Comparison of video-assisted pleurectomy/decortication surgery plus hyperthermic intrathoracic chemotherapy with VATS talc pleurodesis for the treatment of malignant pleural mesothelioma: A pilot study

Our plain-English summary of Comparison of video-assisted pleurectomy/decortication surgery plus hyperthermic intrathoracic chemotherapy with VATS talc pleurodesis for the treatment of malignant pleural mesothelioma: A pilot study, by M. Migliore, M. Fiore, T. Filippini, et al (Heliyon, 2023).

The study

• Authors: M. Migliore, M. Fiore, T. Filippini, R. Tumino, M. Sabbioni, C. Spatola, R. Polosa, P. Vigneri, M. Nardini, S. Castorina, F. Basile, M. Ferrante, University of Catania Study Group of Malignant Pleural Mesotelioma
• Journal: Heliyon
• Published: 2023;9(6):e16685
• Cited by: 12 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Hyperthermic intrathoracic chemotherapy (HITHOC) adjunct to surgery for Malignant Pleural Mesothelioma (MPM) has no definite role. The primary objective of this pilot-trial was to evaluate the feasibility for future large studies. The study design was a prospective randomized three-centric pilot trial. We recruited patients diagnosed with MPM and prospectively assigned them to two groups: Group A: Video Assisted Thoracic Surgery (VATS) talc pleurodesis or Group B: Video-assisted P/D plus HITHOC. From November-2011 to July-2017 24 males and 3 females, with a median age of 68-years were enrolled (recruitment rate 5 patients/year). Preoperative stage was I-II, and 18 had epithelioid type. 14 patients were in the Group A. Operative mortality was 0. Follow-up ranged 6-80 months. The median overall survival time started to diverge at 20 months, being 19 months (95% CI 12-25) in Group A and 28 months (95% CI 0-56) in Group B. Survival rate for the epithelioid type was 15 months (95% CI 0-34) in Group A and 45 months (95% CI 0-107) in the Group B. These findings suggest that video-assisted P/D plus HITHOC may improve survival time in MPM patients undergoing surgical treatment and support the need for a larger multicenter randomized clinical trial.

© 2023 The Authors.

