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 journalArticle

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

Fingerprint

Pemetrexed
Non-Small Cell Lung Carcinoma
Cisplatin
Placebos
Maintenance
Quality of Life
Safety
Neutropenia
Granulocyte-Macrophage Colony-Stimulating Factor
Drug-Related Side Effects and Adverse Reactions
Double-Blind Method
Granulocytes
Fatigue
Disease Progression
Anemia
Infection

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

Cite this

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

In: Journal of Thoracic Oncology, Vol. 7, No. 11, 11.2012, p. 1713-1721.

Research output: Contribution to journalArticle

Gridelli, C, De Marinis, F, Pujol, JL, Reck, M, Ramlau, R, Parente, B, Pieters, T, Middleton, G, Corral, J, Winfree, K, Melemed, S, Zimmermann, A, John, W, Beyrer, J, Chouaki, N, Visseren-Grul, C & Paz-Ares, LG 2012, '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', Journal of Thoracic Oncology, vol. 7, no. 11, pp. 1713-1721. https://doi.org/10.1097/JTO.0b013e318267cf84
Gridelli, Cesare ; De Marinis, Filippo ; Pujol, Jean Louis ; Reck, Martin ; Ramlau, Rodryg ; Parente, Barbara ; Pieters, Thierry ; Middleton, Gary ; Corral, Jesus ; Winfree, Katherine ; Melemed, Symantha ; Zimmermann, Anna ; John, William ; Beyrer, Julie ; Chouaki, Nadia ; Visseren-Grul, Carla ; Paz-Ares, Luis G. / 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. In: Journal of Thoracic Oncology. 2012 ; Vol. 7, No. 11. pp. 1713-1721.
@article{a21e21fbef0b48e692bff655386bd871,
title = "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",
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",
keywords = "EuroQol 5-dimensional questionnaire, Maintenance, Nonsquamous non-small-cell lung cancer, Pemetrexed, Quality of life",
author = "Cesare Gridelli and {De Marinis}, Filippo and Pujol, {Jean Louis} and Martin Reck and Rodryg Ramlau and Barbara Parente and Thierry Pieters and Gary Middleton and Jesus Corral and Katherine Winfree and Symantha Melemed and Anna Zimmermann and William John and Julie Beyrer and Nadia Chouaki and Carla Visseren-Grul and Paz-Ares, {Luis G.}",
year = "2012",
month = "11",
doi = "10.1097/JTO.0b013e318267cf84",
language = "English",
volume = "7",
pages = "1713--1721",
journal = "Journal of Thoracic Oncology",
issn = "1556-0864",
publisher = "Elsevier Inc.",
number = "11",

}

TY - JOUR

T1 - Safety, resource use, and quality of life in paramount

T2 - A phase III study of maintenance pemetrexed versus placebo after induction pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer

AU - Gridelli, Cesare

AU - De Marinis, Filippo

AU - Pujol, Jean Louis

AU - Reck, Martin

AU - Ramlau, Rodryg

AU - Parente, Barbara

AU - Pieters, Thierry

AU - Middleton, Gary

AU - Corral, Jesus

AU - Winfree, Katherine

AU - Melemed, Symantha

AU - Zimmermann, Anna

AU - John, William

AU - Beyrer, Julie

AU - Chouaki, Nadia

AU - Visseren-Grul, Carla

AU - Paz-Ares, Luis G.

PY - 2012/11

Y1 - 2012/11

N2 - 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

AB - 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

KW - EuroQol 5-dimensional questionnaire

KW - Maintenance

KW - Nonsquamous non-small-cell lung cancer

KW - Pemetrexed

KW - Quality of life

UR - http://www.scopus.com/inward/record.url?scp=84867894352&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84867894352&partnerID=8YFLogxK

U2 - 10.1097/JTO.0b013e318267cf84

DO - 10.1097/JTO.0b013e318267cf84

M3 - Article

C2 - 23059776

AN - SCOPUS:84867894352

VL - 7

SP - 1713

EP - 1721

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

SN - 1556-0864

IS - 11

ER -