Abou-Alfa Ghassan K, Lau George, Kudo Masatoshi, Chan Stephen L, Kelley Robin Kate, Furuse Junji, Sukeepaisarnjaroen Wattana, Kang Yoon Koo, Dao Tu Van, De Toni Enrico N, Rimassa Lorenza, Breder Valeriy, Vasilyev Alexander, Heurgué Alexandra, Tam Vincent C, Mody Kabir, Thungappa Satheesh Chiradoni, Ostapenko Yurii, Yau Thomas, Azevedo Sergio, Varela María, Cheng Ann-Lii, Qin Shukui, Galle Peter R, Ali Sajid, Gupta Charu, Makowsky Mallory, Kurland John F, Negro Alejandra, Sangro Bruno
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Weill Medical College, Cornell University, New York, NY, USA.
Future Oncol. 2023 Dec;19(38):2505-2516. doi: 10.2217/fon-2023-0486. Epub 2023 Sep 6.
WHAT IS THIS SUMMARY ABOUT?: This is a summary of results from a phase 3 clinical study called HIMALAYA. HIMALAYA looked at treatment with one dose of a medication called tremelimumab combined with multiple doses of a medication called durvalumab (the STRIDE regimen) or multiple doses of durvalumab alone. These treatments were compared with a medication called sorafenib in participants with unresectable hepatocellular carcinoma (HCC). HCC is a type of liver cancer that is difficult to treat because it is often diagnosed when it is unresectable, meaning it can no longer be removed with surgery. Sorafenib has been the main treatment for unresectable HCC since 2007. However, people who take sorafenib may experience side effects that can reduce their quality of life, so alternative medicines are being trialed. Tremelimumab and durvalumab are types of drugs called immunotherapies, and they both work in different ways to help the body's immune system fight cancer.
WHAT WERE THE RESULTS OF THE STUDY?: Participants who took STRIDE lived longer than participants who took sorafenib, whilst participants who took durvalumab alone lived a similar length of time as participants who took sorafenib. Participants who took STRIDE or durvalumab had a lower relative risk of experiencing worsening in their quality of life than participants who took sorafenib. The side effects that participants who received STRIDE or durvalumab experienced were expected for these types of treatments and could mostly be managed.
WHAT DO THE RESULTS OF THE STUDY MEAN?: Overall, STRIDE is more effective than sorafenib for people with unresectable HCC.
本摘要内容为何？：这是一项名为HIMALAYA的3期临床研究结果的总结。HIMALAYA研究了单剂量药物曲美木单抗联合多剂量药物度伐利尤单抗（STRIDE方案）或仅使用多剂量度伐利尤单抗进行治疗的情况。这些治疗方法与索拉非尼在无法切除的肝细胞癌（HCC）患者中进行了比较。HCC是一种肝癌，由于通常在无法切除时才被诊断出来，即无法再通过手术切除，所以很难治疗。自2007年以来，索拉非尼一直是无法切除的HCC的主要治疗方法。然而，服用索拉非尼的人可能会出现副作用，从而降低他们的生活质量，因此正在试验替代药物。曲美木单抗和度伐利尤单抗是一类称为免疫疗法的药物，它们以不同方式发挥作用，帮助人体免疫系统对抗癌症。
研究结果如何？：接受STRIDE方案治疗的参与者比接受索拉非尼治疗的参与者寿命更长，而仅接受度伐利尤单抗治疗的参与者的存活时间与接受索拉非尼治疗的参与者相似。接受STRIDE方案或度伐利尤单抗治疗的参与者生活质量恶化的相对风险低于接受索拉非尼治疗的参与者。接受STRIDE方案或度伐利尤单抗治疗的参与者所经历的副作用是这类治疗中预期会出现的，并且大多可以得到控制。
研究结果意味着什么？：总体而言，对于无法切除的HCC患者，STRIDE方案比索拉非尼更有效。
