Phase II trial of the novel taxane BMS-184476 as second-line in non-small-cell lung cancer.

Abstract

BACKGROUND:

The purpose of this study was to evaluate the tolerability and efficacy of BMS-184476, an analog of paclitaxel, in patients with advanced non-small-cell lung cancer (NSCLC) progressing or relapsing following at least one prior chemotherapy regimen.

PATIENTS AND METHODS:

Fifty-six previously treated advanced NSCLC patients received BMS-184476 at a dose of 60 mg/m(2) administered intravenously over 1 h every 21 days.

RESULTS:

The median number of cycles delivered per patient was five (range one to 17). Dose reduction was required in only 3.8% of cycles. Grade 4 neutropenia occurred in 19.6% of patients, but no grade 4 thrombocytopenia or anemia was reported. Febrile neutropenia was observed in only two (3.6%) patients and there were no life-threatening events. Grade 3/4 peripheral sensory-motor neuropathy was reported in 9% of patients. Other non-hematological toxicities, such as nausea and vomiting, myalgia and arthralgia, diarrhea, and mucositis, were uncommon. Partial responses were observed in eight (14.3%) patients and stable disease in 33 (58.9%). Median progression-free survival was 3.7 months [95% confidence interval (CI) 2.7-5.4] and median overall survival was 10 months (95% CI 6-13.4).

CONCLUSIONS:

BMS-184476 was well tolerated at the dose of 60 mg/m(2) and showed evidence of antitumor activity in previously treated NSCLC.

• Authors: C Camps, E Felip, J M Sanchez, B Massuti, A Artal, L Paz-Ares, A Carrato, V Alberola, A Blasco, J Baselga, L Astier, M Voi, R Rosell, Spanish Lung Cancer Group
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 16 Issue 4 Pg. 597-601 (Apr 2005) ISSN: 0923-7534 [Print] England
• PMID: 15684226 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article)

Chemical References

• Taxoids
• 7-methylthiomethylpaclitaxel

Topics

• Adult
• Aged
• Carcinoma, Non-Small-Cell Lung (blood, drug therapy)
• Female
• Gastrointestinal Diseases (chemically induced)
• Humans
• Lung Neoplasms (blood, drug therapy)
• Male
• Middle Aged
• Survival Analysis
• Taxoids (adverse effects, therapeutic use)