Single response assessment of transplant-ineligible multiple myeloma: a supplementary analysis of JCOG1105 (JCOG1105S1)
Abstract Background The International Myeloma Working Group response criteria require two consecutive assessments of paraprotein levels. We conducted an exploratory analysis to evaluate whether a single response assessment could be a substitute for the International Myeloma Working Group criteria us...
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| Veröffentlicht in: | Japanese journal of clinical oncology 2021-07, Vol.51 (7), p.1059-1066 |
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| creator | Nakamura, Nobuhiko Maruyama, Dai Machida, Ryunosuke Ichinohe, Tatsuo Takayama, Nobuyuki Ohba, Rie Ohmachi, Ken Imaizumi, Yoshitaka Tokunaga, Masahito Katsuya, Hiroo Yoshida, Isao Sunami, Kazutaka Kurosawa, Mitsutoshi Kubota, Nobuko Morimoto, Hiroaki Kobayashi, Miki Kato, Harumi Kameoka, Yoshihiro Kagami, Yoshitoyo Kizaki, Masahiro Takeuchi, Kazuto Munakata, Wataru Iida, Shinsuke Nagai, Hirokazu |
| description | Abstract
Background
The International Myeloma Working Group response criteria require two consecutive assessments of paraprotein levels. We conducted an exploratory analysis to evaluate whether a single response assessment could be a substitute for the International Myeloma Working Group criteria using data from JCOG1105, a randomized phase II study on melphalan, prednisolone and bortezomib.
Methods
Of 91 patients with transplant-ineligible newly diagnosed multiple myeloma, 79 patients were included. We calculated the kappa coefficient to evaluate the degree of agreement between the International Myeloma Working Group criteria and the single response assessment.
Results
Based on the International Myeloma Working Group criteria, 11 (13.9%), 20 (25.3%), 36 (45.6%) and 12 (15.2%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. Based on the single response assessment, 17 (21.5%), 19 (24.1%), 35 (44.3%) and 8 (10.1%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. The kappa coefficient was 0.76 (95% confidence interval, 0.65–0.88), demonstrating good agreement. The single response assessment was not inferior to the International Myeloma Working Group criteria in the median progression-free survival (3.8 and 2.9 years) in stringent complete response/complete response patients, suggesting that the single response assessment was not an overestimation.
Conclusions
The single response assessment could be a substitute for the current International Myeloma Working Group criteria for transplant-ineligible newly diagnosed multiple myeloma.
The single response assessment could be a substitute for the current International Myeloma Working Group criteria with two consecutive assessments in patients with transplant-ineligible newly diagnosed multiple myeloma. |
| doi_str_mv | 10.1093/jjco/hyab066 |
| format | Article |
