From: A new promising way of maintenance therapy in advanced ovarian cancer: a comparative clinical study
Characteristic | Arm 1 (n = 46) | Arm 2 (n = 76) | Arm 3 (n = 42) | Arm 4 (n = 40) | Arm 5 (n = 80) |
---|---|---|---|---|---|
Age, years | |||||
Median | 54.0 | 54.0 | 54.5 | 54.2 | 54.1 |
Range | 40–76 | 43–71 | 41–68 | 47–68 | 39–69 |
Ethnicity, No. (%) | |||||
White | 42 (91.3) | 68 (89.5) | 38 (90.5) | 36 (90) | 73 (91.2) |
Asian | 4 (8.7) | 7 (9.2) | 4 (9.5) | 3 (7.5) | 6 (7.5) |
Black | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Other | 0 (0) | 1 (1.3) | 0 (0) | 1 (2.5) | 1 (1.2) |
FIGO stage at screening, No. (%) | |||||
III | 38 (82.6) | 60 (78.9) | 34 (80.9) | 32 (80.0) | 66 (82.5) |
IV | 8 (17.4) | 16 (21.1) | 8 (19.0) | 8 (20.0) | 14 (17.5) |
PCI | |||||
Median | 24 | 27 | 27 | 27 | 29 |
Range | 9–36 | 8–37 | 7–37 | 7–37 | 7–37 |
7–10 (≤ 10), No. (%) | 2 (4.3) | 4 (5.3) | 4 (9.5) | 2 (5.0) | 2 (2.5) |
11–20 | 12 (26.1) | 20 (26.3) | 8 (19.0) | 8 (20.0) | 20 (25.0) |
21–30 | 23 (50.0) | 26 (34.2) | 14 (33.3) | 17 (42.5) | 26 (32.5) |
31–37 | 9 (19.6) | 26 (34.2) | 16 (38.1) | 13 (32.5) | 32 (40.0) |
ECOG performance status at screening, No. (%) | |||||
0 | 40 (87.0) | 67 (88.2) | 37 (88.1) | 34 (85.0) | 69 (86.3) |
1 | 3 (6.5) | 5 (6.6) | 3 (7.1) | 4 (10.0) | 6 (7.5) |
2 | 3 (6.5) | 4 (5.3) | 2 (4.8) | 2 (5.0) | 5 (6.3) |
pa | 0.96 | 0.84 | 0.86 | 0.93 | |
Rate of patients with ascites | |||||
at screeningb, No. (%) | 31 (67.4) | 51 (67.1) | 29 (69.0) | 28 (70.0) | 55 (68.8) |
95% CI | 52–80 | 55–68 | 53–82 | 54–83 | 57–79 |
pb | 0.87 | 0.82 | 0.97 | 0.89 | |
Standard chemotherapy regimen, No. (%) | |||||
ТР | 26 (57) | 40 (53) | 20 (48) | 18 (45) | 37 (46) |
ТС | 20 (43) | 36 (47) | 22 (52) | 22 (55) | 43 (54) |
CA-125 level, U/mL | |||||
at screening | |||||
Mean | 579.78 | 584.32 | 581.85 | 581.98 | 583.75 |
Range | 110- > 600 | 115- > 600 | 120- > 600 | 110- > 600 | 105- > 600 |
at presurgery | |||||
Mean ± SDc | 31.50 ± 5.19 | 37.91 ± 21.43 | 42.26 ± 24.50 | 581.98 ± 85.07 | 68.70 ± 16.23 |
Range | 25–45 | 30–210 | 30–190 | 69- > 600 | 35–110 |
after combined treatment | |||||
Mean ± SDc | 12.78 ± 2.78 | 10.42 ± 4.07 | 12.67 ± 5.48 | 31.05 ± 8.70 | 32.44 ± 6.23 |
Range | 10–20 | 8–42 | 8–35 | 20–54 | 20–55 |
Primary debulking surgery at combined treatmentd, No. (%) | |||||
Complete cytoreduction (no visible tumor foci) | 39 (84.8) | 63 (82.9) | 34 (81.0) | 5 (12.5) | 20 (25.0) |
Optimal cytoreduction (≤ 1 cm) | 7 (15.2) | 13 (17.1) | 8 (19.0) | 21 (52.5) | 51 (63.8) |
Suboptimal cytoreduction (> 1 cm) | 0 (0) | 0 (0) | 0 (0) | 14 (35.0) | 9 (11.3) |
Disease progression (tumor recurrence rate) after combined treatment within five years of follow-up, No. (%) | 38 (82.6) | 61 (80.3) | 33 (78.6) | 38 (95.0) | 78 (97.5) |
Rate of patients without recurrent ovarian cancer within five years of follow-up, No. (%) | 8 (17.4) | 15 (19.7) | 9 (21.4) | 2 (5.0) | 2 (2.5) |