NRG/RTOG 0837: Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Chemoradiation With or Without Cediranib in Newly Diagnosed Glioblastoma

BACKGROUND: A randomized, phase II, placebo-controlled, and blinded clinical trial (NCT01062425) was conducted to determine the efficacy of cediranib, an oral pan-vascular endothelial growth factor receptor tyrosine kinase inhibitor, versus placebo in combination with radiation and temozolomide in newly diagnosed glioblastoma. METHODS: Patients with newly diagnosed glioblastoma were randomly assigned 2:1 to receive (1) cediranib (20 mg) in combination with radiation and temozolomide; (2) placebo in combination with radiation and temozolomide. The primary endpoint was 6-month progression-free survival (PFS) based on blinded, independent radiographic assessment of postcontrast T1-weighted and noncontrast T2-weighted MRI brain scans and was tested using a 1-sided RESULTS: One hundred and fifty-eight patients were randomized, out of which 9 were ineligible and 12 were not evaluable for the primary endpoint, leaving 137 eligible and evaluable. 6-month PFS was 46.6% in the cediranib arm versus 24.5% in the placebo arm ( CONCLUSIONS: This study met its primary endpoint of prolongation of 6-month PFS with cediranib in combination with radiation and temozolomide versus placebo in combination with radiation and temozolomide. There was no difference in overall survival between the 2 arms

Primary neuroendocrine carcinoma of male breast: A cytologically diagnosed rare entity

Primary neuroendocrine (NE) carcinoma of the male breast is very rare. NE breast cancers encompass a heterogeneous group of tumors exhibiting morphological features similar to those of NE tumors of the gut and lung. They express one or more NE markers in at least 50% of the tumor cells. They are rare lesions representing about 2-3% of all breast cancers and more frequently affecting elderly patients. The present case report deals with a NE breast carcinoma in an 80-year-old male who presented with a right breast mass and axillary lymphadenopathy. The cytological features were suggestive of NE carcinoma. A thorough clinical evaluation helped confirm the primary nature of the tumor. The histopathology and immunohistochemistry helped confirm the cytological diagnosis. The histogenesis and prognostic implications of this rare breast tumor with predominant NE differentiation, unusually occurring in a male, is discussed here