| fullrecord | <record><control><sourceid>oup_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8246272</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/jjco/hyab066</oup_id><sourcerecordid>10.1093/jjco/hyab066</sourcerecordid><originalsourceid>FETCH-LOGICAL-c397t-71fea243e81a23aab85f5c4d9b667927b46b06b7411f34541534afd842db6b0e3</originalsourceid><addsrcrecordid>eNp9kUlPwzAQhS0EomW5cUa5ARKhdrwlHJBQBQVUqYfCOZqkTusqcaI4AeXf46iLyoWTnzxvvhn7IXRF8APBER2t12k5WnWQYCGO0JAwwX0qAnJ8oAfozNo1xpiHTJ6iAaURj6TEQ_Qz12aZK69WtiqNVR5Yq6wtlGm8MvOaGoytcjCNr43K9VInzly0eaOrXnQqLwt49MCzbeVu-j6oOw8M5J3Vtmd8jGcTQjD3bndqTu4u0EkGuVWX2_Mcfb2-fI7f_Ols8j5-nvopjWTjS5IpCBhVIYGAAiQhz3jKFlEihIwCmTDh3p1IRkhGGWeEUwbZImTBInEVRc_R04ZbtUmhFqnbr4Y8rmpduD3jEnT8t2L0Kl6W33EYMBHIwAHuN4C0Lq2tVbbvJTjuA4j7AOJtAM5-fThvb979uDPcbAxlW_2P-gUVNJIU</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Single response assessment of transplant-ineligible multiple myeloma: a supplementary analysis of JCOG1105 (JCOG1105S1)</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>Nakamura, Nobuhiko ; Maruyama, Dai ; Machida, Ryunosuke ; Ichinohe, Tatsuo ; Takayama, Nobuyuki ; Ohba, Rie ; Ohmachi, Ken ; Imaizumi, Yoshitaka ; Tokunaga, Masahito ; Katsuya, Hiroo ; Yoshida, Isao ; Sunami, Kazutaka ; Kurosawa, Mitsutoshi ; Kubota, Nobuko ; Morimoto, Hiroaki ; Kobayashi, Miki ; Kato, Harumi ; Kameoka, Yoshihiro ; Kagami, Yoshitoyo ; Kizaki, Masahiro ; Takeuchi, Kazuto ; Munakata, Wataru ; Iida, Shinsuke ; Nagai, Hirokazu</creator><creatorcontrib>Nakamura, Nobuhiko ; Maruyama, Dai ; Machida, Ryunosuke ; Ichinohe, Tatsuo ; Takayama, Nobuyuki ; Ohba, Rie ; Ohmachi, Ken ; Imaizumi, Yoshitaka ; Tokunaga, Masahito ; Katsuya, Hiroo ; Yoshida, Isao ; Sunami, Kazutaka ; Kurosawa, Mitsutoshi ; Kubota, Nobuko ; Morimoto, Hiroaki ; Kobayashi, Miki ; Kato, Harumi ; Kameoka, Yoshihiro ; Kagami, Yoshitoyo ; Kizaki, Masahiro ; Takeuchi, Kazuto ; Munakata, Wataru ; Iida, Shinsuke ; Nagai, Hirokazu</creatorcontrib><description>Abstract
Background
The International Myeloma Working Group response criteria require two consecutive assessments of paraprotein levels. We conducted an exploratory analysis to evaluate whether a single response assessment could be a substitute for the International Myeloma Working Group criteria using data from JCOG1105, a randomized phase II study on melphalan, prednisolone and bortezomib.
Methods
Of 91 patients with transplant-ineligible newly diagnosed multiple myeloma, 79 patients were included. We calculated the kappa coefficient to evaluate the degree of agreement between the International Myeloma Working Group criteria and the single response assessment.
Results
Based on the International Myeloma Working Group criteria, 11 (13.9%), 20 (25.3%), 36 (45.6%) and 12 (15.2%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. Based on the single response assessment, 17 (21.5%), 19 (24.1%), 35 (44.3%) and 8 (10.1%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. The kappa coefficient was 0.76 (95% confidence interval, 0.65–0.88), demonstrating good agreement. The single response assessment was not inferior to the International Myeloma Working Group criteria in the median progression-free survival (3.8 and 2.9 years) in stringent complete response/complete response patients, suggesting that the single response assessment was not an overestimation.
Conclusions
The single response assessment could be a substitute for the current International Myeloma Working Group criteria for transplant-ineligible newly diagnosed multiple myeloma.
