Systemic treatment of AIDS-related kaposi's sarcoma: Results of a randomized trial
Identifieur interne : 002A06 ( Istex/Corpus ); précédent : 002A05; suivant : 002A07Systemic treatment of AIDS-related kaposi's sarcoma: Results of a randomized trial
Auteurs : Parkash S. Gill ; Mark Rarick ; J. Allen Mccutchan ; Lewis Slater ; Barbara Parker ; Elaine Muchmore ; Marjorie Bernstein-Singer ; Bisher Akil ; Byron M. Espina ; Mark Krailo ; Alexandra LevineSource :
- The American Journal of Medicine [ 0002-9343 ] ; 1991.
Abstract
purpose: Patients with acquired immunodeficiency syndrome (AIDS)-related epidemic Kaposi's sarcoma generally respond well to cytotoxic chemotherapy. However, due to the associated myelosuppression, these patients are at risk for developing complicating infections that may affect survival. We therefore conducted a multicenter, randomized clinical trial comparing single-agent against combination chemotherapy in advanced AIDS-related Kaposi's sarcoma. Lowdose chemotherapy was employed to evaluate its role in combination therapy for this disease and the toxicities associated with the lower intensity.patients and methods: Sixty-one patients with extensive mucocutaneous Kaposi's sarcoma or visceral involvement were randomized for treatment with low-dose Adriamycin (doxorubicin, 20 mg/m2) alone (31 cases) or in combination with bleomycin and vincristine (ABV) (30 cases). Patients were randomized within strata based on prognostic features associated with shorter survival in prior studies. Both treatment arms were evenly matched at study entry.results: Complete and partial tumor remissions were significantly higher with ABV (88%) than with Adriamycin alone (48%) (p = 0.004). The median survival was 9 months in both groups. Study entry criteria significantly associated with shorter survival included CD4 lymphocyte counts less than 100/mm3, hemoglobin level less than 10 g/dL, a history of constitutional symptoms, and a prior history of opportunistic infection(s). Toxicities were similar in both arms, and the regimens were well tolerated. Neutropenia (granulocyte count less than 1,000/ mm3) occurred in 34% of patients receiving Adriamycin alone and in 52% of patients receiving ABV and was progressive in successive courses of chemotherapy in both treatment arms. The development of AIDS-defined opportunistic infections was relatively infrequent during therapy (14%).conclusions: Low-dose ABV is an effective chemotherapy regimen for the treatment of extensive Kaposi's sarcoma. ABV chemotherapy is associated with significantly higher responses than Adriamycin alone and with acceptable toxicity.
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DOI: 10.1016/0002-9343(91)90601-S
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Systemic treatment of AIDS-related kaposi's sarcoma: Results of a randomized trial</title><author><name sortKey="Gill, Parkash S" sort="Gill, Parkash S" uniqKey="Gill P" first="Parkash S." last="Gill">Parkash S. Gill</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Rarick, Mark" sort="Rarick, Mark" uniqKey="Rarick M" first="Mark" last="Rarick">Mark Rarick</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Mccutchan, J Allen" sort="Mccutchan, J Allen" uniqKey="Mccutchan J" first="J. Allen" last="Mccutchan">J. Allen Mccutchan</name><affiliation><mods:affiliation>University of California at San Diego, San Diego, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Slater, Lewis" sort="Slater, Lewis" uniqKey="Slater L" first="Lewis" last="Slater">Lewis Slater</name><affiliation><mods:affiliation>University of California at Irvine, Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Parker, Barbara" sort="Parker, Barbara" uniqKey="Parker B" first="Barbara" last="Parker">Barbara Parker</name><affiliation><mods:affiliation>University of California at San Diego, San Diego, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Muchmore, Elaine" sort="Muchmore, Elaine" uniqKey="Muchmore E" first="Elaine" last="Muchmore">Elaine Muchmore</name><affiliation><mods:affiliation>University of California at San Diego, San Diego, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Bernstein Singer, Marjorie" sort="Bernstein Singer, Marjorie" uniqKey="Bernstein Singer M" first="Marjorie" last="Bernstein-Singer">Marjorie Bernstein-Singer</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Akil, Bisher" sort="Akil, Bisher" uniqKey="Akil B" first="Bisher" last="Akil">Bisher Akil</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Espina, Byron M" sort="Espina, Byron M" uniqKey="Espina B" first="Byron M." last="Espina">Byron M. Espina</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Krailo, Mark" sort="Krailo, Mark" uniqKey="Krailo M" first="Mark" last="Krailo">Mark Krailo</name><affiliation><mods:affiliation>Department of Preventive Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Levine, Alexandra" sort="Levine, Alexandra" uniqKey="Levine