Efficacy of Maintenance Therapy With Adjuvant Chemotherapy of Three Steps in Patients Newly Diagnosed With Advanced Ovarian Cancer: A Phase II Randomised Clinical Trial
Zhong Zheng, Huayin Wang, Huijuan Yang, Jie Tang, Xi Cheng, Meiqin Zhang, Yulan Ren, Xiaojun Chen, Xinzhu Ju, Liya Xu, Xiaohua Wu
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引用次数: 0
Abstract
Objective
To evaluate the efficacy and safety of adjuvant chemotherapy of three steps (ACTS) in patients newly diagnosed with advanced ovarian cancer.
Design
Randomised clinical trial.
Setting
The study was conducted at a single centre.
Population
Newly diagnosed patients with advanced ovarian cancer who showed a complete response to standard chemotherapy (paclitaxel plus carboplatin) were included in this study.
Methods
In this open-label phase II trial, patients were randomised 1:1 to receive either ACTS therapy or no maintenance treatment. The ACTS group received step-2 chemotherapy with cyclophosphamide and etoposide (six cycles) and step-3 chemotherapy with cyclophosphamide and carboplatin (six cycles). Key endpoints were overall survival (OS), progression-free survival (PFS) and adverse events.
Main Outcome Measures
The main outcome measures were OS, PFS and adverse events.
Results
Of the 130 enrolled patients, 65 were assigned to the ACTS group and 65 to the control group. The median OS in the ACTS group was 61.2 months, and patients in the ACTS group had a significantly longer PFS than those in the control group (22.2 vs. 9.73 months). The most common grade ≥ 3 adverse events were thrombocytopenia and neutropenia. No treatment-related deaths occurred during the study period.
Conclusions
The Maintenance ACTS Regimen Improved PFS but Not OS and Showed a Tolerable Safety Profile in Patients Newly Diagnosed With Advanced Ovarian cancer.
期刊介绍：
BJOG is an editorially independent publication owned by the Royal College of Obstetricians and Gynaecologists (RCOG). The Journal publishes original, peer-reviewed work in all areas of obstetrics and gynaecology, including contraception, urogynaecology, fertility, oncology and clinical practice. Its aim is to publish the highest quality medical research in women''s health, worldwide.
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