover, the addition of spinal analgesia did not affect the quality of the block, side effects, or patient satisfaction with analgesia, Dr. Shaul Cohen reported in a poster at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

Patients in the CSE group received initiation by 2mg of intrathecal ropivacaine and 5 mcg sufentanil via a PENCAN 25G spinal needle followed by epidural patient-controlled analgesia (PCA). The epidural group received 20 mL of 0.04% ropivacaine plus 1 mcg/mL sufentanil plus 2 mcg/mL epinephrine epidural study solution followed by epidural PCA analgesia.

All patients received an infusion of the study solution at 4 mL/hr, and a PCA dose of 4 mL with a lockout time of 10 minutes, noted Dr. Cohen of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, N.J.

After the initial neuraxial dose administration, patients were asked to rate their pain satisfaction at each contraction. In those with a visual analog score of greater than three at 20 minutes, a 5- to 10-mL bolus of study solution was given every 10 minutes (up to 20 mL) as needed to achieve a score of three or less.

A rescue dose of 5 mL of 0.25% ropivacaine was provided every 10 minutes (up to 20 mL and until patients could no longer ambulate) to those whose score remained above three after the maximum amount of study solution had been provided; the infusion rate was increased by 2 mL/hr at each interval where an intervention was required (to a maximum of 16 mL/hr).

The CSE and epidural groups were similar with regard to weight, height, and parity. Initial pain scores were significantly higher in the CSE group (7.8 vs. 6.9), and mean PCA volume was higher in that group (22 mL vs. 13 mL), but the groups did not differ in regard to first- and second-stage duration, initial cervical dilation, total infusion time, pain scores at time of relief, intravenous Pitocin use, pruritus, sedation, nausea, vomiting, urinary retention, analgesia satisfaction overall and during the first and second stages of labor, number of patients able to ambulate, or APGAR scores, Dr. Balki noted.

HOLLYWOOD, FLA. — The addition of spinal analgesia to a routine walking epidural patient-controlled analgesia regimen shortened the time to pain relief in a randomized study.

In the study of 136 patients who were randomized to receive a combined spinal-epidural (CSE) regimen or a routine epidural regimen, the CSE group achieved full analgesia satisfaction in a mean of 8 minutes, compared with 16 minutes in the epidural group.

Moreover, the addition of spinal analgesia did not affect the quality of the block, side effects, or patient satisfaction with analgesia, Dr. Shaul Cohen reported in a poster at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

Patients in the CSE group received initiation by 2mg of intrathecal ropivacaine and 5 mcg sufentanil via a PENCAN 25G spinal needle followed by epidural patient-controlled analgesia (PCA). The epidural group received 20 mL of 0.04% ropivacaine plus 1 mcg/mL sufentanil plus 2 mcg/mL epinephrine epidural study solution followed by epidural PCA analgesia.

All patients received an infusion of the study solution at 4 mL/hr, and a PCA dose of 4 mL with a lockout time of 10 minutes, noted Dr. Cohen of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, N.J.

After the initial neuraxial dose administration, patients were asked to rate their pain satisfaction at each contraction. In those with a visual analog score of greater than three at 20 minutes, a 5- to 10-mL bolus of study solution was given every 10 minutes (up to 20 mL) as needed to achieve a score of three or less.

A rescue dose of 5 mL of 0.25% ropivacaine was provided every 10 minutes (up to 20 mL and until patients could no longer ambulate) to those whose score remained above three after the maximum amount of study solution had been provided; the infusion rate was increased by 2 mL/hr at each interval where an intervention was required (to a maximum of 16 mL/hr).

The CSE and epidural groups were similar with regard to weight, height, and parity. Initial pain scores were significantly higher in the CSE group (7.8 vs. 6.9), and mean PCA volume was higher in that group (22 mL vs. 13 mL), but the groups did not differ in regard to first- and second-stage duration, initial cervical dilation, total infusion time, pain scores at time of relief, intravenous Pitocin use, pruritus, sedation, nausea, vomiting, urinary retention, analgesia satisfaction overall and during the first and second stages of labor, number of patients able to ambulate, or APGAR scores, Dr. Balki noted.

HOLLYWOOD, FLA. — The addition of spinal analgesia to a routine walking epidural patient-controlled analgesia regimen shortened the time to pain relief in a randomized study.

In the study of 136 patients who were randomized to receive a combined spinal-epidural (CSE) regimen or a routine epidural regimen, the CSE group achieved full analgesia satisfaction in a mean of 8 minutes, compared with 16 minutes in the epidural group.

Moreover, the addition of spinal analgesia did not affect the quality of the block, side effects, or patient satisfaction with analgesia, Dr. Shaul Cohen reported in a poster at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

Patients in the CSE group received initiation by 2mg of intrathecal ropivacaine and 5 mcg sufentanil via a PENCAN 25G spinal needle followed by epidural patient-controlled analgesia (PCA). The epidural group received 20 mL of 0.04% ropivacaine plus 1 mcg/mL sufentanil plus 2 mcg/mL epinephrine epidural study solution followed by epidural PCA analgesia.

All patients received an infusion of the study solution at 4 mL/hr, and a PCA dose of 4 mL with a lockout time of 10 minutes, noted Dr. Cohen of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, N.J.

After the initial neuraxial dose administration, patients were asked to rate their pain satisfaction at each contraction. In those with a visual analog score of greater than three at 20 minutes, a 5- to 10-mL bolus of study solution was given every 10 minutes (up to 20 mL) as needed to achieve a score of three or less.

A rescue dose of 5 mL of 0.25% ropivacaine was provided every 10 minutes (up to 20 mL and until patients could no longer ambulate) to those whose score remained above three after the maximum amount of study solution had been provided; the infusion rate was increased by 2 mL/hr at each interval where an intervention was required (to a maximum of 16 mL/hr).

