NASHVILLE—The benefits of ocrelizumab on 24-week confirmed disability improvement, which were demonstrated in two-year, double-blind, controlled trials, were maintained for two years in an open-label extension study in patients with relapsing-remitting multiple sclerosis (MS), according to data described at the 2018 CMSC Annual Meeting.

The 96-week, double-blind, controlled periods of the OPERA I and II trials demonstrated the efficacy and safety of ocrelizumab in relapsing-remitting MS. Upon completion of the controlled treatment periods, all patients were eligible to enter an open-label extension phase during which they would receive ocrelizumab. Robert T. Naismith, MD, Associate Professor of Neurology at Washington University School of Medicine in St. Louis, and colleagues reviewed data from this extension phase to assess the effect of switching to ocrelizumab or maintaining ocrelizumab therapy on the proportion of patients experiencing disability improvement.

Difference Between Groups Endured

During the controlled treatment period, patients received IV ocrelizumab (600 mg) every 24 weeks or subcutaneous interferon beta-1a (44 μg) three times weekly for 96 weeks. At the start of the open-label extension period, patients continued ocrelizumab or were switched from interferon beta-1a to ocrelizumab. Disability improvement compared with baseline was defined as a reduction in Expanded Disability Status Scale (EDSS) score of 1.0 or more points for patients with a baseline EDSS score from 2.0 to 5.5, or a reduction of 0.5 or more points for patients with a baseline EDSS score greater than 5.5. Time to onset of 24-week confirmed disability improvement was analyzed in patients with a baseline EDSS score of 2.0 or greater.

More than 89% of patients who entered the open-label extension period completed two years of the open-label extension. The group that started and continued ocrelizumab (n = 454), compared with the group that switched from interferon beta-1a to ocrelizumab (n = 419), had a higher proportion of patients with 24-week confirmed disability improvement in the year before the switch (16.8% vs 13.3%). At year 1 of the extension, the group that started and continued ocrelizumab included 399 participants, and 20.6% had 24-week confirmed disability improvement, compared with 16.6% of the group that switched from interferon beta-1a to ocrelizumab, which included 366 participants. At year 2, the former group included 363 patients, and 23.7% had 24-week confirmed disability improvement. The latter group included 339 participants, and 18.9% of them achieved this outcome.

Analyzing Four Years of Treatment

When the investigators examined data for four years of treatment (ie, the double-blind and extension phases), they observed that between 20% and 25% of patients with an EDSS score of 2 or more who received ocrelizumab had improvement in EDSS score. When they examined patients with EDSS scores lower than 2, the results were similar. “This [finding] parallels some of the effects that we see in clinical efficacy, based upon a reduction in MRI parameters such as T1 and T2 lesions,” said Dr. Naismith.

“What we are seeing, especially with some of our high-efficacy therapies, is that patients come back and report that they are feeling better in subsequent visits. I admit, I never tell patients that this is an expectation they should have…. But it is always nice to hear from a patient that they are doing better in some tangible way in their lives,” Dr. Naismith concluded.

—Erik Greb

NASHVILLE—The benefits of ocrelizumab on 24-week confirmed disability improvement, which were demonstrated in two-year, double-blind, controlled trials, were maintained for two years in an open-label extension study in patients with relapsing-remitting multiple sclerosis (MS), according to data described at the 2018 CMSC Annual Meeting.

The 96-week, double-blind, controlled periods of the OPERA I and II trials demonstrated the efficacy and safety of ocrelizumab in relapsing-remitting MS. Upon completion of the controlled treatment periods, all patients were eligible to enter an open-label extension phase during which they would receive ocrelizumab. Robert T. Naismith, MD, Associate Professor of Neurology at Washington University School of Medicine in St. Louis, and colleagues reviewed data from this extension phase to assess the effect of switching to ocrelizumab or maintaining ocrelizumab therapy on the proportion of patients experiencing disability improvement.

Difference Between Groups Endured

During the controlled treatment period, patients received IV ocrelizumab (600 mg) every 24 weeks or subcutaneous interferon beta-1a (44 μg) three times weekly for 96 weeks. At the start of the open-label extension period, patients continued ocrelizumab or were switched from interferon beta-1a to ocrelizumab. Disability improvement compared with baseline was defined as a reduction in Expanded Disability Status Scale (EDSS) score of 1.0 or more points for patients with a baseline EDSS score from 2.0 to 5.5, or a reduction of 0.5 or more points for patients with a baseline EDSS score greater than 5.5. Time to onset of 24-week confirmed disability improvement was analyzed in patients with a baseline EDSS score of 2.0 or greater.

More than 89% of patients who entered the open-label extension period completed two years of the open-label extension. The group that started and continued ocrelizumab (n = 454), compared with the group that switched from interferon beta-1a to ocrelizumab (n = 419), had a higher proportion of patients with 24-week confirmed disability improvement in the year before the switch (16.8% vs 13.3%). At year 1 of the extension, the group that started and continued ocrelizumab included 399 participants, and 20.6% had 24-week confirmed disability improvement, compared with 16.6% of the group that switched from interferon beta-1a to ocrelizumab, which included 366 participants. At year 2, the former group included 363 patients, and 23.7% had 24-week confirmed disability improvement. The latter group included 339 participants, and 18.9% of them achieved this outcome.

Analyzing Four Years of Treatment

When the investigators examined data for four years of treatment (ie, the double-blind and extension phases), they observed that between 20% and 25% of patients with an EDSS score of 2 or more who received ocrelizumab had improvement in EDSS score. When they examined patients with EDSS scores lower than 2, the results were similar. “This [finding] parallels some of the effects that we see in clinical efficacy, based upon a reduction in MRI parameters such as T1 and T2 lesions,” said Dr. Naismith.

“What we are seeing, especially with some of our high-efficacy therapies, is that patients come back and report that they are feeling better in subsequent visits. I admit, I never tell patients that this is an expectation they should have…. But it is always nice to hear from a patient that they are doing better in some tangible way in their lives,” Dr. Naismith concluded.

—Erik Greb

NASHVILLE—The benefits of ocrelizumab on 24-week confirmed disability improvement, which were demonstrated in two-year, double-blind, controlled trials, were maintained for two years in an open-label extension study in patients with relapsing-remitting multiple sclerosis (MS), according to data described at the 2018 CMSC Annual Meeting.

The 96-week, double-blind, controlled periods of the OPERA I and II trials demonstrated the efficacy and safety of ocrelizumab in relapsing-remitting MS. Upon completion of the controlled treatment periods, all patients were eligible to enter an open-label extension phase during which they would receive ocrelizumab. Robert T. Naismith, MD, Associate Professor of Neurology at Washington University School of Medicine in St. Louis, and colleagues reviewed data from this extension phase to assess the effect of switching to ocrelizumab or maintaining ocrelizumab therapy on the proportion of patients experiencing disability improvement.

Difference Between Groups Endured

During the controlled treatment period, patients received IV ocrelizumab (600 mg) every 24 weeks or subcutaneous interferon beta-1a (44 μg) three times weekly for 96 weeks. At the start of the open-label extension period, patients continued ocrelizumab or were switched from interferon beta-1a to ocrelizumab. Disability improvement compared with baseline was defined as a reduction in Expanded Disability Status Scale (EDSS) score of 1.0 or more points for patients with a baseline EDSS score from 2.0 to 5.5, or a reduction of 0.5 or more points for patients with a baseline EDSS score greater than 5.5. Time to onset of 24-week confirmed disability improvement was analyzed in patients with a baseline EDSS score of 2.0 or greater.

More than 89% of patients who entered the open-label extension period completed two years of the open-label extension. The group that started and continued ocrelizumab (n = 454), compared with the group that switched from interferon beta-1a to ocrelizumab (n = 419), had a higher proportion of patients with 24-week confirmed disability improvement in the year before the switch (16.8% vs 13.3%). At year 1 of the extension, the group that started and continued ocrelizumab included 399 participants, and 20.6% had 24-week confirmed disability improvement, compared with 16.6% of the group that switched from interferon beta-1a to ocrelizumab, which included 366 participants. At year 2, the former group included 363 patients, and 23.7% had 24-week confirmed disability improvement. The latter group included 339 participants, and 18.9% of them achieved this outcome.

Analyzing Four Years of Treatment

When the investigators examined data for four years of treatment (ie, the double-blind and extension phases), they observed that between 20% and 25% of patients with an EDSS score of 2 or more who received ocrelizumab had improvement in EDSS score. When they examined patients with EDSS scores lower than 2, the results were similar. “This [finding] parallels some of the effects that we see in clinical efficacy, based upon a reduction in MRI parameters such as T1 and T2 lesions,” said Dr. Naismith.

“What we are seeing, especially with some of our high-efficacy therapies, is that patients come back and report that they are feeling better in subsequent visits. I admit, I never tell patients that this is an expectation they should have…. But it is always nice to hear from a patient that they are doing better in some tangible way in their lives,” Dr. Naismith concluded.

—Erik Greb

New research from the Osteoarthritis Research Society International that suggests that hip pain increases by one third all-cause mortality in people with osteoarthritis. Also today, COPD patient subset gains no benefit from low-dose theophylline, Barrett’s segment length and low-grade dysplasia are tied to an increased risk of neoplastic progression, and the vestibular/oculomotor component of concussions warrants more attention. 

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

New research from the Osteoarthritis Research Society International that suggests that hip pain increases by one third all-cause mortality in people with osteoarthritis. Also today, COPD patient subset gains no benefit from low-dose theophylline, Barrett’s segment length and low-grade dysplasia are tied to an increased risk of neoplastic progression, and the vestibular/oculomotor component of concussions warrants more attention. 

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

New research from the Osteoarthritis Research Society International that suggests that hip pain increases by one third all-cause mortality in people with osteoarthritis. Also today, COPD patient subset gains no benefit from low-dose theophylline, Barrett’s segment length and low-grade dysplasia are tied to an increased risk of neoplastic progression, and the vestibular/oculomotor component of concussions warrants more attention. 

