Surgery News - November 2008 - (Page 27)

NOVEMBER 2008 • SURGERY NEWS THORACIC Number of Nodes Predicts Esophageal Ca Survival BY BRUCE JANCIN Else vier Global Medical Ne ws N E W Y O R K — The number of lymph nodes removed during esophagectomy is a potent independent predictor of survival in esophageal cancer patients, according to a large prospective international study. “To maximize the outcome of surgical therapy, a minimum of 23 nodes should be removed. And the operation most likely to achieve this goal is an en bloc esophagectomy,” Dr. Christian G. Peyre said at the annual meeting of the American Surgical Association. The number of excised lymph nodes was the third-strongest predictor of survival in the study, behind the number of cancer-positive nodes and depth of tumor invasion. Histologic cell type was another independent predictor; squamous cell tumors were associated with worse survival. Dr. Peyre, of the University of Southern California, Los Angeles, reported on 2,303 esophageal cancer patients at nine centers, including three U.S. centers. All underwent esophagectomy with negative tumor margins and were then followed for 5 years. None got adjuvant or neoadjuvant chemotherapy or had T4 disease. Median overall survival was 89 months. Five-year survival in patients who had 23 or more lymph nodes removed was 43%, significantly better than the 37% figure in patients with fewer nodes removed. A more aggressive lymphadenectomy was most beneficial for patients with advanced disease: 5-year survival was 24% in those with at least 23 nodes removed, nearly double the 13% rate in patients with fewer than 23 nodes excised. Three-quarters of study participants had esophagectomy with thoracotomy. Surgeons performed transhiatal, transthoracic, and thoracoabdominal esophagectomies, but en bloc resection had the highest success rate in removing at least 23 nodes. Two-thirds of patients with an en bloc esophagectomy had at least 23 lymph nodes removed; only a minority of patients who underwent any other type of operation achieved that benchmark, according to Dr. Peyre. Discussant Dr. Stephen G. Swisher, an ACS Fellow who is professor and chairman of surgery at the University of Texas M.D. Anderson Cancer Center, Houston, noted that the study implies that the extent of lymphadenectomy is important not only for staging esophageal cancer but also for improving survival. But Dr. Murray F. Brennan, an ACS Fellow and chair of the department of surgery at Memorial Sloan-Kettering Cancer Center, New York, challenged that interpretation. Asserting that a minimum of 23 lymph nodes must be removed to maximize survival is “an extraordinarily strong statement,” he said. Both discussants expressed skepticism that en bloc esophagectomy is superior. Dr. Jeffrey A. Hagen, an ACS Fellow and a senior coinvestigator on the study, replied that the findings are consistent with a report by other investigators based on Survival, Epidemiology, and End Results data showing that the number of nodes removed influences survival in gastric cancer. He conceded that the type of operation performed wasn’t an independent predictor of survival in the international study, but the study wasn’t designed to look at that as an end point. The investigators showed in a separate recent study that en bloc esophagectomy provided a survival advantage over transhiatal resection in esophageal cancer patients who had been given neoadjuvant therapy ( J. Thorac. Cardiovasc. Surg. 2008;135:1228-36), added Dr. Hagen, chief of thoracic/foregut surgery at Los Angeles County Medical Center. ■ INDEX OF ADVERTISERS Adolor Corporation Entereg Cardinal Health, Inc. ChloraPrep Ethicon Endo-Surgery, Inc. Realize Echelon Flex Ligamax General Scientific Corporation SurgiTel Surgi-Cam I-Flow Corporation ON-Q Nashville Surgical Instruments Kumar PRE-VIEW Novartis Pharmaceuticals Corporation Corporate Ortho-McNeil-Janssen Pharmaceuticals, Inc. Corporate Wyeth Pharmaceuticals Inc. Tygacil 2-3 19 8-9 13 23 17 5 12 7, 21 11 27-28 TYGACIL® (tigecycline) Brief Summary See package insert for full Prescribing Information. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. CONTRAINDICATIONS TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline. WARNINGS Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics. TYGACIL may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking tigecycline, the patient should be apprised of the potential hazard to the fetus. Results of animal studies indicate that tigecycline crosses the placenta and is found in fetal tissues. Decreased fetal weights in rats and rabbits (with associated delays in ossification) and fetal loss in rabbits have been observed with tigecycline. (See PRECAUTIONS, Pregnancy.) The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Results of studies in rats with TYGACIL have shown bone discoloration. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS General Caution should be exercised when considering TYGACIL monotherapy in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation. (See ADVERSE REACTIONS.) In Phase 3 cIAI studies (n=1642), 6 patients treated with TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/septic shock. The 6 patients treated with TYGACIL had higher APACHE II scores (median = 13) vs the 2 patients treated with imipenem/cilastatin (APACHE II scores = 4 and 6). Due to differences in baseline APACHE II scores between treatment groups and small overall numbers, the relationship of this outcome to treatment cannot be established. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL. The safety and efficacy of TYGACIL in patients with hospital acquired pneumonia have not been established. In a study of patients with hospital acquired pneumonia, patients were randomized to receive TYGACIL (100 mg initially, then 50 mg every 12 hours) or a comparator. In addition, patients were allowed to receive specified adjunctive therapies. The sub-group of patients with ventilator-associated pneumonia who received TYGACIL had lower cure rates (47.9% versus 70.1% for the clinically evaluable population) and greater mortality (25/131 [19.1%] versus 15/122 [12.3%]) than the comparator. As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken. Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Patients should be counseled that antibacterial drugs including TYGACIL should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When TYGACIL is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by TYGACIL or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Drug Interactions Prot http://www.wyeth.com http://www.wyeth.com

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Surgery News - November 2008

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