Intraperitoneal (IP) delivery of neither carboplatin nor cisplatin (administered at the same time as bevacizumab) improved outcomes for patients with advanced ovarian carcinoma compared with intravenous (IV) delivery of carboplatin plus bevacizumab, data from the GOG-252 trial revealed (Clinical trial identifier: NCT00951496). The open-label, randomized, phase 3 trial results were recently published in the Journal of Clinical Oncology.
The GOG-252 trial included 1560 women with newly diagnosed stage II through stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who were randomly assigned treatment with IV carboplatin (521 individuals), IP carboplatin (518 individuals), or IP cisplatin (521 individuals); all patients were also treated with bevacizumab.
Compared with the IV carboplatin arm (24.9 months), the median progression-free survival (PFS) for IP carboplatin (27.4 months) and IP cisplatin (26.2 months) were not significantly different. Among patients with stage II or III disease and no gross residual disease, the median PFS for IV carboplatin (35.9 months) was not significantly different from either IP carboplatin (38.8 months) or IP cisplatin (35.5 months[).
The median overall survival was 75.5 months for IV carboplatin, 78.9 for IP carboplatin, and 72.9 months for IP cisplatin. The patients on the IV carboplatin arm had a similar risk of dying compared with those on the IP carboplatin arm (hazard ratio [HR]=0.949; 95% CI, 0.799-1.128) and IP cisplatin arm (HR=1.05; 95% CI, 0.884-1.24).
Compared with the IV carboplatin arm (11.5%), patients on the IP carboplatin (17.2%) and IP cisplatin (17.7%) arms had significantly higher incidences of grade 3 or worse infections (P =.008). Compared with the IV carboplatin and IP carboplatin arms, patients on the IP cisplatin arm also had significantly higher incidences of nausea and vomiting of grade 3 or worse (P <.005) and hypertension of grade 3 or worse (P <.005).
“In conclusion, the benefit of IP administration of chemotherapy was not evident in this large randomized clinical trial,” the study authors wrote.
Walker JL, Brady MF, Wenzel L, et al. Randomized trial of intravenous versus intraperitoneal chemotherapy plus bevacizumab in advanced ovarian carcinoma: an NRG Oncology/Gynecologic Oncology Group Study . J Clin Oncol. doi: 10.1200/JCO.18.01568