Women with symptomatic uterine fibroids reported significantly better quality of life (QoL) following myomectomy as compared with uterine artery embolization, a randomized trial showed.
Both fibroid-specific and health-related QoL improved more with myomectomy, although scores for both treatment groups improved from baseline. Scores related to symptom severity favored myomectomy at 6 months and 2 years. Menstrual bleeding scores were similar in the two groups.
Few intraoperative complications occurred in either group, and rates of perioperative/postoperative complications were similar, Jane P. Daniels, PhD, of the University of Nottingham in England, and coauthors reported in the New England Journal of Medicine.
“The 6-to-8-point benefit, on average, in health-related quality-of-life scores in the myomectomy group, as compared with the uterine-artery embolization group, is consistent with a small-to-moderate standardized treatment benefit at 2 years,” the authors said of the results. “However, the 95% confidence interval around these estimates indicates that plausible results can range from almost no benefit of myomectomy over embolization to a moderate (15-point) difference.”
By comparing two alternatives to hysterectomy, the trial provided new information for clinicians and their patients who want to retain the option for reproduction, noted the author of an accompanying editorial, Elizabeth A. Stewart, MD, of the Mayo Clinic in Rochester, Minnesota. Some women want an alternative to hysterectomy for various other reasons, such as maintenance of body integrity and shorter recovery time.
“The FEMME trial is among the first major trials to evaluate alternatives to hysterectomy that included an assessment of the intention for pregnancy and that enrolled women in whom future pregnancy was desired; as such, it is a big step forward,” Stewart wrote. “Although the numbers of pregnancies within 2 years after randomization were low … there were no consistent between-group differences in the levels of biomarkers of ovarian reserve.”
“These findings set the stage for a larger randomized trial of uterine-artery embolization versus myomectomy, powered to detect live birth rates.”
Myomectomy is “far and away” the more common procedure in the United States, Stewart told MedPage Today. Uterine artery embolization is performed less commonly, not only in the U.S. but worldwide. The procedure is almost never performed in women who want to preserve their fertility, because of concerns about adverse effects on fertility. However, the avoidance of embolization in that subgroup is based on low-quality evidence supporting the superiority of myomectomy for better pregnancy outcomes.
“Overall, the field of uterine fibroids has had very little comparative effectiveness research, and so I think this paper is really important for that reason,” said Stewart, who was the lead author of an American College of Obstetricians and Gynecologists Practice Bulletin on hysterectomy alternatives for managing leiomyomas. “Since many women are choosing to have uterine fibroid procedures to pursue pregnancy, understanding reproductive outcomes is really important. We got a clue from this paper that the outcome may be similar.”
FEMME participants’ average age was 40, a factor in the small number of pregnancies and live births in the study, she added. A trial designed specifically to assess reproductive outcomes, including live births, is needed.
Uterine fibroids are the most common type of tumor among women of reproductive age, and the prevalence increases with age. In about half of cases, fibroids cause bothersome symptoms that include heavy menstrual bleeding, abdominal pain, and pressure, which negatively affect quality of life. Some types of fibroids have been associated with reduced fertility and adverse pregnancy outcomes, although the data are inconsistent, Daniels and colleagues pointed out.
Myomectomy and hysterectomy have been the traditional approaches to treating symptomatic fibroids. Myomectomy is a surgical procedure that can be performed a number of ways, requires general anesthesia, and has a risk of excessive blood loss and other potential complications. Whether the procedure improves reproductive outcomes remains unclear.
Performed with local anesthesia, uterine artery embolization involves temporary occlusion of uterine arteries to induce ischemic infarction in fibroids. As compared with myomectomy, the procedure is associated with a shorter hospital stay and earlier return to normal activities but an increased likelihood of additional interventions, as well as at least theoretical concern about adverse effects on ovarian and uterine function.
Trial Design, Key Findings
For the FEMME trial, investigators recruited participants at 29 hospitals in England and Scotland, and randomized 254 patients to uterine-artery embolization or myomectomy. Participants in both groups were older than 40 on average, and about 40% of the patients were Black, notable because fibroids are more common in Black women, Stewart pointed out. The treatment groups did not differ substantially with respect to baseline characteristics, including fibroid number, size, and type.
The primary outcome was fibroid-related quality of life at 2 years, as assessed by the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire. The myomectomy group had a lower (worse) UFS-QoL score at baseline (37.0 vs 42.1), but showed more improvement from baseline at each of the three follow-up assessments:
- 6 months: 80.5 vs 73.9
- 1 year: 84.7 vs 75.7
- 2 years: 84.6 vs 80.0
The estimated mean difference in favor of myomectomy was 7.4 at 6 months, 10.8 at 1 year, and 8.0 at 2 years (P=0.01 at 2 years). The two groups had a mean baseline symptom severity score of 58-56. The myomectomy group had a significantly greater decrease at 6 months (21.6 vs 27.3; mean estimated difference -6.1, 95% CI -11.4 to -0.9), with the difference maintained at 2 years but somewhat diminished (19.5 vs 21.9, mean estimated difference -3.8).
Peri- and postoperative complications occurred in 24% of the embolization group and 29% of the myomectomy group. Hospital stay averaged two days with embolization and four with myomectomy. At two years, 16% of participants in the embolization arm had undergone additional fibroid-related procedures as compared with 7% of the myomectomy group.
Nine women in the embolization arm reported pregnancies within two years of randomization, and six live births occurred. Five women randomized to myomectomy reported pregnancies, resulting in four live births. Hormone levels did not differ substantively between the two groups at any time point.
The study was supported by the National Institute for Health Research
Daniels reported having no relevant relationships with industry.
Stewart disclosed relationships with Bayer, AbbVie, Myovant, UpToDate, Med Learning Group, PeerView, and ObsEva, as well as a patent interest.