Phase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer.

2.50
Hdl Handle:
http://hdl.handle.net/10541/84139
Title:
Phase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer.
Authors:
Von Pawel, J; Gatzemeier, U; Pujol, J L; Moreau, L; Bildat, S; Ranson, Malcolm R; Richardson, G; Steppert, C; Rivière, A; Camlett, I; Lane, S; Ross, G
Abstract:
PURPOSE: Topotecan, administered intravenously, is active in small-cell lung cancer (SCLC). In this study, the comparability of oral topotecan to IV topotecan was investigated. PATIENTS AND METHODS: Patients with SCLC that had relapsed 90 days or more after cessation of initial chemotherapy were randomized to receive either oral topotecan (Hycamtin) 2.3 mg/m(2)/d x 5 (52 patients) or IV topotecan 1.5 mg/m(2)/d x 5 (54 patients), every 21 days. RESULTS: Response rates in this phase II randomized study were 23% (12/52) in the oral topotecan arm and 15% (8/54) in the IV topotecan arm. All radiological responses were confirmed by an independent radiologist. Median survival was 32 weeks (oral) and 25 weeks (IV). Good symptom control, defined as sustained improvement or no deterioration, was evident in both treatment groups. Topotecan was generally well tolerated, with myelosuppression being the major toxicity. Grade 4 neutropenia occurred in 35.3% of patients on oral topotecan and in 67.3% of patients on IV topotecan, which was statistically significant (P =.001). Fever/infection more than or equal to grade 2 associated with grade 4 neutropenia, together with sepsis, occurred in only 5.1% of courses (oral) and 3.3% of courses (IV). Non-hematological toxicity consisted mainly of vomiting (oral: 36.5% of patients; IV: 31.5% of patients) and nausea (oral: 26.9% of patients; IV: 40.7% of patients). CONCLUSION: This study found oral topotecan to be similar in efficacy to IV topotecan in the treatment of patients with relapsed SCLC, sensitive to first-line chemotherapy, with less grade 4 neutropenia and greater convenience of administration.
Affiliation:
Asklepios Fachklinik, Gauting bei München, Munich, Germany.
Citation:
Phase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer. 2001, 19 (6):1743-9 J. Clin. Oncol.
Journal:
Journal of Clinical Oncology
Issue Date:
15-Mar-2001
URI:
http://hdl.handle.net/10541/84139
PubMed ID:
11251005
Type:
Article
Language:
en
ISSN:
0732-183X
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorVon Pawel, Jen
dc.contributor.authorGatzemeier, Uen
dc.contributor.authorPujol, J Len
dc.contributor.authorMoreau, Len
dc.contributor.authorBildat, Sen
dc.contributor.authorRanson, Malcolm Ren
dc.contributor.authorRichardson, Gen
dc.contributor.authorSteppert, Cen
dc.contributor.authorRivière, Aen
dc.contributor.authorCamlett, Ien
dc.contributor.authorLane, Sen
dc.contributor.authorRoss, Gen
dc.date.accessioned2009-10-13T08:53:11Z-
dc.date.available2009-10-13T08:53:11Z-
dc.date.issued2001-03-15-
dc.identifier.citationPhase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer. 2001, 19 (6):1743-9 J. Clin. Oncol.en
dc.identifier.issn0732-183X-
dc.identifier.pmid11251005-
dc.identifier.urihttp://hdl.handle.net/10541/84139-
dc.description.abstractPURPOSE: Topotecan, administered intravenously, is active in small-cell lung cancer (SCLC). In this study, the comparability of oral topotecan to IV topotecan was investigated. PATIENTS AND METHODS: Patients with SCLC that had relapsed 90 days or more after cessation of initial chemotherapy were randomized to receive either oral topotecan (Hycamtin) 2.3 mg/m(2)/d x 5 (52 patients) or IV topotecan 1.5 mg/m(2)/d x 5 (54 patients), every 21 days. RESULTS: Response rates in this phase II randomized study were 23% (12/52) in the oral topotecan arm and 15% (8/54) in the IV topotecan arm. All radiological responses were confirmed by an independent radiologist. Median survival was 32 weeks (oral) and 25 weeks (IV). Good symptom control, defined as sustained improvement or no deterioration, was evident in both treatment groups. Topotecan was generally well tolerated, with myelosuppression being the major toxicity. Grade 4 neutropenia occurred in 35.3% of patients on oral topotecan and in 67.3% of patients on IV topotecan, which was statistically significant (P =.001). Fever/infection more than or equal to grade 2 associated with grade 4 neutropenia, together with sepsis, occurred in only 5.1% of courses (oral) and 3.3% of courses (IV). Non-hematological toxicity consisted mainly of vomiting (oral: 36.5% of patients; IV: 31.5% of patients) and nausea (oral: 26.9% of patients; IV: 40.7% of patients). CONCLUSION: This study found oral topotecan to be similar in efficacy to IV topotecan in the treatment of patients with relapsed SCLC, sensitive to first-line chemotherapy, with less grade 4 neutropenia and greater convenience of administration.en
dc.language.isoenen
dc.subjectLung Canceren
dc.subject.meshAdministration, Oral-
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntineoplastic Agents, Phytogenic-
dc.subject.meshCarcinoma, Small Cell-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshInfusions, Intravenous-
dc.subject.meshLung Neoplasms-
dc.subject.meshMiddle Aged-
dc.subject.meshNeutropenia-
dc.subject.meshTopotecan-
dc.subject.meshTreatment Outcome-
dc.titlePhase II comparator study of oral versus intravenous topotecan in patients with chemosensitive small-cell lung cancer.en
dc.typeArticleen
dc.contributor.departmentAsklepios Fachklinik, Gauting bei München, Munich, Germany.en
dc.identifier.journalJournal of Clinical Oncologyen

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