The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Eur Urol Focus. 2021 Nov;7(6):1409-1417. doi: 10.1016/j.euf.2020.06.012. Epub 2020 Jul 6.
Cancer-specific survival for men with clinical stage I (CSI) seminoma approaches 100%, regardless of the management approach chosen after orchiectomy. Given the young age and high survival rate of these patients, there has been a shift toward minimizing treatment-related morbidity and cost. In this context, non-risk-adapted active surveillance (NRAS) has emerged as a desirable management strategy.
To evaluate the clinical, quality of life, and economic values of postorchiectomy NRAS for CSI seminoma.
DESIGN, SETTING, AND PARTICIPANTS: We developed a decision analytic Markov model to estimate the costs and health outcomes of competing postorchiectomy management strategies for otherwise healthy 30-yr-old men with CSI seminoma.
Real-world current practice, comprising active surveillance and adjuvant therapies (reference arm), was compared with empiric adjuvant radiotherapy (option 1), empiric adjuvant chemotherapy (option 2), risk-adapted active surveillance (RAAS; option 3), and NRAS (option 4).
Quality-adjusted life-years (QALYs), medical costs, incremental cost-effectiveness ratio, mortality, and unnecessary treatment avoidance were estimated over a 10-yr period. Uncertainties in model input values were accounted for using univariate, scenario, and probabilistic sensitivity analyses.
NRAS dominated all other management options, offering the lowest per-patient health care cost ($3839) and the highest QALYs gained (7.74) over 10 yr. On probabilistic sensitivity analysis, NRAS had the highest chance of being most cost effective. Although NRAS resulted in the highest rate of salvage chemotherapy (20% vs 6% radiotherapy, 6% chemotherapy, 15% current practice, and 16% RAAS), it had the same mortality rate compared to current practice (2.5%). NRAS also allowed 80% of patients to avoid unnecessary treatment compared with 46% for current practice and 52% for RAAS. Study limitations included model simplifications, model parameter assumptions, as well as the absence of patient preference as a decision factor.
NRAS maintains high cure rates for CSI seminoma, minimizes unnecessary treatment, and is cost effective compared with other management strategies.
Clinical stage I (CSI) seminoma is one of the most common forms of testicular cancer. Surgery is the first step in the treatment of men with this disease, and some men may receive additional treatment with radiation or chemotherapy afterward. As most men are cured with surgery alone, non-risk-adapted active surveillance (NRAS), which involves routine monitoring with imaging and blood tests for disease recurrence after surgery, has become a desirable treatment option. Our study shows that in addition to maintaining high survival rates and avoiding unnecessary radiation and chemotherapy, NRAS is cost effective for the health care system.
对于临床 I 期（CSI）精原细胞瘤患者，无论在睾丸切除术之后选择何种治疗方法，其癌症特异性生存率都接近 100%。鉴于这些患者年龄较轻且生存率较高，人们已经开始转向将与治疗相关的发病率和成本最小化。在这种情况下，非风险适应性主动监测（NRAS）已成为一种理想的治疗策略。
评估 CSI 精原细胞瘤患者睾丸切除术后 NRAS 的临床、生活质量和经济价值。
设计、环境和参与者：我们开发了一个决策分析马尔可夫模型，以估计其他方面健康的 30 岁男性 CSI 精原细胞瘤患者接受不同睾丸切除术后管理策略的成本和健康结果。
真实世界的当前实践（包括主动监测和辅助治疗[参考臂]）与经验性辅助放疗（方案 1）、经验性辅助化疗（方案 2）、风险适应性主动监测（RAAS；方案 3）和 NRAS（方案 4）进行了比较。
在 10 年内估计了质量调整生命年（QALYs）、医疗成本、增量成本效益比、死亡率和不必要的治疗避免情况。使用单变量、情景和概率敏感性分析来考虑模型输入值的不确定性。
NRAS 主导了所有其他管理方案，每个患者的医疗保健成本最低（$3839），10 年内获得的 QALYs 最高（7.74）。在概率敏感性分析中，NRAS 成为最具成本效益的可能性最高。尽管 NRAS 导致挽救性化疗的发生率最高（20%比放疗 6%、化疗 6%、当前实践 15%和 RAAS 16%），但与当前实践相比，其死亡率相同（2.5%）。NRAS 还使 80%的患者能够避免不必要的治疗，而当前实践和 RAAS 分别为 46%和 52%。研究的局限性包括模型简化、模型参数假设以及缺乏作为决策因素的患者偏好。
NRAS 可保持 CSI 精原细胞瘤的高治愈率，最大限度地减少不必要的治疗，并且与其他管理策略相比具有成本效益。
临床 I 期（CSI）精原细胞瘤是最常见的睾丸癌形式之一。手术是治疗此类疾病男性的第一步，一些男性可能在手术后接受额外的放疗或化疗。由于大多数男性仅通过手术即可治愈，因此非风险适应性主动监测（NRAS）已成为一种理想的治疗选择，它涉及在手术后通过影像学和血液检查定期监测疾病复发。我们的研究表明，除了保持高生存率和避免不必要的放疗和化疗外，NRAS 对医疗保健系统具有成本效益。
