Keith Holmes1, Ulrike Pötschger2, Andrew D J Pearson3, Sabine Sarnacki4, Giovanni Cecchetto5, Javier Gomez-Chacon6, Roly Squire7, Enrique Freud8,9, Adam Bysiek10, Lucas E Matthyssens11, Martin Metzelder12, Tom Monclair13, Jakob Stenman14, Michal Rygl15, Lars Rasmussen16, Jean-Marc Joseph17, Sabine Irtan18, Stefano Avanzini19, Jan Godzinski20, Kristin Björnland13,21, Martin Elliott7, Roberto Luksch22, Victoria Castel6, Shifra Ash8, Walentyna Balwierz23, Geneviève Laureys24, Ellen Ruud13,21, Vassilios Papadakis25, Josef Malis15, Cormac Owens26, Henrik Schroeder27, Maja Beck-Popovic17, Toby Trahair28, Ana Forjaz de Lacerda29, Peter F Ambros2, Mark N Gaze30, Kieran McHugh31, Dominique Valteau-Couanet32, Ruth Lydia Ladenstein33. 1. Paediatric Surgery, St George's Hospital London and Royal Marsden Hospital, Sutton, United Kingdom. 2. Children's Cancer Research Institute, Department of Paediatrics, Medical University of Vienna, Vienna, Austria. 3. Institute of Cancer Research and Royal Marsden Hospital, Sutton, United Kingdom. 4. Department of Pediatric Surgery, Necker Enfants-Malades Hospital, Assistance Publique Hôpitaux de Paris, University de Paris, Paris, France. 5. Pediatric Surgery, Department of Women's and Children's Health, University of Padua, Padua, Italy. 6. Paediatric Oncology, Paediatric Surgical Oncology Unit, Hospital Universitario La FE, Valencia, Spain. 7. Paediatric Oncology, Leeds Teaching Hospital, Leeds, United Kingdom. 8. Schneider Children's Medical Center of Israel, Petach, Tikvah, Israel. 9. Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. 10. Department of Pediatric Surgery, University Children's Hospital, Kraków, Poland. 11. Department of Gastrointestinal and Paediatric Surgery, Princess Elisabeth Children's Hospital, Ghent University Hospital, Ghent, Belgium. 12. Paediatric Surgery, Medical University of Vienna, Vienna, Austria. 13. Oslo University Hospital Rikshospitalet, Oslo, Norway. 14. Karolinska University Hospital, Stockholm, Sweden. 15. University Hospital Motol, Prague, Czech Republic. 16. Department of Surgical Gastroenterology A, Odense University Hospital, Odense, Denmark. 17. University Hospital Lausanne, Lausanne, Switzerland. 18. Sorbonne University, Department of Visceral and Neonatal Pediatric Surgery, Armand Trousseau Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France. 19. Pediatric Surgery Unit, IRCCS Istituto Giannina Gaslini, Genoa, Italy. 20. Department of Paediatric Surgery, Marciniak Hospital, and Department of Paediatric Traumatology and Emergency Medicine, Wroclaw Medical University, Wroclaw, Poland. 21. University of Oslo, Oslo, Norway. 22. Paediatric Oncology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy. 23. Jagiellonian University Medical College, Kraków, Poland. 24. Department of Paediatric Haematology and Oncology, Princess Elisabeth Children's Hospital, Ghent University Hospital, Ghent, Belgium. 25. Agia Sofia Children's Hospital, Athens, Greece. 26. Paediatric Haematology/Oncology, Our Lady's Children's Hospital, Crumlin, Dublin, Republic of Ireland. 27. University Hospital of Aarhus, Aarhus, Denmark. 28. Sydney Children's Hospital, Randwick, New South Wales, Australia. 29. Portuguese Institute of Oncology, Lisbon, Portugal. 30. University College Hospital, London, United Kingdom. 31. Paediatric Oncology, Great Ormond Street Hospital, London, United Kingdom. 32. Institut Gustave Roussy, Villejuif, Paris, France. 33. St Anna Children's Hospital and Children's Cancer Research Institute, Department of Paediatrics, Medical University of Vienna, Vienna, Austria.
