Adjuvant combination chemotherapy for operable breast cancer. Trials in progress at the Istituto Nazionale Tumori of Milan.

Adjuvant trials ongoing at the Istituto Nazionale Tumori of Milan for operable breast cancer with nodal involvement are reviewed in this paper. In the first trial (cyclophosphamide, methotrexate, 5-fluorouracil [CMF] versus control), the early 5-year results confirm the usefulness of combination chemotherapy in significantly affecting the relapse-free survival (RFS) and total survival rates. The degree of axillary node involvement remains the most important prognostic indicator also in patients receiving adjuvant chemotherapy. The contention concerning the therapeutic effect of CMF in pre- versus postmenopausal women is overcome by the observation that about 80% of patients receiving greater than 85% of the planned dose are surviving relapse free at 5 years regardless of their menopausal status. The 3-year results of the second CMF trial indicate that both RFS and total survival are comparable between the groups receiving 12 or 6 cycles of adjuvant CMF. The results were not affected by drug-induced amenorrhea nor by estrogen receptor status. Provided the percent of dose administered is high, there is probably no real advantage in prolonging CMF chemotherapy beyond the sixth month. However, the results are still preliminary.