Five-Day Intravascular Methotrexate Versus Biweekly Actinomycin-D in the Treatment of Low-Risk Gestational Trophoblastic Neoplasia: A Clinical Randomized Trial

2016 ◽  
Vol 26 (5) ◽  
pp. 971-976 ◽  
Author(s):  
Fariba Yarandi ◽  
Azamsadat Mousavi ◽  
Fereshteh Abbaslu ◽  
Soheila Aminimoghaddam ◽  
Sepideh Nekuie ◽  
...  
Keyword(s):  
Complete Remission ◽  
Actinomycin D ◽  
Remission Rate ◽  
Single Agent ◽  
Low Risk ◽  
Multiple Drug ◽  
Gestational Trophoblastic Neoplasia ◽  
First Line ◽  
Significant Difference ◽  
Line Chemotherapy

ObjectivesMethotrexate (MTX) and Actinomycin-D (Act-D) are effective drugs used in the treatment of low-risk gestational trophoblastic neoplasia (LRGTNs). The aim of the present study was to compare intravenous (IV) MTX and IV Act-D in the treatment of LRGTNs.Materials and MethodsSixty-two patients with LRGTN were enrolled in a prospective randomized clinical trial between 2010 and 2013 in Moheb e Yas Hospital, Tehran University of Medical Sciences. Primary treatment regimens were IV MTX, 0.4 mg/kg daily for 5 days every 14 days (25 mg maximum daily dose), and IV Act-D, 1.25 mg/m2 (2 mg maximum dose) every 14 days.ResultsThirty-two and 30 patients were enrolled to MTX and Act-D groups, respectively. Complete remission after receiving first-line chemotherapy was achieved in 79% of all cases, 80% in the Act-D group and 78.1% in the MTX group.Twenty percent of the Act-D patients and 21.9% of the MTX patients showed resistance to the first-line chemotherapy, of which 16.7% and 15.6% responded completely to the second-line monotherapy, respectively. Multiple drug therapy was needed in 3.3% of the Act-D group and 6.3% of the MTX group.We did not find any correlation between treatment response and beta–human chorionic gonadotropin level, uterine mass size, lung metastasis, antecedent pregnancy, and duration from diagnosis to treatment. Adverse effects were not statistically different between the 2 groups.ConclusionsSingle-agent chemotherapy in the treatment of LRGTNs resulted in an overall complete remission rate of 79%, 80% in the Act-D group and 78.1% in MTX group, with no statistically significant difference. Whereas this study represents an important step in comparing single-agent treatments, comparison of other regimens will be required to determine the optimal single-agent therapy.

scholarly journals Direct Comparisons of Efficacy and Safety Between Actinomycin-D and Methotrexate in Women With Low-Risk Gestational Trophoblastic Neoplasia: A Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Jiatao Hao ◽  
Weihua Zhou ◽  
Mengzhao Zhang ◽  
Hui Yu ◽  
Taohong Zhang ◽  
...  
Keyword(s):  
Complete Remission ◽  
Fixed Effects ◽  
Actinomycin D ◽  
Remission Rate ◽  
Meta Analysis ◽  
Low Risk ◽  
Controlled Trials ◽  
Gestational Trophoblastic Neoplasia ◽  
Efficacy And Safety ◽  
Significant Difference

Abstract Background: Actinomycin-D (Act-D) and Methotrexate (MTX) are both effective first-line agents for low-risk gestational trophoblastic neoplasia (LRGTN) with no consensus regarding which is more effective or less toxic. The primary objective of this meta-analysis is to compare Act-D with MTX in the treatment of LRGTN.Methods: We systematically searched electronic databases, conferences abstracts and trial registries for randomized controlled trials (RCTs) and high-quality non-randamized controlled trials (non-RCTs), comparing Act-D with MTX for patients with LRGTN. Studies were full-text screened for quality assessment and data extraction. Eligible studies must have reported complete remission rate. A fixed-effects meta-analysis was conducted to quantify the efficacy and safety of Act-D and MTX on odds ratios (ORs) and 95% confidence intervals (95%CIs), respectively.Results: A total of 8 RCTs and 9 non-RCTs (1674 patients) were included. In terms of efficacy, Act-D is superior to MTX in complete remission (OR 2.15, 95%CI 1.70 to 2.73). In the stratified analysis, patients from RCTs and non-RCTs both had a better CR from Act-D-based regimen (RCTs: OR 2.17, 95%CI 1.49 to 3.16; non-RCTs: OR 2.14, 95%CI 1.57 to 2.92). In terms of safety, patients receiving Act-D had higher risks of suffering nausea (OR 2.35, 95%CI 1.68 to 3.27), vomiting (OR 2.40, 95%CI 1.63 to 3.54), and alopecia (OR 2.76, 95%CI 1.60 to 4.75). Notably, liver toxicity (OR 0.38, 95%CI 0.19 to 0.76) was the only one that was conformed to have a higher risk for patients receiving MTX. In addition, the pooled results showed no significant difference of anaemia, leucocytopenia, neutropenia, thrombocytopnia, constipation, diarrhea, anorexia, and fatigue between Act-D and MTX.Conclusions: Our meta-analysis suggests that Act-D had better efficacy profile in general, and MTX had less toxicities in LRGTN. Future clinical trials should be better orchestrated to provide more valid data on efficacy and toxicity.

