Originally published as JCO Early Release 10.1200/JCO.2008.17.3146 on September 22 2008

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Phase II Trial of Weekly Paclitaxel for Unresectable Angiosarcoma: The ANGIOTAX Study

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

From the Département de Cancérologie Générale, Unité de Biostatistiques, and Département d’Imagerie Médicale, Centre Oscar Lambret; Equipe d’Accueil 2694, Santé Publique, Epidémiologie et modélisation des maladies chroniques, Université Lille II, Lille; Département d’Oncologie Médicale, Institut Bergonié, Bordeaux; Département d’Oncologie Médicale, Centre Jean Perrin, Clermont-Ferrand; Département d’Oncologie Médicale, Centre Val d’Aurelle, Montpellier; Département d’Oncologie Médicale, and Unité L’Institut National de la Santé et de la Recherche Médicale 590, Centre Léon Bérard; Service d’Oncologie Médicale, Hôpital Edouard Herriot, Lyon; Département d’Oncologie Médicale, Institut Curie; Bureau des Etudes Cliniques et Thérapeutiques, Fédération Nationale des Centres de Lutte Contre le Cancer, Paris; Département d’Oncologie Médicale, Centre Eugène Marquis, Rennes; Département d’Oncologie Médicale, Centre Georges-François Leclerc, Dijon; Département d’Oncologie Médicale, Centre Antoine Lacassagne, Nice; Département d’Oncologie Médicale, Institut Claudius Regaud, Toulouse; Département d’Oncologie Médicale, Centre René Gauducheau, Nantes; and the Département d’Oncologie Médicale, Centre René Huguenin, Saint-Cloud, France

Corresponding author: Nicolas Penel, MD, Département de Cancérologie Générale, Centre Oscar Lambret, 3 rue Frédéric Combemale, 59020, Lille, France; e-mail: n-penel{at}o-lambret.fr

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/m² 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.

published online ahead of print at www.jco.org on September 22, 2008.

Supported by La Ligue National Contre le Cancer, Mayne Pharma France, and Chugai Pharma France.

Presented in oral format at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-4, 2007, Chicago, IL.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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