The CSE and epidural groups were similar with regard to weight, height, and parity. Initial pain scores were significantly higher in the CSE group (7.8 vs. 6.9), and mean PCA volume was higher in that group (22 mL vs. 13 mL), but the groups did not differ in regard to first- and second-stage duration, initial cervical dilation, total infusion time, pain scores at time of relief, intravenous Pitocin use, pruritus, sedation, nausea, vomiting, urinary retention, analgesia satisfaction overall and during the first and second stages of labor, number of patients able to ambulate, or APGAR scores, Dr. Balki noted.

MIAMI BEACH — Individuals born preterm have diminished short- and long-term survival, as well as diminished reproductive capacity, and women born preterm are at increased risk of giving birth to their own offspring preterm, an analysis of data from a large birth registry suggests.

Data from about 610,000 men and 578,000 women entered into the Medical Birth Registry of Norway between 1967 and 1988 were analyzed and showed an overall rate of preterm birth of 5.7%, with 5.3% among females and 6.2% among males.

Those born preterm, compared with those born between 37 and 42 weeks' gestation, had “considerably higher” perinatal and infant mortality, and the increased mortality risk persisted through adolescence, Dr. Geeta K. Swamy reported at the annual meeting of the Society for Maternal-Fetal Medicine.

The odds ratios for early childhood death in those born extremely preterm (from 22 to 27 weeks' gestation) were 6.1 for males and 8.7 for females, and for those born very preterm (28–32 weeks' gestation), the odds ratios were 2.5 for males and 2.1 for females.

The odds ratio for late childhood death in those born extremely preterm was 6.3 for males (no females died in late childhood in this group), and for those born very preterm they were 1.9 for males, and 0.9 for females, said Dr. Swamy of Duke University, Durham, N.C.

Reproduction was significantly diminished in both men and women born extremely preterm who survived until at least age 18 years (odds ratio 0.48 for men and 0.52 for women) and in those born very preterm who survived to at least age 18 years (odds ratio 0.75 for men and 0.81 for women).

The risk for having offspring born preterm was increased only among women who were born preterm.

Approximately 17% of those born extremely preterm gave birth prematurely, compared with 7% of those born at term.

“The findings emphasize the increased need for health care and social services well beyond the neonatal and infant life periods,” Dr. Swamy said, adding that further study will analyze gender-specific causes of mortality to better determine how preterm birth affects long-term health.

A reevaluation to determine how continually improving survival rates among the extremely preterm affect overall reproduction is also warranted, Dr. Swamy concluded.

MIAMI BEACH — Individuals born preterm have diminished short- and long-term survival, as well as diminished reproductive capacity, and women born preterm are at increased risk of giving birth to their own offspring preterm, an analysis of data from a large birth registry suggests.

Data from about 610,000 men and 578,000 women entered into the Medical Birth Registry of Norway between 1967 and 1988 were analyzed and showed an overall rate of preterm birth of 5.7%, with 5.3% among females and 6.2% among males.

Those born preterm, compared with those born between 37 and 42 weeks' gestation, had “considerably higher” perinatal and infant mortality, and the increased mortality risk persisted through adolescence, Dr. Geeta K. Swamy reported at the annual meeting of the Society for Maternal-Fetal Medicine.

The odds ratios for early childhood death in those born extremely preterm (from 22 to 27 weeks' gestation) were 6.1 for males and 8.7 for females, and for those born very preterm (28–32 weeks' gestation), the odds ratios were 2.5 for males and 2.1 for females.

The odds ratio for late childhood death in those born extremely preterm was 6.3 for males (no females died in late childhood in this group), and for those born very preterm they were 1.9 for males, and 0.9 for females, said Dr. Swamy of Duke University, Durham, N.C.

Reproduction was significantly diminished in both men and women born extremely preterm who survived until at least age 18 years (odds ratio 0.48 for men and 0.52 for women) and in those born very preterm who survived to at least age 18 years (odds ratio 0.75 for men and 0.81 for women).

The risk for having offspring born preterm was increased only among women who were born preterm.

Approximately 17% of those born extremely preterm gave birth prematurely, compared with 7% of those born at term.

“The findings emphasize the increased need for health care and social services well beyond the neonatal and infant life periods,” Dr. Swamy said, adding that further study will analyze gender-specific causes of mortality to better determine how preterm birth affects long-term health.

A reevaluation to determine how continually improving survival rates among the extremely preterm affect overall reproduction is also warranted, Dr. Swamy concluded.

MIAMI BEACH — Individuals born preterm have diminished short- and long-term survival, as well as diminished reproductive capacity, and women born preterm are at increased risk of giving birth to their own offspring preterm, an analysis of data from a large birth registry suggests.

Data from about 610,000 men and 578,000 women entered into the Medical Birth Registry of Norway between 1967 and 1988 were analyzed and showed an overall rate of preterm birth of 5.7%, with 5.3% among females and 6.2% among males.

Those born preterm, compared with those born between 37 and 42 weeks' gestation, had “considerably higher” perinatal and infant mortality, and the increased mortality risk persisted through adolescence, Dr. Geeta K. Swamy reported at the annual meeting of the Society for Maternal-Fetal Medicine.

The odds ratios for early childhood death in those born extremely preterm (from 22 to 27 weeks' gestation) were 6.1 for males and 8.7 for females, and for those born very preterm (28–32 weeks' gestation), the odds ratios were 2.5 for males and 2.1 for females.

The odds ratio for late childhood death in those born extremely preterm was 6.3 for males (no females died in late childhood in this group), and for those born very preterm they were 1.9 for males, and 0.9 for females, said Dr. Swamy of Duke University, Durham, N.C.

Reproduction was significantly diminished in both men and women born extremely preterm who survived until at least age 18 years (odds ratio 0.48 for men and 0.52 for women) and in those born very preterm who survived to at least age 18 years (odds ratio 0.75 for men and 0.81 for women).

The risk for having offspring born preterm was increased only among women who were born preterm.

Approximately 17% of those born extremely preterm gave birth prematurely, compared with 7% of those born at term.

