S Limpongsanurak1. 1. Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.
Abstract
OBJECTIVE: To evaluate the effectiveness of one course of prophylactic actinomycin D in reducing the malignant sequelae requiring chemotherapy in high-risk complete hydatidiform mole (CHM). STUDY DESIGN: A double-blind, randomized, controlled clinical trial was carried out at King Chulalongkorn Memorial Hospital. Sixty cases of CHM classified as high risk were recruited and randomly allocated to a chemoprophylactic or control group. Within one week after evacuation of molar tissues, actinomycin D was administered in the chemoprophylactic group. Patients in the control group were given only intravenous fluid and analgesic drugs. The number of patients with malignant sequelae who required therapeutic chemotherapy after evacuation of hydatidiform mole in each group was recorded. RESULTS: The incidence of malignant sequelae was 13.8% (95% confidence interval [CI] = 3.9-31.7%) in the chemoprophylactic group and 50.0% (95% CI = 31.3-68.7%) in the control group. The risk reduction of malignant sequelae with one course of actinomycin D chemoprophylaxis in high-risk CHM was 72.4% (95% CI = 26.7-89.6%) (P = .005). The side effects of prophylactic chemotherapy were stomatitis, nausea/vomiting, sore throat with oral ulcer and hair loss. CONCLUSION: One course of actinomycin D given as chemoprophylaxis decreased by 72.4% malignant sequelae after evacuation of molar tissue in patients with high-risk CHM. This may be particularly beneficial in patients with high-risk CHM who cannot be followed closely, whose compliance is in question and for whom hormonal follow-up is not available or unreliable.
RCT Entities:
OBJECTIVE: To evaluate the effectiveness of one course of prophylactic actinomycin D in reducing the malignant sequelae requiring chemotherapy in high-risk complete hydatidiform mole (CHM). STUDY DESIGN: A double-blind, randomized, controlled clinical trial was carried out at King Chulalongkorn Memorial Hospital. Sixty cases of CHM classified as high risk were recruited and randomly allocated to a chemoprophylactic or control group. Within one week after evacuation of molar tissues, actinomycin D was administered in the chemoprophylactic group. Patients in the control group were given only intravenous fluid and analgesic drugs. The number of patients with malignant sequelae who required therapeutic chemotherapy after evacuation of hydatidiform mole in each group was recorded. RESULTS: The incidence of malignant sequelae was 13.8% (95% confidence interval [CI] = 3.9-31.7%) in the chemoprophylactic group and 50.0% (95% CI = 31.3-68.7%) in the control group. The risk reduction of malignant sequelae with one course of actinomycin D chemoprophylaxis in high-risk CHM was 72.4% (95% CI = 26.7-89.6%) (P = .005). The side effects of prophylactic chemotherapy were stomatitis, nausea/vomiting, sore throat with oral ulcer and hair loss. CONCLUSION: One course of actinomycin D given as chemoprophylaxis decreased by 72.4% malignant sequelae after evacuation of molar tissue in patients with high-risk CHM. This may be particularly beneficial in patients with high-risk CHM who cannot be followed closely, whose compliance is in question and for whom hormonal follow-up is not available or unreliable.