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

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82 Breast Cancer <strong>KCE</strong> <strong>reports</strong> 63<br />

Chemotherapy for <strong>in</strong>vasive breast cancer.<br />

Study ID Ref Search<br />

date<br />

Anthracycl<strong>in</strong>e-based regimens<br />

Arriagada 2005 [82] 311 high risk N0<br />

premenopausal<br />

women<br />

835 high risk<br />

postmenopausal<br />

women<br />

Hutch<strong>in</strong>s 2005 [83] Women <strong>with</strong> T1 to<br />

T3a node negative<br />

<strong>in</strong>vasive<br />

adenocarc<strong>in</strong>oma<br />

Poole 2006 [182] Early breast cancer<br />

(T1-3)<br />

(n= 2391)<br />

Population Intervention Outcomes Results Comments Study<br />

type<br />

No adjuvant<br />

chemotherapy (n = 573)<br />

vs. 6 courses of<br />

anthracycl<strong>in</strong>e-based<br />

chemotherapy (FAC or<br />

FEC) (n = 573)<br />

CMF (cyclophosphamide,<br />

methotrexate and<br />

fluorouracil) vs. CAF<br />

(cyclophosphamide,<br />

doxorubic<strong>in</strong> and<br />

fluroruracil) <strong>with</strong> or<br />

<strong>with</strong>out tamoxifen (TAM)<br />

NEAT:<br />

4 cycles of epirubic<strong>in</strong><br />

followed by 4 cycles of<br />

CMF<br />

versus 6 cycles of CMF<br />

alone<br />

BR9601<br />

4 cycles of epirubic<strong>in</strong><br />

followed by 4 cycles of<br />

CMF<br />

versus 8 cycles of CMF<br />

alone<br />

10-year survival<br />

10-year distant<br />

metastasis<br />

10 year local<br />

recurrence rates<br />

Disease free<br />

survival (DFS)<br />

Overall survival<br />

(OS)<br />

Disease free<br />

survival (DFS)<br />

Overall survival<br />

(OS)<br />

Survival: 60% <strong>in</strong> control group and 65% <strong>in</strong> CT<br />

group): p = 0.01<br />

Metas: 28% (control) and 23% (CT group): p<br />

= 0.02<br />

Local rec: 12% (control) and 10% (CT<br />

group): p= 0.024<br />

Chemotherapy was significantly less effective<br />

<strong>in</strong> post menopausal women <strong>with</strong> estrogen<br />

receptor tumors.<br />

After up to 10 years of follow-up, deferr<strong>in</strong>g<br />

radiotherapy after chemotherapy did not<br />

compromise local control<br />

Ten years estimates <strong>in</strong>dicated that CAF was<br />

not significantly better than CMF for DFS.<br />

Slight effect of CAF on OS (IC 0.99 to 1.43)<br />

Greater toxicity of CAF<br />

Epirubic<strong>in</strong> + CMF is superior to CMF alone<br />

as adjuvant treatment<br />

Randomization after<br />

primary surgery<br />

In post menop women: + at<br />

least 2 years tamoxifen<br />

Comb<strong>in</strong>ed results of 2<br />

RCTs<br />

Comb<strong>in</strong>ed two studies<br />

RCTs<br />

RCT High<br />

RCT High<br />

Level of<br />

evidence<br />

High

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