scholarly journals Direct comparisons of efficacy and safety between actinomycin-D and methotrexate in women with low-risk gestational trophoblastic neoplasia: a meta-analysis of randomized and high-quality non-randomized studies

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jiatao Hao ◽  
Weihua Zhou ◽  
Mengzhao Zhang ◽  
Hui Yu ◽  
Taohong Zhang ◽  
...  
Keyword(s):  
Complete Remission ◽  
Fixed Effects ◽  
Actinomycin D ◽  
Meta Analysis ◽  
Low Risk ◽  
Controlled Trials ◽  
Gestational Trophoblastic Neoplasia ◽  
Efficacy And Safety ◽  
High Quality ◽  
Significant Difference

Abstract Background Actinomycin-D (Act-D) and Methotrexate (MTX) are both effective first-line agents for low-risk gestational trophoblastic neoplasia (LRGTN) with no consensus regarding which is more effective or less toxic. The primary objective of this meta-analysis is to compare Act-D with MTX in the treatment of LRGTN. Methods We systematically searched electronic databases, conferences abstracts and trial registries for randomized controlled trials (RCTs) and high-quality non-randamized controlled trials (non-RCTs), comparing Act-D with MTX for patients with LRGTN. Studies were full-text screened for quality assessment and data extraction. Eligible studies must have reported complete remission rate. A fixed-effects meta-analysis was conducted to quantify the efficacy and safety of Act-D and MTX on odds ratios (ORs) and 95% confidence intervals (95%CIs), respectively. Results A total of 8 RCTs and 9 non-RCTs (1674 patients) were included. In terms of efficacy, Act-D is superior to MTX in complete remission (80.2% [551/687] vs 65.1% [643/987]; OR 2.15, 95%CI 1.70 to 2.73). In the stratified analysis, patients from RCTs and non-RCTs both had a better complete remission from Act-D-based regimen (RCTs: 81.2% [259/319] vs 66.1% [199/301], OR 2.17, 95%CI 1.49 to 3.16; non-RCTs: 79.3% [292/368] vs 65.0% [444/686], OR 2.14, 95%CI 1.57 to 2.92). In terms of safety, patients receiving Act-D had higher risks of suffering nausea (OR 2.35, 95%CI 1.68 to 3.27), vomiting (OR 2.40, 95%CI 1.63 to 3.54), and alopecia (OR 2.76, 95%CI 1.60 to 4.75). Notably, liver toxicity (OR 0.38, 95%CI 0.19 to 0.76) was the only one that was conformed to have a higher risk for patients receiving MTX. In addition, the pooled results showed no significant difference of anaemia, leucocytopenia, neutropenia, thrombocytopnia, constipation, diarrhea, anorexia, and fatigue between Act-D and MTX. Conclusions Our meta-analysis suggests that Act-D had better efficacy profile in general, and MTX had less toxicities in LRGTN. Future clinical trials should be better orchestrated to provide more valid data on efficacy and toxicity.

scholarly journals Prognosis of Gestational Trophoblastic Neoplasia in Women at 40 Years Old and Above: A Multicentre Retrospective Study

2020 ◽  
pp. 1-6
Author(s):  
Reda Hemida ◽  
Reda Hemida ◽  
Philippe Sauthier ◽  
Eman Toson ◽  
Nataly Tsip ◽  
...  
Keyword(s):  
High Risk ◽  
Remission Rate ◽  
Single Agent ◽  
Treatment Strategies ◽  
Low Risk ◽  
Gestational Trophoblastic Neoplasia ◽  
Second Line ◽  
Historical Cohort ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy

Purpose: To investigate the outcome of different treatment strategies in patients with gestational trophoblastic neoplasia (GTN) in women at 40 years old and above. Patients and Methods: We analysed a historical cohort from 5 referral centres from 5 countries, including all women with GTN treated between 2012 and 2017, who were 40 years old and older. Baseline characteristics and outcome of different treatment strategies were recorded and evaluated. The patients were categorized into low-risk non-metastatic, low-risk metastatic and high-risk, based on the FIGO classification. Results: A total of 141 cases were identified, of which 112 cases fulfilled the inclusion criteria. Mean age was 45.4 years ± 4.2SD. Of 80 patients with LR non-metastatic GTN, 46 women received single agent chemotherapy and 34 a hysterectomy with or without (n = 4) chemotherapy. Higher remission rate and shorter treatment duration (P=0.001) was seen in the group that underwent hysterectomy. Seven of the 14 patients with low-risk, metastatic GTN were cured with methotrexate. Two of the 18 high risk patients died before treatment, four were treated with polychemotherapy; two of them needed second line chemotherapy for incomplete response. Two cases received induction with methotrexate followed by EMA/CO. Ten highrisk patients were treated with hysterectomy and chemotherapy, of these six achieved complete remission, three needed second line chemotherapy, and one patient died during chemotherapy treatment. Conclusion: In this cohort of women with GTN at 40 years old or above, we found high proportions of metastatic and high-risk cases, of methotrexate resistance, and of need for multiple treatment lines. In all groups, hysterectomy was performed, but its role remains controversial in metastatic low-risk and high-risk disease.

scholarly journals Gestational trophoblastic neoplasia: A 6 year retrospective study

2014 ◽  
Vol 03 (01) ◽  
pp. 033-037 ◽  
Author(s):  
Sushruta Shrivastava ◽  
Amal Chandra Kataki ◽  
Debabrata Barmon ◽  
Pankaj Deka ◽  
Chidananda Bhuyan ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Complete Remission ◽  
Risk Score ◽  
Single Agent ◽  
Response To Treatment ◽  
Gestational Trophoblastic Neoplasia ◽  
Response To Chemotherapy ◽  
Chemotherapy Patients ◽  
Line Chemotherapy

Abstract Aims and Objectives: To study the clinical presentations of gestational trophoblastic neoplasia and its response to chemotherapy. Materials and Methods: This is a retrospective study of 28 women of gestational trophoblastic neoplasia evaluated over a period of 6 years from January 2004 to December 2009. Patients were evaluated on the basis of their age, number of deliveries, history of abortion or molar pregnancy, and the treatment received. All patients were scored on the basis of WHO scoring system. Patients with low risk (score </=6) received single agent chemotherapy with methotrexate or actinomycin D. Patients with high risk (score >/=7) received multiple agent chemotherapy with EMACO regimen. After completion of chemotherapy patients were followed for a minimum of 2 years. The response to treatment was evaluated during follow-up by clinical examination, beta hCG levels and imaging as and when required. Results: Out of 28 women only 27 could be evaluated, because 1 patient was lost to follow-up. Out of 27 patients, 18 patients (66.67%) achieved complete remission with the first-line chemotherapy and additional 25.92% (7/27) achieved complete remission with second line chemotherapy resulting in complete remission of 92.5% (25/27). Conclusion: Gestational trophoblastic neoplasia is curable if patient is properly evaluated and scored. It shows good response to chemotherapy.

Etoposide-Actinomycin as Salvage Regimen for the Treatment of Nonmetastatic and Low-Risk Metastatic Gestational Trophoblastic Neoplasia: Experience at the Philippine General Hospital

2016 ◽  
Vol 26 (5) ◽  
pp. 977-983 ◽  
Author(s):  
Mariel S. Nevado-Gammad ◽  
Agnes L. Soriano-Estrella
Keyword(s):  
General Hospital ◽  
Remission Rate ◽  
Single Agent ◽  
Salvage Chemotherapy ◽  
Normal Serum ◽  
Salvage Treatment ◽  
Low Risk ◽  
Gestational Trophoblastic Neoplasia ◽  
Salvage Regimen ◽  
Trophoblastic Diseases

