Phase I study of granulocyte colony-stimulating factor in patients with transitional cell carcinoma of the urothelium
Recombinant human granulocyte colony-stimulating factor (rhG-CSF) was administered at a dose of 1-60 micrograms/kg of body weight to 22 patients with transitional cell carcinoma before chemotherapy as part of a Phase I/II study. In all patients, a specific dose-dependent increase in the absolute neu...
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| Veröffentlicht in: | The Journal of clinical investigation 1988-10, Vol.82 (4), p.1454-1461 |
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| creator | GABRILOVE, J. L JAKUBOWSKI, A ALTON, K BOONE, T ALTROCK, B WELTE, K SOUZA, L FAIN, K GROUS, J SCHER, H STERNBERG, C YAGODA, A CLARKSON, B BONILLA, M. A OETTGEN, H. F |
| description | Recombinant human granulocyte colony-stimulating factor (rhG-CSF) was administered at a dose of 1-60 micrograms/kg of body weight to 22 patients with transitional cell carcinoma before chemotherapy as part of a Phase I/II study. In all patients, a specific dose-dependent increase in the absolute neutrophil count (ANC) of 1.8-12 fold was seen. In addition, this augmentation in the ANC was accompanied by an increase in leukocyte alkaline phosphatase, a marker of secondary granule formation. In six of eight patients analyzed, an increase in bone marrow myeloid to erythroid cell ratio was seen. Day 14 peripheral blood cell derived colony forming unit granulocyte macrophage were also increased by day 6 of rhG-CSF treatment. Circulating levels of eosinophils and basophils were unchanged; however, a 10-fold increase in monocytes was observed in patients treated at the highest doses. There was also a small increase in CD3+ lymphocytes that was not dose dependent. Hemoglobin, hematocrit, and platelet count remained near baseline throughout the period of rhG-CSF administration. These findings demonstrate that rhG-CSF is a potent stimulus for normal neutrophil proliferation and maturation. |
| doi_str_mv | 10.1172/JCI113751 |
| format | Article |
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L ; JAKUBOWSKI, A ; ALTON, K ; BOONE, T ; ALTROCK, B ; WELTE, K ; SOUZA, L ; FAIN, K ; GROUS, J ; SCHER, H ; STERNBERG, C ; YAGODA, A ; CLARKSON, B ; BONILLA, M. A ; OETTGEN, H. F</creator><creatorcontrib>GABRILOVE, J. L ; JAKUBOWSKI, A ; ALTON, K ; BOONE, T ; ALTROCK, B ; WELTE, K ; SOUZA, L ; FAIN, K ; GROUS, J ; SCHER, H ; STERNBERG, C ; YAGODA, A ; CLARKSON, B ; BONILLA, M. A ; OETTGEN, H. F</creatorcontrib><description>Recombinant human granulocyte colony-stimulating factor (rhG-CSF) was administered at a dose of 1-60 micrograms/kg of body weight to 22 patients with transitional cell carcinoma before chemotherapy as part of a Phase I/II study. In all patients, a specific dose-dependent increase in the absolute neutrophil count (ANC) of 1.8-12 fold was seen. In addition, this augmentation in the ANC was accompanied by an increase in leukocyte alkaline phosphatase, a marker of secondary granule formation. In six of eight patients analyzed, an increase in bone marrow myeloid to erythroid cell ratio was seen. Day 14 peripheral blood cell derived colony forming unit granulocyte macrophage were also increased by day 6 of rhG-CSF treatment. Circulating levels of eosinophils and basophils were unchanged; however, a 10-fold increase in monocytes was observed in patients treated at the highest doses. There was also a small increase in CD3+ lymphocytes that was not dose dependent. Hemoglobin, hematocrit, and platelet count remained near baseline throughout the period of rhG-CSF administration. These findings demonstrate that rhG-CSF is a potent stimulus for normal neutrophil proliferation and maturation.</description><identifier>ISSN: 0021-9738</identifier><identifier>EISSN: 1558-8238</identifier><identifier>DOI: 10.1172/JCI113751</identifier><identifier>PMID: 2459163</identifier><identifier>CODEN: JCINAO</identifier><language>eng</language><publisher>Ann Arbor, MI: American Society for Clinical Investigation</publisher><subject>Adult ; Aged ; Biological and medical sciences ; Bone Marrow - pathology ; Carcinoma, Transitional Cell - blood ; Carcinoma, Transitional Cell - drug therapy ; Carcinoma, Transitional Cell - pathology ; Colony-Forming Units Assay ; Colony-Stimulating Factors - adverse effects ; Colony-Stimulating Factors - pharmacokinetics ; Colony-Stimulating Factors - therapeutic use ; Drug Evaluation ; Granulocyte Colony-Stimulating Factor ; Hematopoietic Stem Cells - pathology ; Humans ; Leukocyte Count - drug effects ; Medical sciences ; Middle Aged ; Nephrology. Urinary tract diseases ; Neutrophils - pathology ; Recombinant Proteins - adverse effects ; Recombinant