What is the best next step in managing a 63-year-old postmenopausal woman with daily vaginal spotting, pain during intercourse, and a 1-cm ulcerated vaginal lesion, who has a history of smoking and is overweight, with an atrophic vagina and a 3-mm endometrial stripe on pelvic ultrasound?

From the Guidelines

The best next step in management for this 63-year-old woman with postmenopausal bleeding is to perform a vaginal biopsy of the ulcerated lesion. This patient presents with concerning symptoms including progressive postmenopausal bleeding, pain with intercourse, and a visible 1-cm ulcerated lesion in the vagina with malodorous discharge. While some of her symptoms might suggest vaginal atrophy, the presence of an ulcerated lesion requires immediate evaluation to rule out malignancy, particularly vaginal or cervical cancer. The patient has multiple risk factors for gynecologic malignancy, including long-term smoking, obesity, lack of routine healthcare for over 30 years (suggesting no cancer screenings), and the physical finding of an ulcerated lesion. The normal endometrial stripe on ultrasound (3 mm) makes endometrial pathology less likely as the source of bleeding, further directing attention to the vaginal lesion. Tissue diagnosis through biopsy is essential before initiating any treatment, as management will differ significantly depending on whether the lesion is benign, precancerous, or malignant. Delaying diagnosis with empiric treatments would be inappropriate given the high suspicion for malignancy in this clinical scenario, as supported by the most recent guidelines 1.

Some of the patient's symptoms, such as vaginal dryness and pain with intercourse, could be addressed with treatments like vaginal estrogen or ospemifene, as suggested by recent studies 1. However, these treatments should not be initiated until a definitive diagnosis is made, as they may not be appropriate for all potential causes of the patient's symptoms. The use of vaginal estrogen, for example, has been shown to be effective in treating vaginal atrophy and dyspareunia in postmenopausal women, but its safety in survivors of estrogen-dependent cancers is not well established 1. Similarly, ospemifene has been found to be effective in treating dyspareunia and vaginal atrophy in postmenopausal women without a history of estrogen-dependent cancers, but its use in women with a history of cancer or on endocrine therapy is not well studied 1.

Given the high suspicion for malignancy and the need for a definitive diagnosis, a vaginal biopsy of the ulcerated lesion is the most appropriate next step in management. This will allow for a tissue diagnosis to be made, and treatment can be tailored accordingly. The patient's symptoms and risk factors suggest that malignancy is a strong possibility, and delaying diagnosis could have significant implications for her morbidity, mortality, and quality of life. Therefore, a biopsy should be performed as soon as possible to determine the cause of the patient's symptoms and to guide further management.

From the FDA Drug Label

For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding The best next step in management of this patient is to perform an endometrial sampling to rule out malignancy, given the patient's und diagnosed persistent or recurring abnormal vaginal bleeding and uterus 2.

• The patient's symptoms of postmenopausal bleeding, daily vaginal spotting, and pain with intercourse, along with the presence of a 1-cm ulcerated lesion in the vagina, necessitate further investigation to exclude malignancy.
• The patient's low endometrial stripe of 3-mm on pelvic ultrasound does not rule out the possibility of endometrial cancer, and therefore, endometrial sampling is necessary 2.

From the Research

Patient Presentation and History

The patient is a 63-year-old postmenopausal woman presenting with postmenopausal bleeding, initially post-coital bleeding that has progressed to daily vaginal spotting, and pain with intercourse. She has a history of smoking, a BMI of 30 kg/m2, and has not had routine health care for over 30 years.

Clinical Findings

• The vagina appears atrophic with minimal rugation and a 1-cm ulcerated lesion in the upper third of the posterior wall.
• Malodorous watery discharge is present.
• Wet mount microscopy shows numerous squamous epithelial cells with rare leukocytes.
• Potassium hydroxide test is negative.
• Pelvic ultrasound indicates an anteverted uterus with a 3-mm endometrial stripe.

Management Considerations

• The patient's symptoms and clinical findings suggest vaginal atrophy, a common condition in postmenopausal women that can significantly decrease quality of life 3.
• Given the presence of an ulcerated lesion, further evaluation to rule out other conditions such as cancer is necessary.
• Treatment options for vaginal atrophy include vaginal moisturizers and local hormone replacement therapy, such as conjugated equine estrogen cream, a sustained-release intravaginal estradiol ring, or a low-dose estradiol tablet 3.
• The use of vaginal estrogen therapy may be beneficial for treating vaginal atrophy, even in women with a history of cancer, after assessing the risk/benefit ratio 4.
• Non-hormonal alternatives and the optimal route of hormone administration for improving symptoms and quality of life in postmenopausal women require further study 5.

Next Steps

• A comprehensive approach to diagnosis, including further evaluation of the ulcerated lesion, is necessary.
• Consideration of the patient's overall health, including her smoking history and BMI, is important in managing her condition.
• Discussion of available therapeutic options, including local hormone replacement therapy and non-hormonal alternatives, should be tailored to the patient's specific needs and medical history 6, 7.