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

CHICAGO – Elderly cancer patients have better communication with their oncologists and report greater satisfaction with their care when the oncologists are provided with geriatric assessment summaries prior to the patient visit.

Although “satisfaction” can be subjective, the conclusion about the benefit of previsit geriatric assessments is objective, reported Supriya Gupta Mohile, MD, of the University of Rochester, New York.

Neil Osterweil/MDedge News

Each domain independently predicts morbidity and/or mortality in older patients.

The investigators enrolled 31 oncology practices in the National Cancer Institute’s Community Oncology Research Program that were treating patients aged 70 or older with advanced solid tumors or lymphoma. Patients who were enrolled had at least one impaired GA domain. In all, 542 patients across the sites were enrolled.

All patients in each arm completed the GA.

Randomization was by practice, with practices in arm 1 randomized to receive GA intervention results. Oncologists in this trial arm were provided with a GA summary and list of recommended GA-guided interventions.

Practices in arm 2 (controls) did not receive summaries or lists of recommendations, but oncologists were notified if patients had clinically significant depression or cognitive impairment.

In the intervention group, patients completed all assessments within 30 minutes, and less than 10 minutes of practice staff time was required for administration of objective tests.

The investigators made audio recordings and transcripts of clinic visits after GA in both arms, with two blinded coders evaluating quality of communication and plans for follow-up interventions. Patients were surveyed by telephone about their satisfaction, via the Health Care Climate Questionnaire (HCCQ) and the same instrument modified for age-related concerns (HCCQ-age).

“We found that patients enrolled in the study had a high prevalence of impairments of Geriatric Assessment domains, ranging from over 90% for physical performance, to 25% for psychological status, mainly depression. Of note, more than 30% of patients ... screened positive for cognitive impairment.” Dr. Mohile said.

For the coprimary endpoint of communication about age-related concerns, the mean number of discussions was 7.74 in the GA arm, compared with 4.24 in the control arm, a difference of 3.5 (P less than .0001).

Arm 1 was rated as having more discussions with higher-quality communications (mean 4.42 vs. 2.47, P less than .0001), and had more discussions leading to an intervention (3.08 vs. 1.15, P less than .0001).

Patients in arm 1 consistently rated their satisfaction with communication (the other coprimary endpoint) higher than did patients in arm 2, at both baseline, 4-6 weeks after the visit, and 3 months after the visit.

Neil Osterweil/MDedge News

“This is a very important study that I think is likely to have a direct impact on the care of older patients with cancer,” ASCO expert Joshua A. Jones, MD, of the University of Pennsylvania, Philadelphia, said at the meeting.

“This study shows in a randomized fashion that we can, with a simple intervention, improve communication about what’s really important to older patients with cancer,” he said. “We have interventions, things like physical therapy, things like counseling, supports that can be provided to patients and families as they are thinking through treatment decisions, helping us to provide the most appropriate care for these individuals.”

SOURCE: Mohile SG et al. ASCO 2018, abstract LBA10003.

CHICAGO – Elderly cancer patients have better communication with their oncologists and report greater satisfaction with their care when the oncologists are provided with geriatric assessment summaries prior to the patient visit.

Although “satisfaction” can be subjective, the conclusion about the benefit of previsit geriatric assessments is objective, reported Supriya Gupta Mohile, MD, of the University of Rochester, New York.

Neil Osterweil/MDedge News

Each domain independently predicts morbidity and/or mortality in older patients.

The investigators enrolled 31 oncology practices in the National Cancer Institute’s Community Oncology Research Program that were treating patients aged 70 or older with advanced solid tumors or lymphoma. Patients who were enrolled had at least one impaired GA domain. In all, 542 patients across the sites were enrolled.

All patients in each arm completed the GA.

Randomization was by practice, with practices in arm 1 randomized to receive GA intervention results. Oncologists in this trial arm were provided with a GA summary and list of recommended GA-guided interventions.

Practices in arm 2 (controls) did not receive summaries or lists of recommendations, but oncologists were notified if patients had clinically significant depression or cognitive impairment.

In the intervention group, patients completed all assessments within 30 minutes, and less than 10 minutes of practice staff time was required for administration of objective tests.

The investigators made audio recordings and transcripts of clinic visits after GA in both arms, with two blinded coders evaluating quality of communication and plans for follow-up interventions. Patients were surveyed by telephone about their satisfaction, via the Health Care Climate Questionnaire (HCCQ) and the same instrument modified for age-related concerns (HCCQ-age).

“We found that patients enrolled in the study had a high prevalence of impairments of Geriatric Assessment domains, ranging from over 90% for physical performance, to 25% for psychological status, mainly depression. Of note, more than 30% of patients ... screened positive for cognitive impairment.” Dr. Mohile said.

For the coprimary endpoint of communication about age-related concerns, the mean number of discussions was 7.74 in the GA arm, compared with 4.24 in the control arm, a difference of 3.5 (P less than .0001).

Arm 1 was rated as having more discussions with higher-quality communications (mean 4.42 vs. 2.47, P less than .0001), and had more discussions leading to an intervention (3.08 vs. 1.15, P less than .0001).

Patients in arm 1 consistently rated their satisfaction with communication (the other coprimary endpoint) higher than did patients in arm 2, at both baseline, 4-6 weeks after the visit, and 3 months after the visit.

Neil Osterweil/MDedge News

“This is a very important study that I think is likely to have a direct impact on the care of older patients with cancer,” ASCO expert Joshua A. Jones, MD, of the University of Pennsylvania, Philadelphia, said at the meeting.

“This study shows in a randomized fashion that we can, with a simple intervention, improve communication about what’s really important to older patients with cancer,” he said. “We have interventions, things like physical therapy, things like counseling, supports that can be provided to patients and families as they are thinking through treatment decisions, helping us to provide the most appropriate care for these individuals.”

SOURCE: Mohile SG et al. ASCO 2018, abstract LBA10003.

CHICAGO – Elderly cancer patients have better communication with their oncologists and report greater satisfaction with their care when the oncologists are provided with geriatric assessment summaries prior to the patient visit.

Although “satisfaction” can be subjective, the conclusion about the benefit of previsit geriatric assessments is objective, reported Supriya Gupta Mohile, MD, of the University of Rochester, New York.

Neil Osterweil/MDedge News

Each domain independently predicts morbidity and/or mortality in older patients.

The investigators enrolled 31 oncology practices in the National Cancer Institute’s Community Oncology Research Program that were treating patients aged 70 or older with advanced solid tumors or lymphoma. Patients who were enrolled had at least one impaired GA domain. In all, 542 patients across the sites were enrolled.

All patients in each arm completed the GA.

Randomization was by practice, with practices in arm 1 randomized to receive GA intervention results. Oncologists in this trial arm were provided with a GA summary and list of recommended GA-guided interventions.

Practices in arm 2 (controls) did not receive summaries or lists of recommendations, but oncologists were notified if patients had clinically significant depression or cognitive impairment.

In the intervention group, patients completed all assessments within 30 minutes, and less than 10 minutes of practice staff time was required for administration of objective tests.

The investigators made audio recordings and transcripts of clinic visits after GA in both arms, with two blinded coders evaluating quality of communication and plans for follow-up interventions. Patients were surveyed by telephone about their satisfaction, via the Health Care Climate Questionnaire (HCCQ) and the same instrument modified for age-related concerns (HCCQ-age).

“We found that patients enrolled in the study had a high prevalence of impairments of Geriatric Assessment domains, ranging from over 90% for physical performance, to 25% for psychological status, mainly depression. Of note, more than 30% of patients ... screened positive for cognitive impairment.” Dr. Mohile said.

For the coprimary endpoint of communication about age-related concerns, the mean number of discussions was 7.74 in the GA arm, compared with 4.24 in the control arm, a difference of 3.5 (P less than .0001).

Arm 1 was rated as having more discussions with higher-quality communications (mean 4.42 vs. 2.47, P less than .0001), and had more discussions leading to an intervention (3.08 vs. 1.15, P less than .0001).

Patients in arm 1 consistently rated their satisfaction with communication (the other coprimary endpoint) higher than did patients in arm 2, at both baseline, 4-6 weeks after the visit, and 3 months after the visit.

Neil Osterweil/MDedge News

“This is a very important study that I think is likely to have a direct impact on the care of older patients with cancer,” ASCO expert Joshua A. Jones, MD, of the University of Pennsylvania, Philadelphia, said at the meeting.

“This study shows in a randomized fashion that we can, with a simple intervention, improve communication about what’s really important to older patients with cancer,” he said. “We have interventions, things like physical therapy, things like counseling, supports that can be provided to patients and families as they are thinking through treatment decisions, helping us to provide the most appropriate care for these individuals.”

SOURCE: Mohile SG et al. ASCO 2018, abstract LBA10003.

More young women with early-stage cervical cancer are opting for fertility-sparing trachelectomy, based on a recent analysis of the National Cancer Database.

Of 15,150 patients analyzed, the vast majority (97.1%) underwent hysterectomy, but trachelectomy performance increased from 1.5% (95% confidence interval, 0.8%-2.2%; P less than .001) in 2004 to 3.8% (95% CI, 2.7%-4.8%; P less than .001) by 2014. The increase was mostly seen among women younger than 30 years old. In that group, trachelectomy increased from 4.6% (95% CI, 1.0%-8.2%; P less than .001) in 2004 to 17% (95% CI, 10.2%-23.7%; P less than .001) in 2014. Rates among women aged 30-49 years were relatively stable over the same period.

“A possible explanation for this rise in trachelectomy is the trend in delayed childbearing in women in the United States,” wrote Rosa R. Cui, MD, a resident at Columbia University, New York, and her coauthors.

