A phase II trial of gefitinib for recurrent or metastatic cancer of the esophagus or gastroesophageal junction
A phase II trial of gefitinib for recurrent or metastatic cancer of the esophagus or gastroesophageal junction
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DOI：
10.1007/s10637-011-9736-z
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发表时间：
2012-08-01
影响因子：
3.4
通讯作者：
Rice, Thomas W.
中科院分区：
文献类型：
--
作者：
Adelstein, David J.;Rodriguez, Cristina P.;Rice, Thomas W.
背景：传统化疗药物对复发或转移性食管癌或胃食管交界处癌（GEJ）患者的疗效有限。我们报告了在该人群中使用口服表皮生长因子受体抑制剂吉非替尼的II期试验结果。患者和方法入选条件为食管或GEJ腺癌或鳞状细胞癌，经初始治疗后转移或复发且无法治愈。之前的化疗方案不允许超过一种。治疗包括每日250毫克吉非替尼，持续至少8周。结果2003年4月至2010年1月，58例患者入组，其中18例为化疗na < ve。毒性一般，尽管大多数经历1-2级腹泻和/或皮疹。部分缓解者4例（7%），病情稳定者10例（17%）。临床获益（部分缓解和病情稳定）中位持续6.1个月。所有患者的中位生存期为5.5个月，预计1年生存率为24.6%，2年生存率为12.5%。结论吉非替尼治疗食管癌、食管癌复发转移患者耐受性良好，但疗效有限。进一步研究这种或类似的药物将需要更好的患者选择。
Background Conventional chemotherapeutic agents are of limited benefit in patients with recurrent or metastatic cancer of the esophagus or gastroesophageal junction (GEJ). We report results from a phase II trial in this population using gefitinib, an oral epidermal growth factor receptor inhibitor. Patients and methods Eligibility required a diagnosis of esophageal or GEJ adenocarcinoma or squamous cell carcinoma, which was either metastatic or recurrent and incurable after initial therapy. No more than one prior chemotherapy regimen was permitted. Treatment consisted of gefitinib 250 mg daily for a minimum of 8 weeks. Results Between April 2003 and January 2010, 58 patients, including 18 who were chemotherapy-na < ve, were entered into this trial. Toxicity was modest, although most experienced grade 1-2 diarrhea and/or skin rash. There were 4 partial responders (7%) and 10 patients with stable disease (17%). The clinical benefit (partial response and stable disease) lasted for a median 6.1 months. Median survival for all patients was 5.5 months with survival projections at 1-year of 24.6% and at 2-years of 12.5%. Conclusion Gefitinib was well tolerated but of limited efficacy in patients with recurrent or metastatic esophageal or GEJ cancer. Further study of this or similar agents will require better patient selection.