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German adjuvant intergroup node-positive study: a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2013 Oct 01; Vol. 31 (28), pp. 3531-9. Date of Electronic Publication: 2013 Aug 26. - Publication Year :
- 2013
-
Abstract
- Purpose: Bisphosphonates prevent skeletal-related events in patients with metastatic breast cancer. Their effect in early breast cancer is controversial. Ibandronate is an orally and intravenously available amino-bisphosphonate with a favorable toxicity profile. It therefore qualifies as potential agent for adjuvant use.<br />Patients and Methods: The GAIN (German Adjuvant Intergroup Node-Positive) study was an open-label, randomized, controlled phase III trial with a 2 × 2 factorial design. Patients with node-positive early breast cancer were randomly assigned 1:1 to two different dose-dense chemotherapy regimens and 2:1 to ibandronate 50 mg per day orally for 2 years or observation. In all, 2,640 patients and 728 events were estimated to be required to demonstrate an increase in disease-free survival (DFS) by ibandronate from 75% to 79.5% by using a two-sided α = .05 and 1-β of 80%. We report here the efficacy analysis for ibandronate, which was released by the independent data monitoring committee because the futility boundary was not crossed after 50% of the required DFS events were observed.<br />Results: Between June 2004 and August 2008, 2,015 patients were randomly assigned to ibandronate and 1,008 to observation. Patients randomly assigned to ibandronate showed no superior DFS or overall survival (OS) compared with patients randomly assigned to observation (DFS: hazard ratio, 0.945; 95% CI, 0.768 to 1.161; P = .589; OS: HR, 1.040; 95% CI, 0.763 to 1.419; P = .803). DFS was numerically longer if ibandronate was used in patients younger than 40 years or older than 60 years compared with patients age 40 to 59 years (test for interaction P = .093).<br />Conclusion: Adjuvant treatment with oral ibandronate did not improve outcome of patients with high-risk early breast cancer who received dose-dense chemotherapy.
- Subjects :
- Adult
Aged
Breast Neoplasms mortality
Breast Neoplasms pathology
Capecitabine
Carcinoma, Ductal, Breast mortality
Carcinoma, Ductal, Breast pathology
Carcinoma, Lobular mortality
Carcinoma, Lobular pathology
Chemotherapy, Adjuvant
Cyclophosphamide administration & dosage
Deoxycytidine administration & dosage
Deoxycytidine analogs & derivatives
Diphosphonates administration & dosage
Epirubicin administration & dosage
Female
Fluorouracil administration & dosage
Fluorouracil analogs & derivatives
Follow-Up Studies
Germany
Humans
Ibandronic Acid
Middle Aged
Neoplasm Grading
Neoplasm Staging
Paclitaxel administration & dosage
Prognosis
Survival Rate
Young Adult
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Breast Neoplasms drug therapy
Carcinoma, Ductal, Breast drug therapy
Carcinoma, Lobular drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 31
- Issue :
- 28
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 23980081
- Full Text :
- https://doi.org/10.1200/JCO.2012.47.2167