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

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

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<strong>KCE</strong> <strong>reports</strong> 63 Breast Cancer 75<br />

Study ID Ref Search<br />

date<br />

Martelli G 2005 [170] NA Women, 65 to<br />

80 years of age,<br />

<strong>with</strong> early<br />

breast cancer<br />

(T ≤2 cm) and<br />

Population Intervention Outcomes Results Comments Study<br />

type<br />

cN0<br />

Tom<strong>in</strong>aga T 2004 [171] NA Stage II breast<br />

cancer (T2 N0<br />

or T2 N1a)<br />

(n=1209)<br />

Louis-Sylvestre C<br />

2004<br />

[78] NA Patients <strong>with</strong> a<br />

breast<br />

carc<strong>in</strong>oma less<br />

than 3 cm <strong>in</strong><br />

diameter and<br />

N0M0 (n=658)<br />

Conservative breast<br />

surgery <strong>with</strong>(n = 109)<br />

or <strong>with</strong>out axillary<br />

dissection (n = 110)<br />

Level II (n = 604) vs.<br />

level III axillary node<br />

dissection (n = 605)<br />

Lumpectomy plus<br />

axillary radiotherapy (n<br />

= 332) versus<br />

lumpectomy plus<br />

axillary dissection (n =<br />

326)<br />

MeSH term(s) used: Breast Neoplasms, Lymphatic Metastasis.<br />

Axillary events<br />

Overall mortality<br />

Breast cancer mortality<br />

Breast events<br />

Survival<br />

Disease-free survival<br />

Survival<br />

Axillary events<br />

No significant differences <strong>in</strong> overall or<br />

breast cancer mortality, or crude<br />

cumulative <strong>in</strong>cidence of breast events<br />

10-year cumulative survival rate: 86.6%<br />

after level II vs. 85.7% after level III<br />

axillary dissection (HR 1.02; P = 0.931,<br />

log rank test)<br />

10-year disease-free survival rate: 73.3%<br />

vs. 77.8% respectively (HR 0.94, P =<br />

0.666)<br />

Overall survival and disease-free survival<br />

rates <strong>in</strong> the two groups were similar after<br />

both procedures<br />

Increased survival rate <strong>in</strong> the axillary<br />

dissection group at 5 years (p=0.009), but<br />

not at 10 and 15 years (73.8% v 75.5% at<br />

15 years).<br />

Recurrences <strong>in</strong> the axillary node were<br />

less frequent <strong>in</strong> the axillary dissection<br />

group at 15 years (1% v 3%; p=0.04).<br />

There was no difference <strong>in</strong> recurrence<br />

rates <strong>in</strong> the breast or supraclavicular and<br />

distant metastases between the two<br />

groups.<br />

RCT High<br />

RCT High<br />

RCT High<br />

Level of<br />

evidence

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