If noninferiority of survival is confirmed when the survival analysis is conducted in 2017, neoadjuvant chemotherapy will be the new standard of care for advanced ovarian cancer.
—Takashi Onda, MD, PhD
Neoadjuvant chemotherapy followed by interval debulking surgery may be a better strategy for the initial treatment of advanced ovarian cancer than the current standard of care, suggest results of a phase III trial. Neoadjuvant chemotherapy followed by interval debulking surgery led to fewer complications and was less invasive compared with upfront debulking surgery followed by chemotherapy.
“Treatment starting with neoadjuvant chemotherapy is less invasive than standard treatment for advanced ovarian cancer. If noninferiority of survival compared with the standard treatment is confirmed when the survival analysis is conducted in 2017, neoadjuvant chemotherapy will be the new standard of care for advanced ovarian cancer,” stated lead author Takashi Onda, MD, PhD, Kitasato University School of Medicine, Japan. Dr. Onda presented results of the Japan Clinical Oncology Group (JCOG) 0602 trial at the 2014 ASCO Annual Meeting.1
The study was designed to compare the efficacy and invasiveness of neoadjuvant chemotherapy followed by interval debulking surgery vs the standard of care, which is primary debulking surgery followed by intravenous chemotherapy with paclitaxel/carboplatin.
Two previous studies showed noninferior survival for neoadjuvant chemotherapy followed by interval debulking surgery compared with standard treatment. Unfortunately, invasiveness of treatment starting with neoadjuvant chemotherapy followed by interval debulking surgery has not yet been fully analyzed. The present study was designed to compare the two strategies regarding invasiveness of the treatments in addition to survival.
JCOG 0602 took almost 5 years to complete accrual. A total of 301 patients with stage III/IV ovarian, tubal, and peritoneal cancers were enrolled and randomly assigned to either standard therapy (surgery followed by eight cycles of chemotherapy) or four cycles of neoadjuvant chemotherapy followed by interval debulking surgery followed by an additional four cycles of chemotherapy. Interval debulking surgery was optional for patients in the standard therapy arm whose surgical results were suboptimal and mandatory for patients whose surgeries left any of the uterus, adnexa, and omentum with primary debulking surgery.
Approximately 30% of patients in both arms had stage IV disease. Patients in both arms were exposed to a similar number of cycles of chemotherapy.
Optimal surgery (defined as maximum residual tumor < 1 cm in diameter) was possible in 62% of patients in the standard arm vs 72% in the neoadjuvant chemotherapy arm. Patients treated with standard therapy underwent more surgeries and had longer operation times compared with neoadjuvant chemotherapy. Of the 149 patients assigned to standard therapy, 147 underwent primary debulking surgery and 48 required subsequent interval debulking surgery; in the neoadjuvant chemotherapy arm, 131 of 152 patients underwent interval debulking surgery. Total operating time was longer in the standard arm (P < .001).
Pelvic and para-aortic lymphadenectomy was required more frequently in the neoadjuvant chemotherapy arm, but these patients needed bowel or organ resection less often (P = .012).
Amounts of blood loss and ascitic fluid loss were higher in the standard therapy arm. The frequency of intraoperative injury was low in both arms, but fewer postoperative adverse events were reported in the neoadjuvant chemotherapy arm. ■
Disclosure: Dr. Onda reported no potential conflicts of interest.
1. Onda T, Yoshikawa H, Shibata T, et al: Comparison of treatment invasiveness between upfront debulking surgery versus interval debulking surgery following neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and peritoneal cancers in phase III randomized trial: JCOG0602. ASCO Annual Meeting. Abstract 5508. Presented May 31, 2014.
Formal discussant of the JCOG 0602 trial at the ASCO Annual Meeting, Dennis S. Chi, MD, Deputy Chief of the Gynecology Service at Memorial Sloan Kettering Cancer Center, New York, reviewed the strengths and weakness of the study.
“This is the third study to evaluate primary debulking surgery vs...