Seifem

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Studies Completed

Isavuconazole in real life: preliminary data of an observational multicentric SEIFEM STUDY

  • Chiara Cattaneo
  • SC Ematologia e Dipartimento di Oncologia Clinica, A.O. Spedali Civili Brescia
  • 14 Mar, 2018

Introduction

AIM:  to evaluate the impact of isavuconazole on hematological and stem cell transplant (SCT) patients in real-life

PRIMARY OBJECTIVES:

  1. To evaluate the hematological setting of treated patients
  2. To evaluate the timing of isavuconazole treatment
  3. To evaluate the response and outcome of patients treated with isavuconazole
  4. To evaluate the safety of isavuconazole

PATIENTS AND METHODS

Since July 1st 2016, all hematologic and SCT patients with a diagnosis of possible, probable or proven invasive fungal infection (IFI) are recorded (minimum period: 18 months).

IFI were classified according to EORTC/MSG criteria (2008)

The variable considered for the analysis of data are:

  1. Age/sex
  2. Type and phase of hematological disease
  3. Type of IFI
  4. Timing of isavuconazole treatment
  5. Outcome
  6. Adverse events

RESULTS

Twenty-seven patients were enrolled (M/F ratio 19/8; median age 55.5y, range 20-77y). Patients were affected by acute myeloid leukemia (AML) (13), acute lymphoblastic leukemia (ALL) (4), lymphoma (Ly) (8), hairy cell leukemia (HCL) (1) and severe aplastic anemia (SAA) (1). Phase of hematological disease was clinical onset in 8 patients, complete (CR) or partial remission (PR) in 10 and relapsed or refractory disease in 9. Eight patients underwent SCT.

IFI were classified as possible in 10 patients, probable in 14 and proven in 3. Lung was the most frequent site of disease (23 cases); paranasal sinuses were involved in 2 cases, liver and brain were involved in 1 case each. Aspergillus spp was responsible for 13 IFI and Mucor spp in 1; in 3 cases microbiological identification was not possible.

Isavuconazole was used as first line treatment in 5 cases and in second or subsequent in 22. Median time of duration of 1st line treatment before isavuconazole was 17 days (range 5-58).

Intravenous and oral formulation of isavuconazole was used in 6 and 18 patients, respectively; three patients receiving intravenous formulation were switched to oral.

The overall response rate (ORR) was 63% (17/27). After a median follow up of 2.7 mo, 10 patients died (37%). Four out of 10 died of IFI (14.8%); 1 patient was in CR of hematological disease, 1 at clinical onset and 2 with relapsed/refractory disease.

Only 4 patients experienced adverse events and only 1 patient developed grade 3 hypokaliemia, nausea/vomiting and weight loss, leading to permanent discontinuation of isavuconazole.

PRELIMINARY CONCLUSIONS

Isavuconazole is used mainly as second line treatment in hematological and SCT patients. Preliminary data of outcome seem to confirm clinical efficacy and tolerability in the real life setting.

 

Completed Studies