Randomized trial of daily<i>versus</i>weekly administration of 2-chlorodeoxyadenosine in patients with hairy cell leukemia: a multicenter phase III trial (SAKK 32/98)

Zenhäusern, Reinhard; Schmitz, Shu Fang Hsu; Solenthaler, Max; Heim, Dominik; Meyer-Monard, Sandrine; Hess, U.; Leoncini, Leda; Bargetzi, Mario; Rufener, B.; Tobler, Andreas

doi:10.1080/10428190903131755

Cited by 36 publications

(19 citation statements)

References 21 publications

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“…The initial response rate with the first course of cladribine was 97.3%, and the majority of responses were complete responses (80.7%). The results reported confirm previous observations that cladribine administered to patients with HCL induces high response rates [9,[15][16][17][18][19][20][21][22]. In 1998, Saven et al [17] obtained a CR in 91% of their patients and a PR in 7% in the first treatment with cladribine, and reported relapse in 26% of them in a median time of 29 months, a CR in 62% and a PR of 26% in their second use of cladribine, in their study evaluating the results in 358 HCL patients treated with cladribine.…”

Section: Discussionsupporting

confidence: 90%

Multicenter retrospective analysis regarding the clinical manifestations and treatment results in patients with hairy cell leukemia: twenty‐four year Turkish experience in cladribine therapy

Hacioglu

Bilen

Eser

et al. 2014

Hematological Oncology

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In this multicenter retrospective analysis, we aimed to present clinical, laboratory and treatment results of 94 patients with Hairy cell leukemia diagnosed in 13 centers between 1990 and 2014. Sixty-six of the patients were males and 28 were females, with a median age of 55. Splenomegaly was present in 93.5% of cases at diagnosis. The laboratory findings that came into prominence were pancytopenia with grade 3 bone marrow fibrosis. Most of the patients with an indication for treatment were treated with cladribine as first-line treatment. Total and complete response of cladribine was 97.3% and 80.7%. The relapse rate after cladribine was 16.6%, and treatment related mortality was 2.5%. Most preferred therapy (95%) was again cladribine at second-line, and third line with CR rate of 68.4% and 66.6%, respectively. The 28-month median OS was 91.7% in all patients and 25-month median OS 96% for patients who were given cladribine as first-line therapy. In conclusion, the first multicenter retrospective Turkish study where patients with HCL were followed up for a long period has revealed demographic characteristics of patients with HCL, and confirmed that cladribine treatment might be safe and effective in a relatively large series of the Turkish study population.

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Section: Discussionsupporting

confidence: 90%

Multicenter retrospective analysis regarding the clinical manifestations and treatment results in patients with hairy cell leukemia: twenty‐four year Turkish experience in cladribine therapy

Hacioglu

Bilen

Eser

et al. 2014

Hematological Oncology

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“…Selected publications are summarized in Table 2. 25, 26, 32, 33, 34, 35, 36, 37, 38 A single course of therapy corresponding to a duration of 5–7 days is already able to achieve complete remissions with durable responses: ORR of 87–100% 14, 39, 40 and CRR of 85-91% 39, 40 have been reported. The 5-year progression-free survival (PFS) rates vary between 72–84% and the OS at 12 years vary between 75–87%.…”

Section: Treatment Options Results and New Insightsmentioning

confidence: 99%

Hairy cell leukemia: short review, today’s recommendations and outlook

Maevis¹,

Mey

Schmidt-Wolf³

et al. 2014

Blood Cancer Journal

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Hairy cell leukemia (HCL) is part of the low-grade non-Hodgkin lymphoma family and represents approximately 2% of all leukemias. Treatment with splenectomy and interferon-α historically belonged to the first steps of therapeutic options, achieving partial responses/remissions (PR) in most cases with a median survival between 4 and 6 years in the 1980s. The introduction of the purine analogs (PA) pentostatin and cladribine made HCL a well-treatable disease: overall complete response rates (CRR) range from 76 to 98%, with a median disease-free survival (DFS) of 16 years a normal lifespan can be reached and HCL-related deaths are rare. However, insufficient response to PA with poorer prognosis and relapse rates of 30–40% after 5–10 years of follow-up may require alternative strategies. Minimal residual disease can be detected by additional examinations of bone marrow specimens after treatment with PA. The use of immunotherapeutic monoclonal antibodies (mAB) like rituximab as a single agent or in combination with a PA or more recently clinical trials with recombinant immunotoxins (RIT) show promising results to restrict these problems. Recently, the identification of the possible disease-defining BRAF V600E mutation may allow the development of new therapeutic targets.