In the analysis, mortality risk and 5-year survival rates were similar between the two procedures. Overall cohort 5-year survival was nearly identical with hysterectomy and trachelectomy at 92.4% and 92.3%, respectively. For stages IA2, IB1, and IB not specified, tumor stage was not associated with differences in 5-year survival for the two procedures. As few patients with stage IB2 tumors received trachelectomy, that data was excluded from the analysis.

Though increasing tumor size made trachelectomy less likely, 30% of patients in the study who underwent trachelectomy had a tumor greater than 2 cm in diameter, and 4% had a tumor greater than 4 cm in diameter. The researchers noted studies published in the past few years suggest abdominal radical trachelectomy may be a safe option for larger tumors, compared with vaginal trachelectomy. In the current analysis, they did not find a statistically significant decrease in survival for trachelectomy patients with tumors greater than 2 cm in diameter, but the sample size was small.

“The trachelectomy procedure has evolved significantly since it was initially described and now encompasses several approaches,” and can be performed more or less conservatively depending on the diagnosis “without compromising outcomes,” wrote Dr. Cui and her coauthors.

The researchers noted that the National Cancer Database does not have data on fertility outcomes, a possible focus of future studies of trachelectomy.

Two coauthors disclosed grants and a fellowship from the National Cancer Institute, and others disclosed consulting for several pharmaceutical companies including Pfizer, Teva, and Eisai.

[email protected]

SOURCE: Cui RR et al. Obstet Gynecol. 2018 Jun;131(6):1085-94.

More young women with early-stage cervical cancer are opting for fertility-sparing trachelectomy, based on a recent analysis of the National Cancer Database.

Of 15,150 patients analyzed, the vast majority (97.1%) underwent hysterectomy, but trachelectomy performance increased from 1.5% (95% confidence interval, 0.8%-2.2%; P less than .001) in 2004 to 3.8% (95% CI, 2.7%-4.8%; P less than .001) by 2014. The increase was mostly seen among women younger than 30 years old. In that group, trachelectomy increased from 4.6% (95% CI, 1.0%-8.2%; P less than .001) in 2004 to 17% (95% CI, 10.2%-23.7%; P less than .001) in 2014. Rates among women aged 30-49 years were relatively stable over the same period.

“A possible explanation for this rise in trachelectomy is the trend in delayed childbearing in women in the United States,” wrote Rosa R. Cui, MD, a resident at Columbia University, New York, and her coauthors.

In the analysis, mortality risk and 5-year survival rates were similar between the two procedures. Overall cohort 5-year survival was nearly identical with hysterectomy and trachelectomy at 92.4% and 92.3%, respectively. For stages IA2, IB1, and IB not specified, tumor stage was not associated with differences in 5-year survival for the two procedures. As few patients with stage IB2 tumors received trachelectomy, that data was excluded from the analysis.

Though increasing tumor size made trachelectomy less likely, 30% of patients in the study who underwent trachelectomy had a tumor greater than 2 cm in diameter, and 4% had a tumor greater than 4 cm in diameter. The researchers noted studies published in the past few years suggest abdominal radical trachelectomy may be a safe option for larger tumors, compared with vaginal trachelectomy. In the current analysis, they did not find a statistically significant decrease in survival for trachelectomy patients with tumors greater than 2 cm in diameter, but the sample size was small.

“The trachelectomy procedure has evolved significantly since it was initially described and now encompasses several approaches,” and can be performed more or less conservatively depending on the diagnosis “without compromising outcomes,” wrote Dr. Cui and her coauthors.

The researchers noted that the National Cancer Database does not have data on fertility outcomes, a possible focus of future studies of trachelectomy.

Two coauthors disclosed grants and a fellowship from the National Cancer Institute, and others disclosed consulting for several pharmaceutical companies including Pfizer, Teva, and Eisai.

[email protected]

SOURCE: Cui RR et al. Obstet Gynecol. 2018 Jun;131(6):1085-94.

More young women with early-stage cervical cancer are opting for fertility-sparing trachelectomy, based on a recent analysis of the National Cancer Database.

Of 15,150 patients analyzed, the vast majority (97.1%) underwent hysterectomy, but trachelectomy performance increased from 1.5% (95% confidence interval, 0.8%-2.2%; P less than .001) in 2004 to 3.8% (95% CI, 2.7%-4.8%; P less than .001) by 2014. The increase was mostly seen among women younger than 30 years old. In that group, trachelectomy increased from 4.6% (95% CI, 1.0%-8.2%; P less than .001) in 2004 to 17% (95% CI, 10.2%-23.7%; P less than .001) in 2014. Rates among women aged 30-49 years were relatively stable over the same period.

“A possible explanation for this rise in trachelectomy is the trend in delayed childbearing in women in the United States,” wrote Rosa R. Cui, MD, a resident at Columbia University, New York, and her coauthors.

In the analysis, mortality risk and 5-year survival rates were similar between the two procedures. Overall cohort 5-year survival was nearly identical with hysterectomy and trachelectomy at 92.4% and 92.3%, respectively. For stages IA2, IB1, and IB not specified, tumor stage was not associated with differences in 5-year survival for the two procedures. As few patients with stage IB2 tumors received trachelectomy, that data was excluded from the analysis.

Though increasing tumor size made trachelectomy less likely, 30% of patients in the study who underwent trachelectomy had a tumor greater than 2 cm in diameter, and 4% had a tumor greater than 4 cm in diameter. The researchers noted studies published in the past few years suggest abdominal radical trachelectomy may be a safe option for larger tumors, compared with vaginal trachelectomy. In the current analysis, they did not find a statistically significant decrease in survival for trachelectomy patients with tumors greater than 2 cm in diameter, but the sample size was small.

“The trachelectomy procedure has evolved significantly since it was initially described and now encompasses several approaches,” and can be performed more or less conservatively depending on the diagnosis “without compromising outcomes,” wrote Dr. Cui and her coauthors.

The researchers noted that the National Cancer Database does not have data on fertility outcomes, a possible focus of future studies of trachelectomy.

Two coauthors disclosed grants and a fellowship from the National Cancer Institute, and others disclosed consulting for several pharmaceutical companies including Pfizer, Teva, and Eisai.

[email protected]

SOURCE: Cui RR et al. Obstet Gynecol. 2018 Jun;131(6):1085-94.

A 56-year-old man presents for his annual physical. He brings in blood work done for all employees in his workplace (he is an aerospace engineer), and wants to talk about the lab that has an asterisk by it. All his labs are normal, except that his mean corpuscular volume (MCV) is 101. His hematocrit (HCT) is 42. He has no symptoms and a normal physical exam.

What test or tests would most likely be abnormal?

A. Thyroid-stimulating hormone.

B. Vitamin B₁₂/folate.

C. Testosterone.

D. Gamma-glutamyl-transferase (GGT).

The finding of macrocytosis is fairly common in primary care, estimated to be found in 3% of complete blood count results.¹ Most students in medical school quickly learn that vitamin B₁₂ and folate deficiency can cause macrocytic anemias. The standard workups for patients with macrocytosis began and ended with checking vitamin B₁₂ and folate levels, which are usually normal in the vast majority of patients with macrocytosis.

For this patient, the correct answer would be an abnormal GGT, because chronic moderate to heavy alcohol use can raise GGT levels, as well as MCVs.

Dr. David Savage and colleagues evaluated the etiology of macrocytosis in 300 consecutive hospitalized patients with macrocytosis.² They found that the most common causes were medications, alcohol, liver disease, and reticulocytosis. The study was done in New York and was published in 2000, so zidovudine (AZT) was a common medication cause of the macrocytosis. This medication is much less commonly used today. Zidovudine causes macrocytosis in more than 80% of patients who take it. They also found in the study that very high MCVs (> 120) were most commonly associated with vitamin B₁₂ deficiency.

Dr. Kaija Seppä and colleagues looked at all outpatients who had a blood count done over an 8-month period. A total of 9,527 blood counts were ordered, and 287 (3%) had macrocytosis.¹ Further workup was done for 113 of the patients. The most common cause found for macrocytosis was alcohol abuse, in 74 (65%) of the patients (80% of the men and 36% of the women). No cause of the macrocytosis was found in 24 (21%) of the patients.

Dr. A. Wymer and colleagues looked at 2,800 adult outpatients who had complete blood counts. A total of 138 (3.7%) had macrocytosis, with 128 of these patients having charts that could be reviewed.³ A total of 73 patients had a workup for their macrocytosis. Alcohol was the diagnostic cause of the macrocytosis in 47 (64%). Only five of the patients had B₁₂ deficiency (7%).

Pearl: Strongly consider alcohol as the cause of the incidental finding of macrocytosis, especially in patients without anemia.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the university. Contact Dr. Paauw at [email protected].

References

1. J Stud Alcohol. 1996 Jan;57(1):97-100.

2. Am J Med Sci. 2000 Jun;319(6):343-52.

3. J Gen Intern Med. 1990 May-Jun;5(3):192-7.

4. Alcohol. 1993 Sep-Oct;10(5):343-7.

5. South Med J. 2013 Feb;106(2):121-5.

A 56-year-old man presents for his annual physical. He brings in blood work done for all employees in his workplace (he is an aerospace engineer), and wants to talk about the lab that has an asterisk by it. All his labs are normal, except that his mean corpuscular volume (MCV) is 101. His hematocrit (HCT) is 42. He has no symptoms and a normal physical exam.

What test or tests would most likely be abnormal?

A. Thyroid-stimulating hormone.

B. Vitamin B₁₂/folate.

C. Testosterone.

D. Gamma-glutamyl-transferase (GGT).

The finding of macrocytosis is fairly common in primary care, estimated to be found in 3% of complete blood count results.¹ Most students in medical school quickly learn that vitamin B₁₂ and folate deficiency can cause macrocytic anemias. The standard workups for patients with macrocytosis began and ended with checking vitamin B₁₂ and folate levels, which are usually normal in the vast majority of patients with macrocytosis.

For this patient, the correct answer would be an abnormal GGT, because chronic moderate to heavy alcohol use can raise GGT levels, as well as MCVs.

