TBD Meeting (2910-20)

Younger women treated for uterine or ovarian cancer are at increased risk for decreased bone mineral density and osteoporosis, especially in the first year after diagnosis, and they should be screened for bone changes, investigators advise.

This recommendation is based on results from a retrospective study of women, age 65 years and younger, all of whom underwent oophorectomy and most of whom received chemotherapy. Half of the women who had normal bone mineral density (BMD) at baseline were at risk for osteopenia or osteoporosis 5 years after diagnosis.

Rates of patients at risk for osteoporosis roughly doubled each year for the first 3 years of follow-up, reported study author Janelle Sobecki, MD, of the University of Wisconsin–Madison, and colleagues.

Their research is detailed in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“Clinicians should follow current National Comprehensive Cancer Network guidelines regarding bone mineral density screening in women under 65 years old with cancer who have undergone therapy affecting their ovarian function [ovarian removal and/or antiestrogen therapies],” Dr. Sobecki said in an interview.

“Our findings indicate women with gynecologic cancer undergoing ovarian removal and chemotherapy may warrant sooner bone density evaluation, as early as 1 year following treatment. Bone loss screening in this population is feasible using opportunistic CT imaging,” she added.

Current guidelines recommending routine BMD evaluation every 2 years in women who received treatments impairing ovarian function are based largely on data in breast cancer patients, but there is a paucity of data on women who undergo oophorectomy and cancer therapies, both of which are known risk factors for bone loss, Dr. Sobecki noted.

“Bone loss is an important issue for women’s cancer survivorship, particularly for women who we expect to have long survival,” she said. “Identifying bone loss early is important for long-term bone health and prevention of osteoporosis in cancer survivors.”
 

Patient analysis

To get a better picture of long-term BMD changes and osteoporosis risk in younger patients, Dr. Sobecki and colleagues conducted a retrospective cohort study of women with uterine or ovarian cancers who underwent oophorectomy from 2010 to 2015.

The investigators calculated CT-based L1 trabecular attenuation BMD measurements (Hounsfield units, HU) on CT scans performed at baseline and at 1 year, 3 years, 5 years, and beyond 5 years after cancer diagnosis.

Osteoporosis risk was defined based on HU. Less than 100 HU was deemed “concerning” for osteoporosis, 100-150 HU was suggestive of osteopenia, and more than 150 HU indicated normal BMD.

The investigators reviewed scans for 185 patients with a median age of 55 years and a mean body mass index of 32 kg/m². Each patient had at least a baseline scan and one additional CT scan during follow-up.

The majority of patients (78.1%) had ovarian cancer, 78.1% underwent chemotherapy, and 17.1% were treated with external beam radiation. As of 2019, 118 patients (63.6%) were still alive.
 

Results and next steps

The investigators found that BMD decreased from a mean of 179.4 HU at baseline to 146.5 HU at 1 year, a significant decline (P < .001), and to 123.63 HU beyond 5 years (P < .001). As noted before, half of the patients with normal BMD at baseline were at risk for osteopenia or osteoporosis at 5 years.

The proportion of patients at risk for osteoporosis at baseline was 4.3%, compared with 7.4% at 1 year, 15.7% at 3 years, 18% at 5 years, and 23.3% beyond 5 years. BMD at baseline was a significant predictor for bone loss at all time points. In multivariate analysis, chemotherapy predicted bone loss at 1 year (P = .03), and current smoking predicted BMD decrease at 5 years (^P < .01).

“We plan to further investigate the role of chemotherapy in bone loss in gynecologic cancer patients, including chemotherapy dose-related bone loss,” Dr. Sobecki said. “We also plan to investigate bone loss in older women [over the age of 65] undergoing treatment for gynecologic cancer as they may be at greater risk than their baseline age-related risk.”

This study was internally funded. Dr. Sobecki reported no conflicts of interest.

SOURCE: Sobecki J et al. SGO 2020, Abstract 130.

Younger women treated for uterine or ovarian cancer are at increased risk for decreased bone mineral density and osteoporosis, especially in the first year after diagnosis, and they should be screened for bone changes, investigators advise.

This recommendation is based on results from a retrospective study of women, age 65 years and younger, all of whom underwent oophorectomy and most of whom received chemotherapy. Half of the women who had normal bone mineral density (BMD) at baseline were at risk for osteopenia or osteoporosis 5 years after diagnosis.

Rates of patients at risk for osteoporosis roughly doubled each year for the first 3 years of follow-up, reported study author Janelle Sobecki, MD, of the University of Wisconsin–Madison, and colleagues.

Their research is detailed in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“Clinicians should follow current National Comprehensive Cancer Network guidelines regarding bone mineral density screening in women under 65 years old with cancer who have undergone therapy affecting their ovarian function [ovarian removal and/or antiestrogen therapies],” Dr. Sobecki said in an interview.

“Our findings indicate women with gynecologic cancer undergoing ovarian removal and chemotherapy may warrant sooner bone density evaluation, as early as 1 year following treatment. Bone loss screening in this population is feasible using opportunistic CT imaging,” she added.

Current guidelines recommending routine BMD evaluation every 2 years in women who received treatments impairing ovarian function are based largely on data in breast cancer patients, but there is a paucity of data on women who undergo oophorectomy and cancer therapies, both of which are known risk factors for bone loss, Dr. Sobecki noted.

“Bone loss is an important issue for women’s cancer survivorship, particularly for women who we expect to have long survival,” she said. “Identifying bone loss early is important for long-term bone health and prevention of osteoporosis in cancer survivors.”
 

Patient analysis

To get a better picture of long-term BMD changes and osteoporosis risk in younger patients, Dr. Sobecki and colleagues conducted a retrospective cohort study of women with uterine or ovarian cancers who underwent oophorectomy from 2010 to 2015.

The investigators calculated CT-based L1 trabecular attenuation BMD measurements (Hounsfield units, HU) on CT scans performed at baseline and at 1 year, 3 years, 5 years, and beyond 5 years after cancer diagnosis.

