Table 4 Comparison of toxicities grade ≥ 3 during tandem HDCT/auto-SCT
|  | First HDCT in NB-2009 (n = 52) | Second HDCT in NB-2009 (n = 47) | P value | TM-TBI in NB-2004 (n = 42) | 131I-MIBG-TM in NB-2009 (n = 43) | P value |
|---|---|---|---|---|---|---|
Hematologic toxicity | ||||||
 CD34+ cells (×106/kg), median (range) | 2.7 (1.0–14.1) | 2.4 (1.0–14.1) | 0.321 | 1.9 (1.0–16.0) | 2.3 (1.0–14.1) | 0.184 |
 Time (days) to reach an ANC 0.5 × 109/La, median (range) | 11 (9–14) | 10 (8–15) | 0.339 | 11 (8–16) | 10 (8–15) | 0.038 |
 Time (days) to reach a PLT count 20 × 109/Lb, median (range) | 24 (13–52) | 32 (16–275) | 0.004 | 40 (18–1 248) | 32 (16–275) | 0.041 |
 Days of BT ≥38.0 °C, median (range) | 3 (0–16) | 4 (0–11) | 0.221 | 8 (2–27) | 4 (0–11) | <0.001 |
 Positive blood culture, n (%) | 3 (5.8) | 3 (6.4) | 0.898 | 2 (4.8) | 3 (7.0) | 0.511 |
Non-hematologic toxicity | ||||||
 Vomiting, n (%) | 12 (23.1) | 6 (12.8) | 0.184 | 11 (26.2) | 5 (11.6) | 0.086 |
 Stomatitis, n (%) | 9 (17.3) | 18 (38.3) | 0.019 | 28 (66.7) | 15 (34.9) | 0.003 |
 Diarrhea (frequency ≥10/day), n (%) | 16 (30.8) | 17 (36.2) | 0.569 | 23 (54.8) | 15 (34.9) | 0.065 |
 Elevation of liver enzyme, n (%) | 44 (84.6) | 1 (2.1) | <0.001 | 7 (16.7) | 1 (2.3) | 0.030 |
 Hepatic VOD, n (%) | 3 (5.8) | 0 (0.0) | 0.245 | 4 (9.5) | 1 (2.3) | 0.202 |
 Renal insufficiency, n (%) | 4 (7.7) | 0 (0.0) | 0.119 | 2 (4.8) | 0 (0.0) | 0.241 |
 Hypokalemia, n (%) | 17 (32.7) | 3 (6.4) | 0.001 | 17 (40.5) | 3 (7.0) | <0.001 |
 Myocarditis, n (%) | 3 (5.8) | 0 (0.0) | 0.245 | 0 (0.0) | 0 (0.0) | >0.999 |
 Intracranial hemorrhage, n (%) | 1 (1.9) | 0 (0.0) | 0.525 | 0 (0.0) | 0 (0.0) | >0.999 |
 Toxic death, n (%) | 5 (9.6) | 0 (0.0) | 0.058 | 0 (0.0) | 0 (0.0) | >0.999 |
Time (days) to discharge from day 0 of SCT, median (range) | 17 (12–51) | 18 (12–31) | 0.135 | 19 (15–81) | 18 (12–31) | 0.098 |