Matched-paired analysis of patients treated for invasive mucormycosis: standard treatment versus posaconazole new formulations (MoveOn)

FungiScope® ECMM/ISHAM Working Group

Research output: Contribution to journalArticle

Abstract

BACKGROUND: First-line antifungal treatment for invasive mucormycosis (IM) consists of liposomal amphotericin B. Salvage treatment options are limited and often based on posaconazole oral suspension. With the approval of posaconazole new formulations, patients could benefit from improved pharmacokinetics, safety and tolerability. OBJECTIVES: Our aim was to assess the effectiveness of posaconazole new formulations for IM treatment. METHODS: We performed a case-matched analysis with proven or probable IM patients from the FungiScope® Registry. First-line posaconazole new formulations (1st-POSnew) and first-line amphotericin B plus posaconazole new formulations (1st-AMB+POSnew) cases were matched with first-line amphotericin B-based (1st-AMB) treatment controls. Salvage posaconazole new formulations (SAL-POSnew) cases were matched with salvage posaconazole oral suspension (SAL-POSsusp) controls. Each case was matched with up to three controls (based on severity, haematological/oncological malignancy, surgery and/or renal dysfunction). RESULTS: Five patients receiving 1st-POSnew, 18 receiving 1st-AMB+POSnew and 22 receiving SAL-POSnew were identified. By day 42, a favourable response was reported for 80.0% (n = 4/5) of patients receiving 1st-POSnew, for 27.8% (n = 5/18) receiving 1st-AMB+POSnew and for 50.0% (n = 11/22) receiving SAL-POSnew. Day 42 all-cause mortality of patients receiving posaconazole new formulations was lower compared with controls [20.0% (n = 1/5) in 1st-POSnew versus 53.3% (n = 8/15) in 1st-AMB; 33.3% (n = 6/18) in 1st-AMB+POSnew versus 52.0% (n = 26/50) in 1st-AMB; and 0.0% (n = 0/22) in SAL-POSnew versus 4.4% (n = 2/45) in SAL-POSsusp]. CONCLUSIONS: Posaconazole new formulations were effective in terms of treatment response and associated mortality of IM. While posaconazole new formulations may be an alternative for treatment of IM, the limited sample size of our study calls for a cautious interpretation of these observations.

Original languageEnglish
Pages (from-to)3315-3327
Number of pages13
JournalThe Journal of antimicrobial chemotherapy
Volume74
Issue number11
DOIs
Publication statusPublished - 1 Nov 2019

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Mucormycosis
Therapeutics
Suspensions
Amphotericin B
posaconazole
Salvage Therapy
Mortality
Hematologic Neoplasms

