Breast Cancer · Medical · Neoadjuvant therapy

NSABP B-27

Does adding docetaxel to neoadjuvant doxorubicin/cyclophosphamide increase pathological response in operable breast cancer?

Population2,411 women with operable breast cancer.ArmsPreoperative AC alone; AC followed by preoperative docetaxel; or AC followed by surgery and postoperative docetaxel.Primary questionEffect of docetaxel sequencing on response, DFS and OS.Key endpointPathologic complete response and long-term disease outcomes.

Absolute Effect

pCR

26.1% vs 13.7% (+12.4 points)

Preoperative docetaxel after AC versus AC alone, P<.001.

Clinical complete response

63.6% vs 40.1% (+23.5 points)

Docetaxel increased clinical complete response after neoadjuvant AC.

Long-term outcomes

The final analysis found that adding docetaxel did not significantly improve OS, although DFS was modestly improved and local recurrence was reduced.

Clinical interpretation

B-27 demonstrates a large absolute improvement in pathological response from taxane intensification, but pCR is an intermediate endpoint and did not translate into a statistically significant overall-survival advantage in the overall historical cohort.

Toxicity

Grade 4 toxicity occurred in 10.3% during AC and 23.4% during docetaxel treatment in the preliminary report.

NNT / NNH

For pCR, the absolute increase of 12.4 points corresponds to an NNT of about 8 to produce one additional pCR. A formal NNH is not calculated because grade 4 toxicity was reported across treatment periods rather than as a clean randomized fixed-time comparison.

Primary / authoritative sources

NSABP B-27 final report — PubMed

B-27 response report — PubMed