Kerri Wachter

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Rilpivirine has been approved for the treatment of HIV-1 infection, in combination with other antiretroviral drugs, in treatment-naive adults, according to a statement by the Food and Drug Administration.

The May 20 decision adds an alternative option to the armamentarium of highly active antiretroviral therapies intended to suppress the viral load in the blood.

The approval is based in part on 48-week safety and effectiveness data from two phase III trials involving a total of 1,368 adult patients with HIV infection. In the two trials, rilpivirine was compared with efavirenz, which is also approved for the treatment of HIV infection. Both are non-nucleoside reverse transcriptase inhibitors, which block HIV viral replication. In the study, both agents were given in combination with other antiretroviral therapies, according to the statement.

Rilpivirine was as effective as efavirenz in lowering viral load. After 48 weeks of treatment, 83% and 80% of each group, respectively, had undetectable levels of HIV in their blood. However, fewer patients stopped taking rilpivirine due to side effects that included depression, insomnia, headache, and rash, according to the FDA statement.

Rilpivirine (Edurant) is manufactured by Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

Maintenance therapy with the novel PARP inhibitor olaparib may fill a gap in the treatment of advanced ovarian cancer by significantly delaying progression of the disease, according to the results of a phase II trial that will be presented at the annual meeting of the American Society of Clinical Oncology.

Olaparib extended median progression-free survival by almost 4 months in women who had a partial or complete response to platinum-based chemotherapy for recurring high-grade serous ovarian cancer – 8.4 months with olaparib vs. 4.8 months with placebo (Hazard Ratio .35, P less than .00001).

"This is a very significant difference – a 65% improvement," said the principal investigator Dr. Jonathan A. Ledermann during a May 18 press briefing, where the results were disclosed.

"This is the first study to demonstrate a statistically significant benefit of maintenance treatment for platinum-sensitive, relapsed serous ovarian cancer," noted Dr. Ledermann, a professor of medical oncology at the University College London Cancer Institute.

The results may mean a better quality of life longer for women with this type of ovarian cancer, added Dr. Mark G. Kris, chair of the ASCO Cancer Communications Committee and moderator of the briefing.

This study "fills a previously unmet need for women fighting ovarian cancer ... to lengthen the time that disease is controlled after the complete of successful initial therapy. Generally disease control translates into a normal or near-normal life, which is really the goal of cancer therapy," said Dr. Kris, chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City,

The study was sponsored by AstraZeneca, which is developing olaparib. The drug is among the leading candidates in a new class of agents that inhibit the enzyme poly (adenosine diphosphate-ribose) polymerase (PARP), which is involved in DNA repair. As many as half of women with high-grade serous ovarian cancer may have a DNA repair deficiency, and this makes them more susceptible to death of cancer cells by what is called "synthetic lethality" when treated with PARP inhibitors.

The randomized double-blind placebo-controlled phase II study was conducted at 82 sites in 16 countries. Participants had platinum-sensitive, high-grade serous ovarian cancer (the most common subtype), had undergone at least two platinum regimens, and had maintained a partial or complete response following the last platinum regimen.

A total of 136 women were randomized to 400 mg oral olaparib twice daily and 129 women received placebo. The primary end point was progression-free survival based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Dr. Ledermann reported that half the women on olaparib but only 16 on placebo had not relapsed and were still on treatment at the time of the data analysis. Nausea was present in 68% of patients on olaparib, compared with 35% on placebo; fatigue in 49% vs. 38% and vomiting in 32% vs. 14%, respectively.

"The drug was very well-tolerated. ... These side effects were present in patients on placebo, too, because these are patients who have ovarian cancer, but they were more common in the olaparib group," noted Dr. Ledermann.

"Further studies are now being performed to determine the role of olaparib in the routine treatment of ovarian cancer," he said.

Many of the study authors reported either employment with AstraZeneca or other significant financial relationships with the company and several other drugmakers.

Abstracts of studies to be presented during ASCO are posted online at www.asco.org.

Maintenance therapy with the novel PARP inhibitor olaparib may fill a gap in the treatment of advanced ovarian cancer by significantly delaying progression of the disease, according to the results of a phase II trial that will be presented at the annual meeting of the American Society of Clinical Oncology.

Olaparib extended median progression-free survival by almost 4 months in women who had a partial or complete response to platinum-based chemotherapy for recurring high-grade serous ovarian cancer – 8.4 months with olaparib vs. 4.8 months with placebo (Hazard Ratio .35, P less than .00001).

"This is a very significant difference – a 65% improvement," said the principal investigator Dr. Jonathan A. Ledermann during a May 18 press briefing, where the results were disclosed.

"This is the first study to demonstrate a statistically significant benefit of maintenance treatment for platinum-sensitive, relapsed serous ovarian cancer," noted Dr. Ledermann, a professor of medical oncology at the University College London Cancer Institute.

The results may mean a better quality of life longer for women with this type of ovarian cancer, added Dr. Mark G. Kris, chair of the ASCO Cancer Communications Committee and moderator of the briefing.

This study "fills a previously unmet need for women fighting ovarian cancer ... to lengthen the time that disease is controlled after the complete of successful initial therapy. Generally disease control translates into a normal or near-normal life, which is really the goal of cancer therapy," said Dr. Kris, chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City,

The study was sponsored by AstraZeneca, which is developing olaparib. The drug is among the leading candidates in a new class of agents that inhibit the enzyme poly (adenosine diphosphate-ribose) polymerase (PARP), which is involved in DNA repair. As many as half of women with high-grade serous ovarian cancer may have a DNA repair deficiency, and this makes them more susceptible to death of cancer cells by what is called "synthetic lethality" when treated with PARP inhibitors.

The randomized double-blind placebo-controlled phase II study was conducted at 82 sites in 16 countries. Participants had platinum-sensitive, high-grade serous ovarian cancer (the most common subtype), had undergone at least two platinum regimens, and had maintained a partial or complete response following the last platinum regimen.

A total of 136 women were randomized to 400 mg oral olaparib twice daily and 129 women received placebo. The primary end point was progression-free survival based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Dr. Ledermann reported that half the women on olaparib but only 16 on placebo had not relapsed and were still on treatment at the time of the data analysis. Nausea was present in 68% of patients on olaparib, compared with 35% on placebo; fatigue in 49% vs. 38% and vomiting in 32% vs. 14%, respectively.

"The drug was very well-tolerated. ... These side effects were present in patients on placebo, too, because these are patients who have ovarian cancer, but they were more common in the olaparib group," noted Dr. Ledermann.

"Further studies are now being performed to determine the role of olaparib in the routine treatment of ovarian cancer," he said.

Many of the study authors reported either employment with AstraZeneca or other significant financial relationships with the company and several other drugmakers.

Abstracts of studies to be presented during ASCO are posted online at www.asco.org.

Maintenance therapy with the novel PARP inhibitor olaparib may fill a gap in the treatment of advanced ovarian cancer by significantly delaying progression of the disease, according to the results of a phase II trial that will be presented at the annual meeting of the American Society of Clinical Oncology.

Olaparib extended median progression-free survival by almost 4 months in women who had a partial or complete response to platinum-based chemotherapy for recurring high-grade serous ovarian cancer – 8.4 months with olaparib vs. 4.8 months with placebo (Hazard Ratio .35, P less than .00001).

"This is a very significant difference – a 65% improvement," said the principal investigator Dr. Jonathan A. Ledermann during a May 18 press briefing, where the results were disclosed.

"This is the first study to demonstrate a statistically significant benefit of maintenance treatment for platinum-sensitive, relapsed serous ovarian cancer," noted Dr. Ledermann, a professor of medical oncology at the University College London Cancer Institute.

The results may mean a better quality of life longer for women with this type of ovarian cancer, added Dr. Mark G. Kris, chair of the ASCO Cancer Communications Committee and moderator of the briefing.

This study "fills a previously unmet need for women fighting ovarian cancer ... to lengthen the time that disease is controlled after the complete of successful initial therapy. Generally disease control translates into a normal or near-normal life, which is really the goal of cancer therapy," said Dr. Kris, chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City,

The study was sponsored by AstraZeneca, which is developing olaparib. The drug is among the leading candidates in a new class of agents that inhibit the enzyme poly (adenosine diphosphate-ribose) polymerase (PARP), which is involved in DNA repair. As many as half of women with high-grade serous ovarian cancer may have a DNA repair deficiency, and this makes them more susceptible to death of cancer cells by what is called "synthetic lethality" when treated with PARP inhibitors.

The randomized double-blind placebo-controlled phase II study was conducted at 82 sites in 16 countries. Participants had platinum-sensitive, high-grade serous ovarian cancer (the most common subtype), had undergone at least two platinum regimens, and had maintained a partial or complete response following the last platinum regimen.

A total of 136 women were randomized to 400 mg oral olaparib twice daily and 129 women received placebo. The primary end point was progression-free survival based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Dr. Ledermann reported that half the women on olaparib but only 16 on placebo had not relapsed and were still on treatment at the time of the data analysis. Nausea was present in 68% of patients on olaparib, compared with 35% on placebo; fatigue in 49% vs. 38% and vomiting in 32% vs. 14%, respectively.

"The drug was very well-tolerated. ... These side effects were present in patients on placebo, too, because these are patients who have ovarian cancer, but they were more common in the olaparib group," noted Dr. Ledermann.

"Further studies are now being performed to determine the role of olaparib in the routine treatment of ovarian cancer," he said.

Many of the study authors reported either employment with AstraZeneca or other significant financial relationships with the company and several other drugmakers.

Abstracts of studies to be presented during ASCO are posted online at www.asco.org.

Maintenance therapy with the novel PARP inhibitor olaparib may fill a gap in the treatment of advanced ovarian cancer by significantly delaying progression of the disease, according to the results of a phase II trial that will be presented at the annual meeting of the American Society of Clinical Oncology.

Olaparib extended median progression-free survival by almost 4 months in women who had a partial or complete response to platinum-based chemotherapy for recurring high-grade serous ovarian cancer – 8.4 months with olaparib vs. 4.8 months with placebo (Hazard Ratio .35, P less than .00001).

