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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.
- Source :
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Clinical lung cancer [Clin Lung Cancer] 2014 Nov; Vol. 15 (6), pp. 418-25. Date of Electronic Publication: 2014 Jun 21. - Publication Year :
- 2014
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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.<br />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/m(2), 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.<br />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 < .05) low-grade events (grade 1/2 nausea, grade 2 anemia, edema, and neutropenia) than placebo. Overall, the incidence of low-grade fatigue, anemia, and neutropenia decreased with long-term pemetrexed exposure; however, renal events increased across treatment arms. EQ-5D analyses demonstrated no treatment-by-time interaction or overall treatment differences between the 2 arms.<br />Conclusion: PARAMOUNT demonstrated a low incidence of low-grade toxicities with long-term pemetrexed exposure without compromising QoL in patients with NS-NSCLC.<br /> (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Anemia etiology
Carcinoma, Non-Small-Cell Lung mortality
Cisplatin administration & dosage
Cisplatin adverse effects
Disease Progression
Glutamates adverse effects
Guanine administration & dosage
Guanine adverse effects
Humans
Induction Chemotherapy
Lung Neoplasms mortality
Male
Middle Aged
Nausea etiology
Neoplasm Staging
Pemetrexed
Quality of Life
Survival Analysis
Treatment Outcome
Withholding Treatment
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Carcinoma, Non-Small-Cell Lung drug therapy
Glutamates administration & dosage
Guanine analogs & derivatives
Lung Neoplasms drug therapy
Maintenance Chemotherapy
Subjects
Details
- Language :
- English
- ISSN :
- 1938-0690
- Volume :
- 15
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Clinical lung cancer
- Publication Type :
- Academic Journal
- Accession number :
- 25104617
- Full Text :
- https://doi.org/10.1016/j.cllc.2014.06.007