Lifestyle, body mass index, diabetes, and the risk of pancreatic cancer in a nationwide population-based cohort study with 7.4 million Korean subjects.

BACKGROUND: Large-scale epidemiological studies on pancreatic cancer in non-Western populations are insufficient. We investigated the risk factors for pancreatic cancer. METHODS: Using the Korean National Health Insurance database, subjects who participated in the health examination program between 2005 and 2006 were identified and followed up until 2017. Adjusted hazard ratios (HRs) for pancreatic cancer risk were estimated using a Cox proportional hazards model. RESULTS: During 11.5 years follow-up, 22,543 of 7,445,947 participants were newly diagnosed with pancreatic cancer. Compared with normal-weight subjects, pancreatic cancer risk was increased in those with severe obesity (BMI ≥ 28 kg/m2) (HR = 1.16; 95% CI, 1.11-1.23). Subjects with diabetes had an increased risk compared with those without diabetes (HR = 1.48; 95% CI, 1.43-1.53). Current smokers had a higher risk than never smokers (HR = 1.43; 95% CI, 1.38-1.48). Current smoking combined with diabetes increased the risk compared with never smokers without diabetes (HR = 2.13; 95% CI, 2.00-2.28). Current smoking combined with BMI ≥ 25 kg/m2 had an increased risk compared with never smokers with BMI < 23 kg/m2 (HR = 1.55; 95% CI, 1.46-1.65). CONCLUSION: Smoking, obesity, and diabetes are significant risk factors for pancreatic cancer in Koreans. Lifestyle modifications for smoking and obesity would be beneficial for pancreatic cancer prevention.

Carbohydrate antigen 19-9 elevation without evidence of malignant or pancreatobiliary diseases.

Although carbohydrate antigen 19-9 (CA 19-9) may be elevated in benign diseases, elevated CA 19-9 may cause a fear of cancer and unnecessary follow-up studies. Research on how to approach systematically in this case is very limited. The purpose of this study was to analyze the clinical features and the causes of CA 19-9 elevation without evidence of malignant or pancreatobiliary diseases. We retrospectively reviewed the medical records of patients who had CA 19-9 elevation (≥80 U/mL) and were found to be unrelated to cancer after follow-up. After exclusion, 192 patients were included in this study. The median level of CA 19-9 was 136.5 U/mL. The causes of CA 19-9 elevation were determined in 147 (76.6%) patients, and that was unknown in 45 (23.4%). The estimated causative diseases were hepatic diseases in 63 patients, pulmonary diseases in 32, gynecologic diseases in 38, endocrine diseases in 13, and spleen disease in 1. Of 45 patients with unknown cause, 35 had normalization of CA 19-9 and 10 had persistently elevated CA 19-9. In conclusion, CA 19-9 elevation without malignancies or pancreatobiliary diseases should be systematically evaluated and followed up. We suggest an algorithm to investigate the causes and follow up these patients.

Clinical Value of Contrast-Enhanced Harmonic Endoscopic Ultrasonography in the Differential Diagnosis of Pancreatic and Gallbladder Masses.

BACKGROUND/AIMS: Recent studies have revealed that contrast-enhanced harmonic endoscopic ultrasonography (CEH-EUS) is beneficial in the differential diagnosis of malignant neoplasms of the pancreas and gallbladder from benign masses, in terms of the evaluation of microvasculature and real-time perfusion. In this study, we aimed to prove the clinical value of CEH-EUS in the differential diagnosis of pancreatic and gallbladder masses by direct comparison with that of conventional EUS. METHODS: We reviewed the sonographic images and medical information of 471 patients who underwent conventional EUS and CEH-EUS for the diagnosis of pancreatic and gallbladder masses at a single medical center (Severance Hospital, Seoul, Korea) between March 2010 and March 2016. RESULTS: The enhancement pattern of CEH-EUS of the pancreatic solid masses showed higher sensitivity and specificity in differentiating pancreatic adenocarcinoma and neuroendocrine tumors (82.0% and 87.9% for pancreatic adenocarcinoma and 81.1% and 90.9% for neuroendocrine tumors, respectively), and the area under the receiver operating characteristic curves was higher than that of conventional EUS. The enhancement texture of CEH-EUS of the gallbladder masses showed a higher sensitivity in differentiating malignant masses than that of conventional EUS; however, the difference between the areas under the receiver operating characteristic curves was not statistically significant. CONCLUSIONS: CEH-EUS can complement conventional EUS in the diagnosis of pancreatic and gallbladder masses, in terms of the limitations of the latter.