Cite this

@article{536020ff2bcf49f7ba2b22505690b2aa,
title = "Matched-paired analysis of patients treated for invasive mucormycosis: standard treatment versus posaconazole new formulations (MoveOn)",
abstract = "BACKGROUND: First-line antifungal treatment for invasive mucormycosis (IM) consists of liposomal amphotericin B. Salvage treatment options are limited and often based on posaconazole oral suspension. With the approval of posaconazole new formulations, patients could benefit from improved pharmacokinetics, safety and tolerability. OBJECTIVES: Our aim was to assess the effectiveness of posaconazole new formulations for IM treatment. METHODS: We performed a case-matched analysis with proven or probable IM patients from the FungiScope{\circledR} Registry. First-line posaconazole new formulations (1st-POSnew) and first-line amphotericin B plus posaconazole new formulations (1st-AMB+POSnew) cases were matched with first-line amphotericin B-based (1st-AMB) treatment controls. Salvage posaconazole new formulations (SAL-POSnew) cases were matched with salvage posaconazole oral suspension (SAL-POSsusp) controls. Each case was matched with up to three controls (based on severity, haematological/oncological malignancy, surgery and/or renal dysfunction). RESULTS: Five patients receiving 1st-POSnew, 18 receiving 1st-AMB+POSnew and 22 receiving SAL-POSnew were identified. By day 42, a favourable response was reported for 80.0{\%} (n = 4/5) of patients receiving 1st-POSnew, for 27.8{\%} (n = 5/18) receiving 1st-AMB+POSnew and for 50.0{\%} (n = 11/22) receiving SAL-POSnew. Day 42 all-cause mortality of patients receiving posaconazole new formulations was lower compared with controls [20.0{\%} (n = 1/5) in 1st-POSnew versus 53.3{\%} (n = 8/15) in 1st-AMB; 33.3{\%} (n = 6/18) in 1st-AMB+POSnew versus 52.0{\%} (n = 26/50) in 1st-AMB; and 0.0{\%} (n = 0/22) in SAL-POSnew versus 4.4{\%} (n = 2/45) in SAL-POSsusp]. CONCLUSIONS: Posaconazole new formulations were effective in terms of treatment response and associated mortality of IM. While posaconazole new formulations may be an alternative for treatment of IM, the limited sample size of our study calls for a cautious interpretation of these observations.",
author = "{FungiScope{\circledR} ECMM/ISHAM Working Group} and Jon Salmanton-Garc{\'i}a and Danila Seidel and Philipp Koehler and Mellinghoff, {Sibylle C.} and Raoul Herbrecht and Nikolai Klimko and Zdeněk R{\'a}čil and Iker Falces-Romero and Paul Ingram and Ben{\'i}tez-Pe{\~n}uela, {Miguel {\'A}ngel} and Rodr{\'i}guez, {Jos{\'e} Yesid} and Guillaume Desoubeaux and Aleksandra Barać and Carolina Garc{\'i}a-Vidal and Martin Hoenigl and Mehta, {Sanjay R.} and Cheng, {Matthew P.} and Galina Klyasova and Heinz, {Werner J.} and Nousheen Iqbal and Robert Krause and Helmut Ostermann and Olaf Penack and Enrico Schalk and Sheppard, {Donald C.} and Birgit Willinger and Hilmar Wisplinghoff and Vehreschild, {J. Janne} and Cornely, {Oliver A.} and Vehreschild, {Maria J.G.T.}",
year = "2019",
month = "11",
day = "1",
doi = "10.1093/jac/dkz344",
language = "English",
volume = "74",
pages = "3315--3327",
journal = "Journal of Antimicrobial Chemotherapy",
issn = "0305-7453",
publisher = "Oxford University Press",
number = "11",

}

Matched-paired analysis of patients treated for invasive mucormycosis : standard treatment versus posaconazole new formulations (MoveOn). / FungiScope® ECMM/ISHAM Working Group .

In: The Journal of antimicrobial chemotherapy, Vol. 74, No. 11, 01.11.2019, p. 3315-3327.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Matched-paired analysis of patients treated for invasive mucormycosis

T2 - standard treatment versus posaconazole new formulations (MoveOn)

AU - FungiScope® ECMM/ISHAM Working Group

AU - Salmanton-García, Jon

AU - Seidel, Danila

AU - Koehler, Philipp

AU - Mellinghoff, Sibylle C.

AU - Herbrecht, Raoul

AU - Klimko, Nikolai

AU - Ráčil, Zdeněk

AU - Falces-Romero, Iker

AU - Ingram, Paul

AU - Benítez-Peñuela, Miguel Ángel

AU - Rodríguez, José Yesid

AU - Desoubeaux, Guillaume

AU - Barać, Aleksandra

AU - García-Vidal, Carolina

AU - Hoenigl, Martin

AU - Mehta, Sanjay R.

AU - Cheng, Matthew P.

AU - Klyasova, Galina

AU - Heinz, Werner J.

AU - Iqbal, Nousheen

AU - Krause, Robert

AU - Ostermann, Helmut

AU - Penack, Olaf

AU - Schalk, Enrico

AU - Sheppard, Donald C.

AU - Willinger, Birgit

AU - Wisplinghoff, Hilmar

AU - Vehreschild, J. Janne

AU - Cornely, Oliver A.

AU - Vehreschild, Maria J.G.T.

