A randomized comparative study on maintenance gemcitabine versus supportive care in pleural mesothelioma

Area of Science:

• Oncology
• Clinical Trials
• Cancer Therapeutics

Background:

• Pleural mesothelioma (PM) is a rare, aggressive cancer often linked to asbestos exposure.
• Limited treatment options exist, particularly in low-resource settings.
• Immune checkpoint inhibitors show promise but face access challenges globally.

Purpose of the Study:

• To evaluate the efficacy and safety of switch-maintenance gemcitabine versus best supportive care (BSC) in unresectable PM patients.
• To assess the impact on progression-free survival (PFS) and overall survival (OS).

Main Methods:

• Prospective randomized study at Ain Shams University Hospital (Nov 2022 - Dec 2024).
• 42 patients with unresectable PM, post-chemotherapy, randomized to gemcitabine or BSC.
• Assessed PFS, OS, and toxicity (CTCAE v5.0).

Main Results:

• Maintenance gemcitabine significantly improved PFS (8.9 vs. 5.2 months, p=0.022).
• OS favored gemcitabine (16.2 vs. 13.4 months, p=0.138).
• Gemcitabine was well-tolerated with manageable adverse events.

Conclusions:

• Switch-maintenance gemcitabine offers a significant PFS benefit for unresectable PM.
• It is a practical, affordable, and well-tolerated treatment option.
• Clinical trial registration: NCT05660616.