ABSTRACT
BACKGROUND: The addition of lapatinib (L) to trastuzumab (T) was previously found to be synergistic in preclinical models and in the neoadjuvant setting. Prior to the results of the ALTTO trial, this study assessed the safety and feasibility of adding L to the standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen in early-stage HER2-positive breast cancer (HER2+ BC). METHODS: In this single-arm, 2-stage, phase II study, patients with stages I-III HER2+ BC received TCH plus L at 1000 mg daily for a total of 12 months. The primary endpoint was the safety and tolerability, including the rate of diarrhea. Secondary endpoints included adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety. RESULTS: Thirty eligible patients were enrolled. Median follow-up is 5.3 years. Diarrhea was the most common AE with 50% Grade (G)1/2 and 43% G3 diarrhea. However, it was responsive to dose reduction of L (750 mg) and institution of anti-diarrheal medications. Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment. CONCLUSION: TCHL was a tolerable regimen at a starting L dose of 750 mg PO daily when given concurrently with chemotherapy.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Receptor, ErbB-2/metabolism , Adult , Aged , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carboplatin/administration & dosage , Carcinoma, Ductal, Breast/drug therapy , Carcinoma, Ductal, Breast/metabolism , Carcinoma, Ductal, Breast/pathology , Carcinoma, Ductal, Breast/surgery , Carcinoma, Lobular/drug therapy , Carcinoma, Lobular/metabolism , Carcinoma, Lobular/pathology , Carcinoma, Lobular/surgery , Docetaxel/administration & dosage , Female , Follow-Up Studies , Humans , Lapatinib/administration & dosage , Middle Aged , Neoadjuvant Therapy , Pilot Projects , Prognosis , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism , Survival Rate , Trastuzumab/administration & dosageABSTRACT
PURPOSE: To describe the clinical course of a 52-year-old white man with previously undiagnosed hemophilia who suffered blunt trauma to the right eye with consequent delayed, spontaneous suprachoroidal hemorrhage. DESIGN: Observational case report. METHODS: The patient's clinical course from the time of trauma to postenucleation is discussed and correlated with B-scan ultrasonography and histopathology. RESULTS: The patient developed recurrent hyphemas, delayed choroidal hemorrhage with detachment and eventually loss of the eye. Hematologic evaluation established a diagnosis of mild factor VIII deficiency. CONCLUSION: Despite mild hemophilia, this patient had not experienced any clinically important morbidity until his eye injury. Ophthalmologists should be aware that bleeding disorders such as hemophilia predispose patients to spontaneous intraocular hemorrhage.