"This is a very significant difference – a 65% improvement," said the principal investigator Dr. Jonathan A. Ledermann during a May 18 press briefing, where the results were disclosed.

"This is the first study to demonstrate a statistically significant benefit of maintenance treatment for platinum-sensitive, relapsed serous ovarian cancer," noted Dr. Ledermann, a professor of medical oncology at the University College London Cancer Institute.

The results may mean a better quality of life longer for women with this type of ovarian cancer, added Dr. Mark G. Kris, chair of the ASCO Cancer Communications Committee and moderator of the briefing.

This study "fills a previously unmet need for women fighting ovarian cancer ... to lengthen the time that disease is controlled after the complete of successful initial therapy. Generally disease control translates into a normal or near-normal life, which is really the goal of cancer therapy," said Dr. Kris, chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City,

The study was sponsored by AstraZeneca, which is developing olaparib. The drug is among the leading candidates in a new class of agents that inhibit the enzyme poly (adenosine diphosphate-ribose) polymerase (PARP), which is involved in DNA repair. As many as half of women with high-grade serous ovarian cancer may have a DNA repair deficiency, and this makes them more susceptible to death of cancer cells by what is called "synthetic lethality" when treated with PARP inhibitors.

The randomized double-blind placebo-controlled phase II study was conducted at 82 sites in 16 countries. Participants had platinum-sensitive, high-grade serous ovarian cancer (the most common subtype), had undergone at least two platinum regimens, and had maintained a partial or complete response following the last platinum regimen.

A total of 136 women were randomized to 400 mg oral olaparib twice daily and 129 women received placebo. The primary end point was progression-free survival based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Dr. Ledermann reported that half the women on olaparib but only 16 on placebo had not relapsed and were still on treatment at the time of the data analysis. Nausea was present in 68% of patients on olaparib, compared with 35% on placebo; fatigue in 49% vs. 38% and vomiting in 32% vs. 14%, respectively.

"The drug was very well-tolerated. ... These side effects were present in patients on placebo, too, because these are patients who have ovarian cancer, but they were more common in the olaparib group," noted Dr. Ledermann.

"Further studies are now being performed to determine the role of olaparib in the routine treatment of ovarian cancer," he said.

Many of the study authors reported either employment with AstraZeneca or other significant financial relationships with the company and several other drugmakers.

Abstracts of studies to be presented during ASCO are posted online at www.asco.org.

Maintenance therapy with the novel PARP inhibitor olaparib may fill a gap in the treatment of advanced ovarian cancer by significantly delaying progression of the disease, according to the results of a phase II trial that will be presented at the annual meeting of the American Society of Clinical Oncology.

Olaparib extended median progression-free survival by almost 4 months in women who had a partial or complete response to platinum-based chemotherapy for recurring high-grade serous ovarian cancer – 8.4 months with olaparib vs. 4.8 months with placebo (Hazard Ratio .35, P less than .00001).

"This is a very significant difference – a 65% improvement," said the principal investigator Dr. Jonathan A. Ledermann during a May 18 press briefing, where the results were disclosed.

"This is the first study to demonstrate a statistically significant benefit of maintenance treatment for platinum-sensitive, relapsed serous ovarian cancer," noted Dr. Ledermann, a professor of medical oncology at the University College London Cancer Institute.

The results may mean a better quality of life longer for women with this type of ovarian cancer, added Dr. Mark G. Kris, chair of the ASCO Cancer Communications Committee and moderator of the briefing.

This study "fills a previously unmet need for women fighting ovarian cancer ... to lengthen the time that disease is controlled after the complete of successful initial therapy. Generally disease control translates into a normal or near-normal life, which is really the goal of cancer therapy," said Dr. Kris, chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City,

The study was sponsored by AstraZeneca, which is developing olaparib. The drug is among the leading candidates in a new class of agents that inhibit the enzyme poly (adenosine diphosphate-ribose) polymerase (PARP), which is involved in DNA repair. As many as half of women with high-grade serous ovarian cancer may have a DNA repair deficiency, and this makes them more susceptible to death of cancer cells by what is called "synthetic lethality" when treated with PARP inhibitors.

The randomized double-blind placebo-controlled phase II study was conducted at 82 sites in 16 countries. Participants had platinum-sensitive, high-grade serous ovarian cancer (the most common subtype), had undergone at least two platinum regimens, and had maintained a partial or complete response following the last platinum regimen.

A total of 136 women were randomized to 400 mg oral olaparib twice daily and 129 women received placebo. The primary end point was progression-free survival based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Dr. Ledermann reported that half the women on olaparib but only 16 on placebo had not relapsed and were still on treatment at the time of the data analysis. Nausea was present in 68% of patients on olaparib, compared with 35% on placebo; fatigue in 49% vs. 38% and vomiting in 32% vs. 14%, respectively.

"The drug was very well-tolerated. ... These side effects were present in patients on placebo, too, because these are patients who have ovarian cancer, but they were more common in the olaparib group," noted Dr. Ledermann.

"Further studies are now being performed to determine the role of olaparib in the routine treatment of ovarian cancer," he said.

Many of the study authors reported either employment with AstraZeneca or other significant financial relationships with the company and several other drugmakers.

Abstracts of studies to be presented during ASCO are posted online at www.asco.org.

Maintenance therapy with the novel PARP inhibitor olaparib may fill a gap in the treatment of advanced ovarian cancer by significantly delaying progression of the disease, according to the results of a phase II trial that will be presented at the annual meeting of the American Society of Clinical Oncology.

Olaparib extended median progression-free survival by almost 4 months in women who had a partial or complete response to platinum-based chemotherapy for recurring high-grade serous ovarian cancer – 8.4 months with olaparib vs. 4.8 months with placebo (Hazard Ratio .35, P less than .00001).

"This is a very significant difference – a 65% improvement," said the principal investigator Dr. Jonathan A. Ledermann during a May 18 press briefing, where the results were disclosed.

"This is the first study to demonstrate a statistically significant benefit of maintenance treatment for platinum-sensitive, relapsed serous ovarian cancer," noted Dr. Ledermann, a professor of medical oncology at the University College London Cancer Institute.

The results may mean a better quality of life longer for women with this type of ovarian cancer, added Dr. Mark G. Kris, chair of the ASCO Cancer Communications Committee and moderator of the briefing.

This study "fills a previously unmet need for women fighting ovarian cancer ... to lengthen the time that disease is controlled after the complete of successful initial therapy. Generally disease control translates into a normal or near-normal life, which is really the goal of cancer therapy," said Dr. Kris, chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City,

The study was sponsored by AstraZeneca, which is developing olaparib. The drug is among the leading candidates in a new class of agents that inhibit the enzyme poly (adenosine diphosphate-ribose) polymerase (PARP), which is involved in DNA repair. As many as half of women with high-grade serous ovarian cancer may have a DNA repair deficiency, and this makes them more susceptible to death of cancer cells by what is called "synthetic lethality" when treated with PARP inhibitors.

The randomized double-blind placebo-controlled phase II study was conducted at 82 sites in 16 countries. Participants had platinum-sensitive, high-grade serous ovarian cancer (the most common subtype), had undergone at least two platinum regimens, and had maintained a partial or complete response following the last platinum regimen.

A total of 136 women were randomized to 400 mg oral olaparib twice daily and 129 women received placebo. The primary end point was progression-free survival based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Dr. Ledermann reported that half the women on olaparib but only 16 on placebo had not relapsed and were still on treatment at the time of the data analysis. Nausea was present in 68% of patients on olaparib, compared with 35% on placebo; fatigue in 49% vs. 38% and vomiting in 32% vs. 14%, respectively.

"The drug was very well-tolerated. ... These side effects were present in patients on placebo, too, because these are patients who have ovarian cancer, but they were more common in the olaparib group," noted Dr. Ledermann.

"Further studies are now being performed to determine the role of olaparib in the routine treatment of ovarian cancer," he said.

Many of the study authors reported either employment with AstraZeneca or other significant financial relationships with the company and several other drugmakers.

Abstracts of studies to be presented during ASCO are posted online at www.asco.org.

Maintenance therapy with the novel PARP inhibitor olaparib may fill a gap in the treatment of advanced ovarian cancer by significantly delaying progression of the disease, according to the results of a phase II trial that will be presented at the annual meeting of the American Society of Clinical Oncology.

Olaparib extended median progression-free survival by almost 4 months in women who had a partial or complete response to platinum-based chemotherapy for recurring high-grade serous ovarian cancer – 8.4 months with olaparib vs. 4.8 months with placebo (Hazard Ratio .35, P less than .00001).

"This is a very significant difference – a 65% improvement," said the principal investigator Dr. Jonathan A. Ledermann during a May 18 press briefing, where the results were disclosed.

"This is the first study to demonstrate a statistically significant benefit of maintenance treatment for platinum-sensitive, relapsed serous ovarian cancer," noted Dr. Ledermann, a professor of medical oncology at the University College London Cancer Institute.

The results may mean a better quality of life longer for women with this type of ovarian cancer, added Dr. Mark G. Kris, chair of the ASCO Cancer Communications Committee and moderator of the briefing.

This study "fills a previously unmet need for women fighting ovarian cancer ... to lengthen the time that disease is controlled after the complete of successful initial therapy. Generally disease control translates into a normal or near-normal life, which is really the goal of cancer therapy," said Dr. Kris, chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City,

The study was sponsored by AstraZeneca, which is developing olaparib. The drug is among the leading candidates in a new class of agents that inhibit the enzyme poly (adenosine diphosphate-ribose) polymerase (PARP), which is involved in DNA repair. As many as half of women with high-grade serous ovarian cancer may have a DNA repair deficiency, and this makes them more susceptible to death of cancer cells by what is called "synthetic lethality" when treated with PARP inhibitors.

The randomized double-blind placebo-controlled phase II study was conducted at 82 sites in 16 countries. Participants had platinum-sensitive, high-grade serous ovarian cancer (the most common subtype), had undergone at least two platinum regimens, and had maintained a partial or complete response following the last platinum regimen.

