Abstract
19025 Background: A prospective randomized phase III trial for advanced non-small cell lung cancer (NSCLC) compared paclitaxel (P) plus carboplatin (C) vs. vinorelbine (V), gemcitabine (G) followed by docetaxel (D) in the Japan-Multinational Trial Organization (JMTO LC0003) (Kawahara ASCO 06). This trial was conducted jointly with SWOG 0003 using a common arm of PC. Pharmacogenomic studies of samples from both trials demonstrated significant associations between genotype and clinical outcome (Gandara ASCO 07). Previous analysis of SWOG 0003 samples showed that elevated osteopontin (OPN) plasma levels were highly prognostic (Mack ASCO 05). Our correlative study (JMTO LC 0004) of JMTO LC 0003 was originally designed to assess β-tubulin mutations, which was determined to be insignificant. We elected to study and validate OPN as a prognostic marker, using stock samples under additional approval of JMTO IRB. Method: A total of 20 ml of blood was collected prior to treatment from patients enrolled in JMTO LC0003. Serum concentrations of OPN and basic fibroblast growth factor (bFGF) were measured by ELISA. The relationships between OPN, bFGF levels and patients characteristics were examined using χ2 test, including treatment arm, age, smoking status, histology, clinical stage, performance status, weight loss and LDH. Effect of OPN and bFGF levels on progression-free survival (PFS) and overall survival (OS) were examined by multivariate analysis adjusted by treatment arm, smoking status, clinical stage, performance status, weight loss and LDH. Results: Seventy-one samples were obtained, including 32 specimens from the PC arm and 39 from the VGD arm. There were no significant relationships between either OPN or bFGF levels with patient characteristics. However, smokers tended to have higher OPN levels (p=0.083). In analysis of clinical outcome, low OPN levels correlated with better PFS (p<0.001), and high bFGF correlated with better OS (p=0.003). Conclusion: Consistent with findings from SWOG 0003, low OPN serum levels were significantly associated with a favorable prognosis in the JMTO LC 0004. Additionally, high bFGF levels were associated with improved survival. No significant financial relationships to disclose.
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