الفهرس 
Title : Gemcitabine As Maintenance Treatment Of Malignant Pleural Mesothelioma (GEMO): Randomized Phase II Study
ContantsOnly 14 pages are availabe for public view
 |  | from | 134 |  |  |
| | | from | 134 | | |
Abstract
Mesothelioma is a rare serosal membrane cancer accounting for only 0.2% of new cases and 0.3% of cancer deaths worldwide. It commonly affects the pleura, peritoneum, pericardium, and testes. However, it is characterized by a poor prognosis with a median overall survival between 8 and 18 months. Moreover, most patients present with advanced disease, where palliative systemic therapy is the only available treatment to improve survival. First-line chemotherapy with a combination of Pemetrexed and Cisplatin is the standard upfront treatment of pleural mesothelioma (PM). However, there is no evidence supporting maintenance therapy for these patients.
Therefore, this phase II clinical trial aimed to evaluate the efficacy and safety of gemcitabine versus best supportive care (BSC) as maintenance therapy after first-line chemotherapy for patients with unresectable PM in terms of progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and treatment safety.
The study involved 64 patients with confirmed histological diagnosis of an unresectable PM who completed 4-6 cycles of first-line platinum-based chemotherapy within 60 days. They were randomized into two equal groups to receive intravenous (IV) Gemcitabine 1000 mg/m2 D1& D8 every 21 days (GEM group) or best supportive care (BSC group). The disease progression was evaluated every eight weeks. The median follow-up period was 4.4 months (range: 0.03-19.6).