Assessment of the Risk of Colorectal Cancer Survivors Developing a Second Primary Pancreatic Cancer.

BACKGROUND/AIMS: We aimed to investigate the incidence of second primary pancreatic cancer (PC) after colorectal cancer (CRC) and to identify risk factors associated with subsequent PC. METHODS: The observed incidence of a subsequent PC in patients with CRC was standardized using a population with CRC from the Korean Central Cancer Registry (KCCR). The expected incidence rate of PC was obtained by assuming that the select group experienced the same cancer incidence as the corresponding general population in the KCCR. RESULTS: The registry included 4,822 patients with CRC aged 45 to 74 years, representing 16,725.1 person-years of follow-up. Thirteen patients (0.3%) were diagnosed with a subsequent PC, and the overall age-adjusted incidence of second primary PC was 269.6 per 100,000 cases. In contrast, the overall incidence of primary PC in the general population was 18.68 per 100,000 individuals. The standardized incidence ratio of subsequent PC was 14.44, which was significantly higher in patients with CRC than in the general population. Sex, diabetes mellitus, smoking, body mass index, and a history of receiving chemotherapy as a treatment for CRC did not increase the risk of subsequent development of PC. CONCLUSIONS: The risk of a second primary PC was higher in patients with CRC. Further studies are needed to identify the risk factors and generate a screening strategy for cancer survivors.

Clinical characteristics of second primary pancreatic cancer.

PURPOSE: Several studies reported the increased risk of second primary pancreatic ductal adenocarcinoma (2nd PDAC) in cancer survivors. However, data on the characteristics of 2nd PDAC are insufficient. METHODS: This retrospective cohort study included 1759 patients with PDAC. They were classified as having 2nd PDAC or first primary PDAC (1st PDAC) according to a prior diagnosed cancer of different origin, at least 6 months before PDAC diagnosis. RESULTS: There were 110 patients (6.4%) with 2nd PDAC and 1606 (93.6%) patients with 1st PDAC. Patients with 2nd PDAC presented with older age (66.5 vs. 62.2 years, p < 0.001) and higher rate of resectability (26.4% vs. 15.9%, p = 0.004) at diagnosis than those with 1st PDAC. Multivariate analysis without considering resectable status showed that 2nd PDAC (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.56-0.94, p = 0.016) was associated with better overall survival. After adjusting for resectable status, however, 2nd PDAC (HR 0.85, 95% CI 0.66-1.09, p = 0.198) was no longer associated with overall survival. When subgroups were separately analyzed according to initial treatment modality, the effectiveness of surgery and chemotherapy were similar between 2nd and 1st PDAC (33.1 vs. 28.5 months, p = 0.860 and 10.8 vs. 10.7 months, p = 0.952). CONCLUSIONS: The proportion of resectable cases was significantly higher in 2nd PDAC. When surgery with curative aim was possible, the overall survival was increased even in patients with 2nd PDAC. These results suggest the importance of screening for second primary cancer in cancer survivors.

Efficacy and treatment-related adverse events of gemcitabine plus nab-paclitaxel for treatment of metastatic pancreatic cancer "in a Korean" population: A single-center cohort study.