The single response assessment could be a substitute for the current International Myeloma Working Group criteria with two consecutive assessments in patients with transplant-ineligible newly diagnosed multiple myeloma.</description><identifier>ISSN: 1465-3621</identifier><identifier>ISSN: 0368-2811</identifier><identifier>EISSN: 1465-3621</identifier><identifier>DOI: 10.1093/jjco/hyab066</identifier><identifier>PMID: 33959770</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Original</subject><ispartof>Japanese journal of clinical oncology, 2021-07, Vol.51 (7), p.1059-1066</ispartof><rights>The Author(s) 2021. Published by Oxford University Press. 2021</rights><rights>The Author(s) 2021. Published by Oxford University Press.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c397t-71fea243e81a23aab85f5c4d9b667927b46b06b7411f34541534afd842db6b0e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,1578,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33959770$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nakamura, Nobuhiko</creatorcontrib><creatorcontrib>Maruyama, Dai</creatorcontrib><creatorcontrib>Machida, Ryunosuke</creatorcontrib><creatorcontrib>Ichinohe, Tatsuo</creatorcontrib><creatorcontrib>Takayama, Nobuyuki</creatorcontrib><creatorcontrib>Ohba, Rie</creatorcontrib><creatorcontrib>Ohmachi, Ken</creatorcontrib><creatorcontrib>Imaizumi, Yoshitaka</creatorcontrib><creatorcontrib>Tokunaga, Masahito</creatorcontrib><creatorcontrib>Katsuya, Hiroo</creatorcontrib><creatorcontrib>Yoshida, Isao</creatorcontrib><creatorcontrib>Sunami, Kazutaka</creatorcontrib><creatorcontrib>Kurosawa, Mitsutoshi</creatorcontrib><creatorcontrib>Kubota, Nobuko</creatorcontrib><creatorcontrib>Morimoto, Hiroaki</creatorcontrib><creatorcontrib>Kobayashi, Miki</creatorcontrib><creatorcontrib>Kato, Harumi</creatorcontrib><creatorcontrib>Kameoka, Yoshihiro</creatorcontrib><creatorcontrib>Kagami, Yoshitoyo</creatorcontrib><creatorcontrib>Kizaki, Masahiro</creatorcontrib><creatorcontrib>Takeuchi, Kazuto</creatorcontrib><creatorcontrib>Munakata, Wataru</creatorcontrib><creatorcontrib>Iida, Shinsuke</creatorcontrib><creatorcontrib>Nagai, Hirokazu</creatorcontrib><title>Single response assessment of transplant-ineligible multiple myeloma: a supplementary analysis of JCOG1105 (JCOG1105S1)</title><title>Japanese journal of clinical oncology</title><addtitle>Jpn J Clin Oncol</addtitle><description>Abstract
Background
The International Myeloma Working Group response criteria require two consecutive assessments of paraprotein levels. We conducted an exploratory analysis to evaluate whether a single response assessment could be a substitute for the International Myeloma Working Group criteria using data from JCOG1105, a randomized phase II study on melphalan, prednisolone and bortezomib.
Methods
Of 91 patients with transplant-ineligible newly diagnosed multiple myeloma, 79 patients were included. We calculated the kappa coefficient to evaluate the degree of agreement between the International Myeloma Working Group criteria and the single response assessment.
Results
Based on the International Myeloma Working Group criteria, 11 (13.9%), 20 (25.3%), 36 (45.6%) and 12 (15.2%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. Based on the single response assessment, 17 (21.5%), 19 (24.1%), 35 (44.3%) and 8 (10.1%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. The kappa coefficient was 0.76 (95% confidence interval, 0.65–0.88), demonstrating good agreement. The single response assessment was not inferior to the International Myeloma Working Group criteria in the median progression-free survival (3.8 and 2.9 years) in stringent complete response/complete response patients, suggesting that the single response assessment was not an overestimation.
Conclusions
The single response assessment could be a substitute for the current International Myeloma Working Group criteria for transplant-ineligible newly diagnosed multiple myeloma.
