Abstract
BackgroundWe report here a correlation analysis conducted along with a phase II trial assessing bevacizumab in combination with weekly paclitaxel.MethodsCirculating pro/anti-angiogenic factors were assessed on day 1 (D1) and day 8 (D8). The prognostic value for progression-free survival (PFS) was evaluated using a Cox model with biomarkers as continuous variables.ResultsAmong the 51 patients enrolled and treated in this trial, biomarker analysis was performed for 42: 18 in Arm A (single-agent) and 24 in Arm B (combination). With a median follow-up of 46 months, PFS was 5.5 versus 5.7 months, respectively (p = 0.75). According to univariate analysis, factors associated with a poor PFS were as follows: visceral angiosarcoma, de novo angiosarcoma, and high PlGF and low VEGF-C baseline values. In multivariate analysis, de novo angiosarcoma (HR = 2.5; p = 0.024) and baseline VEGF-C value (HR = 0.7; p = 0.003) were significant prognostic factors. We observed a significant increase in circulating PlGF (< 0.001) and a decrease in VEGF (< 0.001) during bevacizumab treatment. An increase in FGF was associated with a poor outcome.ConclusionsDe novo angiosarcoma and a low baseline level of VEGF-C were found to be associated with a poor prognosis. Addition of bevacizumab induces major changes in circulating biomarkers (VEGF and PlGF) in a short timeframe without impacting PFS.Trial registrationRetrospectively registered on EudraCT N° 2009–017020-59 and NCT01303497 (February 24, 2011).
Highlights
We report here a correlation analysis conducted along with a phase II trial assessing bevacizumab in combination with weekly paclitaxel
Angiosarcomas account for approximately 1% of adult soft-tissue sarcomas, the latter of which account for 1–2% of adult malignancies
Overall description of the study population and progression-free survival (PFS) Among the 51 patients enrolled and treated in the clinical trial, samples were collected on day 1 (D1) for 45, and on day 8 (D8) for 42
Summary
We report here a correlation analysis conducted along with a phase II trial assessing bevacizumab in combination with weekly paclitaxel. Angiosarcomas are heterogeneous and involve at least, on the one hand, de novo versus radio-induced sarcoma and, on the other hand, skin or scalp locations versus visceral locations [1]. Regardless, these entities exhibit aggressive behavior, leading to a poor outcome. Localized angiosarcomas are best treated by large en-bloc surgery followed by adjuvant radiotherapy. Advanced (not amenable to curative-intent surgery) or metastatic angiosarcomas are treated with palliative chemotherapy aiming to alleviate symptoms and maintain quality of life [1].
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