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Randomized phase III trial of gemcitabine-based chemotherapy with in situ RRM1 and ERCC1 protein levels for response prediction in non-small-cell lung cancer
Journal of Clinical Oncology, 11/05/09

Reynolds C et al. – This study evaluated the efficacy of gemcitabine versus gemcitabine and carboplatin in patients with advanced non–small-cell lung cancer (NSCLC) and a performance status (PS) of 2 and assessed if tumoral RRM1 and ERCC1 protein levels are predictive of response to therapy. Single-agent chemotherapy remains the standard of care for patients with advanced NSCLC and poor PS. Quantitative analysis of RRM1 and ERCC1 protein expression in routinely collected tumor specimens in community oncology practices is predictive of response to gemcitabine and gemcitabine and carboplatin therapy.

Methods

Randomized phase III trial
Tumor specimens collected a priori and shipped to single laboratory for blinded determination of in situ RRM1 and ERCC1 protein expression levels by an automated quantitative immunofluorescent-based technology

Results

170 patients randomly assigned
Overall median survival 5.1 months for gemcitabine and 6.7 months for gemcitabine and carboplatin
RRM1 (range, 5.3 to 105.6; median, 34.1) and ERCC1 (range, 5.2 to 131.3; median, 34.7) values significantly and inversely correlated with disease response
Model for response prediction that included RRM1, ERCC1, and treatment arm, highly predictive of treatment response observed
We did not find statistically significant associations between survival and RRM1 or ERCC1 levels

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