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.
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Dirksen Uta, Brennan Bernadette, Le Deley Marie-Cécile, Cozic Nathalie, van den Berg Henk, Bhadri Vivek, Brichard Bénédicte, Claude Line, Craft Alan, Amler Susanne, Gaspar Natalie, Gelderblom Hans, Goldsby Robert, Gorlick Richard, Grier Holcombe E, Guinbretiere Jean-Marc, Hauser Peter, Hjorth Lars, Janeway Katherine, Juergens Heribert, Judson Ian, Krailo Mark, Kruseova Jarmila, Kuehne Thomas, Ladenstein Ruth, Lervat Cyril, Lessnick Stephen L, Lewis Ian, Linassier Claude, Marec-Berard Perrine, Marina Neyssa, Morland Bruce, Pacquement Hélène, Paulussen Michael, Randall R Lor, Ranft Andreas, Le Teuff Gwénaël, Wheatley Keith, Whelan Jeremy, Womer Richard, Oberlin Odile, Hawkins Douglas S, Euro-E.W.I.N.G. 99 and Ewing 2008 Investigators
Аннотация
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.