Table 2: Uni- and multivariate analysis of prognostic factors concerning tumor response, IPFS, TDM and OS.
|
Prognostic factor |
CR |
|
IPFS |
|
TDM |
|
OS |
|||
|
|
Univariate OR |
Multivariate OR |
Univariate HR |
Multivariate HR |
Univariate HR |
Multivariate HR |
Univariate HR |
Multivariate HR |
||
|
Sex; Male vs Female |
0.45 (0.16) |
0.73 (0.37) |
1.86 (0.05) |
2.34 (0.03) |
1.64 (0.07) |
|||||
|
Age |
0.98 (0.32) |
1.01 (0.38) |
1.01 (0.40) |
1.01 (0.10) |
||||||
|
Primary tumor localization |
||||||||||
|
Below vs Above the knee/elbow |
(***) |
(**) |
0.70 (0.56) |
0.61 (0.34) |
||||||
|
Primary vs No primary tumor |
0.95 (0.94) |
1.76 (0.20) |
1.55 (0.32) |
1.30 (0.52) |
||||||
|
Highest lesion localization |
||||||||||
|
Below vs Above the knee/elbow |
1.43 (0.47) |
1.16 (0.62) |
0.70 (0.22) |
0.86 (0.58) |
||||||
|
Number of lesions before ILP |
1.00 (0.98) |
(0.03) (*) |
(0.12) (*) |
1.00 (0.30) |
1.00 (0.98) |
|||||
|
Time diagnosis to ILP |
1.00 (0.38) |
0.84 (0.33) |
1.15 (0.32) |
0.71 (0.70) |
||||||
|
Number of previous relapses (> 1 vs ≤ 1) |
0.80 (0.70) |
2.23 (0.01) |
0.98 (0.97) |
1.27 (0.36) |
||||||
|
Mean time between relapses |
1.01 (0.61) |
(0.04) (*) |
0.99 (0.23) |
0.98 (0.11) |
||||||
|
Number of lesions at ILP |
0.99 (0.57) |
0.99 (0.88) |
0.99 (0.30) |
1.00 (0.49) |
||||||
|
SNB; Yes vs No |
1.52 (0.45) |
0.80 (0.54) |
0.39 (0.02) |
0.43 (0.13) |
0.53 (0.06) |
|||||
|
LND before ILP; Yes vs No |
0.36 (0.04) |
0.15 (0.01) |
2.43 (0.003) |
2.11 (0.02) |
1.92 (0.03) |
3.45 (0.004) |
1.54 (0.11) |
|||
|
Result LND before ILP; N+ vs N- |
2.89 (0.27) |
1.83 (0.28) |
2.57 (0.10) |
2.17 (0.16) |
||||||
|
LND at ILP; N+ vs N- |
0.84 (0.75) |
0.59 (0.15) |
1.55 (0.17) |
1.25 (0.45) |
||||||
|
Clark level; 4/5 vs 2/3 |
0.42 (0.31) |
4.15 (0.05) |
2.43 (0.15) |
2.86 (0.05) |
2.63 (0.07) |
|||||
|
Breslow |
0.79 (0.14) |
1.01 (0.92) |
1.09 (0.35) |
1.06 (0.44) |
||||||
|
Subtype |
-0.91 |
-0.07 |
-0.01 |
-0.37 |
-0.02 |
-0.1 |
||||
|
Acral lentiginous vs Nodular |
2.90 (0.02) |
4.53 (0.001) |
0.44 (0.33) |
3.35 (0.003) |
2.53 (0.03) |
|||||
|
Acral lentiginous vs Superficial spreading |
1.60 (0.27) |
2.70 (0.02) |
1.10 (0.90) |
2.01 (0.06) |
1.52 (0.28) |
|||||
|
Nodular vs Superficial spreading |
0.55 (0.12) |
0.60 (0.18) |
2.47 (0.08) |
0.60 (0.13) |
0.60 (0.14) |
|||||
|
Ulceration; Yes vs No |
0.72 (0.55) |
0.83 (0.59) |
2.69 (0.01) |
2.91 (0.006) |
1.80 (0.05) |
1.87 (0.04) |
||||
|
Mitotic index (/mm²); ≤ 6 vs > 6 |
3.85 (0.03) |
5.56 (0.02) |
1.15 (0.70) |
0.60 (0.18) |
0.63 (0.16) |
|||||
|
Lymphovascular invasion; Yes vs No |
1.98 (0.37) |
0.69 (0.48) |
1.85 (0.13) |
1.21 (0.63) |
||||||
|
Stage (M.D. Anderson Stage (modified) [7]) |
-0.18 |
-0.007 |
-0.04 |
-0.04 |
||||||
|
IIIA vs III(B)A |
0.54 (0.14) |
0.34 (0.009) |
0.37 (0.01) |
|||||||
|
IIIA vs III AB |
1.65 (0.18) |
0.62 (0.13) |
0.76 (0.37) |
|||||||
|
III(B)A vs IIIAB |
3.07 (0.02) |
1.79 (0.15) |
2.04 (0.07) |
|||||||
|
IIIAB vs IV |
0.17 (0.0006) |
/ |
0.48 (0.11) |
|||||||
|
III(B)A vs IV |
0.53 (0.24) |
/ |
0.98 (0.97) |
|||||||
|
State of remission |
||||||||||
|
CR vs nCR |
/ |
0.25 (0.0001) |
0.21 (0.0001) |
0.28 (0.0001) |
||||||
|
CR vs Resection |
/ |
1.58 (0.41) |
0.41 (0.03) |
0.52 (0.10) |
||||||
|
nCR vs Resection |
/ |
6.42 (0.0007) |
1.89 (0.11) |
1.89 (0.09) |
||||||
|
No resection vs Resection |
/ |
3.19 (0.03) |
0.89 (0.74) |
0.99 (0.99) |
||||||
Regarding continuous variables, linear relationship displayed. Quadratic relationship only mentioned if significant. P-values in parenthesis.
HR IPFS / TDM / OS: HR<1 indicates lower risk for the first category and HR>1 indicates higher risk for the first category; OR CR: OR<1 indicates lower probability of CR for first than second category, OR>1 indicates higher probability of CR for first than second category; (*) P-value based on quadratic relationship (Appendix); (**) No events in subgroup “Above the knee/elbow”; (***) No relevant calculation possible because of the small number of patients in the subgroup “Above the knee/elbow”.
CR: complete response; nCR: non-complete response; “No resection group”: CR + nCR; IPFS: in-field progression-free survival; TDM: time to distant metastases; OS: overall survival; OR: odds ratio; HR: hazard ratio; N: lymph node status; ITM: in-transit metastase; ILP: isolated limb perfusion; SNB: sentinel node biopsy.
LND before ILP: lymph node dissection at least 3 months before ILP; Stage III(B)A: patients with a positive LND at least three months before their ILP, who presented at time of perfusion with ITM without nodal recurrence.