Pancreatic cancer has poor prognosis because of its rapid progression and treatment resistance. Based on the results of the Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT), a combination regimen of gemcitabine with nab-paclitaxel is currently used as standard therapy for the treatment of metastatic pancreatic cancer. However, because studies in Asian populations are lacking, we investigated the treatment efficacy and safety of this combination therapy in Korean population. Patients with metastatic pancreatic cancer (n=81) treated with gemcitabine and nab-paclitaxel (1,000 and 125 mg/m2, respectively) as the first-line chemotherapy from January 2016 were identified using the Severance Hospital Pancreatic Cancer Cohort Registry. Treatment efficacy and treatment-related adverse events (AEs) were analyzed. The median follow-up period was 10.7 months (range, 1.5-23.3 months). Median overall survival, progression-free survival, and objective response rates were 12.1 months (95% confidence interval [CI], 10.7-not estimable), 8.4 months (95% CI, 5.0-11.8), and 46.9%, respectively. The incidence of grade ≥3 neurotoxicity and neutropenia were 18.5% and 46.9%, respectively. Febrile neutropenia and grade ≥3 gastrointestinal AEs occurred in 13 (16.0%) and 16 (19.8%) patients, respectively. Dose reductions because of AEs were required in 60.5% of patients. The combination of gemcitabine with nab-paclitaxel is an effective anti-cancer regimen in Korean population of patients with metastatic pancreatic adenocarcinoma. However, careful monitoring and management are required because of occurrence of treatment-related AEs.

Best options for preoperative biliary drainage in patients with Klatskin tumors.

Operative treatment combined with PBD has been established as a safe management strategy for Klatskin tumors. However, controversy exists regarding the preferred technique for PBD among percutaneous transhepatic biliary drainage (PTBD), endoscopic biliary stenting (EBS), and endoscopic nasobiliary drainage (ENBD). This study aimed to identify the best technique for preoperative biliary drainage (PBD) in Klatskin tumor patients. METHODS: This study evaluated 98 Klatskin tumor patients who underwent PBD prior to operation with a curative aim between 2005 and 2012. The PTBD, EBS, and ENBD groups included 43, 42, and 13 patients, respectively. Baseline characteristics, technical success rate, complications of PBD, and surgical outcomes were compared. RESULTS: Initial technical success rates (97.3 %, PTBD; 90.2 %, endoscopic methods, including EBS and ENBD) and mean duration until biliary decompression (31.0, PTBD; 28.7, EBS; 35.8 days, ENBD) were not significantly different between the groups. Total frequency of complications did not significantly differ between the EBS group (42.9 %) and the PTBD (27.9 %, p = 0.149) and ENBD (15.4 %, p = 0.072) groups. The ENBD group showed a significantly higher rate of conversion to other methods (76.9 %) than the PTBD (4.7 %, p < 0.0001) and EBS (35.7 %, p = 0.009) groups. CONCLUSIONS: PTBD, EBS, and ENBD showed comparable results regarding initial technical success rates, complication rates, and surgical outcomes. As Klatskin tumor patients must undergo PBD prior to 3 weeks before surgery, PTBD and ENBD are uncomfortable and disadvantageous in terms of compliance. EBS was the most suitable method for initial PBD in terms of compliance among Klatskin tumor patients.

The Significance of the Prognostic Nutritional Index for All Stages of Pancreatic Cancer.

