Luis Basbus, Maite Queral, Delfina Peralta Tanco, Mara Bonet, Patricio Levit, Gabriela Malcervelli, Carlos Brocca, Susana Sena, Vanina Wainsztein, Diego Kaen, Sebastian Cinquini, Manglio Rizzo, Nicolas Castagneris, Enrique Aman, Gonzalo Di Mario, Richard Serna, Florencia Tsou, Ivan Macharashvili, Yamila Ferreira, Diego Enrico, Carmen Pupareli, Ignacio Robledo Salas, Florencia Guerra, Carlos Picón, Danisa Fariña, Cintia Novas, Rosario Pasquinelli, Aldo Perfetti, Lorena Lupinacci, Claudio Martin
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However, access to these therapies remains limited for many patients.</p><p><strong>Methods: </strong>We conducted a multicenter retrospective study of patients with metastatic ALK-positive NSCLC (ALKp) treated with first-line tyrosine kinase inhibitors (TKIs) from January 2014 to February 2024. Demographics, treatment patterns, clinical outcomes, and factors affecting treatment accessibility were analyzed.</p><p><strong>Results: </strong>We identified 104 patients with ALKp. The median age was 55 years (IQR, 45-67); 86% had Eastern Cooperative Oncology Group ≤1, 58% were women, and 57% were nonsmokers. Brain metastases were present at diagnosis in 29%, with 50% receiving local treatment. First-line TKIs included alectinib (42%), crizotinib (30%), lorlatinib (16%), and brigatinib (12%). Crizotinib use was frequently due to limited access to new-generation TKIs. Adverse events occurred in 54%, with 21% grade 3 to 4. The objective response rate was 73%. At a median follow-up of 42 months, 48% experienced progression. Crizotinib was associated with higher risk of progression or death compared with newer TKIs (hazard ratio, 3.09 [95% CI, 1.75 to 5.5]; <i>P</i> = .01). CNS progression occurred in 18%, more often with crizotinib (42% <i>v</i> 8%, <i>P</i> = .04). Among those progressing, 82% received second-line therapy, most commonly lorlatinib or alectinib. The overall survival at 24 months was 81%, with 27% of patients deceased at data cutoff.</p><p><strong>Conclusion: </strong>This real-world study describes outcomes and treatment patterns among patients with ALKp in Argentina. It highlights disparities in access to optimal therapies and reinforces the need for equitable access to new-generation ALK inhibitors to improve clinical outcomes.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"11 ","pages":"e2500014"},"PeriodicalIF":3.0000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Outcomes in Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer in Argentina: A Multicenter Retrospective Study (GAOT-ALK001).\",\"authors\":\"Luis Basbus, Maite Queral, Delfina Peralta Tanco, Mara Bonet, Patricio Levit, Gabriela Malcervelli, Carlos Brocca, Susana Sena, Vanina Wainsztein, Diego Kaen, Sebastian Cinquini, Manglio Rizzo, Nicolas Castagneris, Enrique Aman, Gonzalo Di Mario, Richard Serna, Florencia Tsou, Ivan Macharashvili, Yamila Ferreira, Diego Enrico, Carmen Pupareli, Ignacio Robledo Salas, Florencia Guerra, Carlos Picón, Danisa Fariña, Cintia Novas, Rosario Pasquinelli, Aldo Perfetti, Lorena Lupinacci, Claudio Martin\",\"doi\":\"10.1200/GO-25-00014\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>In Argentina, anaplastic lymphoma kinase (ALK) gene rearrangements occur in approximately 6.1% of non-small cell lung cancer (NSCLC) cases. Given the availability of second- and third-generation ALK inhibitors, real-world data are needed to inform optimal treatment strategies. However, access to these therapies remains limited for many patients.</p><p><strong>Methods: </strong>We conducted a multicenter retrospective study of patients with metastatic ALK-positive NSCLC (ALKp) treated with first-line tyrosine kinase inhibitors (TKIs) from January 2014 to February 2024. Demographics, treatment patterns, clinical outcomes, and factors affecting treatment accessibility were analyzed.