Sandro Pasquali1, Chiara Colombo1, Sara Pizzamiglio2, Paolo Verderio2, Dario Callegaro1, Silvia Stacchiotti3, Javier Martin Broto4, Antonio Lopez-Pousa5, Stefano Ferrari6, Andres Poveda7, Antonino De Paoli8, Vittorio Quagliuolo9, Josefina Cruz Jurado10, Alessandro Comandone11, Giovanni Grignani12, Rita De Sanctis13, Elena Palassini3, Antonio Llomboart-Bosch14, Angelo Paolo Dei Tos15, Paolo G Casali3, Piero Picci16, Alessandro Gronchi17. 1. Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 2. Unit of Medical Statistics, Biometry and Bioinformatics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 3. Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 4. Department of Cancer Medicine, Hospital Universitario Virgen del Rocio, Sevilla, Spain. 5. Department of Cancer Medicine, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 6. Department of Cancer Medicine, Istituto Ortopedico Rizzoli, Bologna, Italy. 7. Department of Cancer Medicine, Valencian Oncologic Institute, Valencia, Spain. 8. Department of Radiation Oncology, Centro di Riferimento Oncologico, Aviano, Italy. 9. Department of Surgery, Humanitas Cancer Center, Rozzano, Italy. 10. Department of Cancer Medicine, University of Canarias Hospital, La Laguna, Spain. 11. Department of Cancer Medicine, Presidio Sanitario Gradenigo, Torino, Italy. 12. Department of Cancer Medicine, IRCCS Fondazione Piemontese per la Ricerca sul Cancro, Candiolo, Italy. 13. Department of Cancer Medicine, Humanitas Cancer Center, Rozzano, Italy. 14. Department of Pathology, Medical School University of Valencia, Valencia, Spain. 15. Department of Medicine, University of Padula School of Medicine, Padua, Italy. 16. Laboratory of Oncologic Research, Istituto Ortopedico Rizzoli, Bologna, Italy. 17. Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: alessandro.gronchi@istitutotumori.mi.it.
Abstract
BACKGROUND:Patients with extremity and trunk wall soft tissue sarcoma (STS) with high malignancy grade and size >5 cm are at high-risk of death. This risk varies depending also on other patient and tumour features, including histologic subtype. This study investigated whether a prognostic nomogram can improve risk assessment of these patients. METHODS: Data from high-risk STS patients enrolled in a randomised controlled trial investigating different perioperative chemotherapy regimens were analysed. Ten-year probability of overall survival (OS) and incidence of distant metastasis (DM) were computed using the prognostic nomogram Sarculator (pr-OS and inc-DM, respectively). Tumour response according to RECIST and Choi criteria was also investigated. FINDINGS: Variation in pr-OS and inc-DM were observed and patients stratified in three prognostic groups. The 10-year OS in the low, intermediate, and high pr-OS categories were 0·42 (95%CI 0·32-0·52), 0·63 (95%CI 0·53-0·72), and 0·78 (95%CI 0·68-0·85), respectively. Patients in the intermediate (HR 0·51, P = 0·002) and high (HR 0·28, P < 0·001) pr-OS categories were at statistically significant lower risk of death compared with those in the low pr-OS category. Higher rate of Choi partial tumour responses were detected in intermediate pr-OS category. Tumour response according to Choi but not to RECIST criteria stratified patient survival of pr-OS categories, particularly for patients with intermediate to low pr-OS. Analyses conducted for 10-year inc-DM were consistent with results for pr-OS for prognostic value of Sarculator predictions and Choi tumour response. INTERPRETATION: Sarculator identifies variations in outcomes of high-risk STS treated with perioperative chemotherapy and improve prognostic classification, which is also associated with different patterns of tumour response, an outcome that further stratifies survival particularly for patients predicted at higher risk. Future trials investigating neoadjuvant chemotherapy should consider prognostic tool for selecting patients to be enrolled. TRIAL REGISTRATION NUMBER: European Union Drug Regulating Authorities Clinical Trials No. 2004-003979-36.
RCT Entities:
BACKGROUND:Patients with extremity and trunk wall soft tissue sarcoma (STS) with high malignancy grade and size >5 cm are at high-risk of death. This risk varies depending also on other patient and tumour features, including histologic subtype. This study investigated whether a prognostic nomogram can improve risk assessment of these patients. METHODS: Data from high-risk STS patients enrolled in a randomised controlled trial investigating different perioperative chemotherapy regimens were analysed. Ten-year probability of overall survival (OS) and incidence of distant metastasis (DM) were computed using the prognostic nomogram Sarculator (pr-OS and inc-DM, respectively). Tumour response according to RECIST and Choi criteria was also investigated. FINDINGS: Variation in pr-OS and inc-DM were observed and patients stratified in three prognostic groups. The 10-year OS in the low, intermediate, and high pr-OS categories were 0·42 (95%CI 0·32-0·52), 0·63 (95%CI 0·53-0·72), and 0·78 (95%CI 0·68-0·85), respectively. Patients in the intermediate (HR 0·51, P = 0·002) and high (HR 0·28, P < 0·001) pr-OS categories were at statistically significant lower risk of death compared with those in the low pr-OS category. Higher rate of Choi partial tumour responses were detected in intermediate pr-OS category. Tumour response according to Choi but not to RECIST criteria stratified patient survival of pr-OS categories, particularly for patients with intermediate to low pr-OS. Analyses conducted for 10-year inc-DM were consistent with results for pr-OS for prognostic value of Sarculator predictions and Choi tumour response. INTERPRETATION: Sarculator identifies variations in outcomes of high-risk STS treated with perioperative chemotherapy and improve prognostic classification, which is also associated with different patterns of tumour response, an outcome that further stratifies survival particularly for patients predicted at higher risk. Future trials investigating neoadjuvant chemotherapy should consider prognostic tool for selecting patients to be enrolled. TRIAL REGISTRATION NUMBER: European Union Drug Regulating Authorities Clinical Trials No. 2004-003979-36.
Authors: Suzanne Bock; Douglas G Hoffmann; Yi Jiang; Hao Chen; Dora Il'yasova Journal: Int J Environ Res Public Health Date: 2020-04-15 Impact factor: 3.390
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Authors: Dario Callegaro; Rosalba Miceli; Sylvie Bonvalot; Peter C Ferguson; Dirk C Strauss; Veroniek V M van Praag; Antonin Levy; Anthony M Griffin; Andrew J Hayes; Silvia Stacchiotti; Cecile Le Pèchoux; Myles J Smith; Marco Fiore; Angelo Paolo Dei Tos; Henry G Smith; Charles Catton; Joanna Szkandera; Andreas Leithner; Michiel A J van de Sande; Paolo G Casali; Jay S Wunder; Alessandro Gronchi Journal: EClinicalMedicine Date: 2019-11-22