Overview Fingerprint. Access to Document Link to publication in Scopus. Together they form a unique fingerprint. View full fingerprint. Journal of Clinical Oncology , 23 25 , The trial enrolled 1, chemotherapy-naBve patients with locally advanced or metastatic stage IIIB or IV NSCLC to compare the survival of patients who received daily erlotinib versus placebo administrated concurrently with carboplatin and paclitaxel up to six day cycles , followed by maintenance erlotinib or placebo.
The primary efficacy end point was duration of survival, and the secondary efficacy end points were time to progression TTP , objective response rate ORR, defined by RECIST criteria , duration of response, and time to symptomatic progression.
The erlotinib-containing arm did not show an advantage for any of these variables over the placebo arm At time of enrollment in TRIBUTE, patients were given the option of providing an additional written informed consent to allow release of their archival tumor samples for research purposes.
All samples used in this analysis came from patients who signed this secondary consent. Before FISH analysis, slides were reviewed to assess the quality of the material and tumor content. Formalin-fixed paraffin-embedded tissue sections, which included 55 lung specimens 23 fine needle aspirates, 3 core biopsies, 9 surgical specimens, and 20 specimens of unknown type , 13 lymph node specimens 6 fine needle aspirates, 4 biopsies, and 3 of unknown type , 1 thigh mass biopsy, 1 humerus core biopsy, 1 pericardial surgical biopsy, 1 scalp biopsy, 1 femur biopsy, and 1 fine needle aspirate of the sacrum biopsy.
Because the FISH EGFR assay was developed and validated on histologic sections containing at least 50 tumor cells with no overlapping nuclei, we used only specimens that met these criteria. The analysis reported in this paper is a retrospective exploratory subgroup analysis. Demographic variables were summarized by EGFR gene copy status. ORR was summarized by gene copy status and treatment received. Time to event variables i.
Median time to event was estimated from the Kaplan-Meier curves. Comparisons between groups for time-to-event variables were done via log-rank test. HRs were estimated by Cox regression. All hypothesis tests were two sided. Due to the exploratory nature of the analysis, no adjustment for multiple testing was used. Patients with missing values for a given clinical variable including indeterminant EGFR gene copy status were excluded from any analysis involving that variable.
Archival pathology specimens were released to Genentech, Inc. The primary pathology reports and histopathologic diagnosis were reviewed by a pathologist. Tumor tissue samples from patients, corresponding to At the quality control step, samples from patients were rejected either because there was insufficient tumor material, or because the samples were cytologic samples e.
Of those, The demographic and baseline characteristics of the patients in the FISH subgroup compared with all patients enrolled on the study are presented in Table 1. Overall the patients in the groups were similar. These characteristics included sex, patients who never smoked, and tumor histology.
Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative. Advanced search. Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily. Skip to main content Thank you for visiting nature. Download PDF. Erlotinib and placebo arms were equivalent in adverse events except rash and diarrhea.
Conclusion: Erlotinib with concurrent carboplatin and paclitaxel did not confer a survival advantage over carboplatin and paclitaxel alone in patients with previously untreated advanced NSCLC.
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