</p><p><strong>Results: </strong>We identified 104 patients with ALKp. The median age was 55 years (IQR, 45-67); 86% had Eastern Cooperative Oncology Group ≤1, 58% were women, and 57% were nonsmokers. Brain metastases were present at diagnosis in 29%, with 50% receiving local treatment. First-line TKIs included alectinib (42%), crizotinib (30%), lorlatinib (16%), and brigatinib (12%). Crizotinib use was frequently due to limited access to new-generation TKIs. Adverse events occurred in 54%, with 21% grade 3 to 4. The objective response rate was 73%. At a median follow-up of 42 months, 48% experienced progression. Crizotinib was associated with higher risk of progression or death compared with newer TKIs (hazard ratio, 3.09 [95% CI, 1.75 to 5.5]; <i>P</i> = .01). CNS progression occurred in 18%, more often with crizotinib (42% <i>v</i> 8%, <i>P</i> = .04). Among those progressing, 82% received second-line therapy, most commonly lorlatinib or alectinib. The overall survival at 24 months was 81%, with 27% of patients deceased at data cutoff.</p><p><strong>Conclusion: </strong>This real-world study describes outcomes and treatment patterns among patients with ALKp in Argentina. It highlights disparities in access to optimal therapies and reinforces the need for equitable access to new-generation ALK inhibitors to improve clinical outcomes.</p>\",\"PeriodicalId\":14806,\"journal\":{\"name\":\"JCO Global Oncology\",\"volume\":\"11 \",\"pages\":\"e2500014\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JCO Global Oncology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1200/GO-25-00014\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/10/3 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JCO Global Oncology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1200/GO-25-00014","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/10/3 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的：在阿根廷，间变性淋巴瘤激酶（ALK）基因重排发生在约6.1%的非小细胞肺癌（NSCLC）病例中。鉴于第二代和第三代ALK抑制剂的可用性，需要真实世界的数据来告知最佳治疗策略。然而，对许多患者来说，获得这些疗法的机会仍然有限。方法：我们对2014年1月至2024年2月接受一线酪氨酸激酶抑制剂（TKIs）治疗的转移性alk阳性NSCLC （ALKp）患者进行了多中心回顾性研究。分析了人口统计学、治疗模式、临床结果和影响治疗可及性的因素。结果：我们确定了104例ALKp患者。中位年龄55岁（IQR， 45-67岁）；86%的患者≤1名，其中58%为女性，57%为非吸烟者。29%在诊断时出现脑转移，50%接受局部治疗。一线tki包括alectinib（42%）、crizotinib（30%）、lorlatinib（16%）和brigatinib（12%）。克唑替尼的使用通常是由于新一代tki的获取有限。54%发生不良事件，其中21%为3 - 4级。客观有效率为73%。在中位随访42个月时，48%的患者出现进展。与较新的tki患者相比，克唑替尼与更高的进展或死亡风险相关（风险比为3.09 [95% CI， 1.75至5.5];P = 0.01）。18%的患者出现中枢神经系统进展，克唑替尼组更常见（42% vs 8%, P = 0.04）。在进展的患者中，82%接受了二线治疗，最常见的是氯拉替尼或阿勒替尼。24个月的总生存率为81%，27%的患者在数据截止时死亡。结论：这项真实世界的研究描述了阿根廷alp患者的结果和治疗模式。它突出了在获得最佳疗法方面的差异，并强调了公平获得新一代ALK抑制剂以改善临床结果的必要性。
Real-World Outcomes in Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer in Argentina: A Multicenter Retrospective Study (GAOT-ALK001).
Purpose: In Argentina, anaplastic lymphoma kinase (ALK) gene rearrangements occur in approximately 6.1% of non-small cell lung cancer (NSCLC) cases. Given the availability of second- and third-generation ALK inhibitors, real-world data are needed to inform optimal treatment strategies. However, access to these therapies remains limited for many patients.
Methods: We conducted a multicenter retrospective study of patients with metastatic ALK-positive NSCLC (ALKp) treated with first-line tyrosine kinase inhibitors (TKIs) from January 2014 to February 2024. Demographics, treatment patterns, clinical outcomes, and factors affecting treatment accessibility were analyzed.
Results: We identified 104 patients with ALKp. The median age was 55 years (IQR, 45-67); 86% had Eastern Cooperative Oncology Group ≤1, 58% were women, and 57% were nonsmokers. Brain metastases were present at diagnosis in 29%, with 50% receiving local treatment. First-line TKIs included alectinib (42%), crizotinib (30%), lorlatinib (16%), and brigatinib (12%). Crizotinib use was frequently due to limited access to new-generation TKIs. Adverse events occurred in 54%, with 21% grade 3 to 4. The objective response rate was 73%. At a median follow-up of 42 months, 48% experienced progression. Crizotinib was associated with higher risk of progression or death compared with newer TKIs (hazard ratio, 3.09 [95% CI, 1.75 to 5.5]; P = .01). CNS progression occurred in 18%, more often with crizotinib (42% v 8%, P = .04). Among those progressing, 82% received second-line therapy, most commonly lorlatinib or alectinib. The overall survival at 24 months was 81%, with 27% of patients deceased at data cutoff.
Conclusion: This real-world study describes outcomes and treatment patterns among patients with ALKp in Argentina. It highlights disparities in access to optimal therapies and reinforces the need for equitable access to new-generation ALK inhibitors to improve clinical outcomes.
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