Gemcitabine in patients with nonresectable cancer of the biliary system or advanced gallbladder cancer

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Abstracts

Aim: To assess the pharmacological and clinical efficacy and safety profile of this new synthetic porcine secretin in facilitating cannulation of either the major or minor pancreatic orifice at ERCP. Methods: In this prospective study, patients were administered 0.4 ug/kg IV (max. 16ug) of synthetic porcine secretin if protracted efforts to locate or cannulate the major or minor pancreatic orifice had failed. Exclusion criteria were acute pancreatitis, known sensitivity or adverse reaction to secretin or pregnant or nursing females. Results: Between March and November, 1999, 29 patients were enrolled (M:F 8:21; Average age 52.8 years, range 23– 81 years). The indications for secretin injection were: To aid in minor papilla cannulation in patients with pancreas divisum (18), to aid in finding main PD orifice (4), to find PD orifice post biliary sphincterotomy (3), to facilitate major papilla cannulation (2), to aid in finding minor papilla (1), and to facilitate minor papilla cannulation (1). Successful cannulation was achieved in 26/29 (89.7%) cases. In one case cannulation of the minor papilla was still not possible because of its location in a duodenal diverticulum. In the two remaining cases, deep cannulation of the pancreatic duct was not deemed essential and was not pursued. No adverse events were recorded. Summary: A new, pure, synthetic secretin aided successful cannulation of the major or minor pancreatic orifices in 26/29 patients in whom protracted efforts to locate or cannulate the pancreatic duct had failed. These data suggest this new agent is both effective and safe, with no adverse events recorded. Conclusions: Synthetic porcine secretin is a safe and useful agent, and its administration can be added to the armamentarium of techniques to facilitate pancreatic duct cannulation. 220 Gemcitabine in patients with nonresectable cancer of the biliary system or advanced gallbladder cancer *Dobrila-Dintinjana R, Kovac´ D, Depolo A, Uravic´ M, Dintinjana M. Internal and surgical Clinic, University Hospital, Rijeka, Croatia-EU. Aims: To evaluate effectiveness of gemcitabine(G) for patients(pts) with nonresectable cancer of the biliary system(BSCa) and with advanced gallbladder cancer (GBCa). Methods: Between January 97 and December 99 8 pts with BSCa and 10 pts with GBCa were enrolled. They had all hystological confirmation, no prior chemotherapy: mean age 50.4 years (40 – 66): 14 were females and 6 males. Pts were treated with gemcitabine 1000 mg/m2 i.v. over 30 minutes once per week on outpatient basis. The first cycle included 7 applications followed by one week rest. The following cycles consisted of 3 applications only, followed by one week rest. Staging was performed after each cycle. Results: The number of cycles applicated varied from 1 cycle to 10 cycles (median 4 cycles). There was no complete response but 12 partial responses, for a global response rate of 60% (12/20). Mean follow-up was 32.4 weeks. The median survival time was 25 weeks: 50% of all pts survived longer than 6 months. All (100%) pts achieved clinical benefit response. The median duration clinical benefit was 22 weeks. Overall the regimen was well tolerated. Side effects (WHO) included 10 cases of grade 2 leucopenia, 6 cases of grade 2 flu-like syndrome and 6 cases of grade 2 nausea. Conclusions: This results indicate that the treatment of GBCa and BSCa with G is effective, well tolerated and leads to clinical benefit of pts. 221 Improvement in survival and clinical benefit response for patients with metastatic pancreatic cancer *Dobrila-Dintinjana R, Kovac´ D, Depolo A, Uravic´ M, Dintinjana M. Internal and Surgical Clinic, University Hospital, Rijeka, Croatia-EU. Aims: To compare two protocols in therapy for stage IV of metastatic pancreatic cancer. Methods: The tumors were pathologically confirmed and staged by CT, US and laparotomy as needed. By one protocol patients received Cisplat-

AJG – Vol. 95, No. 9, 2000

in(P), 5 fluorouracil(F) and leukovorin(L). Other patients received Gemcitabine(G) and Cisplatin(P). Clinical benefit was derived from measurement of pain, functional impairment and weight loss. Results: 20 patients presenting with metastatic pancreatic cancer started chemotherapy, 10 patients underwent protocol PLF and other 10 protocol GP. We have no mortality rate in first 90 days, 6 months and 1 year survival was 60% and 40% in PLF group and 80% and 60% in GP group respectively. All patients of GP protocol and 90% of PLF protocol showed clinical benefit response. The median duration clinical benefit was 24 weeks and 18 weeks for GP and PLF group, respectively. Conclusions: We have higher 1-year survival time in GP group than expected and good clinical benefit response in both groups. Although we have small number of patients for evaluation of quality and validity of chemotherapeutic protocol, we can say that GP protocol is better for prognosis improvement and clinical benefit response for patients with pancreatic cancer. 222 Prospective evaluation of quantitative hepatobiliary scintigraphy for RUQ pain and sphincter of Oddi dysfunction John Dumot DO, Steven Shay, MD, FACG, Gregory Zuccaro, MD, FACG, John Vargo, MD, Darwin Conwell, MD, Benedict Kim, DO, Bohdan Bybel, MD. Departments of Gastroenterology and Nuclear Medicine, Cleveland Clinic Foundation, Cleveland, OH. Background: RUQ abdominal pain is common after cholecystectomy. Sphincter of Oddi dysfunction (SOD) in patients with RUQ pain is difficult to diagnose requiring endoscopic manometry (SOM) with considerable risk. Quantitative hepatobiliary scintigraphy (HBS) was reported to be useful as a test for detecting SOD but not validated. Aim: Determine the utility of HBS in diagnosing SOD with SOM as the “gold standard.” Methods: CCK stimulated HBS was independently scored (0 –12) by two nuclear medicine radiologists blinded to all clinical data for 6 previously published criteria: peak and biliary visualization time, biliary prominence, bowel visualization, biliary emptying, and CBD/liver ratio. An experienced gastroenterologist blinded to all clinical data interpreted triple lumen perfusion SOM tracings. A mean basal pressure ⬎40 mmHg was considered abnormal. Results: 40 post-cholecystectomy patients (39 females) with RUQ pain were studied. 20 patients had abnormal SOM. The table below shows sensitivity (sens) and specificity (spec) of HBS in diagnosing SOD according to a minimum score. Interobserver concordance of HBS scores was 93% (kappa 0.8, 95% CI 0.77– 0.99). Conclusions: (1) Interobserver agreement for HBS interpretation was strong. (2) HBS lacks sensitivity to be used as a screening test for SOD in patients with RUQ pain, however, patients with a score ⱖ6 do not require SOM to confirm the diagnosis and can proceed directly to papillotomy. HBS

>1

>2

>3

>4

>5

>6

>7

Sens Spec

100 0

75 35

65 60

30 75

25 85

10 95

5 95

223 Invasive pancreatic function testing: A survey of methods and number of procedures performed in the United States Babak Etemad, Peter B Cotton, Robert H Hawes*. Medical University of South Carolina, Charleston, South Carolina, United States. Purpose: To determine the frequency of and methods used in invasive pancreatic function testing at academic centers in the United States. Methods: Questionnaires were mailed to 150 training programs in the US. Names/addresses were obtained from the list of training programs published in peer review journals. Questionnaire focused on duodenal intubation and pure pancreatic juice testing. Number of procedures/yr, interval and duration of collections, method of stimulation, specific substances