Table 2.
Association of CTC enumeration, apoptosis, and clusters with outcomes.
Baseline | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CTC-Enumerationa | CTC-Apoptosisb | CTC-Clustersc | ||||||||||||||||
ORR | p | CBR | p | PFS | p | ORR | p | CBR | p | PFS | p | ORR | p | CBR | p | PFS | p | |
No | 12/33 (36.4) |
0.25 | 23/33 (69.7) |
0.02 1 | 3.6 | 0.005 | 3/14 (21.4) |
1.0 | 6/14 (42.9) |
0.60 | 1.9 | 0.47 | 5/24 (20.8) |
1.0 | 11124 (45.8) |
1.0 | 2.3 | 0.34 |
Yes | 4/19 (21.1) |
7/19 (36.8) |
1.9 | 1/5 (20.0) |
1/5 (20.0) |
2.1 | 1/8 (12.5) |
3/8 (37.5) |
2.0 |
Day 15 | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CTC-Enumerationa | CTC-Apoptosisb | CTC-Clustersc | ||||||||||||||||
ORR | P | CBR | P | PFS | P | ORR | P | CBR | P | PFS | P | ORR | P | CBR | P | PFS | P | |
No | 14/3 8 (36.8) |
0.34 | 26/38 (684) |
0.010 | 3.6 | 0.0003 | 2/7 (28.6) |
1.0 | 2/7 (28.6) |
1.0 | 1.8 | 0.11 | 5/18 (27 .8) |
0.54 | 7/18 (3 8.9) |
0.26 | 2.5 | 0.028 |
Yes | 3/14 (21.4) |
4/14 (28.6) |
1.9 | 1/7 (14.3) |
2/7 (28.6) |
2.1 | 0/4 (0) |
0/4 (0) |
1.8 |
Day 29 | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CTC-Enumerationa | CTC-Apoptosisb | CTC-Clustersc | ||||||||||||||||
ORR | P | CBR | P | PFS | P | ORR | P | CBR | P | PFS | P | ORR | P | CBR | P | PFS | P | |
No | 14/36 (38.9) |
0.043 | 27/36 (75.0) |
0.0002 | 3.7 | 0.0002 | 0/5 (0) |
1.0 | 115 (20.0) |
1.0 | 1.8 | 0.73 | 4112 (33.3) |
0.25 | 6112 (50.0) |
0.04 4 | 2.7 | 0.009 |
Yes. | 1/13 (7.7) |
2/13 (15.4) |
1.9 | 1/8 (12.5) |
1/8 (12.5) |
2.0 | 0/7 (0) |
0/7 (0) |
1.8 |
For CTC-enumeration No<5 CTC/7.5 ml, Yes≥5CTC/7.5 ml;
For CTC-Apoptosis No ≥5CTC/7.5 ml with <25% apoptic, Yes≥5CTC/7.5 ml with 2>25% apoptotic;
CTC-cluster No ≥1 CTC/7.5 ml with no cluster; Yes ≥1 CTC with at least 1 cluster; ORR = overall response rate, sum of complete response (CR) plus partial response (PR); CBR=clinical benefit rate stable disease (SD) plus PR, and CR; PFS=Progression free survival; p=p value. (Note values in parentheses are numbers expressed in %; PFS is median time to progression in months.