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344 Background: Erlotinib is the only targeted agent in combination with gemcitabine showing significantly improved outcomes in pancreatic cancer. Although combining platinum agent with gemcitabine has not provided clear survival benefit over gemcitabine alone, gemcitabine plus platinum resulted in improved response rate and progression-free survival (PFS). We tried to evaluate whether the addition of oxaliplatin to gemcitabine/erlotinib confers a clinical benefit to patients with locally advanced or metastatic pancreatic cancer. Methods: Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T (gemcitabine 1000mg/m2 IV and oxaliplatin 50mg/m2 IV on day 1, 8 plus erlotinib 100mg daily, every 3weeks) or GT (gemcitabine 1000mg/m2 IV on day 1, 8 plus erlotinib 100mg daily, every 3weeks). The primary endpoint was overall response and secondary endpoints included PFS, overall survival (OS) and toxicity. Results: Between May 2013 and April 2016, 65 patients were randomly assigned to treatment group (33 in GEMOX-T arm, 32 in GT arm). The median age of all patients was 61 years (range, 41-76) and about 80% of patients had metastatic disease. The overall response rate was 18.2 % in GEMOX-T arm and 6.2% in GT arm ( P = 0.051). The disease control rate was significantly superior in GEMOX-T arm compared to GT arm (72.7% vs. 43.8%, P = 0.019), with 1 patient in GEMOX-T group continuing the treatment with stable disease. After a median follow up of 19.7 months, there was significant difference in PFS: the median PFS were 3.9 months for GEMOX-T arm and 1.4 months for GT arm (Hazard ratio: 0.58, 95% CI 0.35-0.96, P = 0.037). However, it did not translate to improvement of OS (median OS; 6.2 m for GEMOX-T arm, 5.1 m for GT arm, P = 0.118). The most common grade ≥ 3 hematologic adverse events were neutropenia (16.9%) and anemia (13.8%). Conclusions: The addition of oxaliplatin to 1st line gemcitabine/erlotinib regimen demonstrated higher response rate and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer.

e15731Background: The PRODIGE trials showed superiority of FOLFIRINOX over gemcitabine. However, some of the grade 3/4 toxicity rates that were significantly greater in the FOLFIRINOX group than in...

9605 Background: Dexamethasone has a high therapeutic index for the prevention of chemotherapy-induced nausea and vomiting; however, the chronic use of high-dose glucocorticoids is associated with ...

e15150 Background: Patients with biliary tract cancer have a poor prognosis and the palliative chemotherapy has shown limited efficacy. This phase II study aimed to evaluate the efficacy and safety...

e15260 Background: In a phase III trial, the addition of erlotinib to gemcitabine improved the survival in advanced pancreatic cancer compared with gemcitabine alone. In addition, gemcitabine in co...

e22199 Background: Lymphangiogenesis plays an important role in cancer metastasis. Although animal models show a strong relationship between lymphangiogenesis and lymph node metastasis and survival, the clinical significance of lymphangiogenesis in colorectal cancer (CRC) remains uncertain. The goal of this study was to evaluate the association between c-Met and lymphangiogenic factors and to elucidate their prognostic significance for patients with CRC. Methods: A total of 379 tissue samples were obtained from surgically resected specimens from patients with CRC in Soonchunhyang University Cheonan Hospital between January 2002 and December 2010. The expressions of c-Met, vascular endothelial growth factor (VEGF)-C, VEGF-D, VEGF receptor (VEGFR)-3, and podoplanin were examined by immunohistochemistry. The expression of each marker and clinical factors were analyzed. Results: Three hundred and one of 379 (79.4%) tissues had c-Met expression. High expression of c-Met in tumor cells was significantly associated with high expression of VEGF-C (P < .001) and VEGFR-3 (P = .001). But, there was no statistically significant association with podoplanin (P = .587) and VEGF-D (P = .096). Of the 103 evaluable patients, expression of c-Met in tumor cells was significantly associated with advanced clinical stage (P = .020), positive lymph node status (P = .038), and high expression of VEGF-C (P = .020). But, there was no statistically significant association with podoplanin (P = .518), VEGFR-3 (P = .085), VEGF-D (P = .203), and overall survival (P = .360). Conclusions: Our results provide indirect evidence for an association and possible regulatory link of c-Met with the lymphangiogenic factors. But, c-Met expression in patients with CRC are not prognostic indicator for overall survival in this retrospective study.

