Nikic Predrag, Babovic Nada, Dzamic Zoran, Salma Svetlana, Stojanovic Vesna, Matkovic Suzana, Pejcic Zoran, Juskic Kristina, Soldatovic Ivan
Clinic of Urology, University Clinical Center of Serbia, Belgrade, Serbia.
University of Belgrade, Faculty of Medicine, Belgrade, Serbia.
Front Oncol. 2022 Jun 8;12:892156. doi: 10.3389/fonc.2022.892156. eCollection 2022.
The emerging new standard of care for metastatic clear cell renal carcinoma (mRCC) becomes a challenge when access to new drugs is limited. In Serbia, sunitinib and pazopanib are the only available first-line therapies. The second-line treatment for mRCC has never been and is still not available. We aimed to assess overall survival (OS) in patients with mRCC who received first-line sunitinib or pazopanib when access to second-line treatment was not available.
This retrospective observational study analyzed data from a nationally representative cohort of 759 patients who started on first-line sunitinib or pazopanib between 1 January 2012 and 30 June 2019, in 4 centers in Serbia. The data cut-off date was 31 December 2019. Key eligibility criteria were clear cell RCC histology, measurable metastatic disease, performance status 0 or 1, and the Memorial Sloan Kettering Cancer Center favorable or intermediate prognosis. The primary outcome was OS from the start of first-line treatment to death or data cut-off date.
The study population included 759 patients with mRCC who started with first-line sunitinib (n = 673; [88.7%]) or pazopanib (n = 86; [11.3%]). Overall, the mean age was 61.0 ± 9.7 years at treatment baseline, and 547 (72%) were men. mRCC was primarily diagnosed in 230 (30%) patients, and most of them underwent cytoreductive nephrectomy prior to systemic therapy (n = 181 [79%]). Additional treatment of metastases prior to and/or during treatment was used in 169 patients (22.3%). Grade 3 and 4 adverse events occurred in 168 (22.1%) and 47 patients (6.2%), respectively, and treatment was permanently stopped because of toxicity in 41 (6.9%). The OS was calculated from the start of first-line treatment, and the median follow-up was 14 months (range, 0-97). The median OS in the entire cohort was 17 months (95% CI, 14.6-19.4).
With only available sunitinib and pazopanib in first-line treatment, modest improvements are seen in the overall survival of patients with mRCC in real world clinical practice. In circumstances of limited availability of cancer medicines, our results can contribute to accelerating patient access to novel cancer therapies that have been shown to prolong survival in mRCC.
当获取新药受到限制时，转移性透明细胞肾细胞癌（mRCC）新出现的护理标准成为一项挑战。在塞尔维亚，舒尼替尼和帕唑帕尼是仅有的一线治疗药物。mRCC的二线治疗过去未曾有过，现在仍然无法获得。我们旨在评估在无法获得二线治疗的情况下，接受一线舒尼替尼或帕唑帕尼治疗的mRCC患者的总生存期（OS）。
这项回顾性观察性研究分析了2012年1月1日至2019年6月30日期间在塞尔维亚4个中心开始接受一线舒尼替尼或帕唑帕尼治疗的759例具有全国代表性队列患者的数据。数据截止日期为2019年12月31日。关键纳入标准为透明细胞RCC组织学、可测量的转移性疾病、体能状态0或1以及纪念斯隆凯特琳癌症中心有利或中等预后。主要结局是从一线治疗开始至死亡或数据截止日期的OS。
研究人群包括759例开始接受一线舒尼替尼（n = 673；[88.7%]）或帕唑帕尼（n = 86；[11.3%]）治疗的mRCC患者。总体而言，治疗基线时的平均年龄为61.0±9.7岁，547例（72%）为男性。230例（30%）患者主要诊断为mRCC，其中大多数在全身治疗前接受了减瘤性肾切除术（n = 181 [79%]）。169例患者（22.3%）在治疗前和/或治疗期间接受了转移灶的额外治疗。3级和4级不良事件分别发生在168例（22.1%）和47例患者（6.2%）中，41例（6.9%）因毒性而永久停止治疗。OS从一线治疗开始计算，中位随访时间为14个月（范围，0 - 97个月）。整个队列的中位OS为17个月（95%CI，14.6 - 19.4）。
在一线治疗仅使用舒尼替尼和帕唑帕尼的情况下，在现实世界临床实践中mRCC患者的总生存期有适度改善。在癌症药物可及性有限的情况下，我们的结果有助于加快患者获得已被证明可延长mRCC生存期的新型癌症治疗方法。
