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Randomized Controlled Trial
. 2022 Jan 1;128(1):85-93.
doi: 10.1002/cncr.33895. Epub 2021 Oct 13.

Neoadjuvant chemotherapy in high-risk soft tissue sarcomas: A Sarculator-based risk stratification analysis of the ISG-STS 1001 randomized trial

Sandro Pasquali  1 , Emanuela Palmerini  2 , Vittorio Quagliuolo  3 , Javier Martin-Broto  4   5 , Antonio Lopez-Pousa  6 , Giovanni Grignani  7 , Antonella Brunello  8 , Jean-Yves Blay  9   10 , Oscar Tendero  11 , Robert Diaz-Beveridge  12 , Virginia Ferraresi  13 , Iwona Lugowska  14 , Gabriele Infante  15 , Luca Braglia  16 , Domenico Franco Merlo  16 , Valeria Fontana  17 , Emanuela Marchesi  18 , Davide Maria Donati  19 , Elena Palassini  20 , Giuseppe Bianchi  19 , Andrea Marrari  21 , Carlo Morosi  22 , Silvia Stacchiotti  20 , Silvia Bagué  23 , Jean Michel Coindre  24 , Angelo Paolo Dei Tos  25   26 , Piero Picci  27 , Paolo Bruzzi  17 , Rosalba Miceli  15 , Paolo Giovanni Casali  19   28 , Alessandro Gronchi  1
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Free article
Randomized Controlled Trial

Neoadjuvant chemotherapy in high-risk soft tissue sarcomas: A Sarculator-based risk stratification analysis of the ISG-STS 1001 randomized trial

Sandro Pasquali et al. Cancer. .
Free article

Erratum in

Abstract

Background: The value of neoadjuvant chemotherapy in soft tissue sarcoma (STS) is not completely understood. This study investigated the benefit of neoadjuvant chemotherapy according to prognostic stratification based on the Sarculator nomogram for STS.

Methods: This study analyzed data from ISG-STS 1001, a randomized study that tested 3 cycles of neoadjuvant anthracycline plus ifosfamide (AI) or histology-tailored (HT) chemotherapy in adult patients with STS. The 10-year predicted overall survival (pr-OS) was estimated with the Sarculator and was stratified into higher (10-year pr-OS < 60%) and lower risk subgroups (10-year pr-OS ≥ 60%).

Results: The median pr-OS was 0.63 (interquartile range [IQR], 0.51-0.72) for the entire study population, 0.62 (IQR, 0.51-0.70) for the AI arm, and 0.64 (IQR, 0.51-0.73) for the HT arm. Three- and 5-year overall survival (OS) were 0.86 (95% confidence interval [CI], 0.82-0.93) and 0.81 (95% CI, 0.71-0.86) in lower risk patients and 0.69 (95% CI, 0.70-0.85) and 0.59 (95% CI, 0.51-0.72) in the higher risk patients (log-rank test, P = .004). In higher risk patients, the 3- and 5-year Sarculator-predicted and study-observed OS rates were 0.68 and 0.58, respectively, and 0.85 and 0.66, respectively, in the AI arm (P = .04); the corresponding figures in the HT arm were 0.69 and 0.60, respectively, and 0.69 and 0.55, respectively (P > .99). In lower risk patients, the 3- and 5-year Sarculator-predicted and study-observed OS rates were 0.85 and 0.80, respectively, and 0.89 and 0.82, respectively, in the AI arm (P = .507); the corresponding figures in the HT arm were 0.87 and 0.81, respectively, and 0.86 and 0.74, respectively (P = .105).

Conclusions: High-risk patients treated with AI performed better than predicted, and this adds to the evidence for the efficacy of neoadjuvant AI in STS.

Lay summary: People affected by soft tissue sarcomas of the extremities and trunk wall are at some risk of developing metastasis after surgery. Preoperative or postoperative chemotherapy has been tested in clinical trials to reduce the chances of distant metastasis. However, study findings have not been conclusive. This study stratified the risk of metastasis for people affected by sarcomas who were included in a clinical trial testing neoadjuvant chemotherapy. Exploiting the prognostic nomogram Sarculator, it found a benefit for chemotherapy when the predicted risk, based on patient and tumor characteristics, was high.

Keywords: chemotherapy; clinical trial; neoadjuvant; nomogram; sarcoma.

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References

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