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Phase III Trial of Intraperitoneal Therapy With Yttrium-90–Labeled HMFG1 Murine Monoclonal Antibody in Patients With Epithelial Ovarian Cancer After a Surgically Defined Complete Remission

2006; Lippincott Williams & Wilkins; Volume: 24; Issue: 4 Linguagem: Inglês

10.1200/jco.2005.02.5973

1527-7755

René H.M. Verheijen, Leon F.A.G. Massuger, Benedict B. Benigno, Agamemnon A. Epenetos, Alberto Lopes, John T. Soper, Janica Markowska, Rostislav Vyzula, Tom Jobling, Gordon Stamp, Gregory Spiegel, Dennis Thurston, Theo H. M. Falke, Joanna E. Lambert, Michael V. Seiden,

Intraperitoneal and Appendiceal Malignancies

Purpose This was a multinational, open-label, randomized phase III trial comparing yttrium-90–labeled murine HMFG1 ( 90 Y-muHMFG1) plus standard treatment versus standard treatment alone in patients with epithelial ovarian cancer (EOC) who had attained a complete clinical remission after cytoreductive surgery and platinum-based chemotherapy. Patients and Methods In total, 844 International Federation of Gynecology and Obstetrics stage Ic to IV patients were initially screened, of whom 447 patients with a negative second-look laparoscopy (SLL) were randomly assigned to receive either a single dose of 90 Y-muHMFG1 plus standard treatment (224 patients) or standard treatment alone (223 patients). Patients in the active treatment arm received a single intraperitoneal dose of 25 mg of 90 Y-muHMFG1 (target dose 666 MBq/m 2 ). The primary end point was length of survival; secondary end points included time to relapse and safety. The study had an 80% power to detect a 15% change in survival. Results After a median follow-up of 3.5 years (range, 1 to 6 years), 70 patients had died in the active treatment arm compared with 61 patients in the control arm. Cox proportional hazards analysis of survival demonstrated no difference between treatment arms. In the study drug arm, 104 patients experienced relapse compared with 98 patients in the standard treatment arm. No difference in time to relapse was observed between the two study arms. Active therapy was associated with occasional grade 3 or 4 thrombocytopenia and neutropenia and grade 1 or 2 GI symptoms, abdominal discomfort, arthralgia, and myalgia. Conclusion A single IP administration of 90 Y-muHMFG1 to patients with EOC who had a negative SLL after primary therapy did not extend survival or time to relapse.