Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study.

2.50
Hdl Handle:
http://hdl.handle.net/10541/107467
Title:
Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study.
Authors:
Anderson, Heather; Lund, B; Bach, F; Thatcher, Nick; Walling, J; Hansen, H H
Abstract:
PURPOSE: To evaluate the efficacy and safety of gemcitabine, a pyrimidine antimetabolite with activity against solid tumours. PATIENTS AND METHODS: Eighty-two patients with unresectable stage IIIa to IV non-small-cell lung cancer (NSCLC) were entered. The first 54 patients received gemcitabine 800 mg/m2, and subsequent patients 1,000 mg/m2, as a 30-minute intravenous infusion on days 0, 7, and 14. Courses of therapy were repeated every 28 days. Twenty percent dosage escalation was permitted after course no.1 if World Health Organization (WHO) toxicity was < or = 1. RESULTS: Sixteen (20%; 95% confidence interval [CI], 12% to 31%) of 79 patients assessable for response had independently validated partial responses, with a median duration of 7 months. The overall median survival duration was 7 months. Gemcitabine improved disease-related symptoms (70% patients) and increased WHO performance status (44%). Toxicity was generally mild and reversible. Patients experienced little WHO grade 3 and 4 toxicity, with anemia in four (5%), thrombocytopenia in one (1%), leukopenia in six (7%), and neutropenia in 18 (22%). Infection occurred in nine patients (12%) during the study (four were neutropenic), but there were no episodes of WHO grade 3 or 4 infection. WHO grade 3 and 4 biochemical toxicity occurred with transient elevations of transaminases in 10 patients (12%). Two patients had transient WHO grade 3 elevation of serum creatinine levels, and two developed acute renal failure 4 and 6 weeks after the last dose of gemcitabine. There was no WHO grade 4 symptomatic toxicity. WHO grade 3 vomiting occurred in 31 patients (38%) and grade 3 alopecia in one (1%). Flu-like symptoms were associated with gemcitabine administration in 36 patients (44%). Twenty-six patients (32%) experienced fever (1% WHO grade 3), 33 (40%) ankle edema not associated with cardiac failure, 31 (38%) lethargy, and 11 (13%) dyspnea. CONCLUSION: Gemcitabine is an active new agent in the treatment of NSCLC. This schedule was associated with little alopecia or myelosuppression. Gemcitabine warrants further investigation in other malignancies and in combination with other agents.
Affiliation:
Manchester Lung Tumour Study Group, Wythenshawe Hospital, United Kingdom.
Citation:
Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study. 1994, 12 (9):1821-6 J Clin Oncol
Journal:
Journal of Clinical Oncology
Issue Date:
Sep-1994
URI:
http://hdl.handle.net/10541/107467
PubMed ID:
8083706
Type:
Article
Language:
en
ISSN:
0732-183X
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorAnderson, Heatheren
dc.contributor.authorLund, Ben
dc.contributor.authorBach, Fen
dc.contributor.authorThatcher, Nicken
dc.contributor.authorWalling, Jen
dc.contributor.authorHansen, H Hen
dc.date.accessioned2010-07-12T14:47:58Z-
dc.date.available2010-07-12T14:47:58Z-
dc.date.issued1994-09-
dc.identifier.citationSingle-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study. 1994, 12 (9):1821-6 J Clin Oncolen
dc.identifier.issn0732-183X-
dc.identifier.pmid8083706-
dc.identifier.urihttp://hdl.handle.net/10541/107467-
dc.description.abstractPURPOSE: To evaluate the efficacy and safety of gemcitabine, a pyrimidine antimetabolite with activity against solid tumours. PATIENTS AND METHODS: Eighty-two patients with unresectable stage IIIa to IV non-small-cell lung cancer (NSCLC) were entered. The first 54 patients received gemcitabine 800 mg/m2, and subsequent patients 1,000 mg/m2, as a 30-minute intravenous infusion on days 0, 7, and 14. Courses of therapy were repeated every 28 days. Twenty percent dosage escalation was permitted after course no.1 if World Health Organization (WHO) toxicity was < or = 1. RESULTS: Sixteen (20%; 95% confidence interval [CI], 12% to 31%) of 79 patients assessable for response had independently validated partial responses, with a median duration of 7 months. The overall median survival duration was 7 months. Gemcitabine improved disease-related symptoms (70% patients) and increased WHO performance status (44%). Toxicity was generally mild and reversible. Patients experienced little WHO grade 3 and 4 toxicity, with anemia in four (5%), thrombocytopenia in one (1%), leukopenia in six (7%), and neutropenia in 18 (22%). Infection occurred in nine patients (12%) during the study (four were neutropenic), but there were no episodes of WHO grade 3 or 4 infection. WHO grade 3 and 4 biochemical toxicity occurred with transient elevations of transaminases in 10 patients (12%). Two patients had transient WHO grade 3 elevation of serum creatinine levels, and two developed acute renal failure 4 and 6 weeks after the last dose of gemcitabine. There was no WHO grade 4 symptomatic toxicity. WHO grade 3 vomiting occurred in 31 patients (38%) and grade 3 alopecia in one (1%). Flu-like symptoms were associated with gemcitabine administration in 36 patients (44%). Twenty-six patients (32%) experienced fever (1% WHO grade 3), 33 (40%) ankle edema not associated with cardiac failure, 31 (38%) lethargy, and 11 (13%) dyspnea. CONCLUSION: Gemcitabine is an active new agent in the treatment of NSCLC. This schedule was associated with little alopecia or myelosuppression. Gemcitabine warrants further investigation in other malignancies and in combination with other agents.en
dc.language.isoenen
dc.subjectAnaemiaen
dc.subjectLung Canceren
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAnemia-
dc.subject.meshAntimetabolites, Antineoplastic-
dc.subject.meshCarcinoma, Non-Small-Cell Lung-
dc.subject.meshDeoxycytidine-
dc.subject.meshDrug Administration Schedule-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshLeukopenia-
dc.subject.meshLung Neoplasms-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshNausea-
dc.subject.meshRemission Induction-
dc.subject.meshSurvival Rate-
dc.subject.meshVomiting-
dc.titleSingle-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study.en
dc.typeArticleen
dc.contributor.departmentManchester Lung Tumour Study Group, Wythenshawe Hospital, United Kingdom.en
dc.identifier.journalJournal of Clinical Oncologyen

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