Isavuconazole in Hematological Patients: Results of a Real-Life Multicentre Observational Seifem Study
Abstract. Invasive fungal diseases (IFDs) remain a major clinical issue in patients with hematological malignancies (HMs). To confirm the efficacy and safety of the new azole isavuconazole (ISV) in a clinical care setting, we planned a multicenter retrospective study; we collected data on all possib...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2019-12-01
|
| Series: | HemaSphere |
| Online Access: | http://journals.lww.com/10.1097/HS9.0000000000000320 |
| _version_ | 1797226014659575808 |
|---|---|
| author | Chiara Cattaneo Alessandro Busca Doriana Gramegna Francesca Farina Anna Candoni Monica Piedimonte Nicola Fracchiolla Chiara Pagani Maria Ilaria Del Principe Maria Chiara Tisi Massimo Offidani Rosa Fanci Stelvio Ballanti Angelica Spolzino Marianna Criscuolo Francesco Marchesi Gianpaolo Nadali Mario Delia Marco Picardi Margherita Sciumé Valentina Mancini Attilio Olivieri Mario Tumbarello Giuseppe Rossi Livio Pagano |
| author_facet | Chiara Cattaneo Alessandro Busca Doriana Gramegna Francesca Farina Anna Candoni Monica Piedimonte Nicola Fracchiolla Chiara Pagani Maria Ilaria Del Principe Maria Chiara Tisi Massimo Offidani Rosa Fanci Stelvio Ballanti Angelica Spolzino Marianna Criscuolo Francesco Marchesi Gianpaolo Nadali Mario Delia Marco Picardi Margherita Sciumé Valentina Mancini Attilio Olivieri Mario Tumbarello Giuseppe Rossi Livio Pagano |
| author_sort | Chiara Cattaneo |
| collection | DOAJ |
| description | Abstract. Invasive fungal diseases (IFDs) remain a major clinical issue in patients with hematological malignancies (HMs). To confirm the efficacy and safety of the new azole isavuconazole (ISV) in a clinical care setting, we planned a multicenter retrospective study; we collected data on all possible/probable/proven IFDs in patients with HMs treated with ISV in 17 centers. Between July 2016 and November 2018, 128 patients were enrolled, and 122 were fully evaluable. ISV was employed as the 1st line therapy in 43 (35%) patients and as a subsequent therapy in 79 (65%) patients. The response rate was 82/122 patients (67.2%); it was similar when using ISV as a 1st or 2nd line treatment (60.5% vs 70.9%, respectively; p = 0.24). In multivariate analysis, both female sex (OR: 2.992; CI: 1.22–7.34) and induction phase of treatment (OR: 3.953; CI: 1.085–14.403) were predictive of a favorable response. At a median follow-up of 5 months, 43 (35.2%) patients were dead; the 1-year overall survival (OS) was 49.9%. In multivariate analysis, the response to ISV (OR: 0.103; CI: 0.041–0.262) and IFD refractoriness to previous antifungals (OR: 3.413; CI: 1.318–8.838) were statistically significant for OS. Adverse events (AEs) were reported in 15/122 patients (12.3%); grade 3–4 AEs were reported in 5 (4%) and led to ISV discontinuation. Our study confirms the safety and tolerability of ISV, also in diseases other than acute leukemia. Phase of hematological disease, gender and refractoriness to previous antifungals are the main predictive factors for the aforementioned response and outcome. |
| first_indexed | 2024-03-11T15:06:39Z |
| format | Article |
| id | doaj.art-35bb639a5ce34c72adbe279c80120a22 |
| institution | Directory Open Access Journal |
| issn | 2572-9241 |
| language | English |
| last_indexed | 2024-04-24T14:18:10Z |
| publishDate | 2019-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | HemaSphere |
| spelling | doaj.art-35bb639a5ce34c72adbe279c80120a222024-04-03T08:04:36ZengWileyHemaSphere2572-92412019-12-0136e32010.1097/HS9.0000000000000320201912000-00013Isavuconazole in Hematological Patients: Results of a Real-Life Multicentre Observational Seifem StudyChiara CattaneoAlessandro BuscaDoriana GramegnaFrancesca FarinaAnna CandoniMonica PiedimonteNicola FracchiollaChiara PaganiMaria Ilaria Del PrincipeMaria Chiara TisiMassimo OffidaniRosa FanciStelvio BallantiAngelica SpolzinoMarianna CriscuoloFrancesco MarchesiGianpaolo NadaliMario DeliaMarco PicardiMargherita SciuméValentina ManciniAttilio OlivieriMario TumbarelloGiuseppe RossiLivio PaganoAbstract. Invasive fungal diseases (IFDs) remain a major clinical issue in patients with hematological malignancies (HMs). To confirm the efficacy and safety of the new azole isavuconazole (ISV) in a clinical care setting, we planned a multicenter retrospective study; we collected data on all possible/probable/proven IFDs in patients with HMs treated with ISV in 