Does methotrexate (MTX) dosing in a 8-day MTX/FA regimen for the treatment of low-risk gestational trophoblastic neoplasia affect outcomes?

The MITO-9 study

Giorgia Mangili, Raffaella Cioffi, Saverio Danese, Luigi Frigerio, Maria Gabriella Ferrandina, Gennaro Cormio, Emanuela Rabaiotti, Giovanna Scarfone, Angiolo Gadducci, Alice Bergamini, Carmela Pisano, Massimo Candiani

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: To compare clinical outcomes of patients diagnosed with low-risk gestational trophoblastic neoplasia (GTN) receiving intramuscular methotrexate 50 mg total dose/day versus 1 mg/kg/day in a 8-day methotrexate/folinic acid (MTX/FA) regimen.

METHODS: This retrospective, multicenter study included 176 patients: 99 (56%) receiving methotrexate 50 mg total dose/day on days 1, 3, 5, 7 alternated with FA 7,5 mg on days 2, 4, 6, 8, every 14 days (group A); and 77 patients (44%), receiving methotrexate 1 mg/kg/day on days 1, 3, 5, 7 alternated with FA 7,5 mg on days 2, 4, 6, 8, every 14 days (group B). Patients' characteristics and outcomes were compared by univariate analysis.

RESULTS: Forty-five patients (25.6%) developed resistance to MTX and received a second-line treatment, 7 (4%) received a third-line treatment and 8 (4.5%) relapsed after initial remission. There was no difference between group A and B patients in the average number of chemotherapy cycles required to achieve remission (5.7 ± 2.6 vs 6.3 ± 2.3, p = 0.106). The 2 treatment groups showed comparable rates of MTX resistance (28.3% vs 22.1%, p = 0.387) and relapse (3% vs 6.5%, p = 0.300). There was no difference in the incidence of treatment toxicity of any CTCAE grade between group A and B patients (16.2% vs 15.2%, p = 0.999). Subgroup analysis stratifying patients by weight (<50 kg, ≥60 kg, ≥70 kg, ≥80 kg) confirmed these results.

CONCLUSION: The 2 MTX schedules showed comparable efficacy in the treatment of low-risk GTN with an acceptable rate of toxicity.

Original languageEnglish
Pages (from-to)449-452
Number of pages4
JournalGynecologic Oncology
Volume151
Issue number3
DOIs
Publication statusPublished - Dec 2018

Fingerprint

Gestational Trophoblastic Disease
Methotrexate
Therapeutics
Leucovorin
Multicenter Studies
Appointments and Schedules
Retrospective Studies
Weights and Measures
Recurrence
Drug Therapy
Incidence

Keywords

  • Adult
  • Antimetabolites, Antineoplastic/administration & dosage
  • Female
  • Gestational Trophoblastic Disease/drug therapy
  • Humans
  • Methotrexate/administration & dosage
  • Pregnancy
  • Retrospective Studies

Cite this

Does methotrexate (MTX) dosing in a 8-day MTX/FA regimen for the treatment of low-risk gestational trophoblastic neoplasia affect outcomes? The MITO-9 study. / Mangili, Giorgia; Cioffi, Raffaella; Danese, Saverio; Frigerio, Luigi; Ferrandina, Maria Gabriella; Cormio, Gennaro; Rabaiotti, Emanuela; Scarfone, Giovanna; Gadducci, Angiolo; Bergamini, Alice; Pisano, Carmela; Candiani, Massimo.

In: Gynecologic Oncology, Vol. 151, No. 3, 12.2018, p. 449-452.