11030 Background: The ability to achieve pathologic down staging after neoadjuvant chemoradiotherapy (CRT) is correlated with improved survival. However, there is no effective method of predicting which patients will response to neoadjuvant CRT. Neoadjuvant CRT can change the expression of angiogenic factors. However, little is known about its possible changes in response to preoperative CRT. We examined the expression of angiogenic factors in rectal cancer tissues before preoperative CRT and after surgery. Methods: Fifty five patients with locally advanced rectal cancer were studied. All patients were given preoperative CRT of 5040 cGy for 5-6 weeks with concurrent administration of 5-fluorouracil and leucovorin. Surgical resection was performed 6–8 weeks later in all patients. Immunohistochemical staining for angiogenenic markers (vascular endothelial growth factor [VEGF], placenta growth factor [PLGF], hypoxia inducible factor 1α [HIF 1α], stromal cell derived factor [SDF 1α]) were performed on specimens obtained before preoperative CRT and after surgery. A semiquantitative-immunohistochemical score established from the extension and intensity of the angiogenic factors was used for analysis. Results: The positive expression rate of VEGF, PLGF, SDF 1α, and HIF 1α was 56.4% (31/55), 65.5% (36/55), 70.9% (39/55), and 47.3% (26/55), respectively. The expression rate of VEGF, PLGF, SDF 1α, and HIF 1α was increased by 3.6% (2/55), 7.3% (4/55), 30.9% (17/55), and 1.8% (1/55) after neoadjuvant CRT, respectively. Expression of VEGF, PLGF, and HIF 1α protein was downregulated after neoadjuvant CRT in the rectal cancer tissues (P < 0.001, P = 0.001, P = 0.044, respectively). However, SDF 1α was upregulated after neoadjuvant CRT (P < 0.001). And also, upregulated expression of SDF 1α after neoadjuvant CRT was significantly associated with resistance to CRT (P = 0.035). However, SDF 1α showed no correlation with other clinical factors (age, sex, clinical stage). Conclusions: Expression of SDF-1α was increased in the rectal cancer tissue after neoadjuvant CRT, as well as has been associated with CRT resistance. Our data suggests that SDF 1α should be evaluated as new target for antiangiogenic therapy.

e19554 Background: Palonosetron(PAL) is a 5-HT3 antagonist with an approximately 100-fold higher binding affinity for the 5-HT3 receptor compared to the other serotonic antagonists(i.e., ondansetron, granisetron, and dolasetron). Several large phase III trials have demonstrated the superiority of palonosetron compared with other 5-HT3 antagonists in preventing emesis associated with both moderate and high emetic risk chemotherapy regimens. But, these studies carried out in the pre-aprepitant era. We assessed that PAL is still preferred over the other serotonin inhibitors for high emetic risk chemotherapy in the post-aprepitant era. Methods: A retrospective analysis was made of all patients who underwent serotonin inhibitor, aprepitant and dexamethaxone for high emetic risk chemotherapy between 2009 and 2011. Group A received PAL, aprepitant and dexamethaxone. Group B received first-generation serotonin inhibitors(ondansetron, granisetron or dolasetron), aprepitant and dexamethaxone. Results: Four hundred fourty patients were included in the analyses: 331 patients in the Group A and 109 patients in the Group B. No case of grade 3-4 nausea/vomiting was noted. There were no significant differences between Group A and Group B for both acute and delayed CINV. The proportion of patients with a emesis-free during the acute phase(0-24 h) was similar in both groups: 275 of 331 patients(83%) in the Group A vs 88 of 109 patients(81%) in the Group B. The proportion of patients with a emesis-free during the delayed phase(24-120h) was similar in both groups: 255 of 331(77%) vs 76 of 109 (70%). Conclusions: In aprepitant era, all of the serotonin inhibitors seems to be equally effective for high emetic risk chemotherapy.

