Researchers take next steps to understand COVID-19’s impact on people infected during pregnancy
A pilot study conducted by physicians at The Ohio State University Wexner Medical Center and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute suggests fractional CO2 laser therapy is a safe and effective treatment for breast cancer survivors with genitourinary syndrome of menopause (GSM).
Their findings were presented at the 7th Conference of the Scientific Network on Female Sexual Health and Cancer in November 2019. They showed that women who developed GSM after cancer treatments had statistically significant improvements in symptoms following three courses of treatment.
Consequences of cancer treatment
Vaginal dryness and pain during intercourse can be common symptoms among menopausal women. However, postmenopausal women undergoing anti-estrogen therapy for estrogen-sensitive cancers, or those who have had pelvic radiation, may be at greater risk of developing these and other symptoms associated with GSM.
“In the general population, patients can usually treat their symptoms with topical estrogen,” says Andrew Hundley, MD, director of Ohio State’s Division of Female Pelvic Medicine and Reconstructive Surgery. “But some gynecologic cancer survivors, particularly those who had estrogen-receptor-positive breast cancers, are often cautioned against using creams or tablets containing estrogen. This leaves them with limited treatment options, which can put stress on intimate relationships and negatively impact quality of life.”
The first clinical trials to test fractional CO2 laser therapy as a treatment for GSM were conducted in women from the general population. Because those preliminary results were encouraging, specialists at Ohio State decided to study the feasibility and efficacy of this treatment on women with a history of breast cancer.
A multidisciplinary collaboration
Along with Dr. Hundley, who is fellowship-trained in female pelvic medicine and reconstructive surgery, the research team included primary investigators from three different clinical departments:
- Urogynecologist Catherine Hudson, MD, an assistant professor – clinical at the College of Medicine
- Breast oncologist Maryam Lustberg, MD, an associate professor at the College of Medicine
- Radiation oncologist Allison Quick, MD, an assistant professor – clinical at the College of Medicine
Fifty-nine breast cancer survivors with GSM were treated vaginally and at the vulvar area three times over a two-month period. Before and after treatment, the participants completed vaginal and vulvar assessment scales (VAS and VuAS), which are validated physical exams, along with validated quality-of-life questionnaires about urinary incontinence and sexual function.
Promising results
Dr. Hundley, who is an associate professor – clinical at the College of Medicine, says that in previous studies, estrogen was a treatment option for participants along with fractional CO2 laser therapy. But in this case, the team wanted to see if the device was a viable alternative for patients who had no other options.
“We did not assume laser therapy would be a functional alternative, because breast cancer survivors are often undergoing anti-estrogen therapy that can make genitourinary symptoms worse,” he explains. “We weren’t sure if something that worked for a typical patient would work as well in this population, or if it would produce unanticipated side effects. However, our results suggest this can be a safe, useful therapy with real potential value in terms of quality of life.”
Those results include:
- At the time of initial screening, 81.2% of patients reported moderate to severe pain with intercourse, compared to 30.5% one month after treatments were complete.
- Prior to treatment, 88.1% reported moderate to severe vaginal dryness, compared to 30.5% after treatment.
- Patients’ VAS and VuAS scores, as well as their responses to the urinary incontinence and sexual function questionnaires, showed statistically significant improvements.
- There were no clinically significant adverse events.
“This therapy has not yet been approved by the Food and Drug Administration for use in this patient population, so it’s not covered by insurance,” Dr. Hundley says. “But our hope is that research like this will demonstrate the level of clinical utility and patient safety necessary to soon permit its use by physicians in appropriate settings. This is a huge problem for cancer survivors that doesn’t get a lot of attention, but I believe we’re one step closer to finding a safe way to help these patients.”
