Pralsetinib in patients with RET fusion-positive non-small cell lung cancer: A plain language summary of the ARROW study

被引:1
|
作者
Griesinger, Frank [1 ]
Curigliano, Giuseppe [2 ,3 ]
Subbiah, Vivek [4 ]
Baik, Christina S. [5 ]
Tan, Daniel S. W. [6 ]
Lee, Dae H. [7 ]
Misch, Daniel [8 ]
Garralda, Elena [9 ]
Kim, Dong-Wan [10 ,11 ]
van der Wekken, Anthonie J. [12 ,13 ]
Gainor, Justin F. [14 ]
Paz-Ares, Luis [15 ]
Liu, Stephen, V [16 ]
Kalemkerian, Gregory P. [17 ]
Bowles, Daniel W. [18 ]
Mansfield, Aaron S. [19 ]
Lin, Jessica J. [14 ]
Smoljanovic, Vlatka [20 ]
Rahman, Ahmadur [20 ]
Zalutskaya, Alena [21 ]
Louie-Gao, Melinda [21 ]
Boral, Andy L. [21 ]
Mazieres, Julien [22 ]
机构
[1] Carl von Ossietzky Univ Oldenburg, Pius Hosp, Oldenburg, Germany
[2] IRCCS, European Inst Oncol, Milan, Italy
[3] Univ Milan, Milan, Italy
[4] Sarah Cannon Res Inst, Nashville, TN USA
[5] Univ Washington, Sch Med, Seattle, WA USA
[6] Natl Canc Ctr Singapore, Singapore, Singapore
[7] Univ Ulsan, Coll Med, Asan Med Ctr, Seoul, South Korea
[8] Helios Clin Emil von Behring, Berlin, Germany
[9] Vall dHebron Inst Oncol VHIO, Barcelona, Spain
[10] Seoul Natl Univ, Coll Med, Seoul, South Korea
[11] Seoul Natl Univ Hosp, Seoul, South Korea
[12] Univ Groningen, Groningen, Netherlands
[13] Univ Med Ctr Groningen, Groningen, Netherlands
[14] Massachusetts Gen Hosp, Boston, MA 02114 USA
[15] Hosp Univ 12 Octubre, Madrid, Spain
[16] Georgetown Univ, Washington, DC USA
[17] Univ Michigan, Ann Arbor, MI 48109 USA
[18] Univ Colorado, Sch Med, Aurora, CO USA
[19] Mayo Clin, Rochester, NY USA
[20] F Hoffmann La Roche Ltd, Basel, Switzerland
[21] Blueprint Med Corp, Cambridge, MA USA
[22] Inst Univ Canc, Toulouse, France
关键词
clinical trials; frontline therapy; lung; metastasis; non-small cell lung cancer; plain language summary; RET fusion; RET inhibition; targeted therapy;
D O I
10.2217/fon-2023-0155
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
What is this summary about?This is a summary of a research study called ARROW, which tested a medicine called pralsetinib in patients with non-small cell lung cancer (NSCLC), thyroid cancer, and other advanced solid tumours caused by a change in a gene called RET. For the purposes of this summary, only patients with NSCLC with a change in RET called fusion (RET fusion+) are highlighted.What were the results?In total, 281 patients with RET fusion+ NSCLC had taken part in this study across the USA, Europe, and Asia. Patients were asked to take four pills (adding up to 400 mg) of pralsetinib each day and were checked for any changes in their tumours, as well as for any side effects. After an average of 8 months of treatment with pralsetinib, 72% of previously untreated patients and 59% of patients who had previously received chemotherapy had considerable shrinkage of their tumours. Among 10 patients with tumours which had spread to the brain (all of whom had received previous treatments), 70% had their tumours shrink greatly in the brain after treatment with pralsetinib.On average, patients lived with little to no tumour growth for 16 months. In previously untreated patients, the most common severe side effects that were considered related to pralsetinib treatment were decreased white blood cells (neutrophils and lymphocytes), increased blood pressure, and an increase in a blood protein called creatine phosphokinase. In previously treated patients, the severe side effects were decreased white blood cells (neutrophils, lymphocytes, and leukocytes), increased blood pressure, and low levels of red blood cells. In both untreated and previously treated patients, the most common severe side effects that required hospital attention were lung inflammation/swelling causing shortness of breath (pneumonitis) and lung infection (pneumonia).What were the results? In total, 281 patients with RET fusion+ NSCLC had taken part in this study across the USA, Europe, and Asia. Patients were asked to take four pills (adding up to 400 mg) of pralsetinib each day and were checked for any changes in their tumours, as well as for any side effects. After an average of 8 months of treatment with pralsetinib, 72% of previously untreated patients and 59% of patients who had previously received chemotherapy had considerable shrinkage of their tumours. Among 10 patients with tumours which had spread to the brain (all of whom had received previous treatments), 70% had their tumours shrink greatly in the brain after treatment with pralsetinib. On average, patients lived with little to no tumour growth for 16 months. In previously untreated patients, the most common severe side effects that were considered related to pralsetinib treatment were decreased white blood cells (neutrophils and lymphocytes), increased blood pressure, and an increase in a blood protein called creatine phosphokinase. In previously treated patients, the severe side effects were decreased white blood cells (neutrophils, lymphocytes, and leukocytes), increased blood pressure, and low levels of red blood cells. In both untreated and previously treated patients, the most common severe side effects that required hospital attention were lung inflammation/swelling causing shortness of breath (pneumonitis) and lung infection (pneumonia).What do the results mean?Overall, the ARROW study showed that pralsetinib was effective in shrinking tumours in patients with RET fusion+ NSCLC regardless of previous treatment history. The recorded side effects were expected in patients receiving this type of medicine. Clinical Trial Registration: NCT03037385 (ARROW) (ClinicalTrials.gov)
引用
收藏
页码:297 / 306
页数:10
相关论文
共 50 条
  • [1] Analysis of Resistance Mmechanisms to Pralsetinib in Patients with RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC) from the ARROW Study
    Gainor, J.