PY - 2019/11/1

Y1 - 2019/11/1

N2 - BACKGROUND: First-line antifungal treatment for invasive mucormycosis (IM) consists of liposomal amphotericin B. Salvage treatment options are limited and often based on posaconazole oral suspension. With the approval of posaconazole new formulations, patients could benefit from improved pharmacokinetics, safety and tolerability. OBJECTIVES: Our aim was to assess the effectiveness of posaconazole new formulations for IM treatment. METHODS: We performed a case-matched analysis with proven or probable IM patients from the FungiScope® Registry. First-line posaconazole new formulations (1st-POSnew) and first-line amphotericin B plus posaconazole new formulations (1st-AMB+POSnew) cases were matched with first-line amphotericin B-based (1st-AMB) treatment controls. Salvage posaconazole new formulations (SAL-POSnew) cases were matched with salvage posaconazole oral suspension (SAL-POSsusp) controls. Each case was matched with up to three controls (based on severity, haematological/oncological malignancy, surgery and/or renal dysfunction). RESULTS: Five patients receiving 1st-POSnew, 18 receiving 1st-AMB+POSnew and 22 receiving SAL-POSnew were identified. By day 42, a favourable response was reported for 80.0% (n = 4/5) of patients receiving 1st-POSnew, for 27.8% (n = 5/18) receiving 1st-AMB+POSnew and for 50.0% (n = 11/22) receiving SAL-POSnew. Day 42 all-cause mortality of patients receiving posaconazole new formulations was lower compared with controls [20.0% (n = 1/5) in 1st-POSnew versus 53.3% (n = 8/15) in 1st-AMB; 33.3% (n = 6/18) in 1st-AMB+POSnew versus 52.0% (n = 26/50) in 1st-AMB; and 0.0% (n = 0/22) in SAL-POSnew versus 4.4% (n = 2/45) in SAL-POSsusp]. CONCLUSIONS: Posaconazole new formulations were effective in terms of treatment response and associated mortality of IM. While posaconazole new formulations may be an alternative for treatment of IM, the limited sample size of our study calls for a cautious interpretation of these observations.

AB - BACKGROUND: First-line antifungal treatment for invasive mucormycosis (IM) consists of liposomal amphotericin B. Salvage treatment options are limited and often based on posaconazole oral suspension. With the approval of posaconazole new formulations, patients could benefit from improved pharmacokinetics, safety and tolerability. OBJECTIVES: Our aim was to assess the effectiveness of posaconazole new formulations for IM treatment. METHODS: We performed a case-matched analysis with proven or probable IM patients from the FungiScope® Registry. First-line posaconazole new formulations (1st-POSnew) and first-line amphotericin B plus posaconazole new formulations (1st-AMB+POSnew) cases were matched with first-line amphotericin B-based (1st-AMB) treatment controls. Salvage posaconazole new formulations (SAL-POSnew) cases were matched with salvage posaconazole oral suspension (SAL-POSsusp) controls. Each case was matched with up to three controls (based on severity, haematological/oncological malignancy, surgery and/or renal dysfunction). RESULTS: Five patients receiving 1st-POSnew, 18 receiving 1st-AMB+POSnew and 22 receiving SAL-POSnew were identified. By day 42, a favourable response was reported for 80.0% (n = 4/5) of patients receiving 1st-POSnew, for 27.8% (n = 5/18) receiving 1st-AMB+POSnew and for 50.0% (n = 11/22) receiving SAL-POSnew. Day 42 all-cause mortality of patients receiving posaconazole new formulations was lower compared with controls [20.0% (n = 1/5) in 1st-POSnew versus 53.3% (n = 8/15) in 1st-AMB; 33.3% (n = 6/18) in 1st-AMB+POSnew versus 52.0% (n = 26/50) in 1st-AMB; and 0.0% (n = 0/22) in SAL-POSnew versus 4.4% (n = 2/45) in SAL-POSsusp]. CONCLUSIONS: Posaconazole new formulations were effective in terms of treatment response and associated mortality of IM. While posaconazole new formulations may be an alternative for treatment of IM, the limited sample size of our study calls for a cautious interpretation of these observations.

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U2 - 10.1093/jac/dkz344

DO - 10.1093/jac/dkz344

M3 - Article

VL - 74

SP - 3315

EP - 3327

JO - Journal of Antimicrobial Chemotherapy

JF - Journal of Antimicrobial Chemotherapy

SN - 0305-7453

IS - 11

ER -