FOLFIRI/aflibercept（FA）在奥沙利铂为基础的方案治疗失败后的老年转移性结直肠癌（mCRC）患者中的疗效和安全性。
Efficacy and safety of FOLFIRI/aflibercept (FA) in an elderly population with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen.
机构信息
Medical Oncology Department, University Hospital A Coruña, A Coruña, Spain.
Medical Oncology Department, Ourense University Hospital Complex, Ourense, Spain.
出版信息
PLoS One. 2022 Jun 3;17(6):e0269399. doi: 10.1371/journal.pone.0269399. eCollection 2022.
BACKGROUND
The VELOUR study showed the benefit of FOLFIRI-Aflibercept (FA) versus FOLFIRI in patients with metastatic colorectal cancer (mCRC) in second-line treatment. However, only 36% of the included patients were ≥65 years. Thus, we seek to evaluate the efficacy and safety of FA in the elderly population in the context of routine practice.
MATERIALS AND METHODS
We conducted an observational, retrospective, multicenter, observational study of patients ≥70 years with mCRC treated with FA after progression to oxaliplatin chemotherapy in routine clinical practice in 9 hospitals of the GITuD group.
RESULTS
Of 388 patients treated with FA between June 2013 and November 2018, 75 patients ≥70 years were included. The median number of cycles was 10 and the objective response (ORR) and disease control rates (DCR) were 33.8% and 72.0%, respectively. With a median follow-up of 27.1 months, median Progression-free survival (PFS) was 6.6 months and median Overall Survival (OS) was 15.1 months. One third fewer metastasectomies were performed in the ≥75 years' subgroup (24 vs. 52%, p = 0.024) and more initial FOLFIRI dose reductions (68 vs. 36%, p = 0.014). ORR (23.8% vs. 38.3%), DCR (42.8% vs. 85.1%), and PFS (4 vs. 7.8 months; p = 0.017) were significantly less, without difference in OS (9.9 vs. 17.1 months; p = 0.129). The presence of prior hypertension (HT) (PFS 7.9 vs. 5.7 months, p = 0.049) and HT ≥ grade 3 during treatment (PFS 7.6 vs. 6.6 months, p = 0.024) were associated with longer PFS. The most frequent grade 3/4 adverse events were: asthenia (21.3%), neutropenia (14.7%), and diarrhea (14.7%). 57.3% required FOLFIRI dose reduction; 34.7% of aflibercept, including discontinuation (5.3% and 18.7%, respectively).
CONCLUSIONS
FA combination is effective in patients ≥70 years. The occurrence of HT is predictive of efficacy. Close monitoring of toxicity and initial dose adjustment is recommended.
背景
VELOUR 研究表明，在转移性结直肠癌（mCRC）二线治疗中，FOLFIRI-阿柏西普（FA）对比 FOLFIRI 可带来获益。然而，仅有 36%的入组患者年龄≥65 岁。因此，我们旨在评估 FA 在常规临床实践中对老年人群的疗效和安全性。
材料和方法
我们进行了一项回顾性、多中心、观察性研究，纳入了 9 家 GITuD 组医院中年龄≥70 岁、接受过奥沙利铂化疗后进展的 mCRC 患者，分析其接受 FA 治疗的情况。
结果
2013 年 6 月至 2018 年 11 月期间，共有 388 例患者接受 FA 治疗，其中 75 例患者年龄≥70 岁。中位治疗周期数为 10 个，客观缓解率（ORR）和疾病控制率（DCR）分别为 33.8%和 72.0%。中位随访时间为 27.1 个月，中位无进展生存期（PFS）为 6.6 个月，中位总生存期（OS）为 15.1 个月。在≥75 岁的亚组中，接受转移灶切除术的比例（24%比 52%，p=0.024）和初始 FOLFIRI 剂量减少的比例（68%比 36%，p=0.014）均减少了约三分之一。ORR（23.8%比 38.3%）、DCR（42.8%比 85.1%）和 PFS（4 个月比 7.8 个月；p=0.017）显著降低，但 OS 无差异（9.9 个月比 17.1 个月；p=0.129）。治疗前高血压（HT）（PFS 为 7.9 个月比 5.7 个月，p=0.049）和治疗期间 HT≥3 级（PFS 为 7.6 个月比 6.6 个月，p=0.024）与更长的 PFS 相关。最常见的 3/4 级不良事件为乏力（21.3%）、中性粒细胞减少（14.7%）和腹泻（14.7%）。57.3%的患者需要降低 FOLFIRI 剂量；34.7%的患者需要减少阿柏西普剂量，包括停药（分别为 5.3%和 18.7%）。
结论
FA 联合方案在年龄≥70 岁的患者中具有疗效。HT 的发生与疗效相关。建议密切监测毒性并进行初始剂量调整。
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