Abstract
Simple SummarySoft tissue sarcomas (STS) are an uncommon and heterogeneous group of tumors, with scarce options for treatment in advanced cases. There is no consensus regarding which is the best treatment sequence for these patients. Although trabectedin is an approved drug for STS treatment, after progression to anthracyclines, the clinical profile of the patients that most benefit from this drug it is not defined. We have retrospectively analyzed a sample of 357 nonselected sarcoma patients from real-world experience, treated homogeneously with trabectedin, confirming and validating results from previous clinical trials and other retrospective studies. After analyzing clinical prognostic factors, we selected those which predicted a better growth modulation index (GMI > 1.33), and we defined the GEISTRA score, an easy to obtain and reproducible clinical tool, that can help us to optimize the use of trabectedin in advanced sarcoma patients.The aim of this study was to identify an easily reliable prognostic score that selects the subset of advanced soft tissue sarcoma (ASTS) patients with a higher benefit with trabectedin in terms of time to progression and overall survival. A retrospective series of 357 patients with ASTS treated with trabectedin as second- or further-line in 19 centers across Spain was analyzed. First, it was confirmed that patients with high growth modulation index (GMI > 1.33) were associated with the better clinical outcome. Univariate and multivariate analyses were performed to identify factors associated with a GMI > 1.33. Thus, GEISTRA score was based on metastasis free-interval (MFI ≤ 9.7 months), Karnofsky < 80%, Non L-sarcomas and better response in the previous systemic line. The median GMI was 0.82 (0–69), with 198 patients (55%) with a GMI < 1, 41 (11.5%) with a GMI 1–1.33 and 118 (33.1%) with a GMI > 1.33. The lowest GEISTRA score showed a median of time-to-progression (TTP) and overall survival (OS) of 5.7 and 19.5 months, respectively, whereas it was 1.8 and 3.1 months for TTP and OS, respectively, for the GEISTRA 4 score. This prognostic tool can contribute to better selecting candidates for trabectedin treatment in ASTS.
Highlights
Soft tissue sarcomas (STS) are an uncommon and heterogeneous group of 64 locally aggressive and/or malignant sarcoma subtypes according to the last WHO classification [1]
The primary objective of the study was to identify which group of patients with advanced soft tissue sarcoma (ASTS) benefits most from trabectedin given as a second- or later-line chemotherapy by evaluating the concordance among the growth modulation index (GMI) > 1.33, response and survival outcomes, and the clinical characteristics of patients
We collected data from 387 patients with ASTS enrolled by 19 GEIS centers across Spain
Summary
Soft tissue sarcomas (STS) are an uncommon and heterogeneous group of 64 locally aggressive and/or malignant sarcoma subtypes according to the last WHO classification [1]. Trabectedin has a pleiotropic mechanism of action affecting key cell biology processes in tumor cells as well as in the tumor microenvironment with selective anti-inflammatory, immunomodulatory and antiangiogenic properties [5,6,7,8]. All these mechanisms contribute to a characteristic late response to trabectedin with a prolonged stabilization of tumor growth and dormancy of metastases. Trabectedin was the first marine-derived antineoplastic drug approved in 2007 in the European Union, and presently in about 80 countries across the world, for the treatment of patients with advanced STS (ASTS) who progressed after failure of anthracyclines and ifosfamide, or for those patients who are unsuitable to receive these agents [9]. In 2015, trabectedin was approved in the U.S for patients with advanced liposarcoma or leiomyosarcoma (commonly referred as L-sarcomas) based on the results of a pivotal, randomized, phase III study that evaluated the efficacy and safety of trabectedin as compared with dacarbazine, an active comparator used in the treatment of patients with ASTS [10]
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