Department of Medical Oncology, Institut Bergonié, 229, cours de l'Argonne, 33076 Bordeaux cedex, France.
Clin Res Hepatol Gastroenterol. 2011 Dec;35(12):823-30. doi: 10.1016/j.clinre.2011.08.002. Epub 2011 Sep 8.
Current chemotherapy protocols for gastric cancer present high toxicity. The FOLFIRI regimen has shown promising results with elderly colorectal cancer patients and for gastric cancer patients but this is the first report on elderly gastric cancer patients.
In this multicenter non-randomized phase II trial, we administered the FOLFIRI chemotherapy protocol (irinotecan [180 mg/m(2)], fluorouracil [5-FU] [400 mg/m(2)] and folinic acid 400 mg/m(2) or 200mg/m(2) of l-folinic acid) to patients aged over 70 years with locally-advanced or metastatic gastric cancer combined with Comprehensive Geriatric Assessment (CGA). Responses were assessed at 2 months.
Forty-two patients received eight cycles of the FOLFIRI regimen, with 82.5% of patients showing disease control: 10 patients (26%) showing objective (partial or complete) responses and 23 (57.5%) showing stable disease. One-year overall survival (OS) was 41.5% [95%CI 26.5-56.0] and one-year progression-free survival (PFS) was 31.8% [95%CI 18.4-46.1%]. We observed 10 Grade 3/4 hematologic toxicities with one febrile neutropenia. CGA data demonstrated that geriatric functions were not altered by treatment and that nutritional status improved over treatment.
Results show excellent disease control and relatively high survival rates with limited toxicity similar to younger patients indicating that this regimen should be considered as a possible treatment in advanced gastric cancer of the elderly.
目前的胃癌化疗方案毒性较高。FOLFIRI 方案在老年结直肠癌患者和胃癌患者中显示出良好的效果，但这是首次在老年胃癌患者中进行的报告。
在这项多中心非随机 2 期临床试验中，我们对年龄在 70 岁以上的局部晚期或转移性胃癌患者联合使用 FOLFIRI 化疗方案（伊立替康[180mg/m²]、氟尿嘧啶[5-FU] [400mg/m²]和叶酸 400mg/m²或左旋叶酸 200mg/m²），并结合全面老年评估（CGA）。在 2 个月时评估反应。
42 名患者接受了 8 个周期的 FOLFIRI 方案治疗，82.5%的患者显示疾病控制：10 名患者（26%）显示客观（部分或完全）缓解，23 名患者（57.5%）显示稳定疾病。1 年总生存率（OS）为 41.5%[95%CI 26.5-56.0]，1 年无进展生存率（PFS）为 31.8%[95%CI 18.4-46.1%]。我们观察到 10 例 3/4 级血液学毒性，其中 1 例为发热性中性粒细胞减少症。CGA 数据表明，治疗并未改变老年患者的老年功能，且营养状况在治疗过程中得到改善。
结果显示，该方案具有良好的疾病控制效果和相对较高的生存率，毒性有限，与年轻患者相似，表明该方案可作为老年晚期胃癌的一种可能治疗方法。
