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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

From the VU University Medical Center, Amsterdam; Radboud University Medical Center, Nijmegen; Groene Hart Ziekenhuis, Gouda, the Netherlands; Southeastern Gynecologic Oncology, Atlanta, GA; Duke University Medical Center, Durham, NC; Scripps Clinic, La Jolla, CA; Massachusetts General Hospital, Boston, MA; St Bartholomew's Hospital, Imperial College; Hammersmith Hospital; Guy's and St Thomas' National Health Service Foundation Trust, London; Northern Gynaecological Oncology Center, Queen Elizabeth Hospital, Tyne and Wear; Amersham, United Kingdom; University School of Medical Sciences, Poznan, Poland; Mararyk Memorial Cancer Institute, Brno, Czech Republic; and Monash Medical Center, East Bentleigh, Australia

Address reprint requests to R.H.M. Verheijen, MD, PhD, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, VU University Medical Centre, PO Pox 7057, 1007 MB, Amsterdam, the Netherlands; e-mail: r.verheijen{at}vumc.nl

PURPOSE: This was a multinational, open-label, randomized phase III trial comparing yttrium-90–labeled murine HMFG1 (⁹⁰Y-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 ⁹⁰Y-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 ⁹⁰Y-muHMFG1 (target dose 666 MBq/m²). 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 ⁹⁰Y-muHMFG1 to patients with EOC who had a negative SLL after primary therapy did not extend survival or time to relapse.

Supported by Antisoma Ltd, London, United Kingdom, and Hoffmann-La Roche Inc, Basel, Switzerland.

Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004; and at the 10th Meeting of the International Society of Gynecologic Oncology, Edinburgh, United Kingdom, October 3-7, 2004.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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