Nutritional status affects the prognosis of various tumors. The prognostic nutritional index (PNI) is the known predictor of postoperative outcome in resectable pancreatic cancer patients. This study aimed to validate the prognostic value of PNI in all stages of pancreatic cancer. We retrospectively reviewed 499 patients with pancreatic cancer who were diagnosed at Severance Hospital between January 2006 and December 2011. The PNI value was calculated as 10 × serum albumin (g/dL) + 0.005 × total lymphocyte count (/mm3) at initial diagnosis. The median patient age was 62 yr, and 289 were men. The study group comprised resectable disease (n = 121), locally advanced disease (n = 118), and metastatic disease (n = 260). Univariate and multivariate analysis revealed that PNI ≤ 49.5 at initial diagnosis, together with performance status, platelet count, and clinical stage, was significantly associated with overall survival (hazard ratio, 1.562; all P < 0.05). Patients with PNI ≤ 49.5 (n = 208) had shorter median overall survival compared to patients with high PNI (9.8 vs. 14.2 mo; log rank, P < 0.001). In clinical stage subgroup analysis, initial PNI ≤49.5 independently predicted shorter overall survival, especially in resectable and metastatic disease (P = 0.041, P = 0.002, respectively).

Concomitant Statin Use Has a Favorable Effect on Gemcitabine-Erlotinib Combination Chemotherapy for Advanced Pancreatic Cancer.

PURPOSE: Erlotinib-gemcitabine combined chemotherapy is considered as the standard treatment for unresectable pancreatic cancer. This study aimed to determine the clinical factors associated with response to this treatment. MATERIALS AND METHODS: This retrospective study included 180 patients with unresectable pancreatic cancer who received ≥2 cycles of gemcitabine-erlotinib combination therapy as first-line palliative chemotherapy between 2006 and 2014. "Long-term response" was defined as tumor stabilization after >6 chemotherapy cycles. RESULTS: The median progression-free survival (PFS) and overall survival (OS) were 3.9 and 8.1 months, respectively. On univariate analysis, liver metastasis (p=0.023) was negatively correlated with long-term response. Locally advanced stage (p=0.017), a history of statin treatment (p=0.01), and carcinoembryonic antigen levels <4.5 (p=0.029) had a favorable effect on long-term response. On multivariate analysis, a history of statin treatment was the only independent favorable factor for long-term response (p=0.017). Prognostic factors for OS and PFS were significantly correlated with liver metastasis (p=0.031 and 0.013, respectively). A history of statin treatment was also significantly associated with OS after adjusting for all potential confounders (hazard ratio, 0.48; 95% confidence interval, 0.26-0.92; p=0.026). CONCLUSION: These results suggest that statins have a favorable effect on "long-term response" to gemcitabine-erlotinib chemotherapy in unresectable pancreatic cancer patients. Statins may have a chemoadjuvant role in stabilizing long-term tumor growth.

Prospective Study for Comparison of Endoscopic Ultrasound-Guided Tissue Acquisition Using 25- and 22-Gauge Core Biopsy Needles in Solid Pancreatic Masses.

BACKGROUND AND AIMS: Although thicker needles theoretically allow more tissue to be collected, their decreased flexibility can cause mechanical damage to the endoscope, technical failure, and sample blood contamination. The effects of needle gauge on diagnostic outcomes of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) of pancreatic mass lesions remain unknown. This study compared procurement rates of histologic cores obtained from EUS-FNB of pancreatic masses using 25- and 22-gauge core biopsy needles. PATIENTS AND METHODS: From March 2014 to July 2014, 66 patients with solid pancreatic mass underwent EUS-FNB with both 25- and 22-gauge core biopsy needles. Among them, 10 patients were excluded and thus 56 patients were eligible for the analyses. Needle sequences were randomly assigned, and two passes were made with each needle, consisting of 10 uniform to-and-fro movements on each pass with 10 mL syringe suction. A pathologist blinded to needle sequence evaluated specimens for the presence of histologic core. RESULTS: The mean patient age was 65.8 ± 9.5 years (range, 44-89 years); 35 patients (62.5%) were men. The mean pancreatic mass size was 35.3 ± 17.1 mm (range 14-122.3 mm). Twenty-eight patients (50%) had tumors at the pancreas head or uncinate process. There were no significant differences in procurement rates of histologic cores between 25-gauge (49/56, 87.5%) and 22-gauge (46/56, 82.1%, P = 0.581) needles or diagnostic accuracy using only histologic cores (98% and 95%). There were no technical failures or procedure-related adverse events. CONCLUSIONS: The 25-gauge core biopsy needle could offer acceptable and comparable outcomes regarding diagnostic performance including histologic core procurement rates compared to the 22-gauge core biopsy needle, although the differences were not statistically significant. TRIAL REGISTRATION: ClinicalTrials.gov NCT01795066.

