A malignant hilar biliary stricture is usually unresectable at the time of diagnosis and requires multiple biliary stentings. Metallic mesh stents remain patent for a relatively long time in the biliary stricture compared to tube stents [1]. However, employing multiple metallic mesh stents is sometimes very difficult because of their small lumen, which impedes the delivery of a catheter. The Soehendra stent retriever (Soehendra SR; Wilson-Cook Medical Inc., Winston-Salem, North Carolina, USA) is useful for dilating a stenosed biliary or pancreatic duct [2] [3] [4]. We used it to expand the mesh holes in metallic mesh stents placed in patients with malignant biliary hilar stricture who were undergoing multiple stenting.
We conducted a phase II trial of gemcitabine with S-1, oral fluorouracil (5-FU) prodrug tegafur combined with two modulators, 5-chloro-2, 4-dihydroxypyridine and potassium oxonate, to evaluate the activity and toxicity of such a combination in metastatic pancreatic cancer (MPC) patients. Patients who had pathologically proven pancreatic cancer with metastatic lesions were eligible candidates for entry into the study. S-1 was given orally (30 mg m −2 ) b.i.d. for 14 consecutive days and gemcitabine (1000 mg m −2 ) was given on days 8 and 15. The cycle was repeated every 21 days. We enrolled 33 MPC patients. The median number of cycles was eight (range 1–20). Grade 3–4 toxicities were leucopenia (33%), neutropenia (55%), anaemia (9%), thrombocytopenia (15%), anorexia (6%), fever (9%), and interstitial pneumonia (6%). Objective responses were obtained in 16 patients (one complete response and 15 partial responses; response rate, 48%; 95% confidence interval (CI), 33–65). Median survival and 1-year survival rate were 12.5 months (95% CI, 5.9–19.1) and 54% (95% CI, 36–72), respectively. Combination chemotherapy with GEM and S-1 was well tolerated and yielded a significantly high response rate.
14070 Background: S-1 is an oral fluoropyrimidine derivative with reported response rate of 21.1∼37.5% for advanced pancreatic carcinoma (Ueno, Oncology 2005; Furuse, ASCO 2005). The primary objective of this study was to assess the efficacy and safety of S-1 in patients with gemcitabine resistant advanced pancreatic carcinoma. Methods: Patients with histologically or cytologically proven, metastatic pancreatic carcinoma who had failed prior chemotherapy with gemcitabine were eligible for this study. Other eligibility criteria included an ECOG performance status (PS) of 2 or less; an age of at least 20 years; adequate organ function; and written informed consent. S-1 was administered orally at a dose of 40 mg/m2 twice daily for 28 days, followed by a 14-day rest period. Treatment was repeated every 6 weeks until disease progression. Results: Seventeen patients were enrolled with the following characteristics: median age 67 (range 40–75); male/female = 9/8; ECOG PS 0/1/2 = 1/8/8. All patients were included in analysis. Treatment was generally well tolerated and no life threatening toxicity was observed. Grade 3–4 toxicities were anorexia (17.6%) and fatigue (5.9%). Common grade 1–2 toxicities were anorexia (35.3%), anemia (35.3%), leukocytopenia (29.4%) and diarrhea (23.5%). Three patients were discontinued S-1 because of toxicities. Out of the 17 eligible patients, 3 patients (17.6%) achieved a partial response and 5 patients (29.4%) had stable disease. A marked decrease (≥50%) in tumor markers was observed in 5 (29.4%) of the patients. (CA 19–9 in 3 patients, CEA in 1 patient, DUPAN-2 in 1 patient) The median progression-free survival and the median survival time from the date of initiation of S-1 were 4.1 months (95% CI, 2.0 to 6.2 months) and 5.7 months (95% CI, 2.6 to 8.7 months), respectively. Conclusions: S-1 is well tolerated and active in patients with gemcitabine resistant advanced pancreatic carcinoma. Further investigation of this treatment appears warranted. No significant financial relationships to disclose.
Purpose: To evaluate local effects and acute toxicifies of involved field irradiation with concurrent cisplatin (CDDP) for unresectable pancreatic carcinoma.Materials and Methods: Thirty-three patients with unresectable pancreatic carcinoma were treated with chemoradiotherapy. Sixteen were Stage IVA; 17 were Stage IVB. The total prescribed dose of radiotherapy was 50 Gy/25 fractions or 50.4 Gy/28 fractions, using a three-dimensionally determined involved-field that included only the primary tumor and clinically enlarged lymph nodes. Twelve patients received a daily i.v. infusion of CDDP; 21 patients received a combination of CDDP and 5-fluorouracil either i.v. or through the proper hepatic artery.Results: Twenty-seven (82%) patients completed planned chemoradiotherapy. Nausea was the most frequent complaint. No patient experienced Grade 4 toxicities. More than half achieved pain relief. As for the primary site, only 4 patients (12%) achieved a partial response at 4 weeks; however, 3 additional patients attained > 50% tumor reduction thereafter. The most frequent site of disease progression was the liver, and only 3 patients developed local progression alone. No regional lymph nodal progression outside the treatment field was seen. Median survival time and survival at 1 year were 7.1 months and 27%, respectively, for the entire group. Difference in overall survival between patients with and without distant metastases was significant (p = 0.01).Conclusions: Involved-field irradiation with concurrent daily CDDP was well tolerated without compromising locoregional effects. (c) 2005 Elsevier Inc.
Objective. The purpose of this study was to assess the usefulness of a newly developed imaging technique, fusion 3-dimensional ultrasonography (3DUS) in the diagnosis of portal vein (PV) invasion in patients with pancreatic cancer (PC). Methods. Fourteen patients with proven PC were examined by fusion 3DUS presented as shaded volume-rendering and multiplanar reconstruction images. The surgical findings were obtained in all patients (12 with resection and 2 without). The findings were compared with those of 2-dimensional ultrasonography (2DUS), contrast-enhanced computed tomography (CT), dynamic CT (DCT), angiography, and surgical findings. Portal vein invasion was assessed by 3 independent radiologists for each modality, and objectivity of the assessment was examined by interobserver variability analysis (K value). Results. On the basis of surgical findings, the accuracy rates of 2DUS, fusion 3DUS, DCT, and angiography were 78.6%, 92.9%, 85.3%, and 66.7%, respectively. The K values of 2DUS, fusion 3DUS, DCT, and angiography for PV invasion were 0.57, 0.90, 0.63, and 0.49, respectively, being most objective in fusion 3DUS. Conclusions. Fusion 3DUS is useful for diagnosis of PV invasion of PC.