Phase II study of oral topotecan in advanced non-small cell lung cancer.

2.50
Hdl Handle:
http://hdl.handle.net/10541/85464
Title:
Phase II study of oral topotecan in advanced non-small cell lung cancer.
Authors:
White, Shane C; Cheeseman, Sue; Thatcher, Nick; Anderson, Heather; Carrington, Bernadette M; Hearn, Solange; Ross, Graham A; Ranson, Malcolm R
Abstract:
This study was designed to assess the activity of oral topotecan (TPT) in patients with advanced non-small cell lung cancer previously untreated with chemotherapy. Eligible patients had inoperable stage III or stage IV non-small cell lung cancer and were chemotherapy-naive. Other inclusion criteria were Eastern Cooperative Oncology Group performance status 0, 1, or 2, adequate bone marrow, and renal and hepatic function. Of 30 patients, 29 were assessable for response. Oral TPT was administered for 5 days every 21 days for up to six cycles unless disease progression or unacceptable toxicity occurred. Patients received a dose of 2.3 mg/m2/day for the first cycle. Dose modification for subsequent cycles was based on tolerability. Patients completed symptom questionnaires every 3 weeks. Pharmacokinetics were evaluated in all patients during cycle 1. Three patients had radiological responses with a reduction in tumor size of 30-40%. No patients achieved complete or partial responses to treatment. Thirteen patients had a stable disease (43.3%), and the median survival was 39.9 weeks with a 1-year survival of 33.3%. At the time of analysis, 27 patients had died. Median time to progression was 12.3 weeks. Treatment was well tolerated. A total of 125 cycles of treatment were completed. Twelve patients (40%) experienced grade III/IV neutropenia. Five patients (16.6%) had grade III/IV anemia. There were two episodes of grade III/IV thrombocytopenia. The main nonhematological toxicities consisted of grade III nausea (13%) and grade III vomiting (13%). The most frequently reported disease-related symptoms at baseline were dyspnea, cough, and fatigue. There was a subsequent improvement in patient scores of dyspnea in 17% of patients, 31% showed improvement in cough, and 32% showed improvement in fatigue. The mean area under the curve of TPT following 2.3 mg/m2 p.o. was 51.6 ng.h/ml (%SD, 25%). The area under the curve of TPT on day 1 of the first cycle was correlated with the percentage fall in leukocytes. Although oral TPT at the applied dose and schedule showed modest activity as a single agent, almost one-half of the patients had a stable disease, and median time to progression was 12.3 weeks. The overall median survival was a promising 39.9 weeks, and useful palliation of symptoms was seen.
Affiliation:
Department of Medical Oncology, Christie Hospital National Health Service Trust, Manchester, United Kingdom.
Citation:
Phase II study of oral topotecan in advanced non-small cell lung cancer. 2000, 6 (3):868-73 Clin. Cancer Res.
Journal:
Clinical Cancer Research
Issue Date:
Mar-2000
URI:
http://hdl.handle.net/10541/85464
PubMed ID:
10741709
Type:
Article
Language:
en
ISSN:
1078-0432
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorWhite, Shane Cen
dc.contributor.authorCheeseman, Sueen
dc.contributor.authorThatcher, Nicken
dc.contributor.authorAnderson, Heatheren
dc.contributor.authorCarrington, Bernadette Men
dc.contributor.authorHearn, Solangeen
dc.contributor.authorRoss, Graham Aen
dc.contributor.authorRanson, Malcolm Ren
dc.date.accessioned2009-11-05T15:52:15Z-
dc.date.available2009-11-05T15:52:15Z-
dc.date.issued2000-03-
dc.identifier.citationPhase II study of oral topotecan in advanced non-small cell lung cancer. 2000, 6 (3):868-73 Clin. Cancer Res.en
dc.identifier.issn1078-0432-
dc.identifier.pmid10741709-
dc.identifier.urihttp://hdl.handle.net/10541/85464-
dc.description.abstractThis study was designed to assess the activity of oral topotecan (TPT) in patients with advanced non-small cell lung cancer previously untreated with chemotherapy. Eligible patients had inoperable stage III or stage IV non-small cell lung cancer and were chemotherapy-naive. Other inclusion criteria were Eastern Cooperative Oncology Group performance status 0, 1, or 2, adequate bone marrow, and renal and hepatic function. Of 30 patients, 29 were assessable for response. Oral TPT was administered for 5 days every 21 days for up to six cycles unless disease progression or unacceptable toxicity occurred. Patients received a dose of 2.3 mg/m2/day for the first cycle. Dose modification for subsequent cycles was based on tolerability. Patients completed symptom questionnaires every 3 weeks. Pharmacokinetics were evaluated in all patients during cycle 1. Three patients had radiological responses with a reduction in tumor size of 30-40%. No patients achieved complete or partial responses to treatment. Thirteen patients had a stable disease (43.3%), and the median survival was 39.9 weeks with a 1-year survival of 33.3%. At the time of analysis, 27 patients had died. Median time to progression was 12.3 weeks. Treatment was well tolerated. A total of 125 cycles of treatment were completed. Twelve patients (40%) experienced grade III/IV neutropenia. Five patients (16.6%) had grade III/IV anemia. There were two episodes of grade III/IV thrombocytopenia. The main nonhematological toxicities consisted of grade III nausea (13%) and grade III vomiting (13%). The most frequently reported disease-related symptoms at baseline were dyspnea, cough, and fatigue. There was a subsequent improvement in patient scores of dyspnea in 17% of patients, 31% showed improvement in cough, and 32% showed improvement in fatigue. The mean area under the curve of TPT following 2.3 mg/m2 p.o. was 51.6 ng.h/ml (%SD, 25%). The area under the curve of TPT on day 1 of the first cycle was correlated with the percentage fall in leukocytes. Although oral TPT at the applied dose and schedule showed modest activity as a single agent, almost one-half of the patients had a stable disease, and median time to progression was 12.3 weeks. The overall median survival was a promising 39.9 weeks, and useful palliation of symptoms was seen.en
dc.language.isoenen
dc.subjectLung Canceren
dc.subjectCancer Stagingen
dc.subjectAnaemiaen
dc.subject.meshAdministration, Oral-
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAged, 80 and over-
dc.subject.meshAlopecia-
dc.subject.meshAnemia-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshArea Under Curve-
dc.subject.meshCarcinoma, Non-Small-Cell Lung-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshLung Neoplasms-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshNausea-
dc.subject.meshNeoplasm Staging-
dc.subject.meshNeutropenia-
dc.subject.meshThrombocytopenia-
dc.subject.meshTopotecan-
dc.subject.meshTreatment Outcome-
dc.subject.meshVomiting-
dc.titlePhase II study of oral topotecan in advanced non-small cell lung cancer.en
dc.typeArticleen
dc.contributor.departmentDepartment of Medical Oncology, Christie Hospital National Health Service Trust, Manchester, United Kingdom.en
dc.identifier.journalClinical Cancer Researchen

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