Table 2.

Actual‐Over‐Expected Ratio for Trials Using PFS or TTP as a Primary Endpoint

Trial No.	Reference	Setting	Control Arm	Experimental Arm	Expected PFS in Control Arm)	Actual PFS	Sample Size in Control Arm	Size Effect	A/E Ratio
1	Katsumata 200930	First‐line	Paclitaxel and carboplatin	Dose‐dense paclitaxel and carboplatin	16 mo (median)	17.2 mo	320	1.4	1.1
2	Markman 200931	First‐line maintenance	Paclitaxel management (3 cycles)	Paclitaxel maintenance (12 cycles)	20 mo (median)	14 mo	128	1.3	0.7
3	Burger 201012	First‐line	Paclitaxel and carboplatin	Paclitaxel, carboplatin, and bevacizumab	14 mo (median)	10 mo	625	1.3	0.7
4	Perren 201014	First‐line	Paclitaxel and carboplatin	Paclitaxel, carboplatin, and bevacizumab	18 mo (median)	16 mo	764	1.3	0.9
5	Pfisterer 200632	Recurrence	Carboplatin	Carboplatin and gemcitabine	6 mo (median)	5.8 mo	178	1.4	1.0
6	Monk 201033	Recurrence	Pegylated liposomal doxorubicin	Pegylated liposomal doxorubicin and trabectedin	3.7 mo (median)	5.8 mo	335	1.3	1.6
7	Neijt 200034	First‐line	Paclitaxel and cisplatin	Paclitaxel and carboplatin	12 mo (median)	16 mo	108	1.7	1.3
8	Vasey 200435	First‐line	Paclitaxel and carboplatin	Docetaxel and carboplatin	17 mo (median)	14.8 mo	538	1.25	0.9
9	Papadimitriou 200836	First‐line	No further treatment	High‐dose melphalan	18 mo (median)a	18 moa	43	2.0	1.0
10	Bookman 200937	First‐line	Paclitaxel and carboplatin	Paclitaxel, carboplatin and a 3rd agentb	15 mo (median)	16 mo	864	1.25	1.1
11	Pecorelli 200938	First‐line maintenance	Paclitaxel and carboplatin	Paclitaxel, carboplatin and paclitaxel management	50% (2‐y PFS)	54% (2‐y PFS)	99	1.3	1.1
12	Hoskins 201039	First‐line	Paclitaxel and carboplatin	Sequential cisplatin and topotecan and paclitaxel and carboplatin	16 mo (median)	16.2 mo	410	1.25	1.0
13	Lhomme 200840	First‐line	Paclitaxel and carboplatin	Paclitaxel, carboplatin, and valspodar	18 mo (median)a	13.5 moa	377	1.3	0.8
14	Hirte 200641	First‐line maintenance	Observation	Tanomastat	20 mo (median)	9.2 mo	121	1.4	0.5
15	De Placido 200442	First‐line maintenance	Observation	Topotecan	18 mo (median)	28 mo	93	1.5	1.6
16	Ferrandina 200843	Recurrence	Pegylated liposomal doxorubicin	Gemcitabine	2.8 mo (median)a	3.7 moa	76	1.6	1.3
17	Berek 200444	First‐line maintenance	Observation	Oregovomab	18 mo (median)c	10.8 moc	72	1.5	0.6
18	Mobus 200717	First‐line	Paclitaxel and carboplatin ± etoposide	High‐dose chemotherapyd	0.35 (2‐y PFS) 16.8 mo (median)	20.5 mo	89	1.4	1.1
19	Vergote 201045	Recurrence	Pegylated liposomal dxorubicin	Canfosfamide and pegylated liposomal doxorubicin	3.5 mo	3.7 mo	60	1.5	1.1
20	Reed 200646	First‐line	Treosulfan	Carboplatin	9.2 mo	5.0 mo	102	1.5	0.5

Abbreviations: A/E, actual‐over‐expected ratio; PFS, progression‐free survival; TTP, time to disease progression.

Detailed is expected PFS/TTP of the control arm used for statistical calculations, actual PFS/TTP achieved by this arm as well as size effect expected from the experimental treatment. Finally A/E ratio for PFS/TTP of the control arm is given. A/E ratios were rounded to one decimal place.

^aUsed TTP as progression measure.

^bThird chemotherapy agent included gemcitabine, pegylated liposomal doxorubicin, or topotecan.

^cUsed time to disease recurrence as a progression measure.

^dHigh‐dose chemotherapy includes 2 cycles of fortnightly paclitaxel and cyclophosphamide with peripheral blood stem cell harvest followed by 3 cycles of carboplatin and paclitaxel with melphalan included in the final cycle. Both arms have the option of etoposide and up to 4 cycles of maintenance topotecan.