Secondary cytoreduction followed by chemotherapy vs chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): A multicentre, open-label, randomized, phase 3 trial
The Lancet Oncology Mar 19, 2021
Shi T, Zhu J, Feng Y, et al. - In patients with platinum-sensitive relapsed ovarian cancer, researchers investigated the efficacy of secondary cytoreduction plus chemotherapy vs chemotherapy alone. In this multicenter, open-label, randomized, controlled, phase 3 trial (SOC-1), they included women aged 18 years and older with platinum-sensitive relapsed epithelial ovarian cancer with a platinum-free interval of at least 6 months following the end of first-line platinum-based chemotherapy and who were predicted to have potentially resectable disease according to the international model (iMODEL) score and PET-CT imaging. They randomly assigned eligible participants 1:1 to undergo secondary cytoreductive surgery followed by intravenous chemotherapy (six 3-weekly cycles of intravenous paclitaxel (175 mg/m 2 ) or docetaxel (75 mg/m 2 ) in combination with intravenous carboplatin (area under the curve of 5 mg/mL per min; surgery group) or intravenous chemotherapy alone (no surgery group). A total of 357 patients were assigned to the surgery group (182) or to the no surgery group (175; ITT population). Outcomes revealed significantly longer progression-free survival in patients with platinum-sensitive relapsed ovarian cancer in correlation with undergoing secondary cytoreduction followed by chemotherapy vs chemotherapy alone. In the surgery group, median progression-free survival was 17.4 months, while it was 11.9 months in the no surgery group. Median overall survival at the interim overall survival analysis in the surgery group was 58.1 months, while it was 53.9 months in the no surgery group. They emphasize counselling patients regarding the option of secondary cytoreduction in specialized centers.
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