A monocentric study of steroid-refractory acute graft-versus-host disease treatment with tacrolimus and mTOR inhibitor.
Identifieur interne : 000157 ( Main/Exploration ); précédent : 000156; suivant : 000158A monocentric study of steroid-refractory acute graft-versus-host disease treatment with tacrolimus and mTOR inhibitor.
Auteurs : Alienor Xhaard [France] ; Manon Launay [France] ; Flore Sicre De Fontbrune [France] ; David Michonneau [France] ; Aurelien Sutra Del Galy [France] ; Tereza Coman [France] ; Simona Pagliuca [France] ; Nathalie Dhedin [France] ; Marie Robin [France] ; Regis Peffault De Latour [France] ; Gerard Socie [France]Source :
- Bone marrow transplantation [ 1476-5365 ] ; 2020.
Abstract
Acute graft-versus-host disease (aGVHD) remains one of the leading causes of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. No consensus exists on the best second-line treatment of steroid-refractory acute GVHD (SR-aGVHD). Previously published smaller studies on the use of sirolimus in SR-aGVHD treatment report a response rate of 57 to 86%, with 40% overall survival. The association of tacrolimus and mTOR inhibitor is supported by pre-clinical data and has been used as GVHD prophylaxis. We report 42 patients who received tacrolimus and mTOR inhibitor as a second- or third-line treatment of SR-aGVHD. Thirty-one patients were treated in second-line, with an overall response rate of 48.5% (complete response: 42%). Eleven patients were treated in third-line, with an overall response rate of 27%. Thirty-eight patients had at least one episode of infection, due to bacteria, viruses, fungi and parasites in 61, 42, 12 and two episodes, respectively. For patients treated in second-line, six-month and one-year survival were 61% and 42%, respectively. None of the patients treated in third-line survived. These results were not promising enough to initiate a phase three randomized clinical trial, but tacrolimus and mTOR inhibitor can be discussed among other options for patients with SR-aGVHD.
DOI: 10.1038/s41409-019-0633-y
PubMed: 31413313
Affiliations:
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<front><div type="abstract" xml:lang="en">Acute graft-versus-host disease (aGVHD) remains one of the leading causes of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. No consensus exists on the best second-line treatment of steroid-refractory acute GVHD (SR-aGVHD). Previously published smaller studies on the use of sirolimus in SR-aGVHD treatment report a response rate of 57 to 86%, with 40% overall survival. The association of tacrolimus and mTOR inhibitor is supported by pre-clinical data and has been used as GVHD prophylaxis. We report 42 patients who received tacrolimus and mTOR inhibitor as a second- or third-line treatment of SR-aGVHD. Thirty-one patients were treated in second-line, with an overall response rate of 48.5% (complete response: 42%). Eleven patients were treated in third-line, with an overall response rate of 27%. Thirty-eight patients had at least one episode of infection, due to bacteria, viruses, fungi and parasites in 61, 42, 12 and two episodes, respectively. For patients treated in second-line, six-month and one-year survival were 61% and 42%, respectively. None of the patients treated in third-line survived. These results were not promising enough to initiate a phase three randomized clinical trial, but tacrolimus and mTOR inhibitor can be discussed among other options for patients with SR-aGVHD.</div>
</front>
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<Title>Bone marrow transplantation</Title>
<ISOAbbreviation>Bone Marrow Transplant</ISOAbbreviation>
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<Abstract><AbstractText>Acute graft-versus-host disease (aGVHD) remains one of the leading causes of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. No consensus exists on the best second-line treatment of steroid-refractory acute GVHD (SR-aGVHD). Previously published smaller studies on the use of sirolimus in SR-aGVHD treatment report a response rate of 57 to 86%, with 40% overall survival. The association of tacrolimus and mTOR inhibitor is supported by pre-clinical data and has been used as GVHD prophylaxis. We report 42 patients who received tacrolimus and mTOR inhibitor as a second- or third-line treatment of SR-aGVHD. Thirty-one patients were treated in second-line, with an overall response rate of 48.5% (complete response: 42%). Eleven patients were treated in third-line, with an overall response rate of 27%. Thirty-eight patients had at least one episode of infection, due to bacteria, viruses, fungi and parasites in 61, 42, 12 and two episodes, respectively. For patients treated in second-line, six-month and one-year survival were 61% and 42%, respectively. None of the patients treated in third-line survived. These results were not promising enough to initiate a phase three randomized clinical trial, but tacrolimus and mTOR inhibitor can be discussed among other options for patients with SR-aGVHD.</AbstractText>