e14688 Background: There is no evidence that second-line chemotherapy in advanced biliary tract cancer (BTC) will result in substantial prolongation of survival. The purpose of this study was to evaluate prognostic factors for the survival of patients with advanced biliary tract cancer who was refractory BTC for first-line chemotherapy. Methods: We reviewed 89 patients retrospecitively with advanced biliary tract cancer who had enrolled in two clinical trials at three branches of Soonchunhyang university hospital. They received palliative chemotherapy with 2 regimens (biweekly GEMOX and modified FOLFOX-6). GEMOX is consist of gemcitabine 1,000 mg/m2 intravenously on day 1 and oxaliplatin 85 mg/m2 intravenously on day 2 every 2 weeks and mFOLFOX-6 is that oxaliplatin 85mg/m2 and folinic acid 400 mg/m2 on day 1 follwed by a 5-FU bolus 400 mg/m2 and 46-h infusion 2400 mg/m2 every 2 weeks. To evaluate the clinicopathologic factors that affected overall survival, univariate and multivariate analyses were performed on the baseline factors. Results: 89 patients were enrolled from Sep 2006 to Aug 2010. Medain age was 62.14 years (range 35-81). Univariate analysis revealed 4 prognostic factors affecting overall survival after first-line chemotherapy. Performance status of 0-1 vs >2 (p=0.014), salvage chemotherapy (p=0.021), locoregional disease vs disseminated disease (p=0.046) and responder of first-line chemotherapy (p=0.025) was revealed. Multivariate analysis found 2 prognostic factors affecting overall survival. They were salvage chemotherapy and initial responder. Conclusions: This results suggest that 2nd-line chemotherapy is needed for patients with good performance and responder of initial chemotherapy.

e19538 Background: It is clinical experience that end-of-dose failure was commonly observed and many cancer patients increase the frequency of opioid administration because of that. Another treatment option could be to increase the dose of the opioid administered. High-dose fentanyl matrix use is known to be effective in controlling pain in cancer patients. To measure effectiveness of increase in single dose of fentanyl matrix in patients whose pain was not controlled sufficiently with the analgesic use in real practice at the investigator’s discretion, we perform the study. Methods: A multi-center, open-label, prospective, observational study was conducted in 30 hospitals in Korea between August and December 2008. Results: 452 patients were enrolled. A total 404 patients completed the study. Mean pain intensity decresed from 5.27 on the second to 3.37 at the end of the trial. There was significant difference in pain intensity (p < 0.001) between first and last visit. The percentage of pain intensity difference was 30.1%. The prevalence of end-of-dose-failure (EOD) at visit 1 was 73% of the enrolled 452 patients. After the use of the fentanyl patch EOD decreased from 73% to 56%. Pain intensity of patients experiencing EOD was 5.64 at baseline compared to 4.27 in patients without EOD. On Visit 2, pain intensity in patienst with and without EOD was 4.02 and 2.54. Of enrolled 404 patients, mean of increasing dose of fentanyl matrix was 55.6mcg/day. Satisfaction rate of investigator’s global assessment was 66.0%, and that of the patients’ global assessment was 63%. The rate of pain improvement was 33.7% by Clinical Global Improvement- Improvement after the use of the fentanyl patch. The observed adverse events were mainly nausea, asthenia, constipation and diarrhea. Conclusions: This study demonstrated that increasing dose of fentanyl patch decreased pain intensity, and decreased the rate of patients experiencing EOD. Also satisfaction rate was increasing after use fentanyl patch. Thus, fentanyl patch may be effective in cancer patients whose pain was previously not controlled sufficiently or who experienced EOD, the side effects were as could be expected with an opioid.

7071 Background: Integrin β1 mediates cellular adhesion to the extracellular matrix and is correlated with highly invasive and metastatic behavior in small cell lung cancer (SCLC). E-cadherin (ECAD...

10063 Background: Previous Asian studies in small scale suggested that imatinib efficacy might not be different by genotypes of tumor in Asian patients unlike the Western studies. This study was pe...

