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. 2016 May 20;2016(5):CD003139. doi: 10.1002/14651858.CD003139.pub3

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 evidenceHigh 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