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 language | English |
|---|---|
| Pages (from-to) | 1713-1721 |
| Number of pages | 9 |
| Journal | Journal of Thoracic Oncology |
| Volume | 7 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - Nov 2012 |
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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 journal › Article
}
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 -