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Prognosis of patients with early breast cancer receiving 5 years vs 2 years of adjuvant bisphosphonate treatment: A phase 3 randomized clinical trial

JAMA Jun 29, 2021

Friedl TWP, Fehm T, Müller V, et al. - In the randomized phase 3 SUCCESS A clinical trial, researchers compared 2 vs 5 years of zoledronate treatment following adjuvant chemotherapy in patients with early breast cancer. Study participants were first randomized to adjuvant chemotherapy consisting of 3 cycles of fluorouracil, epirubicin, and cyclophosphamide followed by 3 cycles of docetaxel with or without gemcitabine (not presented in this report). Following chemotherapy, patients were randomly assigned to receive 5 years of zoledronate treatment (4 mg intravenously every 3 months for 2 years, followed by 4 mg intravenously every 6 months for 3 years) vs 2 years of zoledronate treatment (4 mg intravenously every 3 months for 2 years). The sample consisted of 2,987 patients, median age 53 (range, 21-86) years. In 2,987 patients with early breast cancer, regardless of menopausal status, there was no statistically significant difference in survival between 5 and 2 years of adjuvant zoledronate treatment. According to the findings of this phase 3 randomized clinical trial, extending zoledronate treatment beyond 2 years does not improve the prognosis of high-risk patients with early breast cancer receiving chemotherapy, implying that the currently recommended bisphosphonate treatment duration of 3 to 5 years could be decreased.

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