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.
总体而言，据估计已有超过350万患者在接受全身性肿瘤治疗时使用了贝伐珠单抗。目前，贝伐珠单抗及其生物类似药已在超过130个国家上市。鉴于贝伐珠单抗在当前肿瘤临床实践中的广泛应用，将“真实世界”结果与对照临床试验中获得的结果进行比较至关重要。本研究旨在描述在“非对照真实世界”条件下，大型癌症患者队列使用贝伐珠单抗在疗效、安全性和治疗成本方面的临床经验。方法：为此，我们开展了一项开放性、观察性、回顾性研究，纳入了2017年至2021年间在布加勒斯特“Prof. Dr. Al. Trestioreanu”肿瘤研究所接受基于贝伐珠单抗全身治疗的实体恶性肿瘤患者。结果：研究共包含625名患者的657个治疗周期（女性/男性 = 1.62/1，中位年龄57.6岁），所治疗的恶性肿瘤主要为结直肠癌、非小细胞肺癌、卵巢癌和乳腺癌。229名患者接受了一线治疗，其余患者将贝伐珠单抗作为二线或后续治疗。除结直肠癌和卵巢癌后续治疗线（记录到的数值较低，分别为27.1%和31.5%）外，基于贝伐珠单抗的治疗在所有适应症中的总体缓解率约为60-65%。整个队列的中位无进展生存期为8.2个月（95% CI 6.8–9.6），中位总生存期为13.2个月（95% CI 11.5–14.9）。观察到了常见的贝伐珠单抗相关毒性，包括出血、高血压、伤口愈合并发症、胃肠道穿孔、其他类型瘘管、感染性并发症和血栓栓塞事件。尽管临床获益毋庸置疑，但在标准化疗基础上加用贝伐珠单抗使总体治疗成本增加了213%。结论：贝伐珠单抗仍是一种高成本疗法，但与标准化疗联合使用时，可增加临床获益（如总生存期、无进展生存期和缓解率）。即使在“真实世界”肿瘤实践中未经筛选的患者队列和非对照条件下，也能观察到与各项对照试验中呈现的相似结果。临床实践中存在超说明书用药情况，鉴于该疗法潜在的副作用，应对此方面进行监测。
Bevacizumab-Based Therapies in Malignant Tumors—Real-World Data on Effectiveness, Safety, and Cost
肿瘤(癌症)患者之家