Dr Wolf on Challenges Conducting Clinical Trials Evaluating Surgery in Mesothelioma 

Andrea Wolf, MD, MPH, director , New York Mesothelioma Program, Icahn School of Medicine, Mount Sinai, discusses common challenges experienced when conducting randomized controlled trials to assess the role of surgery in mesothelioma management, including issues related to standardizing surgical procedures and pathology interpretations.

Wolf begins by emphasizing the achievements of the interventional MARS2 trial (NCT02040272). Following 2 cycles of chemotherapy, 328 patients were randomly assigned to receive extended pleurectomy decortication surgery in addition to chemotherapy vs chemotherapy alone. The study evaluated outcomes such as overall survival, cost-effectiveness, and quality of life.

Despite the MARS2 trial's success in randomly assigning patients to surgery, Wolf states that limitations arise in standardizing the surgical operation itself. Variations in surgical techniques and the extent of resection can lead to inconsistent outcomes, making it difficult to assess the true impact of surgery on patient survival and disease control, she explains.

Standardizing pathology interpretations in mesothelioma trials is also a challenge, Wolf continues, adding that this is particularly evident with blood and tissue samples. The assessment of microscopic disease adds complexity to standardization, as many clinicians believe that this result cannot be consistently reported within this patient population. This variability in pathological evaluations complicates efforts to draw definitive conclusions regarding the benefits of surgery from randomized clinical trials, she explains.

To address these limitations, international collaboration is critical, Wolf emphasizes. 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), she details. These collaborations aim to refine prognostic factors and staging criteria, ultimately helping to identify which patients are most likely to benefit from surgery, Wolf explains.

In the future, mesothelioma treatment will likely involve a combination of surgery and personalized adjuvant therapies, tailored based on biomarkers and tissue characteristics obtained from surgical specimens, Wolf concludes.

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Andrea Wolf, MD, MPH, discusses challenges experienced when conducting randomized trials to assess the role of surgery in mesothelioma management.

 Dr Wolf on Challenges Conducting Clinical Trials Evaluating Surgery in Mesothelioma 

 Dr Wolf on Unmet Needs With Surgery in Mesothelioma Treatment 

Andrea Wolf, MD, MPH, director, the New York Mesothelioma Program, Icahn School of Medicine at Mount Sinai, discusses the unmet needs with randomized controlled trials to assess the role of surgery in treating mesothelioma, highlighting issues related to standardizing surgical procedures and pathology interpretations.

To begin, Wolf highlights the inherent challenges of randomizing patients with mesothelioma in surgical trials, emphasizing the achievements of the MARS2 trial (NCT02040272), which successfully randomly assigned patients to either receive surgery or not. MARS2 specifically compared extended pleurectomy decortication surgery vs no surgery to evaluate outcomes including overall survival, cost-effectiveness, and quality of life.

Despite the MARS2 trial's success in randomizing patients to surgery, Wolf notes that limitations arise in standardizing the surgical operation itself, which presents significant challenges for investigators, Wolf says. Variation in surgical technique and the extent of resection can lead to inconsistent outcomes, making it difficult to assess the true impact of surgery on patient survival and disease control, she explains.

Wolf emphasizes the challenges in standardizing pathology interpretations in mesothelioma trials, particularly with blood and tissue samples. The assessment of microscopic residual disease adds complexity, as some pathologists report complete microscopic resection—a result many clinicians consider to be inconsistently interpretable within this patient population. This variability in pathological evaluations complicates the ability of randomized clinical trials to draw definitive conclusions about the benefits of surgery, she explains, she notes

To address these challenges, Wolf emphasizes the importance of international collaboration. Efforts are underway to standardize treatment protocols and pathology assessments through collaborative networks such as the International Association for the Study of Lung Cancer, she details. These collaborations aim to refine prognostic factors and staging criteria, ultimately helping to identify which patients are most likely to benefit from surgery, Wolf expands.

Looking ahead, the future of mesothelioma treatment will likely involve a combination of surgery and personalized adjuvant therapies, tailored based on biomarkers and tissue characteristics obtained from surgical specimens, Wolf concludes.

Andrea Wolf, MD, MPH, discusses challenges in conducting randomized controlled trials to assess the role of surgery in the treatment of mesothelioma.

Andrea Wolf, MD, MPH

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Dr Wolf on Challenges Conducting Clinical Trials Evaluating Surgery in Mesothelioma

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