First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer
| Autor: | Shaw, A. T., Bauer, T. M., De Marinis, F., Felip, E., Goto, Y., Liu, G., Mazieres, J., Kim, D. -W., Mok, T., Polli, A., Thurm, H., Calella, A. M., Peltz, G., Solomon, B. J., Soto Parra, H. |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Alectinib Lung Neoplasms Carcinoma Non-Small-Cell Lung/drug therapy medicine.medical_treatment 030204 cardiovascular system & hematology Macrocyclic 0302 clinical medicine Carcinoma Non-Small-Cell Lung hemic and lymphatic diseases Anaplastic lymphoma kinase Anaplastic Lymphoma Kinase 030212 general & internal medicine Non-Small-Cell Lung Manchester Cancer Research Centre General Medicine Middle Aged Crizotinib/adverse effects Intention to Treat Analysis Female Hyperlipidemias/chemically induced medicine.drug Adult Lactams Macrocyclic/adverse effects Lactams Lactams Macrocyclic Anaplastic Lymphoma Kinase/antagonists & inhibitors Antineoplastic Agents Hyperlipidemias 03 medical and health sciences Crizotinib ROS1 medicine Humans Lung Neoplasms/drug therapy Lung cancer Aged Chemotherapy business.industry ResearchInstitutes_Networks_Beacons/mcrc Carcinoma Cancer Antineoplastic Agents/adverse effects medicine.disease Survival Analysis Lorlatinib Mutation Cancer research business |
| Zdroj: | CROWN Trial Investigators & Blackhall, F 2020, ' First-line lorlatinib or crizotinib in advanced alk-positive lung cancer ', New England Journal Of Medicine, vol. 383, no. 21, pp. 2018-2029 . https://doi.org/10.1056/NEJMoa2027187 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa2027187 |
| Popis: | BACKGROUND: Lorlatinib, a third-generation inhibitor of anaplastic lymphoma kinase (ALK), has antitumor activity in previously treated patients with ALK-positive non-small-cell lung cancer (NSCLC). The efficacy of lorlatinib, as compared with that of crizotinib, as first-line treatment for advanced ALK-positive NSCLC is unclear. METHODS: We conducted a global, randomized, phase 3 trial comparing lorlatinib with crizotinib in 296 patients with advanced ALK-positive NSCLC who had received no previous systemic treatment for metastatic disease. The primary end point was progression-free survival as assessed by blinded independent central review. Secondary end points included independently assessed objective response and intracranial response. An interim analysis of efficacy was planned after approximately 133 of 177 (75%) expected events of disease progression or death had occurred. RESULTS: The percentage of patients who were alive without disease progression at 12 months was 78% (95% confidence interval [CI], 70 to 84) in the lorlatinib group and 39% (95% CI, 30 to 48) in the crizotinib group (hazard ratio for disease progression or death, 0.28; 95% CI, 0.19 to 0.41; PCONCLUSIONS: In an interim analysis of results among patients with previously untreated advanced ALK-positive NSCLC, those who received lorlatinib had significantly longer progression-free survival and a higher frequency of intracranial response than those who received crizotinib. The incidence of grade 3 or 4 adverse events was higher with lorlatinib than with crizotinib because of the frequent occurrence of altered lipid levels. (Funded by Pfizer; CROWN ClinicalTrials.gov number, NCT03052608.). |
| Databáze: | OpenAIRE |
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