Osteoporosis risk was defined based on HU. Less than 100 HU was deemed “concerning” for osteoporosis, 100-150 HU was suggestive of osteopenia, and more than 150 HU indicated normal BMD.

The investigators reviewed scans for 185 patients with a median age of 55 years and a mean body mass index of 32 kg/m². Each patient had at least a baseline scan and one additional CT scan during follow-up.

The majority of patients (78.1%) had ovarian cancer, 78.1% underwent chemotherapy, and 17.1% were treated with external beam radiation. As of 2019, 118 patients (63.6%) were still alive.
 

Results and next steps

The investigators found that BMD decreased from a mean of 179.4 HU at baseline to 146.5 HU at 1 year, a significant decline (P < .001), and to 123.63 HU beyond 5 years (P < .001). As noted before, half of the patients with normal BMD at baseline were at risk for osteopenia or osteoporosis at 5 years.

The proportion of patients at risk for osteoporosis at baseline was 4.3%, compared with 7.4% at 1 year, 15.7% at 3 years, 18% at 5 years, and 23.3% beyond 5 years. BMD at baseline was a significant predictor for bone loss at all time points. In multivariate analysis, chemotherapy predicted bone loss at 1 year (P = .03), and current smoking predicted BMD decrease at 5 years (^P < .01).

“We plan to further investigate the role of chemotherapy in bone loss in gynecologic cancer patients, including chemotherapy dose-related bone loss,” Dr. Sobecki said. “We also plan to investigate bone loss in older women [over the age of 65] undergoing treatment for gynecologic cancer as they may be at greater risk than their baseline age-related risk.”

This study was internally funded. Dr. Sobecki reported no conflicts of interest.

SOURCE: Sobecki J et al. SGO 2020, Abstract 130.

Younger women treated for uterine or ovarian cancer are at increased risk for decreased bone mineral density and osteoporosis, especially in the first year after diagnosis, and they should be screened for bone changes, investigators advise.

This recommendation is based on results from a retrospective study of women, age 65 years and younger, all of whom underwent oophorectomy and most of whom received chemotherapy. Half of the women who had normal bone mineral density (BMD) at baseline were at risk for osteopenia or osteoporosis 5 years after diagnosis.

Rates of patients at risk for osteoporosis roughly doubled each year for the first 3 years of follow-up, reported study author Janelle Sobecki, MD, of the University of Wisconsin–Madison, and colleagues.

Their research is detailed in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“Clinicians should follow current National Comprehensive Cancer Network guidelines regarding bone mineral density screening in women under 65 years old with cancer who have undergone therapy affecting their ovarian function [ovarian removal and/or antiestrogen therapies],” Dr. Sobecki said in an interview.

“Our findings indicate women with gynecologic cancer undergoing ovarian removal and chemotherapy may warrant sooner bone density evaluation, as early as 1 year following treatment. Bone loss screening in this population is feasible using opportunistic CT imaging,” she added.

Current guidelines recommending routine BMD evaluation every 2 years in women who received treatments impairing ovarian function are based largely on data in breast cancer patients, but there is a paucity of data on women who undergo oophorectomy and cancer therapies, both of which are known risk factors for bone loss, Dr. Sobecki noted.

“Bone loss is an important issue for women’s cancer survivorship, particularly for women who we expect to have long survival,” she said. “Identifying bone loss early is important for long-term bone health and prevention of osteoporosis in cancer survivors.”
 

Patient analysis

To get a better picture of long-term BMD changes and osteoporosis risk in younger patients, Dr. Sobecki and colleagues conducted a retrospective cohort study of women with uterine or ovarian cancers who underwent oophorectomy from 2010 to 2015.

The investigators calculated CT-based L1 trabecular attenuation BMD measurements (Hounsfield units, HU) on CT scans performed at baseline and at 1 year, 3 years, 5 years, and beyond 5 years after cancer diagnosis.

Osteoporosis risk was defined based on HU. Less than 100 HU was deemed “concerning” for osteoporosis, 100-150 HU was suggestive of osteopenia, and more than 150 HU indicated normal BMD.

The investigators reviewed scans for 185 patients with a median age of 55 years and a mean body mass index of 32 kg/m². Each patient had at least a baseline scan and one additional CT scan during follow-up.

The majority of patients (78.1%) had ovarian cancer, 78.1% underwent chemotherapy, and 17.1% were treated with external beam radiation. As of 2019, 118 patients (63.6%) were still alive.
 

Results and next steps

The investigators found that BMD decreased from a mean of 179.4 HU at baseline to 146.5 HU at 1 year, a significant decline (P < .001), and to 123.63 HU beyond 5 years (P < .001). As noted before, half of the patients with normal BMD at baseline were at risk for osteopenia or osteoporosis at 5 years.

The proportion of patients at risk for osteoporosis at baseline was 4.3%, compared with 7.4% at 1 year, 15.7% at 3 years, 18% at 5 years, and 23.3% beyond 5 years. BMD at baseline was a significant predictor for bone loss at all time points. In multivariate analysis, chemotherapy predicted bone loss at 1 year (P = .03), and current smoking predicted BMD decrease at 5 years (^P < .01).

“We plan to further investigate the role of chemotherapy in bone loss in gynecologic cancer patients, including chemotherapy dose-related bone loss,” Dr. Sobecki said. “We also plan to investigate bone loss in older women [over the age of 65] undergoing treatment for gynecologic cancer as they may be at greater risk than their baseline age-related risk.”

This study was internally funded. Dr. Sobecki reported no conflicts of interest.

SOURCE: Sobecki J et al. SGO 2020, Abstract 130.

More than one-fifth of patients being treated for gynecologic malignancies experience financial toxicity, results of a single-center study suggest.

Among 5,188 patients treated for gynecologic cancers, 1,155 (22%) experienced financial toxicity, measured by bills sent to collection, financial assistance, bankruptcy, or similar measures, reported Emeline Aviki, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York, and colleagues.

