TY - JOUR
T1 - Daily Oral Ibandronate With Adjuvant Endocrine Therapy in Postmenopausal Women With Estrogen Receptor-Positive Breast Cancer (BOOG 2006-04)
T2 - Randomized Phase III TEAM-IIB Trial
AU - Vliek, Sonja B.
AU - Noordhoek, Iris
AU - Meershoek-Klein Kranenbarg, Elma
AU - Van Rossum, Annelot G.J.
AU - Dezentje, Vincent O.
AU - Jager, Agnes
AU - Hokken, J. W.Esmeralda
AU - Putter, Hein
AU - Van Der Velden, Annette W.G.
AU - Hendriks, Mathijs P.
AU - Bakker, Sandra D.
AU - Van Riet, Yvonne E.A.
AU - Tjan-Heijnen, Vivianne C.G.
AU - Portielje, Johanneke E.A.
AU - Kroep, Judith R.
AU - Nortier, Johan W.R.
AU - Van De Velde, Cornelis J.H.
AU - Linn, Sabine C.
N1 - Funding Information:
Supported by Roche Nederland B.V. and Pfizer Nederland B.V. by means of unrestricted research grants.
Publisher Copyright: © American Society of Clinical Oncology.
PY - 2022/4/1
Y1 - 2022/4/1
N2 - PURPOSEFor postmenopausal patients with breast cancer, previous subgroup analyses have shown a modest benefit from adjuvant bisphosphonate treatment. However, the efficacy of oral nitrogen-containing bisphosphonates such as ibandronate is unclear in this setting. TEAM-IIB investigates adjuvant ibandronate in postmenopausal women with estrogen receptor-positive (ER+) breast cancer.METHODSTEAM-IIB is a randomized, open-label, multicenter phase III study. Postmenopausal women with stage I-III ER+ breast cancer and an indication for adjuvant endocrine therapy (ET) were randomly assigned 1:1 to 5 years of ET with or without oral ibandronate 50 mg once daily for 3 years. Major ineligibility criteria were bilateral breast cancer, active gastroesophageal problems, and health conditions that might interfere with study treatment. Primary end point was disease-free survival (DFS), analyzed in the intention-to-treat population.RESULTSBetween February 1, 2007, and May 27, 2014, 1,116 patients were enrolled, 565 to ET with ibandronate (ibandronate arm) and 551 to ET alone (control arm). Median follow-up was 8.5 years. DFS was not significantly different between the ibandronate and control arms (HR 0.97; 95% CI, 0.76 to 1.24; log-rank P =.811). Three years after random assignment, DFS was 94% in the ibandronate arm and 91% in the control arm. Five years after random assignment, this was 89% and 86%, respectively. In the ibandronate arm, 97/565 (17%) of patients stopped ibandronate early because of adverse events. Significantly more patients experienced GI issues, mainly dyspepsia, in the ibandronate arm than in the control arm (89 [16%] and 54 [10%], respectively; P <.003). Eleven patients in the ibandronate arm developed osteonecrosis of the jaw.CONCLUSIONIn postmenopausal women with ER+ breast cancer, adjuvant ibandronate 50 mg once daily does not improve DFS and should not be recommended as part of standard treatment regimens.
AB - PURPOSEFor postmenopausal patients with breast cancer, previous subgroup analyses have shown a modest benefit from adjuvant bisphosphonate treatment. However, the efficacy of oral nitrogen-containing bisphosphonates such as ibandronate is unclear in this setting. TEAM-IIB investigates adjuvant ibandronate in postmenopausal women with estrogen receptor-positive (ER+) breast cancer.METHODSTEAM-IIB is a randomized, open-label, multicenter phase III study. Postmenopausal women with stage I-III ER+ breast cancer and an indication for adjuvant endocrine therapy (ET) were randomly assigned 1:1 to 5 years of ET with or without oral ibandronate 50 mg once daily for 3 years. Major ineligibility criteria were bilateral breast cancer, active gastroesophageal problems, and health conditions that might interfere with study treatment. Primary end point was disease-free survival (DFS), analyzed in the intention-to-treat population.RESULTSBetween February 1, 2007, and May 27, 2014, 1,116 patients were enrolled, 565 to ET with ibandronate (ibandronate arm) and 551 to ET alone (control arm). Median follow-up was 8.5 years. DFS was not significantly different between the ibandronate and control arms (HR 0.97; 95% CI, 0.76 to 1.24; log-rank P =.811). Three years after random assignment, DFS was 94% in the ibandronate arm and 91% in the control arm. Five years after random assignment, this was 89% and 86%, respectively. In the ibandronate arm, 97/565 (17%) of patients stopped ibandronate early because of adverse events. Significantly more patients experienced GI issues, mainly dyspepsia, in the ibandronate arm than in the control arm (89 [16%] and 54 [10%], respectively; P <.003). Eleven patients in the ibandronate arm developed osteonecrosis of the jaw.CONCLUSIONIn postmenopausal women with ER+ breast cancer, adjuvant ibandronate 50 mg once daily does not improve DFS and should not be recommended as part of standard treatment regimens.
UR - http://www.scopus.com/inward/record.url?scp=85130172036&partnerID=8YFLogxK
U2 - 10.1200/JCO.21.00311
DO - 10.1200/JCO.21.00311
M3 - Article
C2 - 35442755
AN - SCOPUS:85130172036
SN - 0732-183X
VL - 68
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
M1 - JCO.21.00311
ER -
