Abstract
BackgroundThere is an urgent need for more novel and efficacious therapeutic agents and strategies for the treatment of ovarian cancer - one of the most formidable female malignancies. These approaches should be based on comprehensive understanding of the pathobiology of this cancer and focused on decreasing its recurrence and metastasis. The aim of this study was to evaluate the efficacy of five-year maintenance therapy with indole-3-carbinol (I3C) as well as I3C and epigallocatechin-3-gallate (EGCG) conducted before, during, and after combined treatment compared with combined treatment alone in advanced ovarian cancer.MethodsPatients with stage III-IV serous ovarian cancer were assigned to receive combined treatment plus I3C (arm 1), combined treatment plus I3C and EGCG (arm 2), combined treatment plus I3C and EGCG plus long-term platinum-taxane chemotherapy (arm 3), combined treatment alone without neoadjuvant platinum-taxane chemotherapy (control arm 4), and combined treatment alone (control arm 5). Combined treatment included neoadjuvant platinum-taxane chemotherapy, surgery, and adjuvant platinum-taxane chemotherapy. The primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival (PFS) and rate of patients with recurrent ovarian cancer with ascites after combined treatment.ResultsAfter five years of follow-up, maintenance therapy dramatically prolonged PFS and OS compared to control. Median OS was 60.0 months (95% CI: 58.0–60.0 months) in arm 1, 60.0 months (95% CI: 60.0–60.0 months) in arms 2 and 3 while 46.0 months (95% СI: 28.0–60.0 months) in arm 4, and 44.0 months (95% СI: 33.0–58.0 months) in arm 5. Median PFS was 39.5 months (95% СI: 28.0–49.0 months) in arm 1, 42.5 months (95% СI: 38.0–49.0 months) in arm 2, 48.5 months (95% СI: 39.0–53.0 months) in arm 3, 24.5 months (95% СI: 14.0–34.0 months) in arm 4, 22.0 months (95% СI: 15.0–26.0 months) in arm 5. The rate of patients with recurrent ovarian cancer with ascites after combined treatment was significantly less in maintenance therapy arms compared to control.ConclusionsLong-term usage of I3C and EGCG may represent a new promising way of maintenance therapy in advanced ovarian cancer patients, which achieved better treatment outcomes.Trial registrationRetrospectively registered with ANZCTR number: ACTRN12616000394448. Date of registration: 24/03/2016.
Highlights
There is an urgent need for more novel and efficacious therapeutic agents and strategies for the treatment of ovarian cancer - one of the most formidable female malignancies
FIGO International Federation of Gynecology and Obstetrics, Peritoneal cancer index (PCI) peritoneal cancer index, ECOG Eastern Cooperative Oncology Group, 95% Confidence interval (CI) 95% confidence interval, SD standard deviation aMann-Whitney U-test was applied to determine the differences between arms 1–4 vs arm 5 bChi-square criterion was applied to determine the differences between arms 1–4 vs arm 5 cStudent’s test was applied to determine mean level, standard deviation, and the differences between arms 1–3 vs arm 5
At presurgery and after completion of combined treatment, СА-125 readings demonstrated a statistically significant benefit to maintenance therapy arms 1–3 compared with control arm 5 (p < 0.0001) (Table 1)
Summary
There is an urgent need for more novel and efficacious therapeutic agents and strategies for the treatment of ovarian cancer - one of the most formidable female malignancies. These approaches should be based on comprehensive understanding of the pathobiology of this cancer and focused on decreasing its recurrence and metastasis. 60–80% of such patients relapse in six to 24 months, which requires further chemotherapy and eventually makes the tumor chemoresistant. More effective OC treatment strategies are urgently required to improve survival. They should obviously be focused on minimizing recurrence rate and metastasis and overcoming drug resistance. Targeted antitumor drugs used in a maintenance therapy regimen have recently gained increasing attention as a promising management option for recurrent OC, helping to extend progression-free intervals [9,10,11,12,13]
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