1. 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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3. At least SD post Cis/Pem
Study Design
N=539
Primary Outcome:PFS
Treatment A: Pemetrexed
500 mg/m2 q 3 weeks + BSC
N=359 R
Treatment B: Placebo + BSC
N=180
Stage IIIB/IV
Non-squamous/NSCLC
ECOG 0,1
At least SD post Cis/Pem

4. RESULTS Response Rate (%) PFS by Investigator (median, mos) PFS by IRR
Treatment A B
p-value
Response Rate (%)
2.8
0.6 NA
PFS by Investigator
(median, mos)
4.1
PFS by IRR
3.9
2.6
0.0002

5. 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.

6. 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 % received > 6 cycles
HR for PFS 0.62 was highly statistically significant

7. 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.