Doxil — The First FDA-Approved Nano-Drug: From an Idea to a Product - Harnessing Biomaterials in Nanomedicine: Preparation, Toxicity, and Applications - page 380

∑ AIDS-related Kaposi's sarcoma: Superior efficacy over former
conventional therapy (1995).
∑ Recurrent ovarian cancer: Superior efficacy and improved
safety profile over comparator drug (topotecan) (1998), as
demonstrated first by Gordon et al. (2001) (Figure 12.9).
∑ Metastatic Breast Cancer: Equivalent efficacy and reduced
cardiotoxicity compared with free doxorubicin (2003).
∑ Multiple myeloma: Equivalent efficacy and improved safety
profile compared to free doxorubicin combo. Superior efficacy
in combination with bortezomib over single agent bortezomib
(2007).
In addition, regarding cardiac function, Doxil demonstrates
major reduction of cardiotoxicity as compared to free doxorubicin in
all settings (2000).

CAELYX ™ ( n = 109)
Topotecan ( n = 111)

100

CAELYX ™
108 weeks 80

P =.008

%

60

P
a
t
I
e
n
t
s

40

20

Topotecan
71.1 weeks
weeks
weeks

0

0 20

0

40 80 100 120 140

60

Figure 12.9 Caelyx TM (= Doxil) is superior to topotecan in ovarian cancer
(from Gordon et al., 2001). See also Color Insert.

12.6 Conclusions, Take-Home Lessons, and

Future Directions

To sum-up, the anticancer nano-drug Doxil shows good clinical
performance in a variety of neoplastic conditions due to its improved
antitumor therapeutic efficacy and unique reduced safety profile,
especially its impressive reduction in cardiac toxicity when compared