SOC-1
Trial question
What is the role of surgery in patients with platinum-sensitive, relapsed ovarian cancer?
Study design
Multi-center
Open label
RCT
Population
357 female patients.
Inclusion criteria: women with platinum-sensitive, relapsed ovarian cancer.
Key exclusion criteria: borderline or nonepithelial tumors; planned-interval debulking, second-look surgery, or palliative surgery; > 1 previous chemotherapy; second relapse or more; progression during chemotherapy or relapse within 6 months following first-line therapy.
Interventions
N=182 surgery (surgery followed by chemotherapy 10-14 days later).
N=175 no surgery (chemotherapy alone).
Primary outcome
Median overall survival
58.1 months
52.1 months
58.1 months
43.6 months
29.1 months
14.5 months
0.0 months
Surgery
No
surgery
No significant
difference ↔
No significant difference in median overall survival (58.1 months vs. 52.1 months; HR 1.25, 95% CI 0.95 to 1.64).
Secondary outcomes
Significant increase in median progression-free survival (18 months vs. 11.9 months; HR 1.81, 95% CI 1.45 to 2.27).
Borderline significantly longer median time to first subsequent therapy (19.9 months vs. 13.6 months; HR 1.81, 95% CI 1.43 to 2.27).
Borderline significantly longer median time to second subsequent therapy (34.8 months vs. 28.1 months; HR 1.47, 95% CI 1.15 to 1.81).
Safety outcomes
No significant difference in ≥ grade 3 adverse events during second-line chemotherapy.
Conclusion
In women with platinum-sensitive, relapsed ovarian cancer, surgery was not superior to no surgery with respect to median overall survival.
Reference
Rong Jiang, Yanling Feng, Yulian Chen et al. Surgery versus no surgery in platinum-sensitive relapsed ovarian cancer: final overall survival analysis of the SOC-1 randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2181-2188.
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