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. 2016 Nov 11;8(7):12389–12405. doi: 10.18632/oncotarget.13310

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
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