Increased remissions from one course for intermediate-dose cytosine arabinoside and idarubicin in elderly acute myeloid leukaemia when combined with cladribine. A randomized population-based phase II study
(2003) In British Journal of Haematology 123(5). p.810-818- Abstract
- Cladribine has single-drug activity in acute myeloid leukaemia (AML), and may enhance the formation of the active metabolite (ara-CTP) of cytosine arabinoside (ara-C). To evaluate the feasibility of adding intermittent cladribine to intermediate-dose ara-C (1 g/m(2)/2 h) b.i.d. for 4 d with idarubicin (CCI), we performed a 2:1 randomized phase II trial in AML patients aged over 60 years. Primary endpoints were time to recovery from cytopenia and need for supportive care following the first course. Sixty-three patients (median 71 years, range 60-84 years) were included, constituting 72% of all eligible patients. Toxicity was limited, with no differences between the treatment arms. The early toxic death rate was 11%. The median time to... (More)
- Cladribine has single-drug activity in acute myeloid leukaemia (AML), and may enhance the formation of the active metabolite (ara-CTP) of cytosine arabinoside (ara-C). To evaluate the feasibility of adding intermittent cladribine to intermediate-dose ara-C (1 g/m(2)/2 h) b.i.d. for 4 d with idarubicin (CCI), we performed a 2:1 randomized phase II trial in AML patients aged over 60 years. Primary endpoints were time to recovery from cytopenia and need for supportive care following the first course. Sixty-three patients (median 71 years, range 60-84 years) were included, constituting 72% of all eligible patients. Toxicity was limited, with no differences between the treatment arms. The early toxic death rate was 11%. The median time to recovery from neutropenia and thrombocytopenia was 22 and 17 d from the start of course no. 1, respectively, and the requirement for platelet and red cell transfusions was four and eight units respectively. Patients had a median of 8 d with fever over 38degreesC, and 17 d with intravenous antibiotic treatment. The overall complete remission (CR) rate was 62%, with 51% CR from one course of CCI in comparison with 35% for the two-drug therapy (P = 0.014). The median survival with a 2-year follow-up was 14 months, and the 2-year survival was over 30%, with no differences between the treatment arms. Considering the median age and our population-based approach, the overall results are encouraging. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/295469
- author
- Juliusson, Gunnar LU ; Hoglund, M ; Karlsson, K ; Lofgren, C ; Mollgard, L ; Paul, C ; Tidefelt, U and Bjorkholm, M
- organization
- publishing date
- 2003
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- survival, toxicity, cladribine, AML, elderly
- in
- British Journal of Haematology
- volume
- 123
- issue
- 5
- pages
- 810 - 818
- publisher
- Wiley-Blackwell
- external identifiers
-
- pmid:14632771
- wos:000186695700005
- scopus:0347480385
- ISSN
- 0007-1048
- DOI
- 10.1046/j.1365-2141.2003.04702.x
- language
- English
- LU publication?
- yes
- additional info
- The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Hematology/Transplantation (013022014)
- id
- 5483d236-c50f-424e-b2d9-b392aa880fd5 (old id 295469)
- date added to LUP
- 2016-04-01 12:33:44
- date last changed
- 2022-08-21 08:58:10
@article{5483d236-c50f-424e-b2d9-b392aa880fd5, abstract = {{Cladribine has single-drug activity in acute myeloid leukaemia (AML), and may enhance the formation of the active metabolite (ara-CTP) of cytosine arabinoside (ara-C). To evaluate the feasibility of adding intermittent cladribine to intermediate-dose ara-C (1 g/m(2)/2 h) b.i.d. for 4 d with idarubicin (CCI), we performed a 2:1 randomized phase II trial in AML patients aged over 60 years. Primary endpoints were time to recovery from cytopenia and need for supportive care following the first course. Sixty-three patients (median 71 years, range 60-84 years) were included, constituting 72% of all eligible patients. Toxicity was limited, with no differences between the treatment arms. The early toxic death rate was 11%. The median time to recovery from neutropenia and thrombocytopenia was 22 and 17 d from the start of course no. 1, respectively, and the requirement for platelet and red cell transfusions was four and eight units respectively. Patients had a median of 8 d with fever over 38degreesC, and 17 d with intravenous antibiotic treatment. The overall complete remission (CR) rate was 62%, with 51% CR from one course of CCI in comparison with 35% for the two-drug therapy (P = 0.014). The median survival with a 2-year follow-up was 14 months, and the 2-year survival was over 30%, with no differences between the treatment arms. Considering the median age and our population-based approach, the overall results are encouraging.}}, author = {{Juliusson, Gunnar and Hoglund, M and Karlsson, K and Lofgren, C and Mollgard, L and Paul, C and Tidefelt, U and Bjorkholm, M}}, issn = {{0007-1048}}, keywords = {{survival; toxicity; cladribine; AML; elderly}}, language = {{eng}}, number = {{5}}, pages = {{810--818}}, publisher = {{Wiley-Blackwell}}, series = {{British Journal of Haematology}}, title = {{Increased remissions from one course for intermediate-dose cytosine arabinoside and idarubicin in elderly acute myeloid leukaemia when combined with cladribine. A randomized population-based phase II study}}, url = {{http://dx.doi.org/10.1046/j.1365-2141.2003.04702.x}}, doi = {{10.1046/j.1365-2141.2003.04702.x}}, volume = {{123}}, year = {{2003}}, }