Research output: Contribution to journalArticle

Mangili, G, Cioffi, R, Danese, S, Frigerio, L, Ferrandina, MG, Cormio, G, Rabaiotti, E, Scarfone, G, Gadducci, A, Bergamini, A, Pisano, C & Candiani, M 2018, 'Does methotrexate (MTX) dosing in a 8-day MTX/FA regimen for the treatment of low-risk gestational trophoblastic neoplasia affect outcomes? The MITO-9 study', Gynecologic Oncology, vol. 151, no. 3, pp. 449-452. https://doi.org/10.1016/j.ygyno.2018.09.025
Mangili, Giorgia ; Cioffi, Raffaella ; Danese, Saverio ; Frigerio, Luigi ; Ferrandina, Maria Gabriella ; Cormio, Gennaro ; Rabaiotti, Emanuela ; Scarfone, Giovanna ; Gadducci, Angiolo ; Bergamini, Alice ; Pisano, Carmela ; Candiani, Massimo. / Does methotrexate (MTX) dosing in a 8-day MTX/FA regimen for the treatment of low-risk gestational trophoblastic neoplasia affect outcomes? The MITO-9 study. In: Gynecologic Oncology. 2018 ; Vol. 151, No. 3. pp. 449-452.
@article{2efabb07132b4ab2a285f48f5ac642d2,
title = "Does methotrexate (MTX) dosing in a 8-day MTX/FA regimen for the treatment of low-risk gestational trophoblastic neoplasia affect outcomes?: The MITO-9 study",
abstract = "OBJECTIVE: To compare clinical outcomes of patients diagnosed with low-risk gestational trophoblastic neoplasia (GTN) receiving intramuscular methotrexate 50 mg total dose/day versus 1 mg/kg/day in a 8-day methotrexate/folinic acid (MTX/FA) regimen.METHODS: This retrospective, multicenter study included 176 patients: 99 (56{\%}) receiving methotrexate 50 mg total dose/day on days 1, 3, 5, 7 alternated with FA 7,5 mg on days 2, 4, 6, 8, every 14 days (group A); and 77 patients (44{\%}), receiving methotrexate 1 mg/kg/day on days 1, 3, 5, 7 alternated with FA 7,5 mg on days 2, 4, 6, 8, every 14 days (group B). Patients' characteristics and outcomes were compared by univariate analysis.RESULTS: Forty-five patients (25.6{\%}) developed resistance to MTX and received a second-line treatment, 7 (4{\%}) received a third-line treatment and 8 (4.5{\%}) relapsed after initial remission. There was no difference between group A and B patients in the average number of chemotherapy cycles required to achieve remission (5.7 ± 2.6 vs 6.3 ± 2.3, p = 0.106). The 2 treatment groups showed comparable rates of MTX resistance (28.3{\%} vs 22.1{\%}, p = 0.387) and relapse (3{\%} vs 6.5{\%}, p = 0.300). There was no difference in the incidence of treatment toxicity of any CTCAE grade between group A and B patients (16.2{\%} vs 15.2{\%}, p = 0.999). Subgroup analysis stratifying patients by weight (<50 kg, ≥60 kg, ≥70 kg, ≥80 kg) confirmed these results.CONCLUSION: The 2 MTX schedules showed comparable efficacy in the treatment of low-risk GTN with an acceptable rate of toxicity.",
keywords = "Adult, Antimetabolites, Antineoplastic/administration & dosage, Female, Gestational Trophoblastic Disease/drug therapy, Humans, Methotrexate/administration & dosage, Pregnancy, Retrospective Studies",
author = "Giorgia Mangili and Raffaella Cioffi and Saverio Danese and Luigi Frigerio and Ferrandina, {Maria Gabriella} and Gennaro Cormio and Emanuela Rabaiotti and Giovanna Scarfone and Angiolo Gadducci and Alice Bergamini and Carmela Pisano and Massimo Candiani",
note = "Copyright {\circledC} 2018 Elsevier Inc. All rights reserved.",
year = "2018",
month = "12",
doi = "10.1016/j.ygyno.2018.09.025",
language = "English",
volume = "151",
pages = "449--452",
journal = "Gynecologic Oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "3",

}

TY - JOUR

T1 - Does methotrexate (MTX) dosing in a 8-day MTX/FA regimen for the treatment of low-risk gestational trophoblastic neoplasia affect outcomes?

T2 - The MITO-9 study

AU - Mangili, Giorgia

AU - Cioffi, Raffaella

AU - Danese, Saverio

AU - Frigerio, Luigi

AU - Ferrandina, Maria Gabriella

AU - Cormio, Gennaro

AU - Rabaiotti, Emanuela

AU - Scarfone, Giovanna

AU - Gadducci, Angiolo

AU - Bergamini, Alice

AU - Pisano, Carmela

AU - Candiani, Massimo

N1 - Copyright © 2018 Elsevier Inc. All rights reserved.

