Real-world experience with decitabine as a first-line treatment in 306 elderly acute myeloid leukaemia patients unfit for intensive chemotherapy

被引：22

作者：

Bocchia, Monica ^{[1
,2
]}

Candoni, Anna ^{[3
]}

Borlenghi, Erika ^{[4
]}

Defina, Marzia ^{[1
,2
]}

Fili, Carla ^{[3
]}

Cattaneo, Chiara ^{[4
]}

Sammartano, Vincenzo ^{[1
,2
]}

Fanin, Renato ^{[3
]}

Sciume, Margherita ^{[4
]}

Sicuranza, Anna ^{[1
,2
]}

Imbergamo, Silvia ^{[5
]}

Riva, Marta ^{[6
]}

Fracchiolla, Nicola ^{[7
]}

Latagliata, Roberto ^{[8
]}

Caizzi, Emanuela ^{[9
]}

Mazziotta, Francesco ^{[10
]}

Alunni, Giulia ^{[11
]}

Di Bona, Eros ^{[12
]}

Crugnola, Monica ^{[13
]}

Rossi, Marianna ^{[14
]}

Consoli, Ugo ^{[15
]}

Fontanelli, Giulia ^{[16
]}

Greco, Giuseppina ^{[17
]}

Nadali, Gianpaolo ^{[18
]}

Rotondo, Francesco ^{[19
]}

Todisco, Elisabetta ^{[20
]}

Bigazzi, Catia ^{[21
]}

Capochiani, Enrico ^{[22
]}

Molteni, Alfredo ^{[23
]}

Bernardi, Massimo ^{[24
]}

Fumagalli, Monica ^{[25
]}

Rondoni, Michela ^{[26
]}

Scappini, Barbara ^{[27
]}

Ermacora, Anna ^{[28
]}

Simonetti, Federico ^{[29
]}

Gottardi, Michele ^{[30
]}

Deliliers, Daniela Lambertenghi ^{[31
]}

Michieli, Mariagrazia ^{[14
]}

Basilico, Claudia ^{[32
]}

Galeone, Carlotta ^{[33
]}

Pelucchi, Claudio ^{[33
]}

Rossi, Giuseppe ^{[4
]}

机构：

[1] Azienda Osped Univ Senese, Unita Ematol, Viale Bracci, I-53100 Siena, Italy

[2] Univ Siena, Viale Bracci, I-53100 Siena, Italy

[3] Azienda Sanit Univ Integrata, Ctr Trapianti & Terapie Cellulari, Clin Ematol, Udine, Italy

[4] ASST Spedali Civili Brescia, UO Ematol, Brescia, Italy

[5] Azienda Osped Univ, Ematol Immunol Clin, Padua, Italy

[6] ASST Grande Osped Metropolitano Niguarda, Niguarda Canc Ctr, Dipartimento Ematol & Oncol, SC Ematol, Milan, Italy

[7] Fdn IRCCS Ca Granda Osped Maggiore Policlin, Milan, Italy

[8] Univ Sapienza, Dipartimento Biotecnol Cellulari & Ematol, Ematol, Rome, Italy

[9] Azienda Sanit Univ Integrata, Osped Maggiore, SC Ematol Clin, Trieste, Italy

[10] Univ Pisa, Sez Ematol, Dipartimento Oncol Trapianti & Nuove Tecnol, Pisa, Italy

[11] Univ Perugia, Dipartimento Med & Specialita Med, SC Oncoematol Autotrapianto, Perugia, Italy

[12] Osped S Bortolo, Unita Operat Ematol, Vicenza, Italy

[13] Azienda Osped Univ Parma, Div Ematol, Parma, Italy

[14] IRCCS Aviano, Ctr Riferimento Oncol, SOS Terapia Cellulare & Chemioterapia Alte Dosi, Aviano, Italy

