Klinikum rechts der Isar, 3rd Medical Department, Technische Universität München, Ismaninger Strasse 22, 81675 Munich, Germany.
Br J Cancer. 2010 Feb 2;102(3):500-5. doi: 10.1038/sj.bjc.6605521. Epub 2010 Jan 12.
Cetuximab enhances the efficacy of chemotherapy in several cancer types. This trial assessed the activity of cetuximab and chemotherapy in advanced gastric cancer.
Patients with previously untreated, metastatic, gastric cancer received cetuximab 400 mg m(-2) at first infusion followed by weekly infusions of 250 mg m(-2) combined with FUFOX (oxaliplatin 50 mg m(-2), 5-FU 2000 mg m(-2), and DL-folinic acid 200 mg m(-2) d1, 8, 15 and 22 qd36). The primary endpoint was tumour response.
Overall, 52 patients were enrolled. The most common grade 3/4 toxicities were diarrhoea (33%), and skin toxicity (24%). Efficacy was evaluable in 46 patients who showed a response rate of 65% (CI 95%: 50-79%) including four complete responses. Time to progression (TTP) was 7.6 months (CI 95%: 5.0-10.1 months) and overall survival (OS) was 9.5 months (CI 95%: 7.9-11.1 months). Epidermal growth factor receptor (EGFR) was detectable in 60% of tumours but showed no correlation with treatment outcome. A KRAS mutation was found in only 1 of 32 (3%) tumour samples analysed.
Cetuximab plus FUFOX showed an interesting high response rate in metastatic gastric cancer. Cetuximab plus platinum-fluoropyrimidine chemotherapy is at present being investigated in a phase III randomised controlled trial.
西妥昔单抗可增强多种癌症类型的化疗疗效。本试验评估了西妥昔单抗联合化疗治疗晚期胃癌的疗效。
入组的既往未经治疗的转移性胃癌患者首先接受西妥昔单抗 400mg/m2 静脉滴注，随后每周滴注 250mg/m2，联合 FUFOX（奥沙利铂 50mg/m2，5-氟尿嘧啶 2000mg/m2，亚叶酸钙 200mg/m2，d1、8、15 和 22，qd36）。主要终点是肿瘤反应。
共入组 52 例患者。最常见的 3/4 级毒性是腹泻（33%）和皮肤毒性（24%）。46 例患者可评估疗效，其有效率为 65%（95%CI：50-79%），包括 4 例完全缓解。无进展生存期（TTP）为 7.6 个月（95%CI：5.0-10.1 个月），总生存期（OS）为 9.5 个月（95%CI：7.9-11.1 个月）。60%的肿瘤组织可检测到表皮生长因子受体（EGFR），但与治疗结果无相关性。在 32 例肿瘤样本中，仅 1 例（3%）发现 KRAS 突变。
西妥昔单抗联合 FUFOX 治疗转移性胃癌的有效率较高。西妥昔单抗联合铂类氟嘧啶化疗目前正在进行 III 期随机对照试验。
