TY - JOUR
T1 - Second Uterine Curettage and the Number of Chemotherapy Courses in Postmolar Gestational Trophoblastic Neoplasia
T2 - A Randomized Controlled Trial
AU - Hemida, Reda
AU - Vos, Elvira L
AU - El-Deek, Basem
AU - Arafa, Mohammad
AU - Toson, Eman
AU - Burger, Curt W
AU - van Doorn, Helena C
N1 - Publisher Copyright:
© 2019 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
PY - 2019/5
Y1 - 2019/5
N2 - 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.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.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.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.CLINICAL TRIALS REGISTRATION: Dutch Trial Registry, NTR3390.
AB - 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.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.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.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.CLINICAL TRIALS REGISTRATION: Dutch Trial Registry, NTR3390.
KW - Adult
KW - Antimetabolites, Antineoplastic/administration & dosage
KW - Combined Modality Therapy
KW - Curettage
KW - Female
KW - Gestational Trophoblastic Disease/drug therapy
KW - Humans
KW - Methotrexate/administration & dosage
KW - Pregnancy
KW - Treatment Outcome
KW - Uterine Neoplasms/drug therapy
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U2 - 10.1097/AOG.0000000000003232
DO - 10.1097/AOG.0000000000003232
M3 - Article
C2 - 30969220
SN - 0029-7844
VL - 133
SP - 1024
EP - 1031
JO - Obstetrics and Gynecology
JF - Obstetrics and Gynecology
IS - 5
ER -