Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Department of Healthcare Development, Stockholm County Council, Stockholm, Sweden.
Target Oncol. 2018 Dec;13(6):725-733. doi: 10.1007/s11523-018-0604-z.
Although olaparib, the first poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor approved, has been used in routine clinical practice for over three years, little has been published on its uptake, utilization patterns, and clinical outcomes.
To examine real-world use and outcomes of olaparib treatment in Swedish patients during the first three years following regulatory approval.
This is a population-based cohort study using data from the Swedish national registers. All individuals initiating olaparib treatment from regulatory approval to 31 December 2017 were included. The extent of off-label use was assessed based on recorded diagnoses. Ovarian cancer patients were followed until death or the end of the study period. Starting dose and dose adjustments were assessed. Time to olaparib discontinuation and overall survival were plotted using Kaplan-Meier survival curves.
We identified 109 patients to whom olaparib was dispensed in Sweden during the study period. Nine of these were prescribed olaparib off-label for either breast or prostate cancer and were excluded from further analyses. Median age among the remaining 100 patients with ovarian cancer was 59 years (range: 42-83). Almost all patients (96%) started on the recommended dose (400 mg [eight capsules] taken twice daily). Dose reductions were explicitly recorded for 14% of patients. Median time to discontinuation was 289 days (95% confidence interval [CI]: 226; 338). Median overall survival from olaparib initiation was 1002 days (95% CI: 676; not calculable).
To our knowledge, this is the first population-based study of olaparib real-world use and outcomes. During the first three years following regulatory approval, olaparib was mainly prescribed to ovarian cancer patients. Ovarian cancer patients stayed on olaparib for a median of 9.5 months and the treatment appeared to be well tolerated.
尽管首个聚（二腺苷二磷酸核糖）聚合酶（PARP）抑制剂奥拉帕利自监管批准以来已在常规临床实践中应用超过三年，但关于其应用、使用模式和临床结局的报道甚少。
研究监管批准后三年内瑞典患者使用奥拉帕利治疗的真实世界应用和结局。
这是一项基于人群的队列研究，使用来自瑞典国家登记处的数据。纳入所有自监管批准至 2017 年 12 月 31 日开始接受奥拉帕利治疗的患者。根据记录的诊断评估奥拉帕利的超适应证使用程度。卵巢癌患者随访至死亡或研究结束。评估起始剂量和剂量调整。使用 Kaplan-Meier 生存曲线绘制奥拉帕利停药时间和总生存时间。
研究期间，我们在瑞典发现 109 例开具奥拉帕利处方的患者。其中 9 例因乳腺癌或前列腺癌而超适应证开具奥拉帕利处方，将其排除在进一步分析之外。剩余 100 例卵巢癌患者的中位年龄为 59 岁（范围：42-83）。几乎所有患者（96%）均起始推荐剂量（400mg[8 粒胶囊]，每日两次）。14%的患者明确记录了剂量减少。中位停药时间为 289 天（95%置信区间[CI]：226；338）。从开始使用奥拉帕利至中位总生存时间为 1002 天（95%CI：676；无法计算）。
据我们所知，这是首个关于奥拉帕利真实世界应用和结局的基于人群的研究。在监管批准后的三年内，奥拉帕利主要用于治疗卵巢癌患者。卵巢癌患者中位使用奥拉帕利时间为 9.5 个月，且治疗耐受性良好。
