Phase I/II study of tandem high-dose chemotherapy with autologous peripheral blood stem cell transplantation for advanced multiple myeloma
The efficacy and safety of high-dose chemotherapy with tandem autologous peripheral blood stem cell transplantation (auto-PBSCT) were evaluated in a multicenter clinical study of patients with advanced multiple myeloma. Eligible patients ( n = 40) were consecutively enrolled in the phase I/II study...
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| Veröffentlicht in: | International journal of hematology 2009-12, Vol.90 (5), p.635-642 |
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| container_title | International journal of hematology |
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| creator | Sunami, Kazutaka Shinagawa, Katsuji Sawamura, Morio Sakai, Akira Saburi, Yoshio Imamura, Yutaka Mizuno, Ishikazu Tamaki, Shigehisa Kamimura, Tomohiko Tsuda, Hiroyuki Gondo, Hisashi Hino, Norihiko Shimazaki, Chihiro Miyata, Akira Tajima, Fumihito Takemoto, Yoshinobu Miwa, Akiyoshi Chou, Takaaki Harada, Mine |
| description | The efficacy and safety of high-dose chemotherapy with tandem autologous peripheral blood stem cell transplantation (auto-PBSCT) were evaluated in a multicenter clinical study of patients with advanced multiple myeloma. Eligible patients (
n
= 40) were consecutively enrolled in the phase I/II study and received 2–4 cycles of vincristine–adriamycin–dexamethasone regimen. The responding patients underwent PBSC harvesting following high-dose cyclophosphamide and filgrastim administration. The first auto-PBSCT (
n
= 32) following high-dose melphalan (200 mg/m
2
) was performed within 2 months of PBSC harvesting; the second auto-PBSCT (
n
= 28) was scheduled 3–6 months later. Treatment-related mortality was 2.5% (
n
= 1) throughout the protocol. Grade 4 nonhematologic toxicity occurred in 12.5 and 14.3% of the first and second auto-PBSCT patients, respectively. All but one patient (who died) achieved hematopoietic recovery. For the 28 patients completing the second auto-PBSCT, the results were favorable with a response rate of 65% (complete response rate = 27.5%,
n
= 11); the five-year progression-free survival and overall survival were 20.3 and 66.5%, respectively. In conclusion, high-dose chemotherapy with tandem auto-PBSCT is feasible and safe with a favorable response rate in treating advanced multiple myeloma in Japan. |
| doi_str_mv | 10.1007/s12185-009-0445-8 |
| format | Article |
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n
= 40) were consecutively enrolled in the phase I/II study and received 2–4 cycles of vincristine–adriamycin–dexamethasone regimen. The responding patients underwent PBSC harvesting following high-dose cyclophosphamide and filgrastim administration. The first auto-PBSCT (
n
= 32) following high-dose melphalan (200 mg/m
2
) was performed within 2 months of PBSC harvesting; the second auto-PBSCT (
n
= 28) was scheduled 3–6 months later. Treatment-related mortality was 2.5% (
n
= 1) throughout the protocol. Grade 4 nonhematologic toxicity occurred in 12.5 and 14.3% of the first and second auto-PBSCT patients, respectively. All but one patient (who died) achieved hematopoietic recovery. For the 28 patients completing the second auto-PBSCT, the results were favorable with a response rate of 65% (complete response rate = 27.5%,
n
= 11); the five-year progression-free survival and overall survival were 20.3 and 66.5%, respectively. In conclusion, high-dose chemotherapy with tandem auto-PBSCT is feasible and safe with a favorable response rate in treating advanced multiple myeloma in Japan.