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

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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
Publication statusPublished - Nov 2016

Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Vrdoljak, E., Marschner, N., Zielinski, C., Gligorov, J., Cortes, J., Puglisi, F., Aapro, M., Fallowfield, L., Fontana, A., Inbar, M., Kahan, Z., Welt, A., Lévy, C., Brain, E., Pivot, X., Putzu, C., González Martín, A., de Ducla, S., Easton, V., & von Minckwitz, G. (2016). 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. Annals of Oncology, 27(11), 2046-2052. https://doi.org/10.1093/annonc/mdw316