Despite hematologic toxicities and port-related adverse events, intraperitoneal carboplatin plus intravenous (IV) dose-dense paclitaxel appears to be effective in patients with suboptimally debulked epithelial ovarian or primary peritoneal carcinoma, according to a multicenter, prospective phase II study in Japan, presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3–7 in Chicago (abstract 5504).
“Intraperitoneal carboplatin plus IV dose-dense paclitaxel showed remarkable efficacy in the treatment of suboptimal residual disease,” said lead study author Kosei Hasegawa, MD, PhD, of the Saitama Medical University International Medical Center in Japan.
Intraperitoneal cisplatin chemotherapy and dose-dense paclitaxel and carboplatin have both been tied to improved overall survival among patients with ovarian cancer. Intraperitoneal carboplatin might have reduced toxicity compared to cisplatin and offers “reasonable pharmacokinetics” for suboptimally debulked disease, Dr. Hasegawa noted.
The research team sought to study the safety and efficacy of combined intraperitoneal carboplatin and dose-dense paclitaxel in patients with suboptimally debulked advanced ovarian cancer.
A total of 76 patients with stage II-IV ovarian or primary peritoneal carcinoma who had undergone primary cytoreductive surgery but had residual disease, were enrolled, of whom 71 completed at least 1 cycle of treatment. Patients received intraperitoneal carboplatin (AUC = 6) on day 1 and IV paclitaxel (80 mg/m2) on days 1, 8, and 15.
The objective response rate was 83%. Nine patients experienced complete responses and 50 experienced partial responses. Ten patients had stable disease; no cases of progressive disease were reported, but two patients were deemed not-evaluable.
Median progression-free survival was 18.3 months (range, 15.5–20.2 months). Median overall survival was 55.5 months, but the data remain immature, with only 39.4% of participants having died.
Grade 3/4 neutropenia was observed in 84% of patients and anemia in 57% of patients; 22% experienced thrombocytopenia. Nine (11.8%) patients experienced grade 3/4 port-related events.