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Safety and effectiveness of clofarabine in Japanese patients with relapsed/refractory acute lymphoblastic leukaemia: a post-marketing surveillance study
Clofarabine is used to treat acute lymphoblastic leukaemia, but evidence of its safety and effectiveness in Japanese patients is limited. We evaluated the safety and effectiveness of clofarabine in patients with relapsed/refractory acute lymphoblastic leukaemia in real-world clinical practice in Jap...
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| Published in: | Japanese journal of clinical oncology 2024-07, Vol.54 (7), p.778-786 |
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| container_issue | 7 |
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| container_title | Japanese journal of clinical oncology |
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| creator | Kazama, Hirotaka Nishina, Satoshi Seto, Takeshi |
| description | Clofarabine is used to treat acute lymphoblastic leukaemia, but evidence of its safety and effectiveness in Japanese patients is limited. We evaluated the safety and effectiveness of clofarabine in patients with relapsed/refractory acute lymphoblastic leukaemia in real-world clinical practice in Japan.
An observational, multicenter, post-marketing, all-case surveillance was conducted for safety. Effectiveness analyses were conducted in patients aged ≤21 years and those treated with clofarabine monotherapy and combination therapy (clofarabine plus etoposide and cyclophosphamide).
In the all-case survey, 260 of 264 registered patients were eligible for safety analysis. Among the 225 patients eligible for effectiveness analysis, 139 were aged ≤21 years. For monotherapy and combination therapy, 20/31 and 34/88 patients were eligible, respectively. In the all-case survey, the median age was 16.0 years, and 47.7% of patients were |
| doi_str_mv | 10.1093/jjco/hyae047 |
| format | article |
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An observational, multicenter, post-marketing, all-case surveillance was conducted for safety. Effectiveness analyses were conducted in patients aged ≤21 years and those treated with clofarabine monotherapy and combination therapy (clofarabine plus etoposide and cyclophosphamide).
In the all-case survey, 260 of 264 registered patients were eligible for safety analysis. Among the 225 patients eligible for effectiveness analysis, 139 were aged ≤21 years. For monotherapy and combination therapy, 20/31 and 34/88 patients were eligible, respectively. In the all-case survey, the median age was 16.0 years, and 47.7% of patients were <15 years old. Adverse drug reaction incidence was 83.5% and the most common were hematologic toxicities. The best overall response rates in the population aged ≤21 years were complete remission, 29.7%; complete remission without platelet recovery, 7.3% and partial remission, 10.9%. The rest (52.2%) were classified as ineffective. The sum of complete remission, complete remission without platelet recovery and partial remission rates (effectiveness rate) was 47.8% (66/138 patients). The effectiveness rates in the monotherapy and combination therapy surveys were 10.0% (2/20 patients) and 58.8% (20/34 patients), respectively.
These post-marketing surveys provide real-world evidence of the safety and effectiveness of clofarabine regimens, including monotherapy and combination therapy in Japanese patients with relapsed/refractory acute lymphoblastic leukaemia. The safety and effectiveness profiles were comparable with those of previous prospective studies.</description><identifier>ISSN: 1465-3621</identifier><identifier>ISSN: 0368-2811</identifier><identifier>EISSN: 1465-3621</identifier><identifier>DOI: 10.1093/jjco/hyae047</identifier><identifier>PMID: 38643356</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Arabinonucleosides - administration & dosage ; Arabinonucleosides - adverse effects ; Arabinonucleosides - therapeutic use ; Child ; Child, Preschool ; Clofarabine - administration & dosage ; Clofarabine - therapeutic use ; Cyclophosphamide - administration & dosage ; Cyclophosphamide - adverse effects ; Cyclophosphamide - therapeutic use ; East Asian People ; Etoposide - administration & dosage ; Etoposide - adverse effects ; Female ; Humans ; Japan ; Male ; Middle Aged ; Neoplasm Recurrence, Local - drug therapy ; Original ; Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy ; Product Surveillance, Postmarketing ; Treatment Outcome ; Young Adult</subject><ispartof>Japanese journal of clinical oncology, 2024-07, Vol.54 (7), p.778-786</ispartof><rights>The Author(s) 2024. Published by Oxford University Press.</rights><rights>The Author(s) 2024. Published by Oxford University Press. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c272t-29d6a551fe0a0bb4c4d565ea8cbec9a71e5207f113fd876169031ebc106905e43</cites><orcidid>0009-0007-8340-5773</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,777,781,882,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38643356$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kazama, Hirotaka</creatorcontrib><creatorcontrib>Nishina, Satoshi</creatorcontrib><creatorcontrib>Seto, Takeshi</creatorcontrib><title>Safety and effectiveness of clofarabine in Japanese patients with relapsed/refractory acute lymphoblastic leukaemia: a post-marketing surveillance study</title><title>Japanese journal of clinical oncology</title><addtitle>Jpn J Clin Oncol</addtitle><description>Clofarabine is used to treat acute lymphoblastic leukaemia, but evidence of its safety and effectiveness in Japanese patients is limited. We evaluated the safety and effectiveness of clofarabine in patients with relapsed/refractory acute lymphoblastic leukaemia in real-world clinical practice in Japan.
