Efficacy and safety of maintenance pemetrexed in patients with advanced nonsquamous non-small cell lung cancer following pemetrexed plus cisplatin induction treatment: A cross-trial comparison of two phase III trials

G. V. Scagliotti, C. Gridelli, F. de Marinis, M. Thomas, M. Dediu, J. L. Pujol, C. Manegold, B. San Antonio, P. M. Peterson, W. John, N. Chouaki, C. Visseren-Grul, L. G. Paz-Ares

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: Two phase III trials of advanced NSCLC patients were compared to examine relative efficacy and safety of differing treatment regimens. The JMDB trial investigated first-line pemetrexed-cisplatin (pemetrexed 500mg/m2 plus cisplatin 75mg/m2 every 21 days; maximum: 6 cycles). The PARAMOUNT phase III trial compared maintenance pemetrexed versus placebo after patients with nonsquamous NSCLC completed 4 cycles of first-line pemetrexed-cisplatin without disease progression. Methods: Overall survival (OS) and progression-free survival (PFS), analyzed by Kaplan-Meier and Cox methods, and toxicity rates were compared between the PARAMOUNT arms and a selected homogeneous population from JMDB: 346 patients with disease and prior treatment characteristics matching the PARAMOUNT population. Results: Outcomes for the PARAMOUNT placebo arm were similar to the JMDB homogeneous group (median PFS: 5.6 versus 6.2 months, p = 0.117, HR = 1.16; median OS: 14.0 versus 14.2 months, p = 0.979, HR = 1.00). The PARAMOUNT maintenance pemetrexed group had statistically superior efficacy compared with the JMDB homogeneous group (median PFS: 7.5 versus 6.2 months, p

Original languageEnglish
Pages (from-to)408-414
Number of pages7
JournalLung Cancer
Volume85
Issue number3
DOIs
Publication statusPublished - 2014

Keywords

  • Carcinoma
  • Cisplatin
  • Induction chemotherapy
  • Maintenance chemotherapy
  • Non-small cell lung
  • Nonsquamous
  • Pemetrexed
  • Phase III clinical trial

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research
  • Medicine(all)

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