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Table 3 Characteristics of eligible trials for osteosarcoma only

From: Comprehensive analysis of published phase I/II clinical trials between 1990-2010 in osteosarcoma and Ewing sarcoma confirms limited outcomes and need for translational investment

Author Year Intervention Phase No of Patients Outcome
Salesh RA., et al., Cancer 65:861-5. 1990 Etoposide 72-h i.v 600 mg/m2. Cyclophosphamide 300 mg/m2 every 12 hours for a total dose of 1800 mg/m2. II 17 15 (88%) CR or PR
Kleinerman ES, et al J. Clin. Oncol. 10, 1310-6. [57] 1992 L-MTP-PE 2 mg/m2 infused during a 1-h period twice a wk for 12 wks, then once a wk for 12 wks. II 16 Not mentioned
Kleinerman ES, et al Am J Clin Oncol. 18(2):93-9. [58] 1995 L-MTP-PE, 2 mg/m2, i.v over a 1-h twice a wk for 12 wks in 12 pts (Group 1). 16 pts (Group 2) had 2 mg/m2 L-MTP-PE twice a wk for 12 wks, then once a wk for 12 wks, for a total of 24 wks. II 36 2 (6%) SD
Kleinerman ES, et al J. Immunother. Emphasis Tumor Immunol., 17, 181-93. [59] 1995 IFO 1.8 g/m2 for 5 days every 21 days for up to 8 cycles. L-MTP-PE twice weekly for 12 weeks, then once weekly for 12 weeks IIb 9 Not mentioned
Harris MB, et al Med Ped Oncol 24, 87-92. [60] 1995 Two courses of ifosfamide (2400 mg/m2 × 5 days) administered 3 wks apart II 33 Stratum 1: 1 (11%) CR, 8 (24%) PR
Stratum 2: 1 (3%) CR, 2 (7%) PR
Patel SR, et al Cancer; 78:741-4. [61] 1996 Paclitaxel 175 mg/m2 24-h i.v II 15 0% OR
Gentet JC, et al Eur J Cancer, Vol. 33, No. 2, 232-7 [62] 1997 Two courses of IFO 3 g/m2/day and etoposide 75 mg/m2/day for 4 days. II 27 6 (23%) CR, 7 (25%) PR, 5 (23%) SD
Worth LL, et al Clin Cancer Res. 3(10):1721-9. [63] 1997 IL-1alpha followed by ICE daily for 5 days/3 wks. II 9 3 (34%) PR, 1 (11%) SD
Voûte PA, et al Annals of Oncology 10: 1211-8. [64] 1999 IFO 3 g/m2/dl-2, DOX 25 mg/m2/dl-3 i.v. bolus and CDDP 100 mg/m2/dl. II 103 5 year survival was 62% in limb-non-metastatic, 41% in axial skeletal and 16% in limb metastatic patients.
Fagioli F, et al Journal of Clinical Oncology, Vol 20, Issue 8:2150-6 [65] 2002 High-dose chemotherapy consisted of carboplatin and etoposide followed by stem-cell rescue. I 32 25 (78%) CR, 6 (19%) PD,
3 year OS 20%
3 year DFS 12%
Laverdiere C, et al Cancer; 98:832-40. [66] 2003 Trabectedin 1500 micro g/m2 as a 24-h i.v every 3 wks. II 25 0% OR
McTiernan A, et al. Sarcoma, Vol. 8, No. 2/3, 71-6. [67] 2004 Docetaxel 100 mg/m2 1-h i.v every 3 wks II 14 1 (7%) PR, 2 (14%) SD
Ferrari S et al J Clin Oncol 23:8845-52. [68] 2005 Two blocks of high-dose IFO (15 g/m2), MTX (12 g/m2), CDDP (120 m g/m2), and DOX (75 m g/m2) II 182 5-year EFS 64% and OS 77%
Arpaci F, et al Cancer; 104:1058-65. [69] 2005 2 cycles of CDDP, DOX, and IFO followed by HDC and APBSCT. II 22 3 year: OS was 83% & 70% DFS
McTiernan A, et al Pediatr Blood Cancer. 46(3):345-50. [70] 2006 IFO 2.5 g/m2 etoposide 150 mg/m2 and DOX 20 mg/m2 on days 1-3, every 21 days, with interval MTX 12 g/m2 given on day 14, for a maximum of 8 cycles. I/II 13 0% OR
Seibel NL, et al Cancer 2007; 109:1646-53. [71] 2007 Topotecan daily x5 followed by chemotherapy (IFO, carboplatin, ICE, alternating with CDDP and CD. I 28 1 (6.6%) PR, 1 (6.6%) CLR
2- and 5-year EFS rates 7% & 4%, resp, 2- and 5-year OS rates 44% and 22%, resp.
Basaran M, et al Oncology;72:255-60 [72] 2007 Epirubicin 90 mg/m2 cisplatin 100 mg/m2 on day 1 and IFO 2.0 g/m2 day with an equivalent dose of mesna on days 2-4, repeated every 21 days II 38 10 (26%) CR, 5 year DFS 41.9%, OS 48.2%.
Iwamoto Y, et al J Orthop Sci 14:397-04. [73] 2009 Preoperative chemotherapy: HD-MTX, CDDP, and ADR. II 113 5 year OS 77.9%
5 year EFS 65.5%
Berger M, et al Cancer 115: 2980 -7. [74] 2009 Cyclophosphamide 4 g/m2 on Day 1 followed by etoposide at 200 mg/m2 on Days 2, 3, and 4. II 26 9 (35%) SD, OS at 1 yr 50%, PFS 42%
Chawla S P, et al Mol Ther. 17:1651-7. [51] 2009 Escalating doses of Rexin-G i.v from 8 × 1011 to 24 × 1011 colony forming units (cfu)/cycle. II
I/II
Osteo = 22
Sar = 20
Osteo = 0
10 (58.8%) SD
3 (50%) SD(lowest dose)
10 (71%) SD(higher dose)
  1. Abbreviations- ADR = adriamycin; APBSCT = autologous peripheral blood stem cell support transplantation; CDDP = cisplatin; Cfu = colony forming units; CR = complete response; DOX = doxorubicin; EFS = event free survival; GCSF = Granulocyte colony-stimulating factor; HD-MTX = High-dose Methotrexate; ICE = etoposide; IFO = ifosfamide; IL-6 = interleukin -6; IL-8 = interleukin-8; L-MTP-PE = liposomal muramyl tripeptide phosphatidyl ethanolamine; MTX = methotrexate; OR = objective response; PD = progressive disease; PFS = progression free survival; OS = overall survival; RDI = relative dose intensity; resp = respectively; Sar = sarcoma; TNF = tumour necrosis factor