A total of 136 women were randomized to 400 mg oral olaparib twice daily and 129 women received placebo. The primary end point was progression-free survival based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Dr. Ledermann reported that half the women on olaparib but only 16 on placebo had not relapsed and were still on treatment at the time of the data analysis. Nausea was present in 68% of patients on olaparib, compared with 35% on placebo; fatigue in 49% vs. 38% and vomiting in 32% vs. 14%, respectively.

"The drug was very well-tolerated. ... These side effects were present in patients on placebo, too, because these are patients who have ovarian cancer, but they were more common in the olaparib group," noted Dr. Ledermann.

"Further studies are now being performed to determine the role of olaparib in the routine treatment of ovarian cancer," he said.

Many of the study authors reported either employment with AstraZeneca or other significant financial relationships with the company and several other drugmakers.

Abstracts of studies to be presented during ASCO are posted online at www.asco.org.

Maintenance therapy with the novel PARP inhibitor olaparib may fill a gap in the treatment of advanced ovarian cancer by significantly delaying progression of the disease, according to the results of a phase II trial that will be presented at the annual meeting of the American Society of Clinical Oncology.

Olaparib extended median progression-free survival by almost 4 months in women who had a partial or complete response to platinum-based chemotherapy for recurring high-grade serous ovarian cancer – 8.4 months with olaparib vs. 4.8 months with placebo (Hazard Ratio .35, P less than .00001).

"This is a very significant difference – a 65% improvement," said the principal investigator Dr. Jonathan A. Ledermann during a May 18 press briefing, where the results were disclosed.

"This is the first study to demonstrate a statistically significant benefit of maintenance treatment for platinum-sensitive, relapsed serous ovarian cancer," noted Dr. Ledermann, a professor of medical oncology at the University College London Cancer Institute.

The results may mean a better quality of life longer for women with this type of ovarian cancer, added Dr. Mark G. Kris, chair of the ASCO Cancer Communications Committee and moderator of the briefing.

This study "fills a previously unmet need for women fighting ovarian cancer ... to lengthen the time that disease is controlled after the complete of successful initial therapy. Generally disease control translates into a normal or near-normal life, which is really the goal of cancer therapy," said Dr. Kris, chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City,

The study was sponsored by AstraZeneca, which is developing olaparib. The drug is among the leading candidates in a new class of agents that inhibit the enzyme poly (adenosine diphosphate-ribose) polymerase (PARP), which is involved in DNA repair. As many as half of women with high-grade serous ovarian cancer may have a DNA repair deficiency, and this makes them more susceptible to death of cancer cells by what is called "synthetic lethality" when treated with PARP inhibitors.

The randomized double-blind placebo-controlled phase II study was conducted at 82 sites in 16 countries. Participants had platinum-sensitive, high-grade serous ovarian cancer (the most common subtype), had undergone at least two platinum regimens, and had maintained a partial or complete response following the last platinum regimen.

A total of 136 women were randomized to 400 mg oral olaparib twice daily and 129 women received placebo. The primary end point was progression-free survival based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Dr. Ledermann reported that half the women on olaparib but only 16 on placebo had not relapsed and were still on treatment at the time of the data analysis. Nausea was present in 68% of patients on olaparib, compared with 35% on placebo; fatigue in 49% vs. 38% and vomiting in 32% vs. 14%, respectively.

"The drug was very well-tolerated. ... These side effects were present in patients on placebo, too, because these are patients who have ovarian cancer, but they were more common in the olaparib group," noted Dr. Ledermann.

"Further studies are now being performed to determine the role of olaparib in the routine treatment of ovarian cancer," he said.

Many of the study authors reported either employment with AstraZeneca or other significant financial relationships with the company and several other drugmakers.

Abstracts of studies to be presented during ASCO are posted online at www.asco.org.

Maintenance therapy with the novel PARP inhibitor olaparib may fill a gap in the treatment of advanced ovarian cancer by significantly delaying progression of the disease, according to the results of a phase II trial that will be presented at the annual meeting of the American Society of Clinical Oncology.

Olaparib extended median progression-free survival by almost 4 months in women who had a partial or complete response to platinum-based chemotherapy for recurring high-grade serous ovarian cancer – 8.4 months with olaparib vs. 4.8 months with placebo (Hazard Ratio .35, P less than .00001).

"This is a very significant difference – a 65% improvement," said the principal investigator Dr. Jonathan A. Ledermann during a May 18 press briefing, where the results were disclosed.

"This is the first study to demonstrate a statistically significant benefit of maintenance treatment for platinum-sensitive, relapsed serous ovarian cancer," noted Dr. Ledermann, a professor of medical oncology at the University College London Cancer Institute.

The results may mean a better quality of life longer for women with this type of ovarian cancer, added Dr. Mark G. Kris, chair of the ASCO Cancer Communications Committee and moderator of the briefing.

This study "fills a previously unmet need for women fighting ovarian cancer ... to lengthen the time that disease is controlled after the complete of successful initial therapy. Generally disease control translates into a normal or near-normal life, which is really the goal of cancer therapy," said Dr. Kris, chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City,

The study was sponsored by AstraZeneca, which is developing olaparib. The drug is among the leading candidates in a new class of agents that inhibit the enzyme poly (adenosine diphosphate-ribose) polymerase (PARP), which is involved in DNA repair. As many as half of women with high-grade serous ovarian cancer may have a DNA repair deficiency, and this makes them more susceptible to death of cancer cells by what is called "synthetic lethality" when treated with PARP inhibitors.

The randomized double-blind placebo-controlled phase II study was conducted at 82 sites in 16 countries. Participants had platinum-sensitive, high-grade serous ovarian cancer (the most common subtype), had undergone at least two platinum regimens, and had maintained a partial or complete response following the last platinum regimen.

A total of 136 women were randomized to 400 mg oral olaparib twice daily and 129 women received placebo. The primary end point was progression-free survival based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Dr. Ledermann reported that half the women on olaparib but only 16 on placebo had not relapsed and were still on treatment at the time of the data analysis. Nausea was present in 68% of patients on olaparib, compared with 35% on placebo; fatigue in 49% vs. 38% and vomiting in 32% vs. 14%, respectively.

"The drug was very well-tolerated. ... These side effects were present in patients on placebo, too, because these are patients who have ovarian cancer, but they were more common in the olaparib group," noted Dr. Ledermann.

"Further studies are now being performed to determine the role of olaparib in the routine treatment of ovarian cancer," he said.

Many of the study authors reported either employment with AstraZeneca or other significant financial relationships with the company and several other drugmakers.

Abstracts of studies to be presented during ASCO are posted online at www.asco.org.

Results from a large study confirm that women who test negative for human papillomavirus and who have a normal Pap test when screened for cervical cancer can safely wait 3 years before being retested.

Moreover, the findings strongly suggest that a negative HPV test alone is the more important measure, and could be adequate by itself to extend the testing interval to 3 years.

Investigators deemed the 5-year risk of cervical cancer with a negative HPV test to be "extremely low," at just 3.8/100,000 women per year in the study of 331,818 women who underwent routine co-testing in a managed health plan.

Having a normal Pap test on top of a negative HPV test did not much improve a woman’s chances of not having cervical cancer. The 5-year risk of cancer with good results on both measures was 3.2/100,000 women per year, but the difference between HPV testing alone and co-testing was not significant (P = .8). For all women who had a normal Pap smear, the 5-year risk of cervical cancer with a normal Pap test was 7.5/100,000 women per year (P = .03).

"These findings demonstrate the safety of current guidelines, which recommend a 3-year screening interval for women who test negative for HPV and Pap test," lead author Hormuzd Katki, Ph.D., said during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June.

In addition, "we concluded that a single negative HPV test provided 5 years of extremely low cancer risk for women, and this risk was not appreciably lowered by also having a normal Pap test," said Dr. Katki, a principal investigator in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute.

Screening guidelines from several medical organizations, such as the American College of Obstetricians and Gynecologists and the American Cancer Society, have endorsed concurrent HPV and Pap testing as a safe alternative to Pap testing alone for women aged 30 years and older. These organizations also recommend co-testing every 3 years for women who are HPV negative and have a normal Pap test.

However, there had been no data on the safety of these guidelines in routine clinical practice.

The current study included women aged 30 years and older who enrolled in Kaiser Permanente Northern California’s co-testing program between 2003 and 2005 for 5 years. "I found this to be just a wonderful population-based study from a large real-world experience," said Dr. George W. Sledge Jr., ASCO’s president and Ballve-Lantero Professor of Oncology at Indiana University, Indianapolis.

HPV testing identified more women with a high 5-year risk of cervical cancer or precancer than Pap testing alone. The 5-year risk for HPV-positive women was 7.6%, compared with 4.7% for an abnormal Pap test. "This shows that the HPV test is better able to separate women into categories of high risk of cancer and low risk of cancer," said Dr. Katki. "However, that does not mean that the Pap test is useless. ... When we combine HPV testing and Pap testing, we can get something even better."

For women who tested HPV positive, there were an additional 6 per 100 women who were found to have cervical cancer or precancer if they had a positive Pap test. Most of that extra 6% was found at enrollment in the co-testing program. This "shows that the Pap test is able to identify women who had immediate disease," said Dr. Katki.

"These findings suggest that all HPV-negative women could potentially safely return no earlier than 3 years," he added. Pap testing might be reserved for HPV-positive women. However this will require further testing to verify.

"In the Kaiser population, this would have reduced the number of Pap tests by 95%, and could potentially retain all of the safety of co-testing," said Dr. Katki

The data were provided by Kaiser Permanente and analyzed by researchers at the National Cancer Institute. The authors reported that they have no relevant disclosures.

Results from a large study confirm that women who test negative for human papillomavirus and who have a normal Pap test when screened for cervical cancer can safely wait 3 years before being retested.

Moreover, the findings strongly suggest that a negative HPV test alone is the more important measure, and could be adequate by itself to extend the testing interval to 3 years.

Investigators deemed the 5-year risk of cervical cancer with a negative HPV test to be "extremely low," at just 3.8/100,000 women per year in the study of 331,818 women who underwent routine co-testing in a managed health plan.