Dr. David Savage and colleagues evaluated the etiology of macrocytosis in 300 consecutive hospitalized patients with macrocytosis.² They found that the most common causes were medications, alcohol, liver disease, and reticulocytosis. The study was done in New York and was published in 2000, so zidovudine (AZT) was a common medication cause of the macrocytosis. This medication is much less commonly used today. Zidovudine causes macrocytosis in more than 80% of patients who take it. They also found in the study that very high MCVs (> 120) were most commonly associated with vitamin B₁₂ deficiency.

Dr. Kaija Seppä and colleagues looked at all outpatients who had a blood count done over an 8-month period. A total of 9,527 blood counts were ordered, and 287 (3%) had macrocytosis.¹ Further workup was done for 113 of the patients. The most common cause found for macrocytosis was alcohol abuse, in 74 (65%) of the patients (80% of the men and 36% of the women). No cause of the macrocytosis was found in 24 (21%) of the patients.

Dr. A. Wymer and colleagues looked at 2,800 adult outpatients who had complete blood counts. A total of 138 (3.7%) had macrocytosis, with 128 of these patients having charts that could be reviewed.³ A total of 73 patients had a workup for their macrocytosis. Alcohol was the diagnostic cause of the macrocytosis in 47 (64%). Only five of the patients had B₁₂ deficiency (7%).

Pearl: Strongly consider alcohol as the cause of the incidental finding of macrocytosis, especially in patients without anemia.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the university. Contact Dr. Paauw at [email protected].

References

1. J Stud Alcohol. 1996 Jan;57(1):97-100.

2. Am J Med Sci. 2000 Jun;319(6):343-52.

3. J Gen Intern Med. 1990 May-Jun;5(3):192-7.

4. Alcohol. 1993 Sep-Oct;10(5):343-7.

5. South Med J. 2013 Feb;106(2):121-5.

A 56-year-old man presents for his annual physical. He brings in blood work done for all employees in his workplace (he is an aerospace engineer), and wants to talk about the lab that has an asterisk by it. All his labs are normal, except that his mean corpuscular volume (MCV) is 101. His hematocrit (HCT) is 42. He has no symptoms and a normal physical exam.

What test or tests would most likely be abnormal?

A. Thyroid-stimulating hormone.

B. Vitamin B₁₂/folate.

C. Testosterone.

D. Gamma-glutamyl-transferase (GGT).

The finding of macrocytosis is fairly common in primary care, estimated to be found in 3% of complete blood count results.¹ Most students in medical school quickly learn that vitamin B₁₂ and folate deficiency can cause macrocytic anemias. The standard workups for patients with macrocytosis began and ended with checking vitamin B₁₂ and folate levels, which are usually normal in the vast majority of patients with macrocytosis.

For this patient, the correct answer would be an abnormal GGT, because chronic moderate to heavy alcohol use can raise GGT levels, as well as MCVs.

Dr. David Savage and colleagues evaluated the etiology of macrocytosis in 300 consecutive hospitalized patients with macrocytosis.² They found that the most common causes were medications, alcohol, liver disease, and reticulocytosis. The study was done in New York and was published in 2000, so zidovudine (AZT) was a common medication cause of the macrocytosis. This medication is much less commonly used today. Zidovudine causes macrocytosis in more than 80% of patients who take it. They also found in the study that very high MCVs (> 120) were most commonly associated with vitamin B₁₂ deficiency.

Dr. Kaija Seppä and colleagues looked at all outpatients who had a blood count done over an 8-month period. A total of 9,527 blood counts were ordered, and 287 (3%) had macrocytosis.¹ Further workup was done for 113 of the patients. The most common cause found for macrocytosis was alcohol abuse, in 74 (65%) of the patients (80% of the men and 36% of the women). No cause of the macrocytosis was found in 24 (21%) of the patients.

Dr. A. Wymer and colleagues looked at 2,800 adult outpatients who had complete blood counts. A total of 138 (3.7%) had macrocytosis, with 128 of these patients having charts that could be reviewed.³ A total of 73 patients had a workup for their macrocytosis. Alcohol was the diagnostic cause of the macrocytosis in 47 (64%). Only five of the patients had B₁₂ deficiency (7%).

Pearl: Strongly consider alcohol as the cause of the incidental finding of macrocytosis, especially in patients without anemia.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the university. Contact Dr. Paauw at [email protected].

References

1. J Stud Alcohol. 1996 Jan;57(1):97-100.

2. Am J Med Sci. 2000 Jun;319(6):343-52.

3. J Gen Intern Med. 1990 May-Jun;5(3):192-7.

4. Alcohol. 1993 Sep-Oct;10(5):343-7.

5. South Med J. 2013 Feb;106(2):121-5.

©ASCO/Todd Buchanan 2018

CHICAGO—Cord blood (CB) is a viable source of natural killer (NK) cells for adoptive cellular therapy for multiple myeloma (MM), according to a speaker at the 2018 ASCO Annual Meeting.

Ex-vivo expanded cord blood NK cells were well tolerated without significant graft-versus-host disease (GVHD) or cytokine release syndrome (CRS) in a phase 2 study.

Nina Shah, MD, of the University of California San Francisco, reported these results as abstract 8006.*

The phase 2 study (NCT01729091) included 33 patients with symptomatic MM who were appropriate candidates for autologous stem cell transplant (ASCT).

For each patient, investigators chose cord blood units with at least a 4/6 match at HLA-A, -B and –DR.

Prior to the autologous graft, patients received lenalidomide and melphalan. Lenalidomide was given based on preclinical data suggesting synergy between that immunomodulatory agent and NK cells, Dr Shah said.

Patients were a median age of 59 (range, 25 – 72), 36% had a history of progressive disease or relapse, and 73% had adverse cytogenetics/FISH, were ISS III, or had a history of progressive disease or relapse.

Results

Dr Shah observed that in a generally high-risk population, responses to treatment with cord blood NK cells in the setting of ASCT were “encouraging,” with 79% of patients achieving very good partial response (VGPR) or better.

Twenty-one patients (64%) achieved a complete response (CR) or near CR. And 61% achieved minimal residual disease (MRD) negativity by day 100.

Patients had an estimated 3-year progression-free survival of 52%.

Three patients died, all from disease progression, and 13 patients have progressed.

The investigators observed no infusional toxicities, no GVHD, no CRS, and no neurotoxicity.

One patient experienced graft failure and was rescued with an autologous back-up graft.

"We are able to detect the donor-derived NK cells up to 13 days after infusion,” Dr Shah said, “but I think a more sensitive analysis with flow chimerism will not only allow us to detect more patients, but also better interrogate them to truly understand the in vivo phenotype and activation status of these cells."

Dr Shah indicated she and her colleagues became interested in studying cord blood for NK cell therapy because it is a known source of hematopoietic cells that is immediately available, does not require donor manipulation, and has more flexibility in genetic matching.

Previously, Dr Shah and colleagues conducted a phase 1 study, in which 12 patients received cord blood NK cells up to a dose of 1 x 10⁸ NK cells/kg. “This was determined to be adequate and safe to move on to the phase 2,” she said.

Despite encouraging results, more research needs to be done, according to Dr Shah. “I don't think this is the end-all, be-all for NK cell therapy.”

Some future directions include combination with antibody therapy, improving NK persistence in vivo using cytokine manipulation, and possibly engineering chimeric antigen receptor (CAR)-modified NK cells, Dr Shah observed.

It’s also possible that HLA match may not be needed: “If that is the case, we will truly have an off-the-shelf source of NK cells that we can apply more readily to various patients,” she said.

The study was supported by Celgene Corporation, Stading-Younger Cancer Research Foundation, and the MD Anderson High-Risk Multiple Myeloma Moonshot Project.  

*Data in the presentation differ from the abstract.

©ASCO/Todd Buchanan 2018

CHICAGO—Cord blood (CB) is a viable source of natural killer (NK) cells for adoptive cellular therapy for multiple myeloma (MM), according to a speaker at the 2018 ASCO Annual Meeting.

Ex-vivo expanded cord blood NK cells were well tolerated without significant graft-versus-host disease (GVHD) or cytokine release syndrome (CRS) in a phase 2 study.

Nina Shah, MD, of the University of California San Francisco, reported these results as abstract 8006.*

The phase 2 study (NCT01729091) included 33 patients with symptomatic MM who were appropriate candidates for autologous stem cell transplant (ASCT).

For each patient, investigators chose cord blood units with at least a 4/6 match at HLA-A, -B and –DR.

Prior to the autologous graft, patients received lenalidomide and melphalan. Lenalidomide was given based on preclinical data suggesting synergy between that immunomodulatory agent and NK cells, Dr Shah said.

Patients were a median age of 59 (range, 25 – 72), 36% had a history of progressive disease or relapse, and 73% had adverse cytogenetics/FISH, were ISS III, or had a history of progressive disease or relapse.

Results

Dr Shah observed that in a generally high-risk population, responses to treatment with cord blood NK cells in the setting of ASCT were “encouraging,” with 79% of patients achieving very good partial response (VGPR) or better.

Twenty-one patients (64%) achieved a complete response (CR) or near CR. And 61% achieved minimal residual disease (MRD) negativity by day 100.

Patients had an estimated 3-year progression-free survival of 52%.

Three patients died, all from disease progression, and 13 patients have progressed.

The investigators observed no infusional toxicities, no GVHD, no CRS, and no neurotoxicity.

One patient experienced graft failure and was rescued with an autologous back-up graft.

"We are able to detect the donor-derived NK cells up to 13 days after infusion,” Dr Shah said, “but I think a more sensitive analysis with flow chimerism will not only allow us to detect more patients, but also better interrogate them to truly understand the in vivo phenotype and activation status of these cells."

Dr Shah indicated she and her colleagues became interested in studying cord blood for NK cell therapy because it is a known source of hematopoietic cells that is immediately available, does not require donor manipulation, and has more flexibility in genetic matching.

