Breast-Cancer Adjuvant Therapy with Zoledronic Acid
| Autor: | Robert E, Coleman, Helen, Marshall, David, Cameron, David, Dodwell, Roger, Burkinshaw, Maccon, Keane, Miguel, Gil, Stephen J, Houston, Robert J, Grieve, Peter J, Barrett-Lee, Diana, Ritchie, Julia, Pugh, Claire, Gaunt, Una, Rea, Jennifer, Peterson, Claire, Davies, Victoria, Hiley, Walter, Gregory, Richard, Bell, Jill, Bishop |
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| Rok vydání: | 2011 |
| Předmět: |
medicine.medical_specialty
efficacy Phases of clinical research Antineoplastic Agents Breast Neoplasms Cancer adjuvant treatment Kaplan-Meier Estimate Zoledronic Acid bone doxorubicin survival Disease-Free Survival Càncer de mama Breast cancer prevention Internal medicine follow-up medicine Adjuvant therapy Humans Cumulative incidence Adverse effect Bone Density Conservation Agents Diphosphonates business.industry Hazard ratio Imidazoles Osteonecrosis trials General Medicine medicine.disease Interim analysis Surgery pamidronate Zoledronic acid Chemotherapy Adjuvant Female oral clodronate business Tractament adjuvant del càncer medicine.drug |
| Zdroj: | Dipòsit Digital de la UB Universidad de Barcelona Recercat. Dipósit de la Recerca de Catalunya instname |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa1105195 |
| Popis: | A b s t r ac t Background Data suggest that the adjuvant use of bisphosphonates reduces rates of recurrence and death in patients with early-stage breast cancer. We conducted a study to determine whether treatment with zoledronic acid, in addition to standard adjuvant therapy, would improve disease outcomes in such patients. Methods In this open-label phase 3 study, we randomly assigned 3360 patients to receive standard adjuvant systemic therapy either with or without zoledronic acid. The zoledronic acid was administered every 3 to 4 weeks for 6 doses and then every 3 to 6 months to complete 5 years of treatment. The primary end point of the study was disease-free survival. A second interim analysis revealed that a prespecified boundary for lack of benefit had been crossed. Results At a median follow-up of 59 months, there was no significant between-group difference in the primary end point, with a rate of disease-free survival of 77% in each group (adjusted hazard ratio in the zoledronic acid group, 0.98; 95% confidence interval [CI], 0.85 to 1.13; P = 0.79). Disease recurrence or death occurred in 377 patients in the zoledronic acid group and 375 of those in the control group. The numbers of deaths — 243 in the zoledronic acid group and 276 in the control group — were also similar, resulting in rates of overall survival of 85.4% in the zoledronic acid group and 83.1% in the control group (adjusted hazard ratio, 0.85; 95% CI, 0.72 to 1.01; P = 0.07). In the zoledronic acid group, there were 17 confirmed cases of osteonecrosis of the jaw (cumulative incidence, 1.1%; 95% CI, 0.6 to 1.7; P |
| Databáze: | OpenAIRE |
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