A" first="Alexandra" last="Levine">Alexandra Levine</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:5AABF6C54488C030EFD7AFD84DEA18A99D38E0AF</idno><date when="1991" year="1991">1991</date><idno type="doi">10.1016/0002-9343(91)90601-S</idno><idno type="url">https://api.istex.fr/document/5AABF6C54488C030EFD7AFD84DEA18A99D38E0AF/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">002A06</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">002A06</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Systemic treatment of AIDS-related kaposi's sarcoma: Results of a randomized trial</title><author><name sortKey="Gill, Parkash S" sort="Gill, Parkash S" uniqKey="Gill P" first="Parkash S." last="Gill">Parkash S. Gill</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Rarick, Mark" sort="Rarick, Mark" uniqKey="Rarick M" first="Mark" last="Rarick">Mark Rarick</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Mccutchan, J Allen" sort="Mccutchan, J Allen" uniqKey="Mccutchan J" first="J. Allen" last="Mccutchan">J. Allen Mccutchan</name><affiliation><mods:affiliation>University of California at San Diego, San Diego, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Slater, Lewis" sort="Slater, Lewis" uniqKey="Slater L" first="Lewis" last="Slater">Lewis Slater</name><affiliation><mods:affiliation>University of California at Irvine, Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Parker, Barbara" sort="Parker, Barbara" uniqKey="Parker B" first="Barbara" last="Parker">Barbara Parker</name><affiliation><mods:affiliation>University of California at San Diego, San Diego, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Muchmore, Elaine" sort="Muchmore, Elaine" uniqKey="Muchmore E" first="Elaine" last="Muchmore">Elaine Muchmore</name><affiliation><mods:affiliation>University of California at San Diego, San Diego, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Bernstein Singer, Marjorie" sort="Bernstein Singer, Marjorie" uniqKey="Bernstein Singer M" first="Marjorie" last="Bernstein-Singer">Marjorie Bernstein-Singer</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Akil, Bisher" sort="Akil, Bisher" uniqKey="Akil B" first="Bisher" last="Akil">Bisher Akil</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Espina, Byron M" sort="Espina, Byron M" uniqKey="Espina B" first="Byron M." last="Espina">Byron M. Espina</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Krailo, Mark" sort="Krailo, Mark" uniqKey="Krailo M" first="Mark" last="Krailo">Mark Krailo</name><affiliation><mods:affiliation>Department of Preventive Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Levine, Alexandra" sort="Levine, Alexandra" uniqKey="Levine A" first="Alexandra" last="Levine">Alexandra Levine</name><affiliation><mods:affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">The American Journal of Medicine</title><title level="j" type="abbrev">AJM</title><idno type="ISSN">0002-9343</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1991">1991</date><biblScope unit="volume">90</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="427">427</biblScope><biblScope unit="page" to="433">433</biblScope></imprint><idno type="ISSN">0002-9343</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0002-9343</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">purpose: Patients with acquired immunodeficiency syndrome (AIDS)-related epidemic Kaposi's sarcoma generally respond well to cytotoxic chemotherapy. However, due to the associated myelosuppression, these patients are at risk for developing complicating infections that may affect survival. We therefore conducted a multicenter, randomized clinical trial comparing single-agent against combination chemotherapy in advanced AIDS-related Kaposi's sarcoma. Lowdose chemotherapy was employed to evaluate its role in combination therapy for this disease and the toxicities associated with the lower intensity.patients and methods: Sixty-one patients with extensive mucocutaneous Kaposi's sarcoma or visceral involvement were randomized for treatment with low-dose Adriamycin (doxorubicin, 20 mg/m2) alone (31 cases) or in combination with bleomycin and vincristine (ABV) (30 cases). Patients were randomized within strata based on prognostic features associated with shorter survival in prior studies. Both treatment arms were evenly matched at study entry.results: Complete and partial tumor remissions were significantly higher with ABV (88%) than with Adriamycin alone (48%) (p = 0.004). The median survival was 9 months in both groups. Study entry criteria significantly associated with shorter survival included CD4 lymphocyte counts less than 100/mm3, hemoglobin level less than 10 g/dL, a history of constitutional symptoms, and a prior history of opportunistic infection(s). Toxicities were similar in both arms, and the regimens were well tolerated. Neutropenia (granulocyte count less than 1,000/ mm3) occurred in 34% of patients receiving Adriamycin alone and in 52% of patients receiving ABV and was progressive in successive courses of chemotherapy in both treatment arms. The development of AIDS-defined opportunistic infections was relatively infrequent during therapy (14%).conclusions: Low-dose ABV is an effective chemotherapy regimen for the treatment of extensive Kaposi's sarcoma. ABV chemotherapy is associated with significantly higher responses than Adriamycin alone and with acceptable toxicity.