Extending adjuvant treatment with zoledronate past 2 years didn’t enhance survival in patients with high-risk early breast cancer, based on outcomes of a research study printed in JAMA Oncology.
Though adjuvant bisphosphonates are used to deal with postmenopausal patients with early breast cancer, the optimum period of treatment is unclear, the research authors famous.
Within the phase 3 SUCCESS A trial (ClinicalTrials.gov Identifier: NCT02181101), the authors in contrast 5 years of adjuvant zoledronate with 2 years of adjuvant zoledronate in patients with early breast cancer.
The research enrolled 3754 patients with node-positive or high-risk node-negative illnesses, and 2987 of them have been evaluable. The patients’ median age at baseline was 53 years (vary, 21-86 years).
Patients first acquired 3 cycles of treatment with fluorouracil, epirubicin, and cyclophosphamide. They have been then randomly assigned to three cycles of docetaxel with or without gemcitabine. After chemotherapy, the patients have been randomly assigned to obtain 5 years or 2 years of treatment with zoledronate.
Multivariable analyses confirmed no vital variations in outcomes between the 5-year and 2-year treatment arms. There were no variations in disease-free survival (hazard ratio [HR], 0.97; 95% CI, 0.75-1.25; P =.81), general survival (HR, 0.98; 95% CI, 0.67-1.42; P =.90), or distant disease-free survival (HR, 0.87; 95% CI, 0.65-1.18; P =.38).
Besides, there was no vital between-arm distinction within the presence of circulating tumor cells at 5 years (x2 check, P =.14).
Opposed occasions (AEs) have been extra frequent within the 5-year arm (46.2%) than within the 2-year arm (27.2%). The commonest skeletal-related AEs (within the 5-year and 2-year arms, respectively) have been bone pain (8.3% vs 3.7%) and arthralgia (5.1% vs 3.1%).
Osteonecrosis of the jaw was extra frequent within the 5-year arm (11 patients) than within the 2-year arm (5 patients).
“The outcomes of this part 3 randomized scientific trial point out that extending the zoledronate treatment past 2 years doesn’t enhance the prognosis of high-risk patients with early breast cancer receiving chemotherapy, suggesting that the at present really useful bisphosphonate treatment period of three to five years could be decreased,” the research authors wrote.
Friedl TWP, Fehm T, Müller V, et al. Prognosis of patients with early breast cancer receiving 5 years vs 2 years of adjuvant bisphosphonate treatment: a phase 3 randomized clinical trial. JAMA Oncol. Printed online June 24, 2021. doi:10.1001/jamaoncol.2021.1854