Surgery News - March 2009 - (Page 15) MARCH 2009 • SURGERY NEWS ONCOLOGY ACOSOG Seeks Trial Participants B Y D A V I D M . O TA , M . D . , F A C S ACOSOG Group Co-Chair T he American College of Surgeons Oncology Group, which is dedicated to procedure-oriented cancer trials, encourages surgeons to consider participating in two recently activated cancer trials: Z1072, a phase II trial of cryoablation of T1 breast cancers; and Z6051, a phase III, prospective randomized trial comparing laparoscopic-assisted resection to open resection for rectal cancer. The breast study (Rache Simmons, M.D., FACS, chair) is designed to determine the rate of complete tumor ablation. Secondary objectives include evaluation of the use of magnetic resonance imaging in the postablation setting to determine residual disease, identification of adverse events associated with cryoabla- tion? The rectal cancer trial is designed to determine whether pathologic analysis of the resected specimen is the same for laparoscopic and open procedures. The pathologic variables to be assessed are circumferential tumor margin greater than 1 mm, distal resection margin greater than 2 cm (or greater than 1 cm with clear frozen section in the low rectum), and completeness of transmesorectal excision. Secondary objectives include perioperative benefit, as- sessment of disease control, and assessment of quality of life. Patient eligibility criteria include the following: Histologic diagnosis of adenocarcinoma of the rectum (less than 12 cm from the anal verge). T3N0M0, TanyN1M0 disease as determined by pretreatment CT scans and pelvic MRI or transrectal ultrasound; patients with T4 disease extending to the circumferential margin of the rectum or invading adjacent organs are not eligible. Completion of preoperative 5-fluorouracil-based chemotherapy and/or radiation therapy; capecitabine may be substituted for 5FU. For more information, go to www. acosog.org, or send an e-mail to Dr. James Fleshman, protocol study chair, at fleshman@wudosis.wustl.edu. Surgeons who are interested in being credentialed can also contact Helen Harbett at helen.harbett@duke.edu. THE BREAST CANCER TRIAL SEEKS TO DEFINE THE TUMOR ABLATION RATE. THE RECTAL CANCER TRIAL COMPARES OPEN VERSUS LAPAROSCOPIC SPECIMEN RESECTION. tion, assessment of pain following cryoablation and surgical resection, and identification of technical variables that affect the success of cryoablation. Patients with unifocal primary invasive ductal carcinoma and who have tumors less than 2.0 cm in greatest diameter with no evidence of multicentric disease are eligible. After protocol informed consent is obtained, patients will undergo cryoablation of their primary tumor using ultrasound guidance and the Sanarus V2 ablation system. The procedure can be performed in an office-based setting. An MRI is performed after the ablation and prior to surgical resection. The surgical resection will allow assessment of the pathology and residual tumor. Credentialing criteria for surgeons, radiologists, and pathologists are available on the ACOSOG Web site at www. acosog.org. This trial is supported through a grant from the National Cancer Institute. Laparoscopic approaches to low anterior resection, coloanal resection, and abdominoperineal resection are known to be feasible, but can we achieve the same local cancer control rate of open resec- INDEX OF ADVERTISERS Adolor Corporation Entereg Cardinal Health, Inc. ChloraPrep General Scientific Corporation SurgiTel Surgi-Cam Wyeth Pharmaceuticals Inc. Tygacil 2-4 9 7 15-16 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 Prothrombin time or other suitable anticoagulation test should be monitored if tigecycline is administered with warfarin. (See CLINICAL PHARMACOLOGY, Drug-drug Interactions in full prescribing information.) Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective. Drug/Laboratory Test Interactions There are no reported drug-laboratory test interactions. Carcinogenesis, Mutagenesis, Impairment of Fertility L http://www.acosog.org http://www.acosog.org http://www.wyeth.com http://www.acosog.org http://www.acosog.org http://www.wyeth.com
Table of Contents Feed for the Digital Edition of Surgery News - March 2009 Surgery News - March 2009 Contents Trauma Training More for Less? Stress Test Mentoring Surgery News - March 2009 Surgery News - March 2009 - Contents (Page 1) Surgery News - March 2009 - Contents (Page 2) Surgery News - March 2009 - Contents (Page 3) Surgery News - March 2009 - Contents (Page 4) Surgery News - March 2009 - Contents (Page 5) Surgery News - March 2009 - Trauma Training (Page 6) Surgery News - March 2009 - Trauma Training (Page 7) Surgery News - March 2009 - Trauma Training (Page 8) Surgery News - March 2009 - More for Less? (Page 9) Surgery News - March 2009 - Stress Test (Page 10) Surgery News - March 2009 - Stress Test (Page 11) Surgery News - March 2009 - Stress Test (Page 12) Surgery News - March 2009 - Mentoring (Page 13) Surgery News - March 2009 - Mentoring (Page 14) Surgery News - March 2009 - Mentoring (Page 15) Surgery News - March 2009 - Mentoring (Page 16)
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