Kooperativer Bibliotheksverbund

In: Hematological Oncology, Wiley, Vol. 38, No. 2 ( 2020-04), p. 189-196

Abstract: Pulmonary infections (PIs) are a major complication of patients with myelodysplastic syndromes (MDS). We retrospectively evaluated 234 MDS patients treated with azacytidine (AZA). The total number of AZA cycles was 2886 (median 8 cycles per patient). There were 111 episodes of PI (3.8% of AZA cycles) in 81 patients (34.6%). PIs were considered of fungal origin in 27 cases (24.3%), associated to bacteremia in 11 cases (9.9%), to influenza infection in two cases (1.8%) and of unknown origin in the remaining 71 cases (64.0%). Forty‐five PI episodes were documented in cycles 1 to 4 of AZA (5.1% of 875 cycles) and the remaining 66 episodes beyond the fourth cycle (3.2% of 2011 cycles) ( P = .017). Overall, a fungal PI was documented in 13/875 (1.5%) cycles 1 to 4 and in 13/2011 (0.6%) cycles beyond the fourth cycle ( P = .001). A baseline chronic pulmonary disease was significantly associated to a higher risk of severe PIs. In the survival analysis, cases of PI in patients who progressed to acute leukemia (PAL) were excluded, in view of the predominant influence of PAL on the outcome of the patients. A PI unrelated to PAL documented during the first 4 AZA cycles was an independent factor predicting lower survival (OR, 2.13; 95% CI, 1.37‐3.33; P = .001). In conclusion, PIs are common in MDS patients receiving AZA, in particular during the first cycles of treatment and are associated with an unfavorable outcome. The results of our study raise the issue of the need of a tailored infection prevention strategy.

Type of Medium: Online Resource

ISSN: 0278-0232 , 1099-1069

URL: Issue

URL: Article

DOI: 10.1002/hon.v38.2

DOI: 10.1002/hon.2710

Language: English

Publisher: Wiley

Publication Date: 2020

detail.hit.zdb_id: 2001443-0

In: Blood Cancer Journal, Springer Science and Business Media LLC, Vol. 12, No. 7 ( 2022-07-19)

Abstract: Hairy cell leukemia (HCL) is a rare lymphoproliferative disease with an excellent prognosis after treatment with cladribine (2CDA), although relapse may occur during follow-up. The aim of the study is to review the efficacy, safety, long-term remission rate, and overall survival (OS) in those patients who received 2CDA as first-line treatment. We retrospectively reviewed data of HCL patients treated with 2CDA between March 1991 and May 2019 at 18 Italian Hematological centers: 513 patients were evaluable for study purpose. The median age was 54 years (range 24–88) and ECOG was 0 in 84.9% of cases. A total of 330 (64.3%) patients received 2CDA intravenously and 183 (35.7%) subcutaneously. ORR was 91.8%: CR was obtained in 335 patients (65.3%), PR in 96 (18.7%), and hematological response in 40 (7.8%) patients; in 42 (8.2%) no response was observed. Hemoglobin value ( p  = 0.044), frequency of circulating hairy cells ( p  = 0.039), recovery of absolute neutrophil count ( p  = 0.006), and normalization of spleen ( p  ≤ 0.001) were associated with CR compared to PR in univariable analysis. At a median follow-up of 6.83 years (range 0.04–28.52), the median time to relapse was 12.2 years. A significant difference in duration of response was identified between patients that obtained a CR and PR (19.4 years versus 4.8 years, p   〈  0.0001). Non-hematological grade 3 or higher early toxicity was reported in 103 (20.1%) patients. Median OS was not reached: 95.3%, 92.4%, and 81.8% of patients were estimated to be alive at 5, 10, and 15 years, respectively. Forty-nine patients died (9.5%), following an infection in 14 cases (2.7%), natural causes in 14 (2.7%), cardiovascular events in 13 (2.5%), a second neoplasm in 6 (1.2%), and progression of HCL in 2 cases (0.4%). Following treatment of HCL with 2CDA, 80% of patients are estimated to be alive 15 years after diagnosis.