Proteins - pharmacokinetics ; Recombinant Proteins - therapeutic use ; Tumors of the urinary system ; Urinary tract. Prostate gland ; Urogenital Neoplasms - blood ; Urogenital Neoplasms - drug therapy ; Urogenital Neoplasms - pathology</subject><ispartof>The Journal of clinical investigation, 1988-10, Vol.82 (4), p.1454-1461</ispartof><rights>1989 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c429t-fcc4d0862c7eec8a3a8e986c1b9811b9171d8dbfa357a1afcce37ccffb9327e23</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC442704/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC442704/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,27923,27924,53790,53792</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=7118026$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/2459163$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>GABRILOVE, J. L</creatorcontrib><creatorcontrib>JAKUBOWSKI, A</creatorcontrib><creatorcontrib>ALTON, K</creatorcontrib><creatorcontrib>BOONE, T</creatorcontrib><creatorcontrib>ALTROCK, B</creatorcontrib><creatorcontrib>WELTE, K</creatorcontrib><creatorcontrib>SOUZA, L</creatorcontrib><creatorcontrib>FAIN, K</creatorcontrib><creatorcontrib>GROUS, J</creatorcontrib><creatorcontrib>SCHER, H</creatorcontrib><creatorcontrib>STERNBERG, C</creatorcontrib><creatorcontrib>YAGODA, A</creatorcontrib><creatorcontrib>CLARKSON, B</creatorcontrib><creatorcontrib>BONILLA, M. A</creatorcontrib><creatorcontrib>OETTGEN, H. F</creatorcontrib><title>Phase I study of granulocyte colony-stimulating factor in patients with transitional cell carcinoma of the urothelium</title><title>The Journal of clinical investigation</title><addtitle>J Clin Invest</addtitle><description>Recombinant human granulocyte colony-stimulating factor (rhG-CSF) was administered at a dose of 1-60 micrograms/kg of body weight to 22 patients with transitional cell carcinoma before chemotherapy as part of a Phase I/II study. In all patients, a specific dose-dependent increase in the absolute neutrophil count (ANC) of 1.8-12 fold was seen. In addition, this augmentation in the ANC was accompanied by an increase in leukocyte alkaline phosphatase, a marker of secondary granule formation. In six of eight patients analyzed, an increase in bone marrow myeloid to erythroid cell ratio was seen. Day 14 peripheral blood cell derived colony forming unit granulocyte macrophage were also increased by day 6 of rhG-CSF treatment. Circulating levels of eosinophils and basophils were unchanged; however, a 10-fold increase in monocytes was observed in patients treated at the highest doses. There was also a small increase in CD3+ lymphocytes that was not dose dependent. Hemoglobin, hematocrit, and platelet count remained near baseline throughout the period of rhG-CSF administration. These findings demonstrate that rhG-CSF is a potent stimulus for normal neutrophil proliferation and maturation.</description><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Bone Marrow - pathology</subject><subject>Carcinoma, Transitional Cell - blood</subject><subject>Carcinoma, Transitional Cell - drug therapy</subject><subject>Carcinoma, Transitional Cell - pathology</subject><subject>Colony-Forming Units Assay</subject><subject>Colony-Stimulating Factors - adverse effects</subject><subject>Colony-Stimulating Factors - pharmacokinetics</subject><subject>Colony-Stimulating Factors - therapeutic use</subject><subject>Drug Evaluation</subject><subject>Granulocyte Colony-Stimulating Factor</subject><subject>Hematopoietic Stem Cells - pathology</subject><subject>Humans</subject><subject>Leukocyte Count - drug effects</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Neutrophils - pathology</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - pharmacokinetics</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Tumors of the urinary system</subject><subject>Urinary tract. Prostate gland</subject><subject>Urogenital Neoplasms - blood</subject><subject>Urogenital Neoplasms - drug therapy</subject><subject>Urogenital Neoplasms - pathology</subject><issn>0021-9738</issn><issn>1558-8238</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1988</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU-LFDEQxYMo6-zqwQ8g5CDCHlpTSbqTHDwsg39GFvSg51CTTs9Eujtjklbm25thh0FPXqog7_eKFx4hL4C9AVD87ef1BkCoFh6RFbStbjQX-jFZMcahMUrop-Q65x-MgZStvCJXXLYGOrEiy9c9Zk83NJelP9I40F3CeRmjOxZPXRzjfGxyCdMyYgnzjg7oSkw0zPRQH_xcMv0dyp6WasuhhDjjSJ0f68DkwhwnPF0te0-XFOsawzI9I08GHLN_ft435PuH99_Wn5r7Lx8367v7xkluSjM4J3umO-6U906jQO2N7hxsjYY6QEGv--2AolUIWHEvlHPDsDWCK8_FDXn3cPewbCffuxo34WgPKUyYjjZisP8qc9jbXfxlpeSKyep_ffan-HPxudgp5NPncPZxyVZp2bXKmP-C0DIjRKsrePsAuhRzTn64hAFmT13aS5eVffl3-gt5Lq_qr846ZofjUBtwIV8wBaAZ78QfViSqtA</recordid><startdate>19881001</startdate><enddate>19881001</enddate><creator>GABRILOVE, J. L</creator><creator>JAKUBOWSKI, A</creator><creator>ALTON, K</creator><creator>BOONE, T</creator><creator>ALTROCK, B</creator><creator>WELTE, K</creator><creator>SOUZA, L</creator><creator>FAIN, K</creator><creator>GROUS, J</creator><creator>SCHER, H</creator><creator>STERNBERG, C</creator><creator>YAGODA, A</creator><creator>CLARKSON, B</creator><creator>BONILLA, M. A</creator><creator>OETTGEN, H. F</creator><general>American