Dy Grace K, Govindan Ramaswamy, Velcheti Vamsidhar, Falchook Gerald S, Italiano Antoine, Wolf Jürgen, Sacher Adrian G, Takahashi Toshiaki, Ramalingam Suresh S, Dooms Christophe, Kim Dong-Wan, Addeo Alfredo, Desai Jayesh, Schuler Martin, Tomasini Pascale, Hong David S, Lito Piro, Tran Qui, Jones Simon, Anderson Abraham, Hindoyan Antreas, Snyder Wendy, Skoulidis Ferdinandos, Li Bob T
Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Future Oncol. 2024 Jan;20(3):113-120. doi: 10.2217/fon-2023-0560. Epub 2023 Nov 27.
WHAT IS THIS SUMMARY ABOUT?: This is a plain language summary of a study called CodeBreaK 100. The CodeBreaK 100 study included patients with non-small-cell lung cancer that had spread outside the lung (advanced). Lung cancer is one of the most common forms of cancer. CodeBreaK 100 specifically looked at patients with a particular change(mutation) in the gene resulting in the mutated protein called KRAS G12C. The G12C mutation can lead to development and growth of lung cancer. Patients received a treatment called sotorasib, which has or full approval in over 50 countries for patients with non-small-cell lung cancer with the G12C mutation. The CodeBreaK 100 study looked at whether sotorasib is a safe and effective treatment for advanced non-small-cell lung cancer. Sotorasib is designed to specifically target and lock the mutated KRAS protein in the inactive state to treat non-small-cell lung cancer.
WHAT WERE THE RESULTS?: In total, 174 adults were treated with sotorasib. were seen in 70% of patients and were severe in 21% of patients. The most common side effects included diarrhea, increased liver enzymes, nausea and tiredness. 70 (41%) patients responded to sotorasib and 144 (84%) patients had tumors that either remained stable or shrunk in size. 29 (41%) patients who responded to sotorasib responded for over 12 months. After 2 years, 9 patients with a response remained on sotorasib; there were no notable increases in tumor size or development of new tumors over this time. There were 5patients who received sotorasib for more than 2 years and continued to respond. Long-term benefit was seen for some patients. Patients also benefitted from treatment when the tumor expressed different amounts of a protein called PD-L1.In total, 33% of patients were still alive after 2 years.
WHAT DO THE RESULTS MEAN?: Results show the long-term benefit of sotorasib therapy for people with advanced G12C-mutated non-small-cell lung cancer. : NCT03600883 (CodeBreaK 100) (ClinicalTrials.gov).
本摘要的内容是什么？：这是一项名为CodeBreaK 100研究的通俗语言总结。CodeBreaK 100研究纳入了肺癌已扩散至肺部以外（晚期）的非小细胞肺癌患者。肺癌是最常见的癌症形式之一。CodeBreaK 100特别关注了基因中一种特定变化（突变）导致名为KRAS G12C的突变蛋白的患者。G12C突变可导致肺癌的发生和发展。患者接受了一种名为索托拉西布的治疗，该药物在50多个国家已获得全面批准，用于治疗具有G12C突变的非小细胞肺癌患者。CodeBreaK 100研究旨在探讨索托拉西布对晚期非小细胞肺癌是否为一种安全有效的治疗方法。索托拉西布旨在特异性靶向并将突变的KRAS蛋白锁定在非活性状态，以治疗非小细胞肺癌。
研究结果如何？：共有174名成年人接受了索托拉西布治疗。70%的患者出现了副作用，21%的患者副作用严重。最常见的副作用包括腹泻、肝酶升高、恶心和疲劳。70名（41%）患者对索托拉西布有反应，144名（84%）患者的肿瘤保持稳定或缩小。29名（41%）对索托拉西布有反应的患者反应持续超过12个月。2年后，9名有反应的患者仍在接受索托拉西布治疗；在此期间，肿瘤大小没有显著增加，也没有新肿瘤出现。有5名患者接受索托拉西布治疗超过2年且仍有反应。部分患者获得了长期益处。当肿瘤表达不同量的一种名为PD-LI的蛋白时，患者也从治疗中获益。2年后，共有33%的患者存活。
这些结果意味着什么？：结果显示了索托拉西布治疗对晚期G12C突变的非小细胞肺癌患者的长期益处。：NCT03600883（CodeBreaK 100）（ClinicalTrials.gov）。
