Table 2.
Efficacy outcomes
| |
Fotemustine efficacy |
Interferon-α2b efficacy |
||||
|---|---|---|---|---|---|---|
| FM/DTIC/IFN + FM/DTIC | DTIC/IFN + DTIC | HR* (95% CI) | FM/DTIC/IFN + DTIC/IFN | FM/DTIC + DTIC | HR* (95% CI) | |
|
Overall survival: |
|
|
|
|
|
|
| Events, n (%) |
125 (95%) |
125 (98%) |
|
122 (97%) |
128 (96%) |
|
| Median, months (95% CI) |
7.9 (6.6−10.2) |
8.6 (6.3−10.4) |
0.93 (0.71−1.21) |
9.1 (6.3−11.1) |
7.7 (6.3−9.7) |
0.92 (0.70−1.20) |
|
Progression-free survival: |
|
|
|
|
|
|
| Events, n (%) |
128 (97%) |
125 (98%) |
|
123 (98%) |
130 (97%) |
|
| Median, months (95% CI) |
2.7 (2.4−3.8) |
2.5 (2.3−3.7) |
0.93 (0.72−1.21) |
2.8 (2.4−3.9) |
2.5 (2.3−2.9) |
0.96 (0.73−1.25) |
|
Overall response, n (%) |
32 (34%) |
33 (26%) |
|
34 (27%) |
31 (23%) |
|
| (95% CI) | (17−32%) | (18−33%) | (19−35%) | (16−30%) | ||
* After adjustment by age, sex, performance status, site of metastases, Breslow score and other treatment factor.
FM = fotemustine; DTIC = dacarbazine; IFN = interferon-α2b.