4106 Background: There is no standard palliative chemotherapy regimen in biliary tract cancers (BTC). Fluoropyrimidine or gemcitabine, with or without platinum, are most frequently used. The purpos...

e14532 Background: Gastric cancer is also the most common cancer and the second leading cause of death in South Korea. Acute Disseminated intravascular coagulation (DIC) which manifests as a consumptive coagulopathy with severe bleeding, is a rare but severe complication of cancers. But, Advanced gastric cancer (AGC) appears to be one of the cancers which are most frequently associated with DIC. The treatment of cancer-related acute DIC is difficult and most patients die within 1–4 weeks. The key of treatment is the control of the underlying cancers. Effective chemotherapy of the underlying malignancy may be the only way to control acute DIC. We assessed the effect of chemotherapy agents as the primary treatment of AGC with DIC. Methods: Thirty-six patients with histologically proven gastric adenocarcinoma presented with DIC who be treated with chemotheraphy were enrolled for this study from December 1994 to April 2010. DIC was confirmed by Scoring system by Japanese Association for Acute Medicine criteri...

6563 Background: Several studies showed that a higher CR rate and longer CR duration could be achieved when imatinib was added to the combination chemotherapy for Ph+ALL. Optimum use of imatinib in...

7035 Background: Given the cytostatic nature of molecular targeted agents, the response to targeted agents might be inadequately assessed by traditional size-based radiologic criteria. We devised novel CT response criteria in consideration of tumor constituents (solid and ground-glass opacity [GGO] components), the presence of cavitation, and attenuation changes within target lesions during treatment, and evaluated the efficacy of the criteria for stratifying patient response and for predicting patient prognosis as compared with that of the RECIST 1.1 in patients treated with EGFR TKIs. Methods: Eighty NSCLC patients who were enrolled prospective clinical trial and treated with EGFR TKIs were analyzed. Tumor response was assessed by using both RECIST 1.1 and new criteria and compared between two criteria. To evaluate the ability of RECIST 1.1 and new criteria in predicting patients' prognosis, overall survival (OS) were compared between responders by using a log-rank test. The interobserver agreement betw...

6589 Background: Although daunorubicin (D) has been used as major part of induction treatment for adult acute lymphoblastic leukemia (ALL), its specific role is difficult to understand. The reason ...

e14646 Background: Oxaliplatin has shown considerable activity and synergism with 5-fluorouracil (5-FU) in several phase II studies for treating advanced gastric cancer. We retrospectively determin...

3617 Background: Adjuvant chemotherapy using 5-FU/leucovorin/oxaliplatin (FOLFOX-4) is the standard of care in curatively resected high-risk stage II and stage III colon cancer. Previous reports su...

6612 Background: Clinical trials, which were mostly performed in the Western countries, have demonstrated the effectiveness of decitabine in the treatment of myelodysplastic syndrome (MDS). This st...

e19566 Background: A majority of patients with cancer experience cancer pain of higher than moderate severity during the progression of cancer. Of these, 2/3 of patients with cancer have been repor...

10573 Background: Growing tumors adapt to a hypoxic environment and increase anaerobic glycolysis. This metabolic switch is related to resistance of radiotherapy and chemotherapy. We investigate th...

e19562 Background: There are few prospective evaluation of toxicity and functional consequence of systemic chemotherapy in the elderly cancer patients, especially in Asian population. Methods: We p...

e14507 Background: There is no standard palliative chemotherapy regimen in biliary tract cancers (BTC). Fluoropyrimidine or gemcitabine, with or without platinum, are most frequently used. The purp...

