Comparison of pulsed actinomycin D versus 5‐day methotrexate for the treatment of low‐risk gestational trophoblastic disease

Mousavi, Azam Sadat; Cheraghi, Fatemeh; Yarandi, Fariba; Gilani, Mitra Modaress; Shojaei, Hadi

doi:10.1016/j.ijgo.2011.08.003

Cited by 31 publications

(29 citation statements)

References 24 publications

(37 reference statements)

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“…However, both regimens were less effective when the GTN score was five or six, or when there was a histologic diagnosis of choriocarcinoma 27 . Other studies also found greater primary remission rates for pulsed ActD than weekly MTX 28,29 , MTX for five days 30 and MTX/FA for eight days 31 . A study about GTN treatment at the John I.…”

Section: Low-risk Diseasementioning

confidence: 87%

Diagnosis, classification and treatment of gestational trophoblastic neoplasia

Biscaro¹,

Braga²,

Berkowitz³

2015

Rev. Bras. Ginecol. Obstet.

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Gestational trophoblastic neoplasia (GTN) is the term to describe a set of malignant placental diseases, including invasive mole, choriocarcinoma, placental site trophoblastic tumor and epithelioid trophoblastic tumor. Both invasive mole and choriocarcinoma respond well to chemotherapy, and cure rates are greater than 90%. Since the advent of chemotherapy, low-risk GTN has been treated with a single agent, usually methotrexate or actinomycin D. Cases of high-risk GTN, however, should be treated with multiagent chemotherapy, and the regimen usually selected is EMA-CO, which combines etoposide, methotrexate, actinomycin D, cyclophosphamide and vincristine. This study reviews the literature about GTN to discuss current knowledge about its diagnosis and treatment. ResumoNeoplasia trofoblástica gestacional (NTG) é o termo que descreve o conjunto de anomalias malignas da placenta, incluindo a mola invasora, coriocarcinoma, tumor trofoblástico do sítio placentário e tumor trofoblástico epitelióide. Ambos a mola invasora e o coriocarcinoma respondem bem à quimioterapia, com taxas de cura superiores a 90%. Desde o advento da quimioterapia, NTG de baixo risco tem sido tratada com monoquimioterapia, pelo geral methotrexate ou actinomicina-D. Casos de NTG de alto risco, contudo, devem ser tratados com poliquimioterapia, e o regime usualmente escolhido é o EMA-CO que combina etoposide, methotrexate, actinomicina-D, ciclofosfamida e vincristina. Esse estudo revê a literatura sobre NTG a fim de discutir os conhecimentos atuais sobre seu diagnóstico e tratamento.

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Section: Low-risk Diseasementioning

confidence: 87%

Diagnosis, classification and treatment of gestational trophoblastic neoplasia

Biscaro¹,

Braga²,

Berkowitz³

2015

Rev. Bras. Ginecol. Obstet.

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“…It is easily administered to patients in an outpatient setting and requires no permanent or temporary central venous access. The efficacy of this regimen compared to biweekly pulsed Act-D 1.25 mg/m 2 was assessed by a single center randomized trial of 75 patients by Mousavi et al [8] Miller et al…”

Section: Discussionmentioning

confidence: 99%

“…An early criticism of this study was that there are alternative regimens of MTX with higher historic success rates than the 30 mg/m 2 weekly MTX dose used in the trial [3]. All of these historic regimens' success rates have been documented in single center phase II trials [4,5,6,7] and recent single center phase III trials [8,9] with questionable reporting of bias and severe adverse side effects [10]. Importantly, regardless of first agent used, low-risk GTN remains almost completely curable [3].…”

Section: Introductionmentioning

confidence: 99%

Are different methotrexate regimens as first line therapy for low risk gestational trophoblastic neoplasia more cost effective than the dactinomycin regimen used in GOG 0174?

Miller

Chappell

Leath

et al. 2015

Gynecologic Oncology

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Objectives-Gynecologic Oncology Group (GOG) 0174 compared weekly intramuscular methotrexate (MTX) with biweekly pulsed intravenous dactinomycin (Act-D) as single-agent chemotherapy for low-risk gestational trophoblastic neoplasia (GTN). Act-D had a higher rate of initial complete response (CR) (70% vs. 53%, p = 0.01), but multi-day regimens of MTX have higher historic success rates. We assessed the cost-effectiveness of Act-D vs. MTX per GOG 0174 and explored multi-day MTX regimens.Methods-A cost effectiveness decision model was constructed with data from GOG 0174. Outcome was cost per first-line treatment success expressed in terms of incremental costeffectiveness ratio (ICER). Front-line failures were assumed to receive cross-over single agent therapy, second line failures; multi-agent chemotherapy. GOG 0174 had no quality of life (QOL) evaluation, so equal QOL (utility 1.0) was assumed but varied in sensitivity analysis. A second exploratory model included 5-day and 8-day MTX regimens.Results-Act-D ($18,505) was more expensive compared to weekly MTX ($8950) with an ICER of $56,215 per first-line treatment success compared to weekly MTX. Small decreases in QOL dramatically increased the ICER during sensitivity analysis. Models with multi-day MTX regimens were also more cost-effective than Act-D. If effectiveness was redefined as avoidance of multi-agent chemotherapy, weekly MTX was more effective. HHS Public Access Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptConclusions-With a complete cure rate for low-risk GTN regardless of initial agent, our model supports provider hesitation toward first line Act-D for low risk GTN. While Act-D is more effective for first line treatment success, it is more costly, and does not decrease rate of multi-agent chemotherapy use.

