Abstract
Introduction: Based on a mathematical model of trabectedin-induced neutropenia, we assessed the predictive value of absolute neutrophil count (ANC) on progression-free survival (PFS) in an independent validation cohort of patients treated with trabectedin. Methods: We collected data from 87 patients in two expert centers who received at least two cycles of trabectedin for soft tissue sarcomas (STS) treatment. Correlations between ANC, patients’ characteristics, and survival were assessed, and a multivariate model including tumor grade, performance status, ANC, and hemoglobin level was developed. Results: Therapeutic ANC ≥ 7.5 G/L level was associated with shorter PFS: 3.22 months (95% confidence interval (CI), 1.57–4.87) in patients with ANC ≥ 7.5 G/L vs. 5.78 months (95% CI, 3.95–7.61) in patients with ANC < 7.5 G/L (p = 0.009). Age, primary localization, lung metastases, dose reduction, hemoglobin, and albumin rates were also associated with PFS. In multivariate analysis, ANC ≥ 7.5 G/L was independently associated with poor PFS and overall survival. Conclusion: We validated increased pre-therapeutic ANC as a predictive factor of short PFS in patients starting trabectedin for STS. ANC appears to have an impact on survival rates and may be used as a decision-making tool for personalizing second-line strategies in patients with metastatic STS.
Highlights
Based on a mathematical model of trabectedin-induced neutropenia, we assessed the predictive value of absolute neutrophil count (ANC) on progression-free survival (PFS) in an independent validation cohort of patients treated with trabectedin
A total of 87 patients who received trabectedin for metastatic soft tissue sarcomas (STS) were considered eligible for analysis
The most prevalent histologic type was leiomyosarcomas, followed by liposarcomas, and undifferentiated sarcomas, with 17% of total cases corresponding to translocation-related sarcomas
Summary
Based on a mathematical model of trabectedin-induced neutropenia, we assessed the predictive value of absolute neutrophil count (ANC) on progression-free survival (PFS) in an independent validation cohort of patients treated with trabectedin. Trabectedin is a synthetic antineoplastic agent, derived from a sea squirt It has demonstrated efficacy in several randomized phase II studies [2,3,4] in non-selected patients with advanced, unresectable disease and no previous exposure to chemotherapy [5], who are in compassionate programs [6,7,8]. A very recent, randomized phase III study showed a significant improvement in median progression-free survival (PFS) with trabectedin vs Best Supportive Care, in patients with pre-treated, advanced STS of multiple histological types [9]. Identification of the predictors of response to trabectedin is warranted, as well, because of its morbid and financial toxicity
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