</div></front></TEI><istex><corpusName>elsevier</corpusName><keywords><teeft><json:string>sarcoma</json:string><json:string>adriamycin</json:string><json:string>chemotherapy</json:string><json:string>toxicity</json:string><json:string>bleomycin</json:string><json:string>lymphocyte</json:string><json:string>vincristine</json:string><json:string>lymphocyte counts</json:string><json:string>prognostic</json:string><json:string>regimen</json:string><json:string>granulocyte</json:string><json:string>vinblastine</json:string><json:string>immunodeficiency</json:string><json:string>opportunistic infections</json:string><json:string>opportunistic</json:string><json:string>response rates</json:string><json:string>randomized</json:string><json:string>oncol</json:string><json:string>study entry</json:string><json:string>american journal</json:string><json:string>infectious complications</json:string><json:string>clin oncol</json:string><json:string>cytotoxic chemotherapy</json:string><json:string>clin</json:string><json:string>constitutional symptoms</json:string><json:string>medicine volume</json:string><json:string>treatment arms</json:string><json:string>epidemic sarcoma</json:string><json:string>cytotoxic</json:string><json:string>median</json:string><json:string>sarcoma gill</json:string><json:string>systemic treatment</json:string><json:string>median survival</json:string><json:string>exact test</json:string><json:string>immunodeficiency syndrome</json:string><json:string>lesion</json:string><json:string>cutaneous lesions</json:string><json:string>bacterial infections</json:string><json:string>night sweats</json:string><json:string>granulocyte counts</json:string><json:string>visceral involvement</json:string><json:string>weight loss</json:string><json:string>poor prognosis</json:string><json:string>rank test</json:string><json:string>shorter survival</json:string><json:string>pulmonary involvement</json:string><json:string>partial response</json:string><json:string>pilot studies</json:string><json:string>complete remission</json:string><json:string>hemoglobin level</json:string><json:string>combination therapy</json:string><json:string>combination chemotherapy</json:string><json:string>gill</json:string><json:string>syndrome</json:string></teeft></keywords><author><json:item><name>Parkash S. Gill M.D.</name><affiliations><json:string>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</json:string></affiliations></json:item><json:item><name>Mark Rarick M.D.</name><affiliations><json:string>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</json:string></affiliations></json:item><json:item><name>J.Allen McCutchan M.D.</name><affiliations><json:string>University of California at San Diego, San Diego, California, USA</json:string></affiliations></json:item><json:item><name>Lewis Slater M.D.</name><affiliations><json:string>University of California at Irvine, Irvine, California, USA</json:string></affiliations></json:item><json:item><name>Barbara Parker M.D.</name><affiliations><json:string>University of California at San Diego, San Diego, California, USA</json:string></affiliations></json:item><json:item><name>Elaine Muchmore M.D.</name><affiliations><json:string>University of California at San Diego, San Diego, California, USA</json:string></affiliations></json:item><json:item><name>Marjorie Bernstein-Singer M.D.</name><affiliations><json:string>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</json:string></affiliations></json:item><json:item><name>Bisher Akil M.D.</name><affiliations><json:string>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</json:string></affiliations></json:item><json:item><name>Byron M. Espina A.B.</name><affiliations><json:string>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</json:string></affiliations></json:item><json:item><name>Mark Krailo Ph.D.</name><affiliations><json:string>Department of Preventive Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</json:string></affiliations></json:item><json:item><name>Alexandra Levine M.D.