“The findings emphasize the increased need for health care and social services well beyond the neonatal and infant life periods,” Dr. Swamy said, adding that further study will analyze gender-specific causes of mortality to better determine how preterm birth affects long-term health.

A reevaluation to determine how continually improving survival rates among the extremely preterm affect overall reproduction is also warranted, Dr. Swamy concluded.

Spacers appear to have several advantages over nebulizers for the delivery of β₂-agonists in children with acute asthma, according to a Cochrane review of the literature.

However, the findings should be viewed with caution, according to Dr. Paul Williams, chair of the section on allergy and immunology, American Academy of Pediatrics.

The review was recently updated from 2003 to include four new trials that were conducted in emergency department and community settings as well as to add findings from six trials of inpatients with acute asthma. It includes data on 2,279 children and 642 adults enrolled in a total of 31 trials.

The data show that length of stay in the emergency department was significantly shorter in children (but not in adults) who used a spacer, compared with those who used a nebulizer (mean difference of −0.47 hours).

Pulse rate also was lower in children who used a spacer (mean difference, 7.6% of baseline), Dr. Christopher J. Cates of St. George's University of London and colleagues reported (Cochrane Database Syst. Rev. 2006;[2]:CD000052).

There did not appear to be any difference in admission rates in children treated with spacers vs. nebulizers (relative risk 0.65).

The findings are important because spacers are less expensive in the community setting, and unlike nebulizers, they do not require a power source, the investigators noted.

However, Dr. Cates and his associates also noted several limitations of the studies included in the review.

“Overall, this review supports the equivalence of wet nebuliser and MDI [metered-dose inhaler] with spacer administration of β₂-agonists in the treatment of acute asthma, when treatments are repeated and titrated to the response of the patient.

“This review also suggests that paediatric patients given β₂-agonists by spacer and MDI may have shorter stays in the ED, less hypoxia, and lower pulse rates, compared to patients receiving the same β₂-agonist via wet nebulisation,” the investigators wrote.

But, they added, the findings of the review are limited by the relative lack of studies in the community setting, by the exclusion of patients with life-threatening asthma exacerbations from the studies, by the fact that few authors reported specifically on numbers of patients who were excluded from each study, and by a lack of reporting of intention to treat analyses.

In addition, the analysis of data regarding lung function tests was complicated by a lack of standardized reporting in many of the studies, and standard evaluations related to the changes that were measured were sometimes not reported.

“I agree with (these) comments mentioned by the authors. … There are several cautions that should be expressed when presenting the results,” said Dr. Williams, who also is with the University of Washington, Seattle.

For example, only two of the studies included in the review were conducted in a community emergency department; thus, the results may not be applicable to such settings, he said, stressing that more studies in this setting are needed.

In addition, the doses of albuterol given via spacer were different among the studies, which could be a source of confusion for the practitioner who is trying to decide whether to use the spacer or the nebulizer.

For the nebulizer, the doses are fairly well defined and accepted, but for the MDI and spacer, the doses have not been well studied or defined and varied from 2 puffs every 20 minutes, to 1 puff every 12 seconds, up to 12 puffs per hour, Dr. Williams explained.

As recommended by the authors, more studies are needed using frequent dosing titrated to patient response, Dr. Williams agreed.

But of most concern, he said, is that the studies included in the review used specially trained nurses to administer the medications.

“In a community setting, many, if not most, nurses and perhaps even M.D.s are not familiar with different spacers and techniques for using spacers, nor the developmental stage necessary to use spacers of different types.

Not only are the varied dosing regimens confusing, but the quality of medication administration may vary from staff person to staff person and shift to shift,” Dr. Williams said.

He added that he would like to see studies that look at a standardized regimen of dosing using the spacer and MDI. He said he would also like to see the dissemination of information on using spacers for children through a source such as the American Academy of Pediatrics online PediaLink Module (www.pedialink.org/index.cfm

Spacers appear to have several advantages over nebulizers for the delivery of β₂-agonists in children with acute asthma, according to a Cochrane review of the literature.

However, the findings should be viewed with caution, according to Dr. Paul Williams, chair of the section on allergy and immunology, American Academy of Pediatrics.

The review was recently updated from 2003 to include four new trials that were conducted in emergency department and community settings as well as to add findings from six trials of inpatients with acute asthma. It includes data on 2,279 children and 642 adults enrolled in a total of 31 trials.

The data show that length of stay in the emergency department was significantly shorter in children (but not in adults) who used a spacer, compared with those who used a nebulizer (mean difference of −0.47 hours).

Pulse rate also was lower in children who used a spacer (mean difference, 7.6% of baseline), Dr. Christopher J. Cates of St. George's University of London and colleagues reported (Cochrane Database Syst. Rev. 2006;[2]:CD000052).

There did not appear to be any difference in admission rates in children treated with spacers vs. nebulizers (relative risk 0.65).

The findings are important because spacers are less expensive in the community setting, and unlike nebulizers, they do not require a power source, the investigators noted.

However, Dr. Cates and his associates also noted several limitations of the studies included in the review.

“Overall, this review supports the equivalence of wet nebuliser and MDI [metered-dose inhaler] with spacer administration of β₂-agonists in the treatment of acute asthma, when treatments are repeated and titrated to the response of the patient.

“This review also suggests that paediatric patients given β₂-agonists by spacer and MDI may have shorter stays in the ED, less hypoxia, and lower pulse rates, compared to patients receiving the same β₂-agonist via wet nebulisation,” the investigators wrote.

But, they added, the findings of the review are limited by the relative lack of studies in the community setting, by the exclusion of patients with life-threatening asthma exacerbations from the studies, by the fact that few authors reported specifically on numbers of patients who were excluded from each study, and by a lack of reporting of intention to treat analyses.

In addition, the analysis of data regarding lung function tests was complicated by a lack of standardized reporting in many of the studies, and standard evaluations related to the changes that were measured were sometimes not reported.

