Recombinant human GM-CSF in small cell lung cancer: a phase I/II study.

2.50
Hdl Handle:
http://hdl.handle.net/10541/107853
Title:
Recombinant human GM-CSF in small cell lung cancer: a phase I/II study.
Authors:
Anderson, Heather; Gurney, H; Thatcher, Nick; Swindell, Ric; Scarffe, J Howard; Weiner, J
Abstract:
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)
Affiliation:
CRC Department of Medical Oncology, Christie Hospital, Manchester, United Kingdom.
Citation:
Recombinant human GM-CSF in small cell lung cancer: a phase I/II study. 1991, 121:155-61 Recent Results Cancer Res.
Journal:
Recent Results in Cancer Research
Issue Date:
1991
URI:
http://hdl.handle.net/10541/107853
PubMed ID:
1650015
Type:
Article
Language:
en
ISSN:
0080-0015
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorAnderson, Heatheren
dc.contributor.authorGurney, Hen
dc.contributor.authorThatcher, Nicken
dc.contributor.authorSwindell, Ricen
dc.contributor.authorScarffe, J Howarden
dc.contributor.authorWeiner, Jen
dc.date.accessioned2010-07-17T10:15:20Z-
dc.date.available2010-07-17T10:15:20Z-
dc.date.issued1991-
dc.identifier.citationRecombinant human GM-CSF in small cell lung cancer: a phase I/II study. 1991, 121:155-61 Recent Results Cancer Res.en
dc.identifier.issn0080-0015-
dc.identifier.pmid1650015-
dc.identifier.urihttp://hdl.handle.net/10541/107853-
dc.description.abstractSeventeen 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)en
dc.language.isoenen
dc.subjectLung Canceren
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshBacterial Infections-
dc.subject.meshCarcinoma, Small Cell-
dc.subject.meshDrug Administration Schedule-
dc.subject.meshDrug Evaluation-
dc.subject.meshFemale-
dc.subject.meshGranulocyte-Macrophage Colony-Stimulating Factor-
dc.subject.meshHumans-
dc.subject.meshInjections, Subcutaneous-
dc.subject.meshLeukocyte Count-
dc.subject.meshLung Neoplasms-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshPain-
dc.subject.meshRecombinant Proteins-
dc.titleRecombinant human GM-CSF in small cell lung cancer: a phase I/II study.en
dc.typeArticleen
dc.contributor.departmentCRC Department of Medical Oncology, Christie Hospital, Manchester, United Kingdom.en
dc.identifier.journalRecent Results in Cancer Researchen

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