10558 Background: Previous studies suggested the role of KIT and PDGFRAmutations on treatment outcome of GIST with IMT, but results are heterogeneous. IHC value of PDGFRA and PDGFRB is not established. Methods: We included patients (pts) treated with IMT as a first line therapy for metastastic or relapsed GIST between 2001 and 2008. Tumor DNA was extracted to investigate the mutation status of KITexon 9, exon 11, PDGFRA exon 12 and 18. IHC stain of c-KIT and PDGFRA/B was performed. We assessed the correlation between the treatment outcome, genetic status and IHC results. Results: A total of 85 pts (M:F=49:36, median age 58.4 years) received IMT 400 mg daily. Location of primary disease included stomach (33), small bowel (34), rectum (10), esophagus (1), and omentum/mesentery (7). Complete and partial responses were achieved in 6% and 62% of pts respectively, while 5% of pts had progressive disease. During median follow up of 28.1 months, estimated median PFS was 39.8 months. KIT exon 11 and 9 mutations were detected in 64% and 5% respectively. Exon 11 mutations included 44 deletions, 2 insertions, 5 substitutions and 3 deletion/insertions. PDGFRA exon 12 and 18 mutations were detected in 2% respectively. Positive rate of c-KIT, PDGFRA and PDGFRB using IHC was 96%, 21%, and 26% respectively. PDGFRA and PDGFRB were co-expressed (p=0.001). PDGFRA mutation did not correlate with PDGFRA/B expression. Clinical response was not different according to the mutation status or IHC expression. PFS of KIT exon 11, KITexon 9, PDGFRA mutants and pts without detectable mutations were not different (p=0.397). Pts with KIT exon 11 balanced mutations (substitution or deletion/insertion) showed longer PFS compared with pts with unbalanced mutations (deletion or insertion) (p=0.014) or pts without exon 11 mutations (p=0.033). Median PFS was shorter in pts lacking c-KIT (p=0.001) expression. PDGFRA/B expression did not influence PFS. Conclusions: Balanced mutation of KIT exon 11 predicted longer PFS, while lack of c-KIT protein expression predicted shorter PFS for GIST pts treated with first line IMT. PDGFRA and B were co-expressed without predictive value. No significant financial relationships to disclose.

e15581 Background: Biliary cancer is diagnosed at advanced stage and recurrence is common after surgical resection. Gemcitabine and UFT combination chemotherapy showed promising results in advanced pancreatic cancer(APC) and fixed dose- rate(FDR) infusion(10mg/m2/min) of gemcitabine is more effective than 30min-infusion in APC patients. We conducted a prospective multicenter phase II study to evaluate the efficacy and toxicity of FDR gemcitabine and UFT combination chemotherapy in advanced biliary cancer(ABC) patients. We evaluated the quality of life(QOL) and relationship between treatment outcome and polymorphisms of DNA repair gene such as RecQ1, RAD54L, XRCC1 and ATM. Methods: We included the chemo-naive patients with measurable metastatic or recurrent biliary adenocarcinoma except gall bladder cancer. Patients received gemcitabine infusion of rate of 10mg/m2/min on day 1, 8, and 15 plus oral UFT (400mg/m2) on day 1 to 21. We used modified PCR-RFLP method to evaluate the polymorphism of DNA repair gene. The primary endpoint was response rate. Results: From October 2006 to March 2008, 47 patients were enrolled and 33 of them were included in this analysis. Median age was 58 years(range 33–73 years) and 18 patients were male. Partial response was 24.2% and disease control rate was 51.5%. The estimated median time to progression(TTP) was 87 days(95% CI 51–123). Median overall survival was 243 days(95% CI 114–372). Grade 3/4 neutropenia was observed in 12 of 33 patients(36.4%) and 17 times of 114 cycles of chemotherapy(14.9%). No febrile neutropenia was observed. Grade 3/4 thrombocytopenia occurred in 5 patients(15.2%). Non-hematologic toxicities were mild. Polymorphism of XRCC1 was related to TTP(TTP of wild, heterozygous variant and homozygous variant type was 162, 71 and 25 days, respectively. p=0.0039). QOL as a secondary endpoint was not analyzed at this time. Conclusions: FDR infusion of gemcitabine and UFT combination chemotherapy in chemo-naïve patients with ABC is a well-tolerated and effective regimen. No significant financial relationships to disclose.

15603 Background: A rising of carcinoembryonic antigen (CEA) or carbohydrate antigen 19–9 (CA19–9) after chemotherapy is generally considered as tumor progression in patients with solid tumors. How...

15536 Background: The prognosis for patients with inoperable biliary tract cancer (BTC) is poor and many patients are candidates for palliative systemic chemotherapy. However, the role of systemic ...

15520 Background: The studies on the efficacy of docetaxel and cisplatin in esophageal cancer, especially squamous cell carcinoma in histology, which is the predominant type of esophageal cancer in...

