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Viçosa do Ceará, Brazil

Eleuterio S.J.P.,Federal University of Sao Paulo | Senerchia A.A.,Federal University of Sao Paulo | Almeida M.T.,University of Sao Paulo | Costa C.M.D.,Hospital do Cancer A C Camargo | And 6 more authors.
Pediatric Blood and Cancer | Year: 2015

Background: Childhood cancer is relatively rare and tends to present specific age distribution, as a prognostic factor for some of these diseases. Information on how young age affects prognosis, response to chemotherapy, and local control options in children versus AYA with osteosarcoma (OST) is minimal. Methods: In order to identify the main differences in clinicalpathologic features, surgical approaches and survival rates of primary high grade OST of the extremity between children (n=156; <12 years old) and AYA (n=397; 12-30 years old), the institutional database with 553 patients treated by BOTG studies over 15 years were reviewed. Results: There were no differences in metastasess at diagnosis, tumor size, and grade of necrosis between the two age groups. The rate of amputation was 30% higher in the children group (P=0.018). The rate of limb salvage surgery using reconstruction with allograft or autograft was 70% higher in the children group (P=0.018) while endoprosthesis rate was 40% higher in the AYA group (P=0.018). The log rank test revealed that survival is similar between the two age groups for non-metastatic patients (P=0.424 for OS and P=0.393 for EFS). Metastatic patients of both ages group had higher risk of dying compared to non-metastatic (HR 3.283 95% CI 2.581-4.177; P<0.001). Children with metastases at diagnosis had less OS time (P=0.049) and EFS time (P=0.032) than adolescents. Conclusion: Non-metastatic OST in preadolescent patients does not appear to be significantly differentfrom those seen in AYA patients, but has local control challenges. Children presenting with metastases should be considered an ultra-high-risk group. Pediatr Blood Cancer 2015;62:1209-1213. © 2015 Wiley Periodicals, Inc. Source

Baselga J.,Massachusetts General Hospital | Segalla J.G.M.,Fundacao Dr. Amaral Carvalho | Roche H.,Institute Claudius Regaud | Del Giglio A.,Federal University of ABC | And 18 more authors.
Journal of Clinical Oncology | Year: 2012

Purpose: Sorafenib is a multikinase inhibitor with antiangiogenic/ antiproliferative activity. A randomized, double-blind, placebo-controlled phase IIB trial assessed sorafenib with capecitabine for locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) -negative breast cancer. Patients and Methods: Patients were randomly assigned to first- or second-line capecitabine 1,000 mg/m 2 orally twice a day for days 1 to 14 of every 21-day cycle with sorafenib 400 mg orally twice a day or placebo. The primary end point was progression-free survival (PFS). Results: In total, 229 patients were enrolled. The addition of sorafenib to capecitabine resulted in a significant improvement in PFS versus placebo (median, 6.4 v 4.1 months; hazard ratio [HR], 0.58; 95% CI, 0.41 to 0.81; P = .001) with sorafenib favored across subgroups, including first-line (HR, 0.50; 95% CI, 0.30 to 0.82) and second-line (HR, 0.65; 95% CI, 0.41 to 1.04) treatment. There was no significant improvement for overall survival (median, 22.2 v 20.9 months; HR, 0.86; 95% CI, 0.61 to 1.23; P = .42) and overall response (38% v 31%; P = .25). Toxicities (sorafenib v placebo) of any grade included rash (22% v 8%), diarrhea (58% v 30%), mucosal inflammation (33% v 21%), neutropenia (13% v 4%), hypertension (18% v 12%), and hand-foot skin reaction/handfoot syndrome (HFSR/HFS; 90% v 66%); grade 3 to 4 toxicities were comparable between treatment arms except HFSR/HFS (44% v 14%). Reasons for discontinuation in the sorafenib and placebo arms included disease progression (63% v 82%, respectively), adverse events (20% v 9%, respectively), and death (0% v 1%, respectively). Conclusion: Addition of sorafenib to capecitabine improved PFS in patients with HER2-negative advanced breast cancer. The dose of sorafenib used in this trial resulted in unacceptable toxicity for many patients. A phase III confirmatory trial has been initiated with a reduced sorafenib dose. © 2012 by American Society of Clinical Oncology. Source

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