Results of methotrexate-etoposide-ifosfamide based regimen (M-EI) in osteosarcoma patients included in the French OS2006/sarcome-09 study

Publication date: January 2018
Source:European Journal of Cancer, Volume 88
Author(s): Nathalie Gaspar, Bob-Valéry Occean, Hélène Pacquement, Emmanuelle Bompas, Corine Bouvier, Hervé J. Brisse, Marie-Pierre Castex, Nadir Cheurfa, Nadège Corradini, Jessy Delaye, Natacha Entz-Werlé, Jean-Claude Gentet, Antoine Italiano, Cyril Lervat, Perrine Marec-Berard, Eric Mascard, Françoise Redini, Laure Saumet, Claudine Schmitt, Marie-Dominique Tabone, Cécile Verite-Goulard, Marie-Cécile Le Deley, Sophie Piperno-Neumann, Laurence Brugieres
BackgroundIn most countries, reference chemotherapy for osteosarcoma is MAP regimen (M = high-dose methotrexate, AP = doxorubicin-cisplatinum). In France, the standard preoperative chemotherapy for children/adolescents combines M and etoposide-ifosfamide (EI), based on the OS94-trial. We report the safety and efficacy results of patients ≤25 years treated with preoperative M-EI regimen enroled in the French OS2006-study, between 2007 and 2014.MethodsTreatment comprised preoperative chemotherapy with the 7 M-courses and 2 EI-courses, then surgery and postoperative chemotherapy assigned by risk's groups: standard-risk (good histological response without metastases) received 12 M-courses, 3 EI-courses; high-risk (poor histologic response, initial metastases or unresectable primary) received 5 M-courses alternated with 5 AP-courses. 253 patients were randomised to receive (n = 128) or not (n = 125) zoledronate.Results409/522 patients enroled in the OS2006 study who received preoperative M-EI were analysed. Median age was 14.3 years (4.7–24.5), with 55 patients aged 18–25 years. Primary tumour location was limb in 383 patients (94%) and 85 (21%) presented metastases. Median chemotherapy duration was 37.4 weeks. 381 (96%) patients underwent surgery, 258 patients (65%) had a good histologic response. 187/324 patients (58%) with localised disease did not receive doxorubicin nor cisplatinum. Toxicity was evaluated in the randomised study: most patients experienced ≥1 severe toxicity (grade IV haematological or grade III/IV extra-haematological). Median follow-up was 4.8 years, and 168 patients had events. Five-year event-free survival was 56% (95% CI, 51–62%) and overall survival 71% (66–76%).ConclusionM-EI regimen/strategy was feasible for patient aged ≤25 years with survival rates are comparable to those obtained with MAP regimen.



http://ift.tt/2AdIrqi