Long-Term and Low-Grade Safety Results of a Phase III Study (PARAMOUNT): Maintenance Pemetrexed Plus Best Supportive Care Versus Placebo Plus Best Supportive Care Immediately after Induction Treatment with Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non-Small-Cell Lung Cancer

Jean Louis Pujol, Luis Paz-Ares, Filippo De Marinis, Mircea Dediu, Michael Thomas, Paolo Bidoli, Jesus Corral, Belen San Antonio, Nadia Chouaki, William John, Annamaria Zimmermann, Carla Visseren-Grul, Cesare Gridelli

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction In the PARAMOUNT ("A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care vs. Best Supportive Care Immediately Following Induction Treatment with Pemetrexed Plus Cisplatin for Advanced Non-Squamous Non-Small-Cell Lung Cancer") trial, patients with advanced nonsquamous non-small-cell lung cancer (NS-NSCLC) benefited from pemetrexed maintenance therapy after induction therapy with pemetrexed and cisplatin by extending survival, delaying disease progression, and maintaining quality of life (QoL). However, low-grade 1 or 2 toxicities during long-term maintenance treatment may become burdensome and impact QoL. Materials and Methods Patients in this double-blind study (n = 539), who had completed 4 induction cycles (pemetrexed with cisplatin) without progressive disease (PD) and had an ECOG performance status of 0/1, were randomized 2:1 to pemetrexed maintenance (500 mg/m2, day 1) plus best supportive care (BSC) or placebo plus BSC until PD. Adverse events (by maximum Common Terminology Criteria for Adverse Events [CTCAE] grade) and QoL (EuroQol 5-dimensional [EQ-5D] scale) were assessed. Results A median of 4 maintenance cycles was administered (range, pemetrexed 1-44; mean ± SD 7.9 ± 8.3; placebo 1-38; mean ± SD 5.0 ± 5.2), with 28% of pemetrexed and 12% of placebo patients receiving ≥ 10 maintenance cycles. The pemetrexed dose intensity was 94%. More patients receiving pemetrexed (12%) than placebo discontinued because of possible drug-related CTCAEs (4%; P =.005). Overall, pemetrexed was associated with significantly more (P

Original languageEnglish
Pages (from-to)418-425
Number of pages8
JournalClinical Lung Cancer
Volume15
Issue number6
DOIs
Publication statusPublished - Nov 1 2014

Keywords

  • ALIMTA
  • Low-grade toxicities
  • LY231514
  • NS-NSCLC
  • Post-induction maintenance therapy

ASJC Scopus subject areas

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

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