“I agree with (these) comments mentioned by the authors. … There are several cautions that should be expressed when presenting the results,” said Dr. Williams, who also is with the University of Washington, Seattle.

For example, only two of the studies included in the review were conducted in a community emergency department; thus, the results may not be applicable to such settings, he said, stressing that more studies in this setting are needed.

In addition, the doses of albuterol given via spacer were different among the studies, which could be a source of confusion for the practitioner who is trying to decide whether to use the spacer or the nebulizer.

For the nebulizer, the doses are fairly well defined and accepted, but for the MDI and spacer, the doses have not been well studied or defined and varied from 2 puffs every 20 minutes, to 1 puff every 12 seconds, up to 12 puffs per hour, Dr. Williams explained.

As recommended by the authors, more studies are needed using frequent dosing titrated to patient response, Dr. Williams agreed.

But of most concern, he said, is that the studies included in the review used specially trained nurses to administer the medications.

“In a community setting, many, if not most, nurses and perhaps even M.D.s are not familiar with different spacers and techniques for using spacers, nor the developmental stage necessary to use spacers of different types.

Not only are the varied dosing regimens confusing, but the quality of medication administration may vary from staff person to staff person and shift to shift,” Dr. Williams said.

He added that he would like to see studies that look at a standardized regimen of dosing using the spacer and MDI. He said he would also like to see the dissemination of information on using spacers for children through a source such as the American Academy of Pediatrics online PediaLink Module (www.pedialink.org/index.cfm

Spacers appear to have several advantages over nebulizers for the delivery of β₂-agonists in children with acute asthma, according to a Cochrane review of the literature.

However, the findings should be viewed with caution, according to Dr. Paul Williams, chair of the section on allergy and immunology, American Academy of Pediatrics.

The review was recently updated from 2003 to include four new trials that were conducted in emergency department and community settings as well as to add findings from six trials of inpatients with acute asthma. It includes data on 2,279 children and 642 adults enrolled in a total of 31 trials.

The data show that length of stay in the emergency department was significantly shorter in children (but not in adults) who used a spacer, compared with those who used a nebulizer (mean difference of −0.47 hours).

Pulse rate also was lower in children who used a spacer (mean difference, 7.6% of baseline), Dr. Christopher J. Cates of St. George's University of London and colleagues reported (Cochrane Database Syst. Rev. 2006;[2]:CD000052).

There did not appear to be any difference in admission rates in children treated with spacers vs. nebulizers (relative risk 0.65).

The findings are important because spacers are less expensive in the community setting, and unlike nebulizers, they do not require a power source, the investigators noted.

However, Dr. Cates and his associates also noted several limitations of the studies included in the review.

“Overall, this review supports the equivalence of wet nebuliser and MDI [metered-dose inhaler] with spacer administration of β₂-agonists in the treatment of acute asthma, when treatments are repeated and titrated to the response of the patient.

“This review also suggests that paediatric patients given β₂-agonists by spacer and MDI may have shorter stays in the ED, less hypoxia, and lower pulse rates, compared to patients receiving the same β₂-agonist via wet nebulisation,” the investigators wrote.

But, they added, the findings of the review are limited by the relative lack of studies in the community setting, by the exclusion of patients with life-threatening asthma exacerbations from the studies, by the fact that few authors reported specifically on numbers of patients who were excluded from each study, and by a lack of reporting of intention to treat analyses.

In addition, the analysis of data regarding lung function tests was complicated by a lack of standardized reporting in many of the studies, and standard evaluations related to the changes that were measured were sometimes not reported.

“I agree with (these) comments mentioned by the authors. … There are several cautions that should be expressed when presenting the results,” said Dr. Williams, who also is with the University of Washington, Seattle.

For example, only two of the studies included in the review were conducted in a community emergency department; thus, the results may not be applicable to such settings, he said, stressing that more studies in this setting are needed.

In addition, the doses of albuterol given via spacer were different among the studies, which could be a source of confusion for the practitioner who is trying to decide whether to use the spacer or the nebulizer.

For the nebulizer, the doses are fairly well defined and accepted, but for the MDI and spacer, the doses have not been well studied or defined and varied from 2 puffs every 20 minutes, to 1 puff every 12 seconds, up to 12 puffs per hour, Dr. Williams explained.

As recommended by the authors, more studies are needed using frequent dosing titrated to patient response, Dr. Williams agreed.

But of most concern, he said, is that the studies included in the review used specially trained nurses to administer the medications.

“In a community setting, many, if not most, nurses and perhaps even M.D.s are not familiar with different spacers and techniques for using spacers, nor the developmental stage necessary to use spacers of different types.

Not only are the varied dosing regimens confusing, but the quality of medication administration may vary from staff person to staff person and shift to shift,” Dr. Williams said.

He added that he would like to see studies that look at a standardized regimen of dosing using the spacer and MDI. He said he would also like to see the dissemination of information on using spacers for children through a source such as the American Academy of Pediatrics online PediaLink Module (www.pedialink.org/index.cfm

ATLANTA — Participation in a yoga program during breast cancer treatment is feasible and may improve quality of life, Lorenzo Cohen, Ph.D., reported at the annual meeting of the American Society of Clinical Oncology.

The study, designed mainly to examine the feasibility of integrating yoga into the treatment plan for women with breast cancer who are undergoing radiation treatment, involved a total of 62 women with stages 0–III disease. Patients were randomized to a group that participated in yoga twice weekly during treatment or to a “wait-list control group” that was scheduled to participate in a postradiation yoga program.

Not only was recruitment simple and patient interest and satisfaction with the program high, but also after just 1 week of yoga, patients in the intervention group reported significantly improved physical function (mean adjusted short form-36 health status survey scores of 81.8 vs. 68.6) and general health (mean adjusted SF-36 scores of 78.3 vs. 67.9), and significantly less sleep-related daytime dysfunction (Pittsburgh Sleep Quality Index scores of 0.5 vs. 1.2), compared with the control group, Dr. Cohen said.

