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Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial

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Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial

The Lancet Oncology

Fecha de publicación: 8 de marzo de 2021

DOI: https://doi.org/10.1016/S1470-2045(21)00006-1PlumX Metrics

Autores: Tingyan Shi, MD , Prof Jianqing Zhu, MD, Yanling Feng, MD, Prof Dongsheng Tu, PhD, Yuqin Zhang, MD, Prof Ping Zhang, MD, Huixun Jia, MPH, Xiao Huang, MD, Prof Yunlang Cai, MD, Sheng Yin, Rong Jiang, Wenjuan Tian, MD, Wen Gao, Prof Jihong Liu, MD, Prof Huijuan Yang, MD, Prof Xi Cheng, MD, Prof Rongyu Zang, MD 

Background: The benefits of secondary cytoreduction for platinum-sensitive relapsed ovarian cancer are still widely debated. We aimed to assess the efficacy of secondary cytoreduction plus chemotherapy versus chemotherapy alone in this patient population. Methods: This multicentre, open-label, randomised, controlled, phase 3 trial (SOC-1), was done in four primarily academic centres in China (two in Shanghai, one in Hangzhou, and one in Guangzhou). Eligible patients were women aged 18 years and older with platinum-sensitive relapsed epithelial ovarian cancer with a platinum-free interval of at least 6 months after the end of first-line platinum-based chemotherapy and were predicted to have potentially resectable disease according to the international model (iMODEL) score and PET-CT imaging. iMODEL score was calculated using six variables: International Federation of Gynecology and Obstetrics stage, residual disease after primary surgery, platinum-free interval, Eastern Cooperative Oncology Group performance status, serum level of cancer antigen 125 at recurrence, and presence of ascites at recurrence. An iMODEL score of 4·7 or lower predicted a potentially complete resection.

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