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<ForeName>Tereza</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pagliuca</LastName>
<ForeName>Simona</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Dhedin</LastName>
<ForeName>Nathalie</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>Service d'hématologie adolescents-jeunes adultes, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Robin</LastName>
<ForeName>Marie</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Peffault de Latour</LastName>
<ForeName>Regis</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Socie</LastName>
<ForeName>Gerard</ForeName>
<Initials>G</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0002-2114-7533</Identifier>
<AffiliationInfo><Affiliation>Service d'hématologie-greffe, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Inserm UMR1160, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
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<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2019</Year>
<Month>08</Month>
<Day>14</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Bone Marrow Transplant</MedlineTA>
<NlmUniqueID>8702459</NlmUniqueID>
<ISSNLinking>0268-3369</ISSNLinking>
</MedlineJournalInfo>
<CitationSubset>IM</CitationSubset>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2019</Year>
<Month>01</Month>
<Day>28</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2019</Year>
<Month>06</Month>
<Day>22</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2019</Year>
<Month>06</Month>
<Day>02</Day>
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<PubMedPubDate PubStatus="pubmed"><Year>2019</Year>
<Month>8</Month>
<Day>16</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="medline"><Year>2019</Year>
<Month>8</Month>
<Day>16</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="entrez"><Year>2019</Year>
<Month>8</Month>
<Day>16</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">31413313</ArticleId>
<ArticleId IdType="doi">10.1038/s41409-019-0633-y</ArticleId>
<ArticleId IdType="pii">10.1038/s41409-019-0633-y</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>France</li>
</country>
<region><li>Île-de-France</li>
</region>
<settlement><li>Paris</li>
</settlement>
</list>
<tree><country name="France"><region name="Île-de-France"><name sortKey="Xhaard, Alienor" sort="Xhaard, Alienor" uniqKey="Xhaard A" first="Alienor" last="Xhaard">Alienor Xhaard</name>
</region>
<name sortKey="Coman, Tereza" sort="Coman, Tereza" uniqKey="Coman T" first="Tereza" last="Coman">Tereza Coman</name>
<name sortKey="Dhedin, Nathalie" sort="Dhedin, Nathalie" uniqKey="Dhedin N" first="Nathalie" last="Dhedin">Nathalie Dhedin</name>
<name sortKey="Launay, Manon" sort="Launay, Manon" uniqKey="Launay M" first="Manon" last="Launay">Manon Launay</name>
<name sortKey="Michonneau, David" sort="Michonneau, David" uniqKey="Michonneau D" first="David" last="Michonneau">David Michonneau</name>
<name sortKey="Pagliuca, Simona" sort="Pagliuca, Simona" uniqKey="Pagliuca S" first="Simona" last="Pagliuca">Simona Pagliuca</name>
<name sortKey="Peffault De Latour, Regis" sort="Peffault De Latour, Regis" uniqKey="Peffault De Latour R" first="Regis" last="Peffault De Latour">Regis Peffault De Latour</name>
<name sortKey="Robin, Marie" sort="Robin, Marie" uniqKey="Robin M" first="Marie" last="Robin">Marie Robin</name>
<name sortKey="Sicre De Fontbrune, Flore" sort="Sicre De Fontbrune, Flore" uniqKey="Sicre De Fontbrune F" first="Flore" last="Sicre De Fontbrune">Flore Sicre De Fontbrune</name>
<name sortKey="Socie, Gerard" sort="Socie, Gerard" uniqKey="Socie G" first="Gerard" last="Socie">Gerard Socie</name>
<name sortKey="Socie, Gerard" sort="Socie, Gerard" uniqKey="Socie G" first="Gerard" last="Socie">Gerard Socie</name>
<name sortKey="Sutra Del Galy, Aurelien" sort="Sutra Del Galy, Aurelien" uniqKey="Sutra Del Galy A" first="Aurelien" last="Sutra Del Galy">Aurelien Sutra Del Galy</name>
</country>
</tree>
</affiliations>
</record>
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