Phase I trial of myeloablative conditioning with 3‐day total marrow and lymphoid irradiation for leukemia
This prospective phase I trial aimed to determine the recommended dose of 3‐day total marrow and lymphoid irradiation (TMLI) for a myeloablative conditioning regimen by increasing the dose per fraction. The primary end‐point of this single‐institution dose escalation study was the recommended TMLI d...
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| Veröffentlicht in: | Cancer science 2023-02, Vol.114 (2), p.596-605 |
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| creator | Ogawa, Hiroaki Konishi, Tatsuya Najima, Yuho Kito, Satoshi Hashimoto, Shimpei Kato, Chika Sakai, Satoshi Kanbara, Yasuhiro Atsuta, Yuya Konuma, Ryosuke Wada, Atsushi Murakami, Daisuke Nakasima, Shiori Uchibori, Yusuke Onai, Daishi Hamamura, Atsushi Nishijima, Akihiko Shingai, Naoki Toya, Takashi Shimizu, Hiroaki Kobayashi, Takeshi Ohashi, Kazuteru Doki, Noriko Murofushi, Keiko Nemoto |
| description | This prospective phase I trial aimed to determine the recommended dose of 3‐day total marrow and lymphoid irradiation (TMLI) for a myeloablative conditioning regimen by increasing the dose per fraction. The primary end‐point of this single‐institution dose escalation study was the recommended TMLI dose based on the frequency of dose‐limiting toxicity (DLT) ≤100 days posthematopoietic stem cell transplantation (HSCT); a 3 + 3 design was used to evaluate the safety of TMLI. Three dose levels of TMLI (14/16/18 Gy in six fractions over 3 days) were set. The treatment protocol began at 14 Gy. Dose‐limiting toxicities were defined as grade 3 or 4 nonhematological toxicities. Nine patients, with a median age of 42 years (range, 35–48), eight with acute lymphoblastic leukemia and one with chronic myeloblastic leukemia, received TMLI followed by unrelated bone marrow transplant. The median follow‐up period after HSCT was 575 days (range, 253–1037). Three patients were enrolled for each dose level. No patient showed DLT within 100 days of HSCT. The recommended dose of 3‐day TMLI was 18 Gy in six fractions. All patients achieved neutrophil engraftment at a median of 19 days (range, 14–25). One‐year overall and disease‐free survival rates were 83.3% and 57.1%, respectively. Three patients experienced relapse, and no nonrelapse mortality was documented during the observation period. One patient died due to disease relapse 306 days post‐HSCT. The recommended dose of 3‐day TMLI was 18 Gy in six fractions. The efficacy evaluation of this regimen is currently being planned in a phase II study.
This phase I dose escalation study evaluated the safety of 3‐day total marrow and lymphoid irradiation (TMLI, 14/16/18 Gy in 6 fractions) as myeloablative conditioning for hematopoietic stem cell transplantation. Among enrolled 9 patients (8 with acute lymphoblastic leukemia and 1 with chronic myeloid leukemia), no dose‐limiting toxicity 100‐day after transplant was observed; the one‐year overall survival and non‐relapse mortality were 83.3% and 0%, respectively. The recommended dose of 3‐day TMLI was 18 Gy in 6 fractions, which is currently being planned in a phase II study. |
| doi_str_mv | 10.1111/cas.15611 |
| format | Article |
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This phase I dose escalation study evaluated the safety of 3‐day total marrow and lymphoid irradiation (TMLI, 14/16/18 Gy in 6 fractions) as myeloablative conditioning for hematopoietic stem cell transplantation. Among enrolled 9 patients (8 with acute lymphoblastic leukemia and 1 with chronic myeloid leukemia), no dose‐limiting toxicity 100‐day after transplant was observed; the one‐year overall survival and non‐relapse mortality were 83.3% and 0%, respectively. The recommended dose of 3‐day TMLI was 18 Gy in 6 fractions, which is currently being planned in a phase II study.