The single response assessment could be a substitute for the current International Myeloma Working Group criteria with two consecutive assessments in patients with transplant-ineligible newly diagnosed multiple myeloma.</description><subject>Original</subject><issn>1465-3621</issn><issn>0368-2811</issn><issn>1465-3621</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNp9kUlPwzAQhS0EomW5cUa5ARKhdrwlHJBQBQVUqYfCOZqkTusqcaI4AeXf46iLyoWTnzxvvhn7IXRF8APBER2t12k5WnWQYCGO0JAwwX0qAnJ8oAfozNo1xpiHTJ6iAaURj6TEQ_Qz12aZK69WtiqNVR5Yq6wtlGm8MvOaGoytcjCNr43K9VInzly0eaOrXnQqLwt49MCzbeVu-j6oOw8M5J3Vtmd8jGcTQjD3bndqTu4u0EkGuVWX2_Mcfb2-fI7f_Ols8j5-nvopjWTjS5IpCBhVIYGAAiQhz3jKFlEihIwCmTDh3p1IRkhGGWeEUwbZImTBInEVRc_R04ZbtUmhFqnbr4Y8rmpduD3jEnT8t2L0Kl6W33EYMBHIwAHuN4C0Lq2tVbbvJTjuA4j7AOJtAM5-fThvb979uDPcbAxlW_2P-gUVNJIU</recordid><startdate>20210701</startdate><enddate>20210701</enddate><creator>Nakamura, Nobuhiko</creator><creator>Maruyama, Dai</creator><creator>Machida, Ryunosuke</creator><creator>Ichinohe, Tatsuo</creator><creator>Takayama, Nobuyuki</creator><creator>Ohba, Rie</creator><creator>Ohmachi, Ken</creator><creator>Imaizumi, Yoshitaka</creator><creator>Tokunaga, Masahito</creator><creator>Katsuya, Hiroo</creator><creator>Yoshida, Isao</creator><creator>Sunami, Kazutaka</creator><creator>Kurosawa, Mitsutoshi</creator><creator>Kubota, Nobuko</creator><creator>Morimoto, Hiroaki</creator><creator>Kobayashi, Miki</creator><creator>Kato, Harumi</creator><creator>Kameoka, Yoshihiro</creator><creator>Kagami, Yoshitoyo</creator><creator>Kizaki, Masahiro</creator><creator>Takeuchi, Kazuto</creator><creator>Munakata, Wataru</creator><creator>Iida, Shinsuke</creator><creator>Nagai, Hirokazu</creator><general>Oxford University Press</general><scope>TOX</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20210701</creationdate><title>Single response assessment of transplant-ineligible multiple myeloma: a supplementary analysis of JCOG1105 (JCOG1105S1)</title><author>Nakamura, Nobuhiko ; Maruyama, Dai ; Machida, Ryunosuke ; Ichinohe, Tatsuo ; Takayama, Nobuyuki ; Ohba, Rie ; Ohmachi, Ken ; Imaizumi, Yoshitaka ; Tokunaga, Masahito ; Katsuya, Hiroo ; Yoshida, Isao ; Sunami, Kazutaka ; Kurosawa, Mitsutoshi ; Kubota, Nobuko ; Morimoto, Hiroaki ; Kobayashi, Miki ; Kato, Harumi ; Kameoka, Yoshihiro ; Kagami, Yoshitoyo ; Kizaki, Masahiro ; Takeuchi, Kazuto ; Munakata, Wataru ; Iida, Shinsuke ; Nagai, Hirokazu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c397t-71fea243e81a23aab85f5c4d9b667927b46b06b7411f34541534afd842db6b0e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Original</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nakamura, Nobuhiko</creatorcontrib><creatorcontrib>Maruyama, Dai</creatorcontrib><creatorcontrib>Machida, Ryunosuke</creatorcontrib><creatorcontrib>Ichinohe, Tatsuo</creatorcontrib><creatorcontrib>Takayama, Nobuyuki</creatorcontrib><creatorcontrib>Ohba, Rie</creatorcontrib><creatorcontrib>Ohmachi, Ken</creatorcontrib><creatorcontrib>Imaizumi, Yoshitaka</creatorcontrib><creatorcontrib>Tokunaga, Masahito</creatorcontrib><creatorcontrib>Katsuya, Hiroo</creatorcontrib><creatorcontrib>Yoshida, Isao</creatorcontrib><creatorcontrib>Sunami, Kazutaka</creatorcontrib><creatorcontrib>Kurosawa, Mitsutoshi</creatorcontrib><creatorcontrib>Kubota, Nobuko</creatorcontrib><creatorcontrib>Morimoto, Hiroaki</creatorcontrib><creatorcontrib>Kobayashi, Miki</creatorcontrib><creatorcontrib>Kato, Harumi</creatorcontrib><creatorcontrib>Kameoka, Yoshihiro</creatorcontrib><creatorcontrib>Kagami, Yoshitoyo</creatorcontrib><