15618 Background: Gemcitabine is the only drug approved for use as a single-agent therapy in advanced pancreatic carcinoma (APC). However, gemcitabine-based combination chemotherapy still has not s...

17061 Background: The aim of this study was to explore the use of complementary and alternative medicine (CAM) in cancer patients of Korea. This study was performed to identify the prevalence, types, subjective effects, and side effects of CAM use, reasons for CAM use, and patients' expectations of doctors regarding their CAM use among Korean cancer patients. Methods: From August to December, 2006, face to face structured interviews were conducted and the data were analyzed in the KCSG. Results: A total 251 patients were recruited. 84% of patients had used at least one type of CAM since the time of initial diagnosis. The most prevalent types of CAM used by these patients included special diet (60%), ginseong (54%), medicinal mushrooms (50%). Energy therapies, acupuncture and spiritual therapy were used uncommonly. The main reported reason for the use of CAM was to feel hopeful. Patients expected that CAM could cure cancer (64%) and improve immune system (52%). 62 % of patients did not inform their physicians about their CAM use. Patients attributed the reason of nondisclosure that physicians never asked about CAM (43%) and physicians would disapprove the CAM use (23%). 6% of CAM users experienced side effects. Demographic variables were not predictive for the use of CAM. 60% of patients wanted to get more information about CAM with their doctors. Conclusions: More than two-thirds of cancer patients used various kinds of CAM. Physicians treating cancer patients should aware of the frequency of CAM use and should share their opinion about CAM use with cancer patients. In order to help patients make informed decisions, physician should pay more attention to CAM for making appropriate utilization of CAM. No significant financial relationships to disclose.

15026 Background: The present study was conducted to evaluate the efficacy and safety of a combination regimen of docetaxel plus oxaliplatin in patients with advanced gastric cancer. Methods: Patients with previously untreated metastatic or recurrent, measurable gastric cancer received intravenous docetaxel 65 mg/m2 plus oxaliplatin (Oxalpla®, Yuhan.Co. Seoul, Korea) 120 mg/m2 on days 1 in a 3-week cycle. Treatment was continued until disease progression, patient refusal, or an unacceptable toxicity up to 9 cycles. Results: Forty-two patients were enrolled in the current study. Of these, 39 were assessable for efficacy and 41 assessable for toxicity. Seventeen partial responses were confirmed, giving an overall response rate of 40.5% (95% CI: 26.0% to 54.1%, intention-to-treat analysis). At a median follow-up of 160.5 days, the median time to progression was 6.1 months, whereas median overall survival was not reached yet. Grade 3/4 neutropenia occurred in 10 patients, plus febrile neutropenia was observed in 3 patients. Most common non-hamatologic toxicity was nausea (grade 1/2 56.9%). There were two treatment-related deaths. Conclusions: Docetaxel and oxaliplatin combination was found to be well-tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as an important first-line treatment option for advanced gastric cancer. No significant financial relationships to disclose.

14599 Background: We prospectively conducted a phase II trial to test the efficacy and safety of irinotecan, 5-fluorouracil and leucovorin (FOLFIRI) regimens for the first-line treatment of previously untreated patients with recurrent or metastatic advanced CRC. Methods: Thirty-four previously untreated patients with advanced CRC were enrolled in this study from June 2001 to December 2006. Eligible patients had histologically confirmed adenocarcinoma, no prior systemic therapy in palliative setting, ECOG PS = 2, adequate organ function, written informed consent and at least one measurable disease. The patients received either irinotecan 180 mg/m2 on day 1 with a LV bolus of 200 mg/m2 and a FU bolus of 400 mg/m2, and this was followed by a FU continuous infusion of 600 mg/m2 on day 1 and day 2 (the classic FOLFIRI regimen), or they were treated with a LV bolus of 400 mg/m2 and a FU bolus of 400 mg/m2 followed by a FU continuous infusion of 2,400 mg/m2 for 46 hours (the simplified FOLFIRI regimen), and these treatments were repeated every 2 weeks until disease progression. Results: There were 13 females and 21 males with median age of 54 years (range: 41–79). The most common metastatic sites were lung and liver. A total of 262 cycles were administrated with median 6 cycles per patient (range: 1–22). All pts were evaluable for toxicity, and 30 pts for response to the treatment. The objective response rate was 26.4% with 2 complete responses respectively. Sixteen (47%) pts had stable disease and 7 (20.5%) had a progression. The tumor control rate was 73.4%. The median TTP was 5.3 months, and the overall survival was 10.1 months. The prognostic factor for longer TTP and survival was the ECOG performance status (PS). The type of regimens was not affected on response rate, TTP and survival. The chemotherapy was generally well tolerated and the most common grade 3–4 toxicities were neutropenia, diarrhea. The non- hematological toxicities were similar for both treatment groups, with more frequent grade =3 neutropenia being noted for the simplified FOLFIRI regimen. Conclusions: The FOLFIRI regimen was demonstrated to have a moderate antitumor activity with acceptable toxicity profiles, and tend to show more favorable outcome for patients with good ECOG PS. No significant financial relationships to disclose.