</description><identifier>ISSN: 1347-9032</identifier><identifier>EISSN: 1349-7006</identifier><identifier>DOI: 10.1111/cas.15611</identifier><identifier>PMID: 36221800</identifier><language>eng</language><publisher>England: John Wiley & Sons, Inc</publisher><subject>Acute lymphoblastic leukemia ; Adult ; allogeneic hematopoietic stem cell transplantation ; Bone Marrow ; Bone marrow transplantation ; Chronic myeloblastic leukemia ; Clinical trials ; Graft versus host disease ; Graft vs Host Disease - etiology ; Heart ; Hematopoietic Stem Cell Transplantation - methods ; Humans ; intensity‐modulated radiation therapy ; Leukemia ; Leukocytes (neutrophilic) ; Liver ; Lungs ; Lymphatic Irradiation - methods ; Lymphatic leukemia ; Lymphatic system ; Middle Aged ; myeloablative conditioning regimen ; Myeloblastic leukemia ; Nervous system ; Neutropenia ; Original ; ORIGINAL ARTICLES ; Precursor Cell Lymphoblastic Leukemia-Lymphoma - radiotherapy ; Prospective Studies ; Radiation ; Radiation therapy ; Recurrence ; Stem cell transplantation ; total body irradiation ; total marrow and lymphoid irradiation ; Toxicity ; Transplantation Conditioning - adverse effects ; Transplantation Conditioning - methods ; Transplants & implants</subject><ispartof>Cancer science, 2023-02, Vol.114 (2), p.596-605</ispartof><rights>2022 The Authors. published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.</rights><rights>2022 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.</rights><rights>2023. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4671-4431228ab9e49f215fd2cd06bd487b2563a5febdc8c5eff4186d0e9e10caa3a73</citedby><cites>FETCH-LOGICAL-c4671-4431228ab9e49f215fd2cd06bd487b2563a5febdc8c5eff4186d0e9e10caa3a73</cites><orcidid>0000-0001-8910-0021 ; 0000-0001-6203-9435 ; 0000-0002-7436-972X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9899623/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9899623/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,1411,11541,27901,27902,45550,45551,46027,46451,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36221800$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ogawa, Hiroaki</creatorcontrib><creatorcontrib>Konishi, Tatsuya</creatorcontrib><creatorcontrib>Najima, Yuho</creatorcontrib><creatorcontrib>Kito, Satoshi</creatorcontrib><creatorcontrib>Hashimoto, Shimpei</creatorcontrib><creatorcontrib>Kato, Chika</creatorcontrib><creatorcontrib>Sakai, Satoshi</creatorcontrib><creatorcontrib>Kanbara, Yasuhiro</creatorcontrib><creatorcontrib>Atsuta, Yuya</creatorcontrib><creatorcontrib>Konuma, Ryosuke</creatorcontrib><creatorcontrib>Wada, Atsushi</creatorcontrib><creatorcontrib>Murakami, Daisuke</creatorcontrib><creatorcontrib>Nakasima, Shiori</creatorcontrib><creatorcontrib>Uchibori, Yusuke</creatorcontrib><creatorcontrib>Onai, Daishi</creatorcontrib><creatorcontrib>Hamamura, Atsushi</creatorcontrib><creatorcontrib>Nishijima, Akihiko</creatorcontrib><creatorcontrib>Shingai, Naoki</creatorcontrib><creatorcontrib>Toya, Takashi</creatorcontrib><creatorcontrib>Shimizu, Hiroaki</creatorcontrib><creatorcontrib>Kobayashi, Takeshi</creatorcontrib><creatorcontrib>Ohashi, Kazuteru</creatorcontrib><creatorcontrib>Doki, Noriko</creatorcontrib><creatorcontrib>Murofushi, Keiko Nemoto</creatorcontrib><title>Phase I trial of myeloablative conditioning with 3‐day total marrow and lymphoid irradiation for leukemia</title><title>Cancer science</title><addtitle>Cancer Sci</addtitle><description>This prospective phase I trial aimed to determine the recommended dose of 3‐day total marrow and lymphoid irradiation (TMLI) for a myeloablative conditioning regimen by increasing the dose per fraction. The primary end‐point of this single‐institution dose escalation study was the recommended TMLI dose based on