Background Metastatic colorectal cancer frequently occurs in elderly patients. Bevacizumab in combination with front line chemotherapy (CT) is a standard treatment but some concern raised about tolerance of bevacizumab for these patients. The purpose of PRODIGE 20 was to evaluate tolerance and efficacy of bevacizumab according to specific end points in this population. Patients and methods Patients aged 75 years and over were randomly assigned to bevacizumab + CT (BEV) versus CT. LV5FU2, FOLFOX and FOLFIRI regimen were prescribed according to investigator's choice. The composite co-primary end point, assessed 4 months after randomization, was based on efficacy (tumor control and absence of decrease of the Spitzer QoL index) and safety (absence of severe cardiovascular toxicities and unexpected hospitalization). For each arm, the treatment will be consider as inefficient if 20% or less of the patients met the efficacy criteria and not safe if 40% or less met the safety criteria. Results About 102 patients were randomized (51 BEV and 51 CT), median age was 80 years (range 75-91). Primary end point was met for efficacy in 50% and 58% and for safety in 61% and 71% of patients in BEV and CT, respectively. Median progression-free survival was 9.7 months in BEV and 7.8 months in CT. Median overall survival was 21.7 months in BEV and 19.8 months in CT. The 36-month overall survival rate was 27% in BEV and 10.1% in CT. Severe toxicities grade 3/4 were mainly non-hematologic toxicities (80.4% in BEV, 63.3% in CT). Conclusion Bevacizumab combined with CT was safe and efficient. Both arms met the primary safety and efficacy criteria.

中文翻译：

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未经治疗的转移性结直肠癌老年患者的贝伐单抗+化学疗法与单独化疗的比较：一项II期随机试验-PRODIGE 20研究结果。

背景转移性结直肠癌经常发生在老年患者中。贝伐单抗联合一线化疗（CT）是一种标准治疗方法，但人们对贝伐单抗对这些患者的耐受性提出了一些关注。PRODIGE 20的目的是根据该人群的特定终点评估贝伐单抗的耐受性和疗效。患者和方法将75岁及以上的患者随机分为贝伐单抗+ CT（BEV）和CT。LV5FU2，FOLFOX和FOLFIRI方案根据研究者的选择进行了处方。随机分组后4个月评估的复合共同主要终点基于疗效（肿瘤控制和Spitzer QoL指数未降低）和安全性（无严重心血管毒性和意外住院）。对于每条手臂，如果20％或更少的患者符合疗效标准，则治疗无效；如果40％或更少的患者符合安全标准，则治疗不安全。结果约102例患者被随机分配（51 BEV和51 CT），中位年龄为80岁（范围75-91）。在BEV和CT的患者中，分别达到50％和58％的有效性和61％和71％的安全性的主要终点。BEV的中位无进展生存期为9.7个月，CT的中位无进展生存期为7.8个月。BEV的中位总生存期为21.7个月，CT的中位总生存期为19.8个月。BEV的36个月总生存率为27％，CT的为10.1％。3/4级的严重毒性主要是非血液学毒性（BEV为80.4％，CT为63.3％）。结论贝伐单抗联合CT治疗安全，有效。两组均符合主要的安全性和有效性标准。