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136 Background: The combination chemotherapy of 5-fluorouracil (5-FU) and Oxaliplatin is usually used in gastric cancer (GC) and colorectal cancer (CRC). The safety and efficacy of the combination chemotherapy in patients over 80-years old has not been established yet. The purpose of this study was to assess the clinical outcomes and tolerability in the combination with 5-FU, leucovorin and oxaliplatin as first-line treatment in extremely elderly patients with GC or CRC. Methods: Eligibility included: 1) more than 80-years old, 2) metastatic gastric or colorectal cancer 3) chemotherapy-naive, 4) ECOG PS 0-1, 5) adequate organ function. Patients received the combination chemotherapy of 5-FU, leucovorin and oxaliplatin. Response evaluation was done every 8 weeks with RECIST criteria and toxicity was evaluated with NCI-CTCAE. Results: Between Sep 2008 and Nov 2014, 28 patients were reviewed and composed of equal numbers of GC and CRC. The median age was 82.2 years (80.0-85.6yrs) in GC and 81.1 years (80.0-89.3) in CRC, respectively. Total administrated cycles were 89 with median cycles of 5 in GC and 112 with median cycles of 11 in CRC. The median progression-free survival (PFS) and overall survival (OS) in GC were 5.4 months and 6.6 months, as compared with 7.3 months and 8.1 months, respectively. There were no significant difference in PFS (p = 0.94) and OS (p = 0.28) between GC and CRC. Overall survival rates at 1 year were 35.7% and 42.9%, respectively. After disease progression, salvage chemotherapy in GC and CRC was administrated in 1 and 7 patients, respectively. Common grade 3/4 hematology toxicities in both group were neutropenia, anemia. Frequent non-hematological toxicities were anorexia (60%), neuropathy (40%) and mucositis (25%), which were grade 1/2. Conclusions: The combination chemotherapy of 5-fluorouracil (5-FU) and Oxaliplatin has limited effect on improvement of OS in metastatic gastric or colorectal cancer patients more than age of 80. Further studies on the role of chemotherapy in these extremely elderly patients are needed.

4051 Background: While doublet combination with fluoropyrimidines and platinum is currently considered standard first-line chemotherapy in AGC, there has been a price to pay in terms of toxicity. S...

158 Background: While combination chemotherapy involving fluoropyrimidines and platinum is currently considered a standard regimen in AGC, there has been a price to pay in terms of toxicity. Since the main goal of treatment in AGC remains palliation, the current multi-center phase III trial compares efficacy and safety of XELOX combination with those of X monotherapy in elderly patients with AGC. Methods: AGC Patients aged 70 years or older were randomized 1:1 to receive X (capecitabine 1000 mg/m2 bid po on D1-D14) or XELOX (capecitabine 1000 mg/m2 bid po on D1-D14 plus oxaliplatin 110 mg/m2 iv on D1). Treatment was repeated every 21 days until disease progression, unacceptable toxicity, or patient’s refusal. Primary endpoint was overall survival, and the target sample size was 200 eligible patients. This interim safety analysis contains toxicity data from the first 27 randomized patients. Results: Among the 27 patients (X: 13, XELOX 14), median age was 77 (range, 70-84) years and 24 patients had symptomatic (ECOG PS 1-2) disease. The arms of the study were balanced with respect to baseline characteristics. No treatment-related serious adverse events (SAEs) or unexpected toxicities were observed. The most frequent toxicities were anorexia, fatigue, anemia, and hand-foot skin reactions. Fatigue and sensory neuropathy were more common in XELOX than X patients. QOL data showed no significant differences between the two arms. Conclusions: Our data indicate that the addition of oxaliplatin does not add to the toxicity of single agent capecitabine as first-line chemotherapy in elderly (age ≥70 years) AGC patients. The accrual is currently ongoing (ClinicalTrials.gov, NCT01470742). Clinical trial information: NCT01470742.

7053 Background: Patients (pts) with resected ES NSCLC are at risk for recurrence of disease and mortality but we do not have tools to predict which pts are at highest risk. Risk models have been p...

10531 Background: IGF-1R and Src-family kinase (SFK) signaling pathways have been implicated in non-small cell lung cancer (NSCLC) and suggested to cooperate for enhanced tumor activities. Here we ...

11085 Background: Mammalian target of rapamycin (mTOR) plays a central role in carcinogenesis by coupling intracellular growth stimuli through tyrosine kinase receptors to cell-cycle progression. AMPK has been proposed to act as a cellular fuel sensor allosterically activated under conditions that decrease the ATP/AMP ratio. AMPK is also regulated by phosphorylation following activation of the upstream serine-threonine kinase LKB1. Besides contributing to energy metabolism control, AMPK has been shown to inhibit cell growth via mTOR suppression, thus suggesting a possible role in carcinogenesis. Methods: We determined the distribution of p-AMPK protein levels in tumor specimens from 277 patients (55% female) with non-small cell lung cancer (NSCLC) [94%] or SCLC [6%], using high throughput Western tissue microarrays, and evaluated its impact on survival. Biomarker expression levels in pre-specified subgroups were compared by Wilcoxon and Kruskal-Wallis tests. Survivals between the groups were compared usin...