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Annals of Oncology Advance Access originally published online on February 17, 2008
Annals of Oncology 2008 19(5):939-945; doi:10.1093/annonc/mdm592
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

lung cancer

A randomized phase III trial comparing standard and high-dose pemetrexed as second-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer

M. H. Cullen1,*, P. Zatloukal2, S. Sörenson3, S. Novello4, J. R. Fischer5, A. A. Joy6, M. Zereu7, P. Peterson8, C. M. Visseren-Grul9 and N. Iscoe10

1 Cancer Centre at the Queen Elizabeth Hospital, University Hospital Birmingham, Birmingham, UK
2 Third Faculty of Medicine, Charles University, Postgraduate Medical School, Prague, Czech
3 Department of Pulmonary Medicine, University Hospital, Linköping, Sweden
4 Thoracic Oncology Unit, University of Turin, San Luigi Hospital, Orbassano, Turin, Italy
5 Klinik Loewenstein, Medizinische Klinik II/Onkologie, Loewenstein, Germany
6 Cross Cancer Institute, Edmonton, Alberta, Canada
7 Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil
8 Eli Lilly and Company, Indianapolis, IN, USA
9 Eli Lilly Netherlands, Utrecht, The Netherlands
10 Eli Lilly Canada, Toronto, Canada

* Correspondence to: Dr M. H. Cullen, Cancer Centre at the Queen Elizabeth Hospital, University Hospital Birmingham, Birmingham B15 2TH, UK. Tel: +44-121-627-2444; Fax: +44-121-697-8428; E-mail: michael.cullen{at}uhb.nhs.uk

Background: This phase III randomized trial compared pemetrexed 500 mg/m2 (P500) with pemetrexed 900 mg/m2 (P900) to determine whether higher dosing benefits non-small-cell lung cancer (NSCLC) patients as second-line therapy.

Patients and methods: Patients with locally advanced or metastatic NSCLC, previously treated with platinum-based chemotherapy, were randomly assigned to receive i.v. P500 or P900 every 3 week.

Results: Accrual was terminated with 588/600 patients enrolled because an interim analysis indicated a low probability of improved survival and numerically greater toxicity on the P900 arm. P900 patients were permitted to continue treatment at P500. No statistical difference was observed between the treatment arms (P500 versus P900) for median survival {6.7 versus 6.9 months, hazard ratio [HR] = 1.0132 [95% confidence interval (CI) 0.837–1.226]}, progression-free survival [2.6 versus 2.8 months, HR = 0.9681 (95% CI 0.817–1.147)], or best overall tumor response [7.1% versus 4.3% (P = 0.1616)]. The incidence of drug-related grade 3/4 toxicity was typically <5% on both treatment arms, but was numerically higher on the P900 arm for most toxicity categories.

Conclusions: P900 did not improve any efficacy measure over P500. P500 i.v. every 3 week remains the standard pemetrexed dose for second-line treatment of platinum-pretreated advanced NSCLC.

Key words: advanced NSCLC, pemetrexed, second-line chemotherapy

Received for publication September 13, 2007. Revision received December 5, 2007. Accepted for publication December 10, 2007.


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