Daily Oral Ibandronate With Adjuvant Endocrine Therapy in Postmenopausal Women With Estrogen Receptor-Positive Breast Cancer (BOOG 2006-04): Randomized Phase III TEAM-IIB Trial

Sonja B. Vliek, Iris Noordhoek, Elma Meershoek-Klein Kranenbarg, Annelot G.J. Van Rossum, Vincent O. Dezentje, Agnes Jager, J. W.Esmeralda Hokken, Hein Putter, Annette W.G. Van Der Velden, Mathijs P. Hendriks, Sandra D. Bakker, Yvonne E.A. Van Riet, Vivianne C.G. Tjan-Heijnen, Johanneke E.A. Portielje, Judith R. Kroep, Johan W.R. Nortier, Cornelis J.H. Van De Velde, Sabine C. Linn*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

8 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article numberJCO.21.00311
JournalJournal of Clinical Oncology
Volume68
DOIs
Publication statusPublished - 1 Apr 2022
Externally publishedYes

Bibliographical note

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.

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