Final results of the TANIA randomised phase III trial of bevacizumab after progression on first-line bevacizumab therapy for HER2-negative locally recurrent/metastatic breast cancer

E. Vrdoljak*, N. Marschner, C. Zielinski, J. Gligorov, J. Cortes, F. Puglisi, M. Aapro, L. Fallowfield, A. Fontana, M. Inbar, Z. Kahan, A. Welt, C. Lévy, E. Brain, X. Pivot, C. Putzu, A. González Martín, S. de Ducla, V. Easton, G. von Minckwitz

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The randomised phase III TANIA trial demonstrated that continuing bevacizumab with second-line chemotherapy for locally recurrent/metastatic breast cancer (LR/mBC) after progression on first-line bevacizumabcontaining therapy significantly improved progression-free survival (PFS) compared with chemotherapy alone [hazard ratio (HR) = 0.75, 95% confidence interval (CI) 0.61-0.93].We report final results from the TANIA trial, including overall survival (OS) and health-related quality of life (HRQoL). Patients and methods: Patients with HER2-negative LR/mBC that had progressed on or after first-line bevacizumab plus chemotherapy were randomised to receive standard second-line chemotherapy either alone or with bevacizumab. At second progression, patients initially randomised to bevacizumab continued bevacizumab with their third-line chemotherapy, but those randomised to chemotherapy alone were not allowed to cross over to receive third-line bevacizumab. The primary end point was second-line PFS; secondary end points included third-line PFS, combined second- and thirdline PFS, OS, HRQoL and safety. Results: Of the 494 patients randomised, 483 received second-line therapy; 234 patients (47% of the randomised population) continued to third-line study treatment. The median duration of follow-up at the final analysis was 32.1 months in the chemotherapy-alone arm and 30.9 months in the bevacizumab plus chemotherapy arm. There was no statistically significant difference between treatment arms in third-line PFS (HR = 0.79, 95% CI 0.59-1.06), combined second- and third-line PFS (HR = 0.85, 95% CI 0.68-1.05) or OS (HR = 0.96, 95% CI 0.76-1.21). Third-line safety results showed increased incidences of proteinuria and hypertension with bevacizumab, consistent with safety results for the second-line treatment phase. No differences in HRQoL were detected. Conclusions: In this trial, continuing bevacizumab beyond first and second progression of LR/mBC improved secondline PFS, but no improvement in longer term efficacy was observed. The second-line PFS benefit appears to be achieved without detrimentally affecting quality of life. ClinicalTrials.gov: NCT01250379.

Original languageEnglish
Pages (from-to)2046-2052
Number of pages7
JournalAnnals of Oncology
Volume27
Issue number11
DOIs
StatePublished - Nov 2016
Externally publishedYes

Keywords

  • Antiangiogenesis
  • Bevacizumab
  • Metastatic breast cancer
  • Quality of life
  • Retreatment

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