Annual Meeting Proceedings Part 1 - American Society of Clinical ...

TPS7619 General Poster Session (Board #54E), Sat, 1:15 PM-5:15 PM
A multicenter randomized phase III trial of customized chemotherapy
versus standard of care for first-line treatment of elderly patients with
advanced non-small cell lung cancer (EPIC). Presenting Author: George R.
Simon, Hollings Cancer Center, Medical University of South Carolina,
Charleston, SC
Background: Personalizing therapy based on an individual patient’s molecular
profile is a potentially promising approach to optimize efficacy with the
available agents. Optimizing efficacy in the elderly is particularly relevant
owing to their increased propensity to suffer therapy-induced toxicity. In
this proposal we will attempt to demonstrate optimization of therapy in
good performance EGFR mutation negative elderly patients by taking in to
consideration the histology of the tumor, the ERCC1 (marker of platinum
resistance), RRM1 (for gemcitabine resistance) and TS (for pemetrexed
resistance) status. Methods: Untreated advanced stage NSCLC patients age
�70 years with measurable disease will be enrolled. Patients will be
randomized in a 2:1 randomization to experimental arm (A) or standard arm
(B). In arm A, treatment with single or dual-agent chemotherapy will be
selected based on histology, ERCC1 (E), RRM1(R) and TS (T) expression at
the RNA level. The cut off for high (�, therefore resistant) or low (-,
therefore sensitive) expression have been previously defined. Patients with
squamousNSCLC who are E-R� will be treated with single agent carboplatin,
E�R- with gemcitabine, E-R- with carboplatin and gemcitabine and
E�R� with docetaxel or vinorelbine. In non-squamous NSCLC patients
E-T� will be treated with carboplatin, E�T- withpemetrexed, E-T- with
carboplatin and pemetrexed, E�T�R- with gemcitabine and E�T�R�
with docetaxel or vinorelbine. In arm B treatment with single or dual-agent
chemotherapy will be at the discretion of the care provider, i.e., standard of
care. The primary endpoint of the trial is overall survival (OS). The
secondary endpoint is progression-free survival (PFS). The tertiary endpoint
is disease response. Treatment will continue to maximum of 6 cycles if
tolerated or until disease progression. A sample size of 453 patients will
give us 90% power to detect a three-month improvement in median survival
(8 to 11 months; corresponding to a HR of 0.73) with the log rank test at a
significance level of 5%(1-sided) allowing for a 10% failure rate in gene
analyses.
Lung Cancer—Non-small Cell Metastatic
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