“In any clinical study reporting that over 20% of patients develop a serious complication as a result of treatment, financial toxicity in this case, future efforts to address the complication are critically important,” Dr. Aviki said in an interview.

Her group’s study is detailed in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Study details

To address financial problems patients with gynecologic cancer face, MSKCC assembled a multidisciplinary team that included the strategy and innovation department, the patient financial services department, medical oncologists, radiation oncologists, and surgical oncologists.

The team’s first priority was to measure the prevalence of financial burden among the center’s patients using readily available institutional data. Financial toxicity was defined as one or more of the following:

• Two or more bills sent for collection.
• Application for and granting of a time-payment plan.
• Bill settlement.
• Bankruptcy.
• Enrollment in a financial assistance plan.
• Finance-related social work visit.

In a univariate analysis, factors significantly associated with financial toxicity, and the proportion of patients in each category affected, included cervical cancer (31%), stage 3 (29%) or 4 disease (27%), age younger than 30 years (32%), nonpartnered marital status (28%), black (38%) or Hispanic (33%) race/ethnicity, self-pay (42%) or commercial insurance (26%), clinical trial participation (27%), nine or more imaging studies (33%), one or more emergency department visits (31%), inpatient stays of 20 days or longer (35%), and 20 or more outpatient clinic visits (35%).

In a multivariate analysis controlling for disease and demographics, factors that remained significantly associated with financial toxicity (P < .05) included younger age, nonpartnered marital status, black and Hispanic race/ethnicity, commercial insurance, more imaging studies, and more outpatient physician visits.
 

Implications for patients and providers

“We were really surprised to see the significant increase in financial toxicity associated with patients undergoing more frequent imaging studies,” Dr. Aviki said. “There are randomized controlled studies showing that patients with ovarian cancer do not benefit from more frequent surveillance imaging. However, many providers across the country still order scans every 3 or 4 months. With this new data showing increased financial toxicity in patients who undergo more frequent scans, I think many will pause before ordering their next surveillance scan or at least have the conversation with patients to make sure no financial harm is being done.”

Dr. Aviki and colleagues used the data from this study to create a risk-stratification tool that can be employed to identify patients with gynecologic cancers who are at increased risk for financial toxicity, who can then be offered help through patient financial services.

In addition, the investigators are working to improve provider knowledge about the costs and financial implications surveillance imaging can have for patients.

“When considering interventions that might reduce patient financial burden, we questioned what role providers should play in patient affordability issues,” Dr. Aviki said. “Many providers may believe it is unethical to be informed of their patient’s risk of financial toxicity as it may affect their treatment recommendations. Others may believe it is important for them to be fully aware of any and all treatment-related risks their patients face.”

To get a better sense of how providers see their role in patient finances and care affordability, Dr. Aviki and colleagues surveyed more than 350 attending physicians at MSKCC. The investigators plan to use the results to develop provider-focused interventions.

The study was internally funded. Dr. Aviki reported no conflicts of interest.

SOURCE: Aviki EM et al. SGO 2020, Abstract 144.

More than one-fifth of patients being treated for gynecologic malignancies experience financial toxicity, results of a single-center study suggest.

Among 5,188 patients treated for gynecologic cancers, 1,155 (22%) experienced financial toxicity, measured by bills sent to collection, financial assistance, bankruptcy, or similar measures, reported Emeline Aviki, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York, and colleagues.

“In any clinical study reporting that over 20% of patients develop a serious complication as a result of treatment, financial toxicity in this case, future efforts to address the complication are critically important,” Dr. Aviki said in an interview.

Her group’s study is detailed in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Study details

To address financial problems patients with gynecologic cancer face, MSKCC assembled a multidisciplinary team that included the strategy and innovation department, the patient financial services department, medical oncologists, radiation oncologists, and surgical oncologists.

The team’s first priority was to measure the prevalence of financial burden among the center’s patients using readily available institutional data. Financial toxicity was defined as one or more of the following:

• Two or more bills sent for collection.
• Application for and granting of a time-payment plan.
• Bill settlement.
• Bankruptcy.
• Enrollment in a financial assistance plan.
• Finance-related social work visit.

In a univariate analysis, factors significantly associated with financial toxicity, and the proportion of patients in each category affected, included cervical cancer (31%), stage 3 (29%) or 4 disease (27%), age younger than 30 years (32%), nonpartnered marital status (28%), black (38%) or Hispanic (33%) race/ethnicity, self-pay (42%) or commercial insurance (26%), clinical trial participation (27%), nine or more imaging studies (33%), one or more emergency department visits (31%), inpatient stays of 20 days or longer (35%), and 20 or more outpatient clinic visits (35%).

In a multivariate analysis controlling for disease and demographics, factors that remained significantly associated with financial toxicity (P < .05) included younger age, nonpartnered marital status, black and Hispanic race/ethnicity, commercial insurance, more imaging studies, and more outpatient physician visits.
 

Implications for patients and providers

“We were really surprised to see the significant increase in financial toxicity associated with patients undergoing more frequent imaging studies,” Dr. Aviki said. “There are randomized controlled studies showing that patients with ovarian cancer do not benefit from more frequent surveillance imaging. However, many providers across the country still order scans every 3 or 4 months. With this new data showing increased financial toxicity in patients who undergo more frequent scans, I think many will pause before ordering their next surveillance scan or at least have the conversation with patients to make sure no financial harm is being done.”

Dr. Aviki and colleagues used the data from this study to create a risk-stratification tool that can be employed to identify patients with gynecologic cancers who are at increased risk for financial toxicity, who can then be offered help through patient financial services.

In addition, the investigators are working to improve provider knowledge about the costs and financial implications surveillance imaging can have for patients.

“When considering interventions that might reduce patient financial burden, we questioned what role providers should play in patient affordability issues,” Dr. Aviki said. “Many providers may believe it is unethical to be informed of their patient’s risk of financial toxicity as it may affect their treatment recommendations. Others may believe it is important for them to be fully aware of any and all treatment-related risks their patients face.”

