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Randomized Controlled Trial
Results of API-AI based regimen in osteosarcoma adult patients included in the French OS2006/Sarcome-09 study.
- Sophie Piperno-Neumann, Isabelle Ray-Coquard, Bob-Valéry Occean, Valérie Laurence, Didier Cupissol, Christophe Perrin, Nicolas Penel, Emmanuelle Bompas, Maria Rios, Axel Le Cesne, Antoine Italiano, Philippe Anract, Gonzague de Pinieux, Olivier Collard, François Bertucci, Florence Duffaud, Le DeleyMarie-CécileMCBiostatistics Unit, Gustave Roussy, Villejuif, France.Paris-Saclay University, Paris-Sud University, CESP, INSERM, Villejuif, France., Jessy Delaye, Laurence Brugieres, and Jean-Yves Blay.
- Department of Medical Oncology, Institut Curie, Paris, France.
- Int. J. Cancer. 2020 Jan 15; 146 (2): 413-423.
AbstractIn the OS2006 study, patients younger than 18 years were treated with a methotrexate-based regimen (MTX), patients older than 25 years with a doxorubicin-cisplatin-ifosfamide-based regimen (API-AI), whereas patients aged 18-25 years received either API-AI or MTX. We herein report the prespecified subgroup analysis of the outcome of 106 patients treated with API-AI. Preoperative chemotherapy combined three doxorubicin-ifosfamide-cisplatin (API) and two doxorubicin-ifosfamide (AI) courses. Postoperative chemotherapy was assigned by risk group: localised patients with a good histological response (<10% viable cells) received two AI and two cisplatin-ifosfamide (PI) courses; patients with synchronous metastases, poor histological response or unresectable primary received five cycles of etoposide-ifosfamide (EI). Of the 106 patients, 61 were randomised to receive or not zoledronate. Median age was 30 years (range 18-67), 66 (62%) patients were >25 years. The primary tumours were axial in 28 patients (26%), and 28 (26%) presented with metastases. Ninety-six patients (91%) had surgery, conservative in 82 (85%); 36 patients (38%, 95% CI 28-48%) were good responders. Toxicity was manageable, with no significant difference in severe acute toxicity between patients aged >25 years and those younger. With a median follow-up of 4.8 years, the 5-year event-free survival and overall survival rates were 46% (95% CI 36-56) and 57% (95% CI 47-67), respectively. The primary tumour size and initial metastases correlated with a higher risk of event. In these 106 osteosarcoma adult patients, API-AI proved feasible with no excess of toxicity, and favourable activity despite poor-prognosis factors.© 2019 UICC.
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