creatorcontrib>Kizaki, Masahiro</creatorcontrib><creatorcontrib>Takeuchi, Kazuto</creatorcontrib><creatorcontrib>Munakata, Wataru</creatorcontrib><creatorcontrib>Iida, Shinsuke</creatorcontrib><creatorcontrib>Nagai, Hirokazu</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>PubMed</collection><collection>CrossRef</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>Nakamura, Nobuhiko</au><au>Maruyama, Dai</au><au>Machida, Ryunosuke</au><au>Ichinohe, Tatsuo</au><au>Takayama, Nobuyuki</au><au>Ohba, Rie</au><au>Ohmachi, Ken</au><au>Imaizumi, Yoshitaka</au><au>Tokunaga, Masahito</au><au>Katsuya, Hiroo</au><au>Yoshida, Isao</au><au>Sunami, Kazutaka</au><au>Kurosawa, Mitsutoshi</au><au>Kubota, Nobuko</au><au>Morimoto, Hiroaki</au><au>Kobayashi, Miki</au><au>Kato, Harumi</au><au>Kameoka, Yoshihiro</au><au>Kagami, Yoshitoyo</au><au>Kizaki, Masahiro</au><au>Takeuchi, Kazuto</au><au>Munakata, Wataru</au><au>Iida, Shinsuke</au><au>Nagai, Hirokazu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Single response assessment of transplant-ineligible multiple myeloma: a supplementary analysis of JCOG1105 (JCOG1105S1)</atitle><jtitle>Japanese journal of clinical oncology</jtitle><addtitle>Jpn J Clin Oncol</addtitle><date>2021-07-01</date><risdate>2021</risdate><volume>51</volume><issue>7</issue><spage>1059</spage><epage>1066</epage><pages>1059-1066</pages><issn>1465-3621</issn><issn>0368-2811</issn><eissn>1465-3621</eissn><abstract>Abstract
Background
The International Myeloma Working Group response criteria require two consecutive assessments of paraprotein levels. We conducted an exploratory analysis to evaluate whether a single response assessment could be a substitute for the International Myeloma Working Group criteria using data from JCOG1105, a randomized phase II study on melphalan, prednisolone and bortezomib.
Methods
Of 91 patients with transplant-ineligible newly diagnosed multiple myeloma, 79 patients were included. We calculated the kappa coefficient to evaluate the degree of agreement between the International Myeloma Working Group criteria and the single response assessment.
Results
Based on the International Myeloma Working Group criteria, 11 (13.9%), 20 (25.3%), 36 (45.6%) and 12 (15.2%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. Based on the single response assessment, 17 (21.5%), 19 (24.1%), 35 (44.3%) and 8 (10.1%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. The kappa coefficient was 0.76 (95% confidence interval, 0.65–0.88), demonstrating good agreement. The single response assessment was not inferior to the International Myeloma Working Group criteria in the median progression-free survival (3.8 and 2.9 years) in stringent complete response/complete response patients, suggesting that the single response assessment was not an overestimation.
Conclusions
The single response assessment could be a substitute for the current International Myeloma Working Group criteria for transplant-ineligible newly diagnosed multiple myeloma.
The single response assessment could be a substitute for the current International Myeloma Working Group criteria with two consecutive assessments in patients with transplant-ineligible newly diagnosed multiple myeloma.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>33959770</pmid><doi>10.1093/jjco/hyab066</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Original |
| title | Single response assessment of transplant-ineligible multiple myeloma: a supplementary analysis of JCOG1105 (JCOG1105S1) |
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