High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008
| Autor: | Bénédicte Brichard, Ian Judson, Heribert Juergens, Richard B. Womer, Uta Dirksen, Ian Lewis, Line Claude, Cyril Lervat, Ruth Ladenstein, Michael Paulussen, Peter Hauser, Jean Marc Guinbretiere, Perrine Marec-Berard, Neyssa Marina, Natalie Gaspar, Odile Oberlin, Hans Gelderblom, Keith Wheatley, R. Lor Randall, Bernadette Brennan, Robert E. Goldsby, Lars Hjorth, Douglas S. Hawkins, Katherine A. Janeway, Thomas Kuehne, Alan W. Craft, Claude Linassier, Holcombe E. Grier, Richard Gorlick, Jarmila Kruseova, Gwénaël Le Teuff, Nathalie Cozic, Susanne Amler, Bruce Morland, Marie-Cécile Le Deley, Henk van den Berg, Jeremy Whelan, H. Pacquement, Andreas Ranft, Mark Krailo, Vivek A Bhadri, Stephen L. Lessnick |
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| Přispěvatelé: | UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service d'hématologie et d'oncologie pédiatrique, Paediatric Oncology, CCA - Cancer Treatment and Quality of Life |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Male Cancer Research Lung Neoplasms Time Factors medicine.medical_treatment Medizin Gastroenterology Euro-E.W.I.N.G. 99 and Ewing 2008 Investigators 0302 clinical medicine Risk Factors Antineoplastic Combined Chemotherapy Protocols Child Pneumonectomy Lung Etoposide Adjuvant Cancer Pediatric Ifosfamide Hazard ratio Hematopoietic Stem Cell Transplantation Sarcoma Middle Aged Neoadjuvant Therapy Progression-Free Survival Europe Oncology Local 030220 oncology & carcinogenesis 6.1 Pharmaceuticals Child Preschool Disease Progression Female Autologous medicine.drug Adult medicine.medical_specialty Vincristine Adolescent Clinical Sciences Oncology and Carcinogenesis Bone Neoplasms Sarcoma Ewing Risk Assessment Transplantation Autologous 03 medical and health sciences Young Adult Rare Diseases Clinical Research Internal medicine Ewing medicine Humans Progression-free survival Oncology & Carcinogenesis Preschool Chemotherapy Transplantation Radiotherapy business.industry Evaluation of treatments and therapeutic interventions Infant medicine.disease Stem Cell Research 030104 developmental biology Neoplasm Recurrence Radiotherapy Adjuvant Neoplasm Recurrence Local business |
| Zdroj: | Journal of clinical oncology, Vol. 37, no.34, p. 3192-3202 (2019) Journal of clinical oncology, 37(34), 3192-3202. American Society of Clinical Oncology Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol 37, iss 34 |
| ISSN: | 0732-183X |
| Popis: | PURPOSE The R2Pulm trial was conducted to evaluate the effect of busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI) on event-free survival (main end point) and overall survival, compared with standard chemotherapy with WLI in Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases. METHODS From 2000 to 2015, we enrolled patients younger than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases. Patients received chemotherapy with six courses of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI) by randomized assignment. The analysis was conducted as intention to treat. The estimates of the hazard ratio (HR), 95% CI, and P value were corrected for the three previous interim analyses by the inverse normal method. RESULTS Of 543 potentially eligible patients, 287 were randomly assigned to VAI plus WLI (n = 143) or BuMel (n = 144). Selected patients requiring radiotherapy to an axial primary site were excluded from randomization to avoid excess organ toxicity from interaction between radiotherapy and busulfan. Median follow-up was 8.1 years. We did not observe any significant difference in survival outcomes between treatment groups. Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16). For overall survival, the HR was 1.00 (95% CI, 0.70 to 1.44; P = .99). Four patients died as a result of BuMel-related toxicity, and none died after VAI plus WLI. Significantly more patients in the BuMel arm experienced severe acute toxicities than in the VAI plus WLI arm. CONCLUSION In ES with pulmonary or pleural metastases, there is no clear benefit from BuMel compared with conventional VAI plus WLI. |
| Databáze: | OpenAIRE |
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