Safety, resource use, and quality of life in paramount: A phase III study of maintenance pemetrexed versus placebo after induction pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer

Cesare Gridelli, Filippo De Marinis, Jean Louis Pujol, Martin Reck, Rodryg Ramlau, Barbara Parente, Thierry Pieters, Gary Middleton, Jesus Corral, Katherine Winfree, Symantha Melemed, Anna Zimmermann, William John, Julie Beyrer, Nadia Chouaki, Carla Visseren-Grul, Luis G. Paz-Ares

Research output: Contribution to journalArticlepeer-review

Abstract

INTRODUCTION: In a phase III, randomized, double-blind study (PARAMOUNT), maintenance pemetrexed demonstrated significant benefit in advanced non-small-cell lung cancer (NSCLC). We present safety, resource use, and quality of life (QoL) results. METHODS: After four 21-day cycles of pemetrexed-cisplatin (N = 939), patients with advanced nonsquamous NSCLC, whose disease had not progressed and who had a performance status of 0/1, were randomized 2:1 (N = 539) to maintenance pemetrexed 500 mg/m plus best supportive care or placebo plus best supportive care every 21 days until disease progression or unacceptable toxicity. QoL was measured using the EuroQol 5-dimensional questionnaire (EQ-5D). RESULTS: Frequently reported grade 3 to 4 drug-related toxicities with maintenance pemetrexed versus placebo were anemia (4.5% versus 0.6%; p = 0.016), fatigue (4.2% versus 0.6%; p = 0.016), and neutropenia (3.6% versus 0.0%; p <0.006). No significant differences in drug-related grade 3 to 5 toxicities were observed with long-term pemetrexed exposure (>6 cycles), except grade 3 to 4 neutropenia, which did not result in increased infections. Patients on maintenance pemetrexed required more transfusions (13.4% versus 5.0%; p = 0.003), granulocyte colony- or granulocyte-macrophage colony-stimulating factors (5.3% versus 0.0%; p

Original languageEnglish
Pages (from-to)1713-1721
Number of pages9
JournalJournal of Thoracic Oncology
Volume7
Issue number11
DOIs
Publication statusPublished - Nov 2012

Keywords

  • EuroQol 5-dimensional questionnaire
  • Maintenance
  • Nonsquamous non-small-cell lung cancer
  • Pemetrexed
  • Quality of life

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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