Add clarity to your assessment of pelvic mass patients Combine CA125 + HE4 as ROMA TM to compute likelihood of malignancy 100 90 80 70 60 50 40 30 20 10 0 94 % Epithelial Ovarian Cancer EOC 25 % Benign 75 % Benign High Likelihood Low Likelihood 6 % Better Assessment of Adnexal Masses With CA125 + HE4, ROMA gives you the security to safely keep the majority of benign disease patients. 1 Assessment of adnexal mass is now more clear . 1-3 Data from a study of 472 patients published in August 2011 in Obstetrics & Gynecology showed that: • ROMA correctly stratified 94% of women with epithelial ovarian cancer into a high-risk group 1 • ROMA correctly stratified 75% of women with benign disease into a low-risk group 1 FU10-106270-CoverTip_v2.indd 1 10/12/11 5:30 PM Fujirebio Diagnostics, Inc. • 201 Great Valley Parkway • Malvern, PA 19355-1307 From the company that brought you CA125, Fujirebio Diagnostics brings you HE4, the first FDA-cleared biomarker in 25 years for ovarian cancer management. 4 • Unique CPT code and Medicare reimbursable • Vast body of multi-national peer-reviewed and published clinical evidence supporting the use of HE4 5 Learn more about ROMA ™ and how CA125 + HE4 provides greater diagnostic clarity www.he4test.com PRECAUTION: ROMA (HE4 EIA + ARCHITECT CA125 II) should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of ROMA (HE4 EIA + ARCHITECT CA125 II) carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. FDI-362 Rev. 10/11 The Risk of Ovarian Malignancy Algorithm (ROMA™) is a qualitative serum test that combines the results of HE4 EIA, ARCHITECT CA125 II™ and menopausal status into a numerical score. ROMA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay. REFERENCES: 1. Moore RG, et al. Evaluation of the diagnostic accuracy of the Risk of Ovarian Malignancy Algorithm in women with a pelvic mass. Obstet Gynecol . 2011;118(2, Part 1):280-288. 2. Moore RG, Brown AK, Miller MC, et al. The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass. Gynecol Oncol . 2008;108:402-408. 3. HE4 EIA Ref. No. 404-10 [package insert]. Göteborg, Sweden: Fujirebio Diagnostics, 2008. 4. Diamandis E, et al. Cancer Biomarkers: Can we turn recent failures into success? J Natl Cancer Inst . 2010;102:1-6. 5 . HE4 Publications Brochure. Fujirebio Diagnostics, Inc., Web Site. FU10-106270-CoverTip_v2.indd 2 10/12/11 5:30 PM CONTEMPORARY OB / GYN DECEMBER 2011, Vol. 56, No. 12 UROLITHIASIS ◾ PT FOR PELVIC FLOOR DISORDERS ◾ OFFICE-BASED SURGERY When to use PT for pelvic floor disorders Rebecca G. Rogers, MD Are you ready for office-based surgery? Morris Wortman, MD MFM CONSULT Isolated renal pelviectasis Mary E. Norton, MD VOLUME 56, NUMBER 12 ContemporaryOBGYN.net Translating Science into Sound Clinical Practice DECEMBER 2011 How to manage g U ROLITHIASIS Manoj Monga, MD PREMARIN ® (CONJUGATED ESTROGENS) VAGINAL CREAM BRIEF SUMMARY : See Package Insert for Full Prescribing Information. For further product information and current package insert, please visit www.premarinvaginalcreamhcp.com or call our medical communications department toll-free at 1-800-934-5556. WARNING: CARDIOVASCULAR DISORDERS, ENDOMETRIAL CANCER, BREAST CANCER and PROBABLE DEMENTIA ESTROGEN-ALONE THERAPY ENDOMETRIAL CANCER There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.3)] . CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.2, 5.4), and Clinical Studies (14.2, 14.3) in full prescribing information] . The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg], relative to placebo [see Warnings and Precautions (5.2), and Clinical Studies (14.2) in full prescribing information]. The WHI Memory Study (WHIMS) estrogen alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg) alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.4), Use in Specific Populations (8.5), and Clinical Studies (14.3) in full prescribing information] . In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. ESTROGEN PLUS PROGESTIN THERAPY CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.2, 5.4), and Clinical Studies (14.2, 14.3) in full prescribing information] . The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.2), and Clinical Studies (14.2) in full prescribing information] . The WHIMS estrogen plus progestin ancillary study of the WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.4), Use in Specific Populations (8.5), and Clinical Studies (14.3) in full prescribing information] . BREAST CANCER The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (5.3), and Clinical Studies (14.2) in full prescribing information] . In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. INDICATIONS AND USAGE Treatment of Atrophic Vaginitis and Kraurosis Vulvae Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause CONTRAINDICATIONS PREMARIN Vaginal Cream therapy should not be used in women with any of the following conditions: • Undiagnosed abnormal genital bleeding • Known, suspected, or history of breast cancer • Known or suspected estrogen-dependent neoplasia • Active deep vein thrombosis, pulmonary embolism or a history of these conditions • Active arterial thromboembolic disease (for example, stroke, and myocardial infarction), or a history of these conditions • Known liver dysfunction or disease • Known thrombophilic disorders • Known or suspected pregnancy WARNINGS AND PRECAUTIONS Risks From Systemic Absorption Systemic absorption occurs with the use of PREMARIN Vaginal Cream. The warnings, precautions, and adverse reactions associated with oral PREMARIN treatment should be taken into account. Cardiovascular Disorders An increased risk of stroke and deep vein thrombosis (DVT) has been reported with estrogen-alone therapy. An increased risk of pulmonary embolism, DVT, stroke and myocardial infarction has been reported with estrogen plus progestin therapy. Should any of these occur or be suspected, estrogens with or without progestins should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (for example, personal history of venous thromboembolism [VTE], obesity, and systemic lupus erythematosus) should be managed appropriately. Stroke In the Women’s Health Initiative (WHI) estrogen-alone substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) compared to women in the same age group receiving placebo (45 versus 33 per 10,000 women-years). The increase in risk was demonstrated in year one and persisted [see Clinical Studies (14.2) in full prescribing information ].