摘要
乳腺癌是危害妇女健康的主要恶性肿瘤之一，全世界每年约有130万妇女患乳腺癌，有50万妇女死于乳腺癌。虽然我国是乳腺癌的低发区，近年来也出现明显的上升趋势，已跃居我国城市女性恶性肿瘤的第1～2位，并且具有发病年龄低、早期发现少的特点。对可手术乳腺癌应采取的治疗是以手术治疗为主的综合性治疗。化学治疗在以手术为主的综合治疗中占有重要地位，其目的之一是杀灭手术时已经存在的微小转移灶，并取得了肯定的疗效。新辅助化疗(neoadjuvant chemotherapy)是指在施行手术或放疗前应用的全身性化疗，又称为术前化疗、初始化疗和诱导化疗。目前已成为局部晚期乳腺癌的标准治疗，在较早期可手术乳腺癌中的应用是目前的研究热点之一。有效的新辅助化疗可使绝大多数的乳腺原发肿瘤缩小或消失，从而对乳腺癌手术治疗的方式产生积极的影响，但化疗药物存在诸多毒性，术前过多的化疗可能增加手术风险及术后并发症，对手术产生不利的影
郑州大学2004年硕士论文新辅助化疗在可手术乳腺癌中的应用研究
响。因此，如何正确运用新辅助化疗，新辅助化疗持续的时间及新辅
助化疗与手术的关系是临床治疗中应明确的问题。本研究选取nb期
以上的可手术乳腺癌患者进行新辅助化疗，以探讨新辅助化疗在可手
术乳腺癌中的合理应用。
材料与方法:
1.2001年1月一2004年1月河南省肿瘤医院乳腺科共收治Ilb期
以上的可手术乳腺癌患者526例，均为女性，年龄23一84岁，中位年
龄45岁。选取其中的219例患者为研究对象。其中Ilb期95例，ma
期no例，lllb期14例，随机分为新辅助化疗组和对照组。两组资
料经统计学分析具有可比性。入组标准:(1)年龄簇65岁，乳腺原发
肿瘤最大径>2.ocm且伴有腋淋巴结转移或乳腺原发肿瘤最大径
>5 .ocm;(2)术前B超检查排除胸壁和胸肌侵犯;(3)各项检查无明
显化疗禁忌症，血常规、肝功能和肾功能均正常、胸部X线片、腹
部B超和全身骨扫描排除远处转移，无心肺功能不全等;(4)治疗
前乳腺肿块均经空心针活检(eore needle biopsy，eNB)证实为癌，
腋窝肿大淋巴结经细针抽吸细胞学检查(fine needle aspiration，FNA)
以确定是否癌转移;(5)既往未用过任何治疗。
2.新辅助化疗组107例均采用“FEC”方案化疗3周期，每21
天为1周期:氟脉嚓陡(5一Fu)600mg/mZ，d1，8，持续6一8小时静脉
滴注;表阿霉素(EPI)75mg/mZ，d1，快速静脉滴注;环磷酞胺(CTX)
600m留mZ，d1，8，静脉注射。化疗结束2周内行手术治疗。对照组nZ
例在完善术前检查排除手术禁忌症后即行手术治疗。根据患者的临床
郑州大学2004年硕士论文新辅助化疗在可手术乳腺癌中的应用研究
分期、局部肿块的大小和位置、腋窝淋巴结转移情况等决定手术方式:
乳腺癌根治术、改良根治术或保乳手术。新辅助化疗前后采用体检、
乳腺B超等2种方法分别测量肿瘤最大径及垂直径，同一患者在化
疗前后以同一种方法测量对比，全部病例均由指定的医生，每次至少
两人同时检查，每1化疗周期结束时体检1次;根据UICC制定的乳
腺癌化疗后效果评价标准评价新辅助化疗的疗效。按照WHO的抗癌
药物常见毒副反应分级标准评价新辅助化疗的毒性反应。
3.所有数据应用SPSS10.0统计软件进行统计分析，计数资料之
间比较采用x“检验，以Q二0.05作为检验水准。
结果:
1.新辅助化疗组总有效率(CR十PR)为72.90%，其中临床完全
缓解(CR)15例(14.02%)，部分缓解63例(58.88%)，肿瘤无变
化者29例(27.10%)，无病变进展病例。新辅助化疗使63.04%(29/46)
的Ilb期、60.00%(33/55)的Ixla期肿瘤分期降低。新辅助化疗3周
期后，原发肿瘤大于3cm的患者中有12例临床完全缓解，46例缩小
到3cm以下。2.新辅助化疗胃肠道毒性反应主要表现为恶心、呕吐，
其中I度51例，n度39例，m度3例，未见IV度反应，予以对症
治疗2一3天后症状均缓解。骨髓抑制为主要的血液学毒性反应，以
白细胞降低较为明显，其中I度32例，11度54例，m度9例，未见
IV度反应。未发生由于粒细胞减少引起的严重感染和发热。97.20%
(104/107)患者出现脱发反应。全组患者未发生因化疗而引起严重
肝、肾功能改变者，无充血性心力衰竭、心肌梗塞和需药物治疗的心
郑州大学2(协毒年硕士论文新辅助化疗在可手术乳腺癌中的应用研究
律失常。
3.新辅助化疗组行根治术和改良根治术的比例分别为7.48%
(8/107)和86.91%(93/107)，对照组为18.75%(21/112)和75.00%
(84/112)，差异有统计学意义。保乳手术的比例两组无明显差异，
新辅助化疗组为5.61%(6/107)，对照组为6.25%(7/112)。
4.两组术后切口感染与皮瓣坏死的情况相似，无明显差异。对照
组上肢水肿和上肢运动障碍的发生率较新辅助化疗组高，统计学分析
有显著差异。
结论:
1.“FEC”方案新辅助化疗3周期，患者耐受性好，不增加手术
后并发症的发生率，安全可行;
2.新辅助化疗可缩小原发肿瘤及淋巴结，使部分肿瘤从不可切
除转化为可切除，并可降低可手术乳腺癌的手术难度，缩小手术范围，
减少术后并发症的发生，改善患者的生存质量。
3.新辅助化疗使保乳手术指征不局限于
Breast cancer is one of the most common malignant tumors for women, there are more than 1300,000 new cases of breast cancer worldwide every year. Although its incidence is low in our country, but continues to rise for the past few years, occupying the first place in many cities with the characteristics of younger and locally advanced breast cancer. Surgical treatment is a major means in combined modality therapy for operable breast cancer. Chemotherapy is one of the most important modality and eliminate micrometastases tumor. Neoadjuvant chemotherapy which is referred to preoperative, primary or induction chemotherapy of cancer given before local treatment, such as surgery or radiation, has become the standard of care in the management of patients with locally advanced breast cancer (LABC), and is currently one study
focus for treatment in patients with operable breast cancers.
