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

G Mangili, Raffaela Cioffi, S Danese, L Frigerio, G Ferrandina, G Cormio, E Rabaiotti, G Scarfone, Angiolo Gadducci, A Bergamini, C Pisano, M 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 (
Original languageEnglish
Pages (from-to)449-452
Number of pages4
JournalGynecologic Oncology
Volume151
Issue number3
DOIs
Publication statusPublished - 2018

Fingerprint

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

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, G; Cioffi, Raffaela; Danese, S; Frigerio, L; Ferrandina, G; Cormio, G; Rabaiotti, E; Scarfone, G; Gadducci, Angiolo; Bergamini, A; Pisano, C; Candiani, M.

In: Gynecologic Oncology, Vol. 151, No. 3, 2018, p. 449-452.

Research output: Contribution to journalArticle

Mangili, G, Cioffi, R, Danese, S, Frigerio, L, Ferrandina, G, 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, G ; Cioffi, Raffaela ; Danese, S ; Frigerio, L ; Ferrandina, G ; Cormio, G ; Rabaiotti, E ; Scarfone, G ; Gadducci, Angiolo ; Bergamini, A ; Pisano, C ; Candiani, M. / 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{4f972e0e51884dd090757a7c9222e69a,
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 (",
author = "G Mangili and Raffaela Cioffi and S Danese and L Frigerio and G Ferrandina and G Cormio and E Rabaiotti and G Scarfone and Angiolo Gadducci and A Bergamini and C Pisano and M Candiani",
year = "2018",
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? The MITO-9 study

AU - Mangili, G

AU - Cioffi, Raffaela

AU - Danese, S

AU - Frigerio, L

AU - Ferrandina, G

AU - Cormio, G

AU - Rabaiotti, E

AU - Scarfone, G

AU - Gadducci, Angiolo

AU - Bergamini, A

AU - Pisano, C

AU - Candiani, M

PY - 2018

Y1 - 2018

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 (

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 (

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 -