Oncologie médicale, Centre Antoine Lacassagne, Nice, France.
Radiation Oncology, Gastro-Intestinal and Liver Cancer Unit, Institut Sainte-Catherine, Avignon, France.
Clin Colorectal Cancer. 2020 Sep;19(3):e100-e109. doi: 10.1016/j.clcc.2020.02.009. Epub 2020 Apr 13.
Although elderly patients are the first concerned by colorectal cancer (CRC), they are underrepresented in clinical trials. The real-world CASSIOPEE study was thus conducted in elderly patients treated for metastatic CRC (mCRC).
This French prospective, multicenter, noninterventional study aimed to estimate 1-year progression-free survival (PFS) and overall survival (OS), and describe treatments, patient autonomy (Instrumental Activities of Daily Living; Balducci scale), and safety over 24 months, in patients older than 75 with mCRC, starting first-line bevacizumab plus chemotherapy (NCT01555762).
From 2012 to 2014, 402 patients were included (safety population: n = 383, efficacy population: n = 358). Patient characteristics were as follows: mean age, 81 ± 4 years (<80 years, 46%; 80-85 years, 44%; >85 years, 10%); men, 52%; colon primary tumor, 80%; main metastatic site, liver 66%; Eastern Cooperative Oncology Group performance 0-1, 81%. Median PFS was 9.1 months (95% confidence interval [CI]: 8.3-10.2). It was superior for patients ≤85 years (<80 years: 9.3 months; 80-85 years: 9.5 months) compared with patients >85 years (8.3 months). Median OS was 19.0 months (95% CI, 16.5-21.5) and decreased in the 2 oldest groups (20.6, 17.8, and 13.0 months). Autonomy assessments decreased over time leading to nonconclusive results. Twenty-six percent of patients experienced serious adverse events (SAEs): 7% bevacizumab-related SAEs, and 6% bevacizumab-targeted SAEs. Two fatal bevacizumab-related adverse events were reported (hemorrhagic stroke and intestinal ischemia).
This large French real-world study showed that medically fit older patients with mCRC could have a benefit/risk balance similar to that of younger patients when treated with first-line bevacizumab plus chemotherapy. Improvements in geriatric assessments are needed to better define this population.
尽管老年患者是结直肠癌（CRC）的首要关注对象，但他们在临床试验中的代表性不足。因此，进行了这项真实世界的 CASSIOPEE 研究，以评估转移性结直肠癌（mCRC）老年患者的 1 年无进展生存期（PFS）和总生存期（OS），并描述 24 个月内的治疗、患者自主性（日常生活活动工具性量表；Balducci 量表）和安全性。
这项法国前瞻性、多中心、非干预性研究旨在评估接受一线贝伐珠单抗联合化疗（NCT01555762）治疗的 mCRC 老年患者（年龄>75 岁）的 1 年 PFS 和 OS，以及 24 个月内的治疗、患者自主性（日常生活活动工具性量表；Balducci 量表）和安全性。
2012 年至 2014 年，共纳入 402 例患者（安全性人群：n=383，疗效人群：n=358）。患者特征如下：平均年龄 81±4 岁（<80 岁，46%；80-85 岁，44%；>85 岁，10%）；男性，52%；结肠原发肿瘤，80%；主要转移部位，肝脏 66%；东部肿瘤协作组体能状态 0-1，81%。中位 PFS 为 9.1 个月（95%CI：8.3-10.2）。对于≤85 岁的患者（<80 岁：9.3 个月；80-85 岁：9.5 个月），PFS 优于>85 岁的患者（8.3 个月）。中位 OS 为 19.0 个月（95%CI：16.5-21.5），且在年龄最大的 2 个组中降低（20.6、17.8 和 13.0 个月）。随着时间的推移，自主性评估下降，导致结果无法得出结论。26%的患者发生严重不良事件（SAE）：7%与贝伐珠单抗相关的 SAE，6%与贝伐珠单抗靶向的 SAE。报告了 2 例与贝伐珠单抗相关的致死性不良事件（出血性中风和肠缺血）。
这项大型法国真实世界研究表明，当接受一线贝伐珠单抗联合化疗治疗时，身体状况良好的老年 mCRC 患者可能具有与年轻患者相似的获益/风险平衡。需要改进老年评估，以更好地定义这一人群。