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“…Usually, it is administered using a 5-day EV schedule in the cases of MTX resistance or toxicity 8,11,12 . In order to reduce the high rate and intensity of collateral effects with 5-day Act-D schedule, several authors have investigated the use of the so-called pulsed Act-D regimen 15,16 . When used as first-line ChT for low-risk GTN patients, pulsed Act-D had the following results in 4 studies: mean number of courses was 4.9 -our results, median 2; resistance was 8-24% -our results, 32.9%; and cure rate ranged from 76% (low-risk metastatic GTN) to 86% (non-metastatic GTN) -our results, 67.1%, with most patients in stage I of FIGO 2002 12,13,16 .…”

Section: Discussionmentioning

confidence: 99%

“…The FIGO 2002 defined that low-risk GTN could be treated with single-agent ChT, resulting in final survival rates approaching 100% 3,7 . Several studies with Methotrexate (MTX) and Actinomycin D (Act-D) protocols have been used for treatment of low-risk GTN [8][9][10][11][12] ; nevertheless, few studies compared these two drugs in the management of low-risk GTN [13][14][15][16] . Osborne et al 16 has recently published a randomized study that suggests that the use of a bolus dose of Act-D every 15 days might be more effective than the administration of a weekly dose of MTX 16 .…”

Section: Introductionmentioning

confidence: 99%

Treatment of low-risk gestational trophoblastic neoplasia comparing biweekly eight-day Methotrexate with folinic acid versus bolus-dose Actinomycin-D, among Brazilian women

Uberti¹,

Fajardo²,

Cunha³

et al. 2015

Rev. Bras. Ginecol. Obstet.

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-D), biweekly. At GTN diagnosis, patient opinion was taken into consideration when defining the initial single-agent ChT regimen, and when there was resistance or toxicity to one regimen, the other drug was used preferentially. This study was approved by the Irmandade da Santa Casa de Misericórdia de Porto Alegre Ethical Committee. RESULTS: Both groups were clinically similar (p>0.05). In first-line treatments, frequency of complete response was similar (75.7% with MTX/FA and 67.1% with bolus Act-D); the number of ChT courses -median 3 (range: 1-10) with MTX/FA and 2 (range: 1-6) with bolus Act-D -and the time to remission -median 9 weeks (range: 2-16) with MTX/FA and 10 weeks (range: 2-16) with bolus Act-D) -were not different between the groups. In both groups, first-line side effects frequency were high but intensity was low; stomatitis was higher with MTX/FA (p<0.01) and nausea and vomit with Act-D (p<0.01).Final single-agent ChT responses were high in both groups (94.8% with MTX/FA and 83.5% with bolus Act-D; p<0.01) and 13% higher in the group initially treated with MTX/FA. Rates of hysterectomy and of GTN recurrence were low and similar. No patient died due to GTN. CONCLUSION: The two regimens had similar first-line ChT response. Final single-agent response rates were high and similar in both groups but the final single-agent remission rate was higher in the MTX/FA group. Treatment of low-risk gestational trophoblastic neoplasia comparing biweekly eight-day Methotrexate with folinic acid versus bolus-dose Actinomycin-D, among Brazilian women

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Comparison of pulsed actinomycin D versus 5‐day methotrexate for the treatment of low‐risk gestational trophoblastic disease

Abstract: Based on the present study, pulsed actinomycin D seems to be an appropriate first-line treatment for patients with low-risk gestational trophoblastic disease.

Cited by 31 publications

References 24 publications

Diagnosis, classification and treatment of gestational trophoblastic neoplasia

Diagnosis, classification and treatment of gestational trophoblastic neoplasia

Are different methotrexate regimens as first line therapy for low risk gestational trophoblastic neoplasia more cost effective than the dactinomycin regimen used in GOG 0174?

Treatment of low-risk gestational trophoblastic neoplasia comparing biweekly eight-day Methotrexate with folinic acid versus bolus-dose Actinomycin-D, among Brazilian women

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