Table 3. Grade 3 or 4 Adverse Events among Patients with Negative PET Findings Who Started Their Assigned Treatment.*.
Event | ABVD, Cycles 1 and 2 (N =1203) | ABVD, Cycles 3–6 (N = 468) | AVD, Cycles 3–6 (N = 457) | BEACOPP-14 (N = 94) | Escalated BEACOPP (N = 78) |
---|---|---|---|---|---|
number (percent) | |||||
Any blood or bone marrow event | 711 (59) | 280 (60) | 273 (60) | 68 (72) | 58 (74) |
Neutropenia | 694 (58) | 275 (59) | 269 (59) | 59 (63) | 52 (67) |
Thrombocytopenia† | 16 (1) | 6 (1) | 15 (3) | 18 (19) | 33 (42) |
Any cardiac event | 9 (1) | 6 (1) | 2 (<0.5) | 1 (1) | 0 |
Any constitutional symptom | 36 (3) | 18 (4) | 13 (3) | 11 (12) | 11 (14) |
Fatigue† | 14 (1) | 14 (3) | 5 (1) | 8 (9) | 3 (4) |
Fever | 16 (1) | 4 (1) | 7 (2) | 2 (2) | 9 (12) |
Any infection | 76 (6) | 68 (15) | 47 (10) | 35 (37) | 33 (42) |
Febrile neutropenia† | 24 (2) | 22 (5) | 10 (2) | 10 (11) | 20 (26) |
Any neurologic event | 20 (2) | 23 (5) | 14 (3) | 9 (10) | 3 (4) |
Any pulmonary or upper respiratory event† | 8 (1) | 15 (3) | 3 (1) | 4 (4) | 4 (5) |
Dyspnea† | 5 (<0.5) | 9 (2) | 1 (<0.5) | 2 (2) | 2 (3) |
Pneumonitis | 0 | 5 (1) | 1 (<0.5) | 0 | 2 (3) |
Any vascular event | 18 (1) | 23 (5) | 12 (3) | 8 (9) | 2 (3) |
Thrombosis or embolism related to vascular access | 4 (<0.5) | 4 (1) | 1 (<0.5) | 0 | 0 |
Thrombosis, thrombus, or embolism | 14 (1) | 20 (4) | 11 (2) | 8 (9) | 2 (3) |
Any clinical adverse event‡§ | 188 (16) | 143 (31) | 96 (21) | 52 (55) | 47 (60) |
Any grade 3 or 4 adverse event | 771 (64) | 322 (69) | 299 (65) | 75 (80) | 65 (83) |
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. BEACOPP-14 is an accelerated version of BEACOPP that involves growth-factor support. Escalated BEACOPP involves higher-than-standard doses of etoposide, doxorubicin, and cyclophosphamide.
P<0.05 for the comparison of ABVD with AVD during cycles 3 through 6.
Blood or bone marrow events and laboratory events were excluded.
P<0.005 for the comparison of ABVD with AVD during cycles 3 through 6.