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

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TPS7619 General Poster Session (Board #54E), Sat, 1:15 PM-5:15 PM<br />

A multicenter randomized phase III trial <strong>of</strong> customized chemotherapy<br />

versus standard <strong>of</strong> care for first-line treatment <strong>of</strong> elderly patients with<br />

advanced non-small cell lung cancer (EPIC). Presenting Author: George R.<br />

Simon, Hollings Cancer Center, Medical University <strong>of</strong> South Carolina,<br />

Charleston, SC<br />

Background: Personalizing therapy based on an individual patient’s molecular<br />

pr<strong>of</strong>ile is a potentially promising approach to optimize efficacy with the<br />

available agents. Optimizing efficacy in the elderly is particularly relevant<br />

owing to their increased propensity to suffer therapy-induced toxicity. In<br />

this proposal we will attempt to demonstrate optimization <strong>of</strong> therapy in<br />

good performance EGFR mutation negative elderly patients by taking in to<br />

consideration the histology <strong>of</strong> the tumor, the ERCC1 (marker <strong>of</strong> platinum<br />

resistance), RRM1 (for gemcitabine resistance) and TS (for pemetrexed<br />

resistance) status. Methods: Untreated advanced stage NSCLC patients age<br />

�70 years with measurable disease will be enrolled. Patients will be<br />

randomized in a 2:1 randomization to experimental arm (A) or standard arm<br />

(B). In arm A, treatment with single or dual-agent chemotherapy will be<br />

selected based on histology, ERCC1 (E), RRM1(R) and TS (T) expression at<br />

the RNA level. The cut <strong>of</strong>f for high (�, therefore resistant) or low (-,<br />

therefore sensitive) expression have been previously defined. Patients with<br />

squamousNSCLC who are E-R� will be treated with single agent carboplatin,<br />

E�R- with gemcitabine, E-R- with carboplatin and gemcitabine and<br />

E�R� with docetaxel or vinorelbine. In non-squamous NSCLC patients<br />

E-T� will be treated with carboplatin, E�T- withpemetrexed, E-T- with<br />

carboplatin and pemetrexed, E�T�R- with gemcitabine and E�T�R�<br />

with docetaxel or vinorelbine. In arm B treatment with single or dual-agent<br />

chemotherapy will be at the discretion <strong>of</strong> the care provider, i.e., standard <strong>of</strong><br />

care. The primary endpoint <strong>of</strong> the trial is overall survival (OS). The<br />

secondary endpoint is progression-free survival (PFS). The tertiary endpoint<br />

is disease response. Treatment will continue to maximum <strong>of</strong> 6 cycles if<br />

tolerated or until disease progression. A sample size <strong>of</strong> 453 patients will<br />

give us 90% power to detect a three-month improvement in median survival<br />

(8 to 11 months; corresponding to a HR <strong>of</strong> 0.73) with the log rank test at a<br />

significance level <strong>of</strong> 5%(1-sided) allowing for a 10% failure rate in gene<br />

analyses.<br />

Lung Cancer—Non-small Cell Metastatic<br />

Visit abstract.asco.org and search by abstract for the full list <strong>of</strong> abstract authors and their disclosure information.<br />

509s

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