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MAPS

Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial

Phase 3N = 448NCT00651456

Population
Patients aged 18 to 75 years with unresectable malignant pleural mesothelioma not amenable to curative surgery, no previous chemotherapy, ECOG performance status 0 to 2 and no substantial cardiovascular comorbidity
Design
Randomised, controlled, open-label trial (IFCT-GFPC-0701) at 73 hospitals in France; the abstract calls it phase 3 and the registry record lists phase 2/3. 448 patients were randomly assigned (minimisation, with stratification by histology, performance status, study centre and smoking status) between 13 February 2008 and 5 January 2014 to pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 with or without bevacizumab 15 mg/kg in 21-day cycles for up to six cycles, until progression or toxic effects as worded in the abstract. The primary outcome was overall survival in the intention-to-treat population. The registry record lists an enrolment of 448.
Primary endpoint
OS
Arms
  • Cisplatin-pemetrexed (control, n = 225): Pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 intravenously in 21-day cycles for up to six cycles
  • Cisplatin-pemetrexed plus bevacizumab (experimental, n = 223): The same chemotherapy plus bevacizumab 15 mg/kg intravenously in 21-day cycles
People
Zalcman G
OSHR 0.77 (95% CI 0.62–0.95)Δ median OS+2.7 months
Show the numbers
Results reported for MAPS
EndpointAnalysisCisplatin-pemetrexed plus bevacizumabCisplatin-pemetrexedEffect
OSprimaryZalcman 2016median 18.8 months (15.9–22.6)median 16.1 months (14.0–17.9)HR 0.77 (95% CI 0.62–0.95)P=0.0167
Results reported for MAPS
EndpointAnalysisCisplatin-pemetrexed plus bevacizumabCisplatin-pemetrexedEffect
OSprimaryZalcman 2016median 18.8 months (15.9–22.6)median 16.1 months (14.0–17.9)HR 0.77 (95% CI 0.62–0.95)P=0.0167
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.770.62–0.95
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Cisplatin-pemetrexed plus bevacizumab (experimental)
  • Cisplatin-pemetrexed (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCisplatin-pemetrexed plus bevacizumabCisplatin-pemetrexed
0100.0%100.0%
1264.2%59.7%
2441.3%35.6%
3527.5%22.2%
4717.7%13.2%
Primary publication: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, 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;387(10026):1405-1414. PubMedDOI

Appears in

Sources

  1. Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, 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;387(10026):1405-1414.

    PubMedDOI