</name><affiliations><json:string>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Clinical studies</value></json:item></subject><articleId><json:string>9190601S</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>Full-length article</json:string></originalGenre><abstract>purpose: Patients with acquired immunodeficiency syndrome (AIDS)-related epidemic Kaposi's sarcoma generally respond well to cytotoxic chemotherapy. However, due to the associated myelosuppression, these patients are at risk for developing complicating infections that may affect survival. We therefore conducted a multicenter, randomized clinical trial comparing single-agent against combination chemotherapy in advanced AIDS-related Kaposi's sarcoma. Lowdose chemotherapy was employed to evaluate its role in combination therapy for this disease and the toxicities associated with the lower intensity.patients and methods: Sixty-one patients with extensive mucocutaneous Kaposi's sarcoma or visceral involvement were randomized for treatment with low-dose Adriamycin (doxorubicin, 20 mg/m2) alone (31 cases) or in combination with bleomycin and vincristine (ABV) (30 cases). Patients were randomized within strata based on prognostic features associated with shorter survival in prior studies. Both treatment arms were evenly matched at study entry.results: Complete and partial tumor remissions were significantly higher with ABV (88%) than with Adriamycin alone (48%) (p = 0.004). The median survival was 9 months in both groups. Study entry criteria significantly associated with shorter survival included CD4 lymphocyte counts less than 100/mm3, hemoglobin level less than 10 g/dL, a history of constitutional symptoms, and a prior history of opportunistic infection(s). Toxicities were similar in both arms, and the regimens were well tolerated. Neutropenia (granulocyte count less than 1,000/ mm3) occurred in 34% of patients receiving Adriamycin alone and in 52% of patients receiving ABV and was progressive in successive courses of chemotherapy in both treatment arms. The development of AIDS-defined opportunistic infections was relatively infrequent during therapy (14%).conclusions: Low-dose ABV is an effective chemotherapy regimen for the treatment of extensive Kaposi's sarcoma. ABV chemotherapy is associated with significantly higher responses than Adriamycin alone and with acceptable toxicity.</abstract><qualityIndicators><score>7.165</score><pdfVersion>1.3</pdfVersion><pdfPageSize>611.84 x 827.84 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>1</keywordCount><abstractCharCount>2114</abstractCharCount><pdfWordCount>4165</pdfWordCount><pdfCharCount>29718</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>283</abstractWordCount></qualityIndicators><title>Systemic treatment of AIDS-related kaposi's sarcoma: Results of a randomized trial</title><pii><json:string>0002-9343(91)90601-S</json:string></pii><genre><json:string>research-article</json:string></genre><serie><title>[Abstract]</title><language><json:string>unknown</json:string></language><volume>6</volume><pages><first>5</first></pages></serie><host><title>The American Journal of Medicine</title><language><json:string>unknown</json:string></language><publicationDate>1991</publicationDate><issn><json:string>0002-9343</json:string></issn><pii><json:string>S0002-9343(00)X0978-3</json:string></pii><volume>90</volume><issue>1</issue><pages><first>427</first><last>433</last></pages><genre><json:string>journal</json:string></genre></host><categories><wos><json:string>science</json:string><json:string>medicine, general & internal</json:string></wos><scienceMetrix><json:string>health sciences</json:string><json:string>clinical medicine</json:string><json:string>general & internal medicine</json:string></scienceMetrix><inist><json:string>sciences appliquees, technologies et medecines</json:string><json:string>sciences biologiques et medicales</json:string><json:string>sciences medicales</json:string><json:string>hemopathies</json:string></inist></categories><publicationDate>1991</publicationDate><copyrightDate>1991</copyrightDate><doi><json:string>10.1016/0002-9343(91)90601-S</json:string></doi><id>5AABF6C54488C030EFD7AFD84DEA18A99D38E0AF</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/5AABF6C54488C030EFD7AFD84DEA18A99D38E0AF/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/5AABF6C54488C030EFD7AFD84DEA18A99D38E0AF/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/5AABF6C54488C030EFD7AFD84DEA18A99D38E0AF/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Systemic treatment of AIDS-related kaposi's sarcoma: Results of a randomized trial</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>ELSEVIER</publisher><availability><p>ELSEVIER</p></availability><date>1991</date></publicationStmt><notesStmt><note>This work was supported by funds provided by the State of California and allocated on the recommendation of the University-Wide Task Force on AIDS.</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Systemic treatment of AIDS-related kaposi's sarcoma: Results of a randomized trial</title><author xml:id="author-0000"><persName><forename type="first">Parkash S.</forename><surname>Gill</surname></persName><roleName type="degree">M.D.