the frequency of dose‐limiting toxicity (DLT) ≤100 days posthematopoietic stem cell transplantation (HSCT); a 3 + 3 design was used to evaluate the safety of TMLI. Three dose levels of TMLI (14/16/18 Gy in six fractions over 3 days) were set. The treatment protocol began at 14 Gy. Dose‐limiting toxicities were defined as grade 3 or 4 nonhematological toxicities. Nine patients, with a median age of 42 years (range, 35–48), eight with acute lymphoblastic leukemia and one with chronic myeloblastic leukemia, received TMLI followed by unrelated bone marrow transplant. The median follow‐up period after HSCT was 575 days (range, 253–1037). Three patients were enrolled for each dose level. No patient showed DLT within 100 days of HSCT. The recommended dose of 3‐day TMLI was 18 Gy in six fractions. All patients achieved neutrophil engraftment at a median of 19 days (range, 14–25). One‐year overall and disease‐free survival rates were 83.3% and 57.1%, respectively. Three patients experienced relapse, and no nonrelapse mortality was documented during the observation period. One patient died due to disease relapse 306 days post‐HSCT. The recommended dose of 3‐day TMLI was 18 Gy in six fractions. The efficacy evaluation of this regimen is currently being planned in a phase II study.
This phase I dose escalation study evaluated the safety of 3‐day total marrow and lymphoid irradiation (TMLI, 14/16/18 Gy in 6 fractions) as myeloablative conditioning for hematopoietic stem cell transplantation. Among enrolled 9 patients (8 with acute lymphoblastic leukemia and 1 with chronic myeloid leukemia), no dose‐limiting toxicity 100‐day after transplant was observed; the one‐year overall survival and non‐relapse mortality were 83.3% and 0%, respectively. The recommended dose of 3‐day TMLI was 18 Gy in 6 fractions, which is currently being planned in a phase II study.</description><subject>Acute lymphoblastic leukemia</subject><subject>Adult</subject><subject>allogeneic hematopoietic stem cell transplantation</subject><subject>Bone Marrow</subject><subject>Bone marrow transplantation</subject><subject>Chronic myeloblastic leukemia</subject><subject>Clinical trials</subject><subject>Graft versus host disease</subject><subject>Graft vs Host Disease - etiology</subject><subject>Heart</subject><subject>Hematopoietic Stem Cell Transplantation - methods</subject><subject>Humans</subject><subject>intensity‐modulated radiation therapy</subject><subject>Leukemia</subject><subject>Leukocytes (neutrophilic)</subject><subject>Liver</subject><subject>Lungs</subject><subject>Lymphatic Irradiation - methods</subject><subject>Lymphatic leukemia</subject><subject>Lymphatic system</subject><subject>Middle Aged</subject><subject>myeloablative conditioning regimen</subject><subject>Myeloblastic leukemia</subject><subject>Nervous system</subject><subject>Neutropenia</subject><subject>Original</subject><subject>ORIGINAL ARTICLES</subject><subject>Precursor Cell Lymphoblastic Leukemia-Lymphoma - radiotherapy</subject><subject>Prospective Studies</subject><subject>Radiation</subject><subject>Radiation therapy</subject><subject>Recurrence</subject><subject>Stem cell transplantation</subject><subject>total body irradiation</subject><subject>total marrow and lymphoid irradiation</subject><subject>Toxicity</subject><subject>Transplantation Conditioning - adverse effects</subject><subject>Transplantation Conditioning - methods</subject><subject>Transplants & implants</subject><issn>1347-9032</issn><issn>1349-7006</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kctKJDEUhoOMeF_4AhKYlYvS3CpV2QjSqCMICuo6nMrFjlZVelLV3dTOR5hnnCeZaltlXJhNAvnOd374ETqk5ISO59RAd0JzSekG2qFcqKwgRP54exeZIpxto92ueyaES6HEFtrmkjFaErKDXu6m0Dl8jfsUoMbR42ZwdYSqhj4sHDaxtaEPsQ3tE16Gfor539c_Fgbcx34caCCluMTQWlwPzWwag8UhJbABVlPYx4RrN39xTYB9tOmh7tzB-72HHi8vHia_spvbq-vJ-U1mhCxoJgSnjJVQKSeUZzT3lhlLZGVFWVQslxxy7yprSpM77wUtpSVOOUoMAIeC76GztXc2rxpnjWv7BLWepTCmHXSEoL_-tGGqn-JCq1Ipyfgo-PkuSPH33HW9fo7z1I6ZNSsKVpaS5Ks1x2vKpNh1yfnPDZToVS967EW_9TKyR_9H-iQ_ihiB0zWwDLUbvjfpyfn9WvkPr9Sayw</recordid><startdate>202302</startdate><enddate>202302</enddate><creator>Ogawa, Hiroaki</creator><creator>Konishi, Tatsuya</creator><creator>Najima, Yuho</creator><creator>Kito, Satoshi</creator><creator>Hashimoto, Shimpei</creator><creator>Kato, Chika</creator><creator>Sakai, Satoshi</creator><creator>Kanbara, Yasuhiro</creator><creator>Atsuta, Yuya</creator><creator>Konuma, Ryosuke</creator><creator>Wada, Atsushi</creator><creator>Murakami, Daisuke</creator><creator>Nakasima, Shiori</creator><creator>Uchibori, Yusuke</creator><creator>Onai, Daishi</creator><creator>Hamamura, Atsushi</creator><creator>Nishijima, Akihiko</creator><creator>Shingai, Naoki</creator><creator>Toya, Takashi</creator><creator>Shimizu, Hiroaki</creator><creator>Kobayashi, Takeshi</creator><creator>Ohashi, Kazuteru</creator><creator>Doki, Noriko</creator><creator>Murofushi, Keiko Nemoto</creator><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><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>8FE</scope><scope>8FH</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>LK8</scope><scope>M7P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-8910-0021</orcidid><orcidid>https://orcid.org/0000-0001-6203-9435</orcidid><orcidid>https://orcid.org/0000-0002-7436-972X</orcidid></search><sort><creationdate>202302</creationdate><title>Phase I trial of myeloablative conditioning with 3‐day total marrow and lymphoid irradiation for leukemia</title><author>Ogawa, Hiroaki ; Konishi, Tatsuya ; Najima, Yuho ; Kito, Satoshi ; Hashimoto, Shimpei ; Kato, Chika ; Sakai, Satoshi ; Kanbara, Yasuhiro ; Atsuta, Yuya ; Konuma, Ryosuke ; Wada, Atsushi ; Murakami, Daisuke ; Nakasima, Shiori ; Uchibori, Yusuke ; Onai, Daishi ; Hamamura, Atsushi ; Nishijima, Akihiko ; Shingai, Naoki ; Toya, Takashi ; Shimizu, Hiroaki ; Kobayashi, Takeshi ; Ohashi, Kazuteru ; Doki, Noriko ; Murofushi, Keiko Nemoto</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4671-4431228ab9e49f215fd2cd06bd487b2563a5febdc8c5eff4186d0e9e10caa3a73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Acute lymphoblastic leukemia</topic><topic>Adult</topic><topic>allogeneic hematopoietic stem cell transplantation</topic><topic>Bone Marrow</topic><topic>Bone marrow transplantation</topic><topic>Chronic myeloblastic leukemia</topic><topic>Clinical trials</topic><topic>Graft versus host disease</topic><topic>Graft vs Host Disease - etiology</topic><topic>Heart</topic><topic>Hematopoietic Stem Cell Transplantation - methods</topic><topic>Humans</topic><topic>intensity‐modulated radiation therapy</topic><topic>Leukemia</topic><topic>Leukocytes (neutrophilic)</topic><topic>Liver</topic><topic>Lungs</topic><topic>Lymphatic Irradiation - methods</topic><topic>Lymphatic leukemia</topic><topic>Lymphatic system</topic><topic>Middle Aged</topic><topic>myeloablative conditioning regimen</topic><topic>Myeloblastic leukemia</topic><topic>Nervous system</topic><topic>Neutropenia</topic><topic>Original</topic><topic>ORIGINAL ARTICLES</topic><topic>Precursor Cell Lymphoblastic Leukemia-Lymphoma - radiotherapy</topic><topic>Prospective Studies</topic><topic>Radiation</topic><topic>Radiation therapy</topic><topic>Recurrence</topic><topic>Stem cell transplantation</topic><topic>total body irradiation</topic><topic>total marrow and lymphoid irradiation</topic><topic>Toxicity</topic><topic>Transplantation Conditioning - adverse effects</topic><topic>Transplantation Conditioning - methods</topic><topic>Transplants & implants</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ogawa, Hiroaki</creatorcontrib><creatorcontrib>Konishi, Tatsuya</creatorcontrib><creatorcontrib>Najima, Yuho</creatorcontrib><creatorcontrib>Kito, Satoshi</creatorcontrib><creatorcontrib>Hashimoto, Shimpei</creatorcontrib><creatorcontrib>Kato, Chika</creatorcontrib><creatorcontrib>Sakai, Satoshi</creatorcontrib><creatorcontrib>Kanbara, Yasuhiro</creatorcontrib><creatorcontrib>Atsuta, Yuya</creatorcontrib><creatorcontrib>Konuma, Ryosuke</creatorcontrib><creatorcontrib>Wada, Atsushi</creatorcontrib><creatorcontrib>Murakami, Daisuke</creatorcontrib><creatorcontrib>Nakasima, Shiori</creatorcontrib><creatorcontrib>Uchibori, Yusuke</creatorcontrib><creatorcontrib>Onai, Daishi</creatorcontrib><creatorcontrib>Hamamura, Atsushi</creatorcontrib><creatorcontrib>Nishijima, Akihiko</creatorcontrib><creatorcontrib>Shingai, Naoki</creatorcontrib><creatorcontrib>Toya, Takashi</creatorcontrib><creatorcontrib>Shimizu, Hiroaki</creatorcontrib><creatorcontrib>Kobayashi, Takeshi</creatorcontrib><creatorcontrib>Ohashi, Kazuteru</creatorcontrib><creatorcontrib>Doki, Noriko</creatorcontrib><creatorcontrib>Murofushi, Keiko Nemoto</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Biological Science Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cancer science</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ogawa, Hiroaki</au><au>Konishi, Tatsuya</au><au>Najima, Yuho</au><au>Kito, Satoshi</au><au>Hashimoto, Shimpei</au><au>Kato, Chika</au><au>Sakai, Satoshi</au><au>Kanbara, Yasuhiro</au><au>Atsuta, Yuya</au><au>Konuma, Ryosuke</au><au>Wada, Atsushi</au><au>Murakami, Daisuke</au><au>Nakasima, Shiori</au><au>Uchibori, Yusuke</au><au>Onai, Daishi</au><au>Hamamura, Atsushi</au><au>Nishijima, Akihiko</au><au>Shingai, Naoki</au><au>Toya, Takashi</au><au>Shimizu, Hiroaki</au><au>Kobayashi, Takeshi</au><au>Ohashi, Kazuteru</au><au>Doki, Noriko</au><au>Murofushi, Keiko Nemoto</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I trial of myeloablative conditioning with 3‐day total marrow and lymphoid irradiation for leukemia</atitle><jtitle>Cancer science</jtitle><addtitle>Cancer Sci</addtitle><date>2023-02</date><risdate>2023</risdate><volume>114</volume><issue>2</issue><spage>596</spage><epage>605</epage><pages>596-605</pages><issn>1347-9032</issn><eissn>1349-7006</eissn><abstract>This prospective phase I trial aimed to determine the recommended dose of 3‐day total marrow and lymphoid irradiation (TMLI) for a myeloablative conditioning regimen by increasing the dose per fraction. The primary end‐point of this single‐institution dose escalation study was the recommended TMLI dose based on the frequency of dose‐limiting toxicity (DLT) ≤100 days posthematopoietic stem cell transplantation (HSCT); a 3 + 3 design was used to evaluate the safety of TMLI. Three dose levels of TMLI (14/16/18 Gy in six fractions over 3 days) were set. The treatment protocol began at 14 Gy. Dose‐limiting toxicities were defined as grade 3 or 4 nonhematological toxicities. Nine patients, with a median age of 42 years (range, 35–48), eight with acute lymphoblastic leukemia and one with chronic myeloblastic leukemia, received TMLI followed by unrelated bone marrow transplant. The median follow‐up period after HSCT was 575 days (range, 253–1037). Three patients were enrolled for each dose level. No patient showed DLT within 100 days of HSCT. The recommended dose of 3‐day TMLI was 18 Gy in six fractions. All patients achieved neutrophil engraftment at a median of 19 days (range, 14–25). One‐year overall and disease‐free survival rates were 83.3% and 57.1%, respectively. Three patients experienced relapse, and no nonrelapse mortality was documented during the observation period. One patient died due to disease relapse 306 days post‐HSCT. The recommended dose of 3‐day TMLI was 18 Gy in six fractions. The efficacy evaluation of this regimen is currently being planned in a phase II study.
