Surgery News - June 2008 - (Page 15)

JUNE 2008 • SURGERY NEWS BREAST, SKIN & SOF T TISSUE Guidelines Allow DCIS Patients to Opt Out of Radiation B Y F R A N L O W RY Else vier Global Medical Ne ws H O L LY W O O D , F L A . — All women with ductal carcinoma in situ should have the choice of foregoing radiation therapy, according to updated breast cancer guidelines announced at the annual conference of the National Comprehensive Cancer Network. Previously, the guidelines distinguished between the majority of women who have a typical ductal carcinoma in situ (DCIS) and those few women who have a very small DCIS that is less than 0.5 centimeters, unicentric, and of low grade, said Dr. Stephen B. Edge. For that small subset of women, the guidelines had stipulated treatment by lumpectomy alone with omission of ra- dations about postmastectomy radiation, an issue neglected in past years. The breast cancer guidelines committee now urges the use of radiation therapy for women who have 1-3 positive nodes. The committee stopped short of making this a category 1 recommendation. “Previously we said that patients should consider this, but now we’ve gone so far as to say that women should strongly consider radiation therapy after mastectomy,” Dr. Edge said. Also new are recommendations on the use of breast reconstruction. The guidelines now warn that reconstruction has the potential to affect delivery of radiation therapy. In one study (Int. J. Radiat. Oncol. Biol. Phys. 2006;66:76-82), 52% of women who received radiation after reconstruction had some compromise in the application of radiation, either in terms of the field or the dosing to underlying structures. “Consideration of this must be brought to the patient’s attention,” Dr. Edge said. In general, women undergoing autolo- gous tissue reconstruction should strongly consider delaying reconstruction until after radiation, because reconstruction before radiation may lead to a worse cosmetic outcome. For women who are undergoing implant reconstruction, the guidelines advise that reconstruction before radiation can spare expansion of nonirradiated skin, but they also caution that radiation may lead to capsular contraction. Dr. Edge said he had no financial conflicts of interest to disclose. THE ONUS IS ON THE PHYSICIAN TO DISCUSS WITH THE PATIENT WHETHER TO CHOOSE RADIATION THERAPY FOR DCIS. diation therapy. It was recommended that all other women with DCIS were to be treated with total mastectomy without lymph node dissection or by lumpectomy plus radiation therapy. The updated guidelines incorporate lumpectomy without radiation therapy as an option for all women with DCIS. “This is a major change,” announced Dr. Edge, interim chair of the department of surgical oncology, and chair of the department of health services and outcomes research at Roswell Park Cancer Institute in Buffalo, N.Y. The three treatment options for early stage DCIS with no nodal involvement now comprise the following: Lumpectomy without lymph node surgery, plus whole breast radiation therapy (offered as a category 1 recommendation). Total mastectomy with or without sentinel node biopsy, and with or without breast reconstruction. Lumpectomy alone, with no lymph node surgery and no radiation therapy (offered as a category 2b recommendation). The new guidelines place the onus on the physician to have an appropriate discussion with the patient as to whether or not to choose radiation therapy for DCIS, said Dr. Edge, who is also a professor of surgery at the State University of New York at Buffalo. The guidelines also make recommen- INDEX OF ADVERTISERS General Scientific Corporation SurgiTel Surgi-Cam KCI InfoV.A.C. Wyeth Pharmaceuticals Inc. Tygacil 5 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 contracep http://www.wyeth.com http://www.wyeth.com

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Surgery News - June 2008

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