Pharmacoeconomic evaluation of serplulimab combined with chemotherapy regimens for the first-line treatment of extensive-stage small cell lung cancer / 中国药房

OBJECTIVE To evaluate the economics of serplulimab combined with chemotherapy regimens for the first-line treatment of extensive-stage small cell lung cancer （ES-SCLC） from the perspective of health system in China. METHODS A partitioned survival model was constructed based on the ASTRUM-005 clinical trial and related literature data， with a model simulation time frame of 10 years and a 3-week cycle， and both cost and utility values were discounted using a 5% discount rate. The quality-adjusted life year （QALY） was used as a model output indicator and the incremental cost-effectiveness ratio （ICER） was calculated to evaluate the economics of serplulimab combined with chemotherapy regimens （serplulimab group） versus chemotherapy alone regimens （chemotherapy alone group） for the first-line treatment of ES-SCLC. One-way sensitivity analysis and probabilistic sensitivity analysis were used to verify the robustness of the results of the base-case analysis and to conduct a scenario analysis for the serplulimab patient assistance program. RESULTS The results of the base-case analysis showed that compared with chemotherapy alone group， ICER of serplulimab group was 758 690.27 yuan/QALY， which was higher than 3 times China’s per capita gross domestic product （GDP） in 2022 as the willingness-to-pay （WTP） threshold. The results of the scenario analysis showed that compared with chemotherapy alone group， the ICER of serplulimab group was 172 275.74 yuan/QALY， which was below above WTP threshold. The one-way sensitivity analysis showed that the progress-free survival utility value， serplulimab price and so on had a significant impact on the model results. The results of the probabilistic sensitivity analysis showed that the probability of the serplulimab group being economic was 0 when the serplulimab patient assistance program was not considered， but 100% when the patient assistance program was considered. CONCLUSIONS At a WTP threshold of 3 times China’s per capita GDP in 2022， the serplulimab group is no cost-effectiveness compared to the chemotherapy alone group； however， this result is reversed when the patient assistance program is taken into account.

Safety of thoracic radiotherapy followed by PD-1/PD-L1 inhibitor after induction therapy for extensive-stage small cell lung cancer / 中华放射肿瘤学杂志

Objective:To evaluate the safety and tolerance of sequential thoracic radiotherapy combined with PD-1/PD-L1 inhibitors in patients with extensive-stage small cell lung cancer (ES-SCLC) after induction systemic therapy.Methods:ES-SCLC patients from a phase I trial and a real-world study were enrolled for those who received thoracic radiotherapy after induction systemic treatment (chemotherapy/chemotherapy combined with PD-1/PD-L1 inhibitors) and consolidated with PD-1/PD-L1 inhibitors. These two studies were both approved by the Ethics Committee of Chinese Academy of Medical Sciences Cancer Hospital (Clinical Trials.gov number, NCT03971214, NCT04947774).Results:Between January 2019 and March 2021, a total of 11 patients with ES-SCLC were analyzed, aged 52-73 years, with a median age of 62 years. Among them, five patients (45.5%) received induction chemotherapy and six patients (54.5%) received chemotherapy combined with PD-1/PD-L1 inhibitor, and then all received intensity-modulated thoracic radiotherapy after evaluation of systemic treatment efficacy. Two patients developed treatment-related grade G3-5 toxicity (18.2%, 1 treatment-related pneumonitis and 1 radiation esophagitis). G 1-G 2 hematologic toxicity, pneumonia, and anorexia were common mild toxicities. Only one patient (9.1%) terminated immunotherapy due to immune-related pneumonitis. During a median follow-up time of 12.5 months (range: 3.5-16.4 months), the median disease progression-free survival and overall survival was 7.4 months (95% CI: 6.9-8.0 months) and 14.6 months (95% CI: 9.0-20.2 months), respectively. Conclusions:Sequential thoracic radiotherapy followed by PD-1/PD-L1 inhibitor is safe and feasible in patients with ES-SCLC after induction therapy. Given that both thoracic radiotherapy and immunotherapy benefits the ES-SCLC in survival, this comprehensive treatment modality warrants further investigation.

Advances in thoracic radiotherapy for extensive stage small cell lung cancer / 国际肿瘤学杂志

Extensive stage small cell lung cancer (ES-SCLC) has a poor prognosis and short survival. Although platinum based combined with etoposide regimens and prophylactic craniocerebral irradiation have become the treatment regimens for ES-SCLC, it still faces the challenges of low local control rate and overall survival rate. As a local treatment, radiotherapy has a wide range of applications, which can not only be used for the radical treatment of local lesions, but also for the selective palliative treatment of advanced patients. Thoracic radiotherapy can improve the local control of ES-SCLC, among them, patients with residual intrathoracic lesions after chemotherapy benefit the most. There is still no unified standard for the appropriate population, optimal dose and segmentation of thoracic radiotherapy, and further research is needed.

