First line dosointensive chemotherapy for Disseminated ovarian cancer after non optimal Cyted reduction: Results of the phase ii study
Authors: A.A. Rumyantsev, A.S. Tyulyandina, I.A. Pokataev, K.Yu. Morkhov, V.M. Nechushkina, V.E. Nikulin, S.O. Nikogosyan, K.I. Zhordania, S.A. Tyulyandin
Introduction: patients with advanced ovarian cancer have unfavorable prognosis after primary debulking surgery if the size of residual tumor exceeds 1 cm. The optimal approaches to systemic treatment of these patients remain unknown. We evaluated the efficacy and safety of dose-dense chemotherapy in frontline treatment of ovarian cancer patients after upfront non-optimal debulking surgery.
Patients and methods: this was a non-randomized single-arm phase II trial. We enrolled patients with advanced (FIGO
III–IV) epithelial ovarian who underwent non-optimal upfront debulking surgery with residual tumor size >10 mm. All patients were treated with dose-dense chemotherapy (i.e., paclitaxel 80 mg/m2 day 1, 8, 15 + carboplatin AUC6 day 1, cycled every 21 days – 6 cycles). The primary end point of the trial was progression-free survival (PFS).
Statistical hypothesis: according to the historical data of our department, 1-year PFS in this category of patients equals to 51%. To increase 1-year PFS to 70%, 39 patients should be enrolled with α=0,05 and β=0,20 and estimated data loss for 10% of patients.
Results: the study included 39 patients, median age was 56,9 years, 23% of patients had stage IV disease. Median followup was 24,0 months. The 1-year PFS was 76,9%, the median PFS was 19,8 months. The 1-year overall survival rate was 92,3% with median OS not reached with specified follow-up period. Severe neutropenia, anemia, thrombocytopenia was observed in 82,1%, 53,8%, 15,3% of patients, respectively.
Conclusion: the results of the study showed high efficacy of dose-dense chemotherapy as front line of treatment for advanced ovarian cancer patients after non-optimal upfront debulking surgery