A Di Cataldo1, A Agodi2, J Balaguer3, A Garaventa4, M Barchitta2, V Segura5, M Bianchi6, V Castel5, A Castellano7, S Cesaro8, J M Couselo9, O Cruz10, P D'Angelo11, B De Bernardi4, J Donat12, N G de Andoin13, M I Hernandez14, M La Spina1, M Lillo15, R Lopez-Almaraz16, R Luksch17, S Mastrangelo18, E Mateos19, J Molina20, C Moscheo17, R Mura21, F Porta22, G Russo1, A Tondo23, M Torrent24, S Vetrella25, J A Villegas26, E Viscardi27, G A Zanazzo28, A Cañete5. 1. Unit of Paediatric Haematology and Oncology, Department of Clinical and Experimental Medicine, Hospital Policlinico, University of Catania, Via Santa Sofia 78, 95123, Catania, Italy. 2. Department "GF Ingrassia", University of Catania, Via Santa Sofia 87, 95123, Catania, Italy. 3. Unidad de Oncologia Pediatrica, Hospital Universitari i Politecnic La Fe, Avenida Fernando Abril Martorell, 106, 46026, Valencia, Spain. julbagui@yahoo.es. 4. Paediatric Haematology/Oncology Department, Giannina Gaslini Children's Hospital, 16148, Genoa, Italy. 5. Unidad de Oncologia Pediatrica, Hospital Universitari i Politecnic La Fe, Avenida Fernando Abril Martorell, 106, 46026, Valencia, Spain. 6. Regina Margherita Hospital, Piazza Polonia 94, 10126, Turin, Italy. 7. Department of Paediatric Haematology-Oncology, IRCCS, Ospedale Bambino Gesù, Rome, Italy. 8. Paediatric Haematology-Oncology, Ospedale Borgo Roma, Piazzale LA. Scuro 10, 37134, Verona, Italy. 9. Pediatric Oncology, Hospital Clínico Universitario de Santiago, Travesía de Choupana, s/n, 15706, Santiago de Compostela, Spain. 10. Pediatric Oncology, Hospital San Joande Deu, Passeig de Sant Joan de Déu, 2, Esplugues de Llobregat, 08950, Barcelona, Spain. 11. Paediatric Haematology/Oncology, Civico e Benfratelli Hospital, Piazza Nicola Leotta, 4, Palermo, Italy. 12. Pediatric Oncology, Hospital Clínico de Valencia, Av. de Blasco Ibáñez, 17, 46010, Valencia, Spain. 13. Pediatric Oncology, Hospital Universitario Donostia, Doctor Begiristain Kalea, 117, 20080, Donostia, Spain. 14. Pediatric Oncology, Hospital Universitari Son Espases, Ctra. de Valldemossa, 79, 07010, Palma Mallorca, Spain. 15. Pediatric Oncology, Hospital General Universitario de Albacete, Calle Hermanos Falco, 37, 02006, Albacete, Spain. 16. Pediatric Oncology, Hospital Universitariode Canarias, Carretera de Ofra, s/n, 38320, San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain. 17. Paediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, Milan, Italy. 18. Paediatric Haematology-Oncology, Policlinico Gemelli, Via Pineta Sacchetti, Rome, Italy. 19. Pediatric Oncology, Hospital Univeristario Reina Sofia, Av. Menéndez Pidal s/n, 14004, Córdoba, Spain. 20. Pediatric Oncology, Hospital Virgen Del Camino, C/De Irunlarrea 4, Planta Baja, 31008, Pamplona, Spain. 21. Paediatric Haematology-Oncology, Ospedale Microcitemico, Cagliari, Italy. 22. Paediatric Haematology-Oncology, Spedali Civili, Piazzale Spedali Civili 1, 25123, Brescia, Italy. 23. Paediatric Haematology-Oncology, Meyer Hospital, Via Luca Giordano 13, 50132, Florence, Italy. 24. Paediatric Oncology, Hospital Santa Creui Sant Pau, Carrer de Sant Quintí, 89, 08026, Barcelona, Spain. 25. Paediatric Haematology-Oncology, Santobono Pausilipon Hospital, Via Posillipo 226, 80123, Naples, Italy. 26. Pediatric Oncology, Hospital Universitario Central de Asturias, Avenida de Roma, s/n, 33011, Oviedo, Asturias, Spain. 27. Paediatric Haematology-Oncology, Padova Hospital, Via Giustiniani, 3, 35128, Padua, Italy. 28. Paediatric Haematology-Oncology, Burlo Garofolo Hospital, Via dell'Istria, 65, 34137, Trieste, Italy.
Abstract
INTRODUCTION: SIOPEN INES protocol yielded excellent 5-year survival rates for MYCN-non-amplified metastatic neuroblastoma. Patients deemed ineligible due to lack or delay of MYCN status or late registration were treated, but not included in the study. Our goal was to analyse survival at 10 years among the whole population. MATERIALS AND METHODS: Italian and Spanish metastatic INES patients' data are reported. SPSS 20.0 was used for statistical analysis. RESULTS: Among 98 infants, 27 had events and 19 died, while 79 were disease free. Five- and 10-year event-free survival (EFS) were 73 and 70 %, and overall survival (OS) was 81 and 74 %, respectively. MYCN status was significant for EFS, but not for OS in multivariate analysis. CONCLUSIONS: The survival rates of patients who complied with all the inclusion criteria for INES trials are higher compared to those that included also not registered patients. Five-year EFS and OS for INES 99.2 were 87.8 and 95.7 %, while our stage 4s population obtained 78 and 87 %. Concerning 99.3, 5-year EFS and OS were 86.7 and 95.6 %, while for stage 4 we registered 61 and 68 %. MYCN amplification had a strong impact on prognosis and therefore we consider it unacceptable that many patients were not studied for MYCN and probably inadequately treated. Ten-year survival rates were shown to decrease: EFS from 73 to 70 % and OS from 81 to 74 %, indicating a risk of late events, particularly in stage 4s. Population-based registries like European ENCCA WP 11-task 11 will possibly clarify these data.
INTRODUCTION:SIOPEN INES protocol yielded excellent 5-year survival rates for MYCN-non-amplified metastatic neuroblastoma. Patients deemed ineligible due to lack or delay of MYCN status or late registration were treated, but not included in the study. Our goal was to analyse survival at 10 years among the whole population. MATERIALS AND METHODS: Italian and Spanish metastatic INES patients' data are reported. SPSS 20.0 was used for statistical analysis. RESULTS: Among 98 infants, 27 had events and 19 died, while 79 were disease free. Five- and 10-year event-free survival (EFS) were 73 and 70 %, and overall survival (OS) was 81 and 74 %, respectively. MYCN status was significant for EFS, but not for OS in multivariate analysis. CONCLUSIONS: The survival rates of patients who complied with all the inclusion criteria for INES trials are higher compared to those that included also not registered patients. Five-year EFS and OS for INES 99.2 were 87.8 and 95.7 %, while our stage 4s population obtained 78 and 87 %. Concerning 99.3, 5-year EFS and OS were 86.7 and 95.6 %, while for stage 4 we registered 61 and 68 %. MYCN amplification had a strong impact on prognosis and therefore we consider it unacceptable that many patients were not studied for MYCN and probably inadequately treated. Ten-year survival rates were shown to decrease: EFS from 73 to 70 % and OS from 81 to 74 %, indicating a risk of late events, particularly in stage 4s. Population-based registries like European ENCCA WP 11-task 11 will possibly clarify these data.
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