</description><identifier>ISSN: 0925-5710</identifier><identifier>EISSN: 1865-3774</identifier><identifier>DOI: 10.1007/s12185-009-0445-8</identifier><identifier>PMID: 19936876</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Combined Modality Therapy - methods ; Combined Modality Therapy - mortality ; Dexamethasone - administration & dosage ; Doxorubicin - administration & dosage ; Hematologic and hematopoietic diseases ; Hematology ; Humans ; Immunodeficiencies. Immunoglobulinopathies ; Immunoglobulinopathies ; Immunopathology ; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis ; Medical sciences ; Medicine ; Medicine & Public Health ; Multiple Myeloma - mortality ; Multiple Myeloma - therapy ; Oncology ; Original Article ; Peripheral Blood Stem Cell Transplantation - methods ; Survival Rate ; Transplantation, Autologous ; Treatment Outcome ; Vincristine - administration & dosage</subject><ispartof>International journal of hematology, 2009-12, Vol.90 (5), p.635-642</ispartof><rights>The Japanese Society of Hematology 2009</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c549t-1624677e44b774dc7e698ecc76c5dad24797cfeb5dbcf72a280992c1762b0cd73</citedby><cites>FETCH-LOGICAL-c549t-1624677e44b774dc7e698ecc76c5dad24797cfeb5dbcf72a280992c1762b0cd73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12185-009-0445-8$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12185-009-0445-8$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22368272$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19936876$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sunami, Kazutaka</creatorcontrib><creatorcontrib>Shinagawa, Katsuji</creatorcontrib><creatorcontrib>Sawamura, Morio</creatorcontrib><creatorcontrib>Sakai, Akira</creatorcontrib><creatorcontrib>Saburi, Yoshio</creatorcontrib><creatorcontrib>Imamura, Yutaka</creatorcontrib><creatorcontrib>Mizuno, Ishikazu</creatorcontrib><creatorcontrib>Tamaki, Shigehisa</creatorcontrib><creatorcontrib>Kamimura, Tomohiko</creatorcontrib><creatorcontrib>Tsuda, Hiroyuki</creatorcontrib><creatorcontrib>Gondo, Hisashi</creatorcontrib><creatorcontrib>Hino, Norihiko</creatorcontrib><creatorcontrib>Shimazaki, Chihiro</creatorcontrib><creatorcontrib>Miyata, Akira</creatorcontrib><creatorcontrib>Tajima, Fumihito</creatorcontrib><creatorcontrib>Takemoto, Yoshinobu</creatorcontrib><creatorcontrib>Miwa, Akiyoshi</creatorcontrib><creatorcontrib>Chou, Takaaki</creatorcontrib><creatorcontrib>Harada, Mine</creatorcontrib><title>Phase I/II study of tandem high-dose chemotherapy with autologous peripheral blood stem cell transplantation for advanced multiple myeloma</title><title>International journal of hematology</title><addtitle>Int J Hematol</addtitle><addtitle>Int J Hematol</addtitle><description>The efficacy and safety of high-dose chemotherapy with tandem autologous peripheral blood stem cell transplantation (auto-PBSCT) were evaluated in a multicenter clinical study of patients with advanced multiple myeloma. Eligible patients (
n
= 40) were consecutively enrolled in the phase I/II study and received 2–4 cycles of vincristine–adriamycin–dexamethasone regimen. The responding patients underwent PBSC harvesting following high-dose cyclophosphamide and filgrastim administration. The first auto-PBSCT (
n
= 32) following high-dose melphalan (200 mg/m
2
) was performed within 2 months of PBSC harvesting; the second auto-PBSCT (
n
= 28) was scheduled 3–6 months later. Treatment-related mortality was 2.5% (
n
= 1) throughout the protocol. Grade 4 nonhematologic toxicity occurred in 12.5 and 14.3% of the first and second auto-PBSCT patients, respectively. All but one patient (who died) achieved hematopoietic recovery. For the 28 patients completing the second auto-PBSCT, the results were favorable with a response rate of 65% (complete response rate = 27.5%,
n
= 11); the five-year progression-free survival and overall survival were 20.3 and 66.5%, respectively. In conclusion, high-dose chemotherapy with tandem auto-PBSCT is feasible and safe with a favorable response rate in treating advanced multiple myeloma in Japan.</description><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Combined Modality Therapy - methods</subject><subject>Combined Modality Therapy - mortality</subject><subject>Dexamethasone - administration & dosage</subject><subject>Doxorubicin - administration & dosage</subject><subject>Hematologic and hematopoietic diseases</subject><subject>Hematology</subject><subject>Humans</subject><subject>Immunodeficiencies. Immunoglobulinopathies</subject><subject>Immunoglobulinopathies</subject><subject>Immunopathology</subject><subject>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Multiple Myeloma - mortality</subject><subject>Multiple Myeloma - therapy</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Peripheral Blood Stem Cell Transplantation - methods</subject><subject>Survival Rate</subject><subject>Transplantation, Autologous</subject><subject>Treatment Outcome</subject><subject>Vincristine - administration & dosage</subject><issn>0925-5710</issn><issn>1865-3774</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkk2L1TAUhosoznX0B7iRIIirOkma5CRLGfy4MKALXZc0SW87pE1N0pH7F_zVptyLA4I4qyze57znI29VvST4HcEYrhKhRPIaY1VjxngtH1U7IgWvGwD2uNphRXnNgeCL6llKtxgTwAyeVhdEqUZIELvq19dBJ4f2V_s9Snm1RxR6lPVs3YSG8TDUNhTZDG4KeXBRL0f0c8wD0msOPhzCmtDi4rhsmkedD8EWn1JsnPcoRz2nxes56zyGGfUhIm3v9GycRdPq87h4h6aj82HSz6snvfbJvTi_l9X3jx--XX-ub7582l-_v6kNZyrXRFAmABxjXdnSGnBCSWcMCMOttpSBAtO7jtvO9EA1lVgpaggI2mFjobms3p58lxh-rC7ldhrTNq6eXdmnBSYIb0A1DyOpYvwBJBdScan-TzYNEEmZLOTrv8jbsMa5nKalBBrgmNECkRNkYkgpur5d4jjpeGwJbreQtKeQtCUk7RaSdjN-dTZeu8nZ-4pzKgrw5gzoZLTvyy-aMf3hKC0Yha05PXGpSPPBxfsJ_939N9Gz1Vo</recordid><startdate>20091201</startdate><enddate>20091201</enddate><creator>Sunami, Kazutaka</creator><creator>Shinagawa, Katsuji</creator><creator>Sawamura, Morio</creator><creator>Sakai, Akira</creator><creator>Saburi, Yoshio</creator><creator>Imamura, Yutaka</creator><creator>Mizuno, Ishikazu</creator><creator>Tamaki, Shigehisa</creator><creator>Kamimura, Tomohiko</creator><creator>Tsuda, Hiroyuki</creator><creator>Gondo, Hisashi</creator><creator>Hino, Norihiko</creator><creator>Shimazaki, Chihiro</creator><creator>Miyata, Akira</creator><creator>Tajima, Fumihito</creator><creator>Takemoto, Yoshinobu</creator><creator>Miwa, Akiyoshi</creator><creator>Chou, Takaaki</creator><creator>Harada, Mine</creator><general>Springer Japan</general><general>Springer</general><general>Springer Nature B.V</general><scope>IQODW</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>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7T7</scope><scope>7TM</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>7QO</scope><scope>7U7</scope></search><sort><creationdate>20091201</creationdate><title>Phase I/II study of tandem high-dose chemotherapy with autologous peripheral blood stem cell transplantation for advanced multiple myeloma</title><author>Sunami, Kazutaka ; Shinagawa, Katsuji ; Sawamura, Morio ; Sakai, Akira ; Saburi, Yoshio ; Imamura, Yutaka ; Mizuno, Ishikazu ; Tamaki, Shigehisa ; Kamimura, Tomohiko ; Tsuda, Hiroyuki ; Gondo, Hisashi ; Hino, Norihiko ; Shimazaki, Chihiro ; Miyata, Akira ; Tajima, Fumihito ; Takemoto, Yoshinobu ; Miwa, Akiyoshi ; Chou, Takaaki ; Harada, Mine</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c549t-1624677e44b774dc7e698ecc76c5dad24797cfeb5dbcf72a280992c1762b0cd73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Combined Modality Therapy - methods</topic><topic>Combined Modality Therapy - mortality</topic><topic>Dexamethasone - administration & dosage</topic><topic>Doxorubicin - administration & dosage</topic><topic>Hematologic and hematopoietic diseases</topic><topic>Hematology</topic><topic>Humans</topic><topic>Immunodeficiencies. Immunoglobulinopathies</topic><topic>Immunoglobulinopathies</topic><topic>Immunopathology</topic><topic>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Multiple Myeloma - mortality</topic><topic>Multiple Myeloma - therapy</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Peripheral Blood Stem Cell Transplantation - methods</topic><topic>Survival Rate</topic><topic>Transplantation, Autologous</topic><topic>Treatment Outcome</topic><topic>Vincristine - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sunami, Kazutaka</creatorcontrib><creatorcontrib>Shinagawa, Katsuji</creatorcontrib><creatorcontrib>Sawamura, Morio</creatorcontrib><creatorcontrib>Sakai, Akira</creatorcontrib><creatorcontrib>Saburi, Yoshio</creatorcontrib><creatorcontrib>Imamura, Yutaka</creatorcontrib><creatorcontrib>Mizuno, Ishikazu</creatorcontrib><creatorcontrib>Tamaki, Shigehisa</creatorcontrib><creatorcontrib>Kamimura, Tomohiko</creatorcontrib><creatorcontrib>Tsuda, Hiroyuki</creatorcontrib><creatorcontrib>Gondo, Hisashi</creatorcontrib><creatorcontrib>Hino, Norihiko</creatorcontrib><creatorcontrib>Shimazaki, Chihiro</creatorcontrib><creatorcontrib>Miyata, Akira</creatorcontrib><creatorcontrib>Tajima, Fumihito</creatorcontrib><creatorcontrib>Takemoto, Yoshinobu</creatorcontrib><creatorcontrib>Miwa, Akiyoshi</creatorcontrib><creatorcontrib>Chou, Takaaki</creatorcontrib><creatorcontrib>Harada, Mine</creatorcontrib><collection>Pascal-Francis</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 