Janjigian Yelena Y, Shitara Kohei, Moehler Markus, Garrido Marcelo, Salman Pamela, Wyrwicz Lucjan, Yamaguchi Kensei, Skoczylas Tomasz, Bragagnoli Arinilda Campos, Liu Tianshu, Schenker Michael, Yanez Patricio, Tehfe Mustapha, Kowalyszyn Ruben, Karamouzis Michalis V, Bruges Ricardo, Zander Thomas, Pazo-Cid Roberto, Hitre Erika, Feeney Kynan, Cleary James M, Poulart Valerie, Cullen Dana, Lei Ming, Xiao Hong, Kondo Kaoru, Li Mingshun, Ajani Jaffer A
Memorial Sloan Kettering Cancer Center & Weill Cornell Medical College, New York, NY, USA.
National Cancer Center Hospital East, Kashiwa, Japan.
Future Oncol. 2023 Apr;19(11):739-752. doi: 10.2217/fon-2022-1149. Epub 2023 Mar 15.
WHAT IS THIS SUMMARY ABOUT?: This is a summary of the 1-year results of a clinical research study known as CheckMate 649 published in in June 2021. The 2-year results on the participants' health and overall quality of life from the same study are in a second publication in in March 2022. Until recently, chemotherapy was the only first treatment option for people with advanced or metastatic gastroesophageal adenocarcinoma who had not been treated before. Patients receiving chemotherapy lived on average for less than 1 year. Nivolumab is an immunotherapy that works by activating a person's immune system to fight back against cancer cells. The goal of CheckMate 649 was to find out if the combination of nivolumab and chemotherapy would help patients with advanced or metastatic gastroesophageal adenocarcinoma live longer and without their cancer getting worse.
WHAT WERE THE RESULTS?: Results from the final analysis are reported here. Of 1581 people who took part in the study, 789 received nivolumab and chemotherapy and 792 received chemotherapy. Researchers found that, on average, participants who received nivolumab and chemotherapy lived longer overall than those who received chemotherapy alone. The length of time participants lived without their cancer getting worse was also longer on average with nivolumab and chemotherapy than chemotherapy treatment alone. However, more participants in the nivolumab and chemotherapy group had side effects than those in the chemotherapy group. The three most common side effects in both types of treatment were nausea (urge to vomit), diarrhea and peripheral neuropathy. Participants who received nivolumab and chemotherapy had a lower risk of their cancer symptoms worsening and reported that they were 'less bothered' from side effects of treatment than those receiving chemotherapy alone.
WHAT DO THE RESULTS MEAN?: The nivolumab and chemotherapy combination is considered a new standard treatment option and is approved in several countries as a treatment for adults who have not been treated before for their advanced or metastatic gastroesophageal cancer based on results from CheckMate 649. : NCT02872116 (ClinicalTrials.gov).
本摘要内容是什么？：这是一项名为CheckMate 649的临床研究1年结果的摘要，该研究结果于2021年6月发表。同一研究中关于参与者健康状况和总体生活质量的2年结果在2022年3月的另一篇出版物中公布。直到最近，化疗还是之前未接受过治疗的晚期或转移性胃食管腺癌患者的唯一一线治疗选择。接受化疗的患者平均生存期不到1年。纳武利尤单抗是一种免疫疗法，其作用机制是激活人体免疫系统来对抗癌细胞。CheckMate 649的目标是确定纳武利尤单抗与化疗联合使用是否能帮助晚期或转移性胃食管腺癌患者延长生存期且癌症不进展。
结果如何？：此处报告了最终分析结果。在参与研究的1581人中，789人接受了纳武利尤单抗与化疗，792人接受了单纯化疗。研究人员发现，平均而言，接受纳武利尤单抗与化疗的参与者总体生存期比单纯接受化疗的参与者更长。接受纳武利尤单抗与化疗的参与者癌症不进展的时间平均也比单纯化疗更长。然而，纳武利尤单抗与化疗组出现副作用的参与者比化疗组更多。两种治疗中最常见的三种副作用是恶心（呕吐欲）、腹泻和周围神经病变。接受纳武利尤单抗与化疗的参与者癌症症状恶化的风险较低，并且报告称他们比单纯接受化疗的参与者“较少受到”治疗副作用的困扰。
这些结果意味着什么？：基于CheckMate 649的结果，纳武利尤单抗与化疗联合方案被视为一种新的标准治疗选择，并在多个国家被批准用于治疗之前未接受过治疗的晚期或转移性胃癌成人患者。：NCT02872116（ClinicalTrials.gov）。
