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Purpose: The aim of this study was to verify prognostic factors including sarcopenia in patients with recurrent or metastatic pancreatic cancer receiving gemcitabine-based chemotherapy., Materials and Methods: Medical records and computed tomography scan of consecutive patients treated with palliative gemcitabine-based chemotherapy from 2008 to 2014 were reviewed. The lumbar skeletal muscle index at third lumbar spine level was computed, and together with clinicolaboratory factors, univariate and multivariable analyses for overall survival (OS) were performed., Results: A total of 88 patients were found. Median age was 65 years, and male patients were predominant (67.0%). Most patients had initially metastatic disease (72.7%), and gemcitabine monotherapy was administered in 29 patients (33.0%) while gemcitabine plus erlotinib was administered in 59 patients (67.0%). Seventy-six patients (86.3%) had sarcopenia. With a median follow-up period of 44.3 months (range, 0.6 to 44.3 months), median OS was 5.35 months (95% confidence interval [CI], 4.11 to 6.59). In univariate and multivariable analysis, high carcinoembryonic antigen level (hazard ratio [HR], 4.18; 95% CI, 1.95 to 8.97; p < 0.001), initially metastatic disease (HR, 3.37; 95% CI, 1.55 to 7.32; p=0.002), sarcopenia (HR, 2.97; 95% CI, 1.20 to 7.36; p=0.019), neutrophilia (HR, 2.94; 95% CI, 1.27 to 6.79; p=0.012), and high lactate dehydrogenase level (HR, 1.96; 95% CI, 1.07 to 3.58; p=0.029) were identified as independent prognostic factors for OS., Conclusion: Five independent prognostic factors in patients with recurrent or metastatic pancreatic cancer who received gemcitabine-based chemotherapy were identified. These findings may be helpful in prediction of prognosis in clinical practice and can be used as a stratification factor for clinical trials., Competing Interests: relevant to this article was not reported.

Background Context: Superior vena cava (SVC) obstruction can cause the development of collateral vessels. During contrast-enhanced thoracic computed tomography (CT), contrast material may reflux into the collaterals such as paravertebral venous plexus. However, an unusual pseudopathologic vertebral body enhancement on CT in the presence of SVC obstruction has not been studied previously., Purpose: To demonstrate clinical presentation and imaging findings of pseudopathologic vertebral body enhancement in patients with SVC obstruction., Study Design: Retrospective study of diagnostic CT images examined at our clinic., Patient Sample: From March, 2009 to September, 2012, a retrospective radiologic database review was performed to identify patients with obstruction of SVC causing contrast reflux into collateral vessels and presented with an unusual vertebral body enhancement on thoracic CT. Thirteen patients (11 men, mean age 51.4 years) with vertebral body enhancement were enrolled., Outcome Measures: Enhancement patterns of vertebral bodies were classified as nodular enhancement with round shape occupying less than one-third of vertebral body or polygonal enhancement occupying greater than or equal to one-third of vertebral body on axial image. The locations of enhanced areas within vertebral bodies were described using right lateral/central/left lateral, anterior/posterior, and upper/middle/lower in the x-, y-, or z-axis directions, respectively., Materials and Methods: Enhancement patterns, locations, and the presence of a connection between vertebral body enhancement and the paravertebral venous plexus were evaluated., Results: A total of 39 vertebral body enhancements were found in the 13 patients, involving cervical (n=12), thoracic (n=25), or lumbar (n=2) vertebrae. Vertebral body enhancements showed a nodular (n=19) or a polygonal (n=20) pattern. The central portions of vertebral bodies were more frequently involved. The connection to the paravertebral venous plexus was observed in 34 lesions (87.2%)., Conclusions: Patients with SVC obstruction with extensive collateral vessels might exhibit a pseudopathologic vertebral enhancement. They tended to involve the central portion of the vertebral body, and most of them showed connection to the paravertebral venous plexus., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: Genexol-PM is a Cremorphor EL (CrEL)-free polymeric micelle formulation of paclitaxel that allows higher-dose administration with less hypersensitivity. This study was designed to evaluate the efficacy and safety of Genexol-PM and gemcitabine combination in advanced non-small cell lung cancer patients as a first-line treatment., Patients and Methods: This is a prospective, single-arm, single-center phase II study. Patients with advanced NSCLC received Genexol-PM at 230 mg/m(2) on day 1 and gemcitabine 1,000 mg/m(2) on day 1 and day 8 of a 3-week cycle. Six cycles of chemotherapy were planned unless there was disease progression. The primary endpoint was overall response rate., Results: Forty-three patients received the study drugs with a median of 4 cycles per patient (range 1-6). The overall response rate was 46.5%. The median progression-free survival was 4.0 months (95% CI 2.0-6.0 months), and median overall survival was 14.8 months (95% CI 9.1-20.5 months). The most common toxicities were anemia (n = 29, 67%), asthenia (n = 17, 40%), myalgia (n = 16, 37%), peripheral neuropathy (n = 15, 35 %), and diarrhea (n = 12, 30%). The most common grade 3/4 adverse events were neutropenia (n = 7, 16%) and pneumonia (n = 5, 12%). Two patients died of pneumonia and dyspnea., Conclusions: CrEL-free paclitaxel in combination with gemcitabine demonstrated favorable antitumor activity with little emetogenicities in non-small cell lung cancer patients. However, frequent grade 3/4 toxicities were observed, and safety should be evaluated thoroughly in future studies.

