SAN DIEGO – , a new 5-year prospective study reports.
Findings from the EMBRACE study were presented at the annual American Society for Radiation Oncology (ASTRO) meeting and included 882 women with locally advanced cervical cancer. Of those, 565 women reported regular vaginal dilation and/or sexual intercourse during at least three of their follow-up assessments. Patients who reported both dilation and intercourse had the lowest risk of developing vaginal stenosis of grade ≥ 2 (18%) at 5 years.
The other 317 women were described in the study as having no penetration (13%) or infrequent penetration (23%) and were more likely to experience stenosis of grade ≥ 2 (36% and 37% respectively (P ≤ 0.001)), reported psycho-oncologist, clinical psychologist Kathrin Kirchheiner, PhD, MSc, of the Medical University of Vienna, and colleagues at ASTRO 2023.
While noting that the observational study cannot determine cause and effect, “these long-term data support clinical recommendations worldwide,” said Dr. Kirchheiner at an ASTRO news briefing.
According to Dr. Kirchheiner, external beam radiotherapy, chemotherapy, and internal brachytherapy are the standard of care for locally advanced cervical cancer that cannot be removed by surgery.
Studies have shown that the treatment can cause vaginal shortening and narrowing due to the formation of scar tissue, she said. As a result, there can be “permanent changes in the vaginal tissue that lead to a loss of elasticity. This can often cause problems during the gynecological follow-up examination and pain during sexual intercourse.”
In an earlier reported 2-year analysis of the EMBRACE study (median follow-up of 15 months), the study authors reported that 89% of 588 patients developed grade ≥ 1 vaginal stenosis following their treatment, with 29% at grade ≥ 2 and 3.6% at grade ≥ 3.
The use of medical dilators is commonly recommended after cervical cancer treatment to stretch the vaginal canal. Women are instructed to increase the dilator size over time. But research suggests that adherence may be low.
For the observational, multi-institution study, researchers tracked 1,416 cervical cancer patients from 2008 to 2015 for a median follow-up of 5 years. The new analysis focuses on 882 patients with at least three follow-up assessments, with a median age of 49. Researchers reported that patients who didn’t engage in intercourse or use dilators were most likely to experience vaginal stenosis (37%) vs. those who did both (18%), those who just had intercourse (23%), and those who only used dilators (28%) (P ≤ 0.001).
The findings were confirmed in a multivariable analysis with adjustments for tumor infiltration, age, treatment parameters, and hormonal replacement therapy, the researchers reported.
Regular sexual activity, vaginal dilation, or both were linked to higher risk of mild vaginal dryness at grade ≥ 1 (72% vs. 67% in the no/infrequent penetration group, P = 0.028) and vaginal bleeding at grade ≥ 1 (61% vs. 34% in the no/infrequent penetration group, P ≤ 0.001). There was no link to higher rates of vaginal mucositis.
Dr. Kirchheiner noted that these symptoms can be treated with lubricants, moisturizer, and hormonal replacement therapy.
As for limitations, Dr. Kirchheiner, in a press release provided by ASTRO, noted that “we cannot and should not randomize patients in a clinical trial into groups with and without regular dilation.” She also noted that future research should explore why sexual intercourse had slightly better results than use of dilators, a finding that could be related to blood flow during sexual arousal.
In comments at the news briefing, Akila Viswanathan, MD, MPH, MSc, director of Radiation Oncology and Molecular Radiation Sciences at Johns Hopkins Medicine, Baltimore, praised the new study and noted that quality of life after cervical cancer treatment is “very understudied.”
Vaginal side effects in particular are underreported because physicians often fail to ask about them and patients “are hesitant to accurately describe what they’re feeling,” she said.
The interventions of providing medical dilators and encouraging sexual activity are “very low cost,” Dr. Viswanathan said. But she noted that women – especially older women – may “find the concepts of using a dilator very difficult to understand.”
The study offers the “best evidence to date” supporting vaginal dilation, said Yale University, New Haven, Conn., radiation oncologist Shari Damast, MD, in an interview. It has “a large dataset, longitudinal design, lengthy follow-up, and uses validated tools of measurement. It gives us strong confidence in the efficacy of vaginal dilators.”
In an interview, Deborah Watkins Bruner, RN, PhD, senior vice president for research at Emory University, Atlanta, also praised the research. But she noted that it’s not clear how often vaginal dilation/sexual intercourse should be performed in order to reduce stenosis. “In addition, it is clear that vaginal dilation only is not enough to treat the myriad of symptoms that survivors must deal with,” she said.
Dr. Bruner urged colleagues “to routinely assess symptoms at each visit and offer treatments which should include hormone replacement therapy, vaginal dilation, and appropriate referral for anxiety, depression, or marital problems.”
The study was funded by Elekta and Varian Medical System via the Medical University of Vienna. The study authors, Dr. Bruner, and Dr. Damast have no disclosures. Disclosure information for Dr. Viswanathan was not available.