The yoga group also had marginally better SF-36 scores for social functioning and fatigue at 1 week. However, no differences in anxiety or depression scores were noted between the groups, Dr. Cohen, director of the Integrative Medicine Program at the University of Texas M.D. Anderson Cancer Center in Houston reported at a press briefing.

The yoga program was designed specifically for this patient population. It emphasized breathing, deep relaxation, and meditation techniques. Patients in the yoga group participated in a 60-minute yoga session twice weekly just before or after radiation treatment for 6 weeks; patients in the control group were asked to refrain from practicing yoga until after treatment was complete.

“We show that it was clearly feasible to do this type of research … and that there is some initial indication of efficacy,” Dr. Cohen said. Further analysis, including analysis of 1-month and 3-month patient self-report data and of immune function and cortisol levels (from blood tests and saliva samples, respectively) is planned.

ATLANTA — Participation in a yoga program during breast cancer treatment is feasible and may improve quality of life, Lorenzo Cohen, Ph.D., reported at the annual meeting of the American Society of Clinical Oncology.

The study, designed mainly to examine the feasibility of integrating yoga into the treatment plan for women with breast cancer who are undergoing radiation treatment, involved a total of 62 women with stages 0–III disease. Patients were randomized to a group that participated in yoga twice weekly during treatment or to a “wait-list control group” that was scheduled to participate in a postradiation yoga program.

Not only was recruitment simple and patient interest and satisfaction with the program high, but also after just 1 week of yoga, patients in the intervention group reported significantly improved physical function (mean adjusted short form-36 health status survey scores of 81.8 vs. 68.6) and general health (mean adjusted SF-36 scores of 78.3 vs. 67.9), and significantly less sleep-related daytime dysfunction (Pittsburgh Sleep Quality Index scores of 0.5 vs. 1.2), compared with the control group, Dr. Cohen said.

The yoga group also had marginally better SF-36 scores for social functioning and fatigue at 1 week. However, no differences in anxiety or depression scores were noted between the groups, Dr. Cohen, director of the Integrative Medicine Program at the University of Texas M.D. Anderson Cancer Center in Houston reported at a press briefing.

The yoga program was designed specifically for this patient population. It emphasized breathing, deep relaxation, and meditation techniques. Patients in the yoga group participated in a 60-minute yoga session twice weekly just before or after radiation treatment for 6 weeks; patients in the control group were asked to refrain from practicing yoga until after treatment was complete.

“We show that it was clearly feasible to do this type of research … and that there is some initial indication of efficacy,” Dr. Cohen said. Further analysis, including analysis of 1-month and 3-month patient self-report data and of immune function and cortisol levels (from blood tests and saliva samples, respectively) is planned.

ATLANTA — Participation in a yoga program during breast cancer treatment is feasible and may improve quality of life, Lorenzo Cohen, Ph.D., reported at the annual meeting of the American Society of Clinical Oncology.

The study, designed mainly to examine the feasibility of integrating yoga into the treatment plan for women with breast cancer who are undergoing radiation treatment, involved a total of 62 women with stages 0–III disease. Patients were randomized to a group that participated in yoga twice weekly during treatment or to a “wait-list control group” that was scheduled to participate in a postradiation yoga program.

Not only was recruitment simple and patient interest and satisfaction with the program high, but also after just 1 week of yoga, patients in the intervention group reported significantly improved physical function (mean adjusted short form-36 health status survey scores of 81.8 vs. 68.6) and general health (mean adjusted SF-36 scores of 78.3 vs. 67.9), and significantly less sleep-related daytime dysfunction (Pittsburgh Sleep Quality Index scores of 0.5 vs. 1.2), compared with the control group, Dr. Cohen said.

The yoga group also had marginally better SF-36 scores for social functioning and fatigue at 1 week. However, no differences in anxiety or depression scores were noted between the groups, Dr. Cohen, director of the Integrative Medicine Program at the University of Texas M.D. Anderson Cancer Center in Houston reported at a press briefing.

The yoga program was designed specifically for this patient population. It emphasized breathing, deep relaxation, and meditation techniques. Patients in the yoga group participated in a 60-minute yoga session twice weekly just before or after radiation treatment for 6 weeks; patients in the control group were asked to refrain from practicing yoga until after treatment was complete.

“We show that it was clearly feasible to do this type of research … and that there is some initial indication of efficacy,” Dr. Cohen said. Further analysis, including analysis of 1-month and 3-month patient self-report data and of immune function and cortisol levels (from blood tests and saliva samples, respectively) is planned.

ATLANTA — The recently approved quadrivalent human papillomavirus vaccine shown to be effective for preventing most HPV-related cervical cancers may also prevent most vulvar and vaginal cancers, Dr. Jorma Paavonen reported at the annual meeting of the American Society of Clinical Oncology.

The vaccine (Gardisil, Merck & Co.) received approval from the U.S. Food and Drug Administration in June, after winning unanimous support from an FDA advisory panel.

Gardisil targets HPV 6 and 11, which are associated with anogenital warts, and HPV 16 and 18, which cause most cervical cancers. HPV 16 and 18 are also the most common causes of vulvar and vaginal cancers, said Dr. Paavonen, professor and chief physician in obstetrics and gynecology at the University of Helsinki, Finland.

The FUTURE II study was a combined analysis of data from three randomized, placebo-controlled trials that studied the impact of the vaccine on rates of HPV 16- and 18-related vulvar and vaginal intraepithelial neoplasia grade 2/3. FUTURE II showed that the vaccine was 100% effective up to 2 years of follow-up for preventing these precancerous lesions, said Dr. Paavonen, who has served as a consultant to and received research funding from Merck.

These trials randomized 18,150 women aged 16–26 to receive either the vaccine or placebo. Vaccination occurred at day 1 and at 2 and 6 months. Genital tract specimens were obtained at day 1 and then at 6- to 12-month intervals for up to 48 months, with colposcopy performed as needed following algorithm-based referrals.

