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Analysis of a cohort of 279 patients with hairy-cell leukemia (HCL): 10 years of follow-up.

ABSTRACT: In total, 279 patients with hairy-cell leukemia (HCL) were analyzed, with a median follow-up of 10 years. Data were collected up to June 2018. We analyzed responses to treatment, relapses, survival, and the occurrence of second malignancies during follow-up. The median age was 59 years. In total, 208 patients (75%) were treated with purine analogs (PNAs), either cladribine (159) or pentosatin (49), as the first-line therapy. After a median follow-up of 127 months, the median overall survival was 27 years, and the median relapse-free survival (RFS) was 11 years. The cumulative 10-year relapse incidence was 39%. In patients receiving second-line therapy, the median RFS was 7 years. For the second-line therapy, using the same or another PNA was equivalent. We identified 68?second malignancies in 59 patients: 49 solid cancers and 19 hematological malignancies. The 10-year cumulative incidences of cancers, solid tumors, and hematological malignancies were 15%, 11%, and 5.0%, respectively, and the standardized incidence ratios were 2.22, 1.81, and 6.67, respectively. In multivariate analysis, PNA was not a risk factor for second malignancies. HCL patients have a good long-term prognosis. PNAs are the first-line treatment. HCL patients require long-term follow-up because of their relatively increased risk of second malignancies.

SUBMITTER: Paillassa J

PROVIDER: S-EPMC7253459 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Analysis of a cohort of 279 patients with hairy-cell leukemia (HCL): 10 years of follow-up.

Paillassa Jerome J Cornet Edouard E Noel Stephanie S Tomowiak Cecile C Lepretre Stephane S Vaudaux Sandrine S Dupuis Jehan J Devidas Alain A Joly Bertrand B Petitdidier-Lionnet Charlotte C Haiat Stephanie S Mariette Clara C Thieblemont Catherine C Decaudin Didier D Validire-Charpy Patricia P Drenou Bernard B Eisenmann Jean-Claude JC Uribe Mario Ojeda MO Olivrie Agnès A Touati Mohamed M Lambotte Olivier O Hermine Olivier O Karsenti Jean-Michel JM Feugier Pierre P Vaillant Willy W Gutnecht Jean J Lippert Eric E Huysman Fabienne F Ghomari Kamel K Boubaya Marouane M Levy Vincent V Riou Jeremie J Damaj Gandhi G Tanguy-Schmidt Aline A Hunault-Berger Mathilde M Troussard Xavier X

Blood cancer journal 20200527 5

In total, 279 patients with hairy-cell leukemia (HCL) were analyzed, with a median follow-up of 10 years. Data were collected up to June 2018. We analyzed responses to treatment, relapses, survival, and the occurrence of second malignancies during follow-up. The median age was 59 years. In total, 208 patients (75%) were treated with purine analogs (PNAs), either cladribine (159) or pentosatin (49), as the first-line therapy. After a median follow-up of 127 months, the median overall survival was ...[more]

PMID: 32461544

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Project description:BackgroundMoxetumomab pasudotox is a recombinant CD22-targeting immunotoxin. Here, we present the long-term follow-up analysis of the pivotal, multicenter, open-label trial (NCT01829711) of moxetumomab pasudotox in patients with relapsed/refractory (R/R) hairy cell leukemia (HCL).MethodsEligible patients had received ≥ 2 prior systemic therapies, including ≥ 2 purine nucleoside analogs (PNAs), or ≥ 1 PNA followed by rituximab or a BRAF inhibitor. Patients received 40 µg/kg moxetumomab pasudotox intravenously on Days 1, 3, and 5 of each 28-day cycle for up to six cycles. Disease response and minimal residual disease (MRD) status were determined by blinded independent central review. The primary endpoint was durable complete response (CR), defined as achieving CR with hematologic remission (HR, blood counts for CR) lasting > 180 days.ResultsEighty adult patients were treated with moxetumomab pasudotox and 63% completed six cycles. Patients had received a median of three lines of prior systemic therapy; 49% were PNA-refractory, and 38% were unfit for PNA retreatment. At a median follow-up of 24.6 months, the durable CR rate (CR with HR > 180 days) was 36% (29 patients; 95% confidence interval: 26-48%); CR with HR ≥ 360 days was 33%, and overall CR was 41%. Twenty-seven complete responders (82%) were MRD-negative (34% of all patients). CR lasting ≥ 60 months was 61%, and the median progression-free survival without the loss of HR was 71.7 months. Hemolytic uremic and capillary leak syndromes were each reported in ≤ 10% of patients, and ≤ 5% had grade 3-4 events; these events were generally reversible. No treatment-related deaths were reported.ConclusionsMoxetumomab pasudotox resulted in a high rate of durable responses and MRD negativity in heavily pre-treated patients with HCL, with a manageable safety profile. Thus, it represents a new and viable treatment option for patients with R/R HCL, who currently lack adequate therapy.Trial registrationClinicalTrials.gov identifier: NCT01829711; first submitted: April 9, 2013. https://clinicaltrials.gov/ct2/show/NCT01829711.

Project description:OBJECTIVE:To evaluate the long term association between antidepressant prescribing and body weight. DESIGN:Population based cohort study. SETTING:General practices contributing to the UK Clinical Practice Research Datalink, 2004-14. PARTICIPANTS:136?762 men and 157?957 women with three or more records for body mass index (BMI). MAIN OUTCOME MEASURES:The main outcomes were antidepressant prescribing, incidence of ?5% increase in body weight, and transition to overweight or obesity. Adjusted rate ratios were estimated from a Poisson model adjusting for age, sex, depression recording, comorbidity, coprescribing of antiepileptics or antipsychotics, deprivation, smoking, and advice on diet. RESULTS:In the year of study entry, 17?803 (13.0%) men and 35?307 (22.4%) women with a mean age of 51.5 years (SD 16.6 years) were prescribed antidepressants. During 1?836?452 person years of follow-up, the incidence of new episodes of ?5 weight gain in participants not prescribed antidepressants was 8.1 per 100 person years and in participants prescribed antidepressants was 11.2 per 100 person years (adjusted rate ratio 1.21, 95% confidence interval 1.19 to 1.22, P<0.001). The risk of weight gain remained increased during at least six years of follow-up. In the second year of treatment the number of participants treated with antidepressants for one year for one additional episode of ?5% weight gain was 27 (95% confidence interval 25 to 29). In people who were initially of normal weight, the adjusted rate ratio for transition to overweight or obesity was 1.29 (1.25 to 1.34); in people who were initially overweight, the adjusted rate ratio for transition to obesity was 1.29 (1.25 to 1.33). Associations may not be causal, and residual confounding might contribute to overestimation of associations. CONCLUSION:Widespread utilisation of antidepressants may be contributing to long term increased risk of weight gain at population level. The potential for weight gain should be considered when antidepressant treatment is indicated.

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Analysis of a cohort of 279 patients with hairy-cell leukemia (HCL): 10 years of follow-up.

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Analysis of a cohort of 279 patients with hairy-cell leukemia (HCL): 10 years of follow-up.

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