</roleName><note type="biography">Requests for reprints should be addressed to Parkash S. Gill, M.D., University of Southern California, Norris Cancer Hospital, 1441 Eastlake Avenue, Room 162, Los Angeles, California 90033.</note><affiliation>Requests for reprints should be addressed to Parkash S. Gill, M.D., University of Southern California, Norris Cancer Hospital, 1441 Eastlake Avenue, Room 162, Los Angeles, California 90033.</affiliation><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation></author><author xml:id="author-0001"><persName><forename type="first">Mark</forename><surname>Rarick</surname></persName><roleName type="degree">M.D.</roleName><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation></author><author xml:id="author-0002"><persName><forename type="first">J.Allen</forename><surname>McCutchan</surname></persName><roleName type="degree">M.D.</roleName><affiliation>University of California at San Diego, San Diego, California, USA</affiliation></author><author xml:id="author-0003"><persName><forename type="first">Lewis</forename><surname>Slater</surname></persName><roleName type="degree">M.D.</roleName><affiliation>University of California at Irvine, Irvine, California, USA</affiliation></author><author xml:id="author-0004"><persName><forename type="first">Barbara</forename><surname>Parker</surname></persName><roleName type="degree">M.D.</roleName><affiliation>University of California at San Diego, San Diego, California, USA</affiliation></author><author xml:id="author-0005"><persName><forename type="first">Elaine</forename><surname>Muchmore</surname></persName><roleName type="degree">M.D.</roleName><affiliation>University of California at San Diego, San Diego, California, USA</affiliation></author><author xml:id="author-0006"><persName><forename type="first">Marjorie</forename><surname>Bernstein-Singer</surname></persName><roleName type="degree">M.D.</roleName><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation></author><author xml:id="author-0007"><persName><forename type="first">Bisher</forename><surname>Akil</surname></persName><roleName type="degree">M.D.</roleName><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation></author><author xml:id="author-0008"><persName><forename type="first">Byron M.</forename><surname>Espina</surname></persName><roleName type="degree">A.B.</roleName><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation></author><author xml:id="author-0009"><persName><forename type="first">Mark</forename><surname>Krailo</surname></persName><roleName type="degree">Ph.D.</roleName><affiliation>Department of Preventive Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation></author><author xml:id="author-0010"><persName><forename type="first">Alexandra</forename><surname>Levine</surname></persName><roleName type="degree">M.D.</roleName><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation></author><idno type="istex">5AABF6C54488C030EFD7AFD84DEA18A99D38E0AF</idno><idno type="DOI">10.1016/0002-9343(91)90601-S</idno><idno type="PII">0002-9343(91)90601-S</idno><idno type="ArticleID">9190601S</idno></analytic><monogr><title level="j">The American Journal of Medicine</title><title level="j" type="abbrev">AJM</title><idno type="pISSN">0002-9343</idno><idno type="PII">S0002-9343(00)X0978-3</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1991"></date><biblScope unit="volume">90</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="427">427</biblScope><biblScope unit="page" to="433">433</biblScope></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>1991</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>purpose: Patients with acquired immunodeficiency syndrome (AIDS)-related epidemic Kaposi's sarcoma generally respond well to cytotoxic chemotherapy. However, due to the associated myelosuppression, these patients are at risk for developing complicating infections that may affect survival. We therefore conducted a multicenter, randomized clinical trial comparing single-agent against combination chemotherapy in advanced AIDS-related Kaposi's sarcoma. Lowdose chemotherapy was employed to evaluate its role in combination therapy for this disease and the toxicities associated with the lower intensity.patients and methods: Sixty-one patients with extensive mucocutaneous Kaposi's sarcoma or visceral involvement were randomized for treatment with low-dose Adriamycin (doxorubicin, 20 mg/m2) alone (31 cases) or in combination with bleomycin and vincristine (ABV) (30 cases). Patients were randomized within strata based on prognostic features associated with shorter survival in prior studies. Both treatment arms were evenly matched at study entry.results: Complete and partial tumor remissions were significantly higher with ABV (88%) than with Adriamycin alone (48%) (p = 0.004). The median survival was 9 months in both groups. Study entry