Type of Medium: Online Resource

ISSN: 2044-5385

URL: Article

DOI: 10.1038/s41408-022-00702-9

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2022

detail.hit.zdb_id: 2600560-8

In: Blood, American Society of Hematology, Vol. 136, No. Supplement 1 ( 2020-11-5), p. 32-33

Abstract: Hairy cell leukemia (HCL) is a rare lymphoproliferative disease with specific morphologic and molecular features and excellent prognosis. Although high rate of complete response (CR) has been reported after treatment with purine analogs, expecially cladribine (2CDA), relapse may occur during follow-up. The aim of the study is to review the efficacy, safety, long term remission rate and overall survival (OS) in those patients (pts) that received 2CDA as first line treatment. We retrospectively reviewed data of all HCL pts treated with 2CDA between March 1991 and May 2019 at 18 Italian Hematological centers. Among 553 pts reported, only 513 were evaluable because treated with 2CDA alone. Considering the clinical carachteristics, M/F ratio was 4.5 with a median age of 54 years (range 24-88) and ECOG 0 in 85% of cases. Splenomegaly and presence of circulating hairy cells recorded by morphology were reported in 241 (47%) and 138 (27%) pts, respectively. Thirty-seven (7%) pts presented with an infection. Other comorbidities were cardiovascular in 29 (6%) pts, a previous cancer or diabetes in 27 (5%) each, chronic hepatic disorders in 18 (3%), obstructive pulmonary disease in 16 (3%), chronic kidney disease in 3 (1%). Three hundred-thirty (64%) pts received 2CDA intravenously (253 as daily continuous infusion for 5-7 consecutive days and 77 as weekly infusion for 5-7 consecutive weeks) and 183 (36%) subcutaneously. Response criteria were defined as per recent consensus guidelines (Grever MR et al. Blood 2017). The overall response rate (ORR) was 83%: CR in 335 pts (65%) and partial response (PR) in 96 (19%); 40 (8%) pts obtained hematological improvement (HI) and in 42 (8%) no response was observed. Nine of 11 (82%) pts with HI and 18/25 (72%) non responders who received salvage therapy obtained a major response (fig. 1). A slightly higher hemoglobin value (12.4 vs 11.4 g/dl, p=0.044), a reduced frequency of circulating hairy cells (28.7% vs 31.8%, p=0.039), absence of palpable splenomegaly (p= & lt;0.001) and a faster recovery of ANC (28 days vs 41 days, p= 0.006) were associated with CR compared to PR in univariable analysis. No differences in terms of quality and duration of response, infection rate and time to blood counts recovery were reported according to the 2 routes of administration. Among pts receiving intravenous 2CDA, ORR was 85% for continuous infusion and 78% for weekly infusion: no statistically significant difference could be observed. Median duration of response was 12.2 years: 75.1%, 53.6% and 45.5% of responding pts are expected to be free from relapse at 5, 10 and 15 years, respectively. A statistically significant difference in duration of response was identified between pts that obtained a CR compared to pts in PR (19.4 years versus 4.7 years, p & lt;0.0001) (fig. 2). No other differences in relapse free survival (RFS) were identified. Non-hematological grade-3 or higher early toxicity was reported in 108 (21%) pts, due to infections in 102 cases (20%), mainly fever of unknown origin and pneumonia. In 6 cases infection