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

BACKGROUND

Pleural mesothelioma (PM) is a rare aggressive cancer linked to asbestos exposure, with limited treatment options, especially in low-resource settings. While immune checkpoint inhibitors show promise, access remains limited in many countries.

METHODS

This prospective study was conducted at Ain Shams University Hospital from November 2022 to December 2024. 42 patients with unresectable PM and no progression after 4-6 cycles of platinum-pemetrexed chemotherapy were randomized 1:1 to receive switch-maintenance gemcitabine (1000 mg/m2 on days 1 and 8 every 21 days) or best supportive care (BSC). Progression-free survival (PFS), overall survival (OS), and toxicity (Common Terminology Criteria for Adverse Events CTCAE v5.0) were assessed.

RESULTS

Maintenance gemcitabine significantly improved PFS in unresectable PM (8.9 vs. 5.2 months, p = 0.022), confirmed in univariate analysis (HR = 0.505, p = 0.040) but not multivariate (p = 0.069). OS also favored gemcitabine (16.2 vs. 13.4 months, p = 0.138). Multivariate analysis linked gemcitabine (p = 0.043), females, cisplatin use, and partial response to initial therapy with better OS, while ECOG II and occupational exposure predicted worse OS. Adverse events were manageable.

CONCLUSION

Maintenance gemcitabine significantly improved PFS and was well tolerated, offering a practical and affordable treatment option for PM.

CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT05660616.