Surgery News - August 2008 - (Page 15) AUGUST 2008 • SURGERY NEWS ONCOLOGY Novel Registry Spurs Adjuvant Breast Cancer Treatment B Y F R A N L O W RY Else vier Global Medical Ne ws S A N D I E G O — An innovative system that tracks whether breast cancer patients visit an oncologist after surgery and feeds that information back to their surgeons increased the rate of oncology consultations by 14% at six New York City hospitals. The tracking and feedback registry also reduced the underuse of adjuvant treatment by 7%, and completely eliminated racial disparities in treatment, Dr. Nina Bickell of the Mount Sinai School of Medicine, New York, reported at the annual meeting of the American Association for Cancer Research. Dr. Bickell and her colleagues started the project after their previous research found that African American and Hispanic women were less likely than white women to obtain further treatment following breast cancer surgery. The chance of not getting a beneficial adjuvant treatment was one in six for whites, one in four for Hispanics, and one in three for African Americans. “When we talked to the surgeons to try to understand why this was happening, we found that many of them were surprised to learn that follow-up care did not happen. Several of them had said they would have done something, if they had only known,” Dr. Bickell said. To address the information gap, Dr. Bickell and her colleagues started a tracking and feedback registry at the six hospitals. Pathology reports identified 300 patients with invasive breast cancer who had had definitive surgery. These patients were contacted for information about their upcoming oncology appointments; then the oncologists were called to verify that the patients had been seen. The information was fed back to the surgeons by phone and by letter. The investigators compared 677 patients treated before the intervention to the 300 registry patients. They found that the registry significantly increased completed oncology consultations from 83% before the intervention to 97% afterward (P less than .0001). The decrease in underuse of adjuvant treatment was also significant, dropping from 21% before intervention to 14% post intervention (P less than .001). Underuse of chemotherapy decreased from 22% to 11% (P = .05), and underuse of hormone therapy fell from 20% to 8% (P = .0004). Underuse of radiotherapy among African American and Hispanic women decreased from 23% to 8% (P = .02). Following the intervention, race no longer played a significant role in whether women connected with a subsequent oncology consultation took advantage of therapy. “After the registry was in place, 14% of whites and 13% of Hispanics and African Americans did not get treatments. This makes sense, because we were targeting the system failure cause of underuse, which happens much more commonly in African Americans and Hispanics,” Dr. Bickell said. The registry was a simple intervention that yielded excellent results, she said, recommending the program for consideration by hospitals and tumor registries across the United States. ■ Completed Oncologic Consultations Increased With Intervention 97% 83% Before intervention After intervention (n = 677) (n = 300) Note: Based on tracking and feedback intervention data for patients with invasive breast cancer who have had definitive surgery. Source: Dr. Bickell INDEX OF ADVERTISERS General Scientific Corporation SurgiTel Surgi-Cam KCI InfoV.A.C. Wyeth Pharmaceuticals Inc. Tygacil 7 5 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 Lifetime studies in animals have not been performed to evalu http://www.wyeth.com http://www.wyeth.com
Table of Contents Feed for the Digital Edition of Surgery News - August 2008 Surgery News - August 2008 Contents The 20/20 Vision: Making Amends News From the College: Dedicated Effort Opinion: NOTESworthy? Pediatric Surgery: Burn Remedy Surgery News - August 2008 Surgery News - August 2008 - Contents (Page 1) Surgery News - August 2008 - Contents (Page 2) Surgery News - August 2008 - Contents (Page 3) Surgery News - August 2008 - Contents (Page 4) Surgery News - August 2008 - Contents (Page 5) Surgery News - August 2008 - The 20/20 Vision: Making Amends (Page 6) Surgery News - August 2008 - The 20/20 Vision: Making