Docetaxel plus gemcitabine or docetaxel plus cisplatin in advanced pancreatic carcinoma: randomized phase II study 40984 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group.

PURPOSE: To define the efficacy and toxicity of docetaxel plus gemcitabine or docetaxel plus cisplatin for advanced pancreatic carcinoma. PATIENTS AND METHODS: Chemotherapy-naive patients with measurable disease and WHO performance status less than 2 were randomly assigned to receive 21-day cycles of gemcitabine 800 mg/m2 on days 1 and 8 plus docetaxel 85 mg/m2 on day 8 (arm A) or docetaxel 75 mg/m2 on day 1 plus cisplatin 75 mg/m2 on day 1 (arm B). Primary end points were tumor response and rate of febrile neutropenia grade. RESULTS: Of 96 randomly assigned patients (49 patients in arm A and 47 patients in arm B), 70 patients were analyzed for response (36 in arm A and 34 in arm B) and 89 patients were analyzed for safety (45 in arm A and 44 in arm B). Confirmed responses were observed in 19.4% (95% CI, 8.2% to 36.0%) of patients in arm A and 23.5% (95% CI, 10.7% to 41.2%) in arm B. In arm A, the median progression-free survival (PFS) was 3.9 months (95% CI, 3.0 to 4.7 months), median survival was 7.4 months (95% CI, 5.6 to 11.0 months), and 1-year survival was 30%. In arm B, the median PFS was 2.8 months (95% CI, 2.6 to 4.6 months), median survival was 7.1 months (95% CI, 4.8 to 8.7 months), and 1-year survival was 16%. Febrile neutropenia occurred in 9% and 16% of patients in arms A and B, respectively. CONCLUSION: Both regimens are well tolerated and show activity in advanced pancreatic carcinoma. The safety profile and survival analyses favor docetaxel plus gemcitabine for further evaluation.

The role of endoscopy in early postoperative haemorrhage.

Diagnostic as well as therapeutic endoscopy has a decisive role in management of early postoperative haemorrhage. Endoscopy combines easy access to the upper and lower gastrointestinal tract and application of an array of interventional tools. In near future, even the small bowel will be accessible for diagnostic and therapeutic measures due to the advent of double-balloon enteroscopy. Thus, the endoscopist increasingly replaces the surgeon for diagnosis and therapy of postsurgical bleeding. Published data on frequency and aetiology of postoperative haemorrhage are scarce and mainly casuistic. Sources of gastrointestinal bleeding associated with surgery may be: anastomotic ulcers, mucosal ischaemia, 'stress' ulcers, reflux-induced lesions, coagulopathies (e.g. in sepsis or after organ transplantation) and aortoenteric fistula after bypass surgery. The endoscopist will frequently identify the culprit lesion and guide further management of the patient (e.g. endoscopic approach, repeated surgery, interventional radiology). All accessible lesions in postoperative haemorrhage should primarily be treated by endoscopic means, except aortoenteric fistulas. There is even a place for repeated endoscopy in recurrent bleeding. In the face of lacking controlled data, the endoscopist often has to rely on his personal experience in the selection of therapeutic options.