criteria significantly associated with shorter survival included CD4 lymphocyte counts less than 100/mm3, hemoglobin level less than 10 g/dL, a history of constitutional symptoms, and a prior history of opportunistic infection(s). Toxicities were similar in both arms, and the regimens were well tolerated. Neutropenia (granulocyte count less than 1,000/ mm3) occurred in 34% of patients receiving Adriamycin alone and in 52% of patients receiving ABV and was progressive in successive courses of chemotherapy in both treatment arms. The development of AIDS-defined opportunistic infections was relatively infrequent during therapy (14%).conclusions: Low-dose ABV is an effective chemotherapy regimen for the treatment of extensive Kaposi's sarcoma. ABV chemotherapy is associated with significantly higher responses than Adriamycin alone and with acceptable toxicity.</p></abstract><textClass><keywords scheme="keyword"><list><head>article-category</head><item><term>Clinical studies</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="1991">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/5AABF6C54488C030EFD7AFD84DEA18A99D38E0AF/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Elsevier, elements deleted: tail"><istex:xmlDeclaration>version="1.0" encoding="UTF-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//ES//DTD journal article DTD version 4.5.2//EN//XML" URI="art452.dtd" name="istex:docType"></istex:docType><istex:document><converted-article version="4.5.2" docsubtype="fla" xml:lang="en"><item-info><jid>AJM</jid><aid>9190601S</aid><ce:pii>0002-9343(91)90601-S</ce:pii><ce:doi>10.1016/0002-9343(91)90601-S</ce:doi><ce:copyright type="unknown" year="1991"></ce:copyright><ce:doctopics><ce:doctopic><ce:text>Clinical studies</ce:text></ce:doctopic></ce:doctopics></item-info><head><ce:article-footnote><ce:label>☆</ce:label><ce:note-para>This work was supported by funds provided by the State of California and allocated on the recommendation of the University-Wide Task Force on AIDS.</ce:note-para></ce:article-footnote><ce:title>Systemic treatment of AIDS-related kaposi's sarcoma: Results of a randomized trial</ce:title><ce:author-group><ce:author><ce:given-name>Parkash S.</ce:given-name><ce:surname>Gill</ce:surname><ce:degrees>M.D.</ce:degrees><ce:cross-ref refid="COR1"><ce:sup loc="post">∗</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF1"><ce:sup loc="post">a</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Mark</ce:given-name><ce:surname>Rarick</ce:surname><ce:degrees>M.D.</ce:degrees><ce:cross-ref refid="AFF1"><ce:sup loc="post">a</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>J.Allen</ce:given-name><ce:surname>McCutchan</ce:surname><ce:degrees>M.D.</ce:degrees><ce:cross-ref refid="AFF3"><ce:sup loc="post">c</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Lewis</ce:given-name><ce:surname>Slater</ce:surname><ce:degrees>M.D.</ce:degrees><ce:cross-ref refid="AFF4"><ce:sup loc="post">d</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Barbara</ce:given-name><ce:surname>Parker</ce:surname><ce:degrees>M.D.</ce:degrees><ce:cross-ref refid="AFF3"><ce:sup loc="post">c</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Elaine</ce:given-name><ce:surname>Muchmore</ce:surname><ce:degrees>M.D.</ce:degrees><ce:cross-ref refid="AFF3"><ce:sup loc="post">c</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Marjorie</ce:given-name><ce:surname>Bernstein-Singer</ce:surname><ce:degrees>M.D.</ce:degrees><ce:cross-ref refid="AFF1"><ce:sup loc="post">a</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Bisher</ce:given-name><ce:surname>Akil</ce:surname><ce:degrees>M.D.</ce:degrees><ce:cross-ref refid="AFF1"><ce:sup loc="post">a</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Byron M.</ce:given-name><ce:surname>Espina</ce:surname><ce:degrees>A.B.</ce:degrees><ce:cross-ref refid="AFF1"><ce:sup loc="post">a</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Mark</ce:given-name><ce:surname>Krailo</ce:surname><ce:degrees>Ph.D.</ce:degrees><ce:cross-ref refid="AFF2"><ce:sup loc="post">b</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>Alexandra</ce:given-name><ce:surname>Levine</ce:surname><ce:degrees>M.D.</ce:degrees><ce:cross-ref refid="AFF1"><ce:sup loc="post">a</ce:sup></ce:cross-ref><ce:cross-ref refid="AFF5"><ce:sup loc="post">e</ce:sup></ce:cross-ref></ce:author><ce:affiliation id="AFF1"><ce:label>a</ce:label><ce:textfn>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</ce:textfn></ce:affiliation><ce:affiliation id="AFF2"><ce:label>b</ce:label><ce:textfn>Department of Preventive Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</ce:textfn></ce:affiliation><ce:affiliation id="AFF3"><ce:label>c</ce:label><ce:textfn>University of California at San Diego, San Diego, California, USA</ce:textfn></ce:affiliation><ce:affiliation id="AFF4"><ce:label>d</ce:label><ce:textfn>University of California at Irvine, Irvine, California, USA</ce:textfn></ce:affiliation><ce:affiliation id="AFF5"><ce:label>e</ce:label><ce:textfn>California Collaborative Treatment Group, San Diego, California, USA</ce:textfn></ce:affiliation><ce:correspondence id="COR1"><ce:label>∗</ce:label><ce:text>Requests for reprints should be addressed to Parkash S. Gill, M.D., University of Southern California, Norris Cancer Hospital, 1441 Eastlake Avenue, Room 162, Los Angeles, California 90033.