The grades of evidence (I-III) and levels of recommendation (A-C) are defined at the end of the "Major Recommendations" field.
The following recommendations are based on good and consistent scientific evidence (Level A):
- In women of reproductive age with abnormal bleeding or symptoms that could be caused by a malignancy, beta-human chorionic gonadotropin (beta-hCG) levels should be evaluated to facilitate early diagnosis and treatment of gestational trophoblastic disease.
- In patients with molar pregnancy, the preferred method of evacuation is suction dilation and curettage (D&C). After molar evacuation, all patients should be monitored with serial hCG determinations to diagnose and treat malignant sequelae promptly.
- Oral contraceptives have been demonstrated to be safe and effective during posttreatment monitoring based on randomized controlled trials.
- Women with nonmetastatic gestational trophoblastic disease should be treated with single-agent chemotherapy.
- For women with nonmetastatic gestational trophoblastic disease, weekly doses of 30 to 50 mg/m2 of intramuscular methotrexate has been found to be the most cost-effective treatment when taking efficacy, toxicity, and cost into consideration.
- Women with metastatic gestational trophoblastic disease should be referred to specialists with experience treating this disease.
- Women with high-risk metastatic disease should be treated with multiagent chemotherapy. This includes triple therapy with methotrexate, dactinomycin, and either chlorambucil or cyclophosphamide. More recent regimens further incorporate etoposide with or without cisplatin into combination chemotherapy.
The following recommendations are based on limited or inconsistent scientific evidence (Level B):
- False-positive test results should be suspected if hCG values plateau at relatively low levels and do not respond to therapeutic maneuvers, such as methotrexate given for a presumed persistent mole or ectopic pregnancy.
- Serial quantitative serum hCG determinations should be performed using a commercially available assay capable of detecting beta-hCG to baseline values (<5 milli-international units per milliliter [mIU/mL]). Ideally, serum hCG levels should be obtained within 48 hours of evacuation, every 1 to 2 weeks while elevated, and then at 1 to 2 month intervals for an additional 6 to 12 months.
The following recommendations are based primarily on consensus and expert opinion (Level C):
- Abnormal bleeding for more than 6 weeks following any pregnancy should be evaluated with hCG testing to exclude a new pregnancy or gestational trophoblastic disease.
- In compliant patients, the low morbidity and mortality achieved by monitoring patients with serial hCG determinations and instituting chemotherapy only in patients with postmolar gestational trophoblastic disease outweighs the potential risk and small benefit of routine prophylactic chemotherapy after evacuation of a molar pregnancy.
- Serious complications are not uncommon in women with a uterus size greater than a 16-week gestation, so they should be managed by physicians experienced in the prevention and management of complications.
- Patients for whom initial therapy for nonmetastatic or low-risk metastatic disease fails and those with high-risk malignant gestational trophoblastic disease should be managed in consultation with individuals or facilities with expertise in the complex, multimodality treatment of these patients.
Definitions:
Grades of Evidence
I: Evidence obtained from at least one properly designed randomized controlled trial.
II-1: Evidence obtained from well-designed controlled trials without randomization.
II-2: Evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group.
II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence.
III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
Levels of Recommendations
Level A — Recommendations are based on good and consistent scientific evidence.
Level B — Recommendations are based on limited or inconsistent scientific evidence.
Level C — Recommendations are based primarily on consensus and expert opinion.