Previously, Dr Shah and colleagues conducted a phase 1 study, in which 12 patients received cord blood NK cells up to a dose of 1 x 10⁸ NK cells/kg. “This was determined to be adequate and safe to move on to the phase 2,” she said.

Despite encouraging results, more research needs to be done, according to Dr Shah. “I don't think this is the end-all, be-all for NK cell therapy.”

Some future directions include combination with antibody therapy, improving NK persistence in vivo using cytokine manipulation, and possibly engineering chimeric antigen receptor (CAR)-modified NK cells, Dr Shah observed.

It’s also possible that HLA match may not be needed: “If that is the case, we will truly have an off-the-shelf source of NK cells that we can apply more readily to various patients,” she said.

The study was supported by Celgene Corporation, Stading-Younger Cancer Research Foundation, and the MD Anderson High-Risk Multiple Myeloma Moonshot Project.  

*Data in the presentation differ from the abstract.

©ASCO/Todd Buchanan 2018

CHICAGO—Cord blood (CB) is a viable source of natural killer (NK) cells for adoptive cellular therapy for multiple myeloma (MM), according to a speaker at the 2018 ASCO Annual Meeting.

Ex-vivo expanded cord blood NK cells were well tolerated without significant graft-versus-host disease (GVHD) or cytokine release syndrome (CRS) in a phase 2 study.

Nina Shah, MD, of the University of California San Francisco, reported these results as abstract 8006.*

The phase 2 study (NCT01729091) included 33 patients with symptomatic MM who were appropriate candidates for autologous stem cell transplant (ASCT).

For each patient, investigators chose cord blood units with at least a 4/6 match at HLA-A, -B and –DR.

Prior to the autologous graft, patients received lenalidomide and melphalan. Lenalidomide was given based on preclinical data suggesting synergy between that immunomodulatory agent and NK cells, Dr Shah said.

Patients were a median age of 59 (range, 25 – 72), 36% had a history of progressive disease or relapse, and 73% had adverse cytogenetics/FISH, were ISS III, or had a history of progressive disease or relapse.

Results

Dr Shah observed that in a generally high-risk population, responses to treatment with cord blood NK cells in the setting of ASCT were “encouraging,” with 79% of patients achieving very good partial response (VGPR) or better.

Twenty-one patients (64%) achieved a complete response (CR) or near CR. And 61% achieved minimal residual disease (MRD) negativity by day 100.

Patients had an estimated 3-year progression-free survival of 52%.

Three patients died, all from disease progression, and 13 patients have progressed.

The investigators observed no infusional toxicities, no GVHD, no CRS, and no neurotoxicity.

One patient experienced graft failure and was rescued with an autologous back-up graft.

"We are able to detect the donor-derived NK cells up to 13 days after infusion,” Dr Shah said, “but I think a more sensitive analysis with flow chimerism will not only allow us to detect more patients, but also better interrogate them to truly understand the in vivo phenotype and activation status of these cells."

Dr Shah indicated she and her colleagues became interested in studying cord blood for NK cell therapy because it is a known source of hematopoietic cells that is immediately available, does not require donor manipulation, and has more flexibility in genetic matching.

Previously, Dr Shah and colleagues conducted a phase 1 study, in which 12 patients received cord blood NK cells up to a dose of 1 x 10⁸ NK cells/kg. “This was determined to be adequate and safe to move on to the phase 2,” she said.

Despite encouraging results, more research needs to be done, according to Dr Shah. “I don't think this is the end-all, be-all for NK cell therapy.”

Some future directions include combination with antibody therapy, improving NK persistence in vivo using cytokine manipulation, and possibly engineering chimeric antigen receptor (CAR)-modified NK cells, Dr Shah observed.

It’s also possible that HLA match may not be needed: “If that is the case, we will truly have an off-the-shelf source of NK cells that we can apply more readily to various patients,” she said.

The study was supported by Celgene Corporation, Stading-Younger Cancer Research Foundation, and the MD Anderson High-Risk Multiple Myeloma Moonshot Project.  

*Data in the presentation differ from the abstract.

showing multiple myeloma

Chimeric antigen receptor (CAR) T-cell technology has been successfully used in the treatment of hematologic malignancies such as leukemias and lymphomas. Now, this technology has come to the forefront in multiple myeloma (MM).

Researchers at the National Cancer Institute, led by James N. Kochenderfer, MD, generated CAR T cells expressing the B-cell maturation antigen (BCMA), which is uniquely found on MM cells.

In the first in humans study, 24 patients received CAR-BCMA T cells at doses ranging between 0.3 and 3 x 10⁶ CAR+ T cells/kg. Sixteen patients were treated at the highest dose. These patients had a median of 9.5 lines of prior therapy and 63% were refractory to their last treatment.

Thirteen patients had responses that were either partial or better and the overall response rate was 81%. Median event-free survival was 31 weeks. At the time of the report, 6 patients still have ongoing responses.

Patient cases

The report highlights a case study of a patient who had a large abdominal mass that resolved on computed tomography imaging, with λ light chains decreasing dramatically and becoming undetectable after CAR T-cell infusion. Recovery of normal plasma cells was noticeable with λ chain increases, but the ratio of κ to λ ratio remained normal 6 months after CAR T-cell infusion.

Using immunohistochemistry staining of CS138 before and 2 months after CAR-BMCA infusion, the researchers found effective depletion in bone marrow plasma cells in patients who were evaluated.

In patients who responded to treatment, decline in serum BCMA was also observed. However, in a patient who later progressed, BCMA increases were seen, leading the researchers to suggest that BCMA may be a tumor marker for MM.

The researchers noted that peak levels of CAR T cells occurred between 7 and 14 days after infusion and highest levels were seen in patients who showed antimyeloma responses.

Toxicity

CAR T-cell technology is also associated with accompanying toxicities.

At the highest dose, cytokine release syndrome (CRS) was a substantial toxicity especially in 2 patients who had a significant MM burden: in one case 80% of bone marrow cells were MM plasma cells and in the other the MM burden was 90%.

Six of the 16 patients required vasopressor support for hypotension and 1 patient required mechanical ventilation. The researchers noted that CRS of grade 3/4 was seen in patients who had a higher MM plasma cell burden.

The researchers indicated there is room for improvement. “The importance of persistence of CAR T cells in treating MM requires additional study,” they stated.

The sometimes low or absence of BCMA expression on MM cells may prompt the search for other antigens. “Treatment outcomes varied substantially between patients, and much room for improvement remains in improving the durability of antimyeloma responses and in reducing toxicity,” they concluded.

The researchers reported their findings in the Journal of Clinical Oncology. 

showing multiple myeloma

Chimeric antigen receptor (CAR) T-cell technology has been successfully used in the treatment of hematologic malignancies such as leukemias and lymphomas. Now, this technology has come to the forefront in multiple myeloma (MM).

Researchers at the National Cancer Institute, led by James N. Kochenderfer, MD, generated CAR T cells expressing the B-cell maturation antigen (BCMA), which is uniquely found on MM cells.

In the first in humans study, 24 patients received CAR-BCMA T cells at doses ranging between 0.3 and 3 x 10⁶ CAR+ T cells/kg. Sixteen patients were treated at the highest dose. These patients had a median of 9.5 lines of prior therapy and 63% were refractory to their last treatment.

Thirteen patients had responses that were either partial or better and the overall response rate was 81%. Median event-free survival was 31 weeks. At the time of the report, 6 patients still have ongoing responses.

Patient cases

The report highlights a case study of a patient who had a large abdominal mass that resolved on computed tomography imaging, with λ light chains decreasing dramatically and becoming undetectable after CAR T-cell infusion. Recovery of normal plasma cells was noticeable with λ chain increases, but the ratio of κ to λ ratio remained normal 6 months after CAR T-cell infusion.

Using immunohistochemistry staining of CS138 before and 2 months after CAR-BMCA infusion, the researchers found effective depletion in bone marrow plasma cells in patients who were evaluated.

In patients who responded to treatment, decline in serum BCMA was also observed. However, in a patient who later progressed, BCMA increases were seen, leading the researchers to suggest that BCMA may be a tumor marker for MM.

The researchers noted that peak levels of CAR T cells occurred between 7 and 14 days after infusion and highest levels were seen in patients who showed antimyeloma responses.

Toxicity

CAR T-cell technology is also associated with accompanying toxicities.

At the highest dose, cytokine release syndrome (CRS) was a substantial toxicity especially in 2 patients who had a significant MM burden: in one case 80% of bone marrow cells were MM plasma cells and in the other the MM burden was 90%.

Six of the 16 patients required vasopressor support for hypotension and 1 patient required mechanical ventilation. The researchers noted that CRS of grade 3/4 was seen in patients who had a higher MM plasma cell burden.

The researchers indicated there is room for improvement. “The importance of persistence of CAR T cells in treating MM requires additional study,” they stated.

The sometimes low or absence of BCMA expression on MM cells may prompt the search for other antigens. “Treatment outcomes varied substantially between patients, and much room for improvement remains in improving the durability of antimyeloma responses and in reducing toxicity,” they concluded.

The researchers reported their findings in the Journal of Clinical Oncology. 

showing multiple myeloma

Chimeric antigen receptor (CAR) T-cell technology has been successfully used in the treatment of hematologic malignancies such as leukemias and lymphomas. Now, this technology has come to the forefront in multiple myeloma (MM).

Researchers at the National Cancer Institute, led by James N. Kochenderfer, MD, generated CAR T cells expressing the B-cell maturation antigen (BCMA), which is uniquely found on MM cells.

In the first in humans study, 24 patients received CAR-BCMA T cells at doses ranging between 0.3 and 3 x 10⁶ CAR+ T cells/kg. Sixteen patients were treated at the highest dose. These patients had a median of 9.5 lines of prior therapy and 63% were refractory to their last treatment.

