Multicentre phase II trial of trastuzumab and capecitabine in patients with HER2 overexpressing metastatic pancreatic cancer.
Multicentre phase II trial of trastuzumab and capecitabine in patients with HER2 overexpressing metastatic pancreatic cancer.
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DOI：
10.1038/bjc.2012.18
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发表时间：
2012-03-13
影响因子：
8.8
通讯作者：
Geissler M
中科院分区：
文献类型：
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作者：
Harder J;Ihorst G;Heinemann V;Hofheinz R;Moehler M;Buechler P;Kloeppel G;Röcken C;Bitzer M;Boeck S;Endlicher E;Reinacher-Schick A;Schmoor C;Geissler M
转移性胰腺癌急需新的治疗方案。据报道，在胰腺癌中，表皮生长因子受体2 （HER2）的过表达率高达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胰腺癌HER2过表达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例患者进行了HER2表达筛查。免疫组化（IHC） HER2表达：0级83(40%)，1级71(34%)，2级31(15%)，3级22（11%）。共有17例IHC +3 HER2表达或基因扩增的患者可以评估治疗反应。3/4级治疗毒副反应为：白细胞减少、腹泻、恶心、手足综合征各7%。12周后无进展生存期为23.5%，中位总生存期（OS）为6.9个月。该研究表明，11%的患者中HER2表达或基因扩增为+3。与乳腺癌和胃癌相反，IHC +3 HER2表达的11例患者中只有7例（64%）出现基因扩增。尽管该疗法耐受性良好，但与标准化疗相比，PFS和OS表现不佳。总之，我们不建议进一步评估转移性胰腺癌患者的抗her2治疗。
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.