CAJ | 학술논문

目的探讨西妥昔单抗联合化疗对K-ras基因状态不明的晚期结直肠癌患者的疗效和安全性.方法收集2005年3月至2008年12月间在中山大学肿瘤防治中心接受西妥昔单抗联合化疗的102例晚期结直肠癌患者的资料,统计患者的有效率(ORR)、疾病控制率(DCR)、无进展生存时间(PFS)和总生存期(OS).比较一线与非一线化疗联合应用西妥昔单抗、含奥沙利铂方案与含伊立替康方案的ORR、DCR、PFS和OS的差异.结果 102例患者的ORR和DCR分别为43.1%和74.5%,中位PFS和OS分别为4.0个月和28.5个月,1、3和5年生存率分别为89.2%、50.9%和27.5%.一线与非一线应用西妥昔单抗联合化疗患者的ORR(50.0%和40.0%,P=0.344)、DCR(78.1%和72.9%,P=0.571)和OS(51.0和35.0个月,P=0.396)差异均无统计学意义,但一线应用西妥昔单抗联合化疗患者的PFS(5.5个月)较非一线者显著延长(3.0个月,P=0.001).应用含奥沙利铂方案治疗与应用含伊立替康方案治疗患者的ORR(54.2%和40.0%,P=0.223)、DCR(79.2%和74.7%,P=0.654)、PFS(5.0个月和3.0个月,P=0.726,)和OS(36.0个月和40.0个月,P=0.759)比较,差异均无统计学意义.常见的不良反应有痤疮样皮疹(80.4%,3～4级9.8%)、中性粒细胞下降(66.7%,3～4级18.6%)、腹泻(19.6%,3～4级5.9%),无与治疗相关性死亡病例.结论西妥昔单抗联合化疗治疗K-ras基因状况不明的晚期结直肠癌患者的有效率较高,中位生存时间较长,不良反应少且程度轻.比较一线与非一线应用西妥昔单抗治疗、含奥沙利铂方案与含伊立替康方案间的疗效均无明显差异.
목적 탐토서타석단항연합화료대K-ras기인상태불명적만기결직장암환자적료효화안전성.방법 수집2005년3월지2008년12월간재중산대학종류방치중심접수서타석단항연합화료적102례만기결직장암환자적자료,통계환자적유효솔(ORR)、질병공제솔(DCR)、무진전생존시간(PFS)화총생존기(OS).비교일선여비일선화료연합응용서타석단항、함오사리박방안여함이립체강방안적ORR、DCR、PFS화OS적차이.결과 102례환자적ORR화DCR분별위43.1%화74.5%,중위PFS화OS분별위4.0개월화28.5개월,1、3화5년생존솔분별위89.2%、50.9%화27.5%.일선여비일선응용서타석단항연합화료환자적ORR(50.0%화40.0%,P=0.344)、DCR(78.1%화72.9%,P=0.571)화OS(51.0화35.0개월,P=0.396)차이균무통계학의의,단일선응용서타석단항연합화료환자적PFS(5.5개월)교비일선자현저연장(3.0개월,P=0.001).응용함오사리박방안치료여응용함이립체강방안치료환자적ORR(54.2%화40.0%,P=0.223)、DCR(79.2%화74.7%,P=0.654)、PFS(5.0개월화3.0개월,P=0.726,)화OS(36.0개월화40.0개월,P=0.759)비교,차이균무통계학의의.상견적불량반응유좌창양피진(80.4%,3～4급9.8%)、중성립세포하강(66.7%,3～4급18.6%)、복사(19.6%,3～4급5.9%),무여치료상관성사망병례.결론 서타석단항연합화료치료K-ras기인상황불명적만기결직장암환자적유효솔교고,중위생존시간교장,불량반응소차정도경.비교일선여비일선응용서타석단항치료、함오사리박방안여함이립체강방안간적료효균무명현차이.
Objective To study the efficacy and safety of cetuximab combined with chemotherapy for patients with advanced colorectal cancer (ACRC) and unclear K-ras status. Methods Clinical data of 102 ACRC patients, treated by cetuximab combined with chemotherapy in Sun Yat-sen Cancer Center from March 2005 to December 2008, were collected. The cumulative survival rate, objective response rate (ORR), disease control rate (DCR), progression free survival (PFS) of the cases were calculated. The difference in ORR, DCR, PFS and oval survival (OS) between the regimens used as first-line and non-firstline treatment, and between the regimens including oxaliplatin and irinotecan were compared. Results The overall ORR of cetuximab plus chemotherapy was 43.1%, DCR 73.5 %, median PFS 4.0 months, OS 28.5months, and the l-year, 3-year, and 5-year survival rate was 89.2%, 50.9% and 27.5%, respectively.The differences in ORR (50.0% vs. 40.0%, P=0.344), DCR (78.1% vs. 72.9%, P=0.571) and OS (51.0 months vs. 35.0 months, P =0. 396) between the regimens as first line and as non-first line treatment were not statistically significant. However, the PFS of the regimen as first-line was longer than that as non-first-line treatment (PFS 5.5 months vs. 3.0 months, P=0.001). The differences in ORR (54.2% vs.40.0% ,P=0.223), DCR (79.2% vs. 74.7%, P=0.654), PFS (5.0 months vs. 3.0 months, P=0.726) and OS ( 36.0 months vs. 40. 0 months, P = 0. 759 ) between cetuximab plus oxliplatin and irinotecan were not statistically significant. The most common side effects of cetuximab plus chemotherapy were acneiform eruption (80.4%, grade 3 ～ 4 in 9.8% ), neutropenia (66.7%, grade 3 ～ 4 in 18.6% ), and diarrhea ( 19.6%, grade 3 ～ 4 in 5.9% ). No treatment-related death was recorded. Conclusion Patients with advanced colorectal cancer and unclear K-ras treated by cetuximab combined with chemotherapy have good ORR and OS, and the regimen is safe with less adverse events for them. There is no significant difference between the efficacies of regimens as first line and as non-first line treatment, and between cetuximab plus oxliplatin and cetuximab plus irinotecan regimens.