PMID- 18162375
OWN - NLM
STAT- MEDLINE
DCOM- 20080620
LR  - 20131121
IS  - 0924-8579 (Print)
IS  - 0924-8579 (Linking)
VI  - 31
IP  - 2
DP  - 2008 Feb
TI  - Safety of a weekly high dose of liposomal amphotericin B for prophylaxis of 
      invasive fungal infection in immunocompromised patients: PROPHYSOME Study.
PG  - 135-41
AB  - With its broad spectrum of activity and better tolerability profile than 
      conventional amphotericin B, liposomal amphotericin B (L-AmB) may be the drug of 
      choice for antifungal prophylaxis in haematological patients. An open-label, 
      multicentre, prospective, pilot study was conducted in adult patients receiving 
      chemotherapy for acute leukaemia (AL) or myeloablative allogeneic stem cell 
      transplantation (SCT). Patients received weekly 10mg/kg infusions of L-AmB for 4 
      weeks for AL and 8 weeks for SCT. The primary objective was safety, with 
      particular attention to infusion-related reactions and nephrotoxicity. 
      Twenty-nine adult patients were included: 21 AL (median age 52 years) and 8 SCT 
      (median age 37 years). The most frequent adverse events (AEs) related to study 
      drug were infusion-related reactions, 12 of which (from a total of 76 infusions) 
      led to increased infusion duration for better tolerance. No AE related to the 
      study drug led to discontinuation of prophylactic treatment in AL patients. In 
      SCT patients, eight AEs (in six patients) reported to be related to study 
      treatment led to treatment discontinuation. Enrolment was discontinued in the SCT 
      group as recommended by the independent data review committee in accordance with 
      the 10% limit of AEs (CTC grade 3-4) fixed by the protocol. The appropriate 
      timing of high-dose prophylactic L-AmB remains to be determined in the SCT 
      setting to optimise the safety profile of this regimen. For AL, a 10mg/kg weekly 
      dose appears to be well tolerated during chemotherapy and may represent an 
      important tool towards improving AL patient outcome.
FAU - Cordonnier, Catherine
AU  - Cordonnier C
AD  - Hopital Henri Mondor, Creteil, France. carlcord@club-internet.fr
FAU - Mohty, Mohamad
AU  - Mohty M
FAU - Faucher, Catherine
AU  - Faucher C
FAU - Pautas, Cecile
AU  - Pautas C
FAU - Robin, Marie
AU  - Robin M
FAU - Vey, Norbert
AU  - Vey N
FAU - Monchecourt, Francoise
AU  - Monchecourt F
FAU - Mahi, Lamine
AU  - Mahi L
FAU - Ribaud, Patricia
AU  - Ribaud P
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20071226
PL  - Netherlands
TA  - Int J Antimicrob Agents
JT  - International journal of antimicrobial agents
JID - 9111860
RN  - 0 (Antifungal Agents)
RN  - 0 (liposomal amphotericin B)
RN  - 7XU7A7DROE (Amphotericin B)
SB  - IM
MH  - Adult
MH  - Amphotericin B/*administration & dosage/adverse effects
MH  - Antifungal Agents/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Fungemia/etiology/*prevention & control
MH  - Hematologic Neoplasms/complications/therapy
MH  - Humans
MH  - Immunocompromised Host
MH  - Leukemia, Myeloid, Acute/complications/drug therapy/*immunology/mortality
MH  - Male
MH  - Middle Aged
MH  - Myelodysplastic Syndromes/complications/drug therapy/*immunology/mortality
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Safety
EDAT- 2007/12/29 09:00
MHDA- 2008/06/21 09:00
CRDT- 2007/12/29 09:00
PHST- 2007/06/11 00:00 [received]
PHST- 2007/09/25 00:00 [revised]
PHST- 2007/10/01 00:00 [accepted]
PHST- 2007/12/29 09:00 [pubmed]
PHST- 2008/06/21 09:00 [medline]
PHST- 2007/12/29 09:00 [entrez]
AID - S0924-8579(07)00498-0 [pii]
AID - 10.1016/j.ijantimicag.2007.10.001 [doi]
PST - ppublish
SO  - Int J Antimicrob Agents. 2008 Feb;31(2):135-41. doi: 
      10.1016/j.ijantimicag.2007.10.001. Epub 2007 Dec 26.