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SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients.
Eur J Cancer 2007; 43(4):752-61EJ

Abstract

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.

Authors+Show Affiliations

Service de Biostatistique et d'Epidémiologie, Institut Gustave-Roussy, 39, rue Camille Desmoulins, 94805 Villejuif Cedex, France. le_deley@igr.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17267204

Citation

Le Deley, Marie-Cécile, et al. "SFOP OS94: a Randomised Trial Comparing Preoperative High-dose Methotrexate Plus Doxorubicin to High-dose Methotrexate Plus Etoposide and Ifosfamide in Osteosarcoma Patients." European Journal of Cancer (Oxford, England : 1990), vol. 43, no. 4, 2007, pp. 752-61.
Le Deley MC, Guinebretière JM, Gentet JC, et al. SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients. Eur J Cancer. 2007;43(4):752-61.
Le Deley, M. C., Guinebretière, J. M., Gentet, J. C., Pacquement, H., Pichon, F., Marec-Bérard, P., ... Kalifa, C. (2007). SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients. European Journal of Cancer (Oxford, England : 1990), 43(4), pp. 752-61.
Le Deley MC, et al. SFOP OS94: a Randomised Trial Comparing Preoperative High-dose Methotrexate Plus Doxorubicin to High-dose Methotrexate Plus Etoposide and Ifosfamide in Osteosarcoma Patients. Eur J Cancer. 2007;43(4):752-61. PubMed PMID: 17267204.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients. AU - Le Deley,Marie-Cécile, AU - Guinebretière,Jean-Marc, AU - Gentet,Jean-Claude, AU - Pacquement,Hélène, AU - Pichon,Fabienne, AU - Marec-Bérard,Perrine, AU - Entz-Werlé,Natacha, AU - Schmitt,Claudine, AU - Brugières,Laurence, AU - Vanel,Daniel, AU - Dupoüy,Noëlle, AU - Tabone,Marie-Dominique, AU - Kalifa,Chantal, AU - ,, Y1 - 2007/01/30/ PY - 2006/07/29/received PY - 2006/09/28/revised PY - 2006/10/06/accepted PY - 2007/2/3/pubmed PY - 2007/5/18/medline PY - 2007/2/3/entrez SP - 752 EP - 61 JF - European journal of cancer (Oxford, England : 1990) JO - Eur. J. Cancer VL - 43 IS - 4 N2 - 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. SN - 0959-8049 UR - https://www.unboundmedicine.com/medline/citation/17267204/SFOP_OS94:_a_randomised_trial_comparing_preoperative_high_dose_methotrexate_plus_doxorubicin_to_high_dose_methotrexate_plus_etoposide_and_ifosfamide_in_osteosarcoma_patients_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0959-8049(06)01072-0 DB - PRIME DP - Unbound Medicine ER -