title: A Prospective Randomised Phase III Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated with Trastuzumab for Metastatic Breast Cancer - Anglo Celtic VII.
abstract: A high incidence of central nervous system (CNS) metastases has been reported in patients with HER2-positive tumours receiving trastuzumab therapy for metastatic breast cancer. This study tested whether prophylactic cranial irradiation (PCI) could reduce the incidence of CNS metastases in this setting. This was a prospective, randomised phase III trial. Patients were randomised 1:1 to no PCI or PCI delivered at around 6 weeks after study entry. Cognitive function was assessed prospectively. In total, 51 patients were randomised over a 3 year period; 25 received PCI and 26 did not. The cumulative incidence of CNS metastases at 2 years was 32.4% (standard error = 9.8%) on the no PCI arm and 21.0% (standard error = 8.6%) on the PCI arm; the associated hazard ratio was 0.57 (95% confidence interval 0.18-1.74; P = 0.32). There was no evidence of cognitive dysfunction in PCI patients.
authors.affiliation: Department of Clinical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, UK. Electronic address: pg.canney@me.com.
authors.forename: P
authors.initials: P
authors.lastname: Canney
authors.affiliation: NHS Ayrshire & Arran, Psychological Service, Irvine, UK.
authors.forename: E
authors.initials: E
authors.lastname: Murray
authors.affiliation: Cancer Research UK Clinical Trials Unit, Beatson West of Scotland Cancer Centre, Glasgow, UK.
authors.forename: J
authors.initials: J
authors.lastname: Dixon-Hughes
authors.affiliation: Cancer Research UK Clinical Trials Unit, Beatson West of Scotland Cancer Centre, Glasgow, UK.
authors.forename: L-A
authors.initials: LA
authors.lastname: Lewsley
authors.affiliation: NHS Ayrshire & Arran, Psychological Service, Irvine, UK.
authors.forename: J
authors.initials: J
authors.lastname: Paul
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D001932:Brain Neoplasms / Q000378:metabolism / Q000532:radiotherapy* / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D018890:Chemoprevention; D016371:Cranial Irradiation; D005260:Female; D006801:Humans; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000096:biosynthesis; D000068878:Trastuzumab / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: Breast cancer; CNS metastases; HER2 positive; radiotherapy