Visceral Obesity is Associated with Poor Prognosis in Pancreatic Adenocarcinoma.

An association between obesity and unfavorable outcomes for various types of malignancy has been established. Nevertheless, the impact of visceral obesity (VO) on outcomes in pancreatic cancer is still unknown and controversial. The aim of this study was to uncover an association between VO and pancreatic cancer outcomes. We retrospectively reviewed 499 patients with pancreatic cancer who were diagnosed and treated in Severance Hospital from January 2006 to December 2011. Compared to the low-VO group (n = 260), the high-VO group (n = 239) was mostly male (68.2% vs. 31.8%, P < 0.001) and was more likely to have current smoking status (29.7% vs. 17.7%, P < 0.001), current alcohol intake status (52.3% vs. 26.4%, P < 0.001) and diabetes mellitus (54.4% vs. 31.9%, P = 0.028). The progression free survival (PFS) and overall survival (OS) were found to be significantly shorter by the Kaplan-Meier method in the high-VO group than in the low-VO group (PFS; P = 0.044, OS: P = 0.013). In addition, the higher percentage of visceral fat was correlated with more lymph node metastasis and shorter OS (P = 0.011 and P = 0.017, respectively). In patients with pancreatic cancer, VO at the time of diagnosis is associated with negative outcomes, such as shorter PFS and OS.

Can metformin change the prognosis of pancreatic cancer? Retrospective study for pancreatic cancer patients with pre-existing diabetes mellitus type 2.

BACKGROUNDS: The effect of metformin on survival in patients with pancreatic cancer is controversial. AIMS: To investigate the beneficial effect of metformin in pancreatic cancer patients. METHODS: We retrospectively analyzed patients with pancreatic cancer and pre-existing diabetes mellitus type 2 who were treated at Severance Hospital (Seoul, South Korea) between May 2005 and December 2013. RESULTS: Among 237 enrolled patients, 117 patients (49.4%) were exposed to metformin. The median overall survival was 13.7 months for the metformin group versus 8.9 months for the non-metformin group (P=0.001) In univariate analysis, metformin exposure, low serum carbohydrate antigen 19-9 levels (<1000 U/mL), small tumor size (≤20 mm), no tail involvement, good performance status (ECOG 0 vs. 1 or 2), and resectable cancer stage were associated with favorable survival outcomes (all P<0.05). In multivariate analysis, in addition to low serum carbohydrate antigen 19-9 levels (<1000 U/mL) and resectable cancer stage, metformin exposure was significantly associated with longer survival with a hazard ratio of 0.61 (P=0.001). Additionally, the cumulative duration of metformin use was significantly correlated with a favorable survival outcome. CONCLUSION: Our findings supported that metformin exposure was associated with survival benefits in patients with pancreatic cancer and pre-existing type 2 diabetes mellitus, especially among those with an advanced cancer stage.

The efficacy of endoscopic palliation of obstructive jaundice in hepatocellular carcinoma.

