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


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.


CONCLUSIONS
Weekly paclitaxel at the dose schedule used in the current study was well tolerated and demonstrated clinical benefit.
Penel
Nicolas
N
Département de Cancérologie Générale, Centre Oscar Lambret, Lille, France. n-penel@o-lambret.fr
Bui
Binh Nguyen
BN
Bay
Jacques-Olivier
JO
Cupissol
Didier
D
Ray-Coquard
Isabelle
I
Piperno-Neumann
Sophie
S
Kerbrat
Pierre
P
Fournier
Charles
C
Taieb
Sophie
S
Jimenez
Marta
M
Isambert
Nicolas
N
Peyrade
Frédéric
F
Chevreau
Christine
C
Bompas
Emmanuelle
E
Brain
Etienne G C
EG
Blay
Jean-Yves
JY
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005602:France / Q000453:epidemiology; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006394:Hemangiosarcoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D012535:Scalp; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D012983:Soft Tissue Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel