Cancer
Malignant Melanoma
Malignant melanoma is resistant to most forms of therapy, with
response rates to dacarbazine (DTIC), the most active single
agent, of approximately 17% to 20%, without impact on patient
survival. (149-151) The effects
of Zadaxin in combination with chemotherapy and cytokine therapy
for treatment of malignant melanoma were examined in 3 trials
in Italy with comparisons to historical controls.
| Trial
#1 (152) |
| • |
26 patients |
| • |
Zadaxin
used following DTIC therapy in combination with
IFNα |
| • |
World
Health Organization (WHO) evaluation
criteria |
| • |
Overall
response rate of 50% |
| • |
Mean
duration of response of 13.5 months |
| Trial
#2 (153) |
| • |
20 patients
|
| • |
Stage
III or IV unresectable metastatic melanoma |
|
| • |
Zadaxin used following
DTIC therapy in combination
with IFNα |
| • |
Up to 9 cycles of
therapy |
| • |
50% overall response
to therapy |
| |
| – |
25% complete
response |
| – |
25% partial
response |
|
| • |
Median survival
time 11.5 months (range 6 to 83+) |
| • |
Median time to progression
5.5 months (range 3 to 83+) |
| • |
35% survival >12
months (7/20) |
| • |
15% disease free
after more than 3 years (3/20) |
|
| |
DTIC alone
(Falkson)
|
DTIC/IFN
(Garbe) |
DTIC/IL2
(Flaherty) |
ZDX/IL2/
DTIC
(Lopez) |
ZDX/IFN/
DTIC
(Favalli) |
ZDX/IFN/
DTIC
(Rasi) |
|
Figure
19. Effect of Zadaxin on metastatic melanoma.
The trials involving Zadaxin were Lopez, (148,154)
Favalli, (152)
and Rasi. (153) Percent
response is as defined in each study. (148-150,152-155) |
| Trial #3 (154) |
| • |
42 evaluable
patients |
| • |
Zadaxin administered
following DTIC therapy in combination with IL-2 |
| • |
36% objective
response rate |
| |
| – |
2 complete
responses |
| – |
13 partial
responses |
|
| • |
Median time
to progression 5.5 months |
| • |
Median survival
11 months |
Historical controls have shown response rates of about 27% with
DTIC and IFNα (149)
and about 22% with DTIC and IL-2. (155)
Thus, the Zadaxin-treated patients showed greater overall response
over these other regimens, namely DTIC with IFN or IL-2 (Figure
19).
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