Having a normal Pap test on top of a negative HPV test did not much improve a woman’s chances of not having cervical cancer. The 5-year risk of cancer with good results on both measures was 3.2/100,000 women per year, but the difference between HPV testing alone and co-testing was not significant (P = .8). For all women who had a normal Pap smear, the 5-year risk of cervical cancer with a normal Pap test was 7.5/100,000 women per year (P = .03).

"These findings demonstrate the safety of current guidelines, which recommend a 3-year screening interval for women who test negative for HPV and Pap test," lead author Hormuzd Katki, Ph.D., said during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June.

In addition, "we concluded that a single negative HPV test provided 5 years of extremely low cancer risk for women, and this risk was not appreciably lowered by also having a normal Pap test," said Dr. Katki, a principal investigator in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute.

Screening guidelines from several medical organizations, such as the American College of Obstetricians and Gynecologists and the American Cancer Society, have endorsed concurrent HPV and Pap testing as a safe alternative to Pap testing alone for women aged 30 years and older. These organizations also recommend co-testing every 3 years for women who are HPV negative and have a normal Pap test.

However, there had been no data on the safety of these guidelines in routine clinical practice.

The current study included women aged 30 years and older who enrolled in Kaiser Permanente Northern California’s co-testing program between 2003 and 2005 for 5 years. "I found this to be just a wonderful population-based study from a large real-world experience," said Dr. George W. Sledge Jr., ASCO’s president and Ballve-Lantero Professor of Oncology at Indiana University, Indianapolis.

HPV testing identified more women with a high 5-year risk of cervical cancer or precancer than Pap testing alone. The 5-year risk for HPV-positive women was 7.6%, compared with 4.7% for an abnormal Pap test. "This shows that the HPV test is better able to separate women into categories of high risk of cancer and low risk of cancer," said Dr. Katki. "However, that does not mean that the Pap test is useless. ... When we combine HPV testing and Pap testing, we can get something even better."

For women who tested HPV positive, there were an additional 6 per 100 women who were found to have cervical cancer or precancer if they had a positive Pap test. Most of that extra 6% was found at enrollment in the co-testing program. This "shows that the Pap test is able to identify women who had immediate disease," said Dr. Katki.

"These findings suggest that all HPV-negative women could potentially safely return no earlier than 3 years," he added. Pap testing might be reserved for HPV-positive women. However this will require further testing to verify.

"In the Kaiser population, this would have reduced the number of Pap tests by 95%, and could potentially retain all of the safety of co-testing," said Dr. Katki

The data were provided by Kaiser Permanente and analyzed by researchers at the National Cancer Institute. The authors reported that they have no relevant disclosures.

Results from a large study confirm that women who test negative for human papillomavirus and who have a normal Pap test when screened for cervical cancer can safely wait 3 years before being retested.

Moreover, the findings strongly suggest that a negative HPV test alone is the more important measure, and could be adequate by itself to extend the testing interval to 3 years.

Investigators deemed the 5-year risk of cervical cancer with a negative HPV test to be "extremely low," at just 3.8/100,000 women per year in the study of 331,818 women who underwent routine co-testing in a managed health plan.

Having a normal Pap test on top of a negative HPV test did not much improve a woman’s chances of not having cervical cancer. The 5-year risk of cancer with good results on both measures was 3.2/100,000 women per year, but the difference between HPV testing alone and co-testing was not significant (P = .8). For all women who had a normal Pap smear, the 5-year risk of cervical cancer with a normal Pap test was 7.5/100,000 women per year (P = .03).

"These findings demonstrate the safety of current guidelines, which recommend a 3-year screening interval for women who test negative for HPV and Pap test," lead author Hormuzd Katki, Ph.D., said during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June.

In addition, "we concluded that a single negative HPV test provided 5 years of extremely low cancer risk for women, and this risk was not appreciably lowered by also having a normal Pap test," said Dr. Katki, a principal investigator in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute.

Screening guidelines from several medical organizations, such as the American College of Obstetricians and Gynecologists and the American Cancer Society, have endorsed concurrent HPV and Pap testing as a safe alternative to Pap testing alone for women aged 30 years and older. These organizations also recommend co-testing every 3 years for women who are HPV negative and have a normal Pap test.

However, there had been no data on the safety of these guidelines in routine clinical practice.

The current study included women aged 30 years and older who enrolled in Kaiser Permanente Northern California’s co-testing program between 2003 and 2005 for 5 years. "I found this to be just a wonderful population-based study from a large real-world experience," said Dr. George W. Sledge Jr., ASCO’s president and Ballve-Lantero Professor of Oncology at Indiana University, Indianapolis.

HPV testing identified more women with a high 5-year risk of cervical cancer or precancer than Pap testing alone. The 5-year risk for HPV-positive women was 7.6%, compared with 4.7% for an abnormal Pap test. "This shows that the HPV test is better able to separate women into categories of high risk of cancer and low risk of cancer," said Dr. Katki. "However, that does not mean that the Pap test is useless. ... When we combine HPV testing and Pap testing, we can get something even better."

For women who tested HPV positive, there were an additional 6 per 100 women who were found to have cervical cancer or precancer if they had a positive Pap test. Most of that extra 6% was found at enrollment in the co-testing program. This "shows that the Pap test is able to identify women who had immediate disease," said Dr. Katki.

"These findings suggest that all HPV-negative women could potentially safely return no earlier than 3 years," he added. Pap testing might be reserved for HPV-positive women. However this will require further testing to verify.

"In the Kaiser population, this would have reduced the number of Pap tests by 95%, and could potentially retain all of the safety of co-testing," said Dr. Katki

The data were provided by Kaiser Permanente and analyzed by researchers at the National Cancer Institute. The authors reported that they have no relevant disclosures.

Results from a large study confirm that women who test negative for human papillomavirus and who have a normal Pap test when screened for cervical cancer can safely wait 3 years before being retested.

Moreover, the findings strongly suggest that a negative HPV test alone is the more important measure, and could be adequate by itself to extend the testing interval to 3 years.

Investigators deemed the 5-year risk of cervical cancer with a negative HPV test to be "extremely low," at just 3.8/100,000 women per year in the study of 331,818 women who underwent routine co-testing in a managed health plan.

Having a normal Pap test on top of a negative HPV test did not much improve a woman’s chances of not having cervical cancer. The 5-year risk of cancer with good results on both measures was 3.2/100,000 women per year, but the difference between HPV testing alone and co-testing was not significant (P = .8). For all women who had a normal Pap smear, the 5-year risk of cervical cancer with a normal Pap test was 7.5/100,000 women per year (P = .03).

"These findings demonstrate the safety of current guidelines, which recommend a 3-year screening interval for women who test negative for HPV and Pap test," lead author Hormuzd Katki, Ph.D., said during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June.

In addition, "we concluded that a single negative HPV test provided 5 years of extremely low cancer risk for women, and this risk was not appreciably lowered by also having a normal Pap test," said Dr. Katki, a principal investigator in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute.

Screening guidelines from several medical organizations, such as the American College of Obstetricians and Gynecologists and the American Cancer Society, have endorsed concurrent HPV and Pap testing as a safe alternative to Pap testing alone for women aged 30 years and older. These organizations also recommend co-testing every 3 years for women who are HPV negative and have a normal Pap test.

However, there had been no data on the safety of these guidelines in routine clinical practice.

The current study included women aged 30 years and older who enrolled in Kaiser Permanente Northern California’s co-testing program between 2003 and 2005 for 5 years. "I found this to be just a wonderful population-based study from a large real-world experience," said Dr. George W. Sledge Jr., ASCO’s president and Ballve-Lantero Professor of Oncology at Indiana University, Indianapolis.

HPV testing identified more women with a high 5-year risk of cervical cancer or precancer than Pap testing alone. The 5-year risk for HPV-positive women was 7.6%, compared with 4.7% for an abnormal Pap test. "This shows that the HPV test is better able to separate women into categories of high risk of cancer and low risk of cancer," said Dr. Katki. "However, that does not mean that the Pap test is useless. ... When we combine HPV testing and Pap testing, we can get something even better."

For women who tested HPV positive, there were an additional 6 per 100 women who were found to have cervical cancer or precancer if they had a positive Pap test. Most of that extra 6% was found at enrollment in the co-testing program. This "shows that the Pap test is able to identify women who had immediate disease," said Dr. Katki.

"These findings suggest that all HPV-negative women could potentially safely return no earlier than 3 years," he added. Pap testing might be reserved for HPV-positive women. However this will require further testing to verify.

"In the Kaiser population, this would have reduced the number of Pap tests by 95%, and could potentially retain all of the safety of co-testing," said Dr. Katki

The data were provided by Kaiser Permanente and analyzed by researchers at the National Cancer Institute. The authors reported that they have no relevant disclosures.

Results from a large study confirm that women who test negative for human papillomavirus and who have a normal Pap test when screened for cervical cancer can safely wait 3 years before being retested.

Moreover, the findings strongly suggest that a negative HPV test alone is the more important measure, and could be adequate by itself to extend the testing interval to 3 years.

Investigators deemed the 5-year risk of cervical cancer with a negative HPV test to be "extremely low," at just 3.8/100,000 women per year in the study of 331,818 women who underwent routine co-testing in a managed health plan.

Having a normal Pap test on top of a negative HPV test did not much improve a woman’s chances of not having cervical cancer. The 5-year risk of cancer with good results on both measures was 3.2/100,000 women per year, but the difference between HPV testing alone and co-testing was not significant (P = .8). For all women who had a normal Pap smear, the 5-year risk of cervical cancer with a normal Pap test was 7.5/100,000 women per year (P = .03).

"These findings demonstrate the safety of current guidelines, which recommend a 3-year screening interval for women who test negative for HPV and Pap test," lead author Hormuzd Katki, Ph.D., said during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June.

In addition, "we concluded that a single negative HPV test provided 5 years of extremely low cancer risk for women, and this risk was not appreciably lowered by also having a normal Pap test," said Dr. Katki, a principal investigator in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute.

Screening guidelines from several medical organizations, such as the American College of Obstetricians and Gynecologists and the American Cancer Society, have endorsed concurrent HPV and Pap testing as a safe alternative to Pap testing alone for women aged 30 years and older. These organizations also recommend co-testing every 3 years for women who are HPV negative and have a normal Pap test.

