A comprehensive analysis of clinical trial data has revealed significant underreporting of weight gain in patients with advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer treated with Alecensa (alectinib), raising concerns about long-term patient health management.
The study, published in the Journal of Clinical Oncology, analyzed data from three clinical trials (J-ALEX, ALUR, and ML29453), encompassing 2,622 weight measurements from 302 subjects. The findings exposed a stark discrepancy between documented and actual weight changes, with 49% of patients experiencing weight gain compared to only 5% reported in adverse event records.
Weight Gain Patterns and Clinical Impact
The research demonstrated that 18% of patients experienced a significant weight increase of 10% or more during treatment. Time on Alecensa showed a direct correlation with weight gain, resulting in an average increase of 4.4% over one year of treatment. Notably, baseline body mass index (BMI) showed no significant association with weight change in the J-ALEX and ALUR/ML29453 studies.
Population Characteristics and Treatment Duration
The study revealed demographic variations, with 13.6% of Japanese participants classified as underweight at baseline, compared to 5% in the Western population. Treatment duration varied significantly across trials, with the ML29453 trial showing a median therapy duration of 139 days, considerably shorter than other trials due to early termination when Alecensa became standard treatment.
Clinical Implications and Future Directions
"These findings underscore the importance of raising awareness among physicians regarding weight gain as a side effect," the researchers emphasized, noting that obesity can lead to over 200 other diseases affecting both physical and mental health. The study authors strongly recommend patient counseling before treatment initiation.
Management Strategies Under Consideration
With no current specific guidelines for managing treatment-related weight gain in this population, researchers are exploring various interventions. The team has begun considering approved obesity medications, including:
- Semaglutide
- Liraglutide
- Naltrexone/bupropion
- Orlistat
The need for targeted interventions becomes increasingly critical as Alecensa expands into adjuvant treatment for resected ALK+ NSCLC. The long-term survival prospects of these patients further emphasize the importance of addressing treatment-induced weight gain effectively.
