Dissemin is shutting down on January 1st, 2025

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American Society of Clinical Oncology, Journal of Clinical Oncology, 15_suppl(31), p. e12558-e12558, 2013

DOI: 10.1200/jco.2013.31.15_suppl.e12558

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Long-term responders to first-line bevacizumab-based therapy among patients (pts) with HER2-negative metastatic breast cancer (MBC): Retrospective results of an ambispective observational study.

This paper was not found in any repository, but could be made available legally by the author.
This paper was not found in any repository, but could be made available legally by the author.

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Data provided by SHERPA/RoMEO

Abstract

e12558 Background: LORENA is an ambispective observational study evaluating B-based therapy in a real world setting which purpose is to assess clinical features, treatments and prognosis of HER2-negative MBC pts with ≥12 months (mo.) of PFS to 1st-line B-based chemotherapy (CT). Methods: Pts with MBC receiving 1st-line CT and B are enrolled. No prespecified schedules, doses or assessments. Data since the introduction of the treatment with B were collected at inclusion (retrospective phase), and prospectively at 18 mo. after enrollment for the patients alive at the time of inclusion, including B-targeted adverse events (AEs). Relevant baseline and on-study variables were analyzed by Cox model to identify independent effects on PFS. Results: By Jan 2013, complete retrospective data were available for 84 pts, 33 (39.3%) of them having stage III-IV at diagnosis. Median age, 50 years (r: 29–77); age ≥65 years, 13%; triple negative, 20.2%; bone/liver/lung metastases (%), 55/27/40; ≥2 metastases sites: 46.4%; ECOG status 0-1: 91.7%, ≥2: 5.9%, UK: 2.3%. 67% of pts have received prior (neo)adjuvant CT, with 56 and 30% of them with anthracyclines and taxanes, respectively. The objective response was 78%, including complete responses in 23%. A further 22% had stable disease. Median duration of B-based therapy was 12.4 mo. PFS events had been recorded in 44% of pts. Median PFS: 19.5 mo. (95%CI: 15.6-23.2). Cox proportional hazard multivariate regression model showed that B-based therapy ≥15 vs <15 mo was associated with improved PFS (26.5 vs 14.0 mo, p= 0.009; HR 0.40 [95%CI: 0.19-0.81]). The most common grade ≥3 B-related AEs were: Hypertension 9.5%, proteinuria 3.5%, bleeding 3.5%, and thromboembolic events 1.1%. No B-related death was reported. Conclusions: Outcomes in routine oncology practice for LORENA patients are consistent with those from prospective trials of 1st-line B-containing therapy and ATHENA study. These results suggest a benefit from a maintained VEGF suppression and that B continuation either as a single agent or combined with CT, until disease progression is recommended. Follow-up is ongoing.