Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301).
Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301).
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DOI：
10.1136/gut.2010.216135
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发表时间：
2010-11
期刊：
影响因子：
24.5
通讯作者：
Fédération Francophone de Cancérologie Digestive
中科院分区：
文献类型：
--
作者：
Dahan L;Bonnetain F;Ychou M;Mitry E;Gasmi M;Raoul JL;Cattan S;Phelip JM;Hammel P;Chauffert B;Michel P;Legoux JL;Rougier P;Bedenne L;Seitz JF;Fédération Francophone de Cancérologie Digestive
吉西他滨是转移性胰腺癌患者的标准化疗。虽然5-氟尿嘧啶（5 FU），亚叶酸和顺铂组合（LV5 FU 2-CDDP）是一种选择，但必须确定方案的最佳顺序。进行了第一项比较LV5 FU 2-CDDP随后吉西他滨与吉西他滨随后LV5 FU 2-CDDP的战略性III期试验。将体能状态（PS）0-2、既往未接受化疗的转移性胰腺癌患者随机（1：1）分配至疾病进展或毒性时接受LV5 FU 2-CDDP，随后接受吉西他滨（A组），或接受相反顺序（B组）。必须纳入202例患者，必须观察到170例死亡，以检测A组中位总生存期（OS）从6.5个月至10个月的预期改善（双侧α = 5%和β = 20%）。 纳入202例患者（A组，102例; B组，100例）。两组的中位年龄、男性/女性比例、PS 0-1和既往手术相似。中位随访44个月后，A组的中位OS为6.6个月，而B组为8.0个月（p = 0.85）。 A组和B组的中位无进展生存期相似。与吉西他滨相比，LV5 FU 2-CDDP作为一线治疗给药时观察到更多的3/4级毒性：79% vs 64%（p = 0.018）。该试验未显示使用LV5 FU 2-CDDP作为一线治疗的任何战略优势，表明吉西他滨仍是标准一线治疗。61%的患者能够接受二线化疗。
Gemcitabine is the standard chemotherapy for patients with metastatic pancreatic adenocarcinoma. Although the 5-fluorouracil (5FU), folinic acid and cisplatin combination (LV5FU2-CDDP) is an option, the optimal order of the regimens must be determined. The first strategic phase III trial comparing LV5FU2-CDDP followed by gemcitabine versus gemcitabine followed by LV5FU2-CDDP was conducted. Patients with metastatic pancreatic adenocarcinoma, performance status (PS) 0–2, without prior chemotherapy were randomly assigned (1:1) to receive either LV5FU2-CDDP followed by gemcitabine at disease progression or toxicity (Arm A), or the opposite sequence (Arm B). 202 patients had to be included and 170 deaths had to be observed to detect an expected improvement in median overall survival (OS) from 6.5 to 10 months in Arm A (two-sided α = 5% and β = 20%). 202 patients were included (Arm A, 102; Arm B, 100). Median age, male/female ratio, PS 0–1 and previous surgery were similar in the two arms. After a median follow-up of 44 months, median OS in Arm A was 6.6 months versus 8.0 months in Arm B (p = 0.85). Median progression-free survival was similar between Arms A and B. More grade 3/4 toxicities were observed when LV5FU2-CDDP was administered as a first-line treatment compared with gemcitabine: 79% versus 64% (p = 0.018). This trial did not show any strategic advantage to using LV5FU2-CDDP as a first-line treatment and suggests that gemcitabine remains the standard first-line treatment. Sixty-one per cent of patients were able to receive a second line of chemotherapy.
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