</ce:text></ce:correspondence></ce:author-group><ce:date-received day="15" month="3" year="1990"></ce:date-received><ce:date-accepted day="19" month="11" year="1990"></ce:date-accepted><ce:abstract class="author"><ce:section-title>Abstract</ce:section-title><ce:abstract-sec><ce:simple-para view="all" id="simple-para.0010"><ce:small-caps>purpose:</ce:small-caps> Patients with acquired immunodeficiency syndrome (AIDS)-related epidemic Kaposi's sarcoma generally respond well to cytotoxic chemotherapy. However, due to the associated myelosuppression, these patients are at risk for developing complicating infections that may affect survival. We therefore conducted a multicenter, randomized clinical trial comparing single-agent against combination chemotherapy in advanced AIDS-related Kaposi's sarcoma. Lowdose chemotherapy was employed to evaluate its role in combination therapy for this disease and the toxicities associated with the lower intensity.</ce:simple-para><ce:simple-para view="all" id="simple-para.0015"><ce:small-caps>patients and methods:</ce:small-caps> Sixty-one patients with extensive mucocutaneous Kaposi's sarcoma or visceral involvement were randomized for treatment with low-dose Adriamycin (doxorubicin, 20 mg/m<ce:sup loc="post">2</ce:sup>) alone (31 cases) or in combination with bleomycin and vincristine (ABV) (30 cases). Patients were randomized within strata based on prognostic features associated with shorter survival in prior studies. Both treatment arms were evenly matched at study entry.</ce:simple-para><ce:simple-para view="all" id="simple-para.0020"><ce:small-caps>results:</ce:small-caps> Complete and partial tumor remissions were significantly higher with ABV (88%) than with Adriamycin alone (48%) (p = 0.004). The median survival was 9 months in both groups. Study entry criteria significantly associated with shorter survival included CD4 lymphocyte counts less than 100/mm<ce:sup loc="post">3</ce:sup>, hemoglobin level less than 10 g/dL, a history of constitutional symptoms, and a prior history of opportunistic infection(s). Toxicities were similar in both arms, and the regimens were well tolerated. Neutropenia (granulocyte count less than 1,000/ mm<ce:sup loc="post">3</ce:sup>) occurred in 34% of patients receiving Adriamycin alone and in 52% of patients receiving ABV and was progressive in successive courses of chemotherapy in both treatment arms. The development of AIDS-defined opportunistic infections was relatively infrequent during therapy (14%).</ce:simple-para><ce:simple-para view="all" id="simple-para.0025"><ce:small-caps>conclusions:</ce:small-caps> Low-dose ABV is an effective chemotherapy regimen for the treatment of extensive Kaposi's sarcoma. ABV chemotherapy is associated with significantly higher responses than Adriamycin alone and with acceptable toxicity.</ce:simple-para></ce:abstract-sec></ce:abstract></head></converted-article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Systemic treatment of AIDS-related kaposi's sarcoma: Results of a randomized trial</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>Systemic treatment of AIDS-related kaposi's sarcoma: Results of a randomized trial</title></titleInfo><name type="personal"><namePart type="given">Parkash S.</namePart><namePart type="family">Gill</namePart><namePart type="termsOfAddress">M.D.</namePart><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation><description>Requests for reprints should be addressed to Parkash S. Gill, M.D., University of Southern California, Norris Cancer Hospital, 1441 Eastlake Avenue, Room 162, Los Angeles, California 90033.</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Mark</namePart><namePart type="family">Rarick</namePart><namePart type="termsOfAddress">M.D.</namePart><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.Allen</namePart><namePart type="family">McCutchan</namePart><namePart type="termsOfAddress">M.D.</namePart><affiliation>University of California at San Diego, San Diego, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Lewis</namePart><namePart type="family">Slater</namePart><namePart type="termsOfAddress">M.D.</namePart><affiliation>University of California at Irvine, Irvine, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Barbara</namePart><namePart type="family">Parker</namePart><namePart type="termsOfAddress">M.D.