Efficacy and Clinical Outcomes of Crizotinib in Patients with ROS1-Rearranged NSCLC: A Multicenter Study
<i>Background and Objectives:</i> ROS1 rearrangement is a rare but targetable alteration in non-small-cell lung cancer (NSCLC), occurring in 1–2% of cases. Crizotinib, a tyrosine kinase inhibitor, has demonstrated efficacy in clinical trials, but real-world data remain limited. This stud...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-03-01
|
| Series: | Medicina |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1648-9144/61/3/490 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850091484346318848 |
|---|---|
| author | Alper Topal Goncagul Akdag Sedat Yildirim Oguzcan Kinikoglu Deniz Isik Gizem Yildirim Salih Tunbekici Fatih Kus Aydın Acarbay Murad Guliyev Nargiz Majidova Yasin Kutlu Mustafa Erman Hatice Odabas Nedim Turan Nuri Karadurmus |
| author_facet | Alper Topal Goncagul Akdag Sedat Yildirim Oguzcan Kinikoglu Deniz Isik Gizem Yildirim Salih Tunbekici Fatih Kus Aydın Acarbay Murad Guliyev Nargiz Majidova Yasin Kutlu Mustafa Erman Hatice Odabas Nedim Turan Nuri Karadurmus |
| author_sort | Alper Topal |
| collection | DOAJ |
| description | <i>Background and Objectives:</i> ROS1 rearrangement is a rare but targetable alteration in non-small-cell lung cancer (NSCLC), occurring in 1–2% of cases. Crizotinib, a tyrosine kinase inhibitor, has demonstrated efficacy in clinical trials, but real-world data remain limited. This study evaluates the safety and efficacy of crizotinib in ROS1-rearranged NSCLC patients in a real-world setting. <i>Materials and Methods:</i> This multicenter, retrospective research included 43 individuals with advanced/metastatic NSCLC and confirmed ROS1 rearrangements. Patients were treated with crizotinib in first- or second-line settings. Efficacy endpoints included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR). Safety was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. <i>Results:</i> The median follow-up was 45.8 months. The ORR for first-line crizotinib was 72.1%, with a DCR of 79%. The median PFS was 20.9 months (95% CI: 6.02–35.69), and the median OS was 52.7 months (95% CI: 13.08–92.31). ECOG performance status was a significant prognostic factor for ORR (<i>p</i> = 0.02). The most common adverse events were fatigue (16.2%), elevated transaminases (13.9%), and vision disorders (11.6%). All reported adverse events were grade 1 or 2, with no grade ≥ 3 events observed. <i>Conclusions:</i>Crizotinib demonstrated significant efficacy and a favorable safety profile in real-world individuals with ROS1-rearranged NSCLC. These findings align with pivotal trials, underscoring crizotinib’s role as a standard treatment for this molecular subset. Further prospective studies are warranted to explore intracranial efficacy and long-term outcomes. |
| format | Article |
| id | doaj-art-b43b14acd3404ea29fba10ebc5c5f9b8 |
| institution | DOAJ |
| issn | 1010-660X 1648-9144 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Medicina |
| spelling | doaj-art-b43b14acd3404ea29fba10ebc5c5f9b82025-08-20T02:42:22ZengMDPI AGMedicina1010-660X1648-91442025-03-0161349010.3390/medicina61030490Efficacy and Clinical Outcomes of Crizotinib in Patients with ROS1-Rearranged NSCLC: A Multicenter StudyAlper Topal0Goncagul Akdag1Sedat Yildirim2Oguzcan Kinikoglu3Deniz Isik4Gizem Yildirim5Salih Tunbekici6Fatih Kus7Aydın Acarbay8Murad Guliyev9Nargiz Majidova10Yasin Kutlu11Mustafa Erman12Hatice Odabas13Nedim Turan14Nuri Karadurmus15Department of Medical Oncology, Health Science University, Gulhane Research and Training Hospital, Ankara 06010, TurkeyDepartment of Medical Oncology, Kartal Dr. Lütfi Kirdar City Hospital, Health Science University, Istanbul 34865, TurkeyDepartment of Medical Oncology, Kartal Dr. Lütfi Kirdar City Hospital, Health Science University, Istanbul 34865, TurkeyDepartment of Medical Oncology, Kartal Dr. Lütfi Kirdar City Hospital, Health Science University, Istanbul 34865, TurkeyDepartment of Medical Oncology, Kartal Dr. Lütfi Kirdar City Hospital, Health Science University, Istanbul 34865, TurkeyDepartment of Medical Oncology, Health Science University, Gulhane Research and Training Hospital, Ankara 06010, TurkeyDivision of Medical Oncology, Departmant of Internal Medicine, Ege Universitiy, Izmir 35100, TurkeyDepartment of Medical Oncology, Hacettepe University Oncology Institue, Ankara 06230, TurkeyDivision of Medical Oncology, Departmant of Internal Medicine, Istanbul Medeniyet University, Istanbul 34730, TurkeyDivision of Medical Oncology, Departmant of Internal Medicine, Istanbul University-Cerrahpasa, Istanbul 34098, TurkeyDepartment of Medical Oncology, Marmara University