Table 2.
A comparison of the main characteristics of RMS2005 and CWS2007 trials.
| RMS2005 | CWS2007 | |
|---|---|---|
| Standard chemotherapy before maintenance chemotherapy | 9 cycles of Ifosfamide, vincristine, actinomycin-D +/− doxorubicin | 9 cycles of Ifosfamide, vincristine, actinomycin-D +/− doxorubicin |
| Eligible patients | High-risk localized RMS * | High-risk localized RMS * Undifferentiated sarcoma Extraskeletal Ewing sarcoma Nonresectable Synovial sarcoma |
| Maintenance chemotherapy | 6 cycles of intravenous vinorelbine 25 mg/m2 on days 1, 8, 15 and daily oral cyclophosphamide 25 mg/m2, days 1–28 | Eight 10-day courses consisting of trofosfamide (2 × 75 mg/m2/day) and idarubicine (×5 mg/m2/day 1, 4, 7, 10) alternating with trofosfamide and etoposide(2 × 25 mg/m2/day). All drugs were given orally |
| Patients randomized | 371 (186 vs. 185) | 195 (99 vs. 96) |
| Median Follow-up | 60.3 months (IQR 32·4–89·4) | 4.9 years (IQR 3.0–5.7) |
| Results ** | ||
| DFS/EFS standard arm vs. maintenance chemotherapy arm | 69.8% vs. 77.6% (p = 0.06) |
75% vs. 66.2% (p = 0.07) |
| OS standard arm vs. maintenance chemotherapy arm | 73.7% vs. 86.5% (p = 0.009) |
84.6% vs. 81.9% (p = 0.15) |
* Both studies used the same risk stratification definition apart from patients with alveolar RMS with nodal involvement that was included in CWS2007 only ** Results: RMS2005 used 5 years DFS and OS vs. CWS2007 that used 3-year EFS and OS.