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360 Chapter 6: Breast Cancer<br />

DIFFERENCES BETWEEN EUROPE AND NORTH AMERICA<br />

Apart from the difference in the choice of the number of positive lymph nodes<br />

for high-risk operable breast cancer <strong>and</strong> the use of the combination of peripheral<br />

<strong>blood</strong> progenitor cells <strong>and</strong> <strong>autologous</strong> bone <strong>marrow</strong>, other differences exist<br />

between Europe <strong>and</strong> North America. First, the policy of treating patients outside a<br />

clinical trial seems less accepted in Europe, 7<br />

partly due to the fact that insurance<br />

coverage in Europe generally is provided by the treating center <strong>and</strong> not by the<br />

patients themselves.<br />

In many countries, insurance is still not required <strong>and</strong> this allows an easier<br />

accrual of patients in trials as in the case of other solid tumors.<br />

A common accreditation policy is not yet well established in Europe, <strong>and</strong> the<br />

EBMT together with ISHAGE published some guidelines (minimum number of<br />

patients treated per year, laboratory <strong>and</strong> <strong>blood</strong> bank facilities, etc.) which, it is<br />

hoped, will become m<strong>and</strong>atory for each European center in the near future. So far<br />

in Europe, high-dose chemotherapy <strong>and</strong> hematopoietic rescue has not been<br />

considered st<strong>and</strong>ard therapy for breast carcinoma of any stage, 9<br />

<strong>and</strong> the policy of<br />

treating patients outside clinical trials should be discouraged.<br />

REFERENCES<br />

1. Antman KH, Rowlings PA, Vaughan WP, Pelz CJ, Fay JW, Fields KK, Freytes CO, Gale<br />

RP, Hillner BE, Holl<strong>and</strong> HK, Kennedy MJ, Klein JP, Lazarus HM, McCarthy PL, Saez<br />

R, Spitzer G, Stadmauer EA, Williams SF, Wolff S, Sobocinski KA, Armitage JO,<br />

Horowitz MH: High-dose chemotherapy with <strong>autologous</strong> hematopoietic stem-cell sup­<br />

port for breast cancer in North America. / Clin Oncol 15:1870-1879, 1997<br />

2. Rosti G, Ferrante P, Pico JL, Leyvraz S, Crown J, Ladenstein R, Roché H, Biron P, Viens<br />

P, Niederwieser D, Chauvin F, Koscelniak E, Ledermann J, Marangolo M: Ongoing stud­<br />

ies <strong>and</strong> the EBMT database. In: Rosti G (ed) ESO Scientific Updates, vol. 3. Amsterdam:<br />

Elsevier <strong>Science</strong> B.V., 1998, p. 83-97.<br />

3. Gianni AM, Siena S, Bregni M, Di Nicola M, Orefice S, Cusumano F, Salvadori B, Luini<br />

A, Greco M, Zucali F, Rilke F, Zambetti M, Valagussa P, Bonadonna G: Efficacy, toxi­<br />

city, <strong>and</strong> applicability of high-dose sequential chemotherapy as adjuvant treatment in oper­<br />

able breast cancer with 10 or more involved axillary nodes. Five-year results. J Clin Oncol<br />

15:2312-2321, 1997.<br />

4. Rosti G, Albertazzi L, Ferrante P, Nicoletti P, Mor<strong>and</strong>i P, Bari M, Macchia S, Monti G,<br />

Argnani M, Sebastiani L, Marangolo M: Epirubicin + G-CSF as peripheral <strong>blood</strong> prog­<br />

enitor cells (PBPC) mobilizing agents in breast cancer patients. Ann Oncol 6:1045-1047,<br />

1995.<br />

5. Garcia-Conde J, Sola C, Solano C, Azagra P, Homedo J, Cortes-Funes H, Lopez JJ, Lluch<br />

A: High-dose chemotherapy (HDCT) <strong>and</strong> <strong>autologous</strong> peripheral stem-cell <strong>transplantation</strong><br />

(APSCT) after st<strong>and</strong>ard chemotherapy (CT) in high-risk breast cancer patients (> 10 axil­<br />

lary node involvement) after surgery. Proc ASCO 15:994, 1996.

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