Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie, Augustenburger Platz 1, 13353 Berlin, Germany.
Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.
The value of second-line therapy for metastatic gastric cancer is unclear. So far there are no randomised phase III data comparing second-line chemotherapy to best supportive care (BSC). In this prospective, multicenter, open label, randomised phase III study we compared irinotecan to BSC to evaluate the impact on survival of second-line chemotherapy.
Eligible patients (pts) had metastatic or locally advanced gastro-oesophageal junction or gastric adenocarcinoma, objective tumour progression during or within 6months after first-line chemotherapy and ECOG performance status 0-2. Stratification for time of progression after first-line therapy, ECOG PS and pretreatment secured even distribution of important prognostic factors.
Arm A: Irinotecan 250mg/m(2)q3w (first cycle) to be increased to 350mg/m(2), depending on toxicity. Arm B: BSC.
Between 10/2002 and 12/2006 40 pts were randomised. The study was closed prematurely due to poor accrual. Responsefor arm A (19 pts evaluable): No objective responses, SD 53%, PD 47%. Improvement of tumour related symptoms: Arm A 50% of pts, arm B 7%. Overall Survival: (all events in 40 pts have occurred): The hazard ratio for death was reduced to 0.48 (95%CI 0.25-0.92) in the irinotecan-arm (p=0.012). Median survival arm A: 4.0months (95% CI 3.6-7.5), arm B: 2.4months (95% CI 1.7-4.9).
Irinotecan as second-line chemotherapy significantly prolongs overall survival compared to BSC in the studied pts. Second-line chemotherapy can now be considered as a proven treatment option for metastatic or locally advanced gastric cancer.
The study was supported by a research grant from Aventis and Pfizer.
二线治疗转移性胃癌的价值尚不清楚。到目前为止，尚无比较二线化疗与最佳支持治疗（BSC）的随机 III 期数据。在这项前瞻性、多中心、开放标签、随机 III 期研究中，我们比较了伊立替康与 BSC，以评估二线化疗对生存的影响。
符合条件的患者（pts）患有转移性或局部晚期胃食管交界处或胃腺癌，在一线化疗期间或 6 个月内出现客观肿瘤进展，ECOG 表现状态 0-2。分层为一线治疗后进展时间、ECOG PS 和预处理，以确保重要预后因素的均衡分布。
A 组：伊立替康 250mg/m²，q3w（第一周期），根据毒性增加至 350mg/m²。B 组：BSC。
2002 年 10 月至 2006 年 12 月期间，共 40 例患者被随机分组。由于入组人数不佳，该研究提前终止。A 组（19 例可评估）的反应：无客观反应，SD53%，PD47%。肿瘤相关症状改善：A 组 50%的患者，B 组 7%。总生存：（40 例患者的所有事件均已发生）：伊立替康组的死亡风险比降低至 0.48（95%CI0.25-0.92）（p=0.012）。A 组中位生存时间：4.0 个月（95%CI3.6-7.5），B 组：2.4 个月（95%CI1.7-4.9）。
伊立替康作为二线化疗与 BSC 相比，在研究患者中显著延长了总生存期。二线化疗现在可以被认为是转移性或局部晚期胃癌的一种已证实的治疗选择。
这项研究得到了 Aventis 和辉瑞的研究资助。
