Phase III trial of weekly methotrexate or pulsed dactinomycin for low-risk gestational trophoblastic neoplasia: A gynecologic oncology group study

Raymond J. Osborne, Virginia Filiaci, Julian C. Schink, Robert S. Mannel, Angeles Alvarez Secord, Joseph L. Kelley, Diane Provencher, David Scott Miller, Allan L. Covens, Janice M. Lage

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Abstract

Purpose: There is no consensus on the best regimen for the primary treatment of low-risk gestational trophoblastic neoplasia (GTN). Patients and Methods: Two commonly used single-drug regimens were compared with respect to the proportion of patients meeting the criteria for a complete response (CR) in a randomized phase III trial conducted by the Gynecologic Oncology Group. Eligibility was purposefully broad to maximize the generalizability of the results and included patients with a WHO risk score of 0 to 6 and patients with metastatic disease (limited to lung lesions < 2 cm, adnexa, or vagina) or choriocarcinoma. Results: Two hundred forty women were enrolled, and 216 were deemed eligible. Biweekly intravenous dactinomycin 1.25 mg/m2 was statistically superior to weekly intramuscular (IM) methotrexate 30 mg/m 2 (CR: 70% v 53%; P = .01). Similarly, in patients with low-risk GTN as defined before the 2002 WHO risk score revisions (risk score of 0 to 4 and excluding choriocarcinoma), response was 58% and 73% in the methotrexate and dactinomycin arms, respectively (P = .03). Both regimens were less effective if the WHO risk score was 5 or 6 or if the diagnosis was choriocarcinoma (CR: 9% and 42%, respectively). There were two potential recurrences; one at 4 months (dactinomycin) and one at 22 months (methotrexate). Not all patients completed follow-up. Both regimens were well tolerated. Conclusion: The biweekly dactinomycin regimen has a higher CR rate than the weekly IM methotrexate regimen in low-risk GTN, a generally curable disease.

Original languageEnglish (US)
Pages (from-to)825-831
Number of pages7
JournalJournal of Clinical Oncology
Volume29
Issue number7
DOIs
StatePublished - Mar 1 2011

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Gestational Trophoblastic Disease
Dactinomycin
Methotrexate
Choriocarcinoma
Vagina
Recurrence
Lung

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III trial of weekly methotrexate or pulsed dactinomycin for low-risk gestational trophoblastic neoplasia : A gynecologic oncology group study. / Osborne, Raymond J.; Filiaci, Virginia; Schink, Julian C.; Mannel, Robert S.; Secord, Angeles Alvarez; Kelley, Joseph L.; Provencher, Diane; Miller, David Scott; Covens, Allan L.; Lage, Janice M.

In: Journal of Clinical Oncology, Vol. 29, No. 7, 01.03.2011, p. 825-831.

Research output: Contribution to journalArticle

Osborne, RJ, Filiaci, V, Schink, JC, Mannel, RS, Secord, AA, Kelley, JL, Provencher, D, Miller, DS, Covens, AL & Lage, JM 2011, 'Phase III trial of weekly methotrexate or pulsed dactinomycin for low-risk gestational trophoblastic neoplasia: A gynecologic oncology group study', Journal of Clinical Oncology, vol. 29, no. 7, pp. 825-831. https://doi.org/10.1200/JCO.2010.30.4386
Osborne, Raymond J. ; Filiaci, Virginia ; Schink, Julian C. ; Mannel, Robert S. ; Secord, Angeles Alvarez ; Kelley, Joseph L. ; Provencher, Diane ; Miller, David Scott ; Covens, Allan L. ; Lage, Janice M. / Phase III trial of weekly methotrexate or pulsed dactinomycin for low-risk gestational trophoblastic neoplasia : A gynecologic oncology group study. In: Journal of Clinical Oncology. 2011 ; Vol. 29, No. 7. pp. 825-831.
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abstract = "Purpose: There is no consensus on the best regimen for the primary treatment of low-risk gestational trophoblastic neoplasia (GTN). Patients and Methods: Two commonly used single-drug regimens were compared with respect to the proportion of patients meeting the criteria for a complete response (CR) in a randomized phase III trial conducted by the Gynecologic Oncology Group. Eligibility was purposefully broad to maximize the generalizability of the results and included patients with a WHO risk score of 0 to 6 and patients with metastatic disease (limited to lung lesions < 2 cm, adnexa, or vagina) or choriocarcinoma. Results: Two hundred forty women were enrolled, and 216 were deemed eligible. Biweekly intravenous dactinomycin 1.25 mg/m2 was statistically superior to weekly intramuscular (IM) methotrexate 30 mg/m 2 (CR: 70{\%} v 53{\%}; P = .01). Similarly, in patients with low-risk GTN as defined before the 2002 WHO risk score revisions (risk score of 0 to 4 and excluding choriocarcinoma), response was 58{\%} and 73{\%} in the methotrexate and dactinomycin arms, respectively (P = .03). Both regimens were less effective if the WHO risk score was 5 or 6 or if the diagnosis was choriocarcinoma (CR: 9{\%} and 42{\%}, respectively). There were two potential recurrences; one at 4 months (dactinomycin) and one at 22 months (methotrexate). Not all patients completed follow-up. Both regimens were well tolerated. Conclusion: The biweekly dactinomycin regimen has a higher CR rate than the weekly IM methotrexate regimen in low-risk GTN, a generally curable disease.",
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T1 - Phase III trial of weekly methotrexate or pulsed dactinomycin for low-risk gestational trophoblastic neoplasia

T2 - A gynecologic oncology group study

AU - Osborne, Raymond J.

AU - Filiaci, Virginia

AU - Schink, Julian C.

AU - Mannel, Robert S.

AU - Secord, Angeles Alvarez

AU - Kelley, Joseph L.

AU - Provencher, Diane

AU - Miller, David Scott

AU - Covens, Allan L.

AU - Lage, Janice M.

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N2 - Purpose: There is no consensus on the best regimen for the primary treatment of low-risk gestational trophoblastic neoplasia (GTN). Patients and Methods: Two commonly used single-drug regimens were compared with respect to the proportion of patients meeting the criteria for a complete response (CR) in a randomized phase III trial conducted by the Gynecologic Oncology Group. Eligibility was purposefully broad to maximize the generalizability of the results and included patients with a WHO risk score of 0 to 6 and patients with metastatic disease (limited to lung lesions < 2 cm, adnexa, or vagina) or choriocarcinoma. Results: Two hundred forty women were enrolled, and 216 were deemed eligible. Biweekly intravenous dactinomycin 1.25 mg/m2 was statistically superior to weekly intramuscular (IM) methotrexate 30 mg/m 2 (CR: 70% v 53%; P = .01). Similarly, in patients with low-risk GTN as defined before the 2002 WHO risk score revisions (risk score of 0 to 4 and excluding choriocarcinoma), response was 58% and 73% in the methotrexate and dactinomycin arms, respectively (P = .03). Both regimens were less effective if the WHO risk score was 5 or 6 or if the diagnosis was choriocarcinoma (CR: 9% and 42%, respectively). There were two potential recurrences; one at 4 months (dactinomycin) and one at 22 months (methotrexate). Not all patients completed follow-up. Both regimens were well tolerated. Conclusion: The biweekly dactinomycin regimen has a higher CR rate than the weekly IM methotrexate regimen in low-risk GTN, a generally curable disease.

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