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Uterine Fibroid Types1 Current and Emerging Therapies for Endometriosis and Uterine Fibroids What Do You Need to Know? Georgine Lamvu, MD, MPH Professor of Obstetrics and Gynecology University of Central Florida College of Medicine Gynecologic Surgery and Pelvic Pain Specialist Director of the Fellowship in Advanced and Minimally Invasive Gynecologic Surgery Orlando VA Medical Center Chair of the Board, International Pelvic Pain Society Orlando, Florida Disclosures Georgine Lamvu, MD, MPH, has a financial interest/relationship or affiliation in the form of: Consultant and/or Advisor for AbbVie Inc. and Sola, LLC. Housekeeping Notes Thank you for taking time out of your busy schedules to attend this virtual CME presentation, jointly provided by the Utah Academy of Family Physicians and PVI, PeerView Institute for Medical Education. We would like to thank AbbVie for making this event possible through the provision of an educational grant supporting this activity. I invite you to follow along on the PDF slides you received. You should have also received a link to the online program evaluation. Evaluation: PeerView.com/Endometriosis-survey Your evaluation of the program is very important in helping us to better meet your current and future medical education needs. We welcome your opinions and comments. Uterine Fibroids A Common Scenario • 33-year-old G0 presents with painful menstrual periods and heavy bleeding • Symptoms have worsened over the last 3 years and are causing her to miss work What are her options? • Married; interested in having children What do you recommend? • Negative pregnancy test • Enlarged and moderately tender uterus • Hemoglobin is 9 g/dL • A pelvic ultrasound shows three fibroids measuring 3 to 4 cm Uterine Fibroids1,2 • Detected in up to 80% of women by aged 50 years • 30%-50% of women are symptomatic – Heavy menstrual bleeding (HMB) – Dysmenorrhea – Pelvic pain – Infertility – Obstetric complications – Pelvic pressure – Urgency – Frequency 1. De La Cruz MSD, Buchanan EM. Am Fam Physician. 2017;95:100-107. 2. Donnez J, Dolmans MM. Hum Reprod Update. 2016;22:665-686. Uterine Fibroid Types1 Intramural Submucosal • Symptoms vary based on number, size, and location • Classified on degree of extension into the myometrium and/or the uterine cavity Subserosal Subserosal Peduncle 1. Donnez J, Dolmans MM. Hum Reprod Update. 2016;22:665-686. Pathophysiology of Fibroids1 • Monoclonal benign tumors resulting from mutations in uterine smooth muscle – Mutations in meditator complex subunit 12 (MED12) are the most common mutation representing 70% of all uterine fibroids – High mobility group AT-hook2 (HMGA2) gene mutation – Collagen type IV alpha 5 chain (COL4A5) gene mutation – Collagen type IV alpha 6 chain (COL4A6) gene mutation • Fumarate hydrate (FH) group mutation is an autosomal dominant inherited, and not somatic, mutation associated with cutaneous leiomyomas and an increased risk of uterine and renal cancer 1. Laughlin-Tommaso SK, Stewart EA. Obstet Gynecol. 2018;132:961-971. Risk Factors for Uterine Fibroids1,2 Family Early Race history Age menarche (AA) and genetic (<10 y) factors Caffeine Nulliparity Obesity Other factors and (ie, high BP) alcohol 1. Donnez J, Dolmans MM. Hum Reprod Update. 2016;22:665-686. 2. De La Cruz MSD, Buchanan EM. Am Fam Physician. 2017;95:100-107. Differential Diagnosis of Uterine Masses1 Benign Malignant • Pregnancy • Leiomyosarcoma (myometrial neoplasm) – Intrauterine • Mixed mesodermal tumor – Ectopic • Uterine carcinosarcoma • Adenomyosis (epithelial neoplasm) • Fibroids (leiomyoma) • Endometrial adenocarcinoma • Endometrial polyps • Stromal sarcoma 1. De La Cruz MSD, Buchanan EM. Am Fam Physician. 2017;95:100-107. Methods for Early Detection of Uterine Fibroids Diagnosis of Uterine Fibroids1-4 Screening Labs Pelvic Examination • Abnormal bleeding • Pregnancy test • Bimanual evaluation (heavy, irregular) • CBC for pelvic mass • Pelvic pain • TSH /dysmenorrhea • Pap smear bulk symptoms • Pelvic ultrasound (pressure, frequency) • Endometrial biopsy (>40 y • Anemia with abnormal bleeding) 1. De La Cruz MSD, Buchanan EM. Am Fam Physician. 2017;95:100-107. 2. Donnez J, Dolmans MM. Hum Reprod Update. 2016;22:665-686. 3. Stoehr A et al. Arch Gynecol Obstet. 2019;300:1029-1043. 4. Moore KR et al. Fertil Steril. 2014;101:208-214. Diagnosis of Uterine Fibroids: Imaging1,2 Transvaginal Pelvic Ultrasound Magnetic Resonance Imaging • Preferred initial imaging (MRI) • Evaluates fibroid size Fibroid Uterus and location • Provides information • 90%-99% sensitive on location, size, for detecting fibroids— and distance from the the gold standard Bladder endometrium, as well as • Sonohysterography, vascularization a 3D ultrasound improves • Indicated in women who detection of submucosal are considering surgery fibroids 1. Donnez J, Dolmans MM. Hum Reprod Update. 