In a Chinese phase III trial (PROFIT) reported in Journal of Clinical Oncology, Zhou et al found that mixed-formulation fosrolapitant/palonosetron (HR20013) plus dexamethasone was noninferior to individually dosed fosrolapitant plus palonosetron plus dexamethasone in preventing chemotherapy-induced nausea and vomiting in patients who receive cisplatin-based highly emetogenic chemotherapy.
Study Details
In the multicenter trial, 750 chemotherapy-naive patients were randomly assigned to receive HR20013 on day 1 (n = 373) or fosrolapitant plus palonosetron on day 1 (n = 377) before each cycle of cisplatin-based highly-emetic chemotherapy (two cycles in total), together with oral dexamethasone (days 1–4). The primary outcome measure was overall (0–120 hours) complete response (no vomiting/no rescue therapy) rate in cycle 1. A key secondary outcome measure was complete response rate at the beyond delayed phase (120–168 hours) in cycle 1.
Key Findings
The overall complete response rate in cycle 1 was 77.7% in the HR20013 plus dexamethasone group and 78.2% in the fosrolapitant plus palonosetron plus dexamethasone group (difference = –0.9%, 95% confidence interval = –6.7% to 5.0%, P < .01 for noninferiority). Complete response rates at the beyond delayed phase in cycle 1 were 90.3% vs 86.5% (P = .11).
In cycle 2, the HR20013 plus dexamethasone group had greater proportions of patients reporting no impact on daily life at the delayed (24–120 hours) and beyond delayed phases compared with the fosrolapitant plus palonosetron plus dexamethasone group.
Treatment-related adverse events of any grade occurred in 35.7% of patients during cycle 1 and 42.1% during the entire study in the HR20013 plus dexamethasone group and in 38.2% and 44.0%, respectively, in the fosrolapitant plus palonosetron plus dexamethasone group.
The investigators concluded: “HR20013 [plus dexamethasone] was noninferior to [fosrolapitant plus palonosetron plus dexamethasone] for preventing [highly emetogenic chemotherapy–induced nausea and vomiting] and well tolerated, with the potential to reduce the impact of [chemotherapy-induced nausea and vomiting] on daily life.”
Li Zhang, MD, of Sun Yat-sen University Cancer, Guangdong, Collaborative Innovation Center for Cancer Medicine, Guangzhou, is the corresponding author for the Journal of Clinical Oncology article.
Disclosures: The study was supported by Fujian Shengdi Pharmaceutical Co, Ltd. For full disclosures of all study authors, visit the Journal of Clinical Oncology.
