MAPS
Trial question
What is the role of bevacizumab addition to pemetrexed plus cisplatin in patients with malignant pleural mesothelioma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 448
448 patients (110 female, 338 male).
Inclusion criteria: patients aged 18-75 years with unresectable malignant pleural mesothelioma who had not received previous chemotherapy.
Key exclusion criteria: CNS metastases; treatment with antiaggregant agents, anti-vitamin K drugs at a curative dose, LMWH at a curative dose, or NSAIDs.
Interventions
N=223 bevacizumab plus standard of care (pemetrexed 500 mg/m² IV plus cisplatin 75 mg/m² with bevacizumab 15 mg/kg in 21 day cycles for up to 6 cycles).
N=225 standard of care alone (pemetrexed 500 mg/m² IV plus cisplatin 75 mg/m² in 21 day cycles for up to 6 cycles).
Primary outcome
Median overall survival
18.8 months
16.1 months
18.8 months
14.1 months
9.4 months
4.7 months
0.0 months
Bevacizumab plus standard of
care
Standard of care
alone
Significant
increase ▲
Significant increase in median overall survival (18.8 months vs. 16.1 months; HR 1.3, 95% CI 1.05 to 1.61).
Secondary outcomes
Significant increase in median progression-free survival (9.2 months vs. 7.3 months; HR 1.64, 95% CI 1.33 to 2).
Significantly greater improvement in fatigue (28% vs. 18%; RR 1.56, 95% CI 0.03 to 3.09).
No significant difference in improvement in global health status (23% vs. 23%; RR 1, 95% CI -27.51 to 29.51).
Safety outcomes
No significant difference in hematological and non-hematological adverse events.
Significant differences in discontinuation of first-line treatment because of toxic effects (24.3% vs. 6.0%), grade ≥ 3 hypertension (23% vs. 0%).
Conclusion
In patients aged 18-75 years with unresectable malignant pleural mesothelioma who had not received previous chemotherapy, bevacizumab plus standard of care was superior to standard of care alone with respect to median overall survival.
Reference
Gérard Zalcman, Julien Mazieres, Jacques Margery et al. Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414.
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