Neoadjuvant chemotherapy can reduce the size of most primary tumors and have a positive affection on surgery type, but chemotherapeutant has many adverse effects. Overfull preoperative chemotherapy may increase the risk and complications of surgical treatment. Thus, we ought to well define how to operate the neoadjuvant chemotherapy correctly, how many cycles of neoadjuvant chemotherapy is reasonable and coordinate the relationship of the neoadjuvant chemotherapy and surgery. In our study, operable breast cancer with stage lib, Ilia and Illb were treated with neoadjuvant chemotherapy, and investigate the efficacy and rationality of neoadjuvant chemotherapy in operable breast cancer patients.
Materials and methods
1. Between January 2001 and January 2004, 526 women with clinical stage lib, Ilia and Illb operable breast cancer were treated in department of breast at Henan Tumor hospital. The mean age was 45 years (range, 23 to 84 years). 216 patients were enrolled onto the study, 95 patients were lib and 110 were Ilia, 14 were Illb. All patients were randomized to preoperative group and control group, to ensure that the two groups were similar. Study design and selection of patients : (1) age 65 years, clinical tumor size>2cm with positive axillary nodes or clinical tumor size>5.0cm ; (2) Tumor extension to chest wall or chest muscle by
ultrasonography were excluded; (3) Pretreatment evaluation included physical examination, blood count and serum chemistry, electrocardiogram, chest X-ray, abdominal ultrasonography and ECT bone scan, patients with distant metastases were excluded; (4) All patients with breast cancer were diagnosed by core needle biopsy, and metastatic involvement of axillary nodes were performed by fine-needle aspiration; (5) Patients receive no therapy before.
2. 107 Patients in neoadjuvant group were treated with three cycles of FEC, at intervals of 21 days: 5-fluorouracil -600mg/m intravenously as a 6- 8-hours infusion on day 1 and day 8; epirubicin-75 mg/m, intravenously on day 1; cyclophosphamide-600mg/m, intravenously on day 1 and day 8. Surgical therapy followed within two weeks of the third course of chemotherapy. In control group 112 patients were performed operation after regular examination excluding surgical contraindication. Before surgery patients were assessed with clinical stage, tumor size and location, axillary lymph nodal status, and then were advised to undergo breast conservation surgery, modified radical mastectomy or radical mastectomy. The two largest perpendicular diameters of primary breast tumors were measured by physical examination and ultrasonography before and after the administration of neoadjuvant chemotherapy. To have been considered assessable for tumor response, every patient must be assessed by two doctors respectively, and had bidimensional
measurements recorded after the end of every cycle. Before neoadjuvant chemotherapy or surgery all patients evaluated by routinely examination, such as physical examination, a complete blood cell count with differential count, hepatic and renal function, electrocardiogram, chest X-ray, abdomen ultrasonography, bone-scanning. Clinical response
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