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Table 2 Maintenance therapy efficacy analysis

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

  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: OSa
 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 deathb
 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
pc < 0.0001 < 0.0001 <  0.0001   0.7634   
pd     < 0.0001    
  1. СT combined treatment with neoadjuvant chemotherapy, CT* combined treatment without neoadjuvant chemotherapy,
  2. CT** combined treatment with and without neoadjuvant chemotherapy, I3C indole-3-carbinol, EGCG epigallocatechin-3-gallate,
  3. OS overall survival, PFS progression-free survival, 95% CI 95% confidence interval, Q1 25th percentile, Q3 75th percentile,
  4. r Pearson’s correlation coefficient between OS and PFS (p < 0.05), OC ovarian cancer
  5. 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
  6. bDefined as the time from random assignment to disease progression per RECIST, clinical progression (per investigator) or CA-125
  7. 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
  8. cChi-square criterion was applied to determine the differences between arms 1–4 vs arm 5
  9. dChi-square criterion was applied to determine the difference between arms 2+3 vs arms 4+5