Pendik Training and Research Hospital, Istanbul 34854, TurkeyDepartment of Medical Oncology, Tokat State Hospital, Tokat 60000, TurkeyDepartment of Medical Oncology, Hacettepe University Oncology Institue, Ankara 06230, TurkeyDepartment of Medical Oncology, Kartal Dr. Lütfi Kirdar City Hospital, Health Science University, Istanbul 34865, TurkeyDepartment of Medical Oncology, Kartal Dr. Lütfi Kirdar City Hospital, Health Science University, Istanbul 34865, TurkeyDepartment of Medical Oncology, Health Science University, Gulhane Research and Training Hospital, Ankara 06010, Turkey<i>Background and Objectives:</i> ROS1 rearrangement is a rare but targetable alteration in non-small-cell lung cancer (NSCLC), occurring in 1–2% of cases. Crizotinib, a tyrosine kinase inhibitor, has demonstrated efficacy in clinical trials, but real-world data remain limited. This study evaluates the safety and efficacy of crizotinib in ROS1-rearranged NSCLC patients in a real-world setting. <i>Materials and Methods:</i> This multicenter, retrospective research included 43 individuals with advanced/metastatic NSCLC and confirmed ROS1 rearrangements. Patients were treated with crizotinib in first- or second-line settings. Efficacy endpoints included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR). Safety was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. <i>Results:</i> The median follow-up was 45.8 months. The ORR for first-line crizotinib was 72.1%, with a DCR of 79%. The median PFS was 20.9 months (95% CI: 6.02–35.69), and the median OS was 52.7 months (95% CI: 13.08–92.31). ECOG performance status was a significant prognostic factor for ORR (<i>p</i> = 0.02). The most common adverse events were fatigue (16.2%), elevated transaminases (13.9%), and vision disorders (11.6%). All reported adverse events were grade 1 or 2, with no grade ≥ 3 events observed. <i>Conclusions:</i>Crizotinib demonstrated significant efficacy and a favorable safety profile in real-world individuals with ROS1-rearranged NSCLC. These findings align with pivotal trials, underscoring crizotinib’s role as a standard treatment for this molecular subset. Further prospective studies are warranted to explore intracranial efficacy and long-term outcomes.https://www.mdpi.com/1648-9144/61/3/490ROS1lung cancercrizotinib |
| spellingShingle | Alper Topal Goncagul Akdag Sedat Yildirim Oguzcan Kinikoglu Deniz Isik Gizem Yildirim Salih Tunbekici Fatih Kus Aydın Acarbay Murad Guliyev Nargiz Majidova Yasin Kutlu Mustafa Erman Hatice Odabas Nedim Turan Nuri Karadurmus Efficacy and Clinical Outcomes of Crizotinib in Patients with ROS1-Rearranged NSCLC: A Multicenter Study Medicina ROS1 lung cancer crizotinib |
| title | Efficacy and Clinical Outcomes of Crizotinib in Patients with ROS1-Rearranged NSCLC: A Multicenter Study |
| title_full | Efficacy and Clinical Outcomes of Crizotinib in Patients with ROS1-Rearranged NSCLC: A Multicenter Study |
| title_fullStr | Efficacy and Clinical Outcomes of Crizotinib in Patients with ROS1-Rearranged NSCLC: A Multicenter Study |
| title_full_unstemmed | Efficacy and Clinical Outcomes of Crizotinib in Patients with ROS1-Rearranged NSCLC: A Multicenter Study |
| title_short | Efficacy and Clinical Outcomes of Crizotinib in Patients with ROS1-Rearranged NSCLC: A Multicenter Study |
| title_sort | efficacy and clinical outcomes of crizotinib in patients with ros1 rearranged nsclc a multicenter study |
| topic | ROS1 lung cancer crizotinib |
| url | https://www.mdpi.com/1648-9144/61/3/490 |
| work_keys_str_mv | AT alpertopal efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT goncagulakdag efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT sedatyildirim efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT oguzcankinikoglu efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT denizisik efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT gizemyildirim efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT salihtunbekici efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT fatihkus efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT aydınacarbay efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT muradguliyev efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT nargizmajidova efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT yasinkutlu efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT mustafaerman efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT haticeodabas efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT nedimturan efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy AT nurikaradurmus efficacyandclinicaloutcomesofcrizotinibinpatientswithros1rearrangednsclcamulticenterstudy |