Background: The aim of this study was to evaluate the efficacy of irinotecan (CPT-11) monotherapy and CPT-11 plus 5-fluorouracil (5-FU)/leucovorin (LV) combination (mFOLFIRI) as second-line treatment in patients with advanced gastric cancer (AGC)., Methods: A total of 59 patients were randomly assigned to either CPT-11 (150 mg/m(2) iv on day 1) or mFOLFIRI (CPT-11 150 mg/m(2) plus LV 20 mg/m(2) on day 1 followed by 5-FU 2,000 mg/m(2) over 48 h), every 2 weeks. The primary end point was objective response rate (ORR)., Results: Following random assignment, 29 patients received CPT-11 and 30 patients mFOLFIRI. The ORR was 17.2 % [95 % confidence interval (CI) 3.4-30.9] and 20.0 % (95 % CI 5.6-34.3) for the CPT-11 and mFOLFIRI arms, respectively (P = 0.525). There was no significant difference in median progression-free survival: 2.2 months (95 % CI 0.2-4.3) for CPT-11 versus 3.0 months (95 % CI 2.0-3.7) for mFOLFIRI (P = 0.481) or in median overall survival: 5.8 months (95 % CI 3.0-8.7), compared with 6.7 months (95 % CI 5.3-8.2) (P = 0.514). Grade 3/4 toxicity was observed in 21 and 28 events in the CPT-11 and mFOLFIRI arms, respectively., Conclusions: Although this study had a small sample size and limited statistical power, CPT-11 monotherapy and mFOLFIRI appear to be equally active and tolerable as second-line chemotherapy for AGC. The addition of 5-FU/LV to CPT-11 did not significantly improve efficacy.

Purpose: This study was performed to determine the recommended dose (RD) and dose-limiting toxicity (DLT) associated with epirubicin, oxaliplatin, and S-1 (EOS) combination therapy in patients with previously untreated advanced gastric cancer (AGC)., Materials and Methods: Previously untreated patients with histologically proven metastatic AGC, with an ECOG performance status of 0-2, were enrolled in this study. A fixed dose of epirubicin (50 mg/m(2)) and oxaliplatin (130 mg/m(2)) was intravenously administered on day 1 of treatment, followed by oral S-1 administration twice daily on days 1-14. The S-1 dose was escalated according to the following schedule: level I, 35 mg/m(2); level II, 40 mg/m(2); level III, 45 mg/m(2); Level IV, 50 mg/m(2). Each cycle was repeated every 21 days. DLTs were evaluated during the first two cycles of treatment., Results: Nineteen patients with a median age of 53 years (range, 40-71 years) were enrolled in this study. One case of DLT (grade 4 neutropenia lasting more than 5 days) developed from among the six dose level II patients, while 2 DLTs (grade 3 diarrhea and nausea) were observed among the 4 dose level III patients. Based on these results, dose level II was determined as the RD. Of the 13 patients with measurable lesions, eight achieved partial response, three showed stable disease, and the objective response rate was 61.5 % (95 % confidence interval (CI), 13.3-66.6 %). The median progression-free survival and overall survival of all patients was 6.8 months (95 % CI, 1.4-9.5 months) and 13.3 months (95 % CI, 1.9-24.6 months), respectively., Conclusion: The RD of the EOS regimen in patients with previously untreated AGC was 50 mg/m(2) of epirubicin and 130 mg/m(2) of oxaliplatin on day 1, with administration of 40 mg/m(2) of S-1 twice a day on days 1-14 for each 21-day cycle. The EOS regimen described produced promising results.

