Comparing biweekly single-dose actinomycin D with multiday methotrexate therapy for low-risk gestational trophoblastic neoplasia (FIGO Score 0-4): study protocol for a prospective, multicentre, randomized trial.

BACKGROUND: Single-agent chemotherapy using methotrexate or actinomycin D is the first-line treatment for patients with low-risk gestational trophoblastic neoplasia. Various methotrexate-based and actinomycin D-based single-agent regimens can be used. However, there is insufficient evidence to determine the superior regimen. To guide doctors in selecting a single-agent chemotherapy regimen for patients with low-risk gestational trophoblastic neoplasia, we will compare two regimens. METHODS: We will conduct a multicentre, randomized, prospective clinical trial. Selected low-risk gestational trophoblastic neoplasia patients (FIGO score 0-4) will be randomized 1:1 to a biweekly single-dose actinomycin D group or a multiday methotrexate therapy group. The actinomycin D group will receive IV pulse actinomycin D (1.25 mg/m2) every 14 days, and the methotrexate group will receive methotrexate (50 mg) intramuscularly on days 1, 3, 5, and 7 (4 doses per cycle) and leucovorin (15 mg) intramuscularly on days 2, 4, 6, and 8. This process will be repeated every 14 days. The primary endpoints will include the complete remission rate by single-agent therapy and the overall complete remission rate. The secondary endpoints will include the duration needed to achieve complete remission after single-agent chemotherapy, number of courses needed to achieve complete remission after single-agent chemotherapy, incidence and severity of adverse effects, effects on menstrual conditions and ovarian function based on the anti-Mullerian hormone level, and patient-reported quality of life. DISCUSSION: Previous clinical trials comparing biweekly single-dose actinomycin D with multiday methotrexate therapy for treating low-risk gestational trophoblastic neoplasia patients failed to meet the expected case number. Through this multicentre study, the complete remission ratio and efficacy difference between biweekly single-dose actinomycin D and multiday methotrexate therapy will be obtained. This study will also provide the basis for formulating a preferred regimen for treating patients with low-risk gestational trophoblastic neoplasia. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04562558, Registered on 13 September 2020 (Protocol version 2020-9-24, version 1.0).

Clinical analysis of 21 cases of nongestational ovarian choriocarcinoma.

INTRODUCTION: The objective of the study was to investigate the clinical characters, diagnosis, treatment, and prognosis of nongestational ovarian choriocarcinoma. METHODS: A retrospective analysis was done on 21 patients with nongestational ovarian choriocarcinoma treated in Peking Union Medical College Hospital from January 1985 to October 2008. All patients' conditions were diagnosed by histopathologic examination; in 3 of them, the diagnosis was confirmed by DNA polymorphism analysis at 12 short tandem repeat loci. RESULTS: Correct diagnosis was achieved in only 3 patients before initial treatment. All patients received standard multiple-drug combined chemotherapy and underwent an operation. The mean number of chemotherapy courses for each patient was 10. Of the 21 patients, 16 achieved complete remission, and 4 obtained partial remission; 1 died. In a median follow-up of 71.4 months, the 5-year overall survival rate was 79.4%. CONCLUSIONS: The early diagnosis of nongestational ovarian choriocarcinoma is expected to be improved. DNA polymorphism analysis is a useful tool in determining the origin of ovarian choriocarcinoma. The prognosis is optimistic if managed with standard multiple-drug chemotherapy combined with surgical treatment.

Diagnosis and treatment of cesarean scar pregnancy.

OBJECTIVE: To investigate the early diagnosis and treatment of cesarean scar pregnancy (CSP). METHODS: Clinical data of 28 patients with CSP in Peking Union Medical College Hospital from January 1994 to April 2007, including age, interval from the last cesarean delivery to diagnosis, clinical presentation, location of the lesion, process of diagnosis and treatment, outcome, and follow-up, were retrospectively analyzed. RESULTS: CSP constituted 1.05% of all ectopic pregnancies, and the ratio of CSP to pregnancy was 1:1221. The mean age of the group was 31.4 years. Twenty-six women had only one prior cesarean delivery. The interval from the last cesarean delivery to diagnosis ranged from 4 months to 15 years. The most common presenting symptoms of CSP were amenorrhoea and vaginal bleeding. Seventeen cases were misdiagnosed as early intrauterine pregnancies and 2 were misdiagnosed as gestational trophoblastic tumor. The other 9 were diagnosed definitely before treatment The diagnosis was made based on cesarean delivery history, gynecologic examination, ultrasound, and magnetic resonance imaging (MRI). The treatment of CSP included systemic or local methotrexate administration, conservative surgery, and hysterectomy. The conservative treatment was successful in 24 cases. All of the 28 women were cured through individual therapies. CONCLUSIONS: CSP is rare and usually misdiagnosed as other diseases. Ultrasound is valuable for diagnosing CSP, and MRI can be used as an adjunct to ultrasound scan. Early diagnosis offers the options of conservative treatment and greatly improves the outcome of patients. Individual therapy is strongly recommended.