Lesson learned: Panitumumab plus irinotecan is not active for the treatment of esophageal adenocarcinoma.
Background: Esophageal adenocarcinoma (EAC) is a lethal cancer with increasing incidence. Panitumumab (Pa) is a fully humanized IgG2 monoclonal antibody against human EGFR. Cetuximab (Cx) combined with irinotecan (Ir) is active for second-line treatment of colorectal cancer. This phase II study was designed to evaluate Pa plus Ir as second-line therapy for advanced EAC.
Methods: The primary endpoint was response rate (RR). Patients with one prior treatment were given Pa 9 mg/m2 on day 1 and Ir 125 mg/m2 on days 1 and 8 of each 21-day cycle. Inclusion criteria were confirmed EAC, measurable disease, no prior Ir or Pa, performance status <2, and normal organ function.
Results: Twenty-four patients were enrolled; 18 were eligible and evaluable. These patients were all white, with a median age of 62.5 years (range, 33-79 years), and included 15 men and 3 women. The median number of cycles was 3.5. The most common grade 1-2 adverse events were fatigue, diarrhea, anemia, leukopenia, and hypoalbuminemia. Grade 3-4 adverse events included hematologic, gastrointestinal, electrolyte, rash, fatigue, and weight loss. The median follow-up was 7.2 months (range, 2.3-14 months). There were no complete remissions. The partial response rate was 6% (1/18; 95% confidence interval [CI], 0.01-0.26). The clinical benefit (partial response [PR] plus stable disease [SD]) rate was 50%. The median overall survival was 7.2 months (95% CI, 4.1-8.9) with an 11.1% 1-year survival rate. The median progression-free survival was 2.9 months (95% CI, 1.6-5.3).
Conclusion: Irinotecan and panitumumab as second-line treatment for advanced EAC are not active.
经验获取
• 帕尼单抗联合伊立替康对食管腺癌的治疗效果不佳。
摘要
背景。 食管腺癌 (EAC) 是一种发病率不断上升的致死性恶性肿瘤。帕尼单抗 (Pa) 是一种抗人 EGFR 的完全人源化 IgG2 单克隆抗体。西妥昔单抗 (Cx) 与伊立替康 (Ir) 联合用于结直肠癌的二线治疗。本项II期研究旨在评估 Pa+Ir 作为晚期 EAC 二线治疗的效果。
方法. 主要终点是缓解率(RR)。对既往接受过一次治疗的患者,给予Pa 9 mg/m2,第1天;Ir 125 mg/m2,第1、8天,21天为一疗程。 纳入标准为确定EAC、可预测的疾病、无Ir或Pa使用史、体力状态评分<2、器官功能正常。
结果。24例患者入选;18例符合条件并可评估。这些患者均为白人,年龄中位数62.5岁(范围:33‐79岁),其中包括15名男性和3名女性。疗程数量中位数为3.5。最常见的1‐2级不良事件为疲劳、腹泻、贫血、白细胞减少和低白蛋白血症。3‐4级不良事件包括血液学和胃肠道不良反应、电解质紊乱、皮疹、疲劳和体重减轻。随访期中位数为7.2个月(范围:2.3‐14个月)。无完全缓解病例。部分缓解率为6%[1/18;95%置信区间 (CI),0.01‐0.26]。临床受益 [部分缓解(PR)+病情稳定(SD)]率为50%。总生存期中位数为7.2个月 (95%CI,4.1‐8.9),1年生存率为11.1%。无进展生存期中位数为2.9个月(95%CI,1.6‐5.3)。
结论。 伊立替康和帕尼单抗作为晚期EAC的二线治疗效果不佳。
Trial registration: ClinicalTrials.gov NCT00836277.
© AlphaMed Press; the data published online to support this summary are the property of the authors.