Second Uterine Curettage and the Number of Chemotherapy Courses in Postmolar Gestational Trophoblastic Neoplasia: A...

To investigate the effect of second uterine curettage on the number of chemotherapy courses and relapse rate in low-risk postmolar gestational trophoblastic neoplasia.

In a phase III trial, patients with low risk gestational trophoblastic neoplasia were randomised (1:1) to a second curettage or no curettage group before methotrexate treatment. Eligibility criteria were serum human chorionic gonadotropin (hCG) level 5,000 international units/L or less and fit for treatment with methotrexate. Exclusion criteria were previous uterine perforation and life-threatening bleeding. With a two-sided 5% significance level and a power of 99%, a sample size of 44 patients per group was necessary to detect a mean reduction in 2.3 chemotherapy courses. The primary outcome was the number of chemotherapy courses required for hCG normalization. Secondary outcomes were needed for second-line treatment, toxicity, relapse rates, and variables associated with number of chemotherapy courses.

From October 2011 through February 2016, 89 patients entered the study at the Mansoura Trophoblastic Clinic; in each group, 43 patients were included in the intention-to-treat analyses. Surgical complications did not occur. The mean number of chemotherapy courses required to reach hCG normalization was 4.4±2.2 SD in the control group vs 3.8±2.3 SD in the intervention group (P=.14). Groups were comparable in terms of second-line treatment needed to reach hCG normalization, and relapse within the first year. Only hCG levels related to the number of chemotherapy cycles required for hCG normalization.

Second uterine curettage did not reduce the number of chemotherapy courses required or affect relapse rate in patients with low-risk postmolar gestational trophoblastic neoplasia.

Dutch Trial Registry, NTR3390.