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Eur J Cancer. 2019 Mar;109:51-60. doi: 10.1016/j.ejca.2018.12.009. Epub 2019 Jan 25.

The impact of chemotherapy on survival of patients with extremity and trunk wall soft tissue sarcoma: revisiting the results of the EORTC-STBSG 62931 randomised trial.

Author information

1
Sarcoma Service, Department of Surgery, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. Electronic address: sandro.pasquali@istitutotumori.mi.it.
2
Unit of Bioinformatics and Biostatistics, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
3
European Organisation for Research and Treatment of Cancer (EORTC), Belgium.
4
University of Heidelberg, Mannheim University Medical Center, Interdisciplinary Tumor Center, Sarcoma Unit, Mannheim, Germany.
5
Department of Clinical Oncology, Leiden University Medical Centre, Leiden, the Netherlands.
6
Medical Oncology Unit 2, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
7
The Institute of Cancer Research, Royal Marsden NHS Foundation Trust, London, United Kingdom.
8
Treviso General Hospital, Treviso, Italy; Department of Medicine, University of Padova, Padova, Italy.
9
Medical Oncology Unit 2, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy; The Institute of Cancer Research, Royal Marsden NHS Foundation Trust, London, United Kingdom; Treviso General Hospital, Treviso, Italy; Department of Medicine, University of Padova, Padova, Italy; Oncology and Haemato-Oncology Department, University of Milan, Italy.
10
Academic Unit of Clinical Oncology, University of Sheffield, Sheffield, UK.
11
Sarcoma Service, Department of Surgery, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. Electronic address: alesssandro.gronchi@istitutotumori.mi.it.

Abstract

BACKGROUND:

This study was aimed at determining whether patients with high-risk soft tissue sarcoma (STS), as identified using the nomogram Sarculator, benefitted from adjuvant chemotherapy in the EORTC-STBSG 62931 randomised controlled trial (RCT), which failed to detect an impact for adjuvant doxorubicin plus ifosfamide (Adj) over observation (Obs).

METHODS:

Patients with extremity and trunk wall STS in the EORTC-STBSG 62931 RCT were analysed (N = 290/351). Ten-year predicted probability of overall survival (pr-OS) was calculated using the prognostic nomogram Sarculator. Patients were grouped into three categories of predicted pr-OS: high (pr-OS>66%), intermediate (51<pr-OS≤66) and low (pr-OS≤51%). OS and disease-free survival (DFS) were calculated.

RESULTS:

Nomogram pr-OS was dispersed (median 72%, interquartile range 57-83%) and had prognostic value for OS and DFS (log-rank test: P < 0.001). One hundred seventy, 68 and 52 patients had high (58.6%, 90 Obs/80 Adj), intermediate (23.5%, 34 Obs/34 Adj) and low pr-OS (17.9%, 24 Obs/28 Adj), respectively. Adjuvant chemotherapy halved the risk of recurrence (hazard ratio [HR] = 0.46, 95% confidence interval [CI] 0.24-0.89) and death (HR = 0.46, 95% CI 0.23-0.94) in the low pr-OS category, while no effect was detected in intermediate and high pr-OS categories. To strengthen these findings, study participants with pr-OS<60% were combined (N = 80, 27.6%, 39 Obs/41 Adj), and a significant DFS (HR = 0.49, 95% CI 0.28-0.85) and OS (HR = 0.50, 95% CI 0.30-0.90) benefit was detected.

CONCLUSION:

Patients of the EORTC-STBSG 62931 RCT with extremity and trunk wall STS and a low predicted pr-OS (high-risk patients) had better outcomes when treated with adjuvant chemotherapy. This may help reconcile the disparate results of clinical studies on adjuvant/neoadjuvant chemotherapy in STS.

KEYWORDS:

Adjuvant; Chemotherapy; High risk; Overall survival; Randomised controlled trial; Soft tissue sarcoma

PMID:
30690293
DOI:
10.1016/j.ejca.2018.12.009

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