Istituto di Oncologia, Policlinico di Monza, Monza.
Laboratory of Clinical Research, IRCCS-Istituto di Ricerche Farmacologiche 'Mario Negri', Milano.
Ann Oncol. 2014 Jul;25(7):1373-1378. doi: 10.1093/annonc/mdu146. Epub 2014 Apr 12.
Some trial have demonstrated a benefit of adjuvant fluoropirimidine with or without platinum compounds compared with surgery alone. ITACA-S study was designed to evaluate whether a sequential treatment of FOLFIRI [irinotecan plus 5-fluorouracil/folinic acid (5-FU/LV)] followed by docetaxel plus cisplatin improves disease-free survival in comparison with 5-FU/LV in patients with radically resected gastric cancer.
Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to either FOLFIRI (irinotecan 180 mg/m(2) day 1, LV 100 mg/m(2) as 2 h infusion and 5-FU 400 mg/m(2) as bolus, days 1 and 2 followed by 600 mg/m(2)/day as 22 h continuous infusion, q14 for four cycles) followed by docetaxel 75 mg/m(2) day 1, cisplatin 75 mg/m(2) day 1, q21 for three cycles (sequential arm) or De Gramont regimen (5-FU/LV arm).
From February 2005 to August 2009, 1106 patients were enrolled, and 1100 included in the analysis: 562 in the sequential arm and 538 in the 5-FU/LV arm. With a median follow-up of 57.4 months, 581 patients recurred or died (297 sequential arm and 284 5-FU/LV arm), and 483 died (243 and 240, respectively). No statistically significant difference was detected for both disease-free [hazard ratio (HR) 1.00; 95% confidence interval (CI): 0.85-1.17; P = 0.974] and overall survival (OS) (HR 0.98; 95% CI: 0.82-1.18; P = 0.865). Five-year disease-free and OS rates were 44.6% and 44.6%, 51.0% and 50.6% in the sequential and 5-FU/LV arm, respectively.
A more intensive regimen failed to show any benefit in disease-free and OS versus monotherapy.
ClinicalTrials.gov Identifier: NCT01640782.
一些试验表明，与单独手术相比，辅助氟嘧啶联合或不联合铂类化合物治疗具有优势。ITACA-S 研究旨在评估与 5-FU/LV 相比，接受 FOLFIRI（伊立替康 180mg/m²，第 1 天；LV 100mg/m²，2 小时输注；5-FU 400mg/m²，第 1 和第 2 天推注，随后 600mg/m²/天，22 小时持续输注，q14，共 4 个周期）序贯治疗后再接受多西紫杉醇 75mg/m²，顺铂 75mg/m²，q21，共 3 个周期（序贯组）或 De Gramont 方案（5-FU/LV 组）的根治性切除胃腺癌患者的无病生存期是否有所改善。
将可切除的胃腺癌或胃食管交界处腺癌患者随机分配至 FOLFIRI（伊立替康 180mg/m²，第 1 天；LV 100mg/m²，2 小时输注；5-FU 400mg/m²，第 1 和第 2 天推注，随后 600mg/m²/天，22 小时持续输注，q14，共 4 个周期）序贯治疗后再接受多西紫杉醇 75mg/m²，顺铂 75mg/m²，q21，共 3 个周期（序贯组）或 De Gramont 方案（5-FU/LV 组）。
从 2005 年 2 月至 2009 年 8 月，共纳入 1106 例患者，1100 例患者纳入分析：序贯组 562 例，5-FU/LV 组 538 例。中位随访 57.4 个月时，581 例患者复发或死亡（序贯组 297 例，5-FU/LV 组 284 例），483 例患者死亡（序贯组 243 例，5-FU/LV 组 240 例）。无病生存（危险比 [HR]1.00；95%置信区间 [CI]：0.85-1.17；P=0.974）和总生存（OS）（HR 0.98；95%CI：0.82-1.18；P=0.865）均无统计学差异。无病生存和 OS 的 5 年率分别为 44.6%和 44.6%、51.0%和 50.6%，序贯组和 5-FU/LV 组分别为 44.6%和 51.0%。
与单药治疗相比，更强化的方案并未显示出在无病生存和 OS 方面的优势。
ClinicalTrials.gov 标识符：NCT01640782。
