CAJ | 학술논문

目的：比较EC序贯P 剂量密集方案与TEC方案在乳腺癌新辅助化疗中的疗效和不良反应。方法对2011年2月至2012年8月收治的64例Ⅱa期～Ⅲc期乳腺癌新辅助化疗患者进行回顾性分析，根据化疗方案分为剂量密集组（31例）和TEC组（33例），术前分别接受3～8个周期EC序贯P剂量密集方案和2～6个周期TEC方案新辅助化疗。密集方案：E（表阿霉素）90 mg／m2 d1，联合C（环磷酰胺）600 mg／m2 d1，每14天为1周期，共4个周期，序贯至P（紫杉醇）175 mg／m2d1，每14天为1周期，共4个周期。 TEC方案：T（多西紫杉醇）75 mg／m2d1，E 70 mg／m2 d1，C 600 mg／m2d1，每21天为1周期。按照实体瘤的疗效评价标准（ RECIST ）1?1和术后病理组织学结果评定疗效，按照不良事件常用术语评定标准4?0版（ CTCAE 4?0）评价不良反应。结果全组64例患者均可评价疗效。剂量密集组和TEC组的病理完全缓解率分别为16?1％和12?1％，有效率分别为80?6％和66?7％，两组的病理完全缓解率和有效率的差异无统计学差异（ P＞0?05）；剂量密集组和TEC组的1、2年无病生存率分别为93?5％、86?7％和93?9％、81?8％，1、2年总生存率分别为100?0％、90?3％和100?0％、85?8％，且两组无病生存率和总生存率的差异均无统计学差异（ P＞0?05）；TEC组3～4级中性粒细胞下降的发生率高于剂量密集组（6?4％ vs．33?3％，P＝0?012），剂量密集组1～2级神经毒性（80?6％ vs．36?4％，P＜0?001）和肌肉关节酸痛（67?7％ vs．30?3％，P＝0?005）的发生率均高于TEC组。结论剂量密集EC序贯P新辅助化疗方案与TEC方案疗效相似，毒副反应可以耐受，但安全性更好，有延长无病生存期和总生存期的趋势，是新辅助化疗的优选方案。
목적：비교EC서관P 제량밀집방안여TEC방안재유선암신보조화료중적료효화불량반응。방법대2011년2월지2012년8월수치적64례Ⅱa기～Ⅲc기유선암신보조화료환자진행회고성분석，근거화료방안분위제량밀집조（31례）화TEC조（33례），술전분별접수3～8개주기EC서관P제량밀집방안화2～6개주기TEC방안신보조화료。밀집방안：E（표아매소）90 mg／m2 d1，연합C（배린선알）600 mg／m2 d1，매14천위1주기，공4개주기，서관지P（자삼순）175 mg／m2d1，매14천위1주기，공4개주기。 TEC방안：T（다서자삼순）75 mg／m2d1，E 70 mg／m2 d1，C 600 mg／m2d1，매21천위1주기。안조실체류적료효평개표준（ RECIST ）1?1화술후병리조직학결과평정료효，안조불량사건상용술어평정표준4?0판（ CTCAE 4?0）평개불량반응。결과전조64례환자균가평개료효。제량밀집조화TEC조적병리완전완해솔분별위16?1％화12?1％，유효솔분별위80?6％화66?7％，량조적병리완전완해솔화유효솔적차이무통계학차이（ P＞0?05）；제량밀집조화TEC조적1、2년무병생존솔분별위93?5％、86?7％화93?9％、81?8％，1、2년총생존솔분별위100?0％、90?3％화100?0％、85?8％，차량조무병생존솔화총생존솔적차이균무통계학차이（ P＞0?05）；TEC조3～4급중성립세포하강적발생솔고우제량밀집조（6?4％ vs．33?3％，P＝0?012），제량밀집조1～2급신경독성（80?6％ vs．36?4％，P＜0?001）화기육관절산통（67?7％ vs．30?3％，P＝0?005）적발생솔균고우TEC조。결론제량밀집EC서관P신보조화료방안여TEC방안료효상사，독부반응가이내수，단안전성경호，유연장무병생존기화총생존기적추세，시신보조화료적우선방안。
Objective To compare the efficacy and safety of dose?dense EC followed by P regimen versus TEC regimen in neoadjuvant chemotherapy for breast cancer. Methods In a retrospective comparison, the clinical data of 64 breast cancer patients with stage Ⅱa?Ⅲc in our hospital from February 2011 to August 2012 were analyzed. According to the chemotherapy regimen, 31 cases received dose?dense EC followed by P regimen for 3?8 cycles before surgery( dose?dense group) , and 33 cases received TEC regimen for 2?6 cycles before surgery(TEC group). Dose?dense regimen was as follows: epirubicin(90 mg/m2, d1) plus cyclophosphamide (600 mg/m2, d1) every two weeks for four cycles followed by paclitaxel(175 mg/m2, d1) every two weeks for four cycles. TEC regi?men was as follows:docetaxel(75 mg/m2, d1), epirubicin(70 mg/m2, d1) and cyclophosphamide(600 mg/m2, d1) every 21 days. Response to chemotherapy was assessed by RECIST criteria 1?1 and histopathological reaction after surgery. The toxicity was evaluated according to Common Terminology Criteria Adverse Events( CTCAE) 4?0. Results All patients were evaluable for efficacy and toxici?ty. The assessments of 64 patients were available. The pathologic complete response rates were 16?1% and 12?1%, and the response rates were 80?6% and 66?7% in dose?dense group and TEC group, respectively. No difference was observed on the pathologic complete response rate and response rate between both groups. The 1?, 2?year disease free survival rates were 93?5% and 86?7% in dose?dense group and 93?9% and 81?8% in TEC group, and the 1?, 2?year overall survival rates were 100?0% and 90?3% in dose?dense group and 100% and 85?8% in TEC group without significant difference( P>0?05) . There were higher incidences of grade 1?2 neurotoxicity ( 80?6% vs. 36?4%) and muscle arthrosis ache ( 67?7% vs. 30?3%) but a lower incidence of grade 3?4 neutropenia ( 6?4% vs. 33?3%) in dose?dense group versus TEC group( P<0?05) . Conclusion The efficacy of dose?dense and TEC neoadjuvant chemothera?py regimens are similar. The dose?dense regimen is well tolerated and more secure, which showed a non?significant trend toward better disease free survival and overall survival when compared with the TEC regimen. It is a preferred regimen in neoadjuvant chemotherapy.