Prognostic and predictive factors in a randomized phase III trial comparing cisplatin-pemetrexed versus cisplatin-gemcitabine in advanced non-small-cell lung cancer.
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/m(2) and P, 500 mg/m(2)) or cisplatin plus gemcitabine (CG; C, 75 mg/m(2) and G, 1250 mg/m(2)) 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.
Syrigos
K N
KN
Oncology Unit, Department of Medicine, Athens School of Medicine, Athens, Greece. Electronic address: knsyrigos@usa.net.
Vansteenkiste
J
J
Respiratory Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium.
Parikh
P
P
Department of Medical Oncology, BSES G Municipal Hospital and Railway Hospital, Mumbai, India.
von Pawel
J
J
Department of Oncology, Asklepios-Fachkliniken Munchen Gauting, Gauting.
Manegold
C
C
Department of Surgery-Interdisciplinary Thoracic Oncology, Heidelberg University Medical Center, Mannheim, Germany.
Martins
R G
RG
Division of Medical Oncology, University of Washington Medical Center, Seattle, WA, USA.
Simms
L
L
Department of Statistics and Information Sciences, Eli Lilly Canada, Toronto, Canada.
Sugarman
K P
KP
Medical Oncology, Eli Lilly and Company, Indianapolis, IN, USA.
Visseren-Grul
C
C
Medical Oncology, Eli Lilly Netherlands, Utrecht, The Netherlands.
Scagliotti
G V
GV
Department of Clinical and Biological Sciences, Thoracic Oncology Unit, San Luigi Hospital, University of Turin, Turin, Italy.
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000188:drug therapy* / Q000473:pathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005971:Glutamates / Q000008:administration & dosage; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult; D000093542:Gemcitabine
D005971:Glutamates; D000068437:Pemetrexed; D003841:Deoxycytidine; D006147:Guanine; D002945:Cisplatin; D000093542:Gemcitabine