Cost-utility Analysis of Atezolizumab Combined with Standard Chemotherapy Regimen in the First-line Treatment of Extensive-stage Small-cell Lung Cancer / 中国药房

OBJECTIVE：To evaluate the economics of atezolizumab combined with stardard chemotherapy regimens versus chemotherapy regimens alone as first-line treatment for extensive-stage small-cell lung cancer （ES-SCLC）from the healthcare system perspective. METHODS ：A partitioned survival model was constructed using published phase Ⅲ clinical trial data （IMpower133）and literature data to evaluate the economics of atezolizumaba combined with standard chemotherapy regimens versus chemotherapy regimens alone as first-line treatment for ES-SCLC. One-way sensitivity analysis and probabilistic sensitivity analysis were used to evaluate the stability of the results. RESULTS ：The results of cost-utility analysis showed that the cost of atezolizumab combined with chemotherapy group was 489 598.52 yuan，with utility of 0.70 QALYs；the cost of chemotherapy alone group was 126 276.80 yuan，with utility of 0.55 QALYs；the incremental cost-utility ratio （ICUR）between the two groups was 2 361 709.05 yuan/QALY，far exceeding the willingness-to-pay （WTP）in China （3 times of GDP per capita in 2019，212 676 yuan）. One-way sensitivity analysis showed that progression-free utility value of atezolizumab combined with chemotherapy had the greatest impact on the results of cost-utility analysis ；probabilistic sensitivity analysis suggested that the atezolizumab combined with chemotherapy regimen was not economical within the WTP range of 0-500 000 yuan/QALY. CONCLUSIONS ：Atezolizumab combined with chemotherapy regimen has no cost-utility advantage versus chemotherapy alone in the first-line treatment of ES-CLC under the current economic level of China.

Higher thoracic radiation dose is beneficial in patients with extensive small cell lung cancer

PURPOSE: The effectiveness of thoracic radiation therapy (TRT) in extensive-stage small cell lung cancer (ES-SCLC) patients is increasingly reported, but there is no definite consensus on its application. The aim of this study was to identify factors associated with better outcomes of TRT among patients with ES-SCLC, focusing on whether a higher TRT dose could improve treatment outcome. MATERIALS AND METHODS: The medical records of 85 patients with ES-SCLC who received TRT between January 2008 and June 2017 were retrospectively reviewed. Eligibility criteria were a biological effective dose with α/β = 10 (BED) higher than 30 Gy₁₀ and completion of planned radiotherapy. RESULTS: During a median follow-up of 5.3 months, 68 patients (80.0%) experienced disease progression. In univariate analysis, a BED >50 Gy₁₀ was a significant prognostic factor for overall survival (OS; 40.8% vs. 12.5%, p = 0.006), progression-free survival (PFS; 15.9% vs. 9.6%, p = 0.004), and intrathoracic PFS (IT-PFS; 39.3% vs. 20.5%, p = 0.004) at 1 year. In multivariate analysis, a BED >50 Gy₁₀ remained a significant prognostic factor for OS (hazard ratio [HR] = 0.502; 95% confidence interval [CI], 0.287–0.876; p = 0.015), PFS (HR = 0.453; 95% CI, 0.265–0.773; p = 0.004), and IT-PFS (HR = 0.331; 95% CI, 0.171–0.641; p = 0.001). Response to the last chemotherapy was also associated with better OS in both univariate and multivariate analysis. CONCLUSION: A TRT dose of BED >50 Gy₁₀ may be beneficial for patients with ES-SCLC. Further studies are needed to select patients who will most benefit from high-dose TRT.

Advances in radiotherapy for extensive-stage cell lung cancer / 中国肿瘤临床

Extensive-stage small cell lung cancer (ES-SCLC) accounts for approximately two-thirds of all SCLCs. Chemotherapy is still the main treatment, supplemented with radiotherapy and other comprehensive treatments. Although sensitive to chemotherapy and radiotherapy, almost all ES-SCLCs are vulnerable to treatment resistance and have high recurrence rates. Therefore, novel therapies are needed to improve treatment efficacy. The recent advances in radiotherapy for ES-SCLC include prophylactic cranial irradiation (PCI) and thoracic radiotherapy (TRT). Moreover, immunotherapy has shown good antitumor activity, and immune-checkpoint inhibi-tors may become an important breakthrough in SCLC treatment. This article briefly reviewed the clinical research on radiotherapy and immunotherapy for advanced-stage SCLC.

Correlation of Hemoglobin and Bilirubin with Prognosis of Extensive Stage Small Cell Lung Cancer / 中国医科大学学报

Objective To explore the factors that affect the prognosis of extensive small cell lung cancer by analyzing the association between lab-oratory indicators before treatment of extensive small cell lung cancer patients and the initial evaluation results with disease progression and overall survival. Methods This study retrospectively analyzed 96 cases of hospitalized patients in the medical oncology department of The First Hospital of China Medical University from March 2008 to September 2014. Kaplan-Meier method and Cox proportional hazards models were adopted to ana-lyze the relevant factors affecting the prognosis of extensive small cell lung cancer. P<0.05 was considered statistically significant. Results There was no obvious correlation between HB level before treatment with PFS of patients(P=0.179),but there was obvious significant correlation be-tween HB level and OS of patients(P=0.041). Our results showed that the TBIL level of patients before chemotherapy was significantly associated with the PFS(P=0.039)and OS(P=0.026)of patients. Conclusion HB and TBIL levels are the influencing factors that affect the prognosis and survival of patients with extensive small cell lung cancer.

Correlation of Lactate Dehydrogenase and Neuron?specific Enolase with Prognosis of Extensive Small Cell Lung Cancer / 中国医科大学学报

Objective To determine whether neuron?specific enolase(NSE)affects the prognosis of extensive small cell lung cancer by analyz?ing the association between NSE before treatment and disease progression and overall survival of patients. Methods This study retrospectively an?alyzed 83 inpatients in the medical oncology department of the First Affiliated Hospital of China Medical University from March 2008 to September 2014. The Kaplan?Meier method and Cox proportional hazards models were used to analyze relevant factors affecting the prognosis of extensive small cell lung cancer;statistical significance was determined for a P value less than 0.05. Results The lactate dehydrogenase(LDH)level be?fore treatment was significantly associated with the progression?free survival(PFS)(P=0.001)and overall survival(OS)(P=0.036). The NSE level before treatment was also significantly associated with the PFS(P=0.007)and OS(P=0.013). Conclusion LDH and NSE affect progno?sis and survival of patients with extensive small cell lung cancer.