A phase II study of carboplatin and vinorelbine in patients with poor prognosis small cell lung cancer.

2.50
Hdl Handle:
http://hdl.handle.net/10541/78970
Title:
A phase II study of carboplatin and vinorelbine in patients with poor prognosis small cell lung cancer.
Authors:
Mackay, H J; O'Brien, M; Hill, S; Lees, S M; Thatcher, Nick; Smith, I E; Dunlop, D
Abstract:
AIM: The aim of this study was to evaluate the activity of the combination of carboplatin and vinorelbine in patients with poor prognosis small cell lung cancer (SCLC). Patients with good prognosis disease were included who were not medically fit to tolerate conventional chemotherapy. Activity was assessed primarily as response rate and secondarily in terms of toxicity, time to progression and survival. PATIENTS AND METHODS: Fifty-eight patients, 37 men and 21 women, with histologically or cytologically confirmed SCLC, who had bi-dimensionally measurable disease, with ECOG performance status > or = 2, with adequate haematological, hepatic and renal function received first-line chemotherapy with carboplatin (AUC x 5) day 1 and vinorelbine (30 mg/m2) days 1 and 8 of a 28-day cycle. Response was assessed after every two cycles of chemotherapy, with patients receiving a maximum of six cycles of treatment. RESULTS: The combination of carboplatin and vinorelbine is an active regimen in the treatment of SCLC, with an overall intention-to-treat response rate of 55% [95% confidence interval (CI): 42-68%] with six (10%) of patients having a complete response. Median time to progression was 18 weeks (95% CI: 15-21 weeks). Median overall survival was 26 weeks (95% CI: 21-31 weeks). Ten patients failed to complete two cycles of treatment, and were not evaluable for response for the following reasons: septic death (1 neutropaenic, 1 no myelotoxicity), non-toxic death (1 tumour eroded through the pulmonary artery, 1 ischaemic heart disease) ischaemic heart disease (1) and patient decision (5). There were a total of three toxic deaths all sepsis-complicating neutropaenia. Forty-four (76%) patients experienced grade 3 or 4 neutropaenia, six (11%) grade 3 or 4 thrombocytopaenia, 10 (13%) grade 3 lethargy, three (5%) grade 3 nausea and two (3%) grade 3 diarrhoea. CONCLUSIONS: The combination of carboplatin and vinorelbine is active against SCLC but the toxicity profile in this group of patients suggests that further evaluation is not appropriate.
Affiliation:
CRC Department of Medical Oncology, Beatson Oncology Centre, Western Infirmary, Glasgow, UK. hjmk1z@udcf.gla.ac.uk
Citation:
A phase II study of carboplatin and vinorelbine in patients with poor prognosis small cell lung cancer. 2003, 15 (4):181-5 Clin Oncol
Journal:
Clinical Oncology
Issue Date:
Jun-2003
URI:
http://hdl.handle.net/10541/78970
DOI:
10.1016/S0936-6555(02)00335-7
PubMed ID:
12846495
Type:
Article
Language:
en
ISSN:
0936-6555
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorMackay, H J-
dc.contributor.authorO'Brien, M-
dc.contributor.authorHill, S-
dc.contributor.authorLees, S M-
dc.contributor.authorThatcher, Nick-
dc.contributor.authorSmith, I E-
dc.contributor.authorDunlop, D-
dc.date.accessioned2009-08-27T15:40:14Z-
dc.date.available2009-08-27T15:40:14Z-
dc.date.issued2003-06-
dc.identifier.citationA phase II study of carboplatin and vinorelbine in patients with poor prognosis small cell lung cancer. 2003, 15 (4):181-5 Clin Oncolen
dc.identifier.issn0936-6555-
dc.identifier.pmid12846495-
dc.identifier.doi10.1016/S0936-6555(02)00335-7-
dc.identifier.urihttp://hdl.handle.net/10541/78970-
dc.description.abstractAIM: The aim of this study was to evaluate the activity of the combination of carboplatin and vinorelbine in patients with poor prognosis small cell lung cancer (SCLC). Patients with good prognosis disease were included who were not medically fit to tolerate conventional chemotherapy. Activity was assessed primarily as response rate and secondarily in terms of toxicity, time to progression and survival. PATIENTS AND METHODS: Fifty-eight patients, 37 men and 21 women, with histologically or cytologically confirmed SCLC, who had bi-dimensionally measurable disease, with ECOG performance status > or = 2, with adequate haematological, hepatic and renal function received first-line chemotherapy with carboplatin (AUC x 5) day 1 and vinorelbine (30 mg/m2) days 1 and 8 of a 28-day cycle. Response was assessed after every two cycles of chemotherapy, with patients receiving a maximum of six cycles of treatment. RESULTS: The combination of carboplatin and vinorelbine is an active regimen in the treatment of SCLC, with an overall intention-to-treat response rate of 55% [95% confidence interval (CI): 42-68%] with six (10%) of patients having a complete response. Median time to progression was 18 weeks (95% CI: 15-21 weeks). Median overall survival was 26 weeks (95% CI: 21-31 weeks). Ten patients failed to complete two cycles of treatment, and were not evaluable for response for the following reasons: septic death (1 neutropaenic, 1 no myelotoxicity), non-toxic death (1 tumour eroded through the pulmonary artery, 1 ischaemic heart disease) ischaemic heart disease (1) and patient decision (5). There were a total of three toxic deaths all sepsis-complicating neutropaenia. Forty-four (76%) patients experienced grade 3 or 4 neutropaenia, six (11%) grade 3 or 4 thrombocytopaenia, 10 (13%) grade 3 lethargy, three (5%) grade 3 nausea and two (3%) grade 3 diarrhoea. CONCLUSIONS: The combination of carboplatin and vinorelbine is active against SCLC but the toxicity profile in this group of patients suggests that further evaluation is not appropriate.en
dc.language.isoenen
dc.subjectLung Canceren
dc.subjectCancer Stagingen
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshCarboplatin-
dc.subject.meshCarcinoma, Small Cell-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshLung Neoplasms-
dc.subject.meshMale-
dc.subject.meshNeoplasm Staging-
dc.subject.meshPrognosis-
dc.subject.meshSurvival Analysis-
dc.subject.meshVinblastine-
dc.titleA phase II study of carboplatin and vinorelbine in patients with poor prognosis small cell lung cancer.en
dc.typeArticleen
dc.contributor.departmentCRC Department of Medical Oncology, Beatson Oncology Centre, Western Infirmary, Glasgow, UK. hjmk1z@udcf.gla.ac.uken
dc.identifier.journalClinical Oncologyen

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