Pegylated Liposomal Doxorubicin Sample Clauses

Pegylated Liposomal Doxorubicin. PLD is approved as monotherapy in recurrent PROC. The approved dose and schedule of 50 mg/m2 every 28-days of PLD results in a substantial incidence (approximately 20%–30%) of Grade 3 “hand-foot-syndrome” (Xxxxxxx 2011). Considerable clinical experience generated since the initial regulatory approval of PLD has revealed equivalent clinical activity with substantially less severe adverse events when this agent is administered at a dose of 40 mg/m2 (rather than 50 mg/m2) on a 4-week schedule (Xxxxxxx 2011). Results of two randomized Phase 2 trials (Xxxxxxx 2000, Xxxxxxxx 2004) provide strong support for the conclusion that the 40 mg/m2 dose level of PLD is therapeutically equivalent to the higher (and more toxic) dose approved for standard use in the second-line management of EOC. Recently a study was conducted to show equivalence in efficacy of PLD 40 mg/m2 and PLD 50 mg/m2 (Yoshizawa 2015). This randomized controlled study also supports the use of an initial dose of 40 mg/m2 PLD. PLD is another standard chemotherapy regimen used for treating PROC. The active component of this drug (doxorubicin) is an anthracycline that intercalates DNA, leading to inhibition of replication and, subsequently, the inhibition of proper cell division. Efficacy of PLD in PROC EOC has been confirmed in several Phase 2 trials. In detail, the trial by Xxxxxx et al reported a 26% RR, median PFS of 5.7 months, and OS of 11 months (Muggia 1997). A subsequent trial showed a 17% XXX and median PFS of 4.5 months (Gelmon 2011). Of note, a Phase 3 trial testing Topo treatment vs. PLD treatment showed a trend toward a higher XXX in the PROC patients subset treated with PLD, although there was no improvement of PFS or OS (Xxxxxx 2001, Xxxxxx 2004).
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Pegylated Liposomal Doxorubicin. Label warnings, manufacturer’s recommendations and standard clinical practice should be followed.

Related to Pegylated Liposomal Doxorubicin

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