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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Date
2016-09Author
Grünwald, V
Litière, S
Young, R
Messiou, C
Lia, M
Wardelmann, E
van der Graaf, W
Gronchi, A
Judson, I
EORTC STBSG
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
EORTC STBSG
Humans
Sarcoma
Soft Tissue Neoplasms
Disease Progression
Anthracyclines
Antineoplastic Combined Chemotherapy Protocols
Prognosis
Tumor Burden
Proportional Hazards Models
Predictive Value of Tests
Adult
Middle Aged
Female
Male
Young Adult
Kaplan-Meier Estimate
Research team
Clinical and Translational Sarcoma
Sarcoma Clinical Trials
Language
eng
Date accepted
2016-05-17
License start date
2016-09
Citation
European journal of cancer (Oxford, England : 1990), 2016, 64 pp. 44 - 51