Document Detail

Cladribine (2-CDA) given as subcutaneous bolus injections is active in pretreated Waldenström's macroglobulinaemia. Swiss Group for Clinical Cancer Research (SAKK).
MedLine Citation:
PMID:  9375754     Owner:  NLM     Status:  MEDLINE    
Clinical trials with intravenous cladribine infusions in pretreated patients with Waldenström's macroglobulinaemia have shown a response rate of 40%. Our pharmacokinetic studies revealed that the bioavailability of subcutaneous cladribine is complete but that the concentration-time profile is very different from intravenous administration. We designed this phase II multi-institutional trial to study the activity and toxicity of cladribine given as s.c. bolus injections in patients with symptomatic Waldenström's macroglobulinaemia. Between May 1993 and October 1995, 25 patients were accrued: male/female 18/7, median age 65 years (range 44-85). All except one patient had been pretreated with more than one regimen (median 2, range 0-10). 18 patients had progressed under previous therapy and six were in relapse. All patients received cladribine for a total dose of 0.5 mg/kg per cycle as s.c. bolus injections divided over 5 d at > or = 4 week intervals, for a maximum of six cycles. All 25 patients were evaluable for toxicity and response. A total of 67 cycles were administered (median 3 cycles, range 1-6). Overall response rate including disease stabilization which had been progressive under previous therapy was 68%. 10 patients (40%, 95% CI 21-61%) achieved a partial remission. Seven responders had been progressive under previous therapy. Maximum responses were reached no later than the third cycle. Median time to treatment failure and remission duration were 4.4 (range 0.5-33) and 8 months (5-29), respectively. Four patients (16%) suffered from infections W.H.O. grade > or = 2 (pneumonia grade 2, Staphylococcus septicaemia grade 3, viral encephalitis and pneumonia, both grade 4 with complete resolution). No other severe adverse events were observed. Cladribine given as s.c. 5 d bolus injections was found to be active in pretreated Waldenström's macroglobulinaemia and resulted in durable remissions.
D C Betticher; S F Hsu Schmitz; D Ratschiller; A von Rohr; T Egger; P Pugin; M Stalder; U Hess; M F Fey; T Cerny
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study    
Journal Detail:
Title:  British journal of haematology     Volume:  99     ISSN:  0007-1048     ISO Abbreviation:  Br. J. Haematol.     Publication Date:  1997 Nov 
Date Detail:
Created Date:  1997-12-23     Completed Date:  1997-12-23     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0372544     Medline TA:  Br J Haematol     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  358-63     Citation Subset:  IM    
Institute of Medical Oncology, Inselspital, Berne, Switzerland.
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MeSH Terms
Aged, 80 and over
Cladribine / administration & dosage*,  adverse effects
Immunosuppressive Agents / therapeutic use*
Injections, Intradermal
Middle Aged
Neutropenia / chemically induced
Opportunistic Infections / complications
Thrombocytopenia / chemically induced
Treatment Outcome
Waldenstrom Macroglobulinemia / complications,  drug therapy*
Reg. No./Substance:
0/Immunosuppressive Agents; 4291-63-8/Cladribine

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