Guo Gui-fang, Xia Liang-ping, Qiu Hui-juan, Xu Rui-hua, Zhang Bei, Jiang Wen-qi, Zhou Fei-fei, Wang Fang
State Key Laboratory of Oncology in South China, Guangzhou, China.
Zhonghua Zhong Liu Za Zhi. 2010 Oct;32(10):777-81.
To study the efficacy and safety of cetuximab combined with chemotherapy for patients with advanced colorectal cancer (ACRC) and unclear K-ras status.
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-first-line treatment, and between the regimens including oxaliplatin and irinotecan were compared.
The overall ORR of cetuximab plus chemotherapy was 43.1%, DCR 73.5%, median PFS 4.0 months, OS 28.5 months, and the 1-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.
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.
研究西妥昔单抗联合化疗用于K-ras状态不明的晚期结直肠癌（ACRC）患者的疗效及安全性。
收集2005年3月至2008年12月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ACRC患者的临床资料。计算病例的累积生存率、客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）。比较一线治疗方案与非一线治疗方案之间，以及含奥沙利铂方案与含伊立替康方案之间的ORR、DCR、PFS和总生存期（OS）的差异。
西妥昔单抗联合化疗的总体ORR为43.1%，DCR为73.5%，中位PFS为4.0个月，OS为28.5个月，1年、3年和5年生存率分别为89.2%、50.9%和27.5%。一线治疗方案与非一线治疗方案之间的ORR（50.0%对40.0%，P = 0.344）、DCR（78.1%对72.9%，P = 0.571）和OS（51.0个月对35.0个月，P = 0.396）差异无统计学意义。然而，一线治疗方案的PFS长于非一线治疗方案（PFS 5.5个月对3.0个月，P = 0.001）。西妥昔单抗联合奥沙利铂方案与联合伊立替康方案之间的ORR（54.2%对40.0%，P = 0.223）、DCR（79.2%对74.7%，P = 0.654）、PFS（5.0个月对3.0个月，P = 0.726）和OS（36.0个月对40.0个月，P = 0.759）差异无统计学意义。西妥昔单抗联合化疗最常见的副作用为痤疮样皮疹（80.4%，3 - 4级占9.8%）、中性粒细胞减少（66.7%，3 - 4级占18.6%）和腹泻（19.6%，3 - 4级占5.9%）。未记录到与治疗相关的死亡病例。
西妥昔单抗联合化疗治疗K-ras状态不明的晚期结直肠癌患者具有良好的ORR和OS，且该方案安全，不良事件较少。一线治疗方案与非一线治疗方案之间，以及西妥昔单抗联合奥沙利铂方案与西妥昔单抗联合伊立替康方案之间的疗效无显著差异。
