Table 2. Toxic Effects Reported Within 9 Weeks of Starting Chemotherapy.
Allocation | Randomization, No. (%) | |||||||
---|---|---|---|---|---|---|---|---|
CHEMO-INTENSITYa | CHEMO-BSCa | |||||||
Level A (n = 162) | Level B (n = 162) | Level C (n = 168) | Level C (n = 18) | |||||
Max CTCAE grade (week 1-9)b | ≥2 | ≥3 | ≥2 | ≥3 | ≥2 | ≥3 | ≥2 | ≥3 |
Nausea or vomiting | 47 (29) | 14 (8.6) | 33 (20) | 8 (4.9) | 29 (17) | 12 (7.1) | 2 (11) | 0 |
Anorexia | 45 (28) | 11 (6.7) | 46 (28) | 14 (8.6) | 32 (19) | 3 (1.8) | 13 (17) | 0 |
Diarrhea | 34 (21) | 10 (6.2) | 19 (12) | 10 (6.2) | 7 (4.2) | 3 (1.8) | 1 (5.6) | 1 (5.6) |
Peripheral neuropathy | 24 (15) | 4 (2.5) | 11 (6.7) | 1 (0.6) | 6 (3.6) | 1 (0.6) | 2 (11) | 0 |
Fatigue | 86 (53) | 24 (15) | 72 (44) | 20 (12) | 67 (40) | 18 (11) | 6 (33) | 4 (22) |
Infection | 7 (4.3) | 4 (2.5) | 15 (9.3) | 9 (5.6) | 5 (3.0) | 1 (0.6) | 0 | 0 |
Thrombosis | 5 (3.1) | 5 (3.1) | 4 (2.5) | 3 (1.9) | 3 (1.8) | 2 (1.2) | 2 (11) | 2 (11) |
Any nonhematologicalc | 125 (77) | 62 (38) | 116 (72) | 58 (36) | 101 (60) | 38 (23) | 10 (56) | 7 (39) |
WBC/neutrophils (×109/l) | 10 (6.2) | 1 (0.6) | 3 (1.9) | 0 | 5 (3.0) | 1 (0.6) | 0 | 0 |
Anaemia | 26 (16) | 1 (0.6) | 33 (20) | 6 (3.7) | 22 (13) | 3 (1.8) | 2 (11) | 0 |
Any hematologicald | 33 (20) | 3 (1.9) | 36 (22) | 6 (3.7) | 27 (16) | 4 (2.4) | 2 (11) | 0 |
Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; WBC, white blood cell count.
Treatment pathways are detailed in the Randomization section of Methods.
Maximum CTCAE grade experienced weeks 1-9 in patients receiving ≥1 cycle of their allocated chemotherapy. Individual listings are shown for more common toxic effects.
“Any nonhematological” is defined as any of the following: nausea, vomiting, anorexia, stomatitis, diarrhea, hand-foot syndrome, peripheral neuropathy, fatigue, infection, thrombosis, or dehydration.
“Any hematological” is defined as any of the following: low white blood cell count, low neutrophils/granulocytes, low platelets, or anemia.