16010 Background: We conducted this prospective study to determine the treatment preference of patients receiving chemotherapy in a palliative setting. We investigated the survival threshold for justifying toxicity, the factors influencing individual preference for chemotherapy, and the attitude of patients towards randomized trials. Methods: 138 patients (median age, 58 years; 73% male) with advanced cancer who had received at least one cycle of palliative chemotherapy were recruited. General demographic information, patient preferences for palliative chemotherapy, and randomized trials were determined using structured patient interviews. Results: The median age was 58 years (range, 25–77 years), and the majority of the study population were male (73%). 73 patients (60.1%) answered that they had some support by dependents. Fewer than half were given information about the impact of their chemotherapy on survival (n = 64, 48.1%), and just over one third of patients (n = 53, 40.5%) were presented with an alternative to anticancer therapy, such as supportive care (p < 0.001). While 75.7% of patients agreed to receive chemotherapy with mild toxicity, only 57.9% of patients agreed to chemotherapy with severe toxicity (p = 0.002). The median survival threshold was 12 months for mild toxicity, and 21 months for severe toxicity. Patients who experienced improvement of symptoms or quality of life were more likely to judge the treatment as acceptable. 105 patients (78.4%) refused a clinical trial with randomization between a conventional chemotherapy and supportive care. There were 85 patients (62.6%) that would refuse randomization between conventional chemotherapy and investigational chemotherapy. Finally, 58.6% of patients agreed to participate in trials with investigational agents. Conclusions: In the palliative setting, a discussion of prognosis and the merits of chemotherapy is a necessary part of the treatment decision-making processes, and choosing the proper treatment for cancer patients. Individual preferences assume greater importance in this setting. Randomized trials must be carefully designed with a priori equipoise. No significant financial relationships to disclose.

17049 Background: Genexol is a polymeric micelle loaded paclitaxel without Cremophor EL (CrEL). CrEL has been shown to cause hypersentivity reaction and neuropathy. To evaluate and efficacy, we conducted a phase II study of CrEL-free paclitaxel (genexol) and carboplatin in patients (pts) of advanced or metastatic NSCLC. Methods: Eligibility criteria included: stage IIIB or IV NSCLC without previous chemotherapy and radiotherapy; written informed consent; measurable lesion; age 18–75; ECOG PS 0–3; adequate bone marrow, liver, and renal function; and no CNS disease. The patients received genexol 225 mg/m2 IV on day 1, followed by carboplatin AUC = 6 IV on day 1 every 3 weeks. Primary end points are response and toxicity. Response evaluations were performed after cycles 2, 4, and 6 of chemotherapy according to the RECIST criteria. Results: 36 pts were enrolled between November 2002 and November 2005. Pts characteristics: median age 63 years (range 45–73), median ECOG PS 1 (range 0–3), 13 stage IIIB and 23 IV, 21 adenocarcinoma and 14 squamous cell carcinoma, and 1 large cell carcinoma. At present, 30 pts were evaluable for response and toxicity. Meidan number of treatment cycles was 4 (range 1–6). Seven pts needed dose reduction. Thirteen pts achieved partial response and 13 pts had stable disease. The response rate 43.3%. Grade (gr) 4 neutropenia occurred in 11 pts (36.7%). Gr 1/2 sensory neuropathy occurred in 13 pts (43.3%) and gr 3/4 sensory neuropathy occurred in 5 pts (50%) among 10 pts over 65 year old. Other toxicities included neutropenic fever in 9 pts (30%), gr 4 thrombocytopenia 3 patients (10%), gr 2 hepatic dysfunction 3%, and gr 3 fatigue 10%. Treatment related mortality was not occurred. Complete analysis will be presented. Conclusions: In this trial, the combination of genexol and carboplatin showed a significant activity with acceptable and manageable toxicities as first line treatment for patients with advanced or metastatic NSCLC and dose reduction needed in older patients. No significant financial relationships to disclose.

