New pixantrone fact sheet by monique greer
per chi fosse interessato qui il nuovo fact sheet su Pixantrone:
http://www.celltherapeutics.com/pdf/Pixantrone_fact-4pg.pdf
la parte più interessante e nuova se non ricordo male visto che il vecchio non è più disponibile è la seguente in cui non si fa più riferimento a 140 pazienti, ma a ben 348......dato che è stato fondamentale nella bocciatura da parte di FDA:
"The safety of pixantrone has been evaluated in 348 
patients, which included 278 patients with NHL, nearly 
all of whom had extensive prior anthracycline exposure. 
h roughout its clinical development, the safety proi le of 
pixantrone has demonstrated that it is well tolerated with 
manageable toxicities.
h e primary source for the safety assessment of pixantrone was the well-controlled PIX301 trial, the i rst 
randomized controlled trial in this patient population. In 
that study, pixantrone, administered at a weekly dose of 
85 mg/m2
 on days 1, 8 and 15 of a 28-day cycle, was well 
tolerated in heavily pretreated patients with relapsed or 
refractory aggressive NHL. 
Pixantrone recipients had a low incidence of febrile 
neutropenia (7.4%). Pixantrone patients also experienced 
a low incidence of hair loss (13.2%), a very common side 
ef ect of other drugs in this class. Overall, the incidence 
of serious adverse events was similar between pixantrone 
and the control arm. h e pixantrone patients had a higher 
incidence of leucopenia and neutropenia and numerically 
more serious cardiac events (6 vs. 3) including both events 
reported as related or unrelated to the study drug by the 
investigator. Disease progression reported as an adverse 
event was less frequent in the pixantrone than in the 
control arm (1.5% vs. 13.4%)."