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首页> 外文期刊>British Journal of Cancer >Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer
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Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer

机译：分子非选择性转移性结直肠癌患者的前期FOLFOXIRI +贝伐单抗继之以氟嘧啶和贝伐单抗的维持

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Background: The addition of bevacizumab (BEV) to standard doublet chemotherapy improves outcomes compared with chemotherapy alone in patients with metastatic colorectal cancer (mCRC). The OPAL study examined the effect of BEV+FOLFOXIRI followed by 5FU/LV and BEV maintenance on progression-free survival (PFS) in patients with previously untreated unresectable mCRC. Methods: Eligible patients had histologically confirmed mCRC, ECOG performance status ?1 and were 18–70 years old. Patients received up to 12 cycles of FOLFOXIRI+BEV q2w (induction phase) followed by up to ?40 cycles of 5FU/LV+BEV q2w (maintenance phase). Median PFS was the primary end point; secondary end points included response, OS, secondary resection rate, safety and prognostic value of pharmacogenetic profiling. Results: Ninety-seven patients were enrolled. Of these, 90 received study medication and formed the safety population: 64 males; median age 58 (range 28–71) years; ECOG performance status 0/1 in 54%/46% patients; and liver only disease in 35 patients. Relative dose intensities were 79–85% for all four drugs. The incidence of adverse events (AEs) was as previously reported and there were no new safety signals. In total, 87 serious AEs occurred in 39 patients (43%). Median PFS was 11.1 months (95% CI 9.4–12.0) and did thus not meet the primary objective of 12 months. Median OS was 32.2 months (95% CI 22.6–36.9). Fifty-two patients were pharmacogenetically profiled. Conclusions: FOLFOXIRI+BEV was feasible in this molecularly unselected mCRC patient population, showing a high efficacy in terms of survival, overall response and secondary resection rate. Pharmacogenomic profiling revealed no clinically relevant marker.
机译：背景：与单纯化疗相比，在转移性结直肠癌（mCRC）患者中，将贝伐单抗（BEV）加入标准双线化疗中可改善结局。 OPAL研究检查了BEV + FOLFOXIRI继之以5FU / LV和BEV维持对先前未经治疗的不可切除mCRC患者的无进展生存期（PFS）的影响。方法：符合条件的患者经组织学证实为mCRC，ECOG表现状态为[1]，年龄在18-70岁之间。患者接受了多达12个周期的FOLFOXIRI + BEV q2w（诱导期），随后接受了多达40个周期的5FU / LV + BEV q2w（维持期）。 PFS中位数是主要终点;次要终点包括反应，OS，次要切除率，安全性和药物遗传学分析的预后价值。结果：97例患者入选。其中，有90人接受了研究药物并形成了安全人群：64名男性;中位年龄58岁（范围28-71岁）; 54％/ 46％患者的ECOG绩效状态为0/1;仅有肝脏疾病35例。四种药物的相对剂量强度均为79–85％。不良事件（AEs）的发生率与以前报道的一样，没有新的安全信号。总计39例患者中发生了87例严重AE（43％）。 PFS中位数为11.1个月（95％CI 9.4-12.0），因此未达到12个月的主要目标。 OS中位数为32.2个月（95％CI 22.6-36.9）。 52名患者进行了药物遗传学分析。结论：FOLFOXIRI + BEV在该分子非选择的mCRC患者人群中是可行的，在生存率，总体反应和二次切除率方面显示出很高的疗效。药物基因组分析未显示临床相关标志物。

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