On per-protocol analysis, there were 10 cases of vulvar intraepithelial neoplasia (VIN) 2/3 or vaginal intraepithelial neoplasia (VaIN) 2/3 in the placebo group, and none in the vaccine group, at an average of 18 months of follow-up. On modified intention-to-treat analysis, there were 24 histologically confirmed cases of VIN 2/3 or VaIN 2/3 in the placebo group, at an average of 2 years of follow-up.

“The burden of HPV disease is not restricted to the cervix. HPV is present in nearly 80% of the 6,000 cases of vaginal and vulvar cancers diagnosed in the United States each year,” Dr. Paavonen said.

ATLANTA — The recently approved quadrivalent human papillomavirus vaccine shown to be effective for preventing most HPV-related cervical cancers may also prevent most vulvar and vaginal cancers, Dr. Jorma Paavonen reported at the annual meeting of the American Society of Clinical Oncology.

The vaccine (Gardisil, Merck & Co.) received approval from the U.S. Food and Drug Administration in June, after winning unanimous support from an FDA advisory panel.

Gardisil targets HPV 6 and 11, which are associated with anogenital warts, and HPV 16 and 18, which cause most cervical cancers. HPV 16 and 18 are also the most common causes of vulvar and vaginal cancers, said Dr. Paavonen, professor and chief physician in obstetrics and gynecology at the University of Helsinki, Finland.

The FUTURE II study was a combined analysis of data from three randomized, placebo-controlled trials that studied the impact of the vaccine on rates of HPV 16- and 18-related vulvar and vaginal intraepithelial neoplasia grade 2/3. FUTURE II showed that the vaccine was 100% effective up to 2 years of follow-up for preventing these precancerous lesions, said Dr. Paavonen, who has served as a consultant to and received research funding from Merck.

These trials randomized 18,150 women aged 16–26 to receive either the vaccine or placebo. Vaccination occurred at day 1 and at 2 and 6 months. Genital tract specimens were obtained at day 1 and then at 6- to 12-month intervals for up to 48 months, with colposcopy performed as needed following algorithm-based referrals.

On per-protocol analysis, there were 10 cases of vulvar intraepithelial neoplasia (VIN) 2/3 or vaginal intraepithelial neoplasia (VaIN) 2/3 in the placebo group, and none in the vaccine group, at an average of 18 months of follow-up. On modified intention-to-treat analysis, there were 24 histologically confirmed cases of VIN 2/3 or VaIN 2/3 in the placebo group, at an average of 2 years of follow-up.

“The burden of HPV disease is not restricted to the cervix. HPV is present in nearly 80% of the 6,000 cases of vaginal and vulvar cancers diagnosed in the United States each year,” Dr. Paavonen said.

ATLANTA — The recently approved quadrivalent human papillomavirus vaccine shown to be effective for preventing most HPV-related cervical cancers may also prevent most vulvar and vaginal cancers, Dr. Jorma Paavonen reported at the annual meeting of the American Society of Clinical Oncology.

The vaccine (Gardisil, Merck & Co.) received approval from the U.S. Food and Drug Administration in June, after winning unanimous support from an FDA advisory panel.

Gardisil targets HPV 6 and 11, which are associated with anogenital warts, and HPV 16 and 18, which cause most cervical cancers. HPV 16 and 18 are also the most common causes of vulvar and vaginal cancers, said Dr. Paavonen, professor and chief physician in obstetrics and gynecology at the University of Helsinki, Finland.

The FUTURE II study was a combined analysis of data from three randomized, placebo-controlled trials that studied the impact of the vaccine on rates of HPV 16- and 18-related vulvar and vaginal intraepithelial neoplasia grade 2/3. FUTURE II showed that the vaccine was 100% effective up to 2 years of follow-up for preventing these precancerous lesions, said Dr. Paavonen, who has served as a consultant to and received research funding from Merck.

These trials randomized 18,150 women aged 16–26 to receive either the vaccine or placebo. Vaccination occurred at day 1 and at 2 and 6 months. Genital tract specimens were obtained at day 1 and then at 6- to 12-month intervals for up to 48 months, with colposcopy performed as needed following algorithm-based referrals.

On per-protocol analysis, there were 10 cases of vulvar intraepithelial neoplasia (VIN) 2/3 or vaginal intraepithelial neoplasia (VaIN) 2/3 in the placebo group, and none in the vaccine group, at an average of 18 months of follow-up. On modified intention-to-treat analysis, there were 24 histologically confirmed cases of VIN 2/3 or VaIN 2/3 in the placebo group, at an average of 2 years of follow-up.

“The burden of HPV disease is not restricted to the cervix. HPV is present in nearly 80% of the 6,000 cases of vaginal and vulvar cancers diagnosed in the United States each year,” Dr. Paavonen said.

ATLANTA — Participation in a yoga program during breast cancer treatment is feasible and may improve quality of life, Lorenzo Cohen, Ph.D., reported at the annual meeting of the American Society of Clinical Oncology.

The study, designed mainly to examine the feasibility of integrating yoga into the treatment plan for women with breast cancer who are undergoing radiation treatment, involved a total of 62 women with stages 0-III disease. Patients were randomized to a group that participated in yoga twice weekly during treatment or to a “wait-list control group” that was scheduled to participate in a postradiation yoga program.

Not only was recruitment simple and patient interest and satisfaction with the program high, but also after just 1 week of yoga, patients in the intervention group reported significantly improved physical function (mean adjusted short form-36 health status survey scores of 81.8 vs. 68.6) and general health (mean adjusted SF-36 scores of 78.3 vs. 67.9), and significantly less sleep-related daytime dysfunction (Pittsburgh Sleep Quality Index scores of 0.5 vs. 1.2), compared with the control group, Dr. Cohen said.

