Table 1.
Summary of Responses of Patients With Osteosarcoma Enrolled in Seven Phase II Trials for Refractory/Recurrent Pediatric Solid Tumors and AOST0221 (phase II aerosolized GM-CSF)
| Study (years open) | Agent (dose) | End Point | No. of Enrolled Patients With Osteosarcoma/No. of Patients With Evaluable Response | No. of Patients Who Demonstrated Response According to Study Criteria | Activity According to Study End Point |
|---|---|---|---|---|---|
| CCG096218 (1997-2001) | Docetaxel 125 mg/m2 every 21 days | Radiographic (WHO) | 22/21 | 2 | No activity |
| A0971319 (1999-2003) | Topotecan 0.3 mg/m2 continuous 21-day infusion every 28-day cycle | Radiographic (WHO) | 11/11 | 0 | No activity |
| P976120 (1999-2005) | Irinotecan 50 mg/m2 for 5 days every 21 days | Radiographic (WHO) | 10/9 | 0 | No activity |
| P996321 (2000-2004) | Rebeccamycin 650 mg/m2 every 21 days | Radiographic (RECIST) | 17/16 | 0 | No activity |
| ADVL012222 (2002-2004) | Imatinib 440 mg/m2/day continuously | Radiographic (RECIST)* | 12/10 | 0 | No activity |
| ADVL042123 (2004-2006) | Oxaliplatin 130 mg/m2 every 21 days | Radiographic (RECIST)* | 13/10 | 0 | No activity |
| ADVL052424 (2006-2007) | Ixabepilone 8 mg/m2 once per day for 5 days every 21 days | Radiographic (RECIST)* | 11/10 | 0 | No activity |
| AOST022125 (2004-2008) | Aerosolized GM-CSF 250 µg-1750 µg twice per day on alternate weeks | Biologic (expression of Fas/Fas ligand and presence of dendritic cells) | 43/42 | 12-month EFS, 20% | No observed biologic activity, no improvement in outcome |
Abbreviation: EFS, event-free survival; GM-CSF, granulocyte-macrophage colony-stimulating factor.
*
Studies that also evaluated time to progression.