Table II.
Incidence of specific serious AEs.
| AE patients/Total patients | Heterogeneity | |||||||
|---|---|---|---|---|---|---|---|---|
| System organ | Specific AEs | Trials (n) | T-group | C-group | RR (95% CI) | P-value | P-value | I2 (%) |
| Adjuvant chemotherapy setting | ||||||||
| Hematologic and lymphatic system | Neutropenia | 4 | 805/1,300 | 693/1,278 | 1.14 (1.08–1.21) | <0.0001 | 0.64 | 0 |
| Febrile neutropenia | 4 | 140/1,300 | 115/1,278 | 1.20 (0.95–1.52) | 0.12 | 0.79 | 0 | |
| Anemia | 3 | 34/1,237 | 28/1,218 | 1.19 (0.73–1.94) | 0.49 | 0.47 | 0 | |
| Leukopenia | 2 | 662/1,160 | 558/1,144 | 1.17 (1.08–1.26) | <0.0001 | 0.71 | 0 | |
| Thrombocytopenia | 2 | 22/1,145 | 18/1,124 | 1.20 (0.64–2.23) | 0.57 | 0.40 | 0 | |
| Digestive tract system | Vomiting | 3 | 76/1,237 | 70/1,218 | 1.07 (0.78–1.46) | 0.68 | 0.53 | 0 |
| Diarrhea | 5 | 85/2,982 | 49/2,997 | 1.69 (1.21–2.38) | 0.002 | 0.17 | 38 | |
| Nausea/anorexia | 2 | 63/1,160 | 63/1,144 | 0.98 (0.70–1.38) | 0.93 | 0.54 | 0 | |
| Stomatitis/mucositis | 3 | 34/1,237 | 43/1,218 | 0.78 (0.50–1.21) | 0.27 | 0.80 | 0 | |
| Circulatory system | LVEF decrease | 7 | 331/3,832 | 175/3,935 | 2.00 (1.21–3.29) | 0.007 | 0.0006 | 75 |
| CHF | 7 | 112/4,682 | 18/4,749 | 6.01 (3.71–9.74) | <0.00001 | 0.13 | 40 | |
| Respiratory tract system | Dyspnea | 2 | 4/140 | 6/134 | 0.64 (0.18–2.22) | 0.48 | 0.27 | 16 |
| Nervous system | Sensory neuropathy | 3 | 5/232 | 13/228 | 0.39 (0.15–1.03) | 0.06 | 0.89 | 0 |
| Musculoskeletal system | Arthralgia | 3 | 47/2,842 | 39/2,863 | 1.19 (0.79–1.81) | 0.41 | 0.26 | 25 |
| Myalgia | 2 | 59/1,160 | 58/1,144 | 1.00 (0.70–1.43) | 0.99 | 0.98 | 0 | |
| Other | Edema | 3 | 2/232 | 4/228 | 0.55 (0.12–2.54) | 0.44 | 0.87 | 0 |
| Skin/nail changea | 4 | 62/1,914 | 39/1,947 | 1.55 (1.08–2.21) | 0.02 | 0.98 | 0 | |
| Fever | 2 | 2/169 | 1/168 | 1.66 (0.22–12.50) | 0.63 | 0.63 | 0 | |
| Infection | 4 | 137/2,890 | 124/2,903 | 1.09 (0.86–1.36) | 0.48 | 0.14 | 45 | |
| Asthenia/fatigue | 4 | 92/1,300 | 85/1,278 | 1.06 (0.80–1.41) | 0.68 | 0.77 | 0 | |
| Painb | 2 | 15/1,774 | 8/1,813 | 1.92 (0.82–4.50) | 0.14 | 0.29 | 11 | |
| Fatal AEs | 4 | 17/4,036 | 10/4,060 | 1.66 (0.78–3.51) | 0.19 | 0.47 | 0 | |
| Neoadjuvant chemotherapy setting | ||||||||
| Other | Neutropenia | 3 | 93/262 | 82/248 | 1.13 (0.74–1.74) | 0.56 | 0.08 | 60 |
| Febrile neutropenia | 3 | 26/200 | 20/190 | 1.17 (0.71–1.93) | 0.54 | 0.53 | 0 | |
| Stomatitis/mucositis | 2 | 3/177 | 8/171 | 0.36 (0.10–1.33) | 0.12 | 0.64 | 0 | |
| LVEF decrease | 2 | 35/138 | 24/132 | 1.38 (0.87–2.19) | 0.17 | 0.69 | 0 |
a
Cutaneous rash, erythema, alopecia, onychopathy
b
headache and back pain. AEs, adverse effects; RR, risk ratio; LVEF, left ventricular ejection fraction; CHF, congestive heart failure; CI, confidence interval; T-group, Trastuzumab plus chemotherapy group; C-group, chemotherapy alone group.