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dc.contributor.authorPayne, Miranda
dc.contributor.authorEllis, Paul A
dc.contributor.authorDunlop, D
dc.contributor.authorRanson, Malcolm R
dc.contributor.authorDanson, Sarah
dc.contributor.authorSchacter, Lee
dc.contributor.authorTalbot, Denis
dc.date.accessioned2009-07-06T16:00:39Z
dc.date.available2009-07-06T16:00:39Z
dc.date.issued2006-11
dc.identifier.citationDHA-paclitaxel (Taxoprexin) as first-line treatment in patients with stage IIIB or IV non-small cell lung cancer: report of a phase II open-label multicenter trial. 2006, 1 (9):984-90 J Thorac Oncolen
dc.identifier.issn1556-1380
dc.identifier.pmid17409983
dc.identifier.urihttp://hdl.handle.net/10541/72628
dc.description.abstractINTRODUCTION: This prospective, open-label, non-randomized, multi-institutional phase II study was undertaken to assess the antitumor activity and safety of docosahexaenoic acid-paclitaxel (Taxoprexin) as first-line treatment of patients with advanced non-small cell lung cancer. PATIENTS AND METHODS: Chemotherapy-naive patients were eligible if they had measurable stage IIIB or IV non-small cell lung cancer. Forty-four patients received docosahexaenoic acid-paclitaxel by intravenous infusion every 21 days. Two doses were evaluated: 1100 mg/m and 900 mg/m. Patients were monitored for toxicity and tumor response. RESULTS: Patients received between one and seven (median, two) cycles of treatment. Twenty-eight courses were administered in the cohort starting at 1100 mg/m and 109 courses at 900 mg/m. The starting dose was reduced to 900 mg/m because of toxicity in the first 13 patients. Subsequently, the most severe toxicity was neutropenia (grade III/IV in 68% of patients treated with 900 mg/m). Forty patients were eligible for assessment of tumor response. Two partial responses (4.5%) were documented, and a further 16 patients (36.4%) had stable disease based on an intent-to-treat analysis. The median duration of survival for all patients was 243 days (range, 154-359) and the 1-year survival rate was 35%. CONCLUSION: As a single-agent, docosahexaenoic acid-paclitaxel has little activity in patients with advanced non-small cell lung cancer, with 18 patients (40.1%) achieving either stable disease or a partial response after treatment. Despite the low objective response rate, treatment was associated with survival comparable to that seen with standard platinum-based combination chemotherapy. The dose-limiting toxicity was myelosuppression.
dc.language.isoenen
dc.subjectCancer Stagingen
dc.subject.meshAdult
dc.subject.meshAge Factors
dc.subject.meshAged
dc.subject.meshCarcinoma, Non-Small-Cell Lung
dc.subject.meshDisease-Free Survival
dc.subject.meshDocosahexaenoic Acids
dc.subject.meshDose-Response Relationship, Drug
dc.subject.meshDrug Administration Schedule
dc.subject.meshDrug Combinations
dc.subject.meshFemale
dc.subject.meshFollow-Up Studies
dc.subject.meshHumans
dc.subject.meshInfusions, Intravenous
dc.subject.meshLung Neoplasms
dc.subject.meshMale
dc.subject.meshMaximum Tolerated Dose
dc.subject.meshMiddle Aged
dc.subject.meshNeoplasm Staging
dc.subject.meshPaclitaxel
dc.subject.meshPatient Selection
dc.subject.meshProbability
dc.subject.meshProspective Studies
dc.subject.meshRisk Factors
dc.subject.meshSingle-Blind Method
dc.subject.meshSurvival Analysis
dc.titleDHA-paclitaxel (Taxoprexin) as first-line treatment in patients with stage IIIB or IV non-small cell lung cancer: report of a phase II open-label multicenter trial.en
dc.typeArticleen
dc.contributor.departmentCancer Research UK Oxford Cancer Centre, Oxford, UK.en
dc.identifier.journalJournal of Thoracic Oncologyen
html.description.abstractINTRODUCTION: This prospective, open-label, non-randomized, multi-institutional phase II study was undertaken to assess the antitumor activity and safety of docosahexaenoic acid-paclitaxel (Taxoprexin) as first-line treatment of patients with advanced non-small cell lung cancer. PATIENTS AND METHODS: Chemotherapy-naive patients were eligible if they had measurable stage IIIB or IV non-small cell lung cancer. Forty-four patients received docosahexaenoic acid-paclitaxel by intravenous infusion every 21 days. Two doses were evaluated: 1100 mg/m and 900 mg/m. Patients were monitored for toxicity and tumor response. RESULTS: Patients received between one and seven (median, two) cycles of treatment. Twenty-eight courses were administered in the cohort starting at 1100 mg/m and 109 courses at 900 mg/m. The starting dose was reduced to 900 mg/m because of toxicity in the first 13 patients. Subsequently, the most severe toxicity was neutropenia (grade III/IV in 68% of patients treated with 900 mg/m). Forty patients were eligible for assessment of tumor response. Two partial responses (4.5%) were documented, and a further 16 patients (36.4%) had stable disease based on an intent-to-treat analysis. The median duration of survival for all patients was 243 days (range, 154-359) and the 1-year survival rate was 35%. CONCLUSION: As a single-agent, docosahexaenoic acid-paclitaxel has little activity in patients with advanced non-small cell lung cancer, with 18 patients (40.1%) achieving either stable disease or a partial response after treatment. Despite the low objective response rate, treatment was associated with survival comparable to that seen with standard platinum-based combination chemotherapy. The dose-limiting toxicity was myelosuppression.


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