PARAMOUNT: Phase III study of maintenance pemetrexed
(pem) plus best supportive care (BSC) versus placebo plus
BSC immediately following induction treatment with pem plus
cisplatin for advanced nonsquamous non-small cell lung
cancer (NSCLC).
Authors:L. G. Paz-Ares, F. De Marinis, M. Dediu, M. Thomas, J. Pujol, P. Bidoli, O.
Molinier, T. P. Sahoo, E. Laack, M. Reck, J. Corral, S. A. Melemed, W. J. John, N.
Chouaki, A. Zimmerman, C. M. Visseren Grul, C. Gridelli
Date posted: Post ASCO 2011
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Study Design
N=539
Primary
Outcome:PFS
Treatment A: Pemetrexed
500 mg/m2 q 3 weeks + BSC
N=359
R
Stage IIIB/IV
Non-squamous/NSCLC
ECOG 0,1
At least SD post Cis/Pem
Treatment B: Placebo + BSC
N=180
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RESULTS
Treatment
A
Treatment
B
p-value
Response
Rate (%)
2.8
0.6
NA
PFS by
Investigator
(median,
mos)
4.1
2.8
0.00006
PFS by IRR
(median,
mos)
3.9
2.6
0.0002
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TOXICITY
• No grade 3 or4 toxicity > 5 % of patients
with maintenance Pemetrexed
• No difference in QoL by EQ-5D
• No difference in Drug related death.
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STUDY COMMENTARY
• This is the first trial of induction pemetrexed
(Cis/Pem) followed by continuous maintenance
in patient with at least stable to induction chemo
• Study was powered for OS but insufficient
events at time of analysis
• Median # of cycles maintenance pem was 4 with
range 1-19. 23% received > 6 cycles
• HR for PFS 0.62 was highly statistically
significant
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BOTTOM LINE FOR CANADIAN
MEDICAL ONCOLOGISTS
• It is too early to assess the real value of a
continuous Pemetrexed maintenance approach.
• The 38% improvement in PFS (HR.62) is highly
statistically significant, but the difference in
median PFS is< 6 weeks.
• The study is powered for OS and final judgment
on the value of this strategy should await that
information.
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