Conducting randomized controlled trials to evaluate the role of surgery in mesothelioma management faces significant challenges, particularly in standardizing surgical procedures and pathology interpretations. According to Andrea Wolf, MD, MPH, director of the New York Mesothelioma Program at the Icahn School of Medicine at Mount Sinai, variations in surgical techniques and inconsistencies in pathology assessments can hinder the ability to draw definitive conclusions about the benefits of surgery.
Surgical Standardization Challenges
Despite the success of trials like the interventional MARS2 trial (NCT02040272), which randomized 328 patients after two cycles of chemotherapy to either extended pleurectomy decortication surgery plus chemotherapy or chemotherapy alone, standardizing the surgical operation itself remains a hurdle. "Variations in surgical techniques and the extent of resection can lead to inconsistent outcomes," Wolf explained. This inconsistency makes it difficult to accurately assess the impact of surgery on patient survival and disease control.
Pathology Interpretation Issues
Standardizing pathology interpretations, especially with blood and tissue samples, presents another layer of complexity. The assessment of microscopic disease is particularly challenging, with many clinicians finding it difficult to achieve consistent reporting within the mesothelioma patient population. This variability in pathological evaluations further complicates efforts to draw definitive conclusions regarding the benefits of surgery from randomized clinical trials.
The Path Forward: International Collaboration
To overcome these limitations, international collaboration is essential. Wolf emphasized that efforts are underway to standardize treatment protocols and pathology assessments through collaborative networks such as the International Association for the Study of Lung Cancer (IASLC). These collaborations aim to refine prognostic factors and staging criteria, ultimately helping to identify which patients are most likely to benefit from surgery.
Personalized Adjuvant Therapies
Looking ahead, mesothelioma treatment will likely involve a combination of surgery and personalized adjuvant therapies. These therapies will be tailored based on biomarkers and tissue characteristics obtained from surgical specimens, allowing for a more targeted and effective approach to treatment.