17 centers. Between July 2016 and November 2018, 128 patients were enrolled, and 122 were fully evaluable. ISV was employed as the 1st line therapy in 43 (35%) patients and as a subsequent therapy in 79 (65%) patients. The response rate was 82/122 patients (67.2%); it was similar when using ISV as a 1st or 2nd line treatment (60.5% vs 70.9%, respectively; p = 0.24). In multivariate analysis, both female sex (OR: 2.992; CI: 1.22–7.34) and induction phase of treatment (OR: 3.953; CI: 1.085–14.403) were predictive of a favorable response. At a median follow-up of 5 months, 43 (35.2%) patients were dead; the 1-year overall survival (OS) was 49.9%. In multivariate analysis, the response to ISV (OR: 0.103; CI: 0.041–0.262) and IFD refractoriness to previous antifungals (OR: 3.413; CI: 1.318–8.838) were statistically significant for OS. Adverse events (AEs) were reported in 15/122 patients (12.3%); grade 3–4 AEs were reported in 5 (4%) and led to ISV discontinuation. Our study confirms the safety and tolerability of ISV, also in diseases other than acute leukemia. Phase of hematological disease, gender and refractoriness to previous antifungals are the main predictive factors for the aforementioned response and outcome.http://journals.lww.com/10.1097/HS9.0000000000000320 |
| spellingShingle | Chiara Cattaneo Alessandro Busca Doriana Gramegna Francesca Farina Anna Candoni Monica Piedimonte Nicola Fracchiolla Chiara Pagani Maria Ilaria Del Principe Maria Chiara Tisi Massimo Offidani Rosa Fanci Stelvio Ballanti Angelica Spolzino Marianna Criscuolo Francesco Marchesi Gianpaolo Nadali Mario Delia Marco Picardi Margherita Sciumé Valentina Mancini Attilio Olivieri Mario Tumbarello Giuseppe Rossi Livio Pagano Isavuconazole in Hematological Patients: Results of a Real-Life Multicentre Observational Seifem Study HemaSphere |
| title | Isavuconazole in Hematological Patients: Results of a Real-Life Multicentre Observational Seifem Study |
| title_full | Isavuconazole in Hematological Patients: Results of a Real-Life Multicentre Observational Seifem Study |
| title_fullStr | Isavuconazole in Hematological Patients: Results of a Real-Life Multicentre Observational Seifem Study |
| title_full_unstemmed | Isavuconazole in Hematological Patients: Results of a Real-Life Multicentre Observational Seifem Study |
| title_short | Isavuconazole in Hematological Patients: Results of a Real-Life Multicentre Observational Seifem Study |
| title_sort | isavuconazole in hematological patients results of a real life multicentre observational seifem study |
| url | http://journals.lww.com/10.1097/HS9.0000000000000320 |
| work_keys_str_mv | AT chiaracattaneo isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT alessandrobusca isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT dorianagramegna isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT francescafarina isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT annacandoni isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT monicapiedimonte isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT nicolafracchiolla isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT chiarapagani isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT mariailariadelprincipe isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT mariachiaratisi isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT massimooffidani isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT rosafanci isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT stelvioballanti isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT angelicaspolzino isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT mariannacriscuolo isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT francescomarchesi isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT gianpaolonadali isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT mariodelia isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT marcopicardi isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT margheritasciume isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT valentinamancini isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT attilioolivieri isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT mariotumbarello isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT giusepperossi isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy AT liviopagano isavuconazoleinhematologicalpatientsresultsofareallifemulticentreobservationalseifemstudy |