PARAMOUNT
Trial question
What is the role of pemetrexed continuation maintenance therapy in patients with advanced nonsquamous non-small cell lung cancer?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 539
539 patients (226 female, 313 male).
Inclusion criteria: patients with advanced nonsquamous non-small cell lung cancer who received four cycles of pemetrexed-cisplatin induction therapy.
Key exclusion criteria: concurrent administration of other antitumour therapy and tumour histology that was predominantly squamous cell, mixed small cell, or a combination of both histologies.
Interventions
N=359 pemetrexed (continuation pemetrexed 500 mg/m² IV plus best supportive care, on day 1 of 21-day cycles).
N=180 placebo (0.9% sodium chloride IV plus best supportive care, on day 1 of 21-day cycles).
Primary outcome
Overall survival
13.9 months
11 months
13.9 months
10.4 months
7.0 months
3.5 months
0.0 months
Pemetrexed
Placebo
Significant
increase ▲
Significant increase in overall survival (13.9 months vs. 11 months; HR 1.28, 95% CI 1.04 to 1.56).
Secondary outcomes
No significant difference in survival for complete/partial responders induction response (15.5 months vs. 11.2 months; HR 1.23, 95% CI 0.9 to 1.69).
No significant difference in survival for patients with stable disease (13.7 months vs. 11.1 months; HR 1.32, 95% CI 0.99 to 1.75).
Safety outcomes
Significant differences in durg-related grade 3-4 anemia (6.4% vs. 0.6%), neutropenia (5.8% vs. 0%), and fatigue (4.7% vs. 1.1%).
Conclusion
In patients with advanced nonsquamous non-small cell lung cancer who received four cycles of pemetrexed-cisplatin induction therapy, pemetrexed was superior to placebo with respect to overall survival.
Reference
Paz-Ares LG, de Marinis F, Dediu M et al. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902.
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