After the second cycle of chemotherapy, nine of 16 evaluable patients (56%) with considerable weight loss prior to treatment experienced a weight gain of at least 7%. Twenty-one (45%) patients had significant weight loss at entry. Improved Karnofsky PS was observed in a considerable number of patients during chemotherapy. After completion of the second cycle of chemotherapy, nine of 26 evaluable patients (35%) improved by ≥20 points from baseline, whereas 12 patients (46%) remained stable and five (19%) worsened. Thirty-seven patients had a Karnofky PS ≤80% at study entry. This beneficial effect of chemotherapy on disease-related pain remained constant in most patients after the fourth and the sixth cycle of chemotherapy. After the second cycle of chemotherapy, 21 of 31 evaluable patients (68%) reduced the daily dose of analgesics by >50%. After the second cycle of chemotherapy, 21 of 31 evaluable patients (68%) experienced a self-estimated pain intensity improvement >50%, two (6%) remained stable and eight (26%) worsened. Two patients on NSAIDs were also received fentanyl. All patients consumed regular analgesics in the form of either NSAIDs (25 patients) or fentanyl (12 patients) prior to treatment. Thirty-five (74.5%) patients had severe pain prior to treatment. Endoscopic intervention and stent placement was performed in two patients with obstructive jaundice prior to chemotherapy.Ĭlinical benefit response data are summarized in Table 3. New-onset diabetes was diagnosed in four (8.5%) patients and obstructive jaundice in six (13%). Pain was the most common initial symptom among our patients (74.5%), followed by weight loss (45%), anorexia (40%) and fatigue (15%). The majority of patients (77%) had stage IV disease and 24 patients (51%) had liver metastases. Twenty-two (47%) patients had undergone surgery at first diagnosis for either diagnostic (11 patients) or therapeutic reasons (six patients for palliation and five patients were radically operated with pancreaticoduedonectomy). The median age was 63 years (range 34–76). Overall, 47 patients (31 male, 16 female) were eligible for treatment their characteristics are summarized in Table 1. Three patients were non-eligible: two patients never received protocol treatment and one owing to violation of eligibility criteria. Study end points and assessment of response and toxicityįrom October 2000 to December 2001, 50 patients were registered in this multicenter study. At the end of treatment, all clinical, laboratory and imaging studies were repeated and the patients underwent follow-up examinations every 2 months. A CT scan was repeated every third cycle of chemotherapy to assess objective response. A detailed physical examination was completed before each cycle of chemotherapy and tumor markers were determined every other cycle. During chemotherapy, full blood cell counts with differential and biochemical test were performed weekly. Karnofsky PS, weight, disease-related symptoms and especially pain, as well as analgesic consumption, were evaluated at baseline and at the completion of second, fourth and sixth cycle of chemotherapy thereafter. Further imaging studies were performed upon clinical indication. Additionally, ultrasound of the upper abdomen and computed tomography (CT) scans of the chest and abdomen were also performed. Prior to treatment, each patient was evaluated by medical history, physical examination, full blood cell count with differential and platelet count, blood chemistry, tumor markers (CEA and CA 19-9), urine analysis, electrocardiogram, and vital signs. Informed consent was obtained from all patients, in accordance with institutional and federal guidelines, before study entry. A minimum of 2 weeks was required to have elapsed in cases of prior abdominal exploration or palliative surgery. Additional exclusion criteria were active infection and any other uncontrolled concurrent medical illness. Patients with central nervous system metastases and second primary malignancies, except for adequately treated basal cell cancer, squamous cell skin cancer or in situ cervical cancer, were also excluded. Patients who had received prior chemotherapy or radiotherapy for pancreas carcinoma, as well as patients with ampullary or periampullary carcinoma, were excluded from the study. Furthermore, patients were required to have adequate renal (serum creatinine level < 1.5 mg/dl) and liver functions (total bilirubin level < 1.5 mg/dl and transaminase levels < 2× upper limits of normal) and adequate bone marrow reserve (leucocyte count ≥ 4000/μl, absolute neutrophil count ≥2000/μl and platelet count ≥100 000/μl).
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