Emerging modalities for adjuvant therapy of breast cancer: neoadjuvant chemotherapy.

There is evidence from theoretical models and experimental studies that indicates that preoperative timing of chemotherapy (neoadjuvant treatment) may be a superior treatment strategy than its use postoperatively. We have shown in our pilot study of 43 premenopausal patients with newly diagnosed cancer of the breast that administration of one cycle of CMF chemotherapy preoperatively was safe. Subsequently, a randomized study of preoperative against postoperative adjuvant chemotherapy has been started and to the present time, 98 patients have been randomized. Preliminary assessment of the randomized study confirmed the safety of the adjuvant chemotherapy with one course of cyclophosphamide, methotrexate, and 5-fluorouracil given preoperatively and also showed that the interval between diagnosis and the first course of chemotherapy can be substantially reduced. In addition to the preoperative timing, other aspects of the neoadjuvant approach are discussed. They include a more frequent utilization of fine needle aspiration so that the tissue diagnosis of breast cancer can be obtained and also refinement of diagnostic techniques, used before the preoperative treatment for the selection of high-risk patients (the neoadjuvant staging). The purpose of our presentation is not to recommend presently preoperative chemotherapy routinely but rather to indicate a need for well-controlled studies testing its appealing theoretical rationale. Its use in adjuvant therapy of breast cancer represents a major departure from the conventional management and, therefore, if the cooperation of practitioners and cooperative groups is to be secured, its rationale and safety must be well-defined.

RCT Entities:   Population Interventions Outcomes