However, there had been no data on the safety of these guidelines in routine clinical practice.

The current study included women aged 30 years and older who enrolled in Kaiser Permanente Northern California’s co-testing program between 2003 and 2005 for 5 years. "I found this to be just a wonderful population-based study from a large real-world experience," said Dr. George W. Sledge Jr., ASCO’s president and Ballve-Lantero Professor of Oncology at Indiana University, Indianapolis.

HPV testing identified more women with a high 5-year risk of cervical cancer or precancer than Pap testing alone. The 5-year risk for HPV-positive women was 7.6%, compared with 4.7% for an abnormal Pap test. "This shows that the HPV test is better able to separate women into categories of high risk of cancer and low risk of cancer," said Dr. Katki. "However, that does not mean that the Pap test is useless. ... When we combine HPV testing and Pap testing, we can get something even better."

For women who tested HPV positive, there were an additional 6 per 100 women who were found to have cervical cancer or precancer if they had a positive Pap test. Most of that extra 6% was found at enrollment in the co-testing program. This "shows that the Pap test is able to identify women who had immediate disease," said Dr. Katki.

"These findings suggest that all HPV-negative women could potentially safely return no earlier than 3 years," he added. Pap testing might be reserved for HPV-positive women. However this will require further testing to verify.

"In the Kaiser population, this would have reduced the number of Pap tests by 95%, and could potentially retain all of the safety of co-testing," said Dr. Katki

The data were provided by Kaiser Permanente and analyzed by researchers at the National Cancer Institute. The authors reported that they have no relevant disclosures.

Results from a large study confirm that women who test negative for human papillomavirus and who have a normal Pap test when screened for cervical cancer can safely wait 3 years before being retested.

Moreover, the findings strongly suggest that a negative HPV test alone is the more important measure, and could be adequate by itself to extend the testing interval to 3 years.

Investigators deemed the 5-year risk of cervical cancer with a negative HPV test to be "extremely low," at just 3.8/100,000 women per year in the study of 331,818 women who underwent routine co-testing in a managed health plan.

Having a normal Pap test on top of a negative HPV test did not much improve a woman’s chances of not having cervical cancer. The 5-year risk of cancer with good results on both measures was 3.2/100,000 women per year, but the difference between HPV testing alone and co-testing was not significant (P = .8). For all women who had a normal Pap smear, the 5-year risk of cervical cancer with a normal Pap test was 7.5/100,000 women per year (P = .03).

"These findings demonstrate the safety of current guidelines, which recommend a 3-year screening interval for women who test negative for HPV and Pap test," lead author Hormuzd Katki, Ph.D., said during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June.

In addition, "we concluded that a single negative HPV test provided 5 years of extremely low cancer risk for women, and this risk was not appreciably lowered by also having a normal Pap test," said Dr. Katki, a principal investigator in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute.

Screening guidelines from several medical organizations, such as the American College of Obstetricians and Gynecologists and the American Cancer Society, have endorsed concurrent HPV and Pap testing as a safe alternative to Pap testing alone for women aged 30 years and older. These organizations also recommend co-testing every 3 years for women who are HPV negative and have a normal Pap test.

However, there had been no data on the safety of these guidelines in routine clinical practice.

The current study included women aged 30 years and older who enrolled in Kaiser Permanente Northern California’s co-testing program between 2003 and 2005 for 5 years. "I found this to be just a wonderful population-based study from a large real-world experience," said Dr. George W. Sledge Jr., ASCO’s president and Ballve-Lantero Professor of Oncology at Indiana University, Indianapolis.

HPV testing identified more women with a high 5-year risk of cervical cancer or precancer than Pap testing alone. The 5-year risk for HPV-positive women was 7.6%, compared with 4.7% for an abnormal Pap test. "This shows that the HPV test is better able to separate women into categories of high risk of cancer and low risk of cancer," said Dr. Katki. "However, that does not mean that the Pap test is useless. ... When we combine HPV testing and Pap testing, we can get something even better."

For women who tested HPV positive, there were an additional 6 per 100 women who were found to have cervical cancer or precancer if they had a positive Pap test. Most of that extra 6% was found at enrollment in the co-testing program. This "shows that the Pap test is able to identify women who had immediate disease," said Dr. Katki.

"These findings suggest that all HPV-negative women could potentially safely return no earlier than 3 years," he added. Pap testing might be reserved for HPV-positive women. However this will require further testing to verify.

"In the Kaiser population, this would have reduced the number of Pap tests by 95%, and could potentially retain all of the safety of co-testing," said Dr. Katki

The data were provided by Kaiser Permanente and analyzed by researchers at the National Cancer Institute. The authors reported that they have no relevant disclosures.

Results from a large study confirm that women who test negative for human papillomavirus and who have a normal Pap test when screened for cervical cancer can safely wait 3 years before being retested.

Moreover, the findings strongly suggest that a negative HPV test alone is the more important measure, and could be adequate by itself to extend the testing interval to 3 years.

Investigators deemed the 5-year risk of cervical cancer with a negative HPV test to be "extremely low," at just 3.8/100,000 women per year in the study of 331,818 women who underwent routine co-testing in a managed health plan.

Having a normal Pap test on top of a negative HPV test did not much improve a woman’s chances of not having cervical cancer. The 5-year risk of cancer with good results on both measures was 3.2/100,000 women per year, but the difference between HPV testing alone and co-testing was not significant (P = .8). For all women who had a normal Pap smear, the 5-year risk of cervical cancer with a normal Pap test was 7.5/100,000 women per year (P = .03).

"These findings demonstrate the safety of current guidelines, which recommend a 3-year screening interval for women who test negative for HPV and Pap test," lead author Hormuzd Katki, Ph.D., said during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June.

In addition, "we concluded that a single negative HPV test provided 5 years of extremely low cancer risk for women, and this risk was not appreciably lowered by also having a normal Pap test," said Dr. Katki, a principal investigator in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute.

Screening guidelines from several medical organizations, such as the American College of Obstetricians and Gynecologists and the American Cancer Society, have endorsed concurrent HPV and Pap testing as a safe alternative to Pap testing alone for women aged 30 years and older. These organizations also recommend co-testing every 3 years for women who are HPV negative and have a normal Pap test.

However, there had been no data on the safety of these guidelines in routine clinical practice.

The current study included women aged 30 years and older who enrolled in Kaiser Permanente Northern California’s co-testing program between 2003 and 2005 for 5 years. "I found this to be just a wonderful population-based study from a large real-world experience," said Dr. George W. Sledge Jr., ASCO’s president and Ballve-Lantero Professor of Oncology at Indiana University, Indianapolis.

HPV testing identified more women with a high 5-year risk of cervical cancer or precancer than Pap testing alone. The 5-year risk for HPV-positive women was 7.6%, compared with 4.7% for an abnormal Pap test. "This shows that the HPV test is better able to separate women into categories of high risk of cancer and low risk of cancer," said Dr. Katki. "However, that does not mean that the Pap test is useless. ... When we combine HPV testing and Pap testing, we can get something even better."

For women who tested HPV positive, there were an additional 6 per 100 women who were found to have cervical cancer or precancer if they had a positive Pap test. Most of that extra 6% was found at enrollment in the co-testing program. This "shows that the Pap test is able to identify women who had immediate disease," said Dr. Katki.

"These findings suggest that all HPV-negative women could potentially safely return no earlier than 3 years," he added. Pap testing might be reserved for HPV-positive women. However this will require further testing to verify.

"In the Kaiser population, this would have reduced the number of Pap tests by 95%, and could potentially retain all of the safety of co-testing," said Dr. Katki

The data were provided by Kaiser Permanente and analyzed by researchers at the National Cancer Institute. The authors reported that they have no relevant disclosures.

Results from a large study confirm that women who test negative for human papillomavirus and who have a normal Pap test when screened for cervical cancer can safely wait 3 years before being retested.

Moreover, the findings strongly suggest that a negative HPV test alone is the more important measure, and could be adequate by itself to extend the testing interval to 3 years.

Investigators deemed the 5-year risk of cervical cancer with a negative HPV test to be "extremely low," at just 3.8/100,000 women per year in the study of 331,818 women who underwent routine co-testing in a managed health plan.

Having a normal Pap test on top of a negative HPV test did not much improve a woman’s chances of not having cervical cancer. The 5-year risk of cancer with good results on both measures was 3.2/100,000 women per year, but the difference between HPV testing alone and co-testing was not significant (P = .8). For all women who had a normal Pap smear, the 5-year risk of cervical cancer with a normal Pap test was 7.5/100,000 women per year (P = .03).

"These findings demonstrate the safety of current guidelines, which recommend a 3-year screening interval for women who test negative for HPV and Pap test," lead author Hormuzd Katki, Ph.D., said during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June.

In addition, "we concluded that a single negative HPV test provided 5 years of extremely low cancer risk for women, and this risk was not appreciably lowered by also having a normal Pap test," said Dr. Katki, a principal investigator in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute.

Screening guidelines from several medical organizations, such as the American College of Obstetricians and Gynecologists and the American Cancer Society, have endorsed concurrent HPV and Pap testing as a safe alternative to Pap testing alone for women aged 30 years and older. These organizations also recommend co-testing every 3 years for women who are HPV negative and have a normal Pap test.

However, there had been no data on the safety of these guidelines in routine clinical practice.

The current study included women aged 30 years and older who enrolled in Kaiser Permanente Northern California’s co-testing program between 2003 and 2005 for 5 years. "I found this to be just a wonderful population-based study from a large real-world experience," said Dr. George W. Sledge Jr., ASCO’s president and Ballve-Lantero Professor of Oncology at Indiana University, Indianapolis.

HPV testing identified more women with a high 5-year risk of cervical cancer or precancer than Pap testing alone. The 5-year risk for HPV-positive women was 7.6%, compared with 4.7% for an abnormal Pap test. "This shows that the HPV test is better able to separate women into categories of high risk of cancer and low risk of cancer," said Dr. Katki. "However, that does not mean that the Pap test is useless. ... When we combine HPV testing and Pap testing, we can get something even better."