Society for Clinical Investigation</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>7T5</scope><scope>H94</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>19881001</creationdate><title>Phase I study of granulocyte colony-stimulating factor in patients with transitional cell carcinoma of the urothelium</title><author>GABRILOVE, J. L ; JAKUBOWSKI, A ; ALTON, K ; BOONE, T ; ALTROCK, B ; WELTE, K ; SOUZA, L ; FAIN, K ; GROUS, J ; SCHER, H ; STERNBERG, C ; YAGODA, A ; CLARKSON, B ; BONILLA, M. A ; OETTGEN, H. 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Urinary tract diseases</topic><topic>Neutrophils - pathology</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - pharmacokinetics</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Tumors of the urinary system</topic><topic>Urinary tract. Prostate gland</topic><topic>Urogenital Neoplasms - blood</topic><topic>Urogenital Neoplasms - drug therapy</topic><topic>Urogenital Neoplasms - pathology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>GABRILOVE, J. 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F</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I study of granulocyte colony-stimulating factor in patients with transitional cell carcinoma of the urothelium</atitle><jtitle>The Journal of clinical investigation</jtitle><addtitle>J Clin Invest</addtitle><date>1988-10-01</date><risdate>1988</risdate><volume>82</volume><issue>4</issue><spage>1454</spage><epage>1461</epage><pages>1454-1461</pages><issn>0021-9738</issn><eissn>1558-8238</eissn><coden>JCINAO</coden><abstract>Recombinant human granulocyte colony-stimulating factor (rhG-CSF) was administered at a dose of 1-60 micrograms/kg of body weight to 22 patients with transitional cell carcinoma before chemotherapy as part of a Phase I/II study. In all patients, a specific dose-dependent increase in the absolute neutrophil count (ANC) of 1.8-12 fold was seen. In addition, this augmentation in the ANC was accompanied by an increase in leukocyte alkaline phosphatase, a marker of secondary granule formation. In six of eight patients analyzed, an increase in bone marrow myeloid to erythroid cell ratio was seen. Day 14 peripheral blood cell derived colony forming unit granulocyte macrophage were also increased by day 6 of rhG-CSF treatment. Circulating levels of eosinophils and basophils were unchanged; however, a 10-fold increase in monocytes was observed in patients treated at the highest doses. There was also a small increase in CD3+ lymphocytes that was not dose dependent. Hemoglobin, hematocrit, and platelet count remained near baseline throughout the period of rhG-CSF administration. These findings demonstrate that rhG-CSF is a potent stimulus for normal neutrophil proliferation and maturation.</abstract><cop>Ann Arbor, MI</cop><pub>American Society for Clinical Investigation</pub><pmid>2459163</pmid><doi>10.1172/JCI113751</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Journal of clinical investigation, 1988-10, Vol.82 (4), p.1454-1461 |
| issn | 0021-9738 1558-8238 |
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| source | MEDLINE; PubMed Central (Training); EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Adult Aged Biological and medical sciences Bone Marrow - pathology Carcinoma, Transitional Cell - blood Carcinoma, Transitional Cell - drug therapy Carcinoma, Transitional Cell - pathology Colony-Forming Units Assay Colony-Stimulating Factors - adverse effects Colony-Stimulating Factors - pharmacokinetics Colony-Stimulating Factors - therapeutic use Drug Evaluation Granulocyte Colony-Stimulating Factor Hematopoietic Stem Cells - pathology Humans Leukocyte Count - drug effects Medical sciences Middle Aged Nephrology. Urinary tract diseases Neutrophils - pathology Recombinant Proteins - adverse effects Recombinant Proteins - pharmacokinetics Recombinant Proteins - therapeutic use Tumors of the urinary system Urinary tract. Prostate gland Urogenital Neoplasms - blood Urogenital Neoplasms - drug therapy Urogenital Neoplasms - pathology |
| title | Phase I study of granulocyte colony-stimulating factor in patients with transitional cell carcinoma of the urothelium |
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