PURPOSE: Obstructive jaundice in patients with hepatocellular carcinoma (HCC) is uncommon (0.5-13%). Unlike other causes of obstructive jaundice, the role of endoscopic intervention in obstructive jaundice complicated by HCC has not been clearly defined. The aim of this study was to evaluate the clinical characteristics of obstructive jaundice caused by HCC and predictive factors for successful endoscopic intervention. MATERIALS AND METHODS: From 1999 to 2009, 54 patients with HCC who underwent endoscopic intervention to relieve obstructive jaundice were included. We defined endoscopic intervention as a clinical success when the obstructive jaundice was relieved within 4 weeks. RESULTS: Clinical success was achieved in 23 patients (42.6%). Patients in the clinical success group showed better Child-Pugh liver function (C-P grade A or B/C; 17/6 vs. 8/20), lower total bilirubin levels (8.1±5.3 mg/dL vs. 23.1±10.4 mg/dL) prior to the treatment, and no history of alcohol consumption. The only factor predictive of clinical success by multivariate analysis was low total bilirubin level at the time of endoscopic intervention, regardless of history of alcohol consumption [odds ratio 1.223 (95% confidence interval, 1.071-1.396), p=0.003]. The cut-off value of pre-endoscopic treatment total bilirubin level was 12.8 mg/dL for predicting the clinical prognosis. Median survival after endoscopic intervention in the clinical success group was notably longer than that in the clinical failure group (5.6 months vs. 1.5 months, p≤0.001). CONCLUSION: Before endoscopic intervention, liver function, especially total bilirubin level, should be checked to achieve the best clinical outcome. Endoscopic intervention can be helpful to relieve jaundice in well selected patients with HCC.

Clinical characteristics of long-term survivors of inoperable pancreatic cancer: an 8-year cohort analysis in Korea.

OBJECTIVES: Inoperable pancreatic ductal adenocarcinoma is known to have an extremely poor prognosis. Although rare, there are some patients who have unexpected long-term survival, but the reason is not yet clear. METHODS: A total of 482 inoperable pancreatic ductal adenocarcinoma of 1602 patients diagnosed at Severance Hospital between 2002 and 2009 were evaluated, who were selected statistically with a retrospective cohort study. They were divided into locally advanced pancreatic cancer (LAPC) and metastatic pancreatic cancer (MPC). Short-term survivors (SS group) were defined as patients who survived less than 9 months with LAPC and 6 months with MPC. Patients who survived 3 times longer than the SS group were classified as long-term survivors (LS group). Predictive factors of long-survival were identified by comparing the 2 groups, and effects of these factors on survival were investigated statistically. RESULTS: In multivariate analysis, better performance status and lower CA19-9 were related to overall survival in LAPC. In MPC, younger age, better performance status, peritoneal metastasis, higher serum albumin, lower CA19-9, and CA19-9 variation were related to overall survival. CONCLUSIONS: These parameters related to long-term survivors of advanced pancreatic cancer can be useful for the expectation of survival. In the near future, conjunction of these clinical factors and novel molecular biologic characteristics of individual patients can be used for the personalized therapy.

Clinicopathologic characteristics associated with complications and long-term outcomes of endoscopic papillectomy for adenoma.

PURPOSE: Endoscopic papillectomy (EP) is currently employed for the treatment of ampullary adenoma. This study aimed to evaluate the clinical, endoscopic, and histologic characteristics related to complications and long-term outcomes of EP. MATERIALS AND METHODS: Thirty-nine patients underwent EP for ampullary adenoma. Patients were grouped according to the occurrence of procedure-related complications: no complication group (n=28) and complication group (n=11). RESULTS: The overall complication rate was 28.2%. The most common complication was EP-related pancreatitis (n=7). Amylase (p=0.006) and lipase levels (p=0.007), 24 hours after EP, were significantly higher in the complication group, however, these levels did not differ at earlier times. As the tumor progressed from adenoma to cancer, the complete resection was significantly lessened (p=0.032). The duration of antiprotease injection during the hospital stay was significantly longer (p=0.017) and the transfusion requirements were significantly higher (p=0.018) in the complication group. During a median follow-up of 15 months, three lesions (10.3%) recurred among patients with complete resection (n=29) and five lesions (12.8%) recurred among enrolled patients. One patient with progressive recurrence from low-grade dysplasia to adenocarcinoma was noted during a follow-up of 22 months. CONCLUSION: If symptoms are present, amylase and lipase levels, 24 hours after EP, could help predict possible EP-related pancreatitis. Histologic diagnosis through resected specimens may result in complete resection. Patients with complications need a longer duration of antiprotease injection during their hospital stay and more transfusions. The recurrence rate was not significantly high in completely resected cases, however, there was a possibility of progressive recurrence.

