Efficacy
Locally advanced, recurrent or metastatic NSCLC with predominantly non-squamous cell histology
Response rates and clinical benefit (complete or partial response or stable disease) rates were similar in patients receiving pemetrexed or docetaxel. Overall response rates were 9.1 or 8.8% in patients receiving pemetrexed or docetaxel, respectively.r Median survival (the primary end point of the study) was 8.3 or 7.9 months in those receiving pemetrexed or docetaxel, respectively; however, efficacy of pemetrexed in terms of survival could not be established, since a reliable and consistent effect of docetaxel on survival could not be estimated from historical study data, and crossover between treatments at the time of disease progression may have confounded interpretation of the survival data. Median progression-free survival was 2.9 months and 1-year survival rate was 29.7% in both treatment groups.r
Median Survival Timer
© J Clin Oncol 2004
Maintenance treatment post platinum doublet chemotherapy in non-progressive patients
Ciuleanu et alr reported that maintenance therapy with pemetrexed increased both median progression-free survival (4.3 versus 2.6 months, HR 0.50, 95% CI 0.42-0.61) and median overall survival compared with placebo (13.4 versus 10.6 months, HR 0.79, 95% CI 0.65-0.95).
Median Survival Timer
Overall survival in the intention-to-treat population of 663 randomly assigned patients.
© Lancet 2009
In the PARAMOUNT trial, progression-free survival was significantly increased with pemetrexed compared with placebo (median 4.1 versus 2.8 months, HR 0.62, 95% CI 0.49-0.79).r Overall survival, measured from randomisation to maintenance therapy was significantly increased with pemetrexed compared with placebo (median 13.9 versus 11.0 months, 1 year survival rate 58 versus 45 % and 2 year survival rate 32 versus 21 % ).r
© Lancet Oncol 2012
Efficacy by Histological Group (JMEN)r
Histology Groups |
Median OS, mos |
Median PFS, mos |
Pem |
Placebo |
P-value (HR) |
Pem |
Placebo |
P-value (HR) |
Non Squamous (n=481) |
15.5 |
10.3 |
0.002 (0.70) |
4.4 |
1.8 |
<0.00001 (0.47) |
Adeno (n=329) |
16.8 |
11.5 |
0.026 (0.73) |
4.6 |
2.7 |
<0.00001 (0.51) |
Large Cell (n=20) |
8.4 |
7.9 |
0.964 (0.98) |
4.5 |
1.5 |
0.104 (0.40) |
Other (n=133) |
11.3 |
7.7 |
0.025 (0.61) |
4.1 |
1.6 |
0.0002 (0.44) |
Squamous (n=182) |
9.9 |
10.8 |
0.678 91/07) |
2.4 |
2.5 |
0.896 (1.03) |
There was a statistically significant treatment by histology interaction with both PFS (p=0.036) and OS (p=0.03)