SFOP OS94: A randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients

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• 作者：Marie-Cé ; cile Le Deley ; Jean-Marc Guinebretiè ; re ; Jean-Claude Gentet ; Hé ; lè ; ne Pacquement ; Fabienne Pichon ; Perrine Marec-Bé ; rard ; Natacha Entz-Werlé ; Claudine Schmitt ; Lauren
• 关键词：Osteosarcoma ; Randomised trial ; Chemotherapy ; Etoposide-ifosfamide ; Doxorubicin ; Methotrexate ; Histologic response
• 刊名：European Journal of Cancer
• 出版年：2007
• 出版时间：March 2007
• 年：2007
• 卷：43
• 期：4
• 页码：752-761
• 全文大小：213 K

文摘

The SFOP-OS94 randomised multi-centre trial was designed to determine whether preoperative chemotherapy regimen combining high-dose methotrexate courses and etoposide-ifosfamide could improve the proportion of good histologic response (5 % viable cells) compared to a regimen based on high-dose methotrexate and doxorubicin, in children/adolescents with localised high-grade limb osteosarcoma. Postoperative chemotherapy was adapted to the histologic response.

Overall, 234 patients were randomised between 1994 and 2001. There were 56 % good responders in the etoposide-ifosfamide arm versus 39 % in the doxorubicin arm (p-value = 0.009). With a median follow-up of 77 months, the 5-year event-free survival of the entire population was 62 % , slightly greater in the etoposide-ifosfamide arm than in the doxorubicin arm, but the difference was not significant (Hazard Ratio: HR = 0.71, 95 % CI: 0.5–1.06, p-value = 0.09). Five-year overall survival of the entire population was 76 % , similar in both arms (HR = 0.95, 95 % CI: 0.6–1.6, p-value = 0.85). Toxicity was manageable with different acute toxicity profiles between treatment arms. No acute toxicity related death was reported. About 43 % of the patients in the etoposide-ifosfamide arm were event-free at 3 years without having received any doxorubicin or cisplatin, thus avoiding the risk of long-term cardio- and ototoxicity.

Preliminary results of the study have been presented at the SIOP meeting, Brisbane, 2001 and at the ASCO meeting, Orlando, 2002.

Audited by the French Competent Authority: AFSSAPS (Agence Française de Sécurité SAnitaire des Produits de Santé).

Registered in the ClinicalTrials.gov registry. Trial number: NCT00180908.