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“…A second prospective randomized trial compared cladribine, 0.14 mg/kg, for 5 daily doses with 5 weekly doses. 23 In this Swiss study of 100 patients, no significant differences were found in rates of grade 3 to 4 neutropenia (90% vs 80%), infection, or hospitalization within 10 weeks from treatment. The overall best response rate was 86% in both groups.…”

Section: Alternative Methods Of Administrationmentioning

confidence: 98%

My Treatment Approach to Hairy Cell Leukemia

Naik

Saven

2012

Mayo Clinic Proceedings

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Hairy cell leukemia (HCL) is a rare chronic lymphoproliferative disorder characterized by circulating B cells with cytoplasmic projections, pancytopenia, splenomegaly, and a typical flow cytometry pattern. Recently, the BRAF V600E mutation was uniformly identified in one HCL series, which may provide insights into the pathogenic mechanisms. The disease course is usually indolent but inexorably progressive. Patients require treatment when they have significant cytopenia or occasionally recurrent infections from immunocompromise. In the mid-1980s, interferon replaced splenectomy as the initial treatment. A few years later, 2 purine nucleoside analogs, cladribine and pentostatin, showed promising activity in HCL. Complete response rates approached 95% with cladribine given as a single 7-day intravenous infusion. Newer methods of cladribine administration and modified dosing schedules have since been studied. Pentostatin response rates are comparable. We generally prefer cladribine because of its ease of administration, single infusion schema, and favorable toxicity profile. Since the introduction of these drugs, which have never been randomly compared, long-term follow-up studies have confirmed impressive and durable response durations. However, roughly 40% of patients with HCL eventually relapse. In this setting, patients can be re-treated with purine analogs. Rituximab also has a reasonable response rate in relapsed HCL; it can be given as a single agent sequentially after purine nucleosides or concurrently. Immunotoxins have robust responses but remain in development. Targeting the BRAF pathway will be an exciting future area of research. Many patients have minimal residual disease after initial treatment, but the clinical significance of this remains unknown. H airy cell leukemia (HCL) is a rare adult B-cell lymphoid leukemia characterized by pancytopenia, splenomegaly, and absolute monocytopenia. Morphologically, HCL is characterized by circumferential cytoplasmic projections (Figure 1). Bone marrow biopsy will reveal hypercellularity in most cases, with hairy cells having nuclei widely separated by abundant cytoplasm, giving a "fried-egg" appearance ( Figure 2). Classically, tartrate-resistant acid phosphatase activity confirmed the diagnosis of HCL.1 However, immunophenotyping by flow cytometry is now considered standard practice. Hairy cell leukemia is characterized by the B-cell antigens CD19, CD20, and CD22. In addition, they coexpress the surface antigens CD11c, CD25, and CD103. Hairy cells generally lack CD5, CD10, CD21, and CD23. Immunohistochemical stains for DBA44 and annexin A1 can also help confirm the diagnosis. PATHOGENESISFor decades, the cellular event leading to HCL has evaded scientists and clinical researchers. Recently, 47 patients with HCL in Italy had wholeexome gene sequencing performed on leukemic cells and matched nonleukemic cells. 2 In every patient, the well-known BRAF V600E mutation was identified. This mutation, more commonly known for its presence in melanoma, was a surpr...

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Randomized trial of dailyversusweekly administration of 2-chlorodeoxyadenosine in patients with hairy cell leukemia: a multicenter phase III trial (SAKK 32/98)

Cited by 36 publications

References 21 publications

Multicenter retrospective analysis regarding the clinical manifestations and treatment results in patients with hairy cell leukemia: twenty‐four year Turkish experience in cladribine therapy

Multicenter retrospective analysis regarding the clinical manifestations and treatment results in patients with hairy cell leukemia: twenty‐four year Turkish experience in cladribine therapy

Hairy cell leukemia: short review, today’s recommendations and outlook

My Treatment Approach to Hairy Cell Leukemia

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