Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2018 Jan:88:57-66.
doi: 10.1016/j.ejca.2017.09.036. Epub 2017 Nov 28.

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

Nathalie Gaspar  1 , Bob-Valéry Occean  2 , Hélène Pacquement  3 , Emmanuelle Bompas  4 , Corine Bouvier  5 , Hervé J Brisse  6 , Marie-Pierre Castex  7 , Nadir Cheurfa  2 , Nadège Corradini  8 , Jessy Delaye  9 , Natacha Entz-Werlé  10 , Jean-Claude Gentet  11 , Antoine Italiano  12 , Cyril Lervat  13 , Perrine Marec-Berard  14 , Eric Mascard  15 , Françoise Redini  16 , Laure Saumet  17 , Claudine Schmitt  18 , Marie-Dominique Tabone  19 , Cécile Verite-Goulard  20 , Marie-Cécile Le Deley  21 , Sophie Piperno-Neumann  22 , Laurence Brugieres  23 ; SFCE (Société Française des Cancers de l'Enfant et l'adolescent); GSF-GETO (Groupe Sarcome Français); UNICANCER sarcoma group
Affiliations
Clinical Trial

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

Nathalie Gaspar et al. Eur J Cancer. 2018 Jan.

Abstract

Background: In 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.

Methods: Treatment 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.

Results: 409/522 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%).

Conclusion: M-EI regimen/strategy was feasible for patient aged ≤25 years with survival rates are comparable to those obtained with MAP regimen.

Keywords: Etoposide; Ifosfamide; Methotrexate; Osteosarcoma.

PubMed Disclaimer

Publication types

MeSH terms