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 - 2022/9/1
Y1 - 2022/9/1
N2 - PURPOSE: For 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.METHODS: TEAM-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.RESULTS: Between 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.CONCLUSION: In 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 - PURPOSE: For 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.METHODS: TEAM-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.RESULTS: Between 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.CONCLUSION: In 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.
KW - Bisphosphonate-related osteonecrosis
KW - Zoledronic acid
KW - Mechanisms
KW - Metastases
KW - Clodronate
KW - Tamoxifen
KW - Diagnosis
KW - Jaw
U2 - 10.1200/JCO.21.00311
DO - 10.1200/JCO.21.00311
M3 - Article
C2 - 35442755
SN - 0732-183X
VL - 40
SP - 2934
EP - 2945
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 25
ER -