    Curigliano, G.
    Doebele, R. C.
    Lin, J. J.
    Ou, S. -H.
    Miller, S.
    Turner, C. D.
    Subbiah, V.
    [J]. JOURNAL OF THORACIC ONCOLOGY, 2021, 16 (01) : S5 - S5
  • [2] Pralsetinib: Treatment of metastatic RET fusion-positive non-small cell lung cancer
    Nguyen, Ly
    Monestime, Shanada
    [J]. AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, 2022, 79 (07) : 527 - 533
  • [3] Efficacy and safety of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer
    Zhou, Qing
    Zhao, Jun
    Chang, Jianhua
    Wang, Huijie
    Fan, Yun
    Wang, Ke
    Wu, Gang
    Nian, Weiqi
    Sun, Yuping
    Sun, Meili
    Wang, Xiangcai
    Shi, Huaqiu
    Zheng, Xiangqian
    Yao, Sheng
    Qin, Mengmeng
    Shen, Zhenwei
    Yang, Jason
    Wu, Yi-Long
    [J]. CANCER, 2023, 129 (20) : 3239 - 3251
  • [4] Pralsetinib-associated pneumonia in RET fusion-positive non-small cell lung cancer
    Gao, Ming
    Zhang, Xia
    Yan, Huan
    Sun, Decong
    Yang, Xuejiao
    Yuan, Fang
    Ju, Yanfang
    Wang, Lijie
    Wang, Jinliang
    Zhao, Wei
    Zhang, Dong
    Li, Lin
    Xu, Xiaoyun
    Ma, Junxun
    Hu, Yi
    Zhang, Xiaotao
    [J]. SUPPORTIVE CARE IN CANCER, 2023, 31 (12)
  • [5] Pralsetinib-associated pneumonia in RET fusion-positive non-small cell lung cancer
    Ming Gao
    Xia Zhang
    Huan Yan
    Decong Sun
    Xuejiao Yang
    Fang Yuan
    Yanfang Ju
    Lijie Wang
    Jinliang Wang
    Wei Zhao
    Dong Zhang
    Lin Li
    Xiaoyun Xu
    Junxun Ma
    Yi Hu
    Xiaotao Zhang
    [J]. Supportive Care in Cancer, 2023, 31
  • [6] Safety and efficacy of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer: Update from the ARROW trial.
    Curigliano, Giuseppe
    Gainor, Justin F.
    Griesinger, Frank
    Thomas, Michael
    Subbiah, Vivek
    Baik, Christina S.
    Tan, Daniel Shao-Weng
    Lee, Dae Ho
    Misch, Daniel
    Garralda, Elena
    Kim, Dong-Wan
    Paz-Ares, Luis G.
    Mazieres, Julien
    Liu, Stephen V.
    Kalemkerian, Gregory Peter
    Houvras, Yariv
    Bowles, Daniel W.
    Mansfield, Aaron Scott
    Zalutskaya, Alena
    van der Wekken, Anthonie J.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2021, 39 (15)
  • [7] SORAFENIB IN PATIENTS WITH RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER
    Horiike, Atsushi
    Takeuchi, Kengo
    Uenami, Takeshi
    Kawano, Yuko
    Tanimoto, Azusa
    Kaburaki, Kyohei
    Kobayashi, Hiroshi
    Gyotoku, Hiroshi
    Nishizawa, Hironari
    Tambo, Yuichi
    Nakatomi, Katsumi
    Yanagitani, Noriko
    Ohyanagi, Fumiyoshi
    Hagiwara, Sachiko
    Motoi, Noriko
    Ishikawa, Yuichi
    Horai, Takeshi
    Nishio, Makoto
    [J]. JOURNAL OF THORACIC ONCOLOGY, 2013, 8 : S898 - S898
  • [8] Sorafenib treatment for patients with RET fusion-positive non-small cell lung cancer
    Horiike, Atsushi
    Takeuchi, Kengo
    Uenami, Takeshi
    Kawano, Yuko
    Tanimoto, Azusa
    Kaburaki, Kyohei
    Tambo, Yuichi
    Kudo, Keita
    Yanagitani, Noriko
    Ohyanagi, Fumiyoshi
    Motoi, Noriko
    Ishikawa, Yuichi
    Horai, Takeshi
    Nishio, Makoto
    [J]. LUNG CANCER, 2016, 93 : 43 - 46
  • [9] Targeted therapy of RET fusion-positive non-small cell lung cancer
    Shen, Zixiong
    Qiu, Binxu
    Li, Lin
    Yang, Bo
    Li, Guanghu
    [J]. FRONTIERS IN ONCOLOGY, 2022, 12
  • [10] Small Cell Transformation in a Patient With RET Fusion-Positive Lung Adenocarcinoma on Pralsetinib
    Dimou, Anastasios
    Lo, Ying-Chun
    Merrell, Kenneth W.
    Halling, Kevin C.
    Mansfield, Aaron S.
    [J]. JCO PRECISION ONCOLOGY, 2022, 6