Absence of progression, not extent of tumour shrinkage, defines prognosis in soft-tissue sarcoma - An analysis of the EORTC 62012 study of the EORTC STBSG.
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Authors
Grünwald, V
Litière, S
Young, R
Messiou, C
Lia, M
Wardelmann, E
van der Graaf, W
Gronchi, A
Judson, I
EORTC STBSG,
Litière, S
Young, R
Messiou, C
Lia, M
Wardelmann, E
van der Graaf, W
Gronchi, A
Judson, I
EORTC STBSG,
Document Type
Journal Article
Date
2016-09-01
Date Accepted
2016-05-17
Abstract
BACKGROUND: Anthracycline-based chemotherapy remains the mainstay of first-line treatment in metastatic or advanced soft-tissue sarcoma (STS). Age, performance status, tumour histology and tumour grade are recognised prognostic factors; however, the prognostic value of tumour response and tumour shrinkage is ill-defined. METHODS: Patients recruited to the European Organisation for Research and Treatment of Cancer 62012 trial with advanced intermediate or high-grade STS, who received at least one cycle of chemotherapy and one tumour assessment of response, were eligible for this study. Kaplan-Meier estimates of overall survival (OS) by tumour response were computed using a landmark approach after two, four, and six cycles of chemotherapy. The prognostic role of the kinetics of tumour response was analysed by Cox proportional hazards. RESULTS: Three hundred eighty-nine patients were included in this study. Compared to stable or responding patients, patients with progressive disease (PD) after two, four and six cycles of chemotherapy achieved a worse OS: hazard ratio [HR] 2.62 (95% confidence interval [CI] 1.72-4.00), p < 0.001; HR 2.23 (95% CI 1.4-3.56), p = 0.0001; and HR 3.16 (95% CI 1.96-5.08), p = 0.0001, respectively. However, patients with stable or responding disease achieved similar OS outcomes. Correspondingly, patients with an increase in tumour size by 10% or more correlated with a worse OS in Cox proportional hazard analysis. CONCLUSIONS: No association between prognosis and amount of tumour shrinkage was detected. Interestingly, an increase in tumour size by at least 10% correlated with a worse OS, but re-defining PD as a ≥10% increase in tumour size did not translate into a better discrimination of survival outcomes for responders versus stable disease. Disease control rather than tumour response is a valuable end-point in advanced or metastatic STS receiving palliative anthracycline-based chemotherapy, supporting the use of time-to-event end-points in future STS trials.
Citation
European journal of cancer (Oxford, England : 1990), 2016, 64 pp. 44 - 51
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ELSEVIER SCI LTD
ISSN
0959-8049
eISSN
1879-0852
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Research Team
Clinical and Translational Sarcoma
Sarcoma Clinical Trials
Sarcoma Clinical Trials