3 results on '"Viale, Giuseppe"'
Search Results
2. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer.
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von Minckwitz, Gunter, Procter, Marion, de Azambuja, Evandro, Zardavas, Dimitrios, Benyunes, Mark, Viale, Giuseppe, Suter, Thomas, Arahmani, Amal, Rouchet, Nathalie, Clark, Emma, Knott, Adam, Lang, Istvan, Levy, Christelle, Yardley, Denise A., Bines, Jose, Gelber, Richard D., Piccart, Martine, Baselga, Jose, and APHINITY Steering Committee and Investigators
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TRASTUZUMAB , *ANTINEOPLASTIC agents , *BREAST cancer treatment , *METASTATIC breast cancer , *CANCER invasiveness , *CANCER chemotherapy , *THERAPEUTIC use of monoclonal antibodies , *BREAST tumors , *CELL receptors , *COMBINED modality therapy , *COMPARATIVE studies , *DIARRHEA , *HEART failure , *RESEARCH methodology , *MEDICAL cooperation , *MONOCLONAL antibodies , *PROGNOSIS , *RESEARCH , *RESEARCH funding , *STATISTICAL sampling , *SURVIVAL , *EVALUATION research , *RANDOMIZED controlled trials , *BLIND experiment - Abstract
Background: Pertuzumab increases the rate of pathological complete response in the preoperative context and increases overall survival among patients with metastatic disease when it is added to trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. In this trial, we investigated whether pertuzumab, when added to adjuvant trastuzumab and chemotherapy, improves outcomes among patients with HER2-positive early breast cancer.Methods: We randomly assigned patients with node-positive or high-risk node-negative HER2-positive, operable breast cancer to receive either pertuzumab or placebo added to standard adjuvant chemotherapy plus 1 year of treatment with trastuzumab. We assumed a 3-year invasive-disease-free survival rate of 91.8% with pertuzumab and 89.2% with placebo.Results: In the trial population, 63% of the patients who were randomly assigned to receive pertuzumab (2400 patients) or placebo (2405 patients) had node-positive disease and 36% had hormone-receptor-negative disease. Disease recurrence occurred in 171 patients (7.1%) in the pertuzumab group and 210 patients (8.7%) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.66 to 1.00; P=0.045). The estimates of the 3-year rates of invasive-disease-free survival were 94.1% in the pertuzumab group and 93.2% in the placebo group. In the cohort of patients with node-positive disease, the 3-year rate of invasive-disease-free survival was 92.0% in the pertuzumab group, as compared with 90.2% in the placebo group (hazard ratio for an invasive-disease event, 0.77; 95% CI, 0.62 to 0.96; P=0.02). In the cohort of patients with node-negative disease, the 3-year rate of invasive-disease-free survival was 97.5% in the pertuzumab group and 98.4% in the placebo group (hazard ratio for an invasive-disease event, 1.13; 95% CI, 0.68 to 1.86; P=0.64). Heart failure, cardiac death, and cardiac dysfunction were infrequent in both treatment groups. Diarrhea of grade 3 or higher occurred almost exclusively during chemotherapy and was more frequent with pertuzumab than with placebo (9.8% vs. 3.7%).Conclusions: Pertuzumab significantly improved the rates of invasive-disease-free survival among patients with HER2-positive, operable breast cancer when it was added to trastuzumab and chemotherapy. Diarrhea was more common with pertuzumab than with placebo. (Funded by F. Hoffmann-La Roche/Genentech; APHINITY ClinicalTrials.gov number, NCT01358877 .). [ABSTRACT FROM AUTHOR]- Published
- 2017
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3. A Randomized Comparison of Sentinel-Node Biopsy with Routine Axillary Dissection in Breast Cancer.
- Author
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Veronesi, Umberto, Paganelli, Giovanni, Viale, Giuseppe, Luini, Alberto, Zurrida, Stefano, Galimberti, Viviana, Intra, Mattia, Veronesi, Paolo, Robertson, Chris, Maisonneuve, Patrick, Renne, Giuseppe, De Cicco, Concetta, De Lucia, Francesca, and Gennari, Roberto
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BREAST cancer , *CANCER patients , *CANCER in women , *BIOPSY - Abstract
Background: Although numerous studies have shown that the status of the sentinel node is an accurate predictor of the status of the axillary nodes in breast cancer, the efficacy and safety of sentinel-node biopsy require validation. Methods: From March 1998 to December 1999, we randomly assigned 516 patients with primary breast cancer in whom the tumor was less than or equal to 2 cm in diameter either to sentinel-node biopsy and total axillary dissection (the axillary-dissection group) or to sentinel-node biopsy followed by axillary dissection only if the sentinel node contained metastases (the sentinel-node group). Results: The number of sentinel nodes found was the same in the two groups. A sentinel node was positive in 83 of the 257 patients in the axillary-dissection group (32.3 percent), and in 92 of the 259 patients in the sentinel-node group (35.5 percent). In the axillary-dissection group, the overall accuracy of the sentinel-node status was 96.9 percent, the sensitivity 91.2 percent, and the specificity 100 percent. There was less pain and better arm mobility in the patients who underwent sentinel-node biopsy only than in those who also underwent axillary dissection. There were 15 events associated with breast cancer in the axillary-dissection group and 10 such events in the sentinel-node group. Among the 167 patients who did not undergo axillary dissection, there were no cases of overt axillary metastasis during follow-up. Conclusions: Sentinel-node biopsy is a safe and accurate method of screening the axillary nodes for metastasis in women with a small breast cancer. N Engl J Med 2003;349:546-53. [ABSTRACT FROM AUTHOR]
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- 2003
- Full Text
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