Phase 3 study of docosahexaenoic acid-paclitaxel versus dacarbazine in patients with metastatic malignant melanoma.

Abstract

BACKGROUND:

Docosahexaenoic acid-paclitaxel (DHA-paclitaxel, Taxoprexin(®)) is made by covalently conjugating the essential fatty acid DHA to the paclitaxel molecule. Preclinical studies of DHA-paclitaxel have demonstrated increased activity relative to paclitaxel and the potential for an improved therapeutic ratio. In the present study, the efficacy and toxicity profiles of DHA-paclitaxel were compared with those of dacarbazine.

METHODS:

In this study, 393 chemonaive patients with metastatic melanoma were randomly assigned to receive either DHA-paclitaxel at a starting dose of 900 mg/m(2) IV on day 1 every 3 weeks or dacarbazine at a starting dose of 1000 mg/m(2) IV on day 1 every 3 weeks. The primary end point of the study was the comparison of overall survival (OS).

RESULTS:

No significant difference in OS was noted between patients in the DHA-paclitaxel and dacarbazine arms. Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs. Safety results of the two drugs were as predicted from prior studies. Myelosuppression was more common with DHA-paclitaxel.

CONCLUSIONS:

DHA-paclitaxel was not superior to dacarbazine. We conclude that further studies with the drug on an every 3-week schedule in melanoma are not warranted.

• Authors: A Y Bedikian, R C DeConti, R Conry, S Agarwala, N Papadopoulos, K B Kim, M Ernstoff
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 22 Issue 4 Pg. 787-793 (Apr 2011) ISSN: 1569-8041 [Electronic] England
• PMID: 20855467 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Chemical References

• Dacarbazine
• docosahexaenoyl-paclitaxel
• Paclitaxel

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Dacarbazine (adverse effects, therapeutic use)
• Disease Progression
• Disease-Free Survival
• Female
• Humans
• Male
• Melanoma (drug therapy, pathology)
• Middle Aged
• Neoplasm Metastasis
• Paclitaxel (adverse effects, analogs & derivatives, therapeutic use)