</namePart><affiliation>University of California at San Diego, San Diego, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Elaine</namePart><namePart type="family">Muchmore</namePart><namePart type="termsOfAddress">M.D.</namePart><affiliation>University of California at San Diego, San Diego, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Marjorie</namePart><namePart type="family">Bernstein-Singer</namePart><namePart type="termsOfAddress">M.D.</namePart><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bisher</namePart><namePart type="family">Akil</namePart><namePart type="termsOfAddress">M.D.</namePart><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Byron M.</namePart><namePart type="family">Espina</namePart><namePart type="termsOfAddress">A.B.</namePart><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Mark</namePart><namePart type="family">Krailo</namePart><namePart type="termsOfAddress">Ph.D.</namePart><affiliation>Department of Preventive Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Alexandra</namePart><namePart type="family">Levine</namePart><namePart type="termsOfAddress">M.D.</namePart><affiliation>Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="Full-length article"></genre><originInfo><publisher>ELSEVIER</publisher><dateIssued encoding="w3cdtf">1991</dateIssued><copyrightDate encoding="w3cdtf">1991</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">purpose: Patients with acquired immunodeficiency syndrome (AIDS)-related epidemic Kaposi's sarcoma generally respond well to cytotoxic chemotherapy. However, due to the associated myelosuppression, these patients are at risk for developing complicating infections that may affect survival. We therefore conducted a multicenter, randomized clinical trial comparing single-agent against combination chemotherapy in advanced AIDS-related Kaposi's sarcoma. Lowdose chemotherapy was employed to evaluate its role in combination therapy for this disease and the toxicities associated with the lower intensity.patients and methods: Sixty-one patients with extensive mucocutaneous Kaposi's sarcoma or visceral involvement were randomized for treatment with low-dose Adriamycin (doxorubicin, 20 mg/m2) alone (31 cases) or in combination with bleomycin and vincristine (ABV) (30 cases). Patients were randomized within strata based on prognostic features associated with shorter survival in prior studies. Both treatment arms were evenly matched at study entry.results: Complete and partial tumor remissions were significantly higher with ABV (88%) than with Adriamycin alone (48%) (p = 0.004). The median survival was 9 months in both groups. Study entry criteria significantly associated with shorter survival included CD4 lymphocyte counts less than 100/mm3, hemoglobin level less than 10 g/dL, a history of constitutional symptoms, and a prior history of opportunistic infection(s). Toxicities were similar in both arms, and the regimens were well tolerated. Neutropenia (granulocyte count less than 1,000/ mm3) occurred in 34% of patients receiving Adriamycin alone and in 52% of patients receiving ABV and was progressive in successive courses of chemotherapy in both treatment arms. The development of AIDS-defined opportunistic infections was relatively infrequent during therapy (14%).conclusions: Low-dose ABV is an effective chemotherapy regimen for the treatment of extensive Kaposi's sarcoma. ABV chemotherapy is associated with significantly higher responses than Adriamycin alone and with acceptable toxicity.</abstract><note>This work was supported by funds provided by the State of California and allocated on the recommendation of the University-Wide Task Force on AIDS.</note><subject><genre>article-category</genre><topic>Clinical studies</topic></subject><relatedItem type="host"><titleInfo><title>The American Journal of Medicine</title></titleInfo><titleInfo type="abbreviated"><title>AJM</title></titleInfo><genre type="journal">journal</genre><originInfo><dateIssued encoding="w3cdtf">199101</dateIssued></originInfo><identifier type="ISSN">0002-9343</identifier><identifier type="PII">S0002-9343(00)X0978-3</identifier><part><date>199101</date><detail type="volume"><number>90</number><caption>vol.</caption></detail><detail type="issue"><number>1</number><caption>no.</caption></detail><extent unit="issue pages"><start>A1</start><end>A2</end></extent><extent unit="issue pages"><start>1</start><end>792</end></extent><extent unit="pages"><start>427</start><end>433</end></extent></part></relatedItem><identifier type="istex">5AABF6C54488C030EFD7AFD84DEA18A99D38E0AF</identifier><identifier type="DOI">10.1016/0002-9343(91)90601-S</identifier><identifier type="PII">0002-9343(91)90601-S</identifier><identifier type="ArticleID">9190601S</identifier><recordInfo><recordContentSource>ELSEVIER</recordContentSource></recordInfo></mods></metadata></istex></record>Pour manipuler ce document sous Unix (Dilib)
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