DHA-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.
dc.contributor.author | Payne, Miranda | |
dc.contributor.author | Ellis, Paul A | |
dc.contributor.author | Dunlop, D | |
dc.contributor.author | Ranson, Malcolm R | |
dc.contributor.author | Danson, Sarah | |
dc.contributor.author | Schacter, Lee | |
dc.contributor.author | Talbot, Denis | |
dc.date.accessioned | 2009-07-06T16:00:39Z | |
dc.date.available | 2009-07-06T16:00:39Z | |
dc.date.issued | 2006-11 | |
dc.identifier.citation | DHA-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 Oncol | en |
dc.identifier.issn | 1556-1380 | |
dc.identifier.pmid | 17409983 | |
dc.identifier.uri | http://hdl.handle.net/10541/72628 | |
dc.description.abstract | INTRODUCTION: 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.iso | en | en |
dc.subject | Cancer Staging | en |
dc.subject.mesh | Adult | |
dc.subject.mesh | Age Factors | |
dc.subject.mesh | Aged | |
dc.subject.mesh | Carcinoma, Non-Small-Cell Lung | |
dc.subject.mesh | Disease-Free Survival | |
dc.subject.mesh | Docosahexaenoic Acids | |
dc.subject.mesh | Dose-Response Relationship, Drug | |
dc.subject.mesh | Drug Administration Schedule | |
dc.subject.mesh | Drug Combinations | |
dc.subject.mesh | Female | |
dc.subject.mesh | Follow-Up Studies | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Infusions, Intravenous | |
dc.subject.mesh | Lung Neoplasms | |
dc.subject.mesh | Male | |
dc.subject.mesh | Maximum Tolerated Dose | |
dc.subject.mesh | Middle Aged | |
dc.subject.mesh | Neoplasm Staging | |
dc.subject.mesh | Paclitaxel | |
dc.subject.mesh | Patient Selection | |
dc.subject.mesh | Probability | |
dc.subject.mesh | Prospective Studies | |
dc.subject.mesh | Risk Factors | |
dc.subject.mesh | Single-Blind Method | |
dc.subject.mesh | Survival Analysis | |
dc.title | DHA-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.type | Article | en |
dc.contributor.department | Cancer Research UK Oxford Cancer Centre, Oxford, UK. | en |
dc.identifier.journal | Journal of Thoracic Oncology | en |
html.description.abstract | INTRODUCTION: 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. |