Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0030193 (pain)
 261,466 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Alleviation of tumor-related symptoms may be a more appropriate basis for judging drug efficacy in pancreatic cancer than is tumor shrinkage. Clinical benefit response (CBR), a new way to assess clinical efficacy based on marked, sustained improvement in pain intensity, analgesic consumption, and performance status, was used to evaluate a new chemotherapeutic agent, gemcitabine (2',2'-difluorodeoxycytidine [Gemzar]). A phase III study of newly diagnosed pancreatic cancer patients treated with either gemcitabine or fluorouracil (5-FU) and a phase II trial of gemcitabine in patients whose disease had progressed despite prior treatment with 5-FU both demonstrated that a significant number of patients achieved a CBR with gemcitabine. Prolonged survival was a secondary benefit demonstrated in the phase III trial. In both studies, gemcitabine was well tolerated, with a relatively mild toxicity profile. These results suggest that gemcitabine may serve as a prototype for the development of more effective therapies for pancreatic cancer patients.
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PMID:New developments in chemotherapy for patients with advanced pancreatic cancer. 888 3

An objective end point of quality of life-the clinical benefit response-was developed for use in clinical cancer research. This end point was used in two clinical trials of gemcitabine (Gemzar) in the treatment of advanced pancreatic cancer. To qualify as clinical benefit responders, patients had to demonstrate a marked, sustained improvement in pain and performance status; if both parameters were stable, patients could still be considered responders if they showed at least a 7% increase in dry weight. In a phase III trial in 126 patients with advanced pancreatic cancer, gemcitabine was significantly superior to fluorouracil (5-FU) with regard to clinical benefit, and also produced a survival advantage. In a phase II trial involving 63 patients in whom 5-FU had previously failed, gemcitabine also afforded clinical benefit. We conclude that clinical benefit response is an effective means of evaluating the activity of gemcitabine in advanced pancreatic cancer.
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PMID:Objective outcome measures of quality of life. 895

The treatment of advanced pancreatic carcinoma has been viewed with pessimism. Because of the lack of activity of commonly used agents, there is no consensus regarding a standard chemotherapy regimen. Assessment of response is neither uniform nor reproducible. Debilitating tumor-related symptoms, including pain, anorexia, weight loss, and impaired performance status, are common. Many studies have failed to evaluate the palliative benefit of treatments, although many patients consider such benefit to be of the utmost importance. Tools have been developed to uniformly assess tumor-related symptoms, and the concept of clinical benefit response has been developed as an end point to quantify symptomatic improvement utilizing these tools. Clinical benefit response incorporates palliative measures, such as pain control, analgesic consumption, performance status, and weight gain. In early phase I and II trials, gemcitabine (Gemzar) has shown activity in patients with chemotherapynaive advanced pancreatic carcinoma. In addition to producing some responses and symptomatic benefit, gemcitabine has a favorable toxicity profile. Two recent trials using clinical benefit response as the primary end point have demonstrated that gemcitabine significantly improves disease-related symptoms in approximately one-quarter of patients. These trials also showed improved survival with gemcitabine, as compared with fluorouracil. Additional studies are required to fully assess the role of gemcitabine in both adjuvant and advanced disease settings.
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PMID:Clinical experience with gemcitabine in pancreatic carcinoma. 939 63

We present a case of unusual chemotherapy-induced neurotoxicity in a patient who had undergone radical cystoprostatectomy and ileal conduit diversion for invasive bladder cancer. On routine computed tomography scan several years later, he was diagnosed with metastatic transitional cell carcinoma involving the retroperitoneal lymph nodes. The patient received systemic chemotherapy, including a combination of paclitaxel (Taxol) and gemcitabine (Gemzar). During this treatment, the patient developed spasmodic pain and dysesthesia in the stoma area, with no apparent skin irritation or any other local finding. These symptoms resolved about 3 months after completion of the therapy.
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PMID:Paclitaxel-induced stomal neuropathy: a unique cause of pain in a patient with ileal conduit. 1111 64

