- In patients with newly diagnosed advanced ovarian carcinoma, intraperitoneal (IP) vs intravenous (IV) administration of chemotherapy fails to improve survival, increases toxicity.
Why this matters
- This definitive trial suggests there is no longer any role of IP therapy.
- 3-group, phase 3 Gynecologic Oncology Group (GOG)-252 study.
- 1560 patients with newly diagnosed advanced ovarian carcinoma were randomly assigned to intravenous (IV) paclitaxel with either IV carboplatin or intraperitoneal (IP) carboplatin or IP cisplatin/paclitaxel.
- All patients received bevacizumab.
- Funding: National Cancer Institute.
- Median follow-up, 84.8 months.
- Compared with the IV carboplatin group, median PFS was not significantly different in the IP carboplatin (24.9 vs 27.4 months; HR, 0.925; 95% CI, 0.802-1.07) or IP cisplatin (vs 26.2 months; HR, 0.977; 95% CI, 0.847-1.13) groups.
- No difference in median PFS was observed in patients with stage II/III and residual disease of ≤1 cm and those with stage II/III and no residual disease.
- Median OS was similar in the IV carboplatin vs IP carboplatin group (HR, 0.949; 95% CI, 0.799-1.128) and the IP cisplatin group (HR, 1.05; 95% CI, 0.884-1.24).
- Grade ≥3 infections were more frequent (P=.008) in the IP groups.
- The IP cisplatin group showed higher grade ≥3 hypertension (P<.005 and nausea rates>
- Open-label design.