To get a better sense of how providers see their role in patient finances and care affordability, Dr. Aviki and colleagues surveyed more than 350 attending physicians at MSKCC. The investigators plan to use the results to develop provider-focused interventions.

The study was internally funded. Dr. Aviki reported no conflicts of interest.

SOURCE: Aviki EM et al. SGO 2020, Abstract 144.

More than one-fifth of patients being treated for gynecologic malignancies experience financial toxicity, results of a single-center study suggest.

Among 5,188 patients treated for gynecologic cancers, 1,155 (22%) experienced financial toxicity, measured by bills sent to collection, financial assistance, bankruptcy, or similar measures, reported Emeline Aviki, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York, and colleagues.

“In any clinical study reporting that over 20% of patients develop a serious complication as a result of treatment, financial toxicity in this case, future efforts to address the complication are critically important,” Dr. Aviki said in an interview.

Her group’s study is detailed in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Study details

To address financial problems patients with gynecologic cancer face, MSKCC assembled a multidisciplinary team that included the strategy and innovation department, the patient financial services department, medical oncologists, radiation oncologists, and surgical oncologists.

The team’s first priority was to measure the prevalence of financial burden among the center’s patients using readily available institutional data. Financial toxicity was defined as one or more of the following:

• Two or more bills sent for collection.
• Application for and granting of a time-payment plan.
• Bill settlement.
• Bankruptcy.
• Enrollment in a financial assistance plan.
• Finance-related social work visit.

In a univariate analysis, factors significantly associated with financial toxicity, and the proportion of patients in each category affected, included cervical cancer (31%), stage 3 (29%) or 4 disease (27%), age younger than 30 years (32%), nonpartnered marital status (28%), black (38%) or Hispanic (33%) race/ethnicity, self-pay (42%) or commercial insurance (26%), clinical trial participation (27%), nine or more imaging studies (33%), one or more emergency department visits (31%), inpatient stays of 20 days or longer (35%), and 20 or more outpatient clinic visits (35%).

In a multivariate analysis controlling for disease and demographics, factors that remained significantly associated with financial toxicity (P < .05) included younger age, nonpartnered marital status, black and Hispanic race/ethnicity, commercial insurance, more imaging studies, and more outpatient physician visits.
 

Implications for patients and providers

“We were really surprised to see the significant increase in financial toxicity associated with patients undergoing more frequent imaging studies,” Dr. Aviki said. “There are randomized controlled studies showing that patients with ovarian cancer do not benefit from more frequent surveillance imaging. However, many providers across the country still order scans every 3 or 4 months. With this new data showing increased financial toxicity in patients who undergo more frequent scans, I think many will pause before ordering their next surveillance scan or at least have the conversation with patients to make sure no financial harm is being done.”

Dr. Aviki and colleagues used the data from this study to create a risk-stratification tool that can be employed to identify patients with gynecologic cancers who are at increased risk for financial toxicity, who can then be offered help through patient financial services.

In addition, the investigators are working to improve provider knowledge about the costs and financial implications surveillance imaging can have for patients.

“When considering interventions that might reduce patient financial burden, we questioned what role providers should play in patient affordability issues,” Dr. Aviki said. “Many providers may believe it is unethical to be informed of their patient’s risk of financial toxicity as it may affect their treatment recommendations. Others may believe it is important for them to be fully aware of any and all treatment-related risks their patients face.”

To get a better sense of how providers see their role in patient finances and care affordability, Dr. Aviki and colleagues surveyed more than 350 attending physicians at MSKCC. The investigators plan to use the results to develop provider-focused interventions.

The study was internally funded. Dr. Aviki reported no conflicts of interest.

SOURCE: Aviki EM et al. SGO 2020, Abstract 144.

A survey of gynecologic cancer survivors has revealed why some of these patients don’t participate in clinical trials.

Half of survey respondents with no history of trial participation said their medical team never mentioned the possibility of a trial. About 27% of respondents who never enrolled in a trial said they were interested in trial participation but didn’t qualify, the trial they wanted wasn’t available, their insurance didn’t cover participation, or the trial site was too far away.

Annie Ellis and Mary (Dicey) Jackson Scroggins, who are both ovarian cancer survivors and patient advocates, reported these findings in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“We thought it was important to hear and learn directly from gynecologic cancer survivors,” Ms. Ellis said in an interview. “So we decided to conduct a survey that would expand knowledge about clinical trial participation from a gynecologic cancer patient–specific perspective.”

Ms. Ellis and Ms. Scroggins used survivor networks and social media to distribute a 26-question survey on trial participation. The survey was completed by 189 survivors of gynecologic cancers, 49.19% of whom experienced recurrent disease. The most common diagnoses were ovarian cancer (69.84%) and endometrial or uterine cancer (23.28%).
 

Perspectives of nonparticipants

Most respondents (65.61%) had never participated in a clinical trial. The most common reason was that the patient’s doctor or medical team never discussed trial participation (50.40%).

There were patients who were interested in trial participation but couldn’t enroll because they didn’t qualify (14.40%), the location was too far away (7.20%), the trial they wanted wasn’t available (4.00%), or their insurance didn’t cover trial participation (1.60%).

Patients who were not interested in trial participation said they didn’t want to receive a placebo (11.20%), they weren’t interested in experimental therapies (3.20%), or they didn’t want to be randomized (2.40%). One patient (1.60%) said she does not trust the medical system.

“Given the frequent conversations about distrust in the medical system, we were surprised that only 1 of the 189 respondents indicated distrust in the medical system as a reason for not participating in a clinical trial,” Ms. Ellis said.
 

Perspectives of trial participants

Roughly a third of respondents (34.39%) had participated in a clinical trial. Most (86.15%) said they learned about the trial from their doctor. Other sources included the patient’s own research (13.85%), a trial matching service (3.08%), a family member or friend (3.08%), and a support group (1.54%).

