No differences in overall and progression-free survival were observed at the GOG-0252 trial update among patients with ovarian cancer who were treated with intravenous or intraperitoneal chemotherapy plus bevacizumab.
Investigators found no difference in overall survival (OS) or progression-free survival (PFS) among patients treated with intravenous or intraperitoneal chemotherapy plus bevacizumab (Avastin), regardless of treatment group or patient subgroup, for advanced ovarian cancer with no macroscopic disease, according to updated results from the phase 3 GOG-0252 trial (NCT00951496) that were presented at The Society of Gynecologic Oncology (SGO) 2022 Annual Meeting on Women’s Cancer.
“I had wanted to do this presentation because of a concern that I have that there is currently an excessive use of neoadjuvant chemotherapy. I [also] fear that there is probably not proper selection [as to] who is a good candidate for primary surgical debulking. So, I give this presentation as a reminder that long-term survival is more likely when the patient is left without any residual disease and chemotherapy produces a very low CA-125 [level] tumor marker of less than 10,” said Joan Walker, MD, a professor of the Section of Gynecologic Oncology at the Stephenson Cancer Center, University of Oklahoma College of Medicine, during a presentation of the data.
Median PFS in the intravenous carboplatin arm was 35.9 months, 36.8 months for intraperitoneal carboplatin, and 35.5 months for intraperitoneal cisplatin. When assessing PFS by CA-125 prior to the fourth treatment cycle, investigators reported medians of 44.2 months and 28.5 months in those with nadir levels of 10 IU/ml or lower and greater than 10 IU/ml, respectively.
Additionally, median OS across the 3 groups was 106.6 months for intravenous carboplatin, 114.2 months for intraperitoneal carboplatin, and 107.9 months for intraperitoneal cisplatin for those with microscopic disease only with 10 years of follow up. When assessing OS by CA 125 prior to the fourth treatment cycle, investigators reported a median OS of 89.0 months in the CA 125 greater than 10 IU/ml group. Median OS was not reached in the CA-125 of 10 IU/ml or lower group at over 10 years.
“There was no difference in treatment arm by PFS and OS in patients with no macroscopic disease. [Patients] lived a long time and we want to continue to provide that effort to our patients with ovarian cancer,” Walker said. “The goal is to get to no gross residual disease and to get a CA-125 [level] of less than 10 after 3 cycles. Those are the patients who can live and have a good quality of life.”
During cycles 1 to 6, patients could receive 1 of 3 regimens, all of which included 15 mg/kg of intravenous bevacizumab on day 1 starting cycle 2. One regimen included 80 mg/m2 of intravenous paclitaxel on days 1, 8, and 15, and intravenous carboplatin at AUC 6 on day 1 (arm 1). The second regimen included 80 mg/m2 of intravenous paclitaxel on days 1, 8, and 15, and intraperitoneal carboplatin at AUC 6 on day 1 (arm 2). The final regimen included 135 mg/m2 of intravenous paclitaxel on day 1, 75 mg/m2 of intraperitoneal cisplatin on day 2, and 60 mg/m2 of intraperitoneal paclitaxel on day 8 (arm 3). From cycle 7 to 22, all patients received 15 mg of intravenous bevacizumab on day 1.
To be eligible for the trial, patients needed to have stage II to III epithelial carcinoma of the ovary, fallopian tube, or peritoneum. Patients also needed to have had optimal resection less than or equal to 1 cm. Exploratory eligibility criteria included patients with suboptimal resection (7%) and those with stage IV disease (5%).
From July 2009 to November 2011, a total of 1560 patients were enrolled. The median age was 58 years, and most patients were White. Additionally, most patients had stage III disease (84%), grade 3 serous disease (&2%), and no residual disease (57%).
In terms of safety, 90% of patients across all arms had grade 3 or high adverse effects. In arm 1, 5.3% of patients experienced grade 3 gastrointestinal fistula, necrosis, and leak, and 30% had neuropathy of grade 2 or higher. In arm 3, 20.5% had grade 3 hypertension and 11.2% had grade 3 nausea and vomiting.
Walker JL. Long-term survival of GOG 252 randomized trial of intravenous versus intraperitoneal chemotherapy plus bevacizumab in advanced ovarian carcinoma: an NRG Oncology/GOG Study. Presented at: 2022 SGO Annual Meeting on Women’s Cancer; March 18-21, 2022. Phoenix, Arizona.