ABSTRACT
PURPOSE: Hand-foot syndrome (HFS) is a frequently occurring adverse event associated with anticancer drugs. This study compares a newly introduced ointment containing several antioxidants and exhibiting high radical protection factor, which has been available on the German market since 2011, with urea cream for prevention of HFS in patients treated with capecitabine. PATIENTS AND METHODS: Patients with GI tumors or breast cancer treated with capecitabine were included in this randomized phase III study. The primary end point was prevention of HFS of any grade within 6 weeks of treatment as indicated by a standardized patient diary. The study had 80% power to show a 20% reduction of the incidence of HFS with the new ointment. Secondary end points included time to development of HFS greater than grade 1, evaluation of capecitabine dose intensity, and quality of life analyses. RESULTS: A total of 152 patients were evaluable. In total, 47 of 152 patients experienced HFS (30.9%), 39.5% with the new ointment and 22.4% in the urea arm (stratified odds ratio, 2.37; P = .02). Time to HFS greater than grade 1 was comparable, but time to any-grade HFS was significantly longer in the urea group (P = .03). Capecitabine dose intensity, time under study, and percentage of days with correct administration of study medication were identical, as were adverse events except for HFS. Skin-related quality of life was significantly worse in the group treated with the new ointment at the end of study treatment. CONCLUSION: This trial demonstrated that 10% urea cream was superior to the new ointment at preventing HFS over the first 6 weeks of treatment with capecitabine.
Subject(s)
Antimetabolites, Antineoplastic/adverse effects , Antioxidants/administration & dosage , Deoxycytidine/analogs & derivatives , Fluorouracil/analogs & derivatives , Hand-Foot Syndrome/prevention & control , Keratolytic Agents/administration & dosage , Primary Prevention/methods , Quality of Life , Urea/administration & dosage , Administration, Cutaneous , Adult , Aged , Antimetabolites, Antineoplastic/administration & dosage , Breast Neoplasms/drug therapy , Capecitabine , Deoxycytidine/administration & dosage , Deoxycytidine/adverse effects , Drug Administration Schedule , Female , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Gastrointestinal Neoplasms/drug therapy , Germany , Hand-Foot Syndrome/etiology , Hand-Foot Syndrome/pathology , Humans , Incidence , Male , Middle Aged , Ointments , Severity of Illness Index , Skin Cream , Surveys and Questionnaires , Time Factors , Treatment FailureABSTRACT
BACKGROUND: Capsule endoscopy enables noninvasive diagnostic examination of the entire small intestine. However, sensitivity and specificity of capsule endoscopy have not been adequately defined. We, therefore, compared capsule endoscopy by using intraoperative enteroscopy as a criterion standard in patients with obscure GI bleeding. METHODS: Forty-seven consecutive patients with obscure GI bleeding (11 with ongoing overt bleeding, 24 with previous overt bleeding, and 12 with obscure-occult bleeding) from two German gastroenterologic centers were included. All patients who had a prior nondiagnostic evaluation, including upper endoscopy, colonoscopy with a retrograde examination of the distal ileum, and push enteroscopy, underwent capsule endoscopy followed by intraoperative enteroscopy. RESULTS: Capsule endoscopy identified lesions in 100% of the patients with ongoing overt bleeding, 67% of the patients with previous overt bleeding, and 67% of the patients with obscure-occult bleeding. Angiectasias were the most common source of bleeding (n = 22). Capsule endoscopy showed the source of bleeding in 74.4% of all patients. The method was more effective in patients with ongoing bleeding. Compared with intraoperative enteroscopy sensitivity, specificity, and positive and negative predictive values of capsule endoscopy were 95%, 75%, 95%, and 86%, respectively. CONCLUSIONS: Capsule endoscopy has high sensitivity and specificity to detect a bleeding source in patients with obscure GI bleeding. Thus, wireless capsule endoscopy can be recommended as part of the routine work-up in patients with obscure GI bleeding.
Subject(s)
Endoscopes, Gastrointestinal , Endoscopy, Gastrointestinal/methods , Gastrointestinal Hemorrhage/diagnosis , Radiology, Interventional , Adolescent , Adult , Aged , Aged, 80 and over , Equipment Design , Female , Humans , Intestinal Diseases/diagnosis , Intestine, Small/pathology , Male , Melena/diagnosis , Middle Aged , Occult Blood , Predictive Value of Tests , Prospective Studies , Sensitivity and Specificity , Telangiectasis/diagnosisABSTRACT
BACKGROUND: The small bowel is the most difficult part of the bowel to examine owing to the distance from the mouth to anus. Conventional endoscopic techniques for examining the small bowel are limited by its length and its multiple, complex, looped configurations. However, for a wide variety of specific lesions, the diagnostic value of other tests for imaging the small bowel is low. For the first time wireless capsule endoscopy has made non-invasive imaging of the entire small bowel possible. A number of peer-reviewed studies has been published that compare the method with push-enteroscopy in patients with obscure gastrointestinal bleeding and have shown superior diagnostic results. CONCLUSION: Capsule endoscopy has opened up new horizons for the diagnosis of small-bowel disease. All published studies show a higher diagnostic yield of capsule endoscopy compared with push-enteroscopy and standard radiographic investigations.