Central (Corporate)</collection><collection>ProQuest Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Nucleic Acids Abstracts</collection><collection>ProQuest Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</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>MEDLINE - Academic</collection><collection>Biotechnology Research Abstracts</collection><collection>Toxicology Abstracts</collection><jtitle>International journal of hematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sunami, Kazutaka</au><au>Shinagawa, Katsuji</au><au>Sawamura, Morio</au><au>Sakai, Akira</au><au>Saburi, Yoshio</au><au>Imamura, Yutaka</au><au>Mizuno, Ishikazu</au><au>Tamaki, Shigehisa</au><au>Kamimura, Tomohiko</au><au>Tsuda, Hiroyuki</au><au>Gondo, Hisashi</au><au>Hino, Norihiko</au><au>Shimazaki, Chihiro</au><au>Miyata, Akira</au><au>Tajima, Fumihito</au><au>Takemoto, Yoshinobu</au><au>Miwa, Akiyoshi</au><au>Chou, Takaaki</au><au>Harada, Mine</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I/II study of tandem high-dose chemotherapy with autologous peripheral blood stem cell transplantation for advanced multiple myeloma</atitle><jtitle>International journal of hematology</jtitle><stitle>Int J Hematol</stitle><addtitle>Int J Hematol</addtitle><date>2009-12-01</date><risdate>2009</risdate><volume>90</volume><issue>5</issue><spage>635</spage><epage>642</epage><pages>635-642</pages><issn>0925-5710</issn><eissn>1865-3774</eissn><abstract>The efficacy and safety of high-dose chemotherapy with tandem autologous peripheral blood stem cell transplantation (auto-PBSCT) were evaluated in a multicenter clinical study of patients with advanced multiple myeloma. Eligible patients (
n
= 40) were consecutively enrolled in the phase I/II study and received 2–4 cycles of vincristine–adriamycin–dexamethasone regimen. The responding patients underwent PBSC harvesting following high-dose cyclophosphamide and filgrastim administration. The first auto-PBSCT (
n
= 32) following high-dose melphalan (200 mg/m
2
) was performed within 2 months of PBSC harvesting; the second auto-PBSCT (
n
= 28) was scheduled 3–6 months later. Treatment-related mortality was 2.5% (
n
= 1) throughout the protocol. Grade 4 nonhematologic toxicity occurred in 12.5 and 14.3% of the first and second auto-PBSCT patients, respectively. All but one patient (who died) achieved hematopoietic recovery. For the 28 patients completing the second auto-PBSCT, the results were favorable with a response rate of 65% (complete response rate = 27.5%,
n
= 11); the five-year progression-free survival and overall survival were 20.3 and 66.5%, respectively. In conclusion, high-dose chemotherapy with tandem auto-PBSCT is feasible and safe with a favorable response rate in treating advanced multiple myeloma in Japan.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>19936876</pmid><doi>10.1007/s12185-009-0445-8</doi><tpages>8</tpages></addata></record> |
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| ispartof | International journal of hematology, 2009-12, Vol.90 (5), p.635-642 |
| issn | 0925-5710 1865-3774 |
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| source | MEDLINE; SpringerLink Journals |
| subjects | Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Combined Modality Therapy - methods Combined Modality Therapy - mortality Dexamethasone - administration & dosage Doxorubicin - administration & dosage Hematologic and hematopoietic diseases Hematology Humans Immunodeficiencies. Immunoglobulinopathies Immunoglobulinopathies Immunopathology Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis Medical sciences Medicine Medicine & Public Health Multiple Myeloma - mortality Multiple Myeloma - therapy Oncology Original Article Peripheral Blood Stem Cell Transplantation - methods Survival Rate Transplantation, Autologous Treatment Outcome Vincristine - administration & dosage |
| title | Phase I/II study of tandem high-dose chemotherapy with autologous peripheral blood stem cell transplantation for advanced multiple myeloma |
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