总的来说,据估计,超过3,500,000例患者接受了贝伐单抗作为全身肿瘤治疗的一部分.贝伐单抗及其生物仿制药目前在130多个国家销售。鉴于贝伐单抗在当前肿瘤学实践中的广泛使用,将“真实世界”的结果与对照临床试验中获得的结果进行比较非常重要。本研究旨在描述在“非控制的现实世界”条件下,在癌症患者的大型队列中使用贝伐单抗的临床经验。安全,和治疗费用。
方法:为此,我们进行了一次公开,观察,回顾性研究涉及布加勒斯特肿瘤研究所接受实体恶性肿瘤治疗的所有患者。Al医生.Trestioreanu联合贝伐单抗全身治疗,2017年至2021年。
结果:该研究包括625例患者(F/B=1.62/1,中位年龄为57.6岁)的657次治疗,这些患者接受了恶性肿瘤(大多数结直肠,非小细胞肺,卵巢,和乳腺癌)。229例患者接受了一线治疗,其余患者接受贝伐单抗作为第二或后续治疗.在所有适应症中,以贝伐单抗为基础的治疗的总体反应率约为60-65%,除了结直肠癌和卵巢癌的后续治疗线。记录较低的值(27.1%,分别为31.5%)。整个队列的平均PFS为8.2个月(95%CI6.8-9.6),中位OS为13.2个月(95%CI11.5-14.9)。观察到通常的贝伐单抗相关毒性,包括出血,高血压,伤口愈合并发症,胃肠穿孔,其他类型的瘘管,败血症并发症,和血栓栓塞事件。虽然临床上的好处是不可否认的,在标准化疗中加入贝伐单抗使总治疗成本增加了213%.
结论:贝伐单抗仍然是一种高成本的治疗方法,但它可以增加临床益处(比如总体生存率,无进展生存期,和反应率)与标准化疗结合使用时。即使在“现实世界”肿瘤学实践的不受控制的条件下,未经选择的患者队列中也可以观察到与各种对照试验类似的结果。在临床实践中遇到标签外使用,考虑到治疗的潜在不良反应,应该对这方面进行监测。
Overall, it is estimated that more than 3,500,000 patients have received Bevacizumab as part of systemic oncologic treatment. Bevacizumab and its biosimilars are currently marketed in over 130 countries. Given the wide usage of Bevacizumab in current oncological practice, it is very important to compare the \"real-world\" results to those obtained in controlled clinical trials. This study aims to describe the clinical experience of using Bevacizumab in a large cohort of cancer patients in \"non-controlled real-world\" conditions with regard to effectiveness, safety, and cost of therapy.
METHODS: For this purpose, we conducted an open, observational, retrospective study involving all patients treated for solid malignant tumors in the Bucharest Institute of Oncology with \"Prof. Dr. Al. Trestioreanu\" with Bevacizumab-based systemic therapy, between 2017 and 2021.
RESULTS: The study consisted of 657 treatment episodes in 625 patients (F/B = 1.62/1, with a median age of 57.6 years) which were treated for malignant tumors (majority colorectal, non-small cell lung, ovarian, and breast cancer). First-line treatment was administered in 229 patients, and the rest received Bevacizumab as second or subsequent lines of treatment. The overall response rate to Bevacizumab-based therapies was around 60-65% across all indication except for subsequent treatment lines in colorectal and ovarian cancers, where lower values were recorded (27.1%, and 31.5% respectively). Median PFS for the entire cohort was 8.2 months (95% CI 6.8-9.6), and the median OS was 13.2 months (95% CI 11.5-14.9). Usual bevacizumab-related toxicities were observed, including bleeding, hypertension, wound-healing complications, gastrointestinal perforation, other types of fistulas, septic complications, and thromboembolic events. Although the clinical benefits are undeniable, the addition of Bevacizumab to standard chemotherapy increased the overall treatment cost by 213%.
CONCLUSIONS: Bevacizumab remains a high-cost therapy, but it can add to clinical benefits (like overall survival, progression-free survival, and response rate) when used in conjunction with standard chemotherapy. Similar results as those presented in various controlled trials are observable even on unselected cohorts of patients in the uncontrolled conditions of \"real-world\" oncological practice. Off-label usage is encountered in clinical practice, and this aspect should be monitored given the potential adverse effects of the therapy.