Abstract
PURPOSE: To evaluate the impact of surgeon-assessed extent of primary tumor resection on local progression and survival in patients in the International Society of Pediatric Oncology Europe Neuroblastoma Group High-Risk Neuroblastoma 1 trial. PATIENTS AND METHODS: Patients recruited between 2002 and 2015 with stage 4 disease > 1 year or stage 4/4S with MYCN amplification < 1 year who had completed induction without progression, achieved response criteria for high-dose therapy (HDT), and had no resection before induction were included. Data were collected on the extent of primary tumor excision, severe operative complications, and outcome. RESULTS: A total of 1,531 patients were included (median observation time, 6.1 years). Surgeon-assessed extent of resection included complete macroscopic excision (CME) in 1,172 patients (77%) and incomplete macroscopic resection (IME) in 359 (23%). Surgical mortality was 7 (0.46%) of 1,531. Severe operative complications occurred in 142 patients (9.7%), and nephrectomy was performed in 124 (8.8%). Five-year event-free survival (EFS) ± SE (0.40 ± 0.01) and overall survival (OS; 0.45 ± 0.02) were significantly higher with CME compared with IME (5-year EFS, 0.33 ± 0.03; 5-year OS, 0.37 ± 0.03; P < .001 and P = .004). The cumulative incidence of local progression (CILP) was significantly lower after CME (0.17 ± 0.01) compared with IME (0.30 ± 0.02; P < .001). With immunotherapy, outcomes were still superior with CME versus IME (5-year EFS, 0.47 ± 0.02 v 0.39 ± 0.04; P = .038); CILP was 0.14 ± 0.01 after CME and 0.27 ± 0.03 after IME (P < .002). A hazard ratio of 1.3 for EFS associated with IME compared with CME was observed before and after the introduction of immunotherapy (P = .030 and P = .038). CONCLUSION: In patients with stage 4 high-risk neuroblastoma who have responded to induction therapy, CME of the primary tumor is associated with improved survival and local control after HDT, local radiotherapy (21 Gy), and immunotherapy.
PURPOSE: To evaluate the impact of surgeon-assessed extent of primary tumor resection on local progression and survival in patients in the International Society of Pediatric Oncology Europe Neuroblastoma Group High-Risk Neuroblastoma 1 trial. PATIENTS AND METHODS: Patients recruited between 2002 and 2015 with stage 4 disease > 1 year or stage 4/4S with MYCN amplification < 1 year who had completed induction without progression, achieved response criteria for high-dose therapy (HDT), and had no resection before induction were included. Data were collected on the extent of primary tumor excision, severe operative complications, and outcome. RESULTS: A total of 1,531 patients were included (median observation time, 6.1 years). Surgeon-assessed extent of resection included complete macroscopic excision (CME) in 1,172 patients (77%) and incomplete macroscopic resection (IME) in 359 (23%). Surgical mortality was 7 (0.46%) of 1,531. Severe operative complications occurred in 142 patients (9.7%), and nephrectomy was performed in 124 (8.8%). Five-year event-free survival (EFS) ± SE (0.40 ± 0.01) and overall survival (OS; 0.45 ± 0.02) were significantly higher with CME compared with IME (5-year EFS, 0.33 ± 0.03; 5-year OS, 0.37 ± 0.03; P < .001 and P = .004). The cumulative incidence of local progression (CILP) was significantly lower after CME (0.17 ± 0.01) compared with IME (0.30 ± 0.02; P < .001). With immunotherapy, outcomes were still superior with CME versus IME (5-year EFS, 0.47 ± 0.02 v 0.39 ± 0.04; P = .038); CILP was 0.14 ± 0.01 after CME and 0.27 ± 0.03 after IME (P < .002). A hazard ratio of 1.3 for EFS associated with IME compared with CME was observed before and after the introduction of immunotherapy (P = .030 and P = .038). CONCLUSION: In patients with stage 4 high-risk neuroblastoma who have responded to induction therapy, CME of the primary tumor is associated with improved survival and local control after HDT, local radiotherapy (21 Gy), and immunotherapy.
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