Thirteen patients had responses that were either partial or better and the overall response rate was 81%. Median event-free survival was 31 weeks. At the time of the report, 6 patients still have ongoing responses.

Patient cases

The report highlights a case study of a patient who had a large abdominal mass that resolved on computed tomography imaging, with λ light chains decreasing dramatically and becoming undetectable after CAR T-cell infusion. Recovery of normal plasma cells was noticeable with λ chain increases, but the ratio of κ to λ ratio remained normal 6 months after CAR T-cell infusion.

Using immunohistochemistry staining of CS138 before and 2 months after CAR-BMCA infusion, the researchers found effective depletion in bone marrow plasma cells in patients who were evaluated.

In patients who responded to treatment, decline in serum BCMA was also observed. However, in a patient who later progressed, BCMA increases were seen, leading the researchers to suggest that BCMA may be a tumor marker for MM.

The researchers noted that peak levels of CAR T cells occurred between 7 and 14 days after infusion and highest levels were seen in patients who showed antimyeloma responses.

Toxicity

CAR T-cell technology is also associated with accompanying toxicities.

At the highest dose, cytokine release syndrome (CRS) was a substantial toxicity especially in 2 patients who had a significant MM burden: in one case 80% of bone marrow cells were MM plasma cells and in the other the MM burden was 90%.

Six of the 16 patients required vasopressor support for hypotension and 1 patient required mechanical ventilation. The researchers noted that CRS of grade 3/4 was seen in patients who had a higher MM plasma cell burden.

The researchers indicated there is room for improvement. “The importance of persistence of CAR T cells in treating MM requires additional study,” they stated.

The sometimes low or absence of BCMA expression on MM cells may prompt the search for other antigens. “Treatment outcomes varied substantially between patients, and much room for improvement remains in improving the durability of antimyeloma responses and in reducing toxicity,” they concluded.

The researchers reported their findings in the Journal of Clinical Oncology. 

Vials and a syringe

The US Food and Drug Association (FDA) has approved pegfilgrastim-jmdb (Fulphila™) as the first biosimilar to Neulasta®.

The agents reduce the risk of infection or the duration of febrile neutropenia in patients treated with immunosuppressive chemotherapy for non-myeloid hematologic malignancies.

The FDA approved Fulphila based on evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.

The evidence demonstrated that Fulphila is biosimilar to Amgen’s Neulasta. The FDA, in its announcement, noted that Fulphila has been approved as a biosimilar and not as an interchangeable product.

A biosimilar is a biological product approved based on data showing it is highly similar to a biological product already approved by the FDA, termed the reference product.

A biosimilar has no clinically meaningful differences from the reference product in terms of safety, purity, and effectiveness.

Common side effects of Fulphila include bone pain and pain in extremities.

The FDA cautions that patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors, such as pegfilgrastim or filgrastim products, should not take Fulphila.

Serious side effects from Fulphila include:

• rupture of the spleen
• acute respiratory distress syndrome
• serious allergic reactions including anaphylaxis
• glomerulonephritis
• leukocytosis
• capillary leak syndrome
• potential for tumor growth

Fatal sickle cell crises have also occurred with Fulphila use.

Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

The FDA is planning to release a comprehensive new plan to advance policy efforts that promote biosimilar product development, according to FDA Commissioner Scott Gotlieb, MD.

“We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products,” he said in the announcement.

The FDA granted approval of Fulphila to Mylan GmbH. Mylan is co-developing Fulphila with Biocon.

Last fall, the agency had issued a complete response letter saying it could not approve the proposed biosimilar pending an update to the application.

The complete response letter did not raise any questions on the biosimilarity of Fulphila (investigational drug product MYL-1401H), pharmacokinetic/pharmacodynamic data, clinical data, or immunogenicity, however.

Mylan anticipates launching Fulphila in the coming weeks. 

Vials and a syringe

The US Food and Drug Association (FDA) has approved pegfilgrastim-jmdb (Fulphila™) as the first biosimilar to Neulasta®.

The agents reduce the risk of infection or the duration of febrile neutropenia in patients treated with immunosuppressive chemotherapy for non-myeloid hematologic malignancies.

The FDA approved Fulphila based on evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.

The evidence demonstrated that Fulphila is biosimilar to Amgen’s Neulasta. The FDA, in its announcement, noted that Fulphila has been approved as a biosimilar and not as an interchangeable product.

A biosimilar is a biological product approved based on data showing it is highly similar to a biological product already approved by the FDA, termed the reference product.

A biosimilar has no clinically meaningful differences from the reference product in terms of safety, purity, and effectiveness.

Common side effects of Fulphila include bone pain and pain in extremities.

The FDA cautions that patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors, such as pegfilgrastim or filgrastim products, should not take Fulphila.

Serious side effects from Fulphila include:

• rupture of the spleen
• acute respiratory distress syndrome
• serious allergic reactions including anaphylaxis
• glomerulonephritis
• leukocytosis
• capillary leak syndrome
• potential for tumor growth

Fatal sickle cell crises have also occurred with Fulphila use.

Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

The FDA is planning to release a comprehensive new plan to advance policy efforts that promote biosimilar product development, according to FDA Commissioner Scott Gotlieb, MD.

“We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products,” he said in the announcement.

The FDA granted approval of Fulphila to Mylan GmbH. Mylan is co-developing Fulphila with Biocon.

Last fall, the agency had issued a complete response letter saying it could not approve the proposed biosimilar pending an update to the application.

The complete response letter did not raise any questions on the biosimilarity of Fulphila (investigational drug product MYL-1401H), pharmacokinetic/pharmacodynamic data, clinical data, or immunogenicity, however.

Mylan anticipates launching Fulphila in the coming weeks. 

Vials and a syringe

The US Food and Drug Association (FDA) has approved pegfilgrastim-jmdb (Fulphila™) as the first biosimilar to Neulasta®.

The agents reduce the risk of infection or the duration of febrile neutropenia in patients treated with immunosuppressive chemotherapy for non-myeloid hematologic malignancies.

The FDA approved Fulphila based on evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.

The evidence demonstrated that Fulphila is biosimilar to Amgen’s Neulasta. The FDA, in its announcement, noted that Fulphila has been approved as a biosimilar and not as an interchangeable product.

A biosimilar is a biological product approved based on data showing it is highly similar to a biological product already approved by the FDA, termed the reference product.

A biosimilar has no clinically meaningful differences from the reference product in terms of safety, purity, and effectiveness.

Common side effects of Fulphila include bone pain and pain in extremities.

The FDA cautions that patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors, such as pegfilgrastim or filgrastim products, should not take Fulphila.

Serious side effects from Fulphila include:

• rupture of the spleen
• acute respiratory distress syndrome
• serious allergic reactions including anaphylaxis
• glomerulonephritis
• leukocytosis
• capillary leak syndrome
• potential for tumor growth

Fatal sickle cell crises have also occurred with Fulphila use.

Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

The FDA is planning to release a comprehensive new plan to advance policy efforts that promote biosimilar product development, according to FDA Commissioner Scott Gotlieb, MD.

“We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products,” he said in the announcement.

The FDA granted approval of Fulphila to Mylan GmbH. Mylan is co-developing Fulphila with Biocon.

Last fall, the agency had issued a complete response letter saying it could not approve the proposed biosimilar pending an update to the application.

The complete response letter did not raise any questions on the biosimilarity of Fulphila (investigational drug product MYL-1401H), pharmacokinetic/pharmacodynamic data, clinical data, or immunogenicity, however.

Mylan anticipates launching Fulphila in the coming weeks. 

CHICAGO – Pembrolizumab monotherapy is associated with antitumor activity in patients with advanced recurrent ovarian cancer, interim results from the phase 2 KEYNOTE-100 study suggest.

Notably, objective response rates among study subjects increased in tandem with increased programmed death-ligand 1 (PD-L1) expression, which helps define the population most likely to benefit from single agent pembrolizumab (Keytruda), Ursula A. Matulonis reported during an oral abstract session at the annual meeting of the American Society of Clinical Oncology.

Further, no new safety signals were identified, said Dr. Matulonis, medical director and program leader of the Medical Gynecologic Oncology Program at of Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, both in Boston.

All patients received intravenous pembrolizumab at 200 mg every 3 weeks for 2 years or until progression, death, unacceptable toxicity, or consent withdrawal, and tumor imaging was performed every 9 weeks for a year, then every 12 weeks thereafter until progressive disease, death, or study completion.

The overall response rate (ORR) among 285 patients in Cohort A, who had one to three prior chemotherapy lines for recurrent advanced ovarian cancer and a platinum-free or treatment-free interval of 3-12 months, was 7.4%, with mean duration of response of 8.2 months. The ORR among 91 patients in Cohort B, who had four to six prior chemotherapy lines and a platinum-free or treatment-free interval of at least 3 months, was 9.9%; the mean duration of response was not reached in Cohort B.

Among all-comers, the ORR was 8.0%, including 7 complete responses and 23 partial responses. Mean duration of response was 8.2 months, and 65.5% of responses lasted at least 6 months. Further, responses were observed across all subgroups, Dr. Matulonis said, noting that responses were seen regardless of age, prior lines of treatment, progression-free/treatment-free interval duration, platinum sensitivity, and histology.

“The one factor that did predict response was a [combined positive score] of 10 or higher, where there were more responses,” she said.

The ORRs among those with PD-L1 expression as measured using the combined positive score (CPS), which is defined as the number of PD-L1–positive cells out of the total number of tumor cells x 100, was 5.0% in those with CPS less than 1, 10.2% in those with CPS of 1 or greater, and 17.1% in those with CPS of 10 or greater (vs. the 8.0% ORR in the study), she explained, noting that all complete responses occurred in those with CPS of 10 or higher.