For women who tested HPV positive, there were an additional 6 per 100 women who were found to have cervical cancer or precancer if they had a positive Pap test. Most of that extra 6% was found at enrollment in the co-testing program. This "shows that the Pap test is able to identify women who had immediate disease," said Dr. Katki.

"These findings suggest that all HPV-negative women could potentially safely return no earlier than 3 years," he added. Pap testing might be reserved for HPV-positive women. However this will require further testing to verify.

"In the Kaiser population, this would have reduced the number of Pap tests by 95%, and could potentially retain all of the safety of co-testing," said Dr. Katki

The data were provided by Kaiser Permanente and analyzed by researchers at the National Cancer Institute. The authors reported that they have no relevant disclosures.

Results from a large study confirm that women who test negative for human papillomavirus and who have a normal Pap test when screened for cervical cancer can safely wait 3 years before being retested.

Moreover, the findings strongly suggest that a negative HPV test alone is the more important measure, and could be adequate by itself to extend the testing interval to 3 years.

Investigators deemed the 5-year risk of cervical cancer with a negative HPV test to be "extremely low," at just 3.8/100,000 women per year in the study of 331,818 women who underwent routine co-testing in a managed health plan.

Having a normal Pap test on top of a negative HPV test did not much improve a woman’s chances of not having cervical cancer. The 5-year risk of cancer with good results on both measures was 3.2/100,000 women per year, but the difference between HPV testing alone and co-testing was not significant (P = .8). For all women who had a normal Pap smear, the 5-year risk of cervical cancer with a normal Pap test was 7.5/100,000 women per year (P = .03).

"These findings demonstrate the safety of current guidelines, which recommend a 3-year screening interval for women who test negative for HPV and Pap test," lead author Hormuzd Katki, Ph.D., said during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June.

In addition, "we concluded that a single negative HPV test provided 5 years of extremely low cancer risk for women, and this risk was not appreciably lowered by also having a normal Pap test," said Dr. Katki, a principal investigator in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute.

Screening guidelines from several medical organizations, such as the American College of Obstetricians and Gynecologists and the American Cancer Society, have endorsed concurrent HPV and Pap testing as a safe alternative to Pap testing alone for women aged 30 years and older. These organizations also recommend co-testing every 3 years for women who are HPV negative and have a normal Pap test.

However, there had been no data on the safety of these guidelines in routine clinical practice.

The current study included women aged 30 years and older who enrolled in Kaiser Permanente Northern California’s co-testing program between 2003 and 2005 for 5 years. "I found this to be just a wonderful population-based study from a large real-world experience," said Dr. George W. Sledge Jr., ASCO’s president and Ballve-Lantero Professor of Oncology at Indiana University, Indianapolis.

HPV testing identified more women with a high 5-year risk of cervical cancer or precancer than Pap testing alone. The 5-year risk for HPV-positive women was 7.6%, compared with 4.7% for an abnormal Pap test. "This shows that the HPV test is better able to separate women into categories of high risk of cancer and low risk of cancer," said Dr. Katki. "However, that does not mean that the Pap test is useless. ... When we combine HPV testing and Pap testing, we can get something even better."

For women who tested HPV positive, there were an additional 6 per 100 women who were found to have cervical cancer or precancer if they had a positive Pap test. Most of that extra 6% was found at enrollment in the co-testing program. This "shows that the Pap test is able to identify women who had immediate disease," said Dr. Katki.

"These findings suggest that all HPV-negative women could potentially safely return no earlier than 3 years," he added. Pap testing might be reserved for HPV-positive women. However this will require further testing to verify.

"In the Kaiser population, this would have reduced the number of Pap tests by 95%, and could potentially retain all of the safety of co-testing," said Dr. Katki

The data were provided by Kaiser Permanente and analyzed by researchers at the National Cancer Institute. The authors reported that they have no relevant disclosures.

WASHINGTON  – The initiation of 17P after the recommended 16-21 weeks’ gestation period appears to be beneficial, whereas stopping the drug early may increase a patient’s risk of spontaneous preterm delivery, according to a study of more than 700 women on Medicaid.

There were no significant differences in rates of recurrent spontaneous preterm birth (SPTB) at less than 37, 35, or 32 weeks’ gestation, regardless of whether 17P was started before or after 21 weeks’ gestation. "However, if you look at outcomes of those patients who discontinued early, there is statistically significant difference in each gestational age band in those patients who completed the therapy vs. those who discontinued early," Dr. Brad Lucas said at the annual meeting of the American College of Obstetricians and Gynecologists.

Level I evidence suggests that 17P – a form of progesterone called 17 alphahydroxyprogesterone caproate – is effective in preventing recurrent preterm birth in patients with a prior history of spontaneous preterm delivery. In fact, ACOG recommends progesterone supplementation for the prevention of recurrent preterm birth in patients with current singleton gestation and a prior history of SPTD at less than 37 weeks’ gestation (ACOG Committee Opinion No. 419, 2008). However, compliance issues and social barriers to treatment with 17P are common in the Medicaid population, noted Dr. Lucas, an ob.gyn. employed at Centene Corp., a health management and services company that provides health plans in 11 states.

The Food and Drug Administration approved Makena (a noncompounded form of 17P) earlier this year for the prevention of recurrent preterm birth in women with singleton pregnancies. Makena is marketed by Ther-Rx, a subsidiary of Missouri-based KV Pharmaceutical Co. However, Makenas high price is raising physicians’ ire.

A compounded form of 17P was used in this study.

The investigators performed a retrospective study of data that was prospectively collected between July 2004 and May 2010. They included women with a current singleton pregnancy and a history of one or more prior SPTB (20 to less than 37 weeks’ gestation). These women could have no current or planned cerclage.

"We use the treatment guidelines that are commonly associated with those in the Meis study," he said (N. Engl. J. Med. 2003;348:2379-85). Weekly 17P injections (250 mg on days 6-9) were initiated starting at 16 weeks up to 21 weeks’ gestation. The injections were discontinued at 36 weeks or at preterm delivery.

A total of 790 women with prior SPTB received care through a managed Medicaid health plan. These women were enrolled in a 17P home-administration program for the prevention of recurrent preterm birth, in which a nurse administered a weekly IM injection of compounded 17P (250 mg) to women in their homes. Written and verbal education was also provided by the perinatal nurse. Intensive case management was provided. Patients had round-the-clock telephone access to nurses, who could answer questions or concerns.

The primary outcome in this study was adherence to treatment guidelines (initiation of treatment at 16 to less than 21 weeks vs. initiation at 21 weeks or more). Patients also had to complete the recommended treatment – continuation until within 10 days of 36 weeks’ gestation or until preterm delivery.

The average maternal age was 28 years. Only a small percentage of the patients were teens (3.5%) or were older than 34 years (6%). Interestingly, 36% had had more than one prior preterm delivery.

In terms of adherence to the guidelines, the average gestational age at the start of 17P injections was 21 weeks. More than half of the women (59%) started treatment at 16-21 weeks’ gestation. The average number of injections received was 13. Only seven women refused treatment after the first injection. Most women (89%) received all expected injections.

The average gestational age at delivery was 37 weeks. In all, 28% of women had SPTB prior to 37 weeks, 12% had SPTB prior to 35 weeks, and 6% had SPTB prior to 32 weeks. More than a third of women (36%) had cesarean delivery. Some 15% of infants required care in neonatal ICUs or special-care nurseries. Perinatal loss was less than 1%. Overall, 35% of women delivered before 37 weeks’ gestation and 65% delivered at 37 weeks’ gestation or later.

In terms of early discontinuation of 17P, 38% of mothers who discontinued 17P use early had SPTB at less than 37 weeks’ gestation, compared with only 26% of women who did not discontinue 17P. Likewise, 23% of mothers who discontinued 17P use early had SPTB at less than 35 weeks, compared with only 10% of women who did not discontinue; 12% of mothers who discontinued 17P use early had SPTB at less than 32 weeks, compared with only 4% of women who did not discontinue. All of the differences were significant.

"Early discontinuation of 17P increases a patient’s risk for recurrent spontaneous preterm delivery," said Dr. Lucas.

Dr. Lucas is an employee of Centene Corp. His coauthor, Dr. Gary J. Stanziano, is an employee of Alere, which provides home medical services. However, no funding was received from either company for the completion of this study.

WASHINGTON  – The initiation of 17P after the recommended 16-21 weeks’ gestation period appears to be beneficial, whereas stopping the drug early may increase a patient’s risk of spontaneous preterm delivery, according to a study of more than 700 women on Medicaid.

There were no significant differences in rates of recurrent spontaneous preterm birth (SPTB) at less than 37, 35, or 32 weeks’ gestation, regardless of whether 17P was started before or after 21 weeks’ gestation. "However, if you look at outcomes of those patients who discontinued early, there is statistically significant difference in each gestational age band in those patients who completed the therapy vs. those who discontinued early," Dr. Brad Lucas said at the annual meeting of the American College of Obstetricians and Gynecologists.

Level I evidence suggests that 17P – a form of progesterone called 17 alphahydroxyprogesterone caproate – is effective in preventing recurrent preterm birth in patients with a prior history of spontaneous preterm delivery. In fact, ACOG recommends progesterone supplementation for the prevention of recurrent preterm birth in patients with current singleton gestation and a prior history of SPTD at less than 37 weeks’ gestation (ACOG Committee Opinion No. 419, 2008). However, compliance issues and social barriers to treatment with 17P are common in the Medicaid population, noted Dr. Lucas, an ob.gyn. employed at Centene Corp., a health management and services company that provides health plans in 11 states.

The Food and Drug Administration approved Makena (a noncompounded form of 17P) earlier this year for the prevention of recurrent preterm birth in women with singleton pregnancies. Makena is marketed by Ther-Rx, a subsidiary of Missouri-based KV Pharmaceutical Co. However, Makenas high price is raising physicians’ ire.

A compounded form of 17P was used in this study.

