German adjuvant intergroup node-positive study
Standard
German adjuvant intergroup node-positive study : a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer. / von Minckwitz, Gunter; Möbus, Volker; Schneeweiss, Andreas; Huober, Jens; Thomssen, Christoph; Untch, Michael; Jackisch, Christian; Diel, Ingo J; Elling, Dirk; Conrad, Bettina; Kreienberg, Rolf; Müller, Volkmar; Lück, Hans-Joachim; Bauerfeind, Ingo; Clemens, Michael; Schmidt, Marcus; Noeding, Stefanie; Forstbauer, Helmut; Barinoff, Jana; Belau, Antje; Nekljudova, Valentina; Harbeck, Nadia; Loibl, Sibylle.
In: J CLIN ONCOL, Vol. 31, No. 28, 01.10.2013, p. 3531-9.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - German adjuvant intergroup node-positive study
T2 - a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer
AU - von Minckwitz, Gunter
AU - Möbus, Volker
AU - Schneeweiss, Andreas
AU - Huober, Jens
AU - Thomssen, Christoph
AU - Untch, Michael
AU - Jackisch, Christian
AU - Diel, Ingo J
AU - Elling, Dirk
AU - Conrad, Bettina
AU - Kreienberg, Rolf
AU - Müller, Volkmar
AU - Lück, Hans-Joachim
AU - Bauerfeind, Ingo
AU - Clemens, Michael
AU - Schmidt, Marcus
AU - Noeding, Stefanie
AU - Forstbauer, Helmut
AU - Barinoff, Jana
AU - Belau, Antje
AU - Nekljudova, Valentina
AU - Harbeck, Nadia
AU - Loibl, Sibylle
PY - 2013/10/1
Y1 - 2013/10/1
N2 - 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.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.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).CONCLUSION: Adjuvant treatment with oral ibandronate did not improve outcome of patients with high-risk early breast cancer who received dose-dense chemotherapy.
AB - 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.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.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).CONCLUSION: Adjuvant treatment with oral ibandronate did not improve outcome of patients with high-risk early breast cancer who received dose-dense chemotherapy.
KW - Adult
KW - Aged
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Breast Neoplasms
KW - Carcinoma, Ductal, Breast
KW - Carcinoma, Lobular
KW - Chemotherapy, Adjuvant
KW - Cyclophosphamide
KW - Deoxycytidine
KW - Diphosphonates
KW - Epirubicin
KW - Female
KW - Fluorouracil
KW - Follow-Up Studies
KW - Germany
KW - Humans
KW - Middle Aged
KW - Neoplasm Grading
KW - Neoplasm Staging
KW - Paclitaxel
KW - Prognosis
KW - Survival Rate
KW - Young Adult
U2 - 10.1200/JCO.2012.47.2167
DO - 10.1200/JCO.2012.47.2167
M3 - SCORING: Journal article
C2 - 23980081
VL - 31
SP - 3531
EP - 3539
JO - J CLIN ONCOL
JF - J CLIN ONCOL
SN - 0732-183X
IS - 28
ER -
