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
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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Randomised trials of continuation maintenance have shown improvements in PFS and OS.
“Randomised trials investigating continuation maintenance have shown an improvement of PFS and OS [79,80].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [80]
A large phase III randomised trial found that continuation pemetrexed after four induction cycles of cisplatin plus pemetrexed improves PFS and OS in PS 0-1 patients, confirmed at long-term follow-up.
“A large phase III randomised trial of continuation maintenance with pemetrexed versus placebo after four induction cycles of cisplatin plus pemetrexed chemotherapy demonstrated a PFS and OS improvement in patients with a PS 0-1, confirmed at longterm follow-up [80,81].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [80]
In the PARAMOUNT trial, OS was 2.9 months longer with pemetrexed maintenance (13.9 v 11 months; unadjusted HR P = .019).
“OS was 2.9 months longer (13.9 v 11 months; unadjusted HR P = .019).”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [7]
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- 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
- Venue
- Journal of Clinical Oncology
- Published
- 2013-08-10
- Volume
- 31
- Issue
- 23
- Pages
- 2895-2902
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- 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 · 2012: 4
- 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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