De Tursi Michele, Carella Consiglia, Tomao Silverio, Cinieri Saverio, Lorusso Vito, Marchetti Paolo, Vecchio Stefania, Sansoni Elisabetta, Contu Antonio, Adamo Vincenzo, Silvestris Nicola, Nuzzo Antonio, Rosti Giovanni, Ravaioli Alberto, Danova Marco, Tonini Giuseppe, Passalacqua Rodolfo, Cruciani Giorgio, Faedi Marina, Spada Massimiliano, De Laurentiis Michelino, Amoroso Domenico, Tomao Federica, Sperduti Isabella, Grassadonia Antonino, Tinari Nicola, Natoli Clara, Iacobelli Stefano
Tumori. 2014 Nov-Dec;100(6):e309-13. doi: 10.1700/1778.19310.
Guideline consistency in the prevention of chemotherapy-induced nausea and vomiting (CINV) remains low (29% in the Pan European Emesis Registry study) and very low (11%) in regimens with a high emetogenic risk. The aim of this study was to evaluate the guideline consistency of CINV prophylaxis for acute emesis in daily clinical practice in Italy.
This was a prospective, observational, multicenter study. Patients scheduled to receive antitumor treatment on a single prespecified day were included. Data on patient characteristics (demographic and clinical), type of anticancer therapy, and type of antiemetic therapy prescribed for acute emesis were collected on electronic data capture forms. Chemotherapy regimens and antiemetic prophylaxis were categorized according to the MASCC 2011 guidelines. The study was approved by the local ethics committees.
From July 2013 to February 2014, a total of 502 patients were enrolled at 26 study sites. Median age was 62 years (range 27-87 years). Colorectal cancer and breast cancer were the most common malignancies. The emetogenic potential of the chemotherapy regimens used was high (HEC) (23.7%), moderate (MEC) (40.6%), low (31.3%) or minimal (4.4%). Overall, guideline consistency was 19.3%. Consistency reached 45% when the various 5HT3 receptor antagonists were considered equivalent and interchangeable in MEC regimens. Adherence to guidelines was lowest for MEC and Minimal risk groups. Ten percent of patients in HEC and MEC regimens did not receive any 5HT3 receptor antagonists. NK1 receptor antagonists were used in 8% of all regimens.
Our study indicates that antiemetic guideline inconsistency remains an issue in daily clinical oncology practice in Italy.
预防化疗引起的恶心和呕吐(CINV)的指南一致性仍然很低(泛欧洲呕吐登记研究中为29%),在具有高致吐风险的方案中则非常低(11%)。本研究的目的是评估意大利日常临床实践中急性呕吐的CINV预防的指南一致性。
这是一项前瞻性、观察性、多中心研究。纳入在单个预定日期接受抗肿瘤治疗的患者。通过电子数据采集表收集患者特征(人口统计学和临床特征)、抗癌治疗类型以及为急性呕吐开具的止吐治疗类型的数据。化疗方案和止吐预防措施根据MASCC 2011指南进行分类。该研究获得了当地伦理委员会的批准。
2013年7月至2014年2月,共有502名患者在26个研究地点入组。中位年龄为62岁(范围27 - 87岁)。结直肠癌和乳腺癌是最常见的恶性肿瘤。所使用的化疗方案的致吐潜力为高(HEC)(23.7%)、中(MEC)(40.6%)、低(31.3%)或极小(4.4%)。总体而言,指南一致性为19.3%。当在MEC方案中各种5HT3受体拮抗剂被视为等效且可互换时,一致性达到45%。MEC和极小风险组对指南的依从性最低。HEC和MEC方案中有10%的患者未接受任何5HT3受体拮抗剂。NK1受体拮抗剂在所有方案中的使用比例为8%。
我们的研究表明,在意大利日常临床肿瘤学实践中,止吐指南不一致仍然是一个问题。