due to invasive aspergillosis, bacteric pneumonia and bacteric sepsis caused the death of pts. Other non-hematological adverse events were almost all grade-1 allergy (47 pts, 9%). No late toxicity was reported, but 19 (4%) second cancers were observed. Among 118 pts relapsed after a median of 4.4 years (fig. 1), 85 (72%) were retreated with 2CDA, alone (65 cases) or associated with rituximab (20 cases); 11 (9%) with pentostatin, alone (7 cases) or associated with rituximab (4 cases), 8 (7%) with interferon α, 8 (7%) with rituximab alone, 1 (1%) with vemurafenib and zanubrutinib each; 2 were lost at follow-up and 2 died before retreatment. Overall, 58 (51%) retreated pts obtained a CR (42 after 2CDA), 37 (32%) a PR (32 after 2CDA), 7 (6%) a HI (4 after 2CDA) and 12 (11%) did not show any response (6 after 2CDA). Median OS was not reached; 95.7%, 92.8% and 82.3% of pts are expected to be alive at 5, 10 and 15 years, respectively (fig. 2). Overall 51 pts died (10%), during the induction phase in 6 cases and during follow-up in 45: overall, mortality was HCL-related in 14 patients (2 progression of disease and 12 infections) and HCL-unrelated in 37 patients (cardiovascular events in 16, natural causes in 15, a second cancer in 6). 2CDA is greatly effective in treating HCL, with an ORR of 83%. Early and long term adverse events were rare and easily managed: although HCL-related mortality is still possible, OS at 15 years is higher than 80% Disclosures Motta: Roche: Honoraria; Janssen: Honoraria. Offidani:Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; BMS: Consultancy, Honoraria. Tedeschi:Abbvie: Honoraria, Speakers Bureau; Sunesis: Honoraria, Speakers Bureau; Acerta: Honoraria, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; Beigene: Honoraria, Speakers Bureau. Trentin:Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Octapharma: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Shire: Honoraria. Varettoni:Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Other: Travel/accommodations/expenses; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel/accommodations/expenses. Visentin:Janssen: Honoraria; Gilead: Honoraria; Abbvie: Honoraria. Falini:Roche: Research Funding. Pulsoni:Sandoz: Consultancy; Pfizer: Consultancy; Takeda: Consultancy; Gilead: Speakers Bureau; Bristol Myers Squibb: Speakers Bureau; roche: Consultancy, Speakers Bureau; Merk: Consultancy. Tiacci:Roche: Research Funding; Abbvie: Other: Travel and meeting expenses. Zinzani:Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; ADC Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Kirin Kyowa: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen-Cilag: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Verastem: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Immune Design: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TG Therapeutics, Inc.: Honoraria, Speakers Bureau; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sandoz: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; MSD: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celltrion: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Eusapharma: Consultancy, Speakers Bureau; Kyowa Kirin: Consultancy, Speakers Bureau; Immune Design: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; EUSA Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood-2020-136633

