Table 3.
Poole analyses of grade 3 or worse treatment-related adverse events.
| Trial | PICASSO III-2016 | TH CR-406/SARC021–2017 | subgroup RR (95% CI) | AIO-STS-002–2020 | subgroup RR (95% CI) | Total RR (95% CI) | |||
|---|---|---|---|---|---|---|---|---|---|
| Groups | Doxorubicin + Palifosfamide (n = 220) | Doxorubicin (n = 214) | Doxorubicin + Evofosfamide (n = 313) | Doxorubicin (n = 308) | Trofosfamide (n = 76) | Doxorubicin (n = 39) | |||
| Anemia | 37 | 19 | 150 | 65 |
Fixed effect model: 2.19 (1.75–2.73, P < .0001) Random effects model: 2.20 (1.76–2.74, P < .0001) |
7 | 4 | Fixed effect model: 0.90 (0.28–2.88) Random effects model: 0.90 (0.28–2.88) |
Fixed effect model: 2.11 (1.70–2.62, P < .0001) Random effects model: 2.04 (1.50–2.76, P < .0001) |
| Neutropenia | 65 | 45 | 47 | 92 | Fixed effect model: 0.80 (0.64–1.00, P = .0478) Random effects model: 0.84 (0.31–2.30, P = .7335) |
1 | 13 | Fixed effect model: 0.04 (0.01–0.29) Random effects model: 0.04 (0.01–0.29) |
Fixed effect model: 0.72 (0.58–0.89, P = .0022) Random effects model: 0.49 (0.17–1.45, P = .1995) |
| Thrombocytopenia | 9 | 3 | 45 | 4 | Fixed effect model: 7.57 (3.48–16.46, P < .001) Random effects model: 6.04 (1.61–22.74, P = .0078) |
1 | 0 | Fixed effect model: 1.56 (0.06–37.39) Random effects model: 1.55 (0.06–37.16) |
Fixed effect model: 7.05 (3.34–14.9, P < .0001) Random effects model: 5.25 (1.68–16.42, P = .0044) |
| Nausea | 10 | 4 | 5 | 2 |
Fixed effect model: 2.44 (0.96–6.23, P = .0619) Random effects model: 2.44 (0.96–6.23, P = .0619) |
3 | 0 | Fixed effect model: 3.64 (0.19–68.68) Random effects model: 3.61 (0.19–68.25) |
Fixed effect model: 2.56 (1.05–6.25, P = .0395) Random effects model: 2.53 (1.04–6.18, P = .0414) |
| Vomiting | 12 | 6 | 3 | 1 |
Fixed effect model: 2.09 (0.86–5.05, P = .1021) Random effects model: 2.07 (0.86–5.02, P = .1061) |
2 | 0 | Fixed effect model: 2.60 (0.13–52.81) Random effects model: 2.58 (0.13–52.48) |
Fixed effect model: 2.13 (0.91–4.98, P = .0802) Random effects model: 2.11 (0.90–4.93, P = .0846) |
| Fatigue | 10 | 10 | 16 | 11 |
Fixed effect model: 1.21 (0.69–2.13, P = .5021) Random effects model: 1.21 (0.69–2.13, P = .5085) |
4 | 2 | Fixed effect model: 1.03 (0.20–5.36) Random effects model: 1.03 (0.20–5.36) |
Fixed effect model: 1.19 (0.70–2.03, P = .5183) Random effects model: 1.19 (0.70–2.03, P = .5250) |
| Stomatitis | 4 | 1 | 26 | 7 |
Fixed effect model: 3.68 (1.71–7.94, P = .0009) Random effects model: 3.68 (1.71–7.93, P = .0009) |
0 | 1 | Fixed effect model: 0.17 (0.01–4.15) Random effects model: 0.17 (0.01–4.13) |
Fixed effect model: 2.99 (1.49–6.03, P = .0021) Random effects model: 2.34 (0.59–9.35, P = .2291) |
| Diarrhea | 6 | 0 | 4 | 1 |
Fixed effect model: 6.85 (1.24–37.81, P = .0272) Random effects model: 6.04 (1.06–34.38, P = .0426) |
0 | 1 | Fixed effect model: 0.17 (0.01–4.15) Random effects model: 0.17 (0.01–4.13) |
Fixed effect model: 3.07 (0.94–10.07, P = .0638) Random effects model: 2.35 (0.25–22.43, P = .4591) |
| Asthenia | 4 | 5 | 3 | 1 |
Fixed effect model: 1.14 (0.39–3.36, P = .8137) Random effects model: 1.09 (0.35–3.40, P = .8826) |
3 | 0 | Fixed effect model: 3.64 (0.19–68.68) Random effects model: 3.61 (0.19–68.25) |
Fixed effect model: 1.38 (0.51–3.76, P = .5253) Random effects model: 1.27 (0.44–3.63, P = .6602) |
| Constipation | 1 | 0 | 4 | 0 |
Fixed effect model: 5.88 (0.71–48.60, P = .1002) Random effects model: 5.35 (0.62–46.10, P = .1272) |
6 | 0 | Fixed effect model: 6.75 (0.39–116.86) Random effects model: 6.71 (0.39–116.12) |
Fixed effect model: 6.22 (1.13–34.34, P = .0359) Random effects model: 5.81 (1.04–32.39, P = .0449) |
| Febrile neutropenia | 44 | 25 | 57 | 34 |
Fixed effect model: 1.68 (1.24–2.26, P = .0007) Random effects model: 1.68 (1.24–2.26, P = .007) |
– | – | – | – |
The bold words meant the adopted model in the analysis. The underlines meant the differences were statistically significant.
RR = risk ratio.