The most common reasons patients participated in trials were: “my doctor recommended it,” “to help women in the future,” “to expand my treatment options,” and “to have a chance to benefit personally.”

Additional responses indicated that patients viewed their trial participation in a positive light.

“We were surprised to find that 100% of the respondents who had participated in a clinical trial indicated either that they would participate again (84.62%) or that they were not sure about future participation (15.38%),” Ms. Ellis said. “No respondent indicated that she would not consider another trial. From open comments in the survey, it was clear that even if they did not obtain the result they hoped for or if the experience wasn’t optimal, they maintained the option of participating again.”
 

Implications and next steps

The survey results suggest there is a need for more discussions about clinical trials with patients who have gynecologic cancers, according to Ms. Ellis and Ms. Scroggins.

“We feel that conversations about clinical trials, with health care team members, should be included at every care decision point, even if – or perhaps especially if – the patient belongs to a group perceived to be unlikely to agree to participate in a trial,” Ms. Ellis said.

“These conversations are necessary with all patients-survivors,” she said, “but they are particularly important and necessary with patients from populations underrepresented in the clinical trial system if we want more representative trial populations, more generalizable results, and the potential for better outcomes for all.”

For their part, Ms. Ellis and Ms. Scroggins plan to conduct more research on this topic to gain additional insights.

“We’d like to conduct a larger survey looking deeper into barriers to and reasons for participation, and to work with medical professionals to develop models of communication to encourage consideration of clinical trials,” Ms. Ellis said. “Additionally, we will work to have a more diverse respondent pool across many dimensions.”

Ms. Ellis is a research advocate on the scientific advisory committee of the Ovarian Cancer National Alliance in Washington. Ms. Scroggins is the director of global outreach and engagement at the International Gynecologic Cancer Society in Louisville, Ken. They have no conflicts of interest.

[email protected]

SOURCE: Ellis A and Scroggins MJ. SGO 2020, Abstract 540.

A survey of gynecologic cancer survivors has revealed why some of these patients don’t participate in clinical trials.

Half of survey respondents with no history of trial participation said their medical team never mentioned the possibility of a trial. About 27% of respondents who never enrolled in a trial said they were interested in trial participation but didn’t qualify, the trial they wanted wasn’t available, their insurance didn’t cover participation, or the trial site was too far away.

Annie Ellis and Mary (Dicey) Jackson Scroggins, who are both ovarian cancer survivors and patient advocates, reported these findings in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“We thought it was important to hear and learn directly from gynecologic cancer survivors,” Ms. Ellis said in an interview. “So we decided to conduct a survey that would expand knowledge about clinical trial participation from a gynecologic cancer patient–specific perspective.”

Ms. Ellis and Ms. Scroggins used survivor networks and social media to distribute a 26-question survey on trial participation. The survey was completed by 189 survivors of gynecologic cancers, 49.19% of whom experienced recurrent disease. The most common diagnoses were ovarian cancer (69.84%) and endometrial or uterine cancer (23.28%).
 

Perspectives of nonparticipants

Most respondents (65.61%) had never participated in a clinical trial. The most common reason was that the patient’s doctor or medical team never discussed trial participation (50.40%).

There were patients who were interested in trial participation but couldn’t enroll because they didn’t qualify (14.40%), the location was too far away (7.20%), the trial they wanted wasn’t available (4.00%), or their insurance didn’t cover trial participation (1.60%).

Patients who were not interested in trial participation said they didn’t want to receive a placebo (11.20%), they weren’t interested in experimental therapies (3.20%), or they didn’t want to be randomized (2.40%). One patient (1.60%) said she does not trust the medical system.

“Given the frequent conversations about distrust in the medical system, we were surprised that only 1 of the 189 respondents indicated distrust in the medical system as a reason for not participating in a clinical trial,” Ms. Ellis said.
 

Perspectives of trial participants

Roughly a third of respondents (34.39%) had participated in a clinical trial. Most (86.15%) said they learned about the trial from their doctor. Other sources included the patient’s own research (13.85%), a trial matching service (3.08%), a family member or friend (3.08%), and a support group (1.54%).

The most common reasons patients participated in trials were: “my doctor recommended it,” “to help women in the future,” “to expand my treatment options,” and “to have a chance to benefit personally.”

Additional responses indicated that patients viewed their trial participation in a positive light.

“We were surprised to find that 100% of the respondents who had participated in a clinical trial indicated either that they would participate again (84.62%) or that they were not sure about future participation (15.38%),” Ms. Ellis said. “No respondent indicated that she would not consider another trial. From open comments in the survey, it was clear that even if they did not obtain the result they hoped for or if the experience wasn’t optimal, they maintained the option of participating again.”
 

Implications and next steps

The survey results suggest there is a need for more discussions about clinical trials with patients who have gynecologic cancers, according to Ms. Ellis and Ms. Scroggins.

“We feel that conversations about clinical trials, with health care team members, should be included at every care decision point, even if – or perhaps especially if – the patient belongs to a group perceived to be unlikely to agree to participate in a trial,” Ms. Ellis said.

“These conversations are necessary with all patients-survivors,” she said, “but they are particularly important and necessary with patients from populations underrepresented in the clinical trial system if we want more representative trial populations, more generalizable results, and the potential for better outcomes for all.”

For their part, Ms. Ellis and Ms. Scroggins plan to conduct more research on this topic to gain additional insights.

“We’d like to conduct a larger survey looking deeper into barriers to and reasons for participation, and to work with medical professionals to develop models of communication to encourage consideration of clinical trials,” Ms. Ellis said. “Additionally, we will work to have a more diverse respondent pool across many dimensions.”

Ms. Ellis is a research advocate on the scientific advisory committee of the Ovarian Cancer National Alliance in Washington. Ms. Scroggins is the director of global outreach and engagement at the International Gynecologic Cancer Society in Louisville, Ken. They have no conflicts of interest.

