Table 1. Characteristics of 4 Randomized Controlled Trials.
GOG -0218 | ICON7 | OCEANS | AURELIA | |
---|---|---|---|---|
Overall population Experimental arm 1 Experimental arm 2 Control arm |
1873 623 625 625 |
1528 764 764 |
484 242 242 |
361 179 182 |
Age | <60 yr or 60-69 yr or >70 yr | <60 yr or 60-69 yr or >70 yr | <65 yr or ≥65 yr | <65 yr or ≥65 yr |
GOG/ECOG PS | 0-2 | 0-2 | 0-1 | 0-2 |
Stage/debulking | Stage III≤1 or Stage III>1 or Stage IV | Stage I-III≤1 or Stage I-III>1 or Stage IV and inoperable Stage III | Surgery at relapse or no surgery at relapse | NR |
Treatment Line time to start CT platinum-free interval |
First line post surgery NA |
First line post surgery NA |
Recurrent ovarian cancer NA 6-12 mos or >12 mos |
Recurrent ovarian cancer NA 6-12 mos or >12 mos |
Experimental arm treatment 1 | Cycles 1-6: C AUC6, P 175 mg/mq, BV 15 mg/kg (starting in 2 cycle) q3w; Cycles 7-22: BV 15 mg/kg q3w |
Cycles 1-6: C AUC5/6, P 175 mg/mq, BV 7.5 mg/kg (starting in 2 cycle) q3w; Cycles 7-18: BV 7.5 mg/kg q3w |
C AUC4, Gem 1000 mg/mq, BV 15 mg/kg q3w | P 80 mg/mq days 1, 8, 15, 22 q4w, T 4 mg/mq days 1, 8, 15 q4w (or 1.25 mg/mq days 1-5 q3w), PLD 40 mg/mq day 1 q4w, BV 15 mg/kg q3w |
Experimental arm treatment 2 | Cycles 1-6: C AUC6, P 175 mg/mq, BV 15 mg/kg (starting in 2 cycle) q3w; Cycles 7-22; placebo q3w |
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Control arm treatment | Cycles 1-6: C AUC 6, P 175 mg/mq, placebo (starting in 2 cycle) q3w; Cycles 7-22; placebo q3w |
Cycles 1-6: C AUC5/6, P 175 mg/mq, placebo (starting in 2 cycle) q3w; Cycles 7-18; placebo q3w |
C AUC4, GEM 1000 mg/mq, placebo q3w | P 80 mg/mq days 1, 8, 15, 22 q4w, T 4 mg/mq days 1, 8, 15 q4w (or 1.25 mg/mq days 1-5 q3w), PLD 40 mg/mq day 1 q4w |
Primary endpoint | PFS | PFS | PFS | PFS |
Secondary endpoints | OS, QoL | OS, ORR | OS, ORR, median duration of response | OS, ORR, QoL, safety |
Median follow up | 17.4 mos | 48.9 mos | 42 mos | 13 mos |