Document Detail

Treatment of hairy cell leukemia with cladribine (2-chlorodeoxyadenosine) by subcutaneous bolus injection: a phase II study.
MedLine Citation:
PMID:  12377655     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: To assess the activity and toxicity of 2-chlorodeoxyadenosine (cladribine, CDA) given by subcutaneous bolus injections to patients with hairy cell leukemia (HCL). PATIENTS AND METHODS: Sixty-two eligible patients with classic or prolymphocytic HCL (33 non-pretreated patients, 15 patients with relapse after previous treatment, and 14 patients with progressive disease during a treatment other than CDA) were treated with CDA 0.14 mg/kg/day by subcutaneous bolus injections for five consecutive days. Response status was repeatedly assessed according to the Consensus Resolution criteria. RESULTS: Complete and partial remissions were seen in 47 (76%) and 13 (21%) patients, respectively, for a response rate of 97%. All responses were achieved with a single treatment course. Most responses occurred early (i.e. within 10 weeks) after start of CDA therapy, but response quality improved during weeks and even months after treatment completion. The median time to treatment failure for all patients was 38 months. Leukopenia was the main toxicity. Granulocyte nadir (median 0.2 x 10(9)/l) was strongly associated with the incidence of infections (P = 0.0013). Non-specific lymphopenia occurred early after CDA treatment, and normal lymphocytes recovered slowly over several months. No significant associations were found between infections and nadir count of lymphocytes or any lymphocyte subpopulation. No opportunistic infections were observed. CONCLUSIONS: One course of CDA given by subcutaneous bolus injections is very effective in HCL. The subcutaneous administration is more convenient for patients and care providers, and has a similar toxicity profile to continuous intravenous infusion. The subcutaneous administration of CDA is a substantial improvement and should be offered to every patient with HCL requiring treatment with CDA.
A von Rohr; S-F H Schmitz; A Tichelli; U Hess; D Piguet; M Wernli; N Frickhofen; G Konwalinka; G Zulian; M Ghielmini; B Rufener; C Racine; M F Fey; T Cerny; D Betticher; A Tobler;
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of oncology : official journal of the European Society for Medical Oncology / ESMO     Volume:  13     ISSN:  0923-7534     ISO Abbreviation:  Ann. Oncol.     Publication Date:  2002 Oct 
Date Detail:
Created Date:  2002-10-14     Completed Date:  2003-04-18     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9007735     Medline TA:  Ann Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  1641-9     Citation Subset:  IM    
Institute of Medical Oncology, Inselspital, Bern.
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MeSH Terms
Antineoplastic Agents / administration & dosage,  adverse effects,  pharmacology*
Cladribine / administration & dosage,  adverse effects,  pharmacology*
Disease Progression
Injections, Subcutaneous
Leukemia, Hairy Cell / drug therapy*,  pathology
Leukopenia / chemically induced
Middle Aged
Reg. No./Substance:
0/Antineoplastic Agents; 4291-63-8/Cladribine

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