Ragaz J
NCI Monogr. 1986(1):145-52.
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.
理论模型和实验研究的证据表明,术前化疗(新辅助治疗)可能是比术后使用更优的治疗策略。我们在对43例新诊断的绝经前乳腺癌患者的初步研究中表明,术前给予一个周期的CMF化疗是安全的。随后,一项术前与术后辅助化疗的随机研究已经启动,到目前为止,已有98例患者被随机分组。对该随机研究的初步评估证实了术前给予一个疗程的环磷酰胺、甲氨蝶呤和5-氟尿嘧啶辅助化疗的安全性,并且还表明诊断与第一个化疗疗程之间的间隔可以大幅缩短。除了术前时机外,还讨论了新辅助治疗方法的其他方面。它们包括更频繁地使用细针穿刺,以便获得乳腺癌的组织诊断,以及在术前治疗前用于选择高危患者(新辅助分期)的诊断技术的改进。我们展示的目的不是目前就常规推荐术前化疗,而是指出需要进行严格对照研究来检验其有吸引力的理论依据。其在乳腺癌辅助治疗中的应用代表了与传统治疗方法的重大背离,因此,如果要确保从业者和合作组的合作,其原理和安全性必须明确界定。