Taxanes have clearly demonstrated activities against gastric cancer. We compared the combination of paclitaxel plus 5-fluorouracil (5-FU) (PF) with docetaxel plus 5-FU (DF) as first-line chemotherapy in patients with measurable metastatic gastric cancer. Seventy-seven patients were randomly assigned to receive paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on day 1, in combination with 5-FU 500 mg/m2 continuous infusion on days 1-5. Treatment was repeated every 3 weeks. Of 314 chemotherapy cycles delivered (median 5 in both groups), dose reduction was required more frequently in the DF group, being 9 and 19%, respectively (P<0.01). PF was associated with, although statistically insignificant, substantially less grade 3 or 4 toxicities than DF (68 versus 85%; P=0.09). Global quality of life was similar in both groups, but substantive differences in many symptom scores including pain, dyspnea, constipation and diarrhea favored PF. There were no significant differences in therapeutic efficacy between PF and DF with respect to response rate (42 versus 33%, respectively; P=0.53), and failure-free (3.6 versus 4.2 months; P=0.92) and overall survival (9.9 versus 9.3 months; P=0.42). Both PF and DF appear to have efficacy against metastatic gastric cancer, with different, but acceptable, safety profiles.

Background: Advanced biliary tract carcinomas (BTCs) are associated with a very poor prognosis. New therapeutic strategies therefore are needed to improve efficacy and survival, and the current study was designed with a new, effective drug combination., Methods: Patients with recurrent or metastatic BTC received a combination of epirubicin at a dose of 50 mg/m(2), cisplatin at a dose of 60 mg/m(2) on Day 1, and capecitabine at a dose of 1000 mg/m(2) twice daily for 2 weeks. Treatment was repeated every 3 weeks., Results: A total of 43 patients (22 with extrahepatic cholangiocarcinoma, 15 with intrahepatic cholangiocarcinoma, and 6 with gallbladder carcinoma) were treated. The median age was 53 years (range, 36-69 yrs) and 5 patients had a Zubrod performance status of 2. Seventeen patients achieved a partial response (40%; 95% confidence interval [95% CI], 21-49%) and 10 had stable disease. With a follow-up duration of 18 months, the median survival time was 8 months (95% CI, 6-10 mos). In total, 187 chemotherapy cycles were delivered, with a median of 5 cycles per patient (range, 1-9 cycles). Toxicity was mainly myelosuppression and mucositis, but no patients died of toxicity., Conclusions: This combination chemotherapy with epirubicin, cisplatin, and capecitabine offered promising antitumor activity in patients with advanced BTC.

Objective: To examine the prevalence of anemia and its impact of hemoglobin (Hgb) levels in predicting outcomes of 5-fluorouracil (FU)-based first-line chemotherapy for patients with advanced gastric cancer (AGC)., Methods: We collected data retrospectively from 511 consecutive patients treated with FU-based first-line chemotherapy as a routine clinical practice for AGC and followed up in two centers from 1995 to 2003. FU was given in combination with cisplatin (61%), taxanes (12%), anthracyclines (24%) and/or folinic acid (50%)., Results: Hgb values were <10 g/dl in 41%, and patients with baseline Hgb levels <10 g/dl had significantly lower response rates (9%) than patients with Hgb > or = 10 g/dl (53%; P < 0.001). In addition, Hgb < 10 g/dl served as a predictor for disease progression (RR, 1.77; 95% CI, 1.42-2.21) and death (RR, 1.85; 95% CI, 1.48-2.32) along with chemotherapy response and performance status., Conclusion: Low baseline Hgb level is a strong and independent prognostic factor for the outcomes of AGC patients receiving FU-based first-line chemotherapy. This results strongly suggest that Hgb level, along with performance status, may be considered as a stratification variable in subsequent studies of AGC.

We conducted a phase II study to assess the efficacy and tolerability of irinotecan and cisplatin as salvage chemotherapy in patients with advanced gastric adenocarcinoma, progressing after both 5-fluorouracil (5-FU)- and taxane-containing regimen. Patients with measurable metastatic gastric cancer, progressive after previous chemotherapy that consisted either of a 5-FU-based regimen followed by second-line chemotherapy containing taxanes or a 5-FU and taxane combination were treated with irinotecan and cisplatin. Irinotecan 70 mg/m(2) was administered on day 1 and day 15; cisplatin 70 mg/m(2) was administered on day 1. Treatment was repeated every 4 weeks. For 28 patients registered, a total of 94 chemotherapy cycles were administered. The patients' median age was 51 years and 27 (96%) had an ECOG performance status of 1 or below. In an intent-to-treat analysis, seven patients (25%) achieved a partial response, which maintained for 6.3 months (95% confidence interval 6.2-6.4 months). The median progression-free and overall survival were 3.5 and 5.6 months, respectively. Major toxic effects included nausea, diarrhea and neurotoxicity. Although there was one possible treatment-related death, toxicity profiles were generally predictable and manageable. We conclude that irinotecan and cisplatin is an active combination for patients with metastatic gastric cancer in whom previous chemotherapy with 5-FU and taxanes has failed.

