title: A randomized comparison of caspofungin versus antifungal prophylaxis according to investigator policy in acute leukaemia patients undergoing induction chemotherapy (PROFIL-C study).
abstract: BACKGROUND
  Invasive fungal infections (IFIs) are considered a major problem among patients undergoing acute leukaemia (AL) induction treatment. PROphylaxis of Fungal invasive Infections in Leukaemia-Caspofungin (PROFIL-C) is a multicentre study aiming to assess the comparative yield of using caspofungin versus standard policy (SP) regimens and the overall impact of IFI in routine clinical care conditions.
  
  
  METHODS
  All AL patients receiving IFI prophylaxis according to local SP were prospectively included in the study by Northern Italy Leukaemia Group (NILG) centres. To allow the comparison of caspofungin versus SP regimens as prophylaxis strategies, caspofungin treatment was assigned via a centralized randomized procedure. The study was registered at http://www.clinicaltrial.gov (NCT00501098).
  
  
  RESULTS
  Over a 2 year period, 175 patients were included. The overall incidence of IFI was 32/175 (18.3%) [10/175 (5.7%) probable/proven and 22/175 (12.6%) possible], with no statistically significant differences between caspofungin-based versus SP-based regimens [overall: 15/93 (16.1%) versus 17/82 (20.7%), relative risk (RR) 0.78, 95% confidence interval (CI) 0.42-1.46; probable/proven: 7/93 (7.5%) versus 3/82 (3.7%), RR 2.06, 95% CI 0.55-7.7; possible: 8/93 (8.6%) versus 14/82 (17.1%), RR 0.5, 95% CI 0.22-1.14]. Only one IFI-related death was recorded (10%).
  
  
  CONCLUSIONS
  The incidence and mortality of IFI were lower than expected in this strictly sequential cohort representative of the routine care in the NILG network. The efficacy and safety of caspofungin were similar to other prophylactic regimens.
authors: Department of Haematology, Spedali Civili, Brescia, Italy. chiara.cattaneo@libero.it
authors: Chiara
authors: C
authors: Cattaneo
authors: Simona
authors: S
authors: Monte
authors: Alessandra
authors: A
authors: Algarotti
authors: Ernesta
authors: E
authors: Audisio
authors: Erika
authors: E
authors: Borlenghi
authors: Leonardo
authors: L
authors: Campiotti
authors: Elisa
authors: E
authors: Cerqui
authors: Caterina
authors: C
authors: Fanizza
authors: Rachele
authors: R
authors: Giuliani
authors: Caterina
authors: C
authors: Micò
authors: Roberta
authors: R
authors: Rocconi
authors: Anna
authors: A
authors: Salvi
authors: Flavia
authors: F
authors: Salvi
authors: Luisa
authors: L
authors: Verga
authors: Alessandro
authors: A
authors: Levis
authors: Giorgio
authors: G
authors: Lambertenghi Deliliers
authors: Enrico M
authors: EM
authors: Pogliani
authors: Gianni
authors: G
authors: Tognoni
authors: Alessandro
authors: A
authors: Rambaldi
authors: Giuseppe
authors: G
authors: Rossi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000077336:Caspofungin; D015331:Cohort Studies; D054714:Echinocandins / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007938:Leukemia / Q000150:complications* / Q000188:drug therapy*; D007951:Leukemia, Myeloid / Q000150:complications / Q000188:drug therapy; D055666:Lipopeptides; D008297:Male; D008875:Middle Aged; D054218:Precursor T-Cell Lymphoblastic Leukemia-Lymphoma / Q000150:complications / Q000188:drug therapy; D055732:Pulmonary Aspergillosis / Q000209:etiology / Q000517:prevention & control*; D018401:Sample Size; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D000970:Antineoplastic Agents; D054714:Echinocandins; D055666:Lipopeptides; D000077336:Caspofungin