The investigators performed a retrospective study of data that was prospectively collected between July 2004 and May 2010. They included women with a current singleton pregnancy and a history of one or more prior SPTB (20 to less than 37 weeks’ gestation). These women could have no current or planned cerclage.

"We use the treatment guidelines that are commonly associated with those in the Meis study," he said (N. Engl. J. Med. 2003;348:2379-85). Weekly 17P injections (250 mg on days 6-9) were initiated starting at 16 weeks up to 21 weeks’ gestation. The injections were discontinued at 36 weeks or at preterm delivery.

A total of 790 women with prior SPTB received care through a managed Medicaid health plan. These women were enrolled in a 17P home-administration program for the prevention of recurrent preterm birth, in which a nurse administered a weekly IM injection of compounded 17P (250 mg) to women in their homes. Written and verbal education was also provided by the perinatal nurse. Intensive case management was provided. Patients had round-the-clock telephone access to nurses, who could answer questions or concerns.

The primary outcome in this study was adherence to treatment guidelines (initiation of treatment at 16 to less than 21 weeks vs. initiation at 21 weeks or more). Patients also had to complete the recommended treatment – continuation until within 10 days of 36 weeks’ gestation or until preterm delivery.

The average maternal age was 28 years. Only a small percentage of the patients were teens (3.5%) or were older than 34 years (6%). Interestingly, 36% had had more than one prior preterm delivery.

In terms of adherence to the guidelines, the average gestational age at the start of 17P injections was 21 weeks. More than half of the women (59%) started treatment at 16-21 weeks’ gestation. The average number of injections received was 13. Only seven women refused treatment after the first injection. Most women (89%) received all expected injections.

The average gestational age at delivery was 37 weeks. In all, 28% of women had SPTB prior to 37 weeks, 12% had SPTB prior to 35 weeks, and 6% had SPTB prior to 32 weeks. More than a third of women (36%) had cesarean delivery. Some 15% of infants required care in neonatal ICUs or special-care nurseries. Perinatal loss was less than 1%. Overall, 35% of women delivered before 37 weeks’ gestation and 65% delivered at 37 weeks’ gestation or later.

In terms of early discontinuation of 17P, 38% of mothers who discontinued 17P use early had SPTB at less than 37 weeks’ gestation, compared with only 26% of women who did not discontinue 17P. Likewise, 23% of mothers who discontinued 17P use early had SPTB at less than 35 weeks, compared with only 10% of women who did not discontinue; 12% of mothers who discontinued 17P use early had SPTB at less than 32 weeks, compared with only 4% of women who did not discontinue. All of the differences were significant.

"Early discontinuation of 17P increases a patient’s risk for recurrent spontaneous preterm delivery," said Dr. Lucas.

Dr. Lucas is an employee of Centene Corp. His coauthor, Dr. Gary J. Stanziano, is an employee of Alere, which provides home medical services. However, no funding was received from either company for the completion of this study.

WASHINGTON  – The initiation of 17P after the recommended 16-21 weeks’ gestation period appears to be beneficial, whereas stopping the drug early may increase a patient’s risk of spontaneous preterm delivery, according to a study of more than 700 women on Medicaid.

There were no significant differences in rates of recurrent spontaneous preterm birth (SPTB) at less than 37, 35, or 32 weeks’ gestation, regardless of whether 17P was started before or after 21 weeks’ gestation. "However, if you look at outcomes of those patients who discontinued early, there is statistically significant difference in each gestational age band in those patients who completed the therapy vs. those who discontinued early," Dr. Brad Lucas said at the annual meeting of the American College of Obstetricians and Gynecologists.

Level I evidence suggests that 17P – a form of progesterone called 17 alphahydroxyprogesterone caproate – is effective in preventing recurrent preterm birth in patients with a prior history of spontaneous preterm delivery. In fact, ACOG recommends progesterone supplementation for the prevention of recurrent preterm birth in patients with current singleton gestation and a prior history of SPTD at less than 37 weeks’ gestation (ACOG Committee Opinion No. 419, 2008). However, compliance issues and social barriers to treatment with 17P are common in the Medicaid population, noted Dr. Lucas, an ob.gyn. employed at Centene Corp., a health management and services company that provides health plans in 11 states.

The Food and Drug Administration approved Makena (a noncompounded form of 17P) earlier this year for the prevention of recurrent preterm birth in women with singleton pregnancies. Makena is marketed by Ther-Rx, a subsidiary of Missouri-based KV Pharmaceutical Co. However, Makenas high price is raising physicians’ ire.

A compounded form of 17P was used in this study.

The investigators performed a retrospective study of data that was prospectively collected between July 2004 and May 2010. They included women with a current singleton pregnancy and a history of one or more prior SPTB (20 to less than 37 weeks’ gestation). These women could have no current or planned cerclage.

"We use the treatment guidelines that are commonly associated with those in the Meis study," he said (N. Engl. J. Med. 2003;348:2379-85). Weekly 17P injections (250 mg on days 6-9) were initiated starting at 16 weeks up to 21 weeks’ gestation. The injections were discontinued at 36 weeks or at preterm delivery.

A total of 790 women with prior SPTB received care through a managed Medicaid health plan. These women were enrolled in a 17P home-administration program for the prevention of recurrent preterm birth, in which a nurse administered a weekly IM injection of compounded 17P (250 mg) to women in their homes. Written and verbal education was also provided by the perinatal nurse. Intensive case management was provided. Patients had round-the-clock telephone access to nurses, who could answer questions or concerns.

The primary outcome in this study was adherence to treatment guidelines (initiation of treatment at 16 to less than 21 weeks vs. initiation at 21 weeks or more). Patients also had to complete the recommended treatment – continuation until within 10 days of 36 weeks’ gestation or until preterm delivery.

The average maternal age was 28 years. Only a small percentage of the patients were teens (3.5%) or were older than 34 years (6%). Interestingly, 36% had had more than one prior preterm delivery.

In terms of adherence to the guidelines, the average gestational age at the start of 17P injections was 21 weeks. More than half of the women (59%) started treatment at 16-21 weeks’ gestation. The average number of injections received was 13. Only seven women refused treatment after the first injection. Most women (89%) received all expected injections.

The average gestational age at delivery was 37 weeks. In all, 28% of women had SPTB prior to 37 weeks, 12% had SPTB prior to 35 weeks, and 6% had SPTB prior to 32 weeks. More than a third of women (36%) had cesarean delivery. Some 15% of infants required care in neonatal ICUs or special-care nurseries. Perinatal loss was less than 1%. Overall, 35% of women delivered before 37 weeks’ gestation and 65% delivered at 37 weeks’ gestation or later.

In terms of early discontinuation of 17P, 38% of mothers who discontinued 17P use early had SPTB at less than 37 weeks’ gestation, compared with only 26% of women who did not discontinue 17P. Likewise, 23% of mothers who discontinued 17P use early had SPTB at less than 35 weeks, compared with only 10% of women who did not discontinue; 12% of mothers who discontinued 17P use early had SPTB at less than 32 weeks, compared with only 4% of women who did not discontinue. All of the differences were significant.

"Early discontinuation of 17P increases a patient’s risk for recurrent spontaneous preterm delivery," said Dr. Lucas.

Dr. Lucas is an employee of Centene Corp. His coauthor, Dr. Gary J. Stanziano, is an employee of Alere, which provides home medical services. However, no funding was received from either company for the completion of this study.

Neisseria gonorrhoeae cases resistant to azithromycin detected in San Diego led the Centers for Disease Control and Prevention to issue a “Dear Colleague” letter on May 12 reminding clinicians to limit use of azithromycin monotherapyto treat uncomplicated rectal and genitourinary infections caused by N.gonorrhoeae.*

Such azithromycin monotherapy typically is used in patients allergic to cephalosporins because recommended treatment for uncomplicated rectal and genitourinary N. gonorrhoeae infection is dual therapy including a 1-g dose of azithromycin and a cephalosporin (250 mg of ceftriaxone or 400 mg of cefixime, if ceftriaxone is not an option).*

The resistance concerns are related to five N. gonorrhoeae cases with reduced susceptibility to azithromycin identified in San Diego, the CDC reported in the May 13 Morbidity and Mortality Weekly Report.

"The five N. gonorrhoeae infections with high MICs to azithromycin identified in MSM [men who have sex with men] during a 3-month period in 2010 in San Diego County amount to an unusually large cluster," according to the report (MMWR 2011;60:579-81). The infections were identified in MSM with no known connections to each other – prompting concerns that the gonorrhea strains with reduced drug susceptibility might be more widespread in the community. The men presented with symptomatic urethritis.

The five cases were identified between August and October 2009 at San Diego County’s main municipal sexually transmitted diseases (STD) clinic. The five isolates had high azithromycin minimum inhibitory concentrations (MICs): three with 8 mcg/mL and two with 16 mcg/mL. The five were among 55 (9%) N. gonorrhoeae isolates obtained from men with symptomatic urethritis tested during the 3-month period.

During November 2009 to December 2010, of 229 new isolates obtained from MSM who were examined at the STD clinic, four (1.7%) new isolates at the same clinic were obtained and were found to have high MICs to azithromycin: three with 8 mcg/mL and one with 16 mcg/mL. Through December 2010, no treatment failures had been reported.

"Continued surveillance [using culture and susceptibility testing] for antimicrobial resistance in N. gonorrhoeae is essential for effective disease prevention and control," according to the CDC.

* CORRECTION, 5/17/2011: The original version of this article required clarification of the "Dear Colleague" letter. This version has been updated.

Neisseria gonorrhoeae cases resistant to azithromycin detected in San Diego led the Centers for Disease Control and Prevention to issue a “Dear Colleague” letter on May 12 reminding clinicians to limit use of azithromycin monotherapyto treat uncomplicated rectal and genitourinary infections caused by N.gonorrhoeae.*

Such azithromycin monotherapy typically is used in patients allergic to cephalosporins because recommended treatment for uncomplicated rectal and genitourinary N. gonorrhoeae infection is dual therapy including a 1-g dose of azithromycin and a cephalosporin (250 mg of ceftriaxone or 400 mg of cefixime, if ceftriaxone is not an option).*

The resistance concerns are related to five N. gonorrhoeae cases with reduced susceptibility to azithromycin identified in San Diego, the CDC reported in the May 13 Morbidity and Mortality Weekly Report.