Objectives: The purpose of this study was to evaluate the antitumor activity and safety of an epirubicin, cisplatin, and capecitabine (ECX) combination in patients with metastatic or advanced gastric cancer., Patients and Methods: Patients with metastatic or advanced measurable gastric adenocarcinoma received ECX combination chemotherapy. Epirubicin 50 mg/m2 and cisplatin 60 mg/m2 were administered on day 1 by intravenous injection. Capecitabine 1,000 mg/m2 twice daily was administered orally on day 1-14. The cycle was repeated every 3 weeks., Results: Fifty-four patients were enrolled in this study. Fifty patients were assessable for responses and 53 for toxicity. A total of 250 cycles were administered. The overall best response rate by intent-to-treat analysis was 59% including 52% partial responses and 7% complete responses. Median response duration and time to progression was 5.8 and 6 months, respectively. Median survival for all patients was 9.6 months (95% CI, 8.7-10.5 months). The most common grade 3/4 hematological adverse event was neutropenia in 31% (76 cycles) including febrile neutropenia in 4.8% (11 cycles). Non-hematological toxicity was generally mild and reversible. Grade 3/4 nausea, vomiting and stomatitis occurred in 8, 9, and 8% of the patients, respectively. Hand-foot skin reactions developed in 51% of patients, but most were self-limited. Grade 3 occurred in only 4%. One patient died of neutropenic sepsis., Conclusions: ECX combination regimen showed high anti-tumor activity with a tolerable toxicity pattern as a front-line chemotherapy for patients with metastatic or advanced gastric cancer., ((c) 2005 S. Karger AG, Basel)

Objective: The aim of this study was to evaluate efficacy and safety of the combination chemotherapy with irinotecan plus capecitabine in patients with advanced colorectal adenocarcinoma., Methods: Patients with histologically proven advanced colorectal adenocarcinoma received a first-line chemotherapy with irinotecan 240 mg/m2 on day 1 and capecitabine 2,000 mg/m2/day as an intermittent regimen of 2 weeks of treatment followed by a 1-week rest. Treatment was repeated every 3 weeks., Results: Thirty-nine patients were registered, and 36 were assessable for responses. Sixteen objective responses (44%) were observed with a median response duration of 6.9 months. Stable disease was documented in 14 cases (39%). The median time to progression was 6.7 months. The median overall survival was not reached at the time of analysis, and the 1-year survival rate was 67%. Two patients died: 1 due to sepsis not complicating myelosuppression, and 1 patient, known as a hepatitis B virus carrier prior to chemotherapy, died of hepatic failure, the cause of which was not clinically verified. Frequently encountered therapy-related events were leukopenia and gastrointestinal side effects including diarrhea. Severe hand-and-foot syndrome was observed in only 1 patient., Conclusions: The combination chemotherapy of irinotecan and capecitabine is an active and tolerable regimen for advanced colorectal adenocarcinoma, but the observed deaths suggest a future randomized trial that requires a cautious patient selection.

Background: SKI-2053R (SK Chemicals, Kyungki-Do, South Korea) is a new platinum derivative with antitumor activity against various cell lines, including cisplatin-resistant tumor cell lines. Preclinical studies have suggested that it is less nephrotoxic than cisplatin. This study evaluated the efficacy and toxicity of SKI-2053R in the treatment of patients with advanced gastric adenocarcinoma., Methods: Thirty-seven patients with advanced gastric adenocarcinoma that was unresectable or metastatic were treated. No prior chemotherapy or radiotherapy was allowed. Patients received SKI-2053R 360 mg/m(2) by 1-hour infusion on Day 1. After the first cycle, subsequent doses were adjusted according to the toxicity. Courses were repeated every 28 days., Results: Thirty-five patients were evaluable for response and toxicity. Six patients achieved a major response (17%; 95% confidence interval, 8-33%); 2 were complete and 4 were partial responses. The median duration of response was 7.2 months, with a range of 1-20 months. Patients could tolerate the treatment without significant toxicity. No patients had Grade 3 or 4 toxicity. The most frequent toxicity was Grade 1 or 2 proteinuria (26% of cycles), but it was mild and transient. Leukopenia, thrombocytopenia, azotemia, nausea and vomiting, and neurotoxicity were not frequent. These low toxicity profiles indicated that the dose of SKI-2053R could be increased in future studies., Conclusions: SKI-2053R was active in the treatment of patients with gastric adenocarcinoma and had favorable toxicity profiles., (Copyright 1999 American Cancer Society.)