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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
1
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pubmed:dateCreated |
1997-2-27
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pubmed:abstractText |
The maximum tolerated dose (MTD) of etoposide and carboplatin without growth factor support was previously defined by Cancer and Leukemia Group B (CALGB) as 200 and 125 mg/m2/day x 3, respectively, given every 28 days to previously untreated patients who have extensive, small-cell lung cancer (SCLC). Myelosuppression was dose-limiting. The purpose of this phase I trial was to determine if granulocyte macrophage colony-stimulating factor (GM-CSF) support allows the dosage of the combination of etoposide and carboplatin to be increased above the previously determined MTD. In this CALGB study of 44 evaluable patients with performance status 0-2, cohorts were treated with etoposide and carboplatin given intravenously on days 1-3 followed by GM-CSF (molgramostim) given subcutaneously on days 4-18. Four dose levels of bacteria-derived recombinant GM-CSF (5, 10, 20 microg/kg/day and 5 microg/kg every 12 h), three dose levels of etoposide (200, 250, and 300 mg/m2/day x 3), and two dose levels of carboplatin (125 and 150 mg/m2/day x 3) were evaluated. There was no chemotherapy dose escalation in individual patients. With 5 microg/kg/d GM-CSF, the first etoposide and carboplatin cycle of 300 and 150 mg/m2/day x 3, respectively, could be administered with acceptable toxicity. However, GM-CSF did not allow repeated administration of this dose-escalated regimen every 21 days, since delayed platelet and/or neutrophil recovery was dose limiting in later cycles. These results demonstrate that GM-CSF alone has limited capability to support the repeated administration of high doses of etoposide and carboplatin. CALGB currently is testing the ability of interleukin (IL)-6 given with GM-CSF to ameliorate the cumulative myelosuppression of this intense regimen.
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pubmed:grant | |
pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Feb
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pubmed:issn |
0277-3732
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
20
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
24-30
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pubmed:dateRevised |
2007-11-14
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pubmed:meshHeading |
pubmed-meshheading:9020283-Adult,
pubmed-meshheading:9020283-Aged,
pubmed-meshheading:9020283-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:9020283-Carboplatin,
pubmed-meshheading:9020283-Carcinoma, Small Cell,
pubmed-meshheading:9020283-Dose-Response Relationship, Drug,
pubmed-meshheading:9020283-Drug Administration Schedule,
pubmed-meshheading:9020283-Etoposide,
pubmed-meshheading:9020283-Female,
pubmed-meshheading:9020283-Granulocyte-Macrophage Colony-Stimulating Factor,
pubmed-meshheading:9020283-Humans,
pubmed-meshheading:9020283-Lung Neoplasms,
pubmed-meshheading:9020283-Male,
pubmed-meshheading:9020283-Middle Aged,
pubmed-meshheading:9020283-Remission Induction,
pubmed-meshheading:9020283-Survival Analysis
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pubmed:year |
1997
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pubmed:articleTitle |
Phase I trial of etoposide, carboplatin, and GM-CSF in extensive small-cell lung cancer: a Cancer and Leukemia Group B study (CALGB 8832).
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pubmed:affiliation |
Veterans Administration Medical Center and the University of Minnesota Medical Center, Minneapolis 55417, USA.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Research Support, U.S. Gov't, P.H.S.,
Controlled Clinical Trial,
Clinical Trial, Phase I
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