Grade 3-4 treatment-related adverse events occurred in 19.7% of patients, and included fatigue in 2.7%, and anemia, colitis, increased amylase, increased blood alkaline phosphatase, ascites, and diarrhea in 0.8-1.3%. One treatment-related death occurred in a patient with Stevens-Johnson syndrome, and another occurred in a patient with hypoaldosteronism. Immune-mediated adverse events and infusion reactions were most commonly hyperthyroidism and hypothyroidism, and most cases were grade 1-2, she said.

KEYNOTE-100 is an ongoing study that followed KEYNOTE-028, which demonstrated the clinical activity of pembrolizumab in patients with advanced ovarian cancer. To date, KEYNOTE-100 has enrolled 376 patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer and confirmed recurrence after frontline platinum-based therapy. All had a tumor sample available for biomarker analysis.

The patients had a mean age of 61 years, 64% and 35% had performance status scores of 0 and 1, respectively, and 75% had high-grade serous disease.

Median follow-up in Cohort A at the time of the current analysis was 16.7 months, and in Cohort B, the median follow-up was 17.3 months. Treatment was ongoing in 15 and 6 patients in the cohorts, respectively. Reasons for discontinuation included radiographic progression (204 and 62 patients), clinical progression (24 and 17 patients), adverse events (22 and 3 patients), and patient withdrawal (9 and 3 patients). Complete responses occurred in 1 and 0 patients in the groups, respectively.

Median progression-free survival in both cohorts was 2.1 months, and overall survival was not reached in Cohort A, while it was 17.6 months in the more heavily pretreated Cohort B.

“Recurrent ovarian cancer is the leading cause of death from gynecologic cancer. The majority of our patients relapse after first-line platinum and taxane-based chemotherapy, and the degree of platinum sensitivity will predict the tumor response rates with platinum, as well as survival time,” she said, noting that subsequent recurrences become increasingly platinum and treatment resistant.

Current treatment options in these patients include chemotherapy with or without bevacizumab; the ORRs with single-agent immune checkpoint blockade are about 10%, but in KEYNOTE-028, patients with PD-L1–positive advanced recurrent ovarian cancer had an ORR of 11.5% with pembrolizumab treatment, she said.

“With 16.9 months median follow-up, the results confirm that pembrolizumab monotherapy in recurrent ovarian cancer elicits modest antitumor efficacy,” Dr. Matulonis concluded, noting that further analysis for biomarkers predictive of pembrolizumab response are ongoing.

Invited discussant Janos Laszlo Tanyi, MD, of the University of Pennsylvania, Philadelphia, said the findings underscore the overall modest ORRs of 5.9%-15% seen with anti-PD-1 or PD-L1 monotherapy in patients with advanced recurrent ovarian cancer, but noted the importance of the finding that the subpopulation of patients with increased PD-L1 expression may experience greater benefit.

Dr. Matulonis reported consulting or advisory roles with 2X Oncology, Clovis Oncology, Fujifilm, Geneos Therapeutics, Lilly, Merck, and Myriad Genetics, and research funding from Merck and Novartis. Dr .Tanyi reported having no disclosures.

SOURCE: Matulonis UA et al. ASCO 2018, Abstract 5511.

CHICAGO – Pembrolizumab monotherapy is associated with antitumor activity in patients with advanced recurrent ovarian cancer, interim results from the phase 2 KEYNOTE-100 study suggest.

Notably, objective response rates among study subjects increased in tandem with increased programmed death-ligand 1 (PD-L1) expression, which helps define the population most likely to benefit from single agent pembrolizumab (Keytruda), Ursula A. Matulonis reported during an oral abstract session at the annual meeting of the American Society of Clinical Oncology.

Further, no new safety signals were identified, said Dr. Matulonis, medical director and program leader of the Medical Gynecologic Oncology Program at of Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, both in Boston.

All patients received intravenous pembrolizumab at 200 mg every 3 weeks for 2 years or until progression, death, unacceptable toxicity, or consent withdrawal, and tumor imaging was performed every 9 weeks for a year, then every 12 weeks thereafter until progressive disease, death, or study completion.

The overall response rate (ORR) among 285 patients in Cohort A, who had one to three prior chemotherapy lines for recurrent advanced ovarian cancer and a platinum-free or treatment-free interval of 3-12 months, was 7.4%, with mean duration of response of 8.2 months. The ORR among 91 patients in Cohort B, who had four to six prior chemotherapy lines and a platinum-free or treatment-free interval of at least 3 months, was 9.9%; the mean duration of response was not reached in Cohort B.

Among all-comers, the ORR was 8.0%, including 7 complete responses and 23 partial responses. Mean duration of response was 8.2 months, and 65.5% of responses lasted at least 6 months. Further, responses were observed across all subgroups, Dr. Matulonis said, noting that responses were seen regardless of age, prior lines of treatment, progression-free/treatment-free interval duration, platinum sensitivity, and histology.

“The one factor that did predict response was a [combined positive score] of 10 or higher, where there were more responses,” she said.

The ORRs among those with PD-L1 expression as measured using the combined positive score (CPS), which is defined as the number of PD-L1–positive cells out of the total number of tumor cells x 100, was 5.0% in those with CPS less than 1, 10.2% in those with CPS of 1 or greater, and 17.1% in those with CPS of 10 or greater (vs. the 8.0% ORR in the study), she explained, noting that all complete responses occurred in those with CPS of 10 or higher.

Grade 3-4 treatment-related adverse events occurred in 19.7% of patients, and included fatigue in 2.7%, and anemia, colitis, increased amylase, increased blood alkaline phosphatase, ascites, and diarrhea in 0.8-1.3%. One treatment-related death occurred in a patient with Stevens-Johnson syndrome, and another occurred in a patient with hypoaldosteronism. Immune-mediated adverse events and infusion reactions were most commonly hyperthyroidism and hypothyroidism, and most cases were grade 1-2, she said.

KEYNOTE-100 is an ongoing study that followed KEYNOTE-028, which demonstrated the clinical activity of pembrolizumab in patients with advanced ovarian cancer. To date, KEYNOTE-100 has enrolled 376 patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer and confirmed recurrence after frontline platinum-based therapy. All had a tumor sample available for biomarker analysis.

The patients had a mean age of 61 years, 64% and 35% had performance status scores of 0 and 1, respectively, and 75% had high-grade serous disease.

Median follow-up in Cohort A at the time of the current analysis was 16.7 months, and in Cohort B, the median follow-up was 17.3 months. Treatment was ongoing in 15 and 6 patients in the cohorts, respectively. Reasons for discontinuation included radiographic progression (204 and 62 patients), clinical progression (24 and 17 patients), adverse events (22 and 3 patients), and patient withdrawal (9 and 3 patients). Complete responses occurred in 1 and 0 patients in the groups, respectively.

Median progression-free survival in both cohorts was 2.1 months, and overall survival was not reached in Cohort A, while it was 17.6 months in the more heavily pretreated Cohort B.

“Recurrent ovarian cancer is the leading cause of death from gynecologic cancer. The majority of our patients relapse after first-line platinum and taxane-based chemotherapy, and the degree of platinum sensitivity will predict the tumor response rates with platinum, as well as survival time,” she said, noting that subsequent recurrences become increasingly platinum and treatment resistant.

Current treatment options in these patients include chemotherapy with or without bevacizumab; the ORRs with single-agent immune checkpoint blockade are about 10%, but in KEYNOTE-028, patients with PD-L1–positive advanced recurrent ovarian cancer had an ORR of 11.5% with pembrolizumab treatment, she said.

“With 16.9 months median follow-up, the results confirm that pembrolizumab monotherapy in recurrent ovarian cancer elicits modest antitumor efficacy,” Dr. Matulonis concluded, noting that further analysis for biomarkers predictive of pembrolizumab response are ongoing.

Invited discussant Janos Laszlo Tanyi, MD, of the University of Pennsylvania, Philadelphia, said the findings underscore the overall modest ORRs of 5.9%-15% seen with anti-PD-1 or PD-L1 monotherapy in patients with advanced recurrent ovarian cancer, but noted the importance of the finding that the subpopulation of patients with increased PD-L1 expression may experience greater benefit.

Dr. Matulonis reported consulting or advisory roles with 2X Oncology, Clovis Oncology, Fujifilm, Geneos Therapeutics, Lilly, Merck, and Myriad Genetics, and research funding from Merck and Novartis. Dr .Tanyi reported having no disclosures.

SOURCE: Matulonis UA et al. ASCO 2018, Abstract 5511.

CHICAGO – Pembrolizumab monotherapy is associated with antitumor activity in patients with advanced recurrent ovarian cancer, interim results from the phase 2 KEYNOTE-100 study suggest.

Notably, objective response rates among study subjects increased in tandem with increased programmed death-ligand 1 (PD-L1) expression, which helps define the population most likely to benefit from single agent pembrolizumab (Keytruda), Ursula A. Matulonis reported during an oral abstract session at the annual meeting of the American Society of Clinical Oncology.

Further, no new safety signals were identified, said Dr. Matulonis, medical director and program leader of the Medical Gynecologic Oncology Program at of Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, both in Boston.

All patients received intravenous pembrolizumab at 200 mg every 3 weeks for 2 years or until progression, death, unacceptable toxicity, or consent withdrawal, and tumor imaging was performed every 9 weeks for a year, then every 12 weeks thereafter until progressive disease, death, or study completion.

The overall response rate (ORR) among 285 patients in Cohort A, who had one to three prior chemotherapy lines for recurrent advanced ovarian cancer and a platinum-free or treatment-free interval of 3-12 months, was 7.4%, with mean duration of response of 8.2 months. The ORR among 91 patients in Cohort B, who had four to six prior chemotherapy lines and a platinum-free or treatment-free interval of at least 3 months, was 9.9%; the mean duration of response was not reached in Cohort B.

Among all-comers, the ORR was 8.0%, including 7 complete responses and 23 partial responses. Mean duration of response was 8.2 months, and 65.5% of responses lasted at least 6 months. Further, responses were observed across all subgroups, Dr. Matulonis said, noting that responses were seen regardless of age, prior lines of treatment, progression-free/treatment-free interval duration, platinum sensitivity, and histology.