PY - 2018/12

Y1 - 2018/12

N2 - OBJECTIVE: To compare clinical outcomes of patients diagnosed with low-risk gestational trophoblastic neoplasia (GTN) receiving intramuscular methotrexate 50 mg total dose/day versus 1 mg/kg/day in a 8-day methotrexate/folinic acid (MTX/FA) regimen.METHODS: This retrospective, multicenter study included 176 patients: 99 (56%) receiving methotrexate 50 mg total dose/day on days 1, 3, 5, 7 alternated with FA 7,5 mg on days 2, 4, 6, 8, every 14 days (group A); and 77 patients (44%), receiving methotrexate 1 mg/kg/day on days 1, 3, 5, 7 alternated with FA 7,5 mg on days 2, 4, 6, 8, every 14 days (group B). Patients' characteristics and outcomes were compared by univariate analysis.RESULTS: Forty-five patients (25.6%) developed resistance to MTX and received a second-line treatment, 7 (4%) received a third-line treatment and 8 (4.5%) relapsed after initial remission. There was no difference between group A and B patients in the average number of chemotherapy cycles required to achieve remission (5.7 ± 2.6 vs 6.3 ± 2.3, p = 0.106). The 2 treatment groups showed comparable rates of MTX resistance (28.3% vs 22.1%, p = 0.387) and relapse (3% vs 6.5%, p = 0.300). There was no difference in the incidence of treatment toxicity of any CTCAE grade between group A and B patients (16.2% vs 15.2%, p = 0.999). Subgroup analysis stratifying patients by weight (<50 kg, ≥60 kg, ≥70 kg, ≥80 kg) confirmed these results.CONCLUSION: The 2 MTX schedules showed comparable efficacy in the treatment of low-risk GTN with an acceptable rate of toxicity.

AB - OBJECTIVE: To compare clinical outcomes of patients diagnosed with low-risk gestational trophoblastic neoplasia (GTN) receiving intramuscular methotrexate 50 mg total dose/day versus 1 mg/kg/day in a 8-day methotrexate/folinic acid (MTX/FA) regimen.METHODS: This retrospective, multicenter study included 176 patients: 99 (56%) receiving methotrexate 50 mg total dose/day on days 1, 3, 5, 7 alternated with FA 7,5 mg on days 2, 4, 6, 8, every 14 days (group A); and 77 patients (44%), receiving methotrexate 1 mg/kg/day on days 1, 3, 5, 7 alternated with FA 7,5 mg on days 2, 4, 6, 8, every 14 days (group B). Patients' characteristics and outcomes were compared by univariate analysis.RESULTS: Forty-five patients (25.6%) developed resistance to MTX and received a second-line treatment, 7 (4%) received a third-line treatment and 8 (4.5%) relapsed after initial remission. There was no difference between group A and B patients in the average number of chemotherapy cycles required to achieve remission (5.7 ± 2.6 vs 6.3 ± 2.3, p = 0.106). The 2 treatment groups showed comparable rates of MTX resistance (28.3% vs 22.1%, p = 0.387) and relapse (3% vs 6.5%, p = 0.300). There was no difference in the incidence of treatment toxicity of any CTCAE grade between group A and B patients (16.2% vs 15.2%, p = 0.999). Subgroup analysis stratifying patients by weight (<50 kg, ≥60 kg, ≥70 kg, ≥80 kg) confirmed these results.CONCLUSION: The 2 MTX schedules showed comparable efficacy in the treatment of low-risk GTN with an acceptable rate of toxicity.

KW - Adult

KW - Antimetabolites, Antineoplastic/administration & dosage

KW - Female

KW - Gestational Trophoblastic Disease/drug therapy

KW - Humans

KW - Methotrexate/administration & dosage

KW - Pregnancy

KW - Retrospective Studies

U2 - 10.1016/j.ygyno.2018.09.025

DO - 10.1016/j.ygyno.2018.09.025

M3 - Article

VL - 151

SP - 449

EP - 452

JO - Gynecologic Oncology

JF - Gynecologic Oncology

SN - 0090-8258

IS - 3

ER -