Medizinische Klinik II, Hegau- Bodensee Klinikum, Virchowstraße 10, D-78224 Singen, Germany.
Br J Cancer. 2012 Mar 13;106(6):1033-8. doi: 10.1038/bjc.2012.18. Epub 2012 Feb 28.
New therapeutic options for metastatic pancreatic cancer are urgently needed. In pancreatic cancer, overexpression of the epidermal growth factor receptor 2 (HER2) has been reported in up to 45%. This multicentre phase II study investigated the efficacy and toxicity of the HER2 antibody trastuzumab combined with capecitabine in the patients with pancreatic cancer and HER2 overexpression.
Primary endpoint was progression-free survival (PFS) after 12 weeks. A total of 212 patients were screened for HER2 expression.
Immunohistochemical (IHC) HER2 expression was: 83 (40%) grade 0, 71 (34%) grade 1, 31 (15%) grade 2, 22 (11%) grade 3. A total of 17 patients with IHC +3 HER2 expression or gene amplification could be assessed for the treatment response. Grade 3/4 treatment toxicities were: each 7% leucopenia, diarrhoea, nausea and hand-foot syndrome. Progression-free survival after 12 weeks was 23.5%, median overall survival (OS) 6.9 months.
This study demonstrates +3 HER2 expression or gene amplification in 11% of patients. Contrary to breast and gastric cancer, only 7 out of 11 (64%) patients with IHC +3 HER2 expression showed gene amplification. Although the therapy was well tolerated, PFS and OS did not perform favourably compared with standard chemotherapy. Together, we do not recommend further evaluation of anti-HER2 treatment in patients with metastatic pancreatic cancer.
转移性胰腺癌迫切需要新的治疗选择。在胰腺癌中，表皮生长因子受体 2（HER2）的过表达高达 45%。这项多中心 II 期研究调查了 HER2 抗体曲妥珠单抗联合卡培他滨在 HER2 过表达的胰腺癌患者中的疗效和毒性。
主要终点是 12 周后的无进展生存期（PFS）。共有 212 名患者接受了 HER2 表达筛选。
免疫组化（IHC）HER2 表达为：83 例（40%）0 级，71 例（34%）1 级，31 例（15%）2 级，22 例（11%）3 级。共有 17 例 IHC +3 HER2 表达或基因扩增的患者可评估治疗反应。3/4 级治疗毒性为：白细胞减少症各 7%、腹泻、恶心和手足综合征。12 周后无进展生存期为 23.5%，中位总生存期（OS）为 6.9 个月。
这项研究表明，11%的患者存在+3 HER2 表达或基因扩增。与乳腺癌和胃癌不同，只有 11 例 IHC +3 HER2 表达患者中的 7 例（64%）存在基因扩增。尽管该治疗耐受性良好，但 PFS 和 OS 与标准化疗相比表现不佳。综上所述，我们不建议在转移性胰腺癌患者中进一步评估抗 HER2 治疗。