Gemzar is a nucleoside analog that has been shown to be superior to 5-fluorouracil for the treatment of advanced pancreatic cancer in terms of both clinical benefit and survival. This open label program enrolled 214 patients. Patients eligible for this program had advanced or metastatic pancreatic cancer, received up to one previous chemotherapy, a baseline Karnofsky performance status (KPS) of at least 50, measurable or evaluable disease, adequate organ function defined as: absolute leucocyte count > 3 x 10(9)/L, platelet count > 100 x 10(9)/L, hemoglobin > 9 gr/dL, total bilirubin < 2 x upper limit of normal (ULN), creatinine < 2 x ULN, ALT and AST levels < 5 x ULN and were at least 18 years. A 1000 mg/m2 of Gemzar was administered weekly up to 7 weeks followed by a week of rest, then once weekly for 3 weeks out of every 4 weeks. The median age at inclusion was 64 years, 52% of the patients were male, 27% were 70 year or older, 66% had stage IV disease, 66% had a KPS of 80 or higher and 34% had received no prior chemotherapy. The overall response rate is 7%. A time-to-first-serious-event analysis was performed since only a limited number of dates of death were available. The first serious event (FSE) was considered as the earliest of the following: increase by at least 2 of the pain score, deterioration of KPS of at least 20, documentation of progressive disease or death. The median time to FSE was 4 months, the free FSE rate at 1 year was 14%. We conclude that the results observed in this program confirm the established efficacy of Gemzar in pancreatic cancer.
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PMID:Compassionate use of Gemzar in advanced pancreatic cancer: a Belgian experience. 1188 32

Unresectable pancreatic cancer has few therapeutic options and a dismal prognosis. Cyclooxygenase-2 (COX-2) expression is increased at the RNA and protein levels in most human pancreatic cancers. The purpose of this trial was to determine whether the addition of a COX-2 inhibitor to chemotherapy was beneficial. To date, 11 patients with inoperable pancreatic cancer have been treated with the combination of gemcitabine (Gemzar), irinotecan (Camptosar), and celecoxib (Celebrex) at 400 mg orally twice daily. Encouraging pain relief, improvement in performance status, and decreases in CA 19-9 and carcinoembryonic antigen levels have been observed.
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PMID:Gemcitabine/Irinotecan/celecoxib in pancreatic cancer. 1568 34

Data from a clinical study of 86 pancreatic cancer patients with involuntary, significant weight loss (cachexia) were used to explore the relationship between patient-reported outcomes (PROs) and survival. In all, 28 pancreatic cancer patients with cachexia were given gemcitabine (Gemzar) plus 3 mg/kg of infliximab (Remicade), 28 were given gemcitabine plus 5 mg/kg of infliximab, and 30 were given gemcitabine plus placebo in a double-blinded, phase II, multicenter trial. PRO endpoints included scores from the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Functional Assessment of Anorexia/ Cachexia Therapy (FAACT), Brief Pain Inventory (BPI), and the Short-Form 36 general health survey (SF-36). Population mean scores at baseline indicated fatigue problems (FACIT-F), nutritional health issues (FAACT), and mild-to-moderate pain (BPI "worst pain" score). Baseline normalized SF-36 values for physical functioning, vitality, and mental health indicated substantial impairment. Baseline fatigue and physical-functioning scores predicted survival as well as, or better than, baseline Karnofsky Performance Status or hemoglobin level. A cut-point in the FACIT-F score (median < or = 30) strongly predicted mortality; patients with greater fatigue had a lower median overall survival than did those with less fatigue. These findings supported several features of an a priori clinical-benefit model. Patient-reported fatigue provided powerful prognostic information; tracking of this symptom may be useful for treatment planning and medical monitoring of advanced-stage pancreatic cancer patients with cachexia. These results must be confirmed by larger trials.
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PMID:The prognostic significance of patient-reported outcomes in pancreatic cancer cachexia. 1872 39