Summary of findings 2. Platinum‐containing regimens and toxicity profile.
| Platinum compared to non‐platinum chemotherapy regimens for treatment related death, nausea/vomiting, nephrotoxicity, anaemia, hair loss, leukopaeniaand treatment discontinuation due to adverse event | ||||||
| Patient or population: women with metastatic triple‐negative breast cancer (mTNBC) Setting: hospital Intervention: platinum Comparison: non‐platinum chemotherapy regimens | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (treatment‐ comparisons) | Quality of the evidence (GRADE) | Comments | |
| Risk with non‐platinum chemotherapy regimens | Risk with platinum containing regimens | |||||
| Treatment‐related death (safety population) | 5 per 1000 1 | 5 per 1,000 (1 to 23) | (RR 1.06, 95% CI 0.24 to 4.61) | 843 (5) | ⊕⊕⊝⊝ LOW 3 | Heterogeneity: P = 0.69, I2 0% |
| Nausea/vomiting* grade 3 or 4 (safety population) | 15 per 1,000 1 | 72 per 1,000 (29 to 177) | (RR 4.77, 95% CI 1.93 to 11.81) | 655 (3) | ⊕⊕⊝⊝ LOW 3 | Heterogeneity: P = 0.32, I2 12% |
| Nephrotoxicity (safety population) | ‐ | ‐ | ‐ | ‐ | ‐ | No trials reported this outcome for mTNBC patients. |
| Anaemia grade 3 or 4 (safety population) | 36 per 1,000 1 | 137 per 1,000 (81 to 231) | (RR 3.80, 95% CI 2.25 to 6.42) | 843 (5) | ⊕⊕⊝⊝ LOW 24 | Heterogeneity: P = 0.04, I2 65% |
| Hair loss (safety population) | 3 per 1000 1 | 1 per 1,000 (0 to 24) | (RR 0.33, 95% CI 0.01 to 8.04) | 602 (2) | ⊕⊕⊝⊝ LOW 3 | Heterogeneity not applicable |
| Leukopaenia (safety population) | 155 per 1000 1 | 169 per 1000 (130 to 220) | (RR 1.09, 95% CI 0.84 to 1.42) | 843 (5) | ⊕⊕⊕⊝ MODERATE 2 | Heterogeneity: P = 0.75, I2 0% |
| Treatment discontinuation due to adverse event (safety population) | 93 per 1000 1 | 82 per 1000 (55 to 123) | (RR 0.88, 95% CI 0.59 to 1.32) | 843 (5) | ⊕⊕⊕⊝ MODERATE 2 | Heterogeneity: P = 0.07, I2 57% |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; | ||||||
|
GRADE Working Group grades of evidence
High quality (⊕⊕⊕⊕): We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality (⊕⊕⊕⊝): We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality (⊕⊕⊝⊝): Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality (⊕⊝⊝⊝ or ⊝⊝⊝⊝): We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect Each ⊝ symbol represents a downgrading of the quality of evidence one level from the highest level of 'high quality (⊕⊕⊕⊕).' | ||||||
1Estimated from all treatment‐comparisons contributing data for pooling for this outcome (including treatment‐comparisons with non‐estimable effects due to no events in either arm).
2Downgraded quality of evidence one level for 'serious imprecision' because the confidence interval for the pooled estimate is wide.
3Downgraded quality of evidence two levels for 'very serious imprecision' because the confidence interval for the pooled estimate is very wide.
4Downgraded quality of evidence one level for 'serious inconsistency' because there was evidence of heterogeneity across studies (P < 0.05)
*data on vomiting was included if data on nausea/vomiting was reported separately