Table 3.
Selected toxicities by grade among the 82 patients who began radiation therapy (safety population), according to trial group
| Toxicity | Grade | Group 1 (n=35) | Group 2 (n=47) | Total (N=82) |
|---|---|---|---|---|
| Esophagitis | 0 | 2 (6) | 7 (15) | 9 (11) |
| 1 | 1 (3) | 4 (9) | 5 (6) | |
| 2 | 30 (86) | 33 (70) | 63 (77) | |
| 3 | 2 (6) | 3 (6) | 5 (6) | |
| 4 | 0 | 0 | 0 | |
| 5 | 0 | 0 | 0 | |
| RTPN∗ | 0 | 11 (31) | 24 (51) | 35 (43) |
| 1 | 12 (34) | 10 (21) | 22 (27) | |
| 2 | 10 (29) | 12 (26) | 22 (27) | |
| 3 | 2 (6) | 1 (2) | 3 (4) | |
| 4 | 0 | 0 | 0 | |
| 5 | 0 | 0 | 0 | |
| All toxicities grades ≥3 | 25 (71) | 36 (77) | 61 (74) | |
| 3 | 20 (57) | 26 (55) | 46 (56) | |
| 4 | 3 (9) | 8 (17) | 11 (13) | |
| 5† | 2 (6) | 2 (4) | 4 (5) | |
| Grade ≥3%‡ hematologic | ||||
| White blood cell decreased | 2 (6) | 9 (19) | 11 (13) | |
| Lymphocyte decreased | 1 (3) | 8 (17) | 9 (11) | |
| Neutrophil decreased | 4 (11) | 8 (17) | 12 (15) | |
| Grade ≥3 other | ||||
| Lung infection | 9 (26) | 9 (19) | 18 (22) | |
| FEV decreased | 5 (14) | 7 (15) | 12 (15) | |
Abbreviation: FEV = forced expiratory volume.
Values are number (percentage).
∗
RTPN = radiation therapy pneumonitis. Two patients received higher lung doses than allowed in the protocol. Both received prescribed tumor doses of 63 Gy, one with a lung V20 of 46.5% and one with 40.7%. Neither experienced RTPN.
†
Four patients had grade 5 events: in group 1, 1 patient experienced esophageal perforation and 1, hemoptysis. Two group 2 patients experienced hemoptysis.
‡
There were no relevant hemoglobin-related events.