Report in English with a Dutch summary (KCE reports 63A)

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86 Breast Cancer KCE reports 63 Study ID Ref Search date Bear HD 2006 [191] NA Women with operable breast cancer (n = 2411) Gianni L 2005 [192] NA 1355 women T2-T3, N0-N1, M0 Population Intervention Outcomes Results Comments Study type Preoperative AC (doxorubicin and cyclophosphamide) followed by surgery, or AC followed by T (docetaxel) and surgery, or AC followed by surgery and then T Adjuvant doxorubicin followed by i.v. cyclophosphamide, methotrexate, and fluorouracil (CMF; doxorubicin-->CMF, arm A) vs. the same regimen plus paclitaxel (doxorubicin/ paclitaxel-- >CMF) as adjuvant (arm B) or primary systemic therapy (PST, arm C) Addition of T to AC did not significantly impact DFS or OS. There were trends toward improved DFS with addition of T. The addition of T reduced the incidence of local recurrences as first events (P = .0034). Preoperative T, but not postoperative T, significantly improved DFS in patients who had a clinical partial response after AC (HR = 0.71; 95%CI, 0.55 to 0.91; P = .007). Pathologic complete response, which was doubled by addition of preoperative T, was a significant predictor of OS regardless of treatment (HR = 0.33; 95% CI, 0.23 to 0.47; P < .0001). Pathologic nodal status after chemotherapy was a significant predictor of OS (P < .0001). Grade 3 or 4 National Cancer Institute toxicities were low (
KCE reports 63 Breast Cancer 87 Study ID Ref Search date Cleator SJ 2005 Danforth DN 2003 [193] NA 309 women Operable breast cancer [194] NA 53 BC T2N0, T1N1, T2N1 High-dose chemotherapy with stem-cell Tx Population Intervention Outcomes Results Comments Study type Primary surgery followed by 8 cycles of adjuvant mitoxantrone, methotrexate with tamoxifen (2MT) or 2MT with mitomycin-C (3MT) versus the same regimen for 4 cycles before followed by 4 cycles after surgery Either preop, either postop Same chemo: FU, Leucovorin, doxorubicin and cyclphosphamide (FLAC)/granulocyte colony stimulating factor Clinical response rate Pathologic complete response OS DFS After 10 years follow-up there is no statistically significant difference in diseasefree survival (DFS) (71% versus 71%) or overall survival (OS) (63% versus 70%) when comparing adjuvant versus neoadjuvant treatment, respectively. Of 144 evaluable patients in the neoadjuvant arm, 74 achieved a good clinical response and 70 patients achieved a poor clinical response. Good responders had a superior DFS (80% versus 64%, P=0.01) and OS (77% versus 63%, P=0.03) compared to poor responders. RCT High No significant difference RCT High Level of evidence
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ii Nationale praktijkrichtlijn voor
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