Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer.

2.50
Hdl Handle:
http://hdl.handle.net/10541/72636
Title:
Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer.
Authors:
O'Brien, M; Ciuleanu, Tudor; Tsekov, Hristo; Shparyk, Yaroslav; Cuceviá, Branka; Juhasz, Gabor; Thatcher, Nick; Ross, Graham A; Dane, Graham C; Crofts, Theresa
Abstract:
PURPOSE: For patients with small-cell lung cancer (SCLC), further chemotherapy is routinely considered at relapse after first-line therapy. However, proof of clinical benefit has not been documented. PATIENTS AND METHODS: This study randomly assigned patients with relapsed SCLC not considered as candidates for standard intravenous therapy to best supportive care (BSC) alone (n = 70) or oral topotecan (2.3 mg/m2/d, days 1 through 5, every 21 days) plus BSC (topotecan; n = 71). RESULTS: In the intent-to-treat population, survival (primary end point) was prolonged in the topotecan group (log-rank P = .0104). Median survival with BSC was 13.9 weeks (95% CI, 11.1 to 18.6) and with topotecan, 25.9 weeks (95% CI, 18.3 to 31.6). Statistical significance for survival was maintained in a subgroup of patients with a short treatment-free interval (< or = 60 days). Response to topotecan was 7% partial and 44% stable disease. Patients on topotecan had slower quality of life deterioration and greater symptom control. Principal toxicities with topotecan were hematological: grade 4 neutropenia, 33%; grade 4 thrombocytopenia, 7%; and grade 3/4 anemia, 25%. Comparing topotecan with BSC, infection grade 2 was 14% versus 12% and sepsis 4% versus 1%; other grade 3/4 events included vomiting 3% versus 0, diarrhea 6% versus 0, dyspnea 3% versus 9%, and pain 3% versus 6%. Toxic deaths occurred in four patients (6%) in the topotecan arm. All cause mortality within 30 days of random assignment was 13% on BSC and 7% on topotecan. CONCLUSION: Chemotherapy with oral topotecan is associated with prolongation of survival and quality of life benefit in patients with relapsed SCLC.
Affiliation:
Royal Marsden Hospital, National Health System Trust, Sutton, Surrey, England. mary.o'brien@rmh.nhs.uk
Citation:
Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. 2006, 24 (34):5441-7 J. Clin. Oncol.
Journal:
Journal of Clinical Oncology
Issue Date:
1-Dec-2006
URI:
http://hdl.handle.net/10541/72636
DOI:
10.1200/JCO.2006.06.5821
PubMed ID:
17135646
Type:
Article
Language:
en
ISSN:
1527-7755
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorO'Brien, M-
dc.contributor.authorCiuleanu, Tudor-
dc.contributor.authorTsekov, Hristo-
dc.contributor.authorShparyk, Yaroslav-
dc.contributor.authorCuceviá, Branka-
dc.contributor.authorJuhasz, Gabor-
dc.contributor.authorThatcher, Nick-
dc.contributor.authorRoss, Graham A-
dc.contributor.authorDane, Graham C-
dc.contributor.authorCrofts, Theresa-
dc.date.accessioned2009-07-06T15:15:33Z-
dc.date.available2009-07-06T15:15:33Z-
dc.date.issued2006-12-01-
dc.identifier.citationPhase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. 2006, 24 (34):5441-7 J. Clin. Oncol.en
dc.identifier.issn1527-7755-
dc.identifier.pmid17135646-
dc.identifier.doi10.1200/JCO.2006.06.5821-
dc.identifier.urihttp://hdl.handle.net/10541/72636-
dc.description.abstractPURPOSE: For patients with small-cell lung cancer (SCLC), further chemotherapy is routinely considered at relapse after first-line therapy. However, proof of clinical benefit has not been documented. PATIENTS AND METHODS: This study randomly assigned patients with relapsed SCLC not considered as candidates for standard intravenous therapy to best supportive care (BSC) alone (n = 70) or oral topotecan (2.3 mg/m2/d, days 1 through 5, every 21 days) plus BSC (topotecan; n = 71). RESULTS: In the intent-to-treat population, survival (primary end point) was prolonged in the topotecan group (log-rank P = .0104). Median survival with BSC was 13.9 weeks (95% CI, 11.1 to 18.6) and with topotecan, 25.9 weeks (95% CI, 18.3 to 31.6). Statistical significance for survival was maintained in a subgroup of patients with a short treatment-free interval (< or = 60 days). Response to topotecan was 7% partial and 44% stable disease. Patients on topotecan had slower quality of life deterioration and greater symptom control. Principal toxicities with topotecan were hematological: grade 4 neutropenia, 33%; grade 4 thrombocytopenia, 7%; and grade 3/4 anemia, 25%. Comparing topotecan with BSC, infection grade 2 was 14% versus 12% and sepsis 4% versus 1%; other grade 3/4 events included vomiting 3% versus 0, diarrhea 6% versus 0, dyspnea 3% versus 9%, and pain 3% versus 6%. Toxic deaths occurred in four patients (6%) in the topotecan arm. All cause mortality within 30 days of random assignment was 13% on BSC and 7% on topotecan. CONCLUSION: Chemotherapy with oral topotecan is associated with prolongation of survival and quality of life benefit in patients with relapsed SCLC.en
dc.language.isoenen
dc.subjectLung Canceren
dc.subjectCancer Recurrenceen
dc.subject.meshAdministration, Oral-
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshCarcinoma, Small Cell-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshLung Neoplasms-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoplasm Recurrence, Local-
dc.subject.meshPalliative Care-
dc.subject.meshQuality of Life-
dc.subject.meshSurvival Rate-
dc.subject.meshTopotecan-
dc.titlePhase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer.en
dc.typeArticleen
dc.contributor.departmentRoyal Marsden Hospital, National Health System Trust, Sutton, Surrey, England. mary.o'brien@rmh.nhs.uken
dc.identifier.journalJournal of Clinical Oncologyen

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