An observational, multicenter, post-marketing, all-case surveillance was conducted for safety. Effectiveness analyses were conducted in patients aged ≤21 years and those treated with clofarabine monotherapy and combination therapy (clofarabine plus etoposide and cyclophosphamide).
In the all-case survey, 260 of 264 registered patients were eligible for safety analysis. Among the 225 patients eligible for effectiveness analysis, 139 were aged ≤21 years. For monotherapy and combination therapy, 20/31 and 34/88 patients were eligible, respectively. In the all-case survey, the median age was 16.0 years, and 47.7% of patients were <15 years old. Adverse drug reaction incidence was 83.5% and the most common were hematologic toxicities. The best overall response rates in the population aged ≤21 years were complete remission, 29.7%; complete remission without platelet recovery, 7.3% and partial remission, 10.9%. The rest (52.2%) were classified as ineffective. The sum of complete remission, complete remission without platelet recovery and partial remission rates (effectiveness rate) was 47.8% (66/138 patients). The effectiveness rates in the monotherapy and combination therapy surveys were 10.0% (2/20 patients) and 58.8% (20/34 patients), respectively.
These post-marketing surveys provide real-world evidence of the safety and effectiveness of clofarabine regimens, including monotherapy and combination therapy in Japanese patients with relapsed/refractory acute lymphoblastic leukaemia. The safety and effectiveness profiles were comparable with those of previous prospective studies.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Arabinonucleosides - administration & dosage</subject><subject>Arabinonucleosides - adverse effects</subject><subject>Arabinonucleosides - therapeutic use</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Clofarabine - administration & dosage</subject><subject>Clofarabine - therapeutic use</subject><subject>Cyclophosphamide - administration & dosage</subject><subject>Cyclophosphamide - adverse effects</subject><subject>Cyclophosphamide - therapeutic use</subject><subject>East Asian People</subject><subject>Etoposide - administration & dosage</subject><subject>Etoposide - adverse effects</subject><subject>Female</subject><subject>Humans</subject><subject>Japan</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm Recurrence, Local - drug therapy</subject><subject>Original</subject><subject>Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy</subject><subject>Product Surveillance, Postmarketing</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1465-3621</issn><issn>0368-2811</issn><issn>1465-3621</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpVUctuFDEQHCEiEgI3zshHDgzrx3geXFAU8YoicQDOVo-nnfXGMx5sz6L5k3wuXmWJklOXVKXqrq6ieMPoB0Y7sdnttN9sV0BaNc-KM1bVshQ1Z88f4dPiZYw7Sqlsq-ZFcSrauhJC1mfF3U8wmFYC00DQGNTJ7nHCGIk3RDtvIEBvJyR2IlcwQ6aQzJAsTimSvzZtSUAHc8RhE9AE0MmHbKeXhMSt47z1vYOYrCYOl1vA0cJHAmT2MZUjhFtMdrohcQl7tM7BpJHEtAzrq-LEgIv4-jjPi99fPv-6_FZe__j6_fLiutS84ank3VCDlMwgBdr3la4GWUuEVveoO2gYSk4bw5gwQ9vUrO6oYNhrRjOSWInz4tO977z0Iw465wrg1Bxsvm5VHqx6ykx2q278XjHGedvyLju8OzoE_2fBmNRoo8ZDGPRLVIJWgja8YyJL399LdfAx5n897GFUHdpUhzbVsc0sf_v4tgfx__rEP-8copI</recordid><startdate>20240707</startdate><enddate>20240707</enddate><creator>Kazama, Hirotaka</creator><creator>Nishina, Satoshi</creator><creator>Seto, Takeshi</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0009-0007-8340-5773</orcidid></search><sort><creationdate>20240707</creationdate><title>Safety and effectiveness of clofarabine in Japanese patients with relapsed/refractory acute lymphoblastic leukaemia: a post-marketing surveillance study</title><author>Kazama, Hirotaka ; Nishina, Satoshi ; Seto, Takeshi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c272t-29d6a551fe0a0bb4c4d565ea8cbec9a71e5207f113fd876169031ebc106905e43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Arabinonucleosides - administration & dosage</topic><topic>Arabinonucleosides - adverse effects</topic><topic>Arabinonucleosides - therapeutic use</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Clofarabine - administration & dosage</topic><topic>Clofarabine - therapeutic use</topic><topic>Cyclophosphamide - administration & dosage</topic><topic>Cyclophosphamide - adverse effects</topic><topic>Cyclophosphamide - therapeutic use</topic><topic>East Asian People</topic><topic>Etoposide - administration & dosage</topic><topic>Etoposide - adverse effects</topic><topic>Female</topic><topic>Humans</topic><topic>Japan</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Recurrence, Local - drug therapy</topic><topic>Original</topic><topic>Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy</topic><topic>Product Surveillance, Postmarketing</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kazama, Hirotaka</creatorcontrib><creatorcontrib>Nishina, Satoshi</creatorcontrib><creatorcontrib>Seto, Takeshi</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Japanese journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kazama, Hirotaka</au><au>Nishina, Satoshi</au><au>Seto, Takeshi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and effectiveness of clofarabine in Japanese patients with relapsed/refractory acute lymphoblastic leukaemia: a post-marketing surveillance study</atitle><jtitle>Japanese journal of clinical oncology</jtitle><addtitle>Jpn J Clin Oncol</addtitle><date>2024-07-07</date><risdate>2024</risdate><volume>54</volume><issue>7</issue><spage>778</spage><epage>786</epage><pages>778-786</pages><issn>1465-3621</issn><issn>0368-2811</issn><eissn>1465-3621</eissn><abstract>Clofarabine is used to treat acute lymphoblastic leukaemia, but evidence of its safety and effectiveness in Japanese patients is limited. We evaluated the safety and effectiveness of clofarabine in patients with relapsed/refractory acute lymphoblastic leukaemia in real-world clinical practice in Japan.
An observational, multicenter, post-marketing, all-case surveillance was conducted for safety. Effectiveness analyses were conducted in patients aged ≤21 years and those treated with clofarabine monotherapy and combination therapy (clofarabine plus etoposide and cyclophosphamide).
In the all-case survey, 260 of 264 registered patients were eligible for safety analysis. Among the 225 patients eligible for effectiveness analysis, 139 were aged ≤21 years. For monotherapy and combination therapy, 20/31 and 34/88 patients were eligible, respectively. In the all-case survey, the median age was 16.0 years, and 47.7% of patients were <15 years old. Adverse drug reaction incidence was 83.5% and the most common were hematologic toxicities. The best overall response rates in the population aged ≤21 years were complete remission, 29.7%; complete remission without platelet recovery, 7.3% and partial remission, 10.9%. The rest (52.2%) were classified as ineffective. The sum of complete remission, complete remission without platelet recovery and partial remission rates (effectiveness rate) was 47.8% (66/138 patients). The effectiveness rates in the monotherapy and combination therapy surveys were 10.0% (2/20 patients) and 58.8% (20/34 patients), respectively.
These post-marketing surveys provide real-world evidence of the safety and effectiveness of clofarabine regimens, including monotherapy and combination therapy in Japanese patients with relapsed/refractory acute lymphoblastic leukaemia. The safety and effectiveness profiles were comparable with those of previous prospective studies.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>38643356</pmid><doi>10.1093/jjco/hyae047</doi><tpages>9</tpages><orcidid>https://orcid.org/0009-0007-8340-5773</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1465-3621 |
| ispartof | Japanese journal of clinical oncology, 2024-07, Vol.54 (7), p.778-786 |
| issn | 1465-3621 0368-2811 1465-3621 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11228829 |
| source | Oxford Journals Online |
| subjects | Adolescent Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Arabinonucleosides - administration & dosage Arabinonucleosides - adverse effects Arabinonucleosides - therapeutic use Child Child, Preschool Clofarabine - administration & dosage Clofarabine - therapeutic use Cyclophosphamide - administration & dosage Cyclophosphamide - adverse effects Cyclophosphamide - therapeutic use East Asian People Etoposide - administration & dosage Etoposide - adverse effects Female Humans Japan Male Middle Aged Neoplasm Recurrence, Local - drug therapy Original Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy Product Surveillance, Postmarketing Treatment Outcome Young Adult |
| title | Safety and effectiveness of clofarabine in Japanese patients with relapsed/refractory acute lymphoblastic leukaemia: a post-marketing surveillance study |
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