Department of Internal Medicine, Stauferklinikum Schwäbisch Gmünd, Mutlangen, Germany.
Medical Clinic I, Klinikum Frankfurt (Oder) GmbH, Frankfurt (Oder), Germany.
Adv Ther. 2019 Mar;36(3):670-683. doi: 10.1007/s12325-019-0874-6. Epub 2019 Jan 28.
This study aimed to better understand panitumumab use in real-life clinical practice in first- and second-line treatment of metastatic colorectal cancer in five European countries.
This is a combined analysis of two observational, non-interventional prospective cohort studies, one of which was conducted in Germany and France, the other in Bulgaria, Czech Republic, and Hungary. The studies observed patients with wild-type [Kirsten] rat sarcoma viral oncogene homolog ([K]RAS/RAS) metastatic colorectal cancer (mCRC), who had been treated with panitumumab in combination with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) in the first line or with panitumumab combined with fluorouracil, leucovorin, and irinotecan (FOLFIRI) in the second line following fluoropyrimidine-based chemotherapy. The planned duration of observation was 12 months from the first dose of panitumumab.
A total of 332 patients treated with panitumumab + FOLFOX in the first line and 94 patients treated with panitumumab + FOLFIRI in the second line were analyzed. The median number of panitumumab infusions was 10.0 in first-line FOLFOX patients and 11.5 in second-line FOLFIRI patients; the median duration of panitumumab exposure was 5.7 and 6.9 months, respectively. The unadjusted overall response rate (complete or partial response) in patients with available post-baseline response assessment (n = 290) was 51.7% in first-line FOLFOX and 44.9% in second-line FOLFIRI patients. In the first-line setting, resectability was achieved in 9.3%. Reported hospitalizations were mostly cancer-related visits such as scheduled anticancer treatment administrations, tumor assessment visits, or interventions. The majority of adverse drug reactions were skin disorders, with 75.3% in first-line FOLFOX patients and 72.3% in second-line FOLFIRI patients.
Overall, the study results show that treatment patterns, clinical efficacy, and the safety profile of panitumumab in routine clinical practice were comparable to those in randomized controlled trials. The relatively low skin toxicity rate could be attributed to increasing experience in managing panitumumab-associated rash and some degree of underreporting.
Amgen.
本研究旨在更好地了解帕尼单抗在五个欧洲国家转移性结直肠癌一线和二线治疗中的实际临床应用。
这是两项观察性、非干预性前瞻性队列研究的联合分析，其中一项在德国和法国进行，另一项在保加利亚、捷克共和国和匈牙利进行。这些研究观察了野生型（Kirsten）鼠肉瘤病毒致癌基因同源物（K）RAS/ RAS 转移性结直肠癌（mCRC）患者，他们接受了帕尼单抗联合氟尿嘧啶、亚叶酸钙和奥沙利铂（FOLFOX）一线治疗，或在氟嘧啶类化疗后接受帕尼单抗联合氟尿嘧啶、亚叶酸钙和伊立替康（FOLFIRI）二线治疗。观察的计划持续时间为从帕尼单抗首剂量开始的 12 个月。
共分析了 332 例接受帕尼单抗+ FOLFOX 一线治疗和 94 例接受帕尼单抗+ FOLFIRI 二线治疗的患者。一线 FOLFOX 患者中帕尼单抗输注的中位数为 10.0，二线 FOLFIRI 患者中为 11.5；帕尼单抗暴露的中位数持续时间分别为 5.7 和 6.9 个月。在有基线后反应评估的可评估患者（n=290）中，一线 FOLFOX 患者的总缓解率（完全或部分缓解）为 51.7%，二线 FOLFIRI 患者为 44.9%。在一线治疗中，可切除率为 9.3%。报告的住院主要是癌症相关的就诊，如计划的抗癌治疗管理、肿瘤评估就诊或干预。大多数药物不良反应为皮肤疾病，一线 FOLFOX 患者为 75.3%，二线 FOLFIRI 患者为 72.3%。
总体而言，研究结果表明，帕尼单抗在常规临床实践中的治疗模式、临床疗效和安全性与随机对照试验相当。相对较低的皮肤毒性发生率可能归因于在管理帕尼单抗相关皮疹方面的经验增加，以及一定程度的报告不足。
安进。
