Summary of findings for the main comparison. High‐dose chemotherapy versus chemotherapy without bone marrow transplant or stem cell rescue.
High‐dose chemotherapy versus chemotherapy without bone marrow transplant or stem cell rescue | ||||||
Population: women with early poor prognosis breast cancer Setting: Tertiary Intervention: High‐dose chemotherapy Comparison: Chemotherapy without bone marrow transplant or stem cell rescue (standard chemotherapy) | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with standard chemotherapy | Risk with high dose chemotherapy | |||||
Overall survival at 5‐year follow‐up | 672 per 1000 | 672 per 1000 (645 to 698) | RR 1.00 (0.96 to 1.04) | 3566 (8 RCTs) |
⨁⨁⨁⨁ HIGH | |
Event‐free survival at 5‐year follow‐up | 578 per 1000 | 601 per 1000 (572 to 630) | RR 1.04 (0.99 to 1.10) | 3566 (8 RCTs) | ⨁⨁⨁⨁ HIGH | |
Treatment‐related mortality | 2 per 1000 | 14 per 1000 (7 to 28) | RR 7.97 (3.99 to 15.92) | 5600 (14 RCTs) | ⨁⨁⨁⨁ HIGH | Most deaths occurred within the first year of treatment |
Second cancers at 4 ‐ 9‐year median follow‐up | 25 per 1000 | 31 per 1000 (23 to 43) | RR 1.25 (0.90 to 1.73) | 3423 (7 RCTs) | ⨁⨁⨁⨁ HIGH | |
*The risk in the intervention group (and its 95% confidence interval) is based on the median 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: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |