Overall survival of patients with HER2-negative metastatic breast cancer treated with a first-line paclitaxel with or without bevacizumab in real-life setting: Results of a multicenter national observational study.
2016; Lippincott Williams & Wilkins; Volume: 34; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2016.34.15_suppl.1013
ISSN1527-7755
AutoresSuzette Delaloge, David Pérol, Étienne Brain, Bernard Asselain, Thomas Bachelot, Marc Debled, Véronique Dièras, Mario Campone, Christelle Lévy, William Jacot, Véronique Lorgis, Corinne Veyret, Florence Dalenc, Jean‐Marc Ferrero, Lionel Uwer, Anthony Gonçalvès, Irwin Piot, G. Simon, Mathieu Robain, Christian Cailliot,
Tópico(s)Breast Cancer Treatment Studies
Resumo1013 Background: In 2014, UNICANCER (composed of 18 French Comprehensive Cancer Centers) launched the Epidemiological Strategy and Medical Economics (ESME) program to centralize real-world data in oncology. Metastatic breast cancer (mBC) was first selected to address the value of bevacizumab (B) added to paclitaxel (P) as first-line chemotherapy (CT) for HER2-negative tumours, while randomized trials have led to mixed results on outcome. Methods: The ESME-mBC database was built from information systems, treatment databases and patients' electronic files including quality control processes. All patients who started a first-line anti-cancer treatment for mBC between 01-Jan-2008 and 31-Dec-2013 were selected. The primary objective of the present study was to assess overall survival (OS) in patients with HER2-mBC treated with a first-line P-based CT ± B. Cox regression with adjustment for the main prognostic covariates was used to estimate the hazard ratio (HR) for OS and progression-free survival (PFS). To adjust for confounders, advanced methodological methods including propensity score, matching factor for nested case-control analyses and sensitivity analyses were performed. Results: Among 14,014 patients recorded in the ESME-mBC database, 10,605 had HER2-negative tumors. Of these, 2,127 and 1,299 received P+B and P respectively as first-line CT. OS was significantly higher in the P+B group compared with P alone (HR = 0.672 [95%CI, 0.601;0.752]; median survival time, 27.7 versus 19.8 months). Results were consistent across all supportive and sensitivity analyses, including in triple-negative and estrogen receptor-positive tumors subgroups. PFS was also higher for those receiving P+B versus P (HR = 0.739 [0.672; 0.813]; 8.1 versus 6.4 months). Conclusions: In this large-scale real-life setting database, patients with HER2-negative mBC who received P+B had a significantly better OS and PFS than those receiving P alone. Despite robust methodology, real-world data should be interpreted with caution. However, these data shed light on the potential interest of real-life data in oncology.
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