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Annals of Oncology Advance Access published online on October 14, 2009
Annals of Oncology, doi:10.1093/annonc/mdp392
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© The Author 2009. 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

Prognostic and predictive factors in a randomized phase III trial comparing cisplatin–pemetrexed versus cisplatin–gemcitabine in advanced non-small-cell lung cancer

K. N. Syrigos1,*, J. Vansteenkiste2, P. Parikh3, J. von Pawel4, C. Manegold5, R. G. Martins6, L. Simms7, K. P. Sugarman8, C. Visseren-Grul9 and G. V. Scagliotti10

1 Oncology Unit, Department of Medicine, Athens School of Medicine, Athens, Greece
2 Respiratory Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium
3 Department of Medical Oncology, BSES G Municipal Hospital and Railway Hospital, Mumbai, India
4 Department of Oncology, Asklepios-Fachkliniken Munchen Gauting, Gauting
5 Department of Surgery–Interdisciplinary Thoracic Oncology, Heidelberg University Medical Center, Mannheim, Germany
6 Division of Medical Oncology, University of Washington Medical Center, Seattle, WA, USA
7 Department of Statistics and Information Sciences, Eli Lilly Canada, Toronto, Canada
8 Medical Oncology, Eli Lilly and Company, Indianapolis, IN, USA
9 Medical Oncology, Eli Lilly Netherlands, Utrecht, The Netherlands
10 Department of Clinical and Biological Sciences, Thoracic Oncology Unit, San Luigi Hospital, University of Turin, Turin, Italy

* Correspondence to: Dr K. N. Syrigos, Oncology Unit GPP, Athens School of Medicine, Sotiria General Hospital, Mesogion 152 Avenue, 115 27 Athens, Greece. Tel: +30-2107700220; Fax: +30-210-7781035; E-mail: knsyrigos{at}usa.net

Background: Baseline patient and disease characteristics are investigated in non-small-cell lung cancer (NSCLC) in an effort to predict response to treatment and optimize patients’ outcomes. Histology has recently been identified in multiple NSCLC phase III trials as a predictive factor for survival in patients receiving pemetrexed regimens.

Methods: Cox-adjusted models were used to further analyze a randomized phase III study in 1725 chemonaive patients with stage IIIB or IV NSCLC and Eastern Cooperative Oncology Group performance status (PS) of zero or one who received cisplatin plus pemetrexed (CP; C, 75 mg/m2 and P, 500 mg/m2) or cisplatin plus gemcitabine (CG; C, 75 mg/m2 and G, 1250 mg/m2) every 21 days.

Results: Histology was confirmed to be predictive of CP efficacy and may also be prognostic. Gender, ethnicity, disease stage, smoking status, and PS were not predictive in either treatment arm but were shown to be prognostic in the nonsquamous population, consistent with the results in the overall NSCLC population.

Conclusions: NSCLC histology significantly predicts efficacy outcomes for patients receiving pemetrexed. Several other factors are prognostic for the overall study population as well as a subset of patients with advanced nonsquamous NSCLC.

histology, markers, non-small-cell lung cancer, predictive, prognostic

Received for publication April 14, 2009. Revision received June 8, 2009. Accepted for publication June 9, 2009.


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