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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:dateCreated |
1991-8-29
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pubmed:abstractText |
Seventeen patients with small cell lung cancer were entered into a dose ranging phase I-II study using rhGM-CSF (Glaxo). In the phase I study patients received 50, 150, 300 or 500 micrograms/m2 GM-CSF for 10 days by daily subcutaneous injection. Full blood counts were performed thrice weekly. After 4 days off all therapy patients then received chemotherapy with doxorubicin 50 mg/m2 i.v. bolus, day 1, ifosfamide 5 g/m2 with mesna 5 g/m2 over 24 h by continuous infusion followed by mesna 3 g/m2, and etoposide 120 mg/m2 i.v. on days 1-3. A total of six courses of chemotherapy were given. In the phase II study patients received the same dose of GM-CSF as in the phase I. GM-CSF was given 24 h after the last dose of chemotherapy for 14 days. Full blood counts were checked thrice weekly and the incidence of infections noted. Patients were randomised to receive GM-CSF with either odd or even courses of chemotherapy. The leucocyte count rose from a mean of 8.7 to 21.6 x 10(9)/l at the 50 micrograms/m2 GM-CSF dosage and from 11.4 to 39.4 x 10(9)/l at the 500 micrograms/m2 dosage during the phase I study. Phase I toxicity was: bone pain in 65% of patients, rash in 47%, fever in 24%, lethargy in 12% and diarrhoea in 12%. In the phase II study the duration of neutropenia was less during the chemotherapy courses with GM-CSF (p = 0.04) but the number of infections was similar.(ABSTRACT TRUNCATED AT 250 WORDS)
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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:issn |
0080-0015
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
121
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
155-61
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pubmed:dateRevised |
2008-2-13
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pubmed:meshHeading |
pubmed-meshheading:1650015-Adult,
pubmed-meshheading:1650015-Aged,
pubmed-meshheading:1650015-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:1650015-Bacterial Infections,
pubmed-meshheading:1650015-Carcinoma, Small Cell,
pubmed-meshheading:1650015-Drug Administration Schedule,
pubmed-meshheading:1650015-Drug Evaluation,
pubmed-meshheading:1650015-Female,
pubmed-meshheading:1650015-Granulocyte-Macrophage Colony-Stimulating Factor,
pubmed-meshheading:1650015-Humans,
pubmed-meshheading:1650015-Injections, Subcutaneous,
pubmed-meshheading:1650015-Leukocyte Count,
pubmed-meshheading:1650015-Lung Neoplasms,
pubmed-meshheading:1650015-Male,
pubmed-meshheading:1650015-Middle Aged,
pubmed-meshheading:1650015-Pain,
pubmed-meshheading:1650015-Recombinant Proteins
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pubmed:year |
1991
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pubmed:articleTitle |
Recombinant human GM-CSF in small cell lung cancer: a phase I/II study.
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pubmed:affiliation |
CRC Department of Medical Oncology, Christie Hospital, Manchester, United Kingdom.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial
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