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- W4741852 abstract "Although trastuzumab-based therapy improves progression-free survival and overall survival in patients with human epidermal growth factor receptor–2 (HER-2)–positive metastatic breast cancer, disease progression still occurs in most patients. Pertuzumab (Omnitarg, Roche/Genentech), an investigational fully humanized monoclonal antibody, binds to human epidermal growth factor receptor-2 (HER-2), inducing antibody-dependent, cell-mediated cytotoxicity. Its mechanisms of action complement those of the anti–HER-2 antibody trastuzumab (Herceptin, Genentech). The two antibodies combined have demonstrated superior antitumor activity compared with either antibody alone in preclinical and clinical studies, Dr. Baselga said. Increased drug-related adverse events (AEs) with the combination were manageable.In CLEOPATRA (Clinical Evaluation of Pertuzumab and Trastuzumab), an international, phase 3, double-blind, randomized registration trial, 808 patients (mean age, 54 years) received either placebo plus trastuzumab (an 8-mg/kg loading dose, followed by a 6-mg/kg maintenance dose) plus docetaxel (Taxotere, Sanofi) (75 mg/m2, escalating to 100 mg/m2 if tolerated, for six cycles or more, as recommended) or pertuzumab (an 840-mg loading dose, followed by a 420-mg maintenance dose) plus trastuzumab (an 8-mg/kg loading dose, followed by a 6-mg/kg maintenance dose). Patients were allowed to receive one previous hormonal treatment for metastatic breast cancer and/or prior systemic neoadjuvant or adjuvant therapy, including prior trastuzumab and taxanes.Progression-free survival (the primary endpoint) was reported at a median of 18.5 months with pertuzumab/trastuzumab/docetaxel and at 12.4 months with placebo/trastuzumab/docetaxel (6.1 months; hazard ratio [HR] = 0.62; 95% confidence interval [CI], 0.51–0.75; P < 0.0001).Calling the magnitude of effects with the pertuzumab combination “unprecedented,” Dr. Baselga said: “This is the most positive trial in the history of patients with HER-2–positive advanced disease and, for that matter, with advanced breast cancer.”No cardiac abnormalities were reported. The incidence of diarrhea, rash, mucosal inflammation, and febrile neutropenia, which occurred mostly during docetaxel therapy, was higher with pertuzumab/trastuzumab/docetaxel; however, these AEs were primarily grades 1 and 2 in severity and were manageable.“This new regimen may be practice-changing in HER-2–positive, first-line metastatic breast cancer,” Dr. Baselga said.While calling the data convincing, Dr. Osborne noted that the rarity of complete responses suggested escape pathways that might be addressed by targeting the estrogen receptor.These findings have been published in the New England Journal of Medicine, 2012;366:109–119." @default.
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- W4741852 date "2012-02-01" @default.
- W4741852 modified "2023-09-23" @default.
- W4741852 title "34th annual san antonio breast cancer symposium and 53rd american society of hematology annual meeting and exposition." @default.
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