The yoga group also had marginally better SF-36 scores for social functioning and fatigue at 1 week. However, no differences in anxiety or depression scores were noted between the groups, Dr. Cohen, director of the Integrative Medicine Program at the University of Texas M.D. Anderson Cancer Center in Houston reported at a press briefing.

The yoga program was designed specifically for this patient population and excluded positions that might be difficult given patients' physical condition. It emphasized breathing, deep relaxation, and meditation techniques. Patients in the yoga group participated in a 60-minute yoga session twice weekly just before or after radiation treatment for 6 weeks; patients in the control group were asked to refrain from practicing yoga until after treatment was complete.

“We show that it was clearly feasible to do this type of research … and that there is some initial indication of efficacy,” Dr. Cohen said.

Further analysis, including analysis of 1-month and 3-month patient self-report data and of immune function and cortisol levels (from blood tests and saliva samples, respectively) is planned, and a follow-up study funded by the National Cancer Institute is underway. The study will compare daily yoga, daily stretching exercises, and standard care in a similar patient population, and this will help gauge whether there is something specific to yoga, or if something as simple as stretching can be helpful, he noted.

A study of the effects of Tibetan yoga in women with breast cancer who are undergoing chemotherapy also is planned, he said.

ATLANTA — Participation in a yoga program during breast cancer treatment is feasible and may improve quality of life, Lorenzo Cohen, Ph.D., reported at the annual meeting of the American Society of Clinical Oncology.

The study, designed mainly to examine the feasibility of integrating yoga into the treatment plan for women with breast cancer who are undergoing radiation treatment, involved a total of 62 women with stages 0-III disease. Patients were randomized to a group that participated in yoga twice weekly during treatment or to a “wait-list control group” that was scheduled to participate in a postradiation yoga program.

Not only was recruitment simple and patient interest and satisfaction with the program high, but also after just 1 week of yoga, patients in the intervention group reported significantly improved physical function (mean adjusted short form-36 health status survey scores of 81.8 vs. 68.6) and general health (mean adjusted SF-36 scores of 78.3 vs. 67.9), and significantly less sleep-related daytime dysfunction (Pittsburgh Sleep Quality Index scores of 0.5 vs. 1.2), compared with the control group, Dr. Cohen said.

The yoga group also had marginally better SF-36 scores for social functioning and fatigue at 1 week. However, no differences in anxiety or depression scores were noted between the groups, Dr. Cohen, director of the Integrative Medicine Program at the University of Texas M.D. Anderson Cancer Center in Houston reported at a press briefing.

The yoga program was designed specifically for this patient population and excluded positions that might be difficult given patients' physical condition. It emphasized breathing, deep relaxation, and meditation techniques. Patients in the yoga group participated in a 60-minute yoga session twice weekly just before or after radiation treatment for 6 weeks; patients in the control group were asked to refrain from practicing yoga until after treatment was complete.

“We show that it was clearly feasible to do this type of research … and that there is some initial indication of efficacy,” Dr. Cohen said.

Further analysis, including analysis of 1-month and 3-month patient self-report data and of immune function and cortisol levels (from blood tests and saliva samples, respectively) is planned, and a follow-up study funded by the National Cancer Institute is underway. The study will compare daily yoga, daily stretching exercises, and standard care in a similar patient population, and this will help gauge whether there is something specific to yoga, or if something as simple as stretching can be helpful, he noted.

A study of the effects of Tibetan yoga in women with breast cancer who are undergoing chemotherapy also is planned, he said.

ATLANTA — Participation in a yoga program during breast cancer treatment is feasible and may improve quality of life, Lorenzo Cohen, Ph.D., reported at the annual meeting of the American Society of Clinical Oncology.

The study, designed mainly to examine the feasibility of integrating yoga into the treatment plan for women with breast cancer who are undergoing radiation treatment, involved a total of 62 women with stages 0-III disease. Patients were randomized to a group that participated in yoga twice weekly during treatment or to a “wait-list control group” that was scheduled to participate in a postradiation yoga program.

Not only was recruitment simple and patient interest and satisfaction with the program high, but also after just 1 week of yoga, patients in the intervention group reported significantly improved physical function (mean adjusted short form-36 health status survey scores of 81.8 vs. 68.6) and general health (mean adjusted SF-36 scores of 78.3 vs. 67.9), and significantly less sleep-related daytime dysfunction (Pittsburgh Sleep Quality Index scores of 0.5 vs. 1.2), compared with the control group, Dr. Cohen said.

The yoga group also had marginally better SF-36 scores for social functioning and fatigue at 1 week. However, no differences in anxiety or depression scores were noted between the groups, Dr. Cohen, director of the Integrative Medicine Program at the University of Texas M.D. Anderson Cancer Center in Houston reported at a press briefing.

The yoga program was designed specifically for this patient population and excluded positions that might be difficult given patients' physical condition. It emphasized breathing, deep relaxation, and meditation techniques. Patients in the yoga group participated in a 60-minute yoga session twice weekly just before or after radiation treatment for 6 weeks; patients in the control group were asked to refrain from practicing yoga until after treatment was complete.

“We show that it was clearly feasible to do this type of research … and that there is some initial indication of efficacy,” Dr. Cohen said.

Further analysis, including analysis of 1-month and 3-month patient self-report data and of immune function and cortisol levels (from blood tests and saliva samples, respectively) is planned, and a follow-up study funded by the National Cancer Institute is underway. The study will compare daily yoga, daily stretching exercises, and standard care in a similar patient population, and this will help gauge whether there is something specific to yoga, or if something as simple as stretching can be helpful, he noted.

A study of the effects of Tibetan yoga in women with breast cancer who are undergoing chemotherapy also is planned, he said.

HOLLYWOOD, FLA. — Remifentanil was found to be effective and safe for labor analgesia in a small randomized controlled study, Dr. Mrinalini Balki reported at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

A total of 15 women were randomized to receive either a fixed bolus/increasing infusion regimen, or a fixed infusion/increasing bolus regimen of the short-acting opioid analgesic.