In plain English

This pilot study at three thoracic surgery centres in Sicily, Italy, tested whether a larger trial comparing two operations for malignant pleural mesothelioma was feasible. From November 2011 to July 2017, 27 patients (24 men, 3 women) were included. The study is called randomized, but treatment was decided by the centre a patient attended. Fourteen had keyhole (VATS) talc pleurodesis (Group A). Thirteen had video-assisted pleurectomy/decortication plus heated chemotherapy in the chest (HITHOC, Group B). Eleven of the 27 reported asbestos exposure. No patients died in hospital, and none were lost to follow-up. Median survival after diagnosis was 19 months (95% CI 12–25) in Group A and 28 months (95% CI 0–56) in Group B. The authors called this difference imprecise. The unadjusted hazard ratio was 0.52 (95% CI 0.22–1.23). Among the 9 epithelioid-type patients in each group, median survival was 15 months (95% CI 0–34) in Group A and 45 months (95% CI 0–107) in Group B. The authors concluded that a multicenter randomized trial was feasible and estimated it would need 145 patients. They listed the small number of patients as a limitation.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Pilot feasibility trial, described by the authors as a prospective randomized three-centre trial; in practice the treatment each patient received depended on which participating centre they attended
• Who was studied: 27 patients with malignant pleural mesothelioma (24 men, 3 women; median age 68) treated at thoracic surgery centres in Sicily, Italy. They were enrolled from November 2011 to July 2017 and followed to December 31, 2020. Group A (VATS talc pleurodesis) had 14 patients and Group B (video-assisted P/D plus HITHOC) had 13. Three Palermo patients who did not meet the inclusion criteria were excluded.
• Exposure: The study compared two surgical treatments, not asbestos exposures. Asbestos exposure was recorded as a patient characteristic: 11 of 27 patients reported it (6 of 14 in Group A, 5 of 13 in Group B). Fiber types were not reported for individual patients. Four Group B patients lived in Biancavilla; the authors' discussion mentions fluoro-edenite fibres found there.
• Main results:
  • Feasibility: about five patients were enrolled per year, and the retention rate was 100%, with no patients lost to follow-up
  • Median overall survival after diagnosis was 19 months (95% CI 12–25) in Group A versus 28 months (95% CI 0–56) in Group B
  • Median overall survival after treatment was 19 months (95% CI 12–25) in Group A versus 23 months (95% CI 0–50) in Group B
  • Hazard ratio for overall survival from diagnosis, with Group A as the reference: 0.52 (95% CI 0.22–1.23) unadjusted, and 0.15 (95% CI 0.02–0.91) after adjustment for age, sex, histological subtype, TNM, stage and asbestos exposure. Some patients were left out of the adjusted analysis.
  • Among patients with epithelioid mesothelioma (9 in each group), median survival from diagnosis was 15 months (0–34) in Group A and 45 months (0–107) in Group B. Table 4 and the abstract give these ranges as 95% confidence intervals; the results paragraph labels them IQR.
  • No in-hospital deaths were recorded in either group. Post-operative complications occurred in 8 of 14 Group A patients and 7 of 13 Group B patients.
  • At the end of follow-up, 1 of 14 Group A patients and 4 of 13 Group B patients were still alive
  • Based on the hazard ratio of 0.52, the authors estimated that a future trial would need 145 patients with about 73 deaths
• The authors' conclusion: The authors concluded that the pilot study showed a multicenter randomized trial comparing video-assisted P/D plus HITHOC with VATS talc pleurodesis is feasible. In their abstract, they wrote that the findings suggest P/D plus HITHOC may improve survival time and support the need for a larger trial.
• Limitations the authors state:
  • Small number of patients
  • No specific information on the doses of neoadjuvant or adjuvant chemotherapy, radiotherapy or immunotherapy given to each patient
  • Differences between the groups in how neoadjuvant and adjuvant therapy were given may have affected the results
  • The authors did not know how long patients had quit smoking
  • Nursing staff at Centre A were not formally informed about the study, while those at Centre B were, which could have meant better care at Centre B

Topics

Medical terms in this study, explained in our Lexicon: Pleurectomy/Decortication (P/D), Intrathoracic, Chemotherapy, Video-Assisted Thoracoscopic Surgery (VATS), Talc Pleurodesis, Pleural Mesothelioma, Thoracic Surgery, Epithelioid.

Related studies

• MesoTRAP: a feasibility study that includes a pilot clinical trial comparing video-assisted thoracoscopic partial pleurectomy decortication with indwelling pleural catheter in patients with trapped lung due to malignant pleural mesothelioma designed to address recruitment and randomisation uncertainties and sample size requirements for a phase III trial — C. Matthews, C. Freeman, et al. (2019)
• Local and systemic exposure of cisplatin during hyperthermic intrathoracic chemotherapy perfusion after pleurectomy and decortication for treatment of pleural malignancies — M. Ried, T. Potzger, et al. (2013)
• Life expectancy of patients with malignant pleural effusion treated with video-assisted thoracoscopic talc pleurodesis — T. Laisaar, V. Palmiste, et al. (2006)
• The MesoVATS trial: is there a future for video-assisted thoracoscopic surgery partial pleurectomy? — R.C. Rintoul (2015)
• Postoperative outcomes of laparoscopic vs open cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy for treatment of peritoneal surface malignancies — G. Passot, N. Bakrin, et al. (2014)
• Pleurectomy/decortication and hyperthermic intrapleural chemotherapy for malignant pleural mesothelioma: initial experience — M. Migliore, D. Calvo, et al. (2015)

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