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Second Uterine Curettage and the Number of Chemotherapy Courses in Postmolar Gestational Trophoblastic Neoplasia: A Randomized Controlled Trial.
- Source :
-
Obstetrics and gynecology [Obstet Gynecol] 2019 May; Vol. 133 (5), pp. 1024-1031. - Publication Year :
- 2019
-
Abstract
- Objective: To investigate the effect of second uterine curettage on the number of chemotherapy courses and relapse rate in low-risk postmolar gestational trophoblastic neoplasia.<br />Methods: 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.<br />Results: 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.<br />Conclusion: 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.<br />Clinical Trials Registration: Dutch Trial Registry, NTR3390.
- Subjects :
- Adult
Antimetabolites, Antineoplastic administration & dosage
Antimetabolites, Antineoplastic therapeutic use
Combined Modality Therapy
Female
Gestational Trophoblastic Disease drug therapy
Humans
Methotrexate administration & dosage
Methotrexate therapeutic use
Pregnancy
Treatment Outcome
Uterine Neoplasms drug therapy
Curettage
Gestational Trophoblastic Disease surgery
Uterine Neoplasms surgery
Subjects
Details
- Language :
- English
- ISSN :
- 1873-233X
- Volume :
- 133
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Obstetrics and gynecology
- Publication Type :
- Academic Journal
- Accession number :
- 30969220
- Full Text :
- https://doi.org/10.1097/AOG.0000000000003232