2016;22:665-686. 2. De La Cruz MSD, Buchanan EM. Am Fam Physician. 2017;95:100-107. Evaluating Risk for Uterine Malignancy1-3 • No single test accurately differentiates benign from malignant fibroids • ACOG recommends endometrial biopsy (cytology) in women aged >45 years with abnormal bleeding to rule out endometrial cancer or hyperplasia, even if fibroids are present; sensitivity for stromal malignancy (leiomyosarcoma) is low (~38%) • Revised Preoperative Sarcoma Score (rPRESS) evaluates risk factors for sarcoma – Cutoff value >4 points has positive predictive value (93.7%) and <4 points has negative predictive value (92%-94%) Predictors 0 point 2 points 4 points Age, y <49 ≥49 — Serum LDH level <279 — ≥279 Cytologic findings Negative — Positive Total 10 points — — 1. Bansal N et al. Gynecol Oncol. 2008;110:43-48. 2. ACOG Committee Opinion No. 557. Obstet Gynecol. 2013;121:891-896. 3. Nagai T et al. Springerplus. 2015;4:520. Evidence-Based Therapies for Managing Uterine Fibroids Medical, Interventional Nonsurgical, and Surgical Therapies for Uterine Fibroids1,2 Interventional Medical Surgical nonsurgical • NSAIDs • Uterine artery • Myomectomy • Hormonal embolization • Hysterectomy contraceptives • Endometrial ablation • LNG-IUD • Myolysisa • Tranexamic acid • GnRH agonists • GnRH antagonists • SPRMs/SERMsa Effective in reduction of HMB and dysmenorrhea Effective in reducing fibroid/uterine size a Not routinely available or currently under investigation. 1. Stewart E. N Engl J Med. 2015;372:1646-1655. 2. De La Cruz MSD, Buchanan EM. Am Fam Physician. 2017;95:100-107. Management of HMB Associated With Fibroids1 Most effective LNG-IUD Least effective CHCs, progestins, tranexamic acid NSAIDs 1. Stewart E. N Engl J Med. 2015;372:1646-1655. First-Line Medical Therapies1-3 NSAIDS Combination E+P, hormonal Tranexamic acida (Prostaglandin LNG-IUDa contraceptives, (Antifibrinolytic) inhibitor) and progestins 70% reduction 90% reduction <50% reduction 50% reduction in HMB; in HMB; in HMB; in HMB; dysmenorrhea; dysmenorrhea; dysmenorrhea; reversible effect reversible effect reversible effect no effect on fertility on fertility on fertility on fertility GI AEs, no reduction in fibroid GI-related AEs, size; risk of No reduction Minimal reduction no reduction thrombosis if used in fibroid size in fibroid size in fibroid size with COCs or in smokers aged >35 years a FDA-approved for management of HMB. 1. Maybin JA, Critchley H. Womens Health (Lond). 2016;12:27-34. 2 Stewart E. N Engl J Med. 2015;372:1646-1655. 3. De La Cruz MSD, Buchanan EM. Am Fam Physician. 2017;95:100-107. RCT of LNG-IUD vs Low-Dose COCs1 Treatment Failure Rates • Reduction in monthly blood loss at 12 months: – LNG-IUD 90.9% ± 12.8% vs COC 13.4% ± 11.1% (P < .001) • No significant difference in reduction in fibroid size at 12 months • <12% IUD expulsion rates in women with fibroids 1. Sayed GH et. al. Int J Gynaecol Obstetr, 2011;112:126-130. Hormonal Management of HMB1-3 Bleeding may become more irregular in the first 3 months (especially with oral progestins) Consistent 50%-60% reduction in blood loss occurs after 3-6 months of use Clinical pearls Continuous suppression is recommended in cases of dysmenorrhea and HMB LNG-IUD showed a 90% reduction in menstrual blood loss and 20% complete amenorrhea after 9-12 months of use 1. Maybin JA, Critchley H. Womens Health (Lond). 2016;12:27-34. 2. Damm T et al. Contraception. 2019;1:100002. 3. Sergison JE et al. Am J Obstet Gynecol. 2019;220:440-448. Second-Line Medical Therapies1-7 GnRH GnRH SPRMs, SERMs, and antagonists agonists aromatase inhibitors Reduces blood loss Reduce blood loss Reduce blood loss and dysmenorrhea; and dysmenorrhea; and dysmenorrhea; reversible effect reversible effect reversible effect on fertility on fertility on fertility Initial increase in bleeding (flare Vasomotor symptoms Limited use, effect); vasomotor and bone density loss investigational symptoms; bone density loss 1. Maybin JA, Critchley H. Womens Health (Lond). 2016;12:27-34. 2. Stewart E. N Engl J Med. 2015;372:1646-1655. 3. De La Cruz MSD, Buchanan EM. Am Fam Physician. 2017;95:100-107. 4. Stewart EA et al. Nat Rev Dis Primers. 2016;2:16043. 5. Sohn GS et al. Obstet Gynecol Sci. 2018;61:192-201. 6. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213388s000lbl.pdf. 7. Kumar P, Sharma A. J Hum Reprod Sci. 2014;7:170-174. Mechanism of GnRH Modulators1-3 Hypothalamus GnRH agonists GnRH • Initial overstimulation of GnRH receptors leading to an increase in LH/FSH (flare effect) Pituitary • Chronic administration eventually leads to suppression of LH/FSH and estrogen LH/FSH and progesterone GnRH antagonists Ovaries • Immediately block gonadotropin release with rapid
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