Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study

Ciuleanu, Tudor; Brodowicz, Thomas; Zielinski, Christoph; Kim, Joo Hang; Krzakowski, Maciej; Laack, Eckart; Wu, Yi-Long; Bover, Isabel; Begbie, Stephen; Tzekova, Valentina; Cucevic, Branka; Pereira, Jose Rodrigues; Yang, Sung Hyun; Madhavan, Jayaprakash; Sugarman, Katherine P; Peterson, Patrick; John, William J; Krejcy, Kurt; Belani, Chandra P

doi:10.1016/s0140-6736(09)61497-5

Cited by 1,111Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study

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Ciuleanu, Tudor, Brodowicz, Thomas, Zielinski, Christoph, Kim, Joo Hang, Krzakowski, Maciej, Laack, Eckart, Wu, Yi-Long, Bover, Isabel +11 more·2009·The Lancet

DOI 10.1016/s0140-6736(09)61497-5

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Abstract

Background Several studies have shown the efficacy, tolerability, and ease of administration of pemetrexed-an antifolate antineoplastic agent-in patients with advanced non-small-cell lung cancer. We assessed pemetrexed as maintenance therapy in patients with this disease.Methods This randomised double-blind study was undertaken in 83 centres in 20 countries. 663 patients with stage IIIB or IV disease who had not progressed on four cycles of platinum-based chemotherapy were randomly assigned (2:1 ratio) to receive pemetrexed (500 mg/m(2), day 1) plus best supportive care (n=441) or placebo plus best supportive care (n=222) in 21-day cycles until disease progression. Treatment was randomised with the Simon and Pocock minimisation method. Patients and investigators were masked to treatment. All patients received vitamin B(12), folic acid, and dexamethasone. The primary endpoint of progression-free survival and the secondary endpoint of overall survival were analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00102804.Findings All randomly assigned participants were analysed. Pemetrexed significantly improved progression-free survival (4.3 months [95% CI 4.1-4.7] vs 2.6 months [1.7-2.8]; hazard ratio [HR] 0.50, 95% CI 0.42-0.61, p<0.0001) and overall survival (13.4 months [11.9-15.9] vs 10.6 months [8.7-12.0]; HR 0.79, 0.65-0.95, p=0.012) compared with placebo. Treatment discontinuations due to drug-related toxic effects were higher in the pemetrexed group than in the placebo group (21 [5%] vs three [1%]). Drug-related grade three or higher toxic effects were higher with pemetrexed than with placebo (70 [16%] vs nine [4%]; p<0.0001), specifically fatigue (22 [5%] vs one [1%], p=0.001) and neutropenia (13 [3%] vs 0, p=0.006). No pemetrexed-related deaths occurred. Relatively fewer patients in the pemetrexed group than in the placebo group received systemic post-discontinuation therapy (227 [51%] vs 149 [67%]; p=0.0001).Interpretation Maintenance therapy with pemetrexed is well tolerated and offers improved progression-free and overall survival compared with placebo in patients with advanced non-small-cell lung cancer.Funding Eli Lilly.

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The switch maintenance benefit of pemetrexed was observed only in patients with non-squamous cell carcinoma.
“In the case of pemetrexed, this benefit was seen only in patients with NSCC [I, B].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [57]
In the erlotinib switch maintenance trial, subgroup analyses showed benefit only in patients with stable disease after induction, not in those with tumour response.
“In the erlotinib trial, subgroup analyses revealed a benefit restricted to patients with stable disease (SD) after induction treatment, as opposed to patients with tumour response.”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [57]

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The PARAMOUNT Trial: A Phase III Randomized Study of Maintenance Pemetrexed Versus Placebo Immediately Following Induction First-line Treatment with Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non-Small Cell Lung Cancer
Gridelli, C., Maione, P., & Rossi, A. (2013) · Reviews on Recent Clinical Trials · doi:10.2174/15748871112079990040 · Cited by 7 · see citing works
Pemetrexed in maintenance treatment of advanced non-squamous non-small-cell lung cancer
Minami, S., & Kijima, T. (2015) · Lung Cancer Targets and Therapy · doi:10.2147/lctt.s73268 · Cited by 9 · see citing works
Continuation Maintenance Therapy with Pemetrexed(PEM) ± Bevacizumab(BEV) Following First Line Cisplatin/PEM ± BEV for NSCLC
Niwa, T., Yoshioka, H., Kourogi, Y., et al. (2013) · Annals of Oncology · doi:10.1093/annonc/mdt459.143
Maintenance therapy with pemetrexed and bevacizumab versus pemetrexed monotherapy after induction therapy with carboplatin, pemetrexed, and bevacizumab in patients with advanced non-squamous non small cell lung cancer
Karayama, M., Inui, N., Fujisawa, T., Enomoto, N., Nakamura, Y., Kuroishi, S., Yokomura, K., Koshimizu, N., Sato, M., Toyoshima, M., et al. (2016) · European Journal of Cancer · doi:10.1016/j.ejca.2016.01.013 · Cited by 32 · see citing works

Authors: Ciuleanu, T., Brodowicz, T., Zielinski, C., Kim, J. H., Krzakowski, M., Laack, E., Wu, Y.-L., Bover, I., Begbie, S., Tzekova, V., Cucevic, B., Pereira, J. R., Yang, S. H., Madhavan, J., Sugarman, K. P., Peterson, P., John, W. J., Krejcy, K., & Belani, C. P.
Affiliations: Institute of Oncology Prof. Dr. Ion Chiricuta (RO)
Vienna General Hospital (AT)
Yonsei Cancer Hospital (KR)
Central European Cooperative Oncology Group (AT)
Universität Hamburg (DE)
Guangdong General Hospital (CN)
Hospital Son Llatzer (ES)
Queen Giovanna Hospital (BG)
Regional Cancer Center, Thiruvananthapuram (IN)
Eli Lilly (United States) (US)
Penn State Cancer Institute (US)
Corresponding author: Belani, Chandra P
ORCID: Ciuleanu, Tudor
Zielinski, Christoph
Krzakowski, Maciej
Wu, Yi-Long
Begbie, Stephen
Peterson, Patrick
Belani, Chandra P
Venue: The Lancet
Publisher: Elsevier BV
Published: 2009-10
Volume: 374
Issue: 9699
Pages: 1432-1440
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(09)61497-5
OpenAlex: W2112621029
Cited by: 1,111
References: 41
Citations by year: 2026: 8 · 2025: 8 · 2024: 15 · 2023: 19 · 2022: 16 · 2021: 29 · 2020: 51 · 2019: 38 · 2018: 51 · 2017: 61 · 2016: 57 · 2015: 95 · 2014: 113 · 2013: 136 · 2012: 141
FWCI: 116.20
Type: journal article
Language: en
Open access: green
ir.ymlib.yonsei.ac.kr
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: The Lancet (publishedVersion)
PubMed (publishedVersion)
YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
Funders: Eli Lilly and Company
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: pemetrexed, maintenance therapy, non-small cell lung cancer, best supportive care, progression-free survival, overall survival, platinum-based chemotherapy, antifolate, drug toxicity, neutropenia, fatigue, vitamin B12, folic acid, dexamethasone, advanced lung cancer, treatment discontinuation
MeSH terms: Pemetrexed, Aged, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Double-Blind Method, Fatigue, Female, Glutamates, Guanine, Humans, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Neutropenia, Prognosis, Survival Rate, Proportional Hazards Models, Treatment Outcome, Disease-Free Survival

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Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study

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