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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).

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  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

  2. Thank you for downloading this update. Please feel free to use it for educational purposes. Please acknowledge OncologyEducation.ca and Dr. Charles Butts when using these slides.

  3. 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

  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 1-19. 23% 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.

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