Efficacy of concurrent chemoradiotherapy with 5-fluorouracil or gemcitabine in locally advanced biliary tract cancer.

PURPOSE: There is no established standard treatment for patients with locally advanced biliary tract cancer (BTC). METHODS: We analyzed the treatment results of locally advanced BTC from Jan 1995 to Dec 2010 at single institution of South Korea with retrospective study. One hundred and seventy-six patients were eligible to investigate the treatment response and toxicity. We treated these patients with 5-fluorouracil (5-FU)- or gemcitabine (GEM)-based concurrent chemoradiotherapy (CCRT) or best supportive care (BSC). The primary end point was overall survival. RESULTS: Of these locally advanced BTC patients, 106 patients received CCRT and 70 patients were treated with BSC. The median overall survival was 42.57 weeks (95 % confidence interval [CI], 35.85-49.30) in CCRT group and 13.29 weeks (95 % CI 10.42-16.15) in BSC group (P < 0.001). Nausea and anemia were the most common toxicities observed. CONCLUSIONS: Patients with locally advanced BTC who were treated with 5-FU-based or GEM-based CCRT seem to have a better survival than those who received BSC. The treatment-related toxicity was mild. GEM-based or 5-FU-based CCRT showed similar survival advantages.

Gemcitabine based neoadjuvant chemoradiotherapy therapy in patients with borderline resectable pancreatic cancer.

BACKGROUND: Surgical resection is the only curative treatment for pancreatic cancer, but surgical outcomes for borderline resectable pancreatic cancer (BRPC) are generally poor because of the complexity of the surgery and the advanced nature of the tumor. The aim of this study was to evaluate whether neoadjuvant concurrent chemoradiation therapy (CCRT) in BRPC patients could improve surgical outcome. METHODS: Baseline characteristics and treatment outcomes for patients who underwent surgery for BRPC with (CCRT (+) group) and without neoadjuvant treatment (CCRT (-) group) were retrospectively compared. Treatment outcomes measured included overall survival, recurrence-free survival, and perioperative complications. RESULTS: A total of 30 patients were included in the CCRT (+) group and 21 patients in the CCRT (-) group. Baseline characteristics were not different before CCRT, but pathological examination after resection revealed reduced tumor size and a lower neurovascular invasion rate in the CCRT (+) group. Overall median survival time was 45.0 months in the CCRT (+) group and 23.5 months in the CCRT (-) group (p = 0.045). The CCRT (+) group had a lower recurrence rate (50.0% vs. 81.0%; p = 0.024) and a longer median disease-free survival period (21.0 months vs. 10.6 months; p = 0.004) than the CCRT (-) group. Perioperative complication rates were not different between the two groups. CONCLUSIONS: Neoadjuvant chemoradiation therapy combined with surgical resection yielded better treatment outcomes in patients with BRPC compared with surgery alone. Further larger prospective clinical trials with well defined enrollment criteria and treatment plan are needed.

Phase II Trial of Erlotinib Plus Gemcitabine Chemotherapy in Korean Patients with Advanced Pancreatic Cancer and Prognostic Factors for Chemotherapeutic Response.