[email protected]

SOURCE: Ellis A and Scroggins MJ. SGO 2020, Abstract 540.

A survey of gynecologic cancer survivors has revealed why some of these patients don’t participate in clinical trials.

Half of survey respondents with no history of trial participation said their medical team never mentioned the possibility of a trial. About 27% of respondents who never enrolled in a trial said they were interested in trial participation but didn’t qualify, the trial they wanted wasn’t available, their insurance didn’t cover participation, or the trial site was too far away.

Annie Ellis and Mary (Dicey) Jackson Scroggins, who are both ovarian cancer survivors and patient advocates, reported these findings in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.

“We thought it was important to hear and learn directly from gynecologic cancer survivors,” Ms. Ellis said in an interview. “So we decided to conduct a survey that would expand knowledge about clinical trial participation from a gynecologic cancer patient–specific perspective.”

Ms. Ellis and Ms. Scroggins used survivor networks and social media to distribute a 26-question survey on trial participation. The survey was completed by 189 survivors of gynecologic cancers, 49.19% of whom experienced recurrent disease. The most common diagnoses were ovarian cancer (69.84%) and endometrial or uterine cancer (23.28%).
 

Perspectives of nonparticipants

Most respondents (65.61%) had never participated in a clinical trial. The most common reason was that the patient’s doctor or medical team never discussed trial participation (50.40%).

There were patients who were interested in trial participation but couldn’t enroll because they didn’t qualify (14.40%), the location was too far away (7.20%), the trial they wanted wasn’t available (4.00%), or their insurance didn’t cover trial participation (1.60%).

Patients who were not interested in trial participation said they didn’t want to receive a placebo (11.20%), they weren’t interested in experimental therapies (3.20%), or they didn’t want to be randomized (2.40%). One patient (1.60%) said she does not trust the medical system.

“Given the frequent conversations about distrust in the medical system, we were surprised that only 1 of the 189 respondents indicated distrust in the medical system as a reason for not participating in a clinical trial,” Ms. Ellis said.
 

Perspectives of trial participants

Roughly a third of respondents (34.39%) had participated in a clinical trial. Most (86.15%) said they learned about the trial from their doctor. Other sources included the patient’s own research (13.85%), a trial matching service (3.08%), a family member or friend (3.08%), and a support group (1.54%).

The most common reasons patients participated in trials were: “my doctor recommended it,” “to help women in the future,” “to expand my treatment options,” and “to have a chance to benefit personally.”

Additional responses indicated that patients viewed their trial participation in a positive light.

“We were surprised to find that 100% of the respondents who had participated in a clinical trial indicated either that they would participate again (84.62%) or that they were not sure about future participation (15.38%),” Ms. Ellis said. “No respondent indicated that she would not consider another trial. From open comments in the survey, it was clear that even if they did not obtain the result they hoped for or if the experience wasn’t optimal, they maintained the option of participating again.”
 

Implications and next steps

The survey results suggest there is a need for more discussions about clinical trials with patients who have gynecologic cancers, according to Ms. Ellis and Ms. Scroggins.

“We feel that conversations about clinical trials, with health care team members, should be included at every care decision point, even if – or perhaps especially if – the patient belongs to a group perceived to be unlikely to agree to participate in a trial,” Ms. Ellis said.

“These conversations are necessary with all patients-survivors,” she said, “but they are particularly important and necessary with patients from populations underrepresented in the clinical trial system if we want more representative trial populations, more generalizable results, and the potential for better outcomes for all.”

For their part, Ms. Ellis and Ms. Scroggins plan to conduct more research on this topic to gain additional insights.

“We’d like to conduct a larger survey looking deeper into barriers to and reasons for participation, and to work with medical professionals to develop models of communication to encourage consideration of clinical trials,” Ms. Ellis said. “Additionally, we will work to have a more diverse respondent pool across many dimensions.”

Ms. Ellis is a research advocate on the scientific advisory committee of the Ovarian Cancer National Alliance in Washington. Ms. Scroggins is the director of global outreach and engagement at the International Gynecologic Cancer Society in Louisville, Ken. They have no conflicts of interest.

[email protected]

SOURCE: Ellis A and Scroggins MJ. SGO 2020, Abstract 540.

In a small study, a self-administered vaginal insert containing the antimalarial agent artesunate resolved cervical intraepithelial neoplasia (CIN) 2/3 lesions in two-thirds of patients and cleared human papillomavirus (HPV) genotypes in nearly half of women whose lesions disappeared.

Ying Liu, Shanghai Xinhua News Agency

Among 28 women with biopsy-confirmed CIN 2/3 who used the inserts prior to a planned standard-of-care resection, histologic regression of lesions occurred in 19 patients. In 9 of the 19 women, there was clearance of baseline HPV genotypes.

These results were reported in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic. The study results were also published in Gynecologic Oncology.

An unexpected treatment

“The implications of having a safe, inexpensive, self-administered, shelf-stable, nonsurgical treatment for HPV intraepithelial disease, not only here in the U.S., but also extending to low-resource settings,” are self-evident, said study author Cornelia L. Trimble, MD, of Johns Hopkins University in Baltimore.

“This could change the entire landscape of care,” Dr. Trimble said in an interview. “Who’d have thunk that a freaking Chinese herbal medicine derived from the bark of a tree could have this effect?”

Artesunate is a derivative of artemisinin, an antimalarial isolated from the plant Artemisia annua, which is used in traditional Chinese medicine. According to the Centers for Disease Control and Prevention, intravenous artesunate is the first-line drug for treatment of severe malaria in the United States.

However, artesunate is neither approved by the Food and Drug Administration nor commercially available in the United States. The CDC provides artesunate to U.S. clinicians on an as-needed basis.

In addition to its antimalarial activity, artesunate has been shown to have a cytotoxic effect on squamous cells transformed by HPV in vitro. Dr. Trimble and colleagues are also testing a topical form of the drug for the treatment of vulvar intraepithelial neoplasia.