[15] ARNAS Garibaldi, UOC Ematol, Catania, Italy

[16] Osped San Giuseppe, UOS Ematol, UOC Oncol, Empoli, Italy

[17] Osped Cardinale G Panico, Tricase, Italy

[18] Azienda Osped Univ Integrata, UOC Ematol, Verona, Italy

[19] Osped Infermi, Unita Ematol, Rimini, Italy

[20] IRCCS, IEO, Div Oncoematol, Milan, Italy

[21] Osped CeG Mazzoni, UOC Ematol & Terapia Cellulare, Ascoli Piceno, Italy

[22] Azienda Toscana Nord Ovest, UOC Ematol Aziendale, Livorno, Italy

[23] ASST Cremona, UOC Ematol, Cremona, Italy

[24] IRCCS Ist Sci Univ San Raffaele, UO Ematol & Trapianto Midollo Osseo, Milan, Italy

[25] Osped San Gerardo, ASST Monza, UO Ematol & CTA, Monza, Italy

[26] Azienda Unita Sanit Locale Romagna, UOC Ematol, Ravenna, Italy

[27] Osped Careggi, Dipartimento Ematol, Florence, Italy

[28] Azienda Osped S Maria Angeli, UOC Med Interna, Pordenone, Italy

[29] Azienda Toscana Nord Ovest, Osped Versilia, UOC Ematol Aziendale, Lucca, Italy

[30] Osped Ca Foncello, Azienda ULSS9, UOC Ematol, Treviso, Italy

[31] Presidio Osped San Paolo, ASST Santi Paolo & Carlo, Milan, Italy

[32] ASST Sette Laghi Osped Circolo, Varese, Italy

[33] Univ Milan, Dipartimento Sci Clin & Comunita, Milan, Italy

来源：

HEMATOLOGICAL ONCOLOGY | 2019年 / 37卷 / 04期

关键词：

acute myeloid leukaemia; decitabine; first-line therapy; unfit patients; OLDER PATIENTS; LIFE EXPERIENCE; PHASE-II; MULTICENTER; AZACITIDINE; ADULTS; TRIAL; RECOMMENDATIONS; MANAGEMENT; DIAGNOSIS;

D O I：

10.1002/hon.2663

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Despite widespread use of decitabine to treat acute myeloid leukaemia (AML), data on its effectiveness and safety in the real-world setting are scanty. Thus, to analyze the performance of decitabine in clinical practice, we pooled together patient-level data of three multicentric observational studies conducted since 2013 throughout Italy, including 306 elderly AML patients (median age 75 years), unfit for intensive chemotherapy, treated with first-line decitabine therapy at the registered schedule of 20 mg/m(2)/iv daily for 5 days every 4 weeks. Overall response rate (ORR), overall survival (OS) curves, and multivariate hazard ratios (HRs) of all-cause mortality were computed. Overall, 1940 cycles of therapy were administered (median, 5 cycles/patient). A total of 148 subjects were responders and, therefore, ORR was 48.4%. Seventy-one patients (23.2%) had complete remission, 32 (10.5%) had partial remission, and 45 (14.7%) had haematologic improvement. Median OS was 11.6 months for patients with favourable-intermediate cytogenetic risk and 7.9 months for those with adverse cytogenetic risk. Median relapse-free survival after CR was 10.9 months (95% confidence interval [CI]: 8.7-16.0). In multivariate analysis, mortality was higher in patients with adverse cytogenetic risk (HR=1.58; 95% CI: 1.13-2.21) and increased continuously with white blood cell (WBC) count (HR=1.12; 95% CI: 1.06-1.18). A total of 183 infectious adverse events occurred in 136 patients mainly (>90%) within the first five cycles of therapy. This pooled analysis of clinical care studies confirmed, outside of clinical trials, the effectiveness of decitabine as first-line therapy for AML in elderly patients unfit for intensive chemotherapy. An adverse cytogenetic profile and a higher WBC count at diagnosis were, in this real life setting, unfavourable predictors of survival.

引用

页码：447 / 455

页数：9

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