ObjectivesSingle-agent chemotherapy has been the standard of treatment for nonmetastatic and metastatic low-risk gestational trophoblastic neoplasia (GTN). However, it is estimated that approximately 12% to 32% of patients given single-agent therapy will require a change of chemotherapy regimen because of drug resistance and/or intolerable toxicity. The Section of Trophoblastic Diseases of the Philippine General Hospital started using the combination of etoposide-actinomycin (EA) as salvage chemotherapy in the early 2000s. This study was carried out to describe the local experience with this salvage chemotherapy.Materials and MethodsThis is a retrospective descriptive study aimed to analyze the efficacy and safety of the EA regimen as salvage treatment for the management of nonmetastatic and low-risk metastatic GTN. Records of the Section of Trophoblastic Diseases of the Philippine General Hospital from January 1, 2002 to June 30, 2014 were reviewed to identify all patients who had a diagnosis of nonmetastatic and metastatic low-risk GTN. Primary remission rate and toxicity profile of all patients who received the EA regimen as salvage treatment were determined.ResultsDuring the study period, a total of 67 cycles of the EA regimen were administered to 15 patients as salvage chemotherapy. Patients received a median of 4 cycles of EA, attaining normal serum beta human chorionic gonadotropin after 2 to 3 cycles. Thirteen of the 15 patients achieved complete remission with the EA regimen, giving a remission rate of 87%. The major toxicity that the patients experienced was myelosuppression. Grade 1/2 anemia was addressed by blood transfusion. Grade 3 neutropenia/myelosuppression was addressed by the administration of granulocyte colony-stimulating factor. Alopecia was seen in all of the patients. One patient experienced dermatitis with accompanying myelosuppression.ConclusionThe EA regimen was efficacious and well tolerated for the treatment of refractory nonmetastatic and low- risk metastatic GTN.

scholarly journals First-line chemotherapy in low-risk gestational trophoblastic neoplasia

2016 ◽  
Author(s):  
Theresa A Lawrie ◽  
Mo'iad Alazzam ◽  
John Tidy ◽  
Barry W Hancock ◽  
Raymond Osborne
Keyword(s):  
Low Risk ◽  
Gestational Trophoblastic Neoplasia ◽  
First Line ◽  
Line Chemotherapy

scholarly journals Chemo-resistant gestational trophoblastic neoplasia: a review of cases at a tertiary cancer centre

2019 ◽  
Vol 8 (4) ◽  
pp. 1620
Author(s):  
Sharayu R. Mirji ◽  
Shilpa M. Patel ◽  
Ruchi S. Arora ◽  
Ava D. Desai ◽  
Meeta H. Mankad ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Group ◽  
Complete Response ◽  
High Risk Group ◽  
Low Risk ◽  
Gestational Trophoblastic Neoplasia ◽  
First Line ◽  
Β Hcg ◽  
Cure Rates ◽  
Line Chemotherapy

Background: Gestational trophoblastic neoplasia (GTN) was earlier a dreaded malignancy with high mortality rates. GTN is now considered to be one of the most curable solid tumours in women with cure rates greater than 90% even in the presence of metastases. Despite the high chemo sensitivity, treatment failure or drug resistance has been described in both groups.Methods: In this study, available records of GTN cases over 6 years were reviewed with emphasis on those who were resistant to the first line of chemotherapy. Of these, 37(34.58%) were resistant to the first line of chemotherapy. These cases were studied with respect to age, parity, antecedent pregnancy, interval from antecedent pregnancy, pretreatment β hCG, risk score and presence of metastases. The data was analyzed in order to find any risk factors associated with chemo-resistance.Results: Total number of cases of GTN was 107. Out of these 107 cases, 63 (58.88%) were low risk and 44 (41.12%) were high risk according to FIGO scoring system. Complete response was achieved with first line chemotherapy in 70 (65.42%) patients. The remaining 37 (34.57%) were resistant to first line chemotherapy. In the low risk group, 30 (47.62%) cases, and in the high-risk group, 7(15.91%) were resistant to first line of chemotherapy.Conclusions: Despite the high chemo sensitivity of GTN, resistance to first line chemotherapy may be encountered in up to 40% of cases.  It is important to identify the patients who are at risk to develop resistance, early identification of resistance and change of chemotherapy so as to minimize the exposure of these patients to ineffective chemotherapy.

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