A new promising way of maintenance therapy in advanced ovarian cancer: a comparative clinical study

BMC Cancer

Table 2 Maintenance therapy efficacy analysis

	Arm 1	Arm 2	Arm 3	Arms 2+3	Arm 4	Arm 5	Arms 4+5
	СT + I3C 400 mg	СT + I3C 400 mg + EGCG 200 mg	СT + I3C 400 mg + EGCG 200 mg + long-term chemotherapy	СT + I3C 400 mg + EGCG 200 mg	СT*	СT	СT**
	(n = 46)	(n = 76)	(n = 42)	(n = 118)	(n = 40)	(n = 80)	(n = 120)
Primary end point: OS^a
Deaths, No. (%) Kaplan-Meier OS time, months	16 (34.8)	28 (36.8)	12 (28.6)	40 (33.9)	24 (60.0)	51 (63.8)	75 (62.5)
Median	60	60	60	60	46	44	44
95% CI	58–60	60–60	60–60	60–60	28–60	33–58	34–54
Q1	47	45	58	47	21.5	22	22
Q3	62	60	60	60	60	60	60
Secondary end point: PFS per RECIST, clinical progression, CA-125 progression, or death^b
Kaplan-Meier PFS time, months
Median	39.5	42.5	48.5	44	24.5	22	23
95% CI	28–49	38–49	39–53	40–49	14–34	15–26	19–26
Q1	24	24.5	36	25	12.5	10.5	11.5
Q3	51	54	55	55	37.5	36.5	37
r,	0.811	0.874	0.805	0.855	0.565	0.711	0.661
Secondary end point: Rate of patients with recurrent OC with ascites after combined treatment
No. (%)	3 (7.9)	5 (8.2)	3 (9.1)	8 (8.5)	24 (63.2)	47 (60.3)	71 (61.2)
95% CI, %	1.7–21.4	2.7–18.1	1.9–24.3	3.7–16.1	46.0–78.2	48.5–71.2	51.7–70.1
Rate of patients with recurrent OC without ascites after combined treatment
No. (%)	35 (92.1)	56 (91.8)	30 (90.9)	86 (91.5)	14 (36.8)	31 (39.7)	45 (38.8)
95% CI, %	78.6–98.3	81.9–97.3	75.7–98.1	83.9–96.3	21.8–54.0	28.8–51.5	29.9–48.3
p^c	< 0.0001	< 0.0001	< 0.0001		0.7634
p^d				< 0.0001

СT combined treatment with neoadjuvant chemotherapy, CT* combined treatment without neoadjuvant chemotherapy,
CT** combined treatment with and without neoadjuvant chemotherapy, I3C indole-3-carbinol, EGCG epigallocatechin-3-gallate,
OS overall survival, PFS progression-free survival, 95% CI 95% confidence interval, Q1 25th percentile, Q3 75th percentile,
r Pearson’s correlation coefficient between OS and PFS (p < 0.05), OC ovarian cancer
^aDefined as the time from the date of diagnosis to the date of death from any causes. At the time of this analysis, 30 patients in arm 1, 48 patients in arm 2, 31 patients in arm 3, 21 patients in arm 4, 29 patients in arm 5 were censored
^bDefined as the time from random assignment to disease progression per RECIST, clinical progression (per investigator) or CA-125
progression (per GCIG criteria), or death from any causes. At the time of this analysis, 8 patients in arm 1, 15 patients in arm 2, 9 patients in arm 3, 2 patients in arm 4, 2 patients in arm 5 were censored
^cChi-square criterion was applied to determine the differences between arms 1–4 vs arm 5
^dChi-square criterion was applied to determine the difference between arms 2+3 vs arms 4+5

ISSN: 1471-2407