The Phase III Gynecologic Oncology Group (GOG)-0213 trial results were published today in the New England Journal of Medicine. Early results from this study were first presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.
The overall survival (OS) was 50.6 months in the surgery group and 64.7 months in the no-surgery group. The median progression-free survival (PFS) was 18.9 months with surgery vs.16.2 months without it. The percentage of patients surviving at 3 years was 67% in the surgery group and 74% in the no-surgery group.
“Surgical cytoreduction is recognized as a key component of frontline treatment for primary ovarian cancer, but its role in recurrent disease, while touted as beneficial, had not been formally tested.,” said lead investigator Robert L. Coleman, M.D., professor of Gynecologic Oncology and Reproductive Medicine. “This research is the first randomized clinical trial conducted in this setting and shows that secondary surgery does not benefit these patients.”
The international randomized trial included women with platinum-sensitive, epithelial recurrent ovarian, primary peritoneal, or fallopian-tube cancer who had a complete clinical response to at least three cycles of primary platinum-based chemotherapy and a normal serum CA-125 value.
From December 6, 2007 to June 9, 2017, 240 patients were randomized to secondary surgical cytoreduction followed by platinum-based chemotherapy and 245 patients were randomized to chemotherapy alone. The median follow-up was 48.1 months.
Complete tumor resection, achieved in 67% of the patients receiving surgery, was associated with longer OS and PFS when compared to patients whose tumors could not be completely removed. However, a comparison of the complete resection group with the no-surgery group did not show an OS benefit, although there was a benefit to PFS.
Patient-reported outcomes included quality of life, physical functioning and surgery-related symptoms. Patients in the surgery group reported a significant decrease in quality of life and physical function and an increase in surgery-related symptoms immediately after surgery. There was not a significant difference between the two groups after recovery.
Current National Comprehensive Cancer Network (NCCN) guidelines list secondary cytoreduction as a treatment option for patients who have been treatment-free for six months or more after complete remission from prior chemotherapy.
“Given these study results, we need to question the value of secondary surgery for recurrent ovarian cancer patients,” said Coleman. “Hopefully this study and other ongoing trials will provide the data needed to determine the best course of treatment that will maximize treatment outcomes and quality of life for these patients.”
At least three other ongoing Phase III trials are designed to evaluate similar end points. DESKTOP-III (ClinicalTrials.gov number, NCT01166737), Surgery for Ovarian Cancer Recurrence (SOCceR; Netherlands Trial Register number, NL3137), and Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1; ClinicalTrials.gov number, NCT01611766).
The study was supported by National Cancer Institute (NCI) grants to the GOG Administrative Office (CA27469), the GOG Statistical Office (CA 37517), NRG Oncology (1U10CA180822) and the NRG Operations (U10CA180868) and in part by the National Institutes of Health/NCI under award number P30CA016672. Roche/Genentech supported the NCI cooperative research and development agreement enabling this trial. Dr. Coleman is supported in part by the Ann Rife Cox Chair in Gynecology and the Judy Reis/Albert Pisani, MD Ovarian Cancer Research Fund.
A full list of collaborating researchers and their disclosures are included in the paper.
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