“The one factor that did predict response was a [combined positive score] of 10 or higher, where there were more responses,” she said.

The ORRs among those with PD-L1 expression as measured using the combined positive score (CPS), which is defined as the number of PD-L1–positive cells out of the total number of tumor cells x 100, was 5.0% in those with CPS less than 1, 10.2% in those with CPS of 1 or greater, and 17.1% in those with CPS of 10 or greater (vs. the 8.0% ORR in the study), she explained, noting that all complete responses occurred in those with CPS of 10 or higher.

Grade 3-4 treatment-related adverse events occurred in 19.7% of patients, and included fatigue in 2.7%, and anemia, colitis, increased amylase, increased blood alkaline phosphatase, ascites, and diarrhea in 0.8-1.3%. One treatment-related death occurred in a patient with Stevens-Johnson syndrome, and another occurred in a patient with hypoaldosteronism. Immune-mediated adverse events and infusion reactions were most commonly hyperthyroidism and hypothyroidism, and most cases were grade 1-2, she said.

KEYNOTE-100 is an ongoing study that followed KEYNOTE-028, which demonstrated the clinical activity of pembrolizumab in patients with advanced ovarian cancer. To date, KEYNOTE-100 has enrolled 376 patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer and confirmed recurrence after frontline platinum-based therapy. All had a tumor sample available for biomarker analysis.

The patients had a mean age of 61 years, 64% and 35% had performance status scores of 0 and 1, respectively, and 75% had high-grade serous disease.

Median follow-up in Cohort A at the time of the current analysis was 16.7 months, and in Cohort B, the median follow-up was 17.3 months. Treatment was ongoing in 15 and 6 patients in the cohorts, respectively. Reasons for discontinuation included radiographic progression (204 and 62 patients), clinical progression (24 and 17 patients), adverse events (22 and 3 patients), and patient withdrawal (9 and 3 patients). Complete responses occurred in 1 and 0 patients in the groups, respectively.

Median progression-free survival in both cohorts was 2.1 months, and overall survival was not reached in Cohort A, while it was 17.6 months in the more heavily pretreated Cohort B.

“Recurrent ovarian cancer is the leading cause of death from gynecologic cancer. The majority of our patients relapse after first-line platinum and taxane-based chemotherapy, and the degree of platinum sensitivity will predict the tumor response rates with platinum, as well as survival time,” she said, noting that subsequent recurrences become increasingly platinum and treatment resistant.

Current treatment options in these patients include chemotherapy with or without bevacizumab; the ORRs with single-agent immune checkpoint blockade are about 10%, but in KEYNOTE-028, patients with PD-L1–positive advanced recurrent ovarian cancer had an ORR of 11.5% with pembrolizumab treatment, she said.

“With 16.9 months median follow-up, the results confirm that pembrolizumab monotherapy in recurrent ovarian cancer elicits modest antitumor efficacy,” Dr. Matulonis concluded, noting that further analysis for biomarkers predictive of pembrolizumab response are ongoing.

Invited discussant Janos Laszlo Tanyi, MD, of the University of Pennsylvania, Philadelphia, said the findings underscore the overall modest ORRs of 5.9%-15% seen with anti-PD-1 or PD-L1 monotherapy in patients with advanced recurrent ovarian cancer, but noted the importance of the finding that the subpopulation of patients with increased PD-L1 expression may experience greater benefit.

Dr. Matulonis reported consulting or advisory roles with 2X Oncology, Clovis Oncology, Fujifilm, Geneos Therapeutics, Lilly, Merck, and Myriad Genetics, and research funding from Merck and Novartis. Dr .Tanyi reported having no disclosures.

SOURCE: Matulonis UA et al. ASCO 2018, Abstract 5511.

An injection to the bladder may help improve sexual function along with relieving symptoms, according to a recent statistical analysis.

In a prospective observational study, 32 women with wet idiopathic overactive bladder received a 100 U/10 mL injection of onabotulinumtoxinA (onaBoNT-A) to their detrusor muscle while sedated.

The women in the study had overactive bladder syndrome with urgency urinary incontinence that was refractory to more conservative treatments. All were aged 18 years or older, sexually active, and in a relationship with the same partner for more than 3 months.

The researchers sought to distinguish the effect of the injection treatment on sexual function for women with an idiopathic, rather than neurogenic, version of the syndrome. Sexual function was assessed through a 19-item questionnaire, the Female Sexual Function Index (FSFI), before and after the treatment. To determine the efficacy of the treatment, participants kept a 3-day voiding diary, and completed two more forms: an overactive bladder screener questionnaire and the International Consultation on Incontinence Questionnaire Short Form.

Most of the participants (88.2%) saw an improvement in their overactive bladder symptoms. They also reported statistically meaningful improvement in sexual function on the FSFI, and specifically for arousal, lubrication, orgasm, and satisfaction, though not for desire and pain (average FSFI total score before and after treatment, 20.30 vs. 24.91; P = .0008).

“Although voiding diaries and questionnaires on urinary symptoms showed an improvement after onaBoNT-A injection, we documented a significant correlation only between the reduction of episodes of [urgency urinary incontinence] and improvement of FSFI total score. This finding shows that, in our population, the most relevant urinary symptom reducing the sexual function is urgency urinary incontinence,” Matteo Balzarro, MD, of Azienda Ospedaliera Universitaria Integrata of Verona, Italy, and his coauthors wrote in the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The researchers noted that the small sample size resulted from multiple exclusion criteria applied to an already small population of 157 patients. They also remarked that a control group – which was absent from their study – would be difficult to have because of “ethical considerations.”

The researchers reported having no conflicts of interest.

[email protected]

SOURCE: Balzarro M et al. Eur J Obstet Gynecol Reprod Biol. 2018 Jun;225:228-31.
 

An injection to the bladder may help improve sexual function along with relieving symptoms, according to a recent statistical analysis.

In a prospective observational study, 32 women with wet idiopathic overactive bladder received a 100 U/10 mL injection of onabotulinumtoxinA (onaBoNT-A) to their detrusor muscle while sedated.

The women in the study had overactive bladder syndrome with urgency urinary incontinence that was refractory to more conservative treatments. All were aged 18 years or older, sexually active, and in a relationship with the same partner for more than 3 months.

The researchers sought to distinguish the effect of the injection treatment on sexual function for women with an idiopathic, rather than neurogenic, version of the syndrome. Sexual function was assessed through a 19-item questionnaire, the Female Sexual Function Index (FSFI), before and after the treatment. To determine the efficacy of the treatment, participants kept a 3-day voiding diary, and completed two more forms: an overactive bladder screener questionnaire and the International Consultation on Incontinence Questionnaire Short Form.

Most of the participants (88.2%) saw an improvement in their overactive bladder symptoms. They also reported statistically meaningful improvement in sexual function on the FSFI, and specifically for arousal, lubrication, orgasm, and satisfaction, though not for desire and pain (average FSFI total score before and after treatment, 20.30 vs. 24.91; P = .0008).

“Although voiding diaries and questionnaires on urinary symptoms showed an improvement after onaBoNT-A injection, we documented a significant correlation only between the reduction of episodes of [urgency urinary incontinence] and improvement of FSFI total score. This finding shows that, in our population, the most relevant urinary symptom reducing the sexual function is urgency urinary incontinence,” Matteo Balzarro, MD, of Azienda Ospedaliera Universitaria Integrata of Verona, Italy, and his coauthors wrote in the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The researchers noted that the small sample size resulted from multiple exclusion criteria applied to an already small population of 157 patients. They also remarked that a control group – which was absent from their study – would be difficult to have because of “ethical considerations.”

The researchers reported having no conflicts of interest.

[email protected]

SOURCE: Balzarro M et al. Eur J Obstet Gynecol Reprod Biol. 2018 Jun;225:228-31.
 

An injection to the bladder may help improve sexual function along with relieving symptoms, according to a recent statistical analysis.

In a prospective observational study, 32 women with wet idiopathic overactive bladder received a 100 U/10 mL injection of onabotulinumtoxinA (onaBoNT-A) to their detrusor muscle while sedated.

The women in the study had overactive bladder syndrome with urgency urinary incontinence that was refractory to more conservative treatments. All were aged 18 years or older, sexually active, and in a relationship with the same partner for more than 3 months.

The researchers sought to distinguish the effect of the injection treatment on sexual function for women with an idiopathic, rather than neurogenic, version of the syndrome. Sexual function was assessed through a 19-item questionnaire, the Female Sexual Function Index (FSFI), before and after the treatment. To determine the efficacy of the treatment, participants kept a 3-day voiding diary, and completed two more forms: an overactive bladder screener questionnaire and the International Consultation on Incontinence Questionnaire Short Form.

Most of the participants (88.2%) saw an improvement in their overactive bladder symptoms. They also reported statistically meaningful improvement in sexual function on the FSFI, and specifically for arousal, lubrication, orgasm, and satisfaction, though not for desire and pain (average FSFI total score before and after treatment, 20.30 vs. 24.91; P = .0008).

“Although voiding diaries and questionnaires on urinary symptoms showed an improvement after onaBoNT-A injection, we documented a significant correlation only between the reduction of episodes of [urgency urinary incontinence] and improvement of FSFI total score. This finding shows that, in our population, the most relevant urinary symptom reducing the sexual function is urgency urinary incontinence,” Matteo Balzarro, MD, of Azienda Ospedaliera Universitaria Integrata of Verona, Italy, and his coauthors wrote in the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The researchers noted that the small sample size resulted from multiple exclusion criteria applied to an already small population of 157 patients. They also remarked that a control group – which was absent from their study – would be difficult to have because of “ethical considerations.”

The researchers reported having no conflicts of interest.

[email protected]

SOURCE: Balzarro M et al. Eur J Obstet Gynecol Reprod Biol. 2018 Jun;225:228-31.