2022 World Conference on Lung Cancer (ePosters)-EP14.01-023. A Randomized Phase II Study of Irinotecan Plus Cisplatin With or Without Simvastatin in Ever-Smoking Small Cell Lung Cancer

EP14.01-023. A Randomized Phase II Study of Irinotecan Plus Cisplatin With or Without Simvastatin in Ever-Smoking Small Cell Lung Cancer

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A randomized phase II study was conducted to evaluate the effectiveness of simvastatin, an anti-inflammatory agent, when added to the chemotherapy regimen of irinotecan and cisplatin in ever-smoking small cell lung cancer (SCLC) patients. The study included 125 patients who were randomly assigned to receive either irinotecan and cisplatin alone or in combination with simvastatin. The primary endpoint of the study was progression-free survival (PFS), and secondary endpoints included response rate (RR), overall survival (OS), and toxicity. <br /><br />The results showed that the addition of simvastatin did not significantly improve PFS or OS compared to the control group. The RR was similar between the two groups. Safety evaluation showed that the most common adverse effects were neutropenia, diarrhea, and anemia, with grade 3 or worse adverse effects occurring in more than 5% of patients. However, there were no treatment-related deaths.<br /><br />Subgroup analysis was conducted based on clinical factors and serum biomarkers, but no subgroups showed a survival benefit from simvastatin treatment. The serum LDL level was significantly reduced in the simvastatin group, but this did not translate into improved survival.<br /><br />In conclusion, the study found that the addition of simvastatin to irinotecan and cisplatin chemotherapy did not provide any survival benefit in ever-smoking SCLC patients. These findings suggest that simvastatin may not be an effective addition to this treatment regimen for this particular patient population.

Asset Subtitle

Youngjoo Lee

Meta Tag

Speaker Youngjoo Lee

Topic Small Cell Lung Cancer and Neuro-endocrine Tumours - Informing ES-SCLC

Keywords

randomized phase II study

simvastatin

chemotherapy regimen

irinotecan

cisplatin

small cell lung cancer

progression-free survival

response rate

overall survival

adverse effects