Evaluation of Costs and Outcomes of the Implementation of Treatment Protocol Based on Rational Utilization of Anti-PD1 Agents in Patients With Non-small-cell Lung Cancer in the Brazilian Public Health System
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Total cost of therapy
研究概览
简要总结
Immunotherapy with anti-PD-1/PD-L1 agents either as single agents or combined with chemotherapy is now considered the standard of care for patients with non-small-cell lung cancer. However, it has not been incorporated in the Brazilian Public Health System because of concerns about patient eligibility, safety and costs. It is known that simple biomarkers can be used to select patients for immunotherapy, such as EGRF, ALK and PD-L1 status in the tumors. We created a treatment protocol based on these 3 markers and treated 154 patients with non-small-cell-lung cancer in a Public Hospital in Brazil. The goal of this project is to identify the prevalence of these markers in the Brazilian population (to estimate patient eligibility), outcomes and costs of therapy.
详细描述
Patients with metastatic non-small-cell lung cancer will undergo tumor testing for EGFR (by PCR), ALK and PD-L1 (by immunohistochemistry) and receive therapy based on these results.
- Patients with ALK-translocated tumors will receive first-line therapy with Alectinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel
- Patients with EGFR-mutated tumors will receive first-line therapy with Erlotinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel
- Patients with ALK/EGFRwt tumors and PD-L1>=50% will receive first-line pembrolizumab, second-line carboplatin-pemetrexed and third line docetaxel
- Patients with ALK/EGFRwt tumors and PD-L1<50% will receive first-line carboplatin-pemetrexed, second-line nivolumab and third line docetaxel.
Therapy costs will be estimated, including hospital admissions and reported for each treatment arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IIIc or IV Non-small cell lung cancer
- •Good performance status (ECOG 0-2)
- •Available tissue for tumor markers
- •Plan to undergo systemic therapy
排除标准
- •Inadequate cardiac, renal, liver of bone-marrow function
- •Plan to undergo definitive radiation or curative surgery
- •Consent withdraw
研究组 & 干预措施
ALK-translocated
- st line Alectinib
- nd line Carboplatin pemetrexed
- rd line Docetaxel
干预措施: Alectinib (Drug)
EGFR-mutant
- st line Erlotinib
- nd line Carboplatin pemetrexed
- rd line Docetaxel
干预措施: Erlotinib (Drug)
PD-L1 >= 50%
- st line Pembrolizumab
- nd line Carboplatin pemetrexed
- rd line Docetaxel
干预措施: Pembrolizumab (Drug)
PD-L1< 50%
- st line Carboplatin pemetrexed
- nd line nivolumab
- rd line Docetaxel
干预措施: Nivolumab (Drug)
结局指标
主要结局
Total cost of therapy
时间窗: Up to 3 years after starting systemic therapy
Sum of all direct costs involved in patient care, including admissions
次要结局
- Median overall survival(Up to 3 years after starting systemic therapy)
- Prevalence of ALK, EGFR, PD-L1>=50%(Up to 3 years after starting systemic therapy)