Patients, dosing, and efficacy

In the current study, Dr. Trimble and colleagues enrolled adult immunocompetent women with CIN 2/3, visible residual lesions, and detectable HPV. The patients were assigned sequentially to one of four treatment groups: one 5-day cycle of 50-mg inserts or one, two, or three 5-day cycles using 200-mg inserts.

The patients were instructed to place the inserts at bedtime using a vaginal applicator, followed by a tampon, and then remove the inserts in the morning.

In a modified intention-to-treat analysis including all women who received at least one dose of artesunate and who had endpoint data available, 19 of 28 (67.9%) had histologic regression of CIN lesions. Of the 19 patients, 9 (47.4%) had clearance of all HPV genotypes that had been present at baseline.

Asked how the investigators could distinguish between the treatment effect of the inserts and spontaneous clearance of lesions seen as part of the natural history of CIN in some patients, Dr. Trimble pointed to two observations suggesting an immunologic effect from treatment.

Specifically, although there was lesion regression to CIN 1 or less in all treatment groups, the patients who had only a single treatment cycle had a longer time to regression than those who received two or three cycles.

Additionally, among the nine patients who had viral clearance, three had clearance at the same study time point where histologic regression was observed. For the other six patients, the virus did not clear until several weeks following lesion regression.

These two observations suggest the therapeutic effect of artesunate is recognized by the immune system, which may stimulate a localized immune-mediated cytotoxic effect, Dr. Trimble said.

Safety and next steps

The safety analysis showed that side effects were generally mild and well tolerated. There were 161 adverse events among 29 women for whom safety data were available. The most frequently reported adverse events were vaginal itching (n = 13), vaginal pain (n = 12), vaginal discharge (n = 8), spotting (n = 6), uterine cramping (n = 6), vaginal dryness (n = 4), pelvic pain (n = 1), perineal pain (n = 1), and dyspareunia (n = 1).

Grade 2 adverse events included vaginal yeast infection (n = 6), bacterial vaginosis (n = 2), vaginal inflammation (n = 2), urinary tract infection (n = 2), and noninfective cystitis (n = 1). There were no grade 3 or 4 adverse events reported, and three women reported no noticeable side effects.

Dr. Trimble and colleagues are continuing to study immune responses in cervical tissues and are examining the composition and functions of the cervicovaginal metagenome, looking at bacterial, viral, and fungal components. The team has joined with collaborators at the University of Texas MD Anderson Cancer Center in Houston to look for immune markers in longitudinally collected, subject-matched cervical swabs.

Frantz Viral Therapeutics supplied the artesunate vaginal inserts and partial financial support for this study. Dr. Trimble disclosed relationships with a range of companies and organizations outside this work.

SOURCE: Trimble C L et al. SGO 2020, Abstract LBA 1.

In a small study, a self-administered vaginal insert containing the antimalarial agent artesunate resolved cervical intraepithelial neoplasia (CIN) 2/3 lesions in two-thirds of patients and cleared human papillomavirus (HPV) genotypes in nearly half of women whose lesions disappeared.

Ying Liu, Shanghai Xinhua News Agency

Among 28 women with biopsy-confirmed CIN 2/3 who used the inserts prior to a planned standard-of-care resection, histologic regression of lesions occurred in 19 patients. In 9 of the 19 women, there was clearance of baseline HPV genotypes.

These results were reported in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic. The study results were also published in Gynecologic Oncology.

An unexpected treatment

“The implications of having a safe, inexpensive, self-administered, shelf-stable, nonsurgical treatment for HPV intraepithelial disease, not only here in the U.S., but also extending to low-resource settings,” are self-evident, said study author Cornelia L. Trimble, MD, of Johns Hopkins University in Baltimore.

“This could change the entire landscape of care,” Dr. Trimble said in an interview. “Who’d have thunk that a freaking Chinese herbal medicine derived from the bark of a tree could have this effect?”

Artesunate is a derivative of artemisinin, an antimalarial isolated from the plant Artemisia annua, which is used in traditional Chinese medicine. According to the Centers for Disease Control and Prevention, intravenous artesunate is the first-line drug for treatment of severe malaria in the United States.

However, artesunate is neither approved by the Food and Drug Administration nor commercially available in the United States. The CDC provides artesunate to U.S. clinicians on an as-needed basis.

In addition to its antimalarial activity, artesunate has been shown to have a cytotoxic effect on squamous cells transformed by HPV in vitro. Dr. Trimble and colleagues are also testing a topical form of the drug for the treatment of vulvar intraepithelial neoplasia.

Patients, dosing, and efficacy

In the current study, Dr. Trimble and colleagues enrolled adult immunocompetent women with CIN 2/3, visible residual lesions, and detectable HPV. The patients were assigned sequentially to one of four treatment groups: one 5-day cycle of 50-mg inserts or one, two, or three 5-day cycles using 200-mg inserts.

The patients were instructed to place the inserts at bedtime using a vaginal applicator, followed by a tampon, and then remove the inserts in the morning.

In a modified intention-to-treat analysis including all women who received at least one dose of artesunate and who had endpoint data available, 19 of 28 (67.9%) had histologic regression of CIN lesions. Of the 19 patients, 9 (47.4%) had clearance of all HPV genotypes that had been present at baseline.

Asked how the investigators could distinguish between the treatment effect of the inserts and spontaneous clearance of lesions seen as part of the natural history of CIN in some patients, Dr. Trimble pointed to two observations suggesting an immunologic effect from treatment.

Specifically, although there was lesion regression to CIN 1 or less in all treatment groups, the patients who had only a single treatment cycle had a longer time to regression than those who received two or three cycles.

Additionally, among the nine patients who had viral clearance, three had clearance at the same study time point where histologic regression was observed. For the other six patients, the virus did not clear until several weeks following lesion regression.

