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PARAMOUNT: final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer

Paz-Ares, Luis G., de Marinis, Filippo, Dediu, Mircea, Thomas, Michael, Pujol, Jean-Louis, Bidoli, Paolo, Molinier, Olivier, Sahoo, Tarini Prasad, Laack, Eckart, Reck, Martin, Corral, Jesús, Melemed, Symantha, John, William, Chouaki, Nadia, Zimmermann, Annamaria H., Visseren-Grul, Carla, Gridelli, Cesare·2013·Journal of Clinical Oncology

DOI 10.1200/jco.2012.47.1102

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Abstract

PURPOSE: In the phase III PARAMOUNT trial, pemetrexed continuation maintenance therapy reduced the risk of disease progression versus placebo (hazard ratio [HR], 0.62; 95% CI, 0.49 to 0.79; P < .001). Here we report final overall survival (OS) and updated safety data. PATIENTS AND METHODS: In all, 939 patients with advanced nonsquamous non-small-cell lung cancer (NSCLC) received four cycles of pemetrexed-cisplatin induction therapy; then, 539 patients with no disease progression and Eastern Cooperative Oncology Group performance status 0 or 1 were randomly assigned (2:1) to maintenance pemetrexed (500 mg/m(2) on day 1 of 21-day cycles; n = 359) or placebo (n = 180). Log-rank test compared OS between arms as measured from random assignment (α = .0498). RESULTS: The mean number of maintenance cycles was 7.9 (range, one to 44) for pemetrexed and 5.0 (range, one to 38) for placebo. After 397 deaths (pemetrexed, 71%; placebo, 78%) and a median follow-up of 24.3 months for alive patients (95% CI, 23.2 to 25.1 months), pemetrexed therapy resulted in a statistically significant 22% reduction in the risk of death (HR, 0.78; 95% CI, 0.64 to 0.96; P = .0195; median OS: pemetrexed, 13.9 months; placebo, 11.0 months). Survival on pemetrexed was consistently improved for all patient subgroups, including induction response: complete/partial responders (n = 234) OS HR, 0.81; 95% CI, 0.59 to 1.11 and stable disease (n = 285) OS HR, 0.76; 95% CI, 0.57 to 1.01). Postdiscontinuation therapy use was similar: pemetrexed, 64%; placebo, 72%. No new safety findings emerged. Drug-related grade 3 to 4 anemia, fatigue, and neutropenia were significantly higher in pemetrexed-treated patients. CONCLUSION: Pemetrexed continuation maintenance therapy is well-tolerated and offers superior OS compared with placebo, further demonstrating that it is an efficacious treatment strategy for patients with advanced nonsquamous NSCLC and good performance status who did not progress during pemetrexed-cisplatin induction therapy.

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PARAMOUNT: Final overall survival (OS) results of the phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo (plb) plus BSC immediately following induction treatment with pem plus cisplatin (cis) for advanced nonsquamous (NS) non-small cell lung cancer (NSCLC).
Paz-Ares, L. G., de Marinis, F., Dediu, M., Thomas, M., Pujol, J.-L., Bidoli, P., Molinier, O., Sahoo, T. P., Laack, E., Reck, M., et al. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2012.30.18_suppl.lba7507 · Cited by 19
PARAMOUNT: Descriptive Subgroup Analyses of Final Overall Survival for the Phase III Study of Maintenance Pemetrexed versus Placebo Following Induction Treatment with Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non–Small-Cell Lung Cancer
Reck, M., Paz-Ares, L. G., de Marinis, F., Molinier, O., Sahoo, T. P., Laack, E., John, W. J., Zimmermann, A. H., Visseren‐Grul, C., & Gridelli, C. (2014) · Journal of Thoracic Oncology · doi:10.1097/jto.0000000000000076 · Cited by 16
Littérature commentée décembre 2014
(2014) · La Revue de Médecine Interne · doi:10.1016/j.revmed.2014.10.002
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
Pujol, J.-L., Paz-Ares, L. G., de Marinis, F., Dediu, M., Thomas, M., Bidoli, P., Corral, J., Antonio, B. S., Chouaki, N., John, W. J., et al. (2014) · Clinical Lung Cancer · doi:10.1016/j.cllc.2014.06.007 · Cited by 39
PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC).
Paz-Ares, L. G., Marinis, F. D., Dediu, M., Thomas, M., Pujol, J., Bidoli, P., Molinier, O., Sahoo, T.-P., Laack, E., Reck, M., et al. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2011.29.18_suppl.cra7510 · Cited by 19

See all

Authors: Paz-Ares, L. G., de Marinis, F., Dediu, M., Thomas, M., Pujol, J.-L., Bidoli, P., Molinier, O., Sahoo, T. P., Laack, E., Reck, M., Corral, J., Melemed, S., John, W., Chouaki, N., Zimmermann, A. H., Visseren-Grul, C., & Gridelli, C.
Affiliations: Heidelberg University (DE)
Luis Paz-Ares and Jesús Corral, University Hospital Virgen del Rocío, Seville, Spain; Filippo de Marinis, San Camillo-Forlanini Hospital, Rome; Paolo Bidoli, S. Gerardo Hospital, Monza; Cesare Gridelli, San Giuseppe Moscati Hospital, Avellino, Italy; Mircea Dediu, Institute of Oncology Bucharest, Bucharest, Romania; Michael Thomas, University of Heidelberg, Heidelberg; Eckart Laack, University Medical Center Hamburg-Eppendorf, Hamburg; Martin Reck, Hospital Grosshansdorf, Grosshansdorf, Germany; Jean...
ORCID: Paz-Ares, Luis G.
Dediu, Mircea
Thomas, Michael
Pujol, Jean-Louis
Molinier, Olivier
Reck, Martin
Gridelli, Cesare
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2013-08-10
Volume: 31
Issue: 23
Pages: 2895-2902
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2012.47.1102
OpenAlex: W2167191456
Cited by: 624
References: 32
Citations by year: 2026: 10 · 2025: 18 · 2024: 23 · 2023: 24 · 2022: 31 · 2021: 47 · 2020: 52 · 2019: 53 · 2018: 72 · 2017: 63 · 2016: 66 · 2015: 76 · 2014: 72 · 2013: 13
FWCI: 61.17
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
BOA (University of Milano-Bicocca) (submittedVersion)
Funders: Eli Lilly and Company
American Society of Clinical Oncology
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Keywords: maintenance therapy, pemetrexed, cisplatin, advanced nonsquamous non-small cell lung cancer, overall survival, induction chemotherapy, treatment safety, subgroup analysis, disease progression, prognostic factors, prognostic score, treatment-related adverse events, neutropenia, febrile neutropenia, thrombocytopenia
MeSH terms: Pemetrexed, Antimetabolites, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Cisplatin, Double-Blind Method, Female, Glutamates, Guanine, Humans, Lung Neoplasms, Male, Middle Aged, Remission Induction, Survival Analysis, Treatment Outcome, Disease-Free Survival, Induction Chemotherapy

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PARAMOUNT: final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer

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