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Title: | Sorafenib in Combination With Capecitabine: An Oral Regimen for Patients With HER2-Negative Locally Advanced or Metastatic Breast Cancer |
Authors: | BASELGA, Jose; SEGALLA, Jose Getulio Martins; ROCHE, Henri; GIGLIO, Auro del; PINCZOWSKI, Helio; CIRUELOS, Eva M.; CABRAL FILHO, Sebastiao; GOMEZ, Patricia; EYLL, Brigitte Van; BERMEJO, Begona; LLOMBART, Antonio; GARICOCHEA, Bernardo; DURAN, Miguel Angel Climent; HOFF, Paulo Marcelo Gehm; ESPIE, Marc; MORAES, Andre Augusto Junior Gemeinder de; RIBEIRO, Ronaldo Albuquerque; MATHIAS, Clarissa; GIL, Miguel Gil; OJEDA, Belen; MORALES, Josefa; RO, Sunhee Kwon; LI, Shell; COSTA, Frederico |
Citation: | JOURNAL OF CLINICAL ONCOLOGY, v.30, n.13, p.1484-1491, 2012 |
Abstract: | 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/hand-foot 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. |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - FM/MDR Artigos e Materiais de Revistas Científicas - HC/ICESP Artigos e Materiais de Revistas Científicas - HC/InRad Artigos e Materiais de Revistas Científicas - LIM/24 |
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