2187P - Efficacy and safety of gemcitabine as maintenance treatment in unresectable malignant pleural mesothelioma: A phase II randomized study

Background

Unresectable malignant pleural mesothelioma has limited therapeutic options, with controversial data being present on the role of gemcitabine maintenance. the only previuos trial that assessed the gemcitabine as a maintainance is NVALT19 Trial Our randomized, phase 2, open-label study aimed to evaluate the activity of gemcitabine versus best supportive care as maintenance after first-line chemotherapy in this setting.

Methods

Patients with a histologically confirmed disease, having a complete or partial response or disease stabilization after 4-6 cycles of first-line platinum-based chemotherapy were randomized into 2 groups: (1) gemcitabine 1000 mg/m2 IV in Days 1, 8 of a 21-day-long cycle or (2) best supportive care. The treatment was continued until disease progression or unacceptable toxicity. Objective response rate (ORR) was assessed using the mRECIST criteria, and the adverse events were registered according to the CTC-AE v. 4.0.

Results

A total of 64 patients were included (32 in each group), with no differences between group 1 and 2 in the baseline characteristics except body weight (69.3±15.3 vs 77.4±15.8, p = 0.040) and ECOG PS at randomization (PS I in 25 (78.1%) vs 17 (53.1%), p = 0.035, respectively). Most cases in the two groups were of the epithelioid type (87.5% and 84.4%, p = 1.000). Platinum-pemetrexed doublet was administered in 46.9% and 53.2%, and platinum-gemcitabine doublet in 50% and 43.8% in groups 1 and 2, respectively, with no significant differences in proportions and in the response (p=0.209) between the groups. Maintenance therapy was associated with better ORR (regression+stabilization in 84.4% vs 25.8% of cases, p < 0.001). Dyspnea, fatigue, and chest pain were more common in group 2, while anemia, leucopenia, and nausea were more common in group 1 (all p < 0.001). No grade 3-4 toxicity was observed.

Conclusions

Gemcitabine maintenance has therapeutic efficacy and manageable toxicity in patients with malignant pleural mesothelioma who have responded to first-line chemotherapy.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.