Yin Yuzhen, Yang Hui, Liu Zhuo, Tan Jie, Zhu Chunrong, Chen Minbin, Zhou Rengui, Wang Lei, Qian Jun
Department of Tumor Center, The Affiliated Jiangsu Shengze Hospital of Nanjing Medical University, Suzhou, Jiangsu, People's Republic of China.
Department of Oncology, Suzhou Municipal Hospital, Suzhou, Jiangsu, People's Republic of China.
Cancer Manag Res. 2020 Dec 30;12:13479-13487. doi: 10.2147/CMAR.S281765. eCollection 2020.
BACKGROUND: Human epidermal growth factor receptor 2 ( ) is a member of the family and is a key proto-oncogene in solid tumors. This pilot study investigated the safety and efficacy of pyrotinib in HER2-positive non-breast advanced solid tumors. PATIENTS AND METHODS: Twenty-five patients with -positive advanced solid tumors excluding breast cancer were enrolled to receive pyrotinib-based therapy. The primary end point was progression-free survival (PFS). RESULTS: The median PFS and overall survival (OS) were 3.5 months (95% CI: 2.2-5.0 months) and 9.6 months (95% CI: 4.4-9.9 months), respectively. Ten patients with lung cancer and 9 patients with gastric cancer had a median PFS of 2.5 months (95% CI: 0.97-6.53 months) and 2.9 months (95% CI: 1.50-7.17 months), respectively. The median OS was 9.9 months (95% CI: 4.4-9.9 months) in patients with lung cancer and 5.9 months (95% CI: 4.0-9.6 months) in patients with gastric cancer. No statistical significance of a median OS was observed, nonetheless, patients receiving > 3 lines had a numerically lower median OS than those receiving ≤ 3 lines of treatment (9.9 vs 5.1 months, = 0.706). All 23 patients were available for efficacy evaluation. The objective response rate (ORR) was 52.17% and disease control rate (DCR) was 91.3%. The ORR for lung cancer was 44.4% and for gastric cancer was 50%. In addition, the DCR for lung cancer was 77.8% and for stomach cancer was 100%. Moreover, patients receiving ≤3 lines of treatment had a numerically higher DCR than those receiving >3 lines of treatment (94.1% vs 83.3%, P = 0.462). The most common treatment-related adverse events (TRAEs) were diarrhea (92%), but only 5 (20%) patients reported grade 3 diarrhea which could be well controlled. CONCLUSION: Pyrotinib-based therapy demonstrates promising efficacy for HER2-positive advanced solid tumors excluding breast cancer and toxicities could be well controlled. The study is a pilot study motivating larger studies to elucidate the safety and efficacy of pyrotinib in non-breast solid tumors.
背景：人表皮生长因子受体2（HER2）是表皮生长因子受体家族成员，是实体瘤中的关键原癌基因。本前瞻性研究调查了吡咯替尼在HER2阳性非乳腺癌晚期实体瘤中的安全性和有效性。 患者与方法：纳入25例HER2阳性晚期实体瘤（不包括乳腺癌）患者接受以吡咯替尼为基础的治疗。主要终点为无进展生存期（PFS）。 结果：中位PFS和总生存期（OS）分别为3.5个月（95%CI：2.2 - 5.0个月）和9.6个月（95%CI：4.4 - 9.9个月）。10例肺癌患者和9例胃癌患者的中位PFS分别为2.5个月（95%CI：0.97 - 6.53个月）和2.9个月（95%CI：1.50 - 7.17个月）。肺癌患者的中位OS为9.9个月（95%CI：4.4 - 9.9个月），胃癌患者为5.9个月（95%CI：4.0 - 9.6个月）。未观察到中位OS有统计学意义，然而，接受超过3线治疗的患者中位OS在数值上低于接受≤3线治疗的患者（9.9对比5.1个月，P = 0.706）。所有23例患者均可进行疗效评估。客观缓解率（ORR）为52.17%，疾病控制率（DCR）为91.3%。肺癌的ORR为44.4%，胃癌为50%。此外，肺癌的DCR为77.8%，胃癌为100%。而且，接受≤3线治疗的患者DCR在数值上高于接受>3线治疗的患者（94.1%对比83.3%，P = 0.462）。最常见的治疗相关不良事件（TRAEs）为腹泻（92%），但只有5例（20%）患者报告3级腹泻，且可得到良好控制。 结论：以吡咯替尼为基础的治疗在HER2阳性非乳腺癌晚期实体瘤中显示出有前景的疗效，且毒性可得到良好控制。本研究是一项前瞻性研究，促使开展更大规模研究以阐明吡咯替尼在非乳腺实体瘤中的安全性和有效性。
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