These two observations suggest the therapeutic effect of artesunate is recognized by the immune system, which may stimulate a localized immune-mediated cytotoxic effect, Dr. Trimble said.

Safety and next steps

The safety analysis showed that side effects were generally mild and well tolerated. There were 161 adverse events among 29 women for whom safety data were available. The most frequently reported adverse events were vaginal itching (n = 13), vaginal pain (n = 12), vaginal discharge (n = 8), spotting (n = 6), uterine cramping (n = 6), vaginal dryness (n = 4), pelvic pain (n = 1), perineal pain (n = 1), and dyspareunia (n = 1).

Grade 2 adverse events included vaginal yeast infection (n = 6), bacterial vaginosis (n = 2), vaginal inflammation (n = 2), urinary tract infection (n = 2), and noninfective cystitis (n = 1). There were no grade 3 or 4 adverse events reported, and three women reported no noticeable side effects.

Dr. Trimble and colleagues are continuing to study immune responses in cervical tissues and are examining the composition and functions of the cervicovaginal metagenome, looking at bacterial, viral, and fungal components. The team has joined with collaborators at the University of Texas MD Anderson Cancer Center in Houston to look for immune markers in longitudinally collected, subject-matched cervical swabs.

Frantz Viral Therapeutics supplied the artesunate vaginal inserts and partial financial support for this study. Dr. Trimble disclosed relationships with a range of companies and organizations outside this work.

SOURCE: Trimble C L et al. SGO 2020, Abstract LBA 1.

In a small study, a self-administered vaginal insert containing the antimalarial agent artesunate resolved cervical intraepithelial neoplasia (CIN) 2/3 lesions in two-thirds of patients and cleared human papillomavirus (HPV) genotypes in nearly half of women whose lesions disappeared.

Ying Liu, Shanghai Xinhua News Agency

Among 28 women with biopsy-confirmed CIN 2/3 who used the inserts prior to a planned standard-of-care resection, histologic regression of lesions occurred in 19 patients. In 9 of the 19 women, there was clearance of baseline HPV genotypes.

These results were reported in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic. The study results were also published in Gynecologic Oncology.

An unexpected treatment

“The implications of having a safe, inexpensive, self-administered, shelf-stable, nonsurgical treatment for HPV intraepithelial disease, not only here in the U.S., but also extending to low-resource settings,” are self-evident, said study author Cornelia L. Trimble, MD, of Johns Hopkins University in Baltimore.

“This could change the entire landscape of care,” Dr. Trimble said in an interview. “Who’d have thunk that a freaking Chinese herbal medicine derived from the bark of a tree could have this effect?”

Artesunate is a derivative of artemisinin, an antimalarial isolated from the plant Artemisia annua, which is used in traditional Chinese medicine. According to the Centers for Disease Control and Prevention, intravenous artesunate is the first-line drug for treatment of severe malaria in the United States.

However, artesunate is neither approved by the Food and Drug Administration nor commercially available in the United States. The CDC provides artesunate to U.S. clinicians on an as-needed basis.

In addition to its antimalarial activity, artesunate has been shown to have a cytotoxic effect on squamous cells transformed by HPV in vitro. Dr. Trimble and colleagues are also testing a topical form of the drug for the treatment of vulvar intraepithelial neoplasia.

Patients, dosing, and efficacy

In the current study, Dr. Trimble and colleagues enrolled adult immunocompetent women with CIN 2/3, visible residual lesions, and detectable HPV. The patients were assigned sequentially to one of four treatment groups: one 5-day cycle of 50-mg inserts or one, two, or three 5-day cycles using 200-mg inserts.

The patients were instructed to place the inserts at bedtime using a vaginal applicator, followed by a tampon, and then remove the inserts in the morning.

In a modified intention-to-treat analysis including all women who received at least one dose of artesunate and who had endpoint data available, 19 of 28 (67.9%) had histologic regression of CIN lesions. Of the 19 patients, 9 (47.4%) had clearance of all HPV genotypes that had been present at baseline.

Asked how the investigators could distinguish between the treatment effect of the inserts and spontaneous clearance of lesions seen as part of the natural history of CIN in some patients, Dr. Trimble pointed to two observations suggesting an immunologic effect from treatment.

Specifically, although there was lesion regression to CIN 1 or less in all treatment groups, the patients who had only a single treatment cycle had a longer time to regression than those who received two or three cycles.

Additionally, among the nine patients who had viral clearance, three had clearance at the same study time point where histologic regression was observed. For the other six patients, the virus did not clear until several weeks following lesion regression.

These two observations suggest the therapeutic effect of artesunate is recognized by the immune system, which may stimulate a localized immune-mediated cytotoxic effect, Dr. Trimble said.

Safety and next steps

The safety analysis showed that side effects were generally mild and well tolerated. There were 161 adverse events among 29 women for whom safety data were available. The most frequently reported adverse events were vaginal itching (n = 13), vaginal pain (n = 12), vaginal discharge (n = 8), spotting (n = 6), uterine cramping (n = 6), vaginal dryness (n = 4), pelvic pain (n = 1), perineal pain (n = 1), and dyspareunia (n = 1).

Grade 2 adverse events included vaginal yeast infection (n = 6), bacterial vaginosis (n = 2), vaginal inflammation (n = 2), urinary tract infection (n = 2), and noninfective cystitis (n = 1). There were no grade 3 or 4 adverse events reported, and three women reported no noticeable side effects.

Dr. Trimble and colleagues are continuing to study immune responses in cervical tissues and are examining the composition and functions of the cervicovaginal metagenome, looking at bacterial, viral, and fungal components. The team has joined with collaborators at the University of Texas MD Anderson Cancer Center in Houston to look for immune markers in longitudinally collected, subject-matched cervical swabs.

Frantz Viral Therapeutics supplied the artesunate vaginal inserts and partial financial support for this study. Dr. Trimble disclosed relationships with a range of companies and organizations outside this work.

SOURCE: Trimble C L et al. SGO 2020, Abstract LBA 1.