Is adjuvant systemic therapy necessary for all axillary node negative breast cancer patients?

One hundred eighty-six breast cancer patients with either T1 or T2 primary tumors and negative axillary lymph nodes (N-) underwent only local therapy at Norwalk Hospital from 1978-83. No adjuvant chemotherapy or hormone therapy was given for this favorable group of patients. The actuarial five-year disease free (NED) survival rate for these (N-) patients was 91% (+/- 3%, 95% confidence limits) and the ten-year NED survival rate was 79% (+/- 8%). These NED survival rates are vastly superior to the NED survival rates quoted by the National Cancer Institute (NCI) Clinical Alert for (N-) breast cancer patients who received no adjuvant therapy (67%-77% at three to four years median follow-up time). The NCI Clinical Alert is based on three clinical trials which included (N-) patients with larger tumors than T1 or T2 and excluded patients with small primary tumors. Based on these three clinical trials which demonstrated improved NED survival for (N-) patients treated with adjuvant therapy compared to nontreated patients, the NCI Clinical Alert recommended that adjuvant therapy be considered for all (N-) patients. We conclude that it is premature to recommend that all (N-) breast cancer patients should routinely receive adjuvant therapy until more information is available.