This phase I dose escalation study evaluated the safety of 3‐day total marrow and lymphoid irradiation (TMLI, 14/16/18 Gy in 6 fractions) as myeloablative conditioning for hematopoietic stem cell transplantation. Among enrolled 9 patients (8 with acute lymphoblastic leukemia and 1 with chronic myeloid leukemia), no dose‐limiting toxicity 100‐day after transplant was observed; the one‐year overall survival and non‐relapse mortality were 83.3% and 0%, respectively. The recommended dose of 3‐day TMLI was 18 Gy in 6 fractions, which is currently being planned in a phase II study.</abstract><cop>England</cop><pub>John Wiley & Sons, Inc</pub><pmid>36221800</pmid><doi>10.1111/cas.15611</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-8910-0021</orcidid><orcidid>https://orcid.org/0000-0001-6203-9435</orcidid><orcidid>https://orcid.org/0000-0002-7436-972X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1347-9032 |
| ispartof | Cancer science, 2023-02, Vol.114 (2), p.596-605 |
| issn | 1347-9032 1349-7006 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9899623 |
| source | MEDLINE; Wiley Online Library Open Access; DOAJ Directory of Open Access Journals; Wiley Online Library Journals Frontfile Complete; PubMed Central |
| subjects | Acute lymphoblastic leukemia Adult allogeneic hematopoietic stem cell transplantation Bone Marrow Bone marrow transplantation Chronic myeloblastic leukemia Clinical trials Graft versus host disease Graft vs Host Disease - etiology Heart Hematopoietic Stem Cell Transplantation - methods Humans intensity‐modulated radiation therapy Leukemia Leukocytes (neutrophilic) Liver Lungs Lymphatic Irradiation - methods Lymphatic leukemia Lymphatic system Middle Aged myeloablative conditioning regimen Myeloblastic leukemia Nervous system Neutropenia Original ORIGINAL ARTICLES Precursor Cell Lymphoblastic Leukemia-Lymphoma - radiotherapy Prospective Studies Radiation Radiation therapy Recurrence Stem cell transplantation total body irradiation total marrow and lymphoid irradiation Toxicity Transplantation Conditioning - adverse effects Transplantation Conditioning - methods Transplants & implants |
| title | Phase I trial of myeloablative conditioning with 3‐day total marrow and lymphoid irradiation for leukemia |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-31T07%3A16%3A09IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Phase%20I%20trial%20of%20myeloablative%20conditioning%20with%203%E2%80%90day%20total%20marrow%20and%20lymphoid%20irradiation%20for%20leukemia&rft.jtitle=Cancer%20science&rft.au=Ogawa,%20Hiroaki&rft.date=2023-02&rft.volume=114&rft.issue=2&rft.spage=596&rft.epage=605&rft.pages=596-605&rft.issn=1347-9032&rft.eissn=1349-7006&rft_id=info:doi/10.1111/cas.15611&rft_dat=%3Cproquest_pubme%3E2772886057%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2772886057&rft_id=info:pmid/36221800&rfr_iscdi=true |