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首页> 外文期刊>Gut: Journal of the British Society of Gastroenterology >Gemcitabine plus erlotinib followed by capecitabine versus capecitabine plus erlotinib followed by gemcitabine in advanced pancreatic cancer: Final results of a randomised phase 3 trial of the 'arbeitsgemeinschaft internistische onkologie' (AIO-PK0104)
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Gemcitabine plus erlotinib followed by capecitabine versus capecitabine plus erlotinib followed by gemcitabine in advanced pancreatic cancer: Final results of a randomised phase 3 trial of the 'arbeitsgemeinschaft internistische onkologie' (AIO-PK0104)

机译：吉西他滨联合厄洛替尼联合卡培他滨与卡培他滨联合厄洛替尼联合吉西他滨治疗晚期胰腺癌：“ arbeitsgemeinschaft internistische onkologie”随机3期试验的最终结果（AIO-PK0104）

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AIO-PK0104 investigated two treatment strategies in advanced pancreatic cancer (PC): a reference sequence of gemcitabine/erlotinib followed by 2nd-line capecitabine was compared with a reverse experimental sequence of capecitabine/erlotinib followed by gemcitabine. Methods 281 patients with PC were randomly assigned to 1st-line treatment with either gemcitabine plus erlotinib or capecitabine plus erlotinib. In case of treatment failure (eg, disease progression or toxicity), patients were allocated to 2nd-line treatment with the comparator cytostatic drug without erlotinib. The primary study endpoint was time to treatment failure (TTF) after 1st- and 2nd-line therapy (TTF2; non-inferiority design). KRAS exon 2 mutations were analysed in archival tumour tissue from 173 of the randomised patients. Results Of the 274 eligible patients, 43 had locally advanced and 231 had metastatic disease; 140 (51%) received 2nd-line chemotherapy. Median TTF2 was estimated with 4.2 months in both arms; median overall survival was 6.2 months with gemcitabine/erlotinib followed by capecitabine and 6.9 months with capecitabine/erlotinib followed by gemcitabine, respectively (HR 1.02, p=0.90). TTF for 1st-line therapy (TTF1) was significantly prolonged with gemcitabine/ erlotinib compared to capecitabine/erlotinib (3.2 vs 2.2 months; HR 0.69, p=0.0034). Skin rash was associated with both TTF2 (rash grade 0/1/2e4:2.9/4.3/ 6.7 months, p<0.0001) and survival (3.4/7.0/ 9.6 months, p<0.0001). Each arm showed a safe and manageable toxicity profile during 1st- and 2nd-line therapy. A KRAS wild-type status (52/173 patients, 30%) was associated with an improved overall survival (HR 1.68, ps0.005). Conclusion Both treatment strategies are feasible and demonstrated comparable efficacy; KRAS may serve as biomarker in patients with advanced PC treated with erlotinib.
机译：AIO-PK0104研究了晚期胰腺癌（PC）的两种治疗策略：比较了吉西他滨/厄洛替尼的参考序列和随后的二线卡培他滨，并将卡培他滨/厄洛替尼的反向实验序列与吉西他滨比较。方法将281例PC患者随机分为吉西他滨联合厄洛替尼或卡培他滨联合厄洛替尼一线治疗。如果治疗失败（例如，疾病进展或毒性），则将患者分配至不使用厄洛替尼的比较细胞抑制药物进行二线治疗。主要研究终点为一线和二线治疗（TTF2;非劣效性设计）后的治疗失败时间（TTF）。在随机分组的173名患者的档案肿瘤组织中分析了KRAS外显子2突变。结果274例符合条件的患者中，局部晚期43例，转移性疾病231例。 140（51％）人接受了二线化疗。预计TTF2的中位数为4.2个月。吉西他滨/厄洛替尼联合卡培他滨组的中位总生存期分别为6.2个月和卡培他滨/厄洛替尼联合吉西他滨组的中位生存期分别为6.9个月（HR 1.02，p = 0.90）。与卡培他滨/厄洛替尼相比，吉西他滨/厄洛替尼用于一线治疗的TTF（TTF1）显着延长（3.2 vs 2.2个月; HR 0.69，p = 0.0034）。皮疹与TTF2（皮疹等级0/1 / 2e4：2.9 / 4.3 / 6.7个月，p <0.0001）和存活率（3.4 / 7.0 / 9.6个月，p <0.0001）都相关。在第一线和第二线治疗期间，每个手臂均显示出安全且可控的毒性曲线。 KRAS野生型状态（52/173例患者，30％）与总生存期的改善（HR 1.68，ps0.005）相关。结论两种治疗策略均可行，并具有可比的疗效。在厄洛替尼治疗的晚期PC患者中，KRAS可以作为生物标志物。

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