1. Neoadjuvant chemotherapy in high-risk soft tissue sarcomas: A Sarculator-based risk stratification analysis of the ISG-STS 1001 randomized trial
- Author
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Sandro Pasquali, Emanuela Palmerini, Vittorio Quagliuolo, Javier Martin‐Broto, Antonio Lopez‐Pousa, Giovanni Grignani, Antonella Brunello, Jean‐Yves Blay, Oscar Tendero, Robert Diaz‐Beveridge, Virginia Ferraresi, Iwona Lugowska, Gabriele Infante, Luca Braglia, Domenico Franco Merlo, Valeria Fontana, Emanuela Marchesi, Davide Maria Donati, Elena Palassini, Giuseppe Bianchi, Andrea Marrari, Carlo Morosi, Silvia Stacchiotti, Silvia Bagué, Jean Michel Coindre, Angelo Paolo Dei Tos, Piero Picci, Paolo Bruzzi, Rosalba Miceli, Paolo Giovanni Casali, Alessandro Gronchi, Carla Dani, Chiara Villa, Antonella Messina, Lorella Rusi, Anna Maria Nuzzo, Carmen Nuzzo, Antonino De Paoli, Angela Buonadonna, Alessandro Comandone, Antonella Boglione, Lorenzo Livi, Daniela Greto, Nada Riva, Manuela Monti, Elisabetta Pennacchioli, Tommaso De Pas, Vincenzo Ippolito, Patrico Ledesma, Andres Redondo, Claudia Valverde, Raquel Bratos, Josefina Cruz, Javier Martinez Trufero, Ricardo Cubedo, Isabel Sevilla, Pablo Luna, Rafael Lopez, Pilar Sancho, Olivia Bally, Mehdi Brahmi, Isabelle Ray‐Coquard, Philippe Cassier, Nathalie Marques, Luis Tassy, Pascaline Boudou‐Rouquette, Camille Tlemsani, Jerome Alexandre, Francois Goldwasser, Emmanuelle Bompas, Frederic Rolland, Christophe Perrin, Marie Talarmin, Antoine Italiano, Maud Toulmonde, Mathieu Laramas, Jacques‐Olivier Bay, Pascale Dubray‐Longeras, Piotr Rutkowski, PharmaMar, European Commission, Pasquali, Sandro, Palmerini, Emanuela, Grignani, Giovanni, Brunello, Antonella, Blay, Jean-Yves, Stacchiotti, Silvia, Pasquali S., Palmerini E., Quagliuolo V., Martin-Broto J., Lopez-Pousa A., Grignani G., Brunello A., Blay J.-Y., Tendero O., Diaz-Beveridge R., Ferraresi V., Lugowska I., Infante G., Braglia L., Merlo D.F., Fontana V., Marchesi E., Donati D.M., Palassini E., Bianchi G., Marrari A., Morosi C., Stacchiotti S., Bague S., Coindre J.M., Dei Tos A.P., Picci P., Bruzzi P., Miceli R., Casali P.G., Gronchi A., Dani C., Villa C., Messina A., Rusi L., Nuzzo A.M., Nuzzo C., De Paoli A., Buonadonna A., Comandone A., Boglione A., Livi L., Greto D., Riva N., Monti M., Pennacchioli E., De Pas T., Ippolito V., Ledesma P., Redondo A., Valverde C., Bratos R., Cruz J., Martinez Trufero J., Cubedo R., Sevilla I., Luna P., Lopez R., Sancho P., Bally O., Brahmi M., Ray-Coquard I., Cassier P., Marques N., Tassy L., Boudou-Rouquette P., Tlemsani C., Alexandre J., Goldwasser F., Bompas E., Rolland F., Perrin C., Talarmin M., Italiano A., Toulmonde M., Laramas M., Bay J.-O., Dubray-Longeras P., and Rutkowski P.
- Subjects
Oncology ,Adult ,Cancer Research ,medicine.medical_specialty ,sarcoma ,Anthracycline ,medicine.medical_treatment ,Soft Tissue Neoplasms ,Lower risk ,chemotherapy ,Risk Assessment ,nomogram ,Interquartile range ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Ifosfamide ,Chemotherapy ,business.industry ,Soft tissue sarcoma ,neoadjuvant ,clinical trial ,Nomogram ,medicine.disease ,Neoadjuvant Therapy ,Chemotherapy, Adjuvant ,chemotherapy, clinical trial, neoadjuvant, nomogram, sarcoma ,Sarcoma ,business ,medicine.drug - 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., This was a nonfunded analysis. In the ISG-STS 1001 trial, PharmaMar provided trabectedin for the HG-MRLPS cohort. That trial was partially funded through a European Union grant (EUROSARC FP7 278472).
- Published
- 2022