"The five N. gonorrhoeae infections with high MICs to azithromycin identified in MSM [men who have sex with men] during a 3-month period in 2010 in San Diego County amount to an unusually large cluster," according to the report (MMWR 2011;60:579-81). The infections were identified in MSM with no known connections to each other – prompting concerns that the gonorrhea strains with reduced drug susceptibility might be more widespread in the community. The men presented with symptomatic urethritis.

The five cases were identified between August and October 2009 at San Diego County’s main municipal sexually transmitted diseases (STD) clinic. The five isolates had high azithromycin minimum inhibitory concentrations (MICs): three with 8 mcg/mL and two with 16 mcg/mL. The five were among 55 (9%) N. gonorrhoeae isolates obtained from men with symptomatic urethritis tested during the 3-month period.

During November 2009 to December 2010, of 229 new isolates obtained from MSM who were examined at the STD clinic, four (1.7%) new isolates at the same clinic were obtained and were found to have high MICs to azithromycin: three with 8 mcg/mL and one with 16 mcg/mL. Through December 2010, no treatment failures had been reported.

"Continued surveillance [using culture and susceptibility testing] for antimicrobial resistance in N. gonorrhoeae is essential for effective disease prevention and control," according to the CDC.

* CORRECTION, 5/17/2011: The original version of this article required clarification of the "Dear Colleague" letter. This version has been updated.

Neisseria gonorrhoeae cases resistant to azithromycin detected in San Diego led the Centers for Disease Control and Prevention to issue a “Dear Colleague” letter on May 12 reminding clinicians to limit use of azithromycin monotherapyto treat uncomplicated rectal and genitourinary infections caused by N.gonorrhoeae.*

Such azithromycin monotherapy typically is used in patients allergic to cephalosporins because recommended treatment for uncomplicated rectal and genitourinary N. gonorrhoeae infection is dual therapy including a 1-g dose of azithromycin and a cephalosporin (250 mg of ceftriaxone or 400 mg of cefixime, if ceftriaxone is not an option).*

The resistance concerns are related to five N. gonorrhoeae cases with reduced susceptibility to azithromycin identified in San Diego, the CDC reported in the May 13 Morbidity and Mortality Weekly Report.

"The five N. gonorrhoeae infections with high MICs to azithromycin identified in MSM [men who have sex with men] during a 3-month period in 2010 in San Diego County amount to an unusually large cluster," according to the report (MMWR 2011;60:579-81). The infections were identified in MSM with no known connections to each other – prompting concerns that the gonorrhea strains with reduced drug susceptibility might be more widespread in the community. The men presented with symptomatic urethritis.

The five cases were identified between August and October 2009 at San Diego County’s main municipal sexually transmitted diseases (STD) clinic. The five isolates had high azithromycin minimum inhibitory concentrations (MICs): three with 8 mcg/mL and two with 16 mcg/mL. The five were among 55 (9%) N. gonorrhoeae isolates obtained from men with symptomatic urethritis tested during the 3-month period.

During November 2009 to December 2010, of 229 new isolates obtained from MSM who were examined at the STD clinic, four (1.7%) new isolates at the same clinic were obtained and were found to have high MICs to azithromycin: three with 8 mcg/mL and one with 16 mcg/mL. Through December 2010, no treatment failures had been reported.

"Continued surveillance [using culture and susceptibility testing] for antimicrobial resistance in N. gonorrhoeae is essential for effective disease prevention and control," according to the CDC.

* CORRECTION, 5/17/2011: The original version of this article required clarification of the "Dear Colleague" letter. This version has been updated.

Neisseria gonorrhoeae cases resistant to azithromycin detected in San Diego led the Centers for Disease Control and Prevention to issue a “Dear Colleague” letter on May 12 reminding clinicians to limit use of azithromycin monotherapyto treat uncomplicated rectal and genitourinary infections caused by N.gonorrhoeae.*

Such azithromycin monotherapy typically is used in patients allergic to cephalosporins because recommended treatment for uncomplicated rectal and genitourinary N. gonorrhoeae infection is dual therapy including a 1-g dose of azithromycin and a cephalosporin (250 mg of ceftriaxone or 400 mg of cefixime, if ceftriaxone is not an option).*

The resistance concerns are related to five N. gonorrhoeae cases with reduced susceptibility to azithromycin identified in San Diego, the CDC reported in the May 13 Morbidity and Mortality Weekly Report.

"The five N. gonorrhoeae infections with high MICs to azithromycin identified in MSM [men who have sex with men] during a 3-month period in 2010 in San Diego County amount to an unusually large cluster," according to the report (MMWR 2011;60:579-81). The infections were identified in MSM with no known connections to each other – prompting concerns that the gonorrhea strains with reduced drug susceptibility might be more widespread in the community. The men presented with symptomatic urethritis.

The five cases were identified between August and October 2009 at San Diego County’s main municipal sexually transmitted diseases (STD) clinic. The five isolates had high azithromycin minimum inhibitory concentrations (MICs): three with 8 mcg/mL and two with 16 mcg/mL. The five were among 55 (9%) N. gonorrhoeae isolates obtained from men with symptomatic urethritis tested during the 3-month period.

During November 2009 to December 2010, of 229 new isolates obtained from MSM who were examined at the STD clinic, four (1.7%) new isolates at the same clinic were obtained and were found to have high MICs to azithromycin: three with 8 mcg/mL and one with 16 mcg/mL. Through December 2010, no treatment failures had been reported.

"Continued surveillance [using culture and susceptibility testing] for antimicrobial resistance in N. gonorrhoeae is essential for effective disease prevention and control," according to the CDC.

* CORRECTION, 5/17/2011: The original version of this article required clarification of the "Dear Colleague" letter. This version has been updated.

Neisseria gonorrhoeae cases resistant to azithromycin detected in San Diego led the Centers for Disease Control and Prevention to issue a “Dear Colleague” letter on May 12 reminding clinicians to limit use of azithromycin monotherapyto treat uncomplicated rectal and genitourinary infections caused by N.gonorrhoeae.*

Such azithromycin monotherapy typically is used in patients allergic to cephalosporins because recommended treatment for uncomplicated rectal and genitourinary N. gonorrhoeae infection is dual therapy including a 1-g dose of azithromycin and a cephalosporin (250 mg of ceftriaxone or 400 mg of cefixime, if ceftriaxone is not an option).*

The resistance concerns are related to five N. gonorrhoeae cases with reduced susceptibility to azithromycin identified in San Diego, the CDC reported in the May 13 Morbidity and Mortality Weekly Report.

"The five N. gonorrhoeae infections with high MICs to azithromycin identified in MSM [men who have sex with men] during a 3-month period in 2010 in San Diego County amount to an unusually large cluster," according to the report (MMWR 2011;60:579-81). The infections were identified in MSM with no known connections to each other – prompting concerns that the gonorrhea strains with reduced drug susceptibility might be more widespread in the community. The men presented with symptomatic urethritis.

The five cases were identified between August and October 2009 at San Diego County’s main municipal sexually transmitted diseases (STD) clinic. The five isolates had high azithromycin minimum inhibitory concentrations (MICs): three with 8 mcg/mL and two with 16 mcg/mL. The five were among 55 (9%) N. gonorrhoeae isolates obtained from men with symptomatic urethritis tested during the 3-month period.

During November 2009 to December 2010, of 229 new isolates obtained from MSM who were examined at the STD clinic, four (1.7%) new isolates at the same clinic were obtained and were found to have high MICs to azithromycin: three with 8 mcg/mL and one with 16 mcg/mL. Through December 2010, no treatment failures had been reported.

"Continued surveillance [using culture and susceptibility testing] for antimicrobial resistance in N. gonorrhoeae is essential for effective disease prevention and control," according to the CDC.

* CORRECTION, 5/17/2011: The original version of this article required clarification of the "Dear Colleague" letter. This version has been updated.

Neisseria gonorrhoeae cases resistant to azithromycin detected in San Diego led the Centers for Disease Control and Prevention to issue a “Dear Colleague” letter on May 12 reminding clinicians to limit use of azithromycin monotherapyto treat uncomplicated rectal and genitourinary infections caused by N.gonorrhoeae.*

Such azithromycin monotherapy typically is used in patients allergic to cephalosporins because recommended treatment for uncomplicated rectal and genitourinary N. gonorrhoeae infection is dual therapy including a 1-g dose of azithromycin and a cephalosporin (250 mg of ceftriaxone or 400 mg of cefixime, if ceftriaxone is not an option).*

The resistance concerns are related to five N. gonorrhoeae cases with reduced susceptibility to azithromycin identified in San Diego, the CDC reported in the May 13 Morbidity and Mortality Weekly Report.

"The five N. gonorrhoeae infections with high MICs to azithromycin identified in MSM [men who have sex with men] during a 3-month period in 2010 in San Diego County amount to an unusually large cluster," according to the report (MMWR 2011;60:579-81). The infections were identified in MSM with no known connections to each other – prompting concerns that the gonorrhea strains with reduced drug susceptibility might be more widespread in the community. The men presented with symptomatic urethritis.

The five cases were identified between August and October 2009 at San Diego County’s main municipal sexually transmitted diseases (STD) clinic. The five isolates had high azithromycin minimum inhibitory concentrations (MICs): three with 8 mcg/mL and two with 16 mcg/mL. The five were among 55 (9%) N. gonorrhoeae isolates obtained from men with symptomatic urethritis tested during the 3-month period.

During November 2009 to December 2010, of 229 new isolates obtained from MSM who were examined at the STD clinic, four (1.7%) new isolates at the same clinic were obtained and were found to have high MICs to azithromycin: three with 8 mcg/mL and one with 16 mcg/mL. Through December 2010, no treatment failures had been reported.

"Continued surveillance [using culture and susceptibility testing] for antimicrobial resistance in N. gonorrhoeae is essential for effective disease prevention and control," according to the CDC.

* CORRECTION, 5/17/2011: The original version of this article required clarification of the "Dear Colleague" letter. This version has been updated.