Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study.

Abstract

PURPOSE:

The objective of this phase II trial was to assess the efficacy and toxicity of weekly paclitaxel for patients with metastatic or unresectable angiosarcoma.

PATIENTS AND METHODS:

Thirty patients were entered onto the study from April 2005 through October 2006. Paclitaxel was administered intravenously as a 60-minute infusion at a dose of 80 mg/m(2) on days 1, 8, and 15 of a 4-week cycle. The primary end point was the nonprogression rate after two cycles.

RESULTS:

The progression-free survival rates after 2 and 4 months were 74% and 45%, respectively. With a median follow-up of 8 months, the median time to progression was 4 months and the median overall survival was 8 months. The progression-free survival rate was similar in patients pretreated with chemotherapy and in chemotherapy-naïve patients (77% v 71%). Three patients with locally advanced breast angiosarcoma presented partial response, which enabled a secondary curative-intent surgery with complete histologic response in two cases. One toxic death occurred as a result of a thrombocytopenia episode. Six patients presented with grade 3 toxicities and one patient presented with a grade 4 toxicity. Anemia and fatigue were the most frequently reported toxicities.

CONCLUSION:

Weekly paclitaxel at the dose schedule used in the current study was well tolerated and demonstrated clinical benefit.

• Authors: Nicolas Penel, Binh Nguyen Bui, Jacques-Olivier Bay, Didier Cupissol, Isabelle Ray-Coquard, Sophie Piperno-Neumann, Pierre Kerbrat, Charles Fournier, Sophie Taieb, Marta Jimenez, Nicolas Isambert, Frédéric Peyrade, Christine Chevreau, Emmanuelle Bompas, Etienne G C Brain, Jean-Yves Blay
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 26 Issue 32 Pg. 5269-74 (Nov 10 2008) ISSN: 1527-7755 [Electronic] United States
• PMID: 18809609 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Paclitaxel

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects)
• Breast Neoplasms (drug therapy, mortality, pathology)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• France (epidemiology)
• Head and Neck Neoplasms (drug therapy, mortality, pathology)
• Hemangiosarcoma (drug therapy, mortality, pathology)
• Humans
• Infusions, Intravenous
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Neoplasm Metastasis
• Paclitaxel (administration & dosage, adverse effects)
• Scalp
• Skin Neoplasms (drug therapy, mortality, pathology)
• Soft Tissue Neoplasms (drug therapy, mortality, pathology)
• Time Factors
• Treatment Outcome