BACKGROUND/AIMS: Erlotinib and gemcitabine combined chemotherapy is becoming the treatment of choice in advanced pancreatic cancer. We evaluated the effectiveness of treatment with erlotinib plus gemcitabine and the prognostic factors for chemotherapeutic response in Korean pancreatic cancer patients. METHODS: Sixty-nine patients with advanced pancreatic cancer who were treated with daily erlotinib 100 mg orally and gemcitabine 1,000 mg/m(2)/30 min intravenous infusion on days 1, 8, and 15 of each 4-week cycle from 2006 to 2009 were included in this study. This study was a phase II single-center trial. RESULTS: All 69 patients with advanced pancreatic cancer were chemotherapy-naïve. The objective response rate was 18.8%, and the overall tumor-stabilization rate was 49.2%. The median overall survival was 7.7 months (95% confidence interval [CI], 6.0 to 9.4 months). The median progression-free survival was 1.9 months (95% CI, 1.4 to 2.5 months). Prognostic factors for good chemotherapeutic response were good performance status and the presence of skin rash during chemotherapy. Patients with lower performance scores showed worse chemotherapeutic responses (odds ratio [OR], 7.6; 95% CI, 2.4 to 24.8). Poor responses were predicted by the absence of skin rash during chemotherapy (OR, 3.0; 95% CI, 1.4 to 6.3). CONCLUSIONS: Erlotinib and gemcitabine chemotherapy is a tolerable treatment regimen and has a favorable therapeutic effect in Korean patients with advanced pancreatic cancer.

High level of preoperative carbohydrate antigen 19-9 is a poor survival predictor in gastric cancer.

AIM: To assess the clinical significance and the prognostic value of preoperative serum carbohydrate antigen 19-9 (CA 19-9) level in gastric cancer. METHODS: Between January 2005 and December 2006, 1960 patients underwent surgery for histologically confirmed gastric cancer. Of these, 163 patients had elevated serum levels of CA 19-9 preoperatively, and 1628 patients had normal serum levels of CA 19-9 preoperatively. For this study, 325 patients were selected from the group of 1628 patients by age, sex, and cancer stage to serve as controls. Statistically significant differences in survival rates were calculated using the log-rank test. A P value less than 0.05 was considered statistically significant and was determined using SAS software. RESULTS: The baseline characteristics showed some differences between the two groups with regard to histology. Overall survival (OS) in the elevated and non-elevated group was 37.90 and 68.67 mo, respectively (P < 0.001). N stage (P = 0.001) was a significant predictor of disease-free survival by multivariate analysis. Also, N stage (P < 0.001), and the presence of peritoneal metastasis (P < 0.001) remained independent factors in predicting OS by multivariate analysis. Additionally, preoperative serum CA 19-9 levels were significantly associated with OS in univariate (P = 0.009) and multivariate (P = 0.021) analyses. CONCLUSION: Serum CA 19-9 can be considered an independent prognostic factor in predicting OS in patients anticipating surgery for gastric cancer.

Radiotherapy prolongs biliary metal stent patency in malignant pancreatobiliary obstructions.

BACKGROUND/AIMS: Biliary stenting is the most effective decompressive method for treating malignant biliary obstructive jaundice. Although the main cause of stent occlusion is tumor growth, few studies have investigated whether stent patency is affected by the combination of cancer-treatment modalities. The aim of this study was to evaluate the effects of local radiotherapy on metal-stent patency in patients with malignant biliary obstruction. METHODS: Patients who underwent self-expandable biliary metallic stenting for malignant biliary obstruction from 1999 to 2007 were included. Forty patients received chemotherapy and radiation therapy (radiation group, RG), and 31 patients received only chemotherapy (nonradiation group, NRG). RESULTS: The cumulative median stent patency was significantly longer in the RG than in the NRG (17.7 months; 95% confidence interval [CI], 1.8 to 33.6 months vs 8.7 months; 95% CI, 4.9 to 12.5 months; p=0.025). Stent occlusion caused by tumor growth or stent migration occurred in two (5%) and three (7.5%) cases in the RG and in six (19.3%) and two (6.5%) cases in the NRG, respectively. CONCLUSIONS: The patency of biliary metal stents in pancreatobiliary cancer patients who receive chemoradiation therapy is significantly longer than that in patients who do not receive radiotherapy, which suggests that local cancer control significantly affects stent patency.