The groups had similar overall median satisfaction scores (9 and 9 on a 0–10 scale), and pain scores (6 and 7 on a 0–10 scale), but maternal side effects were more common in the fixed infusion group, and pain control appeared to be less effective in that group, said Dr. Balki of the University of Toronto.

For example, 38% in the fixed bolus group, compared with 100% in the fixed infusion group, experienced drowsiness. Desaturation was noted in 13% in the fixed bolus group, compared with 57% in the fixed infusion group. And effective pain control, as measured by successful patient-controlled analgesia attempts (74% vs. 56%) and drug consumption (407 ng vs. 532 ng), was more common in the fixed bolus group.

Patients in both groups were treated with remifentanil infusion at 0.025 mcg/kg per minute, and patients were offered a patient-controlled analgesia bolus of 0.25 mcg/kg, with a lockout interval of 2 minutes.

The fixed-bolus group had infusions increased in a stepwise manner from 0.025 to 0.05, 0.075, and 0.1 mcg/kg minute as needed, and the bolus was fixed at 0.25 mcg/kg.

In the fixed infusion group, the infusion was fixed at 0.025 mcg/kg per minute and the bolus was increased from 0.25 to 0.5, 0.75, and 1 mcg/kg as needed.

Patient satisfaction in both groups was high, despite high pain scores.

This could reflect patient motivation or altered pain perception among those who choose remifentanil, Dr. Balki explained.

Since those in the fixed bolus group had better pain scores and required less drug, this regimen appears superior.

Neonatal safety was also similar in the two groups. A nonreassuring fetal heart rate was noted in one fetus in the fixed-bolus and in none of those in the fixed-infusion group, and Apgar scores were greater than 7 in all babies in both groups, Dr. Balki noted.

HOLLYWOOD, FLA. — Remifentanil was found to be effective and safe for labor analgesia in a small randomized controlled study, Dr. Mrinalini Balki reported at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

A total of 15 women were randomized to receive either a fixed bolus/increasing infusion regimen, or a fixed infusion/increasing bolus regimen of the short-acting opioid analgesic.

The groups had similar overall median satisfaction scores (9 and 9 on a 0–10 scale), and pain scores (6 and 7 on a 0–10 scale), but maternal side effects were more common in the fixed infusion group, and pain control appeared to be less effective in that group, said Dr. Balki of the University of Toronto.

For example, 38% in the fixed bolus group, compared with 100% in the fixed infusion group, experienced drowsiness. Desaturation was noted in 13% in the fixed bolus group, compared with 57% in the fixed infusion group. And effective pain control, as measured by successful patient-controlled analgesia attempts (74% vs. 56%) and drug consumption (407 ng vs. 532 ng), was more common in the fixed bolus group.

Patients in both groups were treated with remifentanil infusion at 0.025 mcg/kg per minute, and patients were offered a patient-controlled analgesia bolus of 0.25 mcg/kg, with a lockout interval of 2 minutes.

The fixed-bolus group had infusions increased in a stepwise manner from 0.025 to 0.05, 0.075, and 0.1 mcg/kg minute as needed, and the bolus was fixed at 0.25 mcg/kg.

In the fixed infusion group, the infusion was fixed at 0.025 mcg/kg per minute and the bolus was increased from 0.25 to 0.5, 0.75, and 1 mcg/kg as needed.

Patient satisfaction in both groups was high, despite high pain scores.

This could reflect patient motivation or altered pain perception among those who choose remifentanil, Dr. Balki explained.

Since those in the fixed bolus group had better pain scores and required less drug, this regimen appears superior.

Neonatal safety was also similar in the two groups. A nonreassuring fetal heart rate was noted in one fetus in the fixed-bolus and in none of those in the fixed-infusion group, and Apgar scores were greater than 7 in all babies in both groups, Dr. Balki noted.

HOLLYWOOD, FLA. — Remifentanil was found to be effective and safe for labor analgesia in a small randomized controlled study, Dr. Mrinalini Balki reported at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

A total of 15 women were randomized to receive either a fixed bolus/increasing infusion regimen, or a fixed infusion/increasing bolus regimen of the short-acting opioid analgesic.

The groups had similar overall median satisfaction scores (9 and 9 on a 0–10 scale), and pain scores (6 and 7 on a 0–10 scale), but maternal side effects were more common in the fixed infusion group, and pain control appeared to be less effective in that group, said Dr. Balki of the University of Toronto.

For example, 38% in the fixed bolus group, compared with 100% in the fixed infusion group, experienced drowsiness. Desaturation was noted in 13% in the fixed bolus group, compared with 57% in the fixed infusion group. And effective pain control, as measured by successful patient-controlled analgesia attempts (74% vs. 56%) and drug consumption (407 ng vs. 532 ng), was more common in the fixed bolus group.

Patients in both groups were treated with remifentanil infusion at 0.025 mcg/kg per minute, and patients were offered a patient-controlled analgesia bolus of 0.25 mcg/kg, with a lockout interval of 2 minutes.

The fixed-bolus group had infusions increased in a stepwise manner from 0.025 to 0.05, 0.075, and 0.1 mcg/kg minute as needed, and the bolus was fixed at 0.25 mcg/kg.

In the fixed infusion group, the infusion was fixed at 0.025 mcg/kg per minute and the bolus was increased from 0.25 to 0.5, 0.75, and 1 mcg/kg as needed.

Patient satisfaction in both groups was high, despite high pain scores.

This could reflect patient motivation or altered pain perception among those who choose remifentanil, Dr. Balki explained.

Since those in the fixed bolus group had better pain scores and required less drug, this regimen appears superior.

Neonatal safety was also similar in the two groups. A nonreassuring fetal heart rate was noted in one fetus in the fixed-bolus and in none of those in the fixed-infusion group, and Apgar scores were greater than 7 in all babies in both groups, Dr. Balki noted.