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Implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) for the treatment of patients with malignant pleural effusion: study protocol for the Danish phase-I PITAC-OPC5 study. | LitMetric

AI Article Synopsis

  • PITAC (Pressurized IntraThoracic Aerosol Chemotherapy) is a new, minimally invasive treatment for patients with malignant pleural effusion and pleural metastasis that aims to improve safety and effectiveness in cancer care.
  • This phase-I study will involve 20 patients receiving multiple treatments to evaluate feasibility, safety, and effectiveness, focusing on complication rates and other health metrics.
  • Preliminary findings suggest PITAC is safe and potentially effective in reducing effusion volumes, offering hope for improved treatment options in this challenging area of cancer therapy.

Article Abstract

Objectives: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) is a minimally invasive cancer-directed therapy for patients with malignant pleural effusion (MPE) and/or pleural metastasis (PLM). PITAC is based on Pressurized IntraPeritoneal Aerosol Chemotherapy, which has proven to be safe and feasible. Since 2012, 47 PITACs have been published, and prospective data on feasibility, safety and potential local response are lacking.

Methods: The prospective, controlled, phase-I study is designed to treat MPE with PITAC. There are no data to support the estimated number of patients needed, but previous experience estimates the non-access rate to 20 %. Twenty eligible patients with MPE will receive two or more PITACs at four-week intervals. During video-assisted thoracoscopy, MPE and/or pleural lavage fluid is evacuated, and the extent of visible PLM is assessed. Pleural biopsies are collected, if possible, for histological response as per Thoracic Regression Grading Score (TRGS). Patients are screened for treatment-related intra- and postoperative complications. The primary outcome is the number of patients with Clavien-Dindo ≥3b or Common Terminology Criteria for Adverse Events≥4 within 30 days. Secondary objectives include PLM-score, TRGS and cytology, length of hospitalization, personnel safety, quality of life, and change in MPE volume.

Results: PITAC is expected to be safe and feasible for patients and personnel, and achieve positive results in the reduction of MPE volume.

Conclusions: The results may significantly impact the next clinical, technical, and scientific steps in the implementation of PITAC. Given the suboptimal treatment options for MPE and the seemingly promising results of PITAC, we find the implementation of PITAC ethically reasonable and sound.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11661466PMC
http://dx.doi.org/10.1515/pp-2024-0014DOI Listing

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