EARLY PROGRESSION IN PATIENTS WITH HIGH-RISK SOFT TISSUE SARCOMAS AN ANALYSIS FROM A PHASE III RANDOMIZED PROSPECTIVE TRIAL (EORTC 62961/ESHO) OF NEOADJUVANT CHEMOTHERAPY WITH OR WITHOUT REGIONAL HYPERTHERMIA (RHT) R. D. Issels, L.Lindner, Munich, Germany P. Hohenberger, Berlin/Mannheim, Germany 13th Annual CTOS Meeting
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EARLY PROGRESSION IN PATIENTS WITH HIGH-RISK SOFT TISSUE SARCOMAS AN ANALYSIS FROM A PHASE III RANDOMIZED PROSPECTIVE TRIAL (EORTC 62961/ESHO) OF NEOADJUVANT.
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EARLY PROGRESSION IN PATIENTS WITH HIGH-RISK SOFT TISSUE SARCOMAS
AN ANALYSIS FROM A PHASE III RANDOMIZED PROSPECTIVE
TRIAL (EORTC 62961/ESHO) OF NEOADJUVANT CHEMOTHERAPY WITH OR WITHOUT REGIONAL HYPERTHERMIA (RHT)
R. D. Issels, L.Lindner, Munich, GermanyP. Hohenberger, Berlin/Mannheim, Germany
13th Annual CTOS Meeting
Treatment options for locally advanced sarcoma
High grade: multimodal therapy
• Chemotherapy (systemic)
• TNF limb perfusion
• Preop. Radio-(+C) therapy
• Chemotherapy + RHTdeep-wave hyperthermia
Application of EIA with RHT
Etoposide
125 [mg/m²]
Ifosfamide
1500 [mg/m²]
Adriamycin
50 [mg/m²]
Hyperthermia (RHT)60 min [40°C-43°C]
Day
1 2 3 4
RADIATION
Arm A
Arm B
EIA
EIA
RHT
R
RADIATION
Arm A
Arm B
EIA
EIA
RHT
R
Study design
Riskgroups
Stratification: Center, Risk Group, Extremity, Non-Extremity
SURGERY
SURGERY
S1 = primary tumor ≥5 cm, G2/G3
S2 = local recurrence of S1 tumor
S3 = inadequate surgery of S1 or S2 tumor
Regional Hyperthermia (RHT) Technology
Courtesy of BSD Medical Corporation model BSD 2000 3D
ESHO quality assurance guidelines for regional hyperthermia Lagendijk et al. Int J Hyperthermia 1998
a b
ab
Study objectives
Primary Endpoint• Local Progression Free Survival (LPFS)
Secondary Endpoints • Tumor response (WHO)
• Disease Free Survival (DFS)
• Overall Survival
Patient characteristics (1)
n=341 EIA + RHT (n=169) EIA (n=172) p
Sex Male 95 (56%) 94 (55%) NS
Female 74 (44%) 78 (45%)
Age 18 – 39 years 41 (24%) 43 (25%) NS
40 – 70 years 128 (76%) 129 (75%)
Performance (WHO) 0 108 (65%) 115 (67%) NS
1 51 (31%) 50 (29%)
2 8 (4%) 7 (4%)
Patient characteristics (2)
n=341 EIA + RHT (n=169) EIA (n=172) p
Site of tumor
Extremity 73 (43%) 76 (44%) NS
Non-Extremity 96 (57%) 96 (56%)
Risk groups
S1 (primary) 78 (46%) 84 (49%) NS
S2 (recurrence) 19 (11%) 18 (10%)
S3 (inadequate surgery) 72 (43%) 70 (41%)
Patient characteristics (3)
n=341 EIA + RHT (n=169) EIA (n=172) p
Size of tumor (cm) 5-8 59 (35%) 60 (35%) NS
9-12 38 (22%) 48 (28%)
> 12 72 (43%) 64 (37%)
Median 11 11 NS
Grading G2 84 (50%) 77 (45%) NS
G3 84 (50%) 94 (55%)
Preoperative chemotherapy
n=341 EIA + RHT (n=169) EIA (n=172) p
Cycles 1-4
Received 4 cycles 150 (89%) 140 (82%) NS
Received ≤ 3 cycles 15 (9%) 23 (13%)
Received 0 cycles 4 (2%) 9 (5%)
Local treatment after chemotherapy
n=341 EIA + RHT (n=169) EIA (n=172) p
Surgery Yes 100 (59%) 101 (59%) NS
No 67 (40%) 67 (39%) NS
Not operated/ S3 group 55 53
No data 2 (1%) 4 (2%) NS
Radiotherapy Yes 103 (61%) 100 (58%) NS
No 64 (38%) 66 (38%)
No data 2 (1%) 6 (4%)
WHO objective response evaluation (96% response review)
• 117 pts notevaluable for response (61 pts with EIA+ RHT / 56 pts with EIA)
Responder EIA + RHT
(n=108)
EIA
(n=116)
Total
(n=224)
CR/PR 37 (34.3%)* 18 (15.5%)* 55 (24,6%)
SD 63 (58.3%) 71 (61,2%) 134 (59,8%)
PD 8 (7,4%) 27 (23,3%) 35 (15,6%)
* p<0.001
EORTC 62961/ESHO RHT 95-Study
% N=341Disease Free Survival (All Progressions or Death)