Trojan Jörg, Mineur Laurent, Tomášek Jiří, Rouleau Etienne, Fabian Pavel, de Maglio Giovanna, García-Alfonso Pilar, Aprile Giuseppe, Taylor Aliki, Kafatos George, Downey Gerald, Terwey Jan-Henrik, van Krieken J Han
University Hospital, Frankfurt, Germany.
Institute Sainte Catherine, Avignon, France.
PLoS One. 2015 Oct 22;10(10):e0140717. doi: 10.1371/journal.pone.0140717. eCollection 2015.
From 2008-2013, the European indication for panitumumab required that patients' tumor KRAS exon 2 mutation status was known prior to starting treatment. To evaluate physician awareness of panitumumab prescribing information and how physicians prescribe panitumumab in patients with metastatic colorectal cancer (mCRC), two European multi-country, cross-sectional, observational studies were initiated in 2012: a physician survey and a medical records review. The first two out of three planned rounds for each study are reported.
The primary objective in the physician survey was to estimate the prevalence of KRAS testing, and in the medical records review, it was to evaluate the effect of test results on patterns of panitumumab use. The medical records review study also included a pathologists' survey.
In the physician survey, nearly all oncologists (299/301) were aware of the correct panitumumab indication and the need to test patients' tumor KRAS status before treatment with panitumumab. Nearly all oncologists (283/301) had in the past 6 months of clinical practice administered panitumumab correctly to mCRC patients with wild-type KRAS status. In the medical records review, 97.5% of participating oncologists (77/79) conducted a KRAS test for all of their patients prior to prescribing panitumumab. Four patients (1.3%) did not have tumor KRAS mutation status tested prior to starting panitumumab treatment. Approximately one-quarter of patients (85/306) were treated with panitumumab and concurrent oxaliplatin-containing chemotherapy; of these, 83/85 had confirmed wild-type KRAS status prior to starting panitumumab treatment. All 56 referred laboratories that participated used a Conformité Européenne-marked or otherwise validated KRAS detection method, and nearly all (55/56) participated in a quality assurance scheme.
There was a high level of knowledge amongst oncologists around panitumumab prescribing information and the need to test and confirm patients' tumors as being wild-type KRAS prior to treatment with panitumumab, with or without concurrent oxaliplatin-containing therapy.
2008年至2013年期间,帕尼单抗在欧洲的适应证要求患者在开始治疗前已知肿瘤KRAS第2外显子的突变状态。为评估医生对帕尼单抗处方信息的知晓情况以及医生如何为转移性结直肠癌(mCRC)患者开具帕尼单抗,2012年启动了两项欧洲多国的横断面观察性研究:一项医生调查和一项病历审查。本文报告了每项研究计划的三轮中的前两轮。
医生调查的主要目的是估计KRAS检测的普及率,病历审查的主要目的是评估检测结果对帕尼单抗使用模式的影响。病历审查研究还包括一项病理学家调查。
在医生调查中,几乎所有肿瘤学家(299/301)都知晓帕尼单抗的正确适应证以及在使用帕尼单抗治疗前检测患者肿瘤KRAS状态的必要性。在过去6个月的临床实践中,几乎所有肿瘤学家(283/301)都曾正确地为KRAS状态为野生型的mCRC患者使用过帕尼单抗。在病历审查中,97.5%的参与研究的肿瘤学家(77/79)在开具帕尼单抗之前为所有患者进行了KRAS检测。4名患者(1.3%)在开始帕尼单抗治疗前未检测肿瘤KRAS突变状态。约四分之一的患者(85/306)接受了帕尼单抗与含奥沙利铂化疗的联合治疗;其中,83/85名患者在开始帕尼单抗治疗前已确认KRAS状态为野生型。所有参与的56家送检实验室均使用了欧洲合格认证标志或其他经过验证的KRAS检测方法,几乎所有实验室(55/56)都参与了质量保证计划。
肿瘤学家对帕尼单抗处方信息以及在使用或不使用含奥沙利铂联合治疗的情况下,在使用帕尼单抗治疗前检测并确认患者肿瘤为KRAS野生型的必要性有较高的认知水平。