5549 Background: With the improvement seen with CCRT in the management of locoregionally advanced HNSCC, distant failures have become a more relevant problem in terms of survival. As a consequence, more effective strategies including consolidation chemotherapy are warranted. The primary objective of this pilot phase II study was to assess the feasibility and efficacy of docetaxel and cisplatin consolidation following primary CCRT for HNSCC. Methods: Thirty-three patients with previously untreated, stage III/IV HNSCC participated in this study. CCRT consisted of cisplatin 100 mg/m2 on day 1, 22 and 43. Concurrent radiotherapy (70 Gy) to the primary tumor and neck was performed over a period of 7 weeks. After completion of CCRT, patients with no evidence of disease progression received an additional 4 cycles of consolidation chemotherapy with docetaxel 75 mg/m2 and cisplatin 75 mg/m2 every 3 weeks. To minimize the expected accrual into unacceptable treatment, either in terms of clinical response or toxicity, a total of 35 patients would be required in a two-stage design. Results: Baseline characteristics were: male (22), median age (60 years), ECOG performance status 0/1 (15/18), stage III/IV (10/23). Of these, 27 (81%) patients completed CCRT. After CCRT, 3 complete and 19 partial responses were recorded, giving an overall response rate of 67% (95% CI, 51–83%). Of the 19 patients who went to consolidation phase, only 4 (21%) completed all 4 cycles of docetaxel and cisplatin. Failure to consolidation chemotherapy was attributed to the following causes: toxicity (11 including 3 treatment-related deaths), disease progression (4). During consolidation chemotherapy, 13 patients (68%) had grade 3/4 neutropenia and febrile neutropenia occurred in 6 (32%). With consolidation chemotherapy, one patient with initial stable disease achieved a partial response. Median survival in all patients was 11.0 months, and 8.3 months for those treated with consolidation chemotherapy. Conclusions: The poor compliance and the high incidence of severe toxicities, including 3 treatment-related deaths, prompted no further evaluation of this consolidation chemotherapy following CCRT. No significant financial relationships to disclose.

4200 Background: The expression of E-Cadherin(ECD) and Urokinase Plasminogen activator(uPA) has been noted as makers for tumor metastasis and prognosis in several tumors, so we investigated the rel...

3774 Background: This phase II study evaluated the efficacy and safety of a combination of oxaliplatin and UFT/oral leucovorin in Korean Patients with advanced colorectal cancer (ACC) previously treated with a fluorouracil-based regimen. Methods: From December 1998 to December 2001, 28 patients [male : female 12:16, median age 61 (range 37–71)] with measurable disease and Easter Cooperative Oncolgy Group performance status of 0–2 were treated with a combination of oxaliplatin (130 mg/m2 i.v. for 2 hours) on day 1, UFT (300 mg/m2 p.o.) and 5-FU (20mg/m2 p.o.) on day 1–21, every 3 weeks. Results: 10 out of 28 evaluable patients achieved complete (n=3) or partial (n=7) response, leading to an overall response rate of 35.7%. The estimated median time to progression and survival were 5.5 months and 8.5 months respectively. From the 129 cycles analyzed, sensory neuropathy was the most common toxicity (73%), grade 3,4 hematologic toxicities included neutropenia 1.5%, and thrombocytopenia 1.5%, other toxicities w...