Language: English

Publisher: American Society of Hematology

Publication Date: 2020

detail.hit.zdb_id: 1468538-3

detail.hit.zdb_id: 80069-7

In: British Journal of Haematology, Wiley, Vol. 198, No. 2 ( 2022-07)

Type of Medium: Online Resource

ISSN: 0007-1048 , 1365-2141

URL: Issue

URL: Article

DOI: 10.1111/bjh.v198.2

DOI: 10.1111/bjh.18224

Language: English

Publisher: Wiley

Publication Date: 2022

detail.hit.zdb_id: 1475751-5

In: Clinical Lymphoma Myeloma and Leukemia, Elsevier BV, Vol. 21, No. 4 ( 2021-04), p. e328-e333

Type of Medium: Online Resource

ISSN: 2152-2650

URL: Article

DOI: 10.1016/j.clml.2020.11.003

Language: English

Publisher: Elsevier BV

Publication Date: 2021

detail.hit.zdb_id: 2540998-0

detail.hit.zdb_id: 2193618-3

In: Oncology Research and Treatment, S. Karger AG, Vol. 42, No. 12 ( 2019), p. 660-664

Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 In elderly patients with chronic myeloid leukemia (CML) responsive to imatinib, the incidence of clinically significant (CS) late chronic anemia is still unknown. 〈 b 〉 〈 i 〉 Materials and Methods: 〈 /i 〉 〈 /b 〉 To highlight this issue, we revised retrospectively 81 CML patients aged & #x3e;60 years treated at our Institution with front-line imatinib for at least 24 months in durable complete cytogenetic response (CCyR). CS late chronic anemia was defined as the presence of persistent ( & #x3e;6 months) and otherwise unexplained Hb levels ≤10 g/dL, which occurred & #x3e;6 months from imatinib start. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 A condition of CS late chronic anemia occurred in 22 out of 81 patients (27.2%) at different intervals from imatinib start. Seven out of 22 patients (31.8%) needed packed red cell transfusions during the follow-up. At diagnosis, patients who developed CS late chronic anemia were significantly older and had a lower Hb median level. Six out of 22 patients with CS late chronic anemia received subcutaneous recombinant alpha-erythropoietin (EPO) at the standard dosage of 40,000 IU weekly: all 6 patients achieved an erythroid response. A significantly worse event-free survival (EFS) in patients with untreated CS late chronic anemia was observed ( 〈 i 〉 p 〈 /i 〉 = 0.012). 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 CS late chronic anemia during long-term treatment with imatinib is a common complication in responsive elderly patients, with worse EFS if untreated. Results with EPO are encouraging, but larger studies are warranted to define its role.

Type of Medium: Online Resource

ISSN: 2296-5270 , 2296-5262

URL: Article

DOI: 10.1159/000502801

Language: English

Publisher: S. Karger AG

Publication Date: 2019

detail.hit.zdb_id: 2749752-5

In: Leukemia & Lymphoma, Informa UK Limited, Vol. 61, No. 14 ( 2020-12-05), p. 3476-3483

Type of Medium: Online Resource

ISSN: 1042-8194 , 1029-2403

URL: Article

DOI: 10.1080/10428194.2020.1811861

Language: English

Publisher: Informa UK Limited

Publication Date: 2020

detail.hit.zdb_id: 2030637-4

In: Blood, American Society of Hematology, Vol. 132, No. Supplement 1 ( 2018-11-29), p. 5464-5464

Abstract: According to the World Health Organization (WHO) 2008/2016 criteria for classification of myeloid neoplasms, a platelet (PLT) count ≥ 450X109/l, thus reduced from the previous WHO 2001 level ≥ 600 x 109/l, was considered the new PLT threshold for the diagnosis of Essential Thrombocythemia (ET). Aim of the study was to validate in a setting of current clinical practice this important diagnostic change and compare clinical and hematological features at diagnosis and during follow-up of patients with PLT ≥600 x 109/l versus patients with PLT 〈 600 x 109/l. We retrospectively analyzed data from 264 patients with ET according to WHO 2008/2016 criteria, enrolled in our center from 1/2008 to 12/2017. Patients were divided into Group A (G-A) (PLT ≥600 x 109/l at diagnosis) (199 patients - 75.4%) and Group B (G-B) (PLT ≥ 450 x 109/l 〈 600 x 109/l at diagnosis) (65 patients - 24.6%) and compared for clinical features at the onset, clinical course and follow-up. Main features and commonly recognized pro-thrombotic risk factors at diagnosis of the entire cohort as well as of G-A and G-B are reported in the Table 1. Among clinical features, only the median value of leukocytes was significantly higher in G- A [9.1 x 109/l, interquartile range (IQR) 7.8-10.3 vs 7.4 x 109/l, IQR 6.0-9.6; p = 0.001]. Among pro-thrombotic risk factors, only the median cholesterol value was significantly lower in the G-A [187 mg/dl (IQR 164-220) vs 204 mg/dl (RIQ 177-238); p = 0.048] . Cytostatic treatment was administered in 175 patients (71.1%) of entire cohort at different intervals from diagnosis, with a significantly higher rate in patients of G-A (76.9% versus 49.2%, p 〈 0.001). After a median follow-up of 37.5 months (IQR 19.8 - 60.7), 13 thrombotic events (4.9%) were recorded in the entire cohort (7 episodes in the G-A and 6 episodes in the G-B), with a 5-year Cumulative Incidence of Thrombosis (CIT) significantly higher in the G-B [79.6% (95%CI 59.6 - 99.6) versus 95.4% (95%CI 91.8 - 99.0); p=0.047] (Figure 1). No patient evolved in myelofibrotic phase, 2 patients evolved in blastic phase (BP) after 42 and 58 months, respectively [1 patient (0.5%) in the G-A and 1 patient (1.3%) in the G-B; p=0.40). At the last follow-up, 4 patients (1.5%) died (1 from BP, 1 from cerebral hemorrhage, 2 from unavailable cause), 15 (5.7%) were lost to follow-up and 245 (92.8%) are still alive and currently followed at our Institute. The 5-year Overall Survival (OS) of the entire cohort was 96.2% (IC95% 92.2 - 100), without differences between the two groups [96.3% (95% CI 92.0 - 100) in the G-A versus 96.7% (IC95% 91.7 - 100) in the G-B; p=0.898] . Our data indicate a substantial homogeneity among ET patients regardless of the PLT number at diagnosis, thus confirming the usefulness of 2008/2016 WHO diagnostic criteria. Furthermore, the counterintuitive lower CIT observed in G-A, due to a larger use of cytostatic treatments and/or to an acquired Von Willebrand phenomenon when PLT levels 〉 1.000 x 109/l, highlights how thrombotic risk is unrelated to PLT value and leads to consider the administration of adequate cytostatic therapy even in patients with relatively lower PLT count at diagnosis. Disclosures Breccia: Novartis: Honoraria; Pfizer: Honoraria; Incyte: Honoraria; BMS: Honoraria. Foà:INCYTE: Other: ADVISORY BOARD; JANSSEN: Other: ADVISORY BOARD, Speakers Bureau; GILEAD: Speakers Bureau; CELTRION: Other: ADVISORY BOARD; ABBVIE: Other: ADVISORY BOARD, Speakers Bureau; CELGENE: Other: ADVISORY BOARD, Speakers Bureau; AMGEN: Other: ADVISORY BOARD; ROCHE: Other: ADVISORY BOARD, Speakers Bureau; NOVARTIS: Speakers Bureau.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood-2018-99-117905

Language: English

Publisher: American Society of Hematology

Publication Date: 2018

detail.hit.zdb_id: 1468538-3

detail.hit.zdb_id: 80069-7

In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 5544-5544

Abstract: Azacytidine (AZA) is a demethylating agent widely used in the treatment of patients with high-risk Myelodysplastic Syndromes (MDS). Pulmonary infections are often reported in these patients during AZA treatment, however, their incidence, etiology and impact in the overall outcome are still unclear. A major problem is represented by the low level of clinical and microbiological documentation, as most of patients treated with AZA are managed on an outpatient basis. This study aims to evaluate the incidence and clinical impact of pulmonary infections in MDS patients treated with AZA in 5 hematological Institutes in Rome, with a relatively homogeneous infective diagnostic work-up in the presence of fever or other infective clinical signs. We retrospectively evaluated 146 MDS patients [M/F 93/53, median age 69.5 years, interquartile range (IQR) 65.0 - 75.6] treated with AZA at our Institutions from 04/2009 to 01/2016. All patients received AZA cycles at standard dosage (75 mg/m2 for 7 days every 28 days) as outpatients. In the event of febrile neutropenia or other infectious episodes patients underwent blood cultures, culture from other sites, and chest x-ray or (preferably) pulmonary CT-scan. Galactomannan assay from serum and from sputum/bronchoalveolar lavage was performed as indicated. The total number of AZA cycles was 1712, with a median per patient of 9 cycles (IQR 5 - 17 cycles). There were 75 episodes of lung infection (4.1% of AZA cycles), with 58 patients (39.7%) presenting at least 1 episode. Based on the above diagnostic work-up, pulmonary infiltrates were considered of fungal origin in 21 cases (28.0%), associated to bacteremia in 5 cases (6.7%) and of unknown origin in the remaining 49 cases (65.3%). As to the time of occurrence of lung infections, 29 episodes were documented in the first 4 cycles of AZA treatment (5.4% of 535 cycles) and the remaining 46 episodes beyond the 4th cycle of AZA treatment (3.9% of 1177 cycles). Overall, a pulmonary fungal disease was documented in 10 of 535 (1.9%) cycles 1-4 and in 11 of 1177 (0.9%) cycles beyond the 4th (p=0.001). Several clinical features (age, gender, Hb level, WBC and PLT counts, time from diagnosis) were evaluated as predictive factors for the occurrence of pulmonary infection, but none was significant. Out of 58 patients who developed at least one pulmonary infection, 39 (67.2%) definitively discontinued the AZA treatment within 3 months from the infectious episode due to deterioration of clinical conditions, hematologic disease progression and/or death. Attributable mortality rate of patients with pulmonary infection was 22.4% (13 of 58). The median Overall Survival (OS) of the whole cohort was 18.0 months (95%CI 14.4 - 21.5): the median OS of patients with pulmonary infection was 15.6 months (95%CI 13.1 - 18.0) compared with 21.5 months (95%CI 16.3 - 26.6) of patients without pulmonary infection (p=0.031). In conclusion, pulmonary infections are a common complication in MDS patients receiving AZA treatment, and are often associated to an interruption of AZA therapy. Pulmonary fungal infections are more frequently observed early during the first cycles of treatment. It should be defined if the poor outcome of patients who develop pulmonary infections during AZA therapy is an epiphenomenon of an immunologic deterioration associated to the hematologic disease progression or is independently related to the complication. If confirmed in other experiences, the results of our study raise the issue of the need of an antibacterial and/or antifungal prophylaxis particularly during the first months of AZA therapy. Disclosures Latagliata: Novartis: Consultancy, Honoraria; Bristol Myers Squibb: Honoraria; Celgene: Honoraria; Janssen: Consultancy, Honoraria; Shire: Honoraria. Breccia:Celgene: Honoraria; Novartis: Consultancy, Honoraria; Ariad: Honoraria; Bristol Myers Squibb: Honoraria; Pfizer: Honoraria.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood.V128.22.5544.5544

Language: English

Publisher: American Society of Hematology

Publication Date: 2016

detail.hit.zdb_id: 1468538-3

detail.hit.zdb_id: 80069-7

In: Hematological Oncology, Wiley, Vol. 35, No. 2 ( 2017-06), p. 232-236

Abstract: Both Dasision and ENESTnd trials had many exclusion criteria, with a possible selection bias compared with the real‐life. To address the impact of this bias on the first‐line treatment in the current clinical practice, we revised 207 unselected newly diagnosed chronic phase chronic myeloid leukaemia (CML) patients [M/F 108/99, median age 58.8 years, interquartile range 42.3–70.2] treated with front‐line imatinib from June 2002 to June 2013 at our Institution, and evaluated how many of them would have been excluded from enrolment in the two trials. Twenty‐eight patients (13.5%) should have been excluded by both trials because of polycomorbidities (12), severe cardiomyopathy (five), age  〉  80 with frailty (three), drug abuse (two) or other severe concomitant diseases (six). In addition, eight patients should have been excluded by Dasision due to isolated chronic obstructive broncopulmonar disease, and 19 patients should have been excluded by ENESTnd due to isolated diabetes (10), arrhythmia (four), acute myocardial infarction  〉  6 months before CML diagnosis (two), chronic pancreatic disease (two) and peripheral arterial obstructive disease (one). On the whole, 36 patients (17.4%) would have been excluded by Dasision trial and 47 (22.7%) by ENESTnd trial. The patients potentially not eligible for both trials were significantly older and with imatinib had a worse outcome compared with patients potentially eligible. Our data highlight that an automatic transposition of results available in clinical controlled trials into the frontline real‐life management of CML patients should be regarded with caution. Copyright © 2015 John Wiley & Sons, Ltd.

Type of Medium: Online Resource

ISSN: 0278-0232 , 1099-1069

URL: Issue

URL: Article

DOI: 10.1002/hon.v35.2

DOI: 10.1002/hon.2274

Language: English

Publisher: Wiley

Publication Date: 2017

detail.hit.zdb_id: 2001443-0