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%)."