Roila Fausto, Ballatori Enzo, Labianca Roberto, De Braud Filippo, Borgonovo Karen, Martelli Olga, Gallo Ciro, Tinazzi Angelo, Perrone Francesco
Medical Oncology Division, S. Maria Hospital, Terni, Italy.
Tumori. 2009 Nov-Dec;95(6):647-51. doi: 10.1177/030089160909500601.
An appropriate use of drugs should follow the registered indications. Different reasons can induce oncologists to prescribe drugs off-label. The aim of this study was to describe incidence and characteristics of these prescriptions in Italy.
Patients submitted to chemotherapy in 15 Italian oncology centers were evaluated for two randomized non-consecutive days of two weeks in May 2006.
The study enrolled 644 patients receiving 1,053 drugs. Overall, 199 of 1053 (18.9%) prescriptions were off-label. In 92 of 199 cases (46.2%), the drugs were used for a neoplasm for which they were not approved, but there was scientific evidence (one or more randomized clinical trials or more phase II studies published in a major oncology journal) justifying the prescription. In 27 cases (13.6%), the drugs were prescribed for a rare neoplasm (cisplatin and gemcitabine in mesothelioma). In 20/21 cases (10.1%/10.5%), drugs were used in association/alone in contrast with the approved use (capecitabine in association in colorectal cancer). In 28/11 cases (14.0%/5.6%), the drugs were used in lines of chemotherapy subsequent/previous to that approved.
Off-label use of antineoplastic drugs, in this observational survey, represents less than 20% of the prescriptions, and most of them are based on scientific evidence of efficacy.
药物的合理使用应遵循注册的适应证。不同原因可促使肿瘤学家开具未标明适应证的药物。本研究的目的是描述意大利这些处方的发生率和特征。
对2006年5月在意大利15个肿瘤中心接受化疗的患者，在两周内随机抽取不连续的两天进行评估。
该研究纳入了644例患者，共开具了1053种药物。总体而言，1053份处方中有199份（18.9%）为未标明适应证用药。在199例中的92例（46.2%）中，药物用于其未获批的肿瘤，但有科学证据（一项或多项随机临床试验或在主要肿瘤学杂志上发表的更多II期研究）支持该处方。在27例（13.6%）中，药物用于罕见肿瘤（顺铂和吉西他滨用于间皮瘤）。在20/21例（10.1%/10.5%）中，药物的联合使用/单独使用与获批用法相反（卡培他滨用于结直肠癌联合用药）。在28/11例（14.0%/5.6%）中，药物用于获批化疗方案之后/之前的化疗疗程。
在这项观察性调查中，抗肿瘤药物的未标明适应证使用占处方的比例不到20%，且大多数基于疗效的科学证据。
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