Table 4 GRADE evidence profile of outcomes
Outcome | Number of studies | Assessment of evidence quality | Number of participants | Effect(95%CI) | Evidence quality | ||||
|---|---|---|---|---|---|---|---|---|---|
Risk bias | Inconsistency | Indirectness | Imprecision | Publication bias | |||||
OS (T+L vs. T) | 4 | Serious | No | No | No | Undetected | 8999 | HR = 0.84 [0.73, 0.97] | Moderate |
OS (L vs. T) | 6 | Serious | No | No | No | Undetected | 6379 | HR = 1.26 [1.08, 1.46] | Moderate |
OS (L vs. T, neoadjuvant therapy) | 3 | Serious | No | No | Serious | Undetected | 1105 | HR = 0.85 [0.60, 1.20] | Low |
OS (L vs. T, palliative therapy) | 2 | Serious | No | No | No | Undetected | 1077 | HR = 1.40 [1.10, 1.80] | Moderate |
PFS (L vs. T) | 2 | Serious | No | No | No | Undetected | 1077 | HR = 1.35 [1.11, 1.64] | Moderate |
DFS/EFS (T+L vs. T) | 3 | Serious | No | No | No | Undetected | 8761 | HR = 0.89 [0.80, 0.98] | Moderate |
DFS/EFS (L vs. T) | 4 | Serious | No | No | Serious | Detected | 5190 | HR = 1.22 [1.05, 1.41] | Very low |
pCR (T+L vs. T, ypT0/is ypN0) | 7 | Serious | No | No | No | Undetected | 1207 | RR = 1.27 [1.13, 1.43] | Moderate |
pCR (L vs. T, ypT0/is ypN0) | 9 | Serious | No | No | No | Undetected | 1817 | RR = 0.73 [0.65, 0.83] | Moderate |
pCR (T+L vs. T, ypT0/is ypN0/+) | 4 | Serious | No | No | No | Undetected | 987 | RR = 1.31 [1.16, 1.49] | Moderate |
pCR (L vs. T, ypT0/is ypN0/+) | 6 | Serious | Serious | No | No | Undetected | 1626 | RR = 0.79 [0.70, 0.89] | Low |
RFS (T+L vs. T) | 2 | Serious | Serious | No | Serious | Undetected | 4428 | HR = 0.83 [0.72, 0.96] | Very low |
ORR (T+L vs. T) | 4 | Serious | Serious | No | Serious | Undetected | 797 | RR = 1.02 [0.96, 1.09] | Very low |
ORR (L vs. T) | 7 | Serious | No | No | Serious | Undetected | 2027 | RR = 0.98 [0.93, 1.03] | Low |
DCR (L vs. T) | 3 | Serious | No | No | Serious | Undetected | 1228 | RR = 0.96 [0.90, 1.01] | Low |
Rate of BCS (T+L vs. T) | 4 | No | No | No | Serious | Undetected | 817 | RR = 1.01 [0.88, 1.15] | Moderate |
Rate of BCS (L vs. T) | 6 | No | No | No | Serious | Undetected | 1496 | RR = 0.94 [0.86, 1.04] | Moderate |
CHF (T+L vs. T) | 7 | Serious | Serious | No | Serious | Undetected | 9453 | RR = 0.95 [0.73, 1.23] | Very low |
CHF (L vs. T) | 9 | Serious | No | No | Serious | Detected | 5893 | RR = 0.89 [0.62, 1.28] | Very low |
Decline of LVEF (T+L vs. T) | 7 | Serious | Serious | No | Serious | Undetected | 9453 | RR = 0.82 [0.67, 1.01] | Very low |
Decline of LVEF (L vs. T) | 9 | Serious | No | No | No | Undetected | 5890 | RR = 0.67 [0.50, 0.90] | Moderate |
Diarrhea (T+L vs. T) | 8 | Serious | Serious | No | No | Undetected | 9512 | RR = 8.32 [6.49, 10.68] | Low |
Diarrhea (L vs. T) | 11 | Serious | Serious | No | No | Undetected | 6488 | RR = 5.62 [4.41, 7.17] | Low |
Diarrhea (L vs. T, I-III) | 9 | Serious | No | No | No | Undetected | 5866 | RR = 7.90 [5.88, 10.62] | Moderate |
Diarrhea (L vs. T, MBC) | 2 | Serious | No | No | Serious | Undetected | 622 | RR = 0.99 [0.46, 2.15] | Low |
Diarrhea (L vs. T, neoadjuvant therapy) | 8 | Serious | No | No | No | Undetected | 1733 | RR = 6.97 [4.46, 10.91] | Moderate |
Diarrhea (L vs. T, palliative therapy) | 2 | Serious | No | No | Serious | Undetected | 622 | RR = 0.99 [0.46, 2.15] | Low |
Neutropenia (T+L vs. T) | 5 | Serious | No | No | Serious | Undetected | 906 | RR = 1.16 [0.86, 1.56] | Low |
Neutropenia (L vs. T) | 8 | Serious | Serious | No | Serious | Undetected | 2098 | RR = 0.99 [0.89, 1.09] | Very low |
Fatigue (T+L vs. T) | 4 | Serious | No | No | Serious | Undetected | 628 | RR = 0.84 [0.42, 1.67] | Low |
Fatigue (L vs. T) | 6 | Serious | No | No | Serious | Undetected | 1722 | RR = 1.44 [0.97, 2.11] | Low |
Rash/Skin toxicity (T+L vs. T) | 6 | Serious | No | No | No | Undetected | 9357 | RR = 6.75 [4.66, 9.77] | Moderate |
Rash/Skin toxicity (L vs. T) | 5 | Serious | No | No | No | Undetected | 6352 | RR = 8.71 [5.64, 13.45] | Moderate |
Vomiting (T+L vs. T) | 4 | Serious | No | No | Serious | Undetected | 599 | RR = 2.17 [0.91, 5.19] | Low |
Vomiting (L vs. T) | 6 | Serious | No | No | Serious | Undetected | 1718 | RR = 1.29 [0.69, 2.43] | Low |
Nausea (T+L vs. T) | 4 | Serious | No | No | Serious | Undetected | 599 | RR = 1.61 [0.64, 4.06] | Low |
Nausea (L vs. T) | 6 | Serious | No | No | Serious | Detected | 1718 | RR = 1.02 [0.58, 1.80] | Very low |