FOLFIRI 方案治疗吉西他滨和铂类耐药的转移性胰腺腺癌。
FOLFIRI regimen in metastatic pancreatic adenocarcinoma resistant to gemcitabine and platinum-salts.
机构信息
Service de Gastroentérologie-Pancréatologie, Hôpital Beaujon, 100 Boulevard du Général Leclerc, 92110 Clichy La Garenne, AP-HP, France.
出版信息
World J Gastroenterol. 2012 Sep 7;18(33):4533-41. doi: 10.3748/wjg.v18.i33.4533.
AIM
To evaluate the efficacy and safety of the FOLFIRI regimen in patients with metastatic pancreatic adenocarcinoma (PAC) after the failure of gemcitabine and platinum salts.
METHODS
All consecutive patients with histologically confirmed, metastatic PAC and World Health Organization performance status (PS) ≤ 2 received FOLFIRI-1 [irinotecan 180 mg/m(2) on day 1 and leucovorin 400 mg/m(2) followed by 5-fluorouracil (5-FU) 400 mg/m(2) bolus, then 5-FU 2400 mg/m(2) as a 46-h infusion, biweekly] or FOLFIRI-3 (irinotecan 100 mg/m(2) on day 1 and leucovorin 400 mg/m(2), then 5-FU 2400 mg/m(2) as a 46-h infusion and irinotecan 100 mg/m(2) repeated on day 3, biweekly) after failure of gemcitabine and platinum-based chemotherapies as a systematic policy in two institutions between January 2005 and May 2010. Tumor response, time to progression (TTP), overall survival rate (OS) and grade 3-4 toxicities were retrospectively studied. Subgroup analyses were performed to search for prognostic factors.
RESULTS
Sixty-three patients (52.4% male, median age 59 years) were analyzed. Among them, 42.9% were PS 0, 38.1% were PS 1 and 19.0% were PS 2. Fifty one patients (81.0%) had liver metastases. Before the FOLFIRI regimen, patients had received 1 line (n = 19), 2 lines (n = 39) or 3 lines (n = 5) of chemotherapy. Median TTP obtained with the line before FOLFIRI was 3.9 mo (95% CI: 3.4-5.3 mo). A total of 480 cycles was completed (median: 6 cycles, range: 1-51 cycles). The main reason for discontinuing FOLFIRI was tumor progression (90.3%). Tumor control was achieved in 25 patients (39.7%) (partial response: n = 5, stable disease: n = 20) with FOLFIRI. Median TTP was 3.0 mo (95% CI: 2.1-3.9 mo) and median OS was 6.6 mo (95% CI: 5.3-8.1 mo). Dose adaptation was required in 36 patients (57.1%). Fifteen patients (23.8%) had grade 3-4 toxicities, mainly hematological (n = 11) or digestive (n = 4). Febrile neutropenia occurred in 3 patients. There was no toxic death. PS 2 was significantly associated with poor TTP [hazard ratio (HR): 16.036, P < 0.0001] and OS (HR: 4.003, P = 0.004).
CONCLUSION
The FOLFIRI regimen had an acceptable toxicity and an interesting efficacy in our study, limited to patients in good condition (PS 0-1).
目的
评估 FOLFIRI 方案在吉西他滨和铂类化疗失败的转移性胰腺腺癌（PAC）患者中的疗效和安全性。
方法
所有组织学证实的转移性 PAC 患者和世界卫生组织体力状况（PS）≤2 分的患者均接受 FOLFIRI-1[伊立替康 180mg/m²，第 1 天；亚叶酸钙 400mg/m²，随后氟尿嘧啶（5-FU）400mg/m² 推注，然后 5-FU 2400mg/m² 输注 46 小时，每 2 周 1 次]或 FOLFIRI-3（伊立替康 100mg/m²，第 1 天；亚叶酸钙 400mg/m²，随后 5-FU 2400mg/m² 输注 46 小时，伊立替康 100mg/m² 第 3 天重复，每 2 周 1 次）治疗，这是两个机构在 2005 年 1 月至 2010 年 5 月之间的系统治疗方案。回顾性研究了肿瘤反应、疾病进展时间（TTP）、总生存率（OS）和 3-4 级毒性。进行了亚组分析以寻找预后因素。
结果
共分析了 63 例患者（52.4%为男性，中位年龄 59 岁）。其中，42.9%为 PS 0，38.1%为 PS 1，19.0%为 PS 2。51 例（81.0%）有肝转移。在接受 FOLFIRI 方案治疗前，患者接受过 1 线（n=19）、2 线（n=39）或 3 线（n=5）化疗。FOLFIRI 前的中位 TTP 为 3.9 个月（95%CI：3.4-5.3 个月）。共完成 480 个周期（中位数：6 个周期，范围：1-51 个周期）。停止 FOLFIRI 的主要原因是肿瘤进展（90.3%）。FOLFIRI 治疗后 25 例（39.7%）患者肿瘤得到控制（部分缓解：n=5，稳定疾病：n=20）。中位 TTP 为 3.0 个月（95%CI：2.1-3.9 个月），中位 OS 为 6.6 个月（95%CI：5.3-8.1 个月）。36 例（57.1%）需要调整剂量。15 例（23.8%）出现 3-4 级毒性，主要为血液学毒性（n=11）或消化系统毒性（n=4）。3 例发生发热性中性粒细胞减少症。无毒性死亡。PS 2 与较差的 TTP[风险比（HR）：16.036，P<0.0001]和 OS（HR：4.003，P=0.004）显著相关。
结论
FOLFIRI 方案在我们的研究中具有可接受的毒性和令人感兴趣的疗效，仅限于身体状况良好的患者（PS 0-1）。
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