TY - JOUR
T1 - Real-world characteristics and survival outcomes of patients with metastatic ALK fusion-positive solid tumors treated with standard-of-care therapies
AU - Gadgeel, Shirish M.
AU - Fajardo, Otto
AU - Barlesi, Fabrice
AU - Eun Kim, Jeong
AU - Kurzrock, Razelle
AU - Thomas, David M.
AU - Jagtiani, Ritika
AU - Noe, Johannes
AU - Schwemmers, Sven
AU - Nikolaidis, Christos
N1 - Publisher Copyright:
© 2025 The Author(s).
PY - 2025/5/1
Y1 - 2025/5/1
N2 - Background: Anaplastic lymphoma kinase (ALK) fusions can be found in different solid tumors. This study aims to describe the clinical characteristics and investigate survival outcomes of patients with ALK fusion-positive solid tumors (excluding non-small cell lung cancer [NSCLC]) treated with standard-of-care therapies in a real-world setting. Patients and Methods: Data for patients with metastatic solid tumors (excluding NSCLC) who had ≥1 Foundation Medicine comprehensive genomic profiling (CGP) test between January 1, 2011 and September 30, 2023, were obtained from a nationwide (US-based) de-identified multi-tumor clinico-genomic database. Patients with ALK wild-type (ALK-WT) tumors were matched with patients with ALK fusion-positive tumors (4:1 ratio) using pre-specified baseline characteristics. Two models were used to analyze survival outcomes: Model 1 used the CGP report date as the index date; Model 2 used the date of metastatic diagnosis as the index date (including adjustment for immortal time bias). Results: Overall, 22 and 88 patients were included in the ALK fusion-positive and ALK-WT cohorts, respectively. Co-alterations were rare in the ALK fusion-positive cohort. Median overall survival was consistently lower in patients with ALK fusion-positive tumors compared with patients with ALK-WT tumors, across all analyses (hazard ratios between 1.8 and 2.0). Conclusion: Data from this study suggest that ALK fusions have a negative prognostic effect in metastatic solid tumors and highlight the need for further investigation of ALK inhibitors in the tumor-agnostic setting.
AB - Background: Anaplastic lymphoma kinase (ALK) fusions can be found in different solid tumors. This study aims to describe the clinical characteristics and investigate survival outcomes of patients with ALK fusion-positive solid tumors (excluding non-small cell lung cancer [NSCLC]) treated with standard-of-care therapies in a real-world setting. Patients and Methods: Data for patients with metastatic solid tumors (excluding NSCLC) who had ≥1 Foundation Medicine comprehensive genomic profiling (CGP) test between January 1, 2011 and September 30, 2023, were obtained from a nationwide (US-based) de-identified multi-tumor clinico-genomic database. Patients with ALK wild-type (ALK-WT) tumors were matched with patients with ALK fusion-positive tumors (4:1 ratio) using pre-specified baseline characteristics. Two models were used to analyze survival outcomes: Model 1 used the CGP report date as the index date; Model 2 used the date of metastatic diagnosis as the index date (including adjustment for immortal time bias). Results: Overall, 22 and 88 patients were included in the ALK fusion-positive and ALK-WT cohorts, respectively. Co-alterations were rare in the ALK fusion-positive cohort. Median overall survival was consistently lower in patients with ALK fusion-positive tumors compared with patients with ALK-WT tumors, across all analyses (hazard ratios between 1.8 and 2.0). Conclusion: Data from this study suggest that ALK fusions have a negative prognostic effect in metastatic solid tumors and highlight the need for further investigation of ALK inhibitors in the tumor-agnostic setting.
KW - ALK
KW - anaplastic lymphoma kinase
KW - metastatic solid tumors
KW - prognostic
UR - http://www.scopus.com/inward/record.url?scp=105004787358&partnerID=8YFLogxK
U2 - 10.1093/oncolo/oyaf005
DO - 10.1093/oncolo/oyaf005
M3 - Article
C2 - 40338218
AN - SCOPUS:105004787358
SN - 1083-7159
VL - 30
JO - Oncologist
JF - Oncologist
IS - 5
M1 - oyaf005
ER -