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William J. Gradishar, MD, FACP, FASCO


ESMO 2022: METEORA-II Trial Evaluates Triplet Regimen in Advanced Breast Cancer

By: Vanessa A. Carter, BS
Posted: Tuesday, September 13, 2022

Elisabetta Munzone, MD, of the European Institute of Oncology, Milan, Italy, and colleagues aimed to determine whether oral vinorelbine plus cyclophosphamide and capecitabine (VEX) provided a treatment benefit for patients with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer compared with paclitaxel alone. The results of this trial were presented during the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 216MO).

“[The] METEORA-II trial showed VEX significantly improved time to treatment failure compared with paclitaxel,” concluded the investigators. “VEX metronomic oral treatment should be considered as a first-line chemotherapy regimen for patients with ER-positive/HER2-negative metastatic breast cancer that require chemotherapy.”

This phase II trial enrolled 133 patients with ER-positive/HER2-negative metastatic breast cancer who were eligible for chemotherapy. Participants were randomly assigned to receive the VEX regimen (n = 70) or weekly paclitaxel (n = 63) in 4-week cycles. Time to treatment failure was defined from therapy initiation to permanent discontinuation of any agent.

With a median follow-up of 29 months, nearly all patients experienced a time-to-treatment-failure event (n = 128), and 61 patients died. Approximately 16% of participants received prior chemotherapy for their disease, although 56% underwent endocrine therapy. The VEX regimen significantly improved the time to treatment failure compared with paclitaxel, with median times to failure of 8.3 and 5.7 months, respectively; the 12-month time-to-treatment-failure rates were 34.3% and 8.6%.

Moreover, patients given the combination treatment experienced longer median (11.1 vs. 6.9 months) and 12-month (43.5% vs. 21.9%) progression-free survival compared with those given monotherapy; no difference in overall survival was observed. Of note, disease progression was the time-to-treatment-failure event in 56% of individuals, and 23% experienced treatment failure–related adverse events. Of note, adverse events of grade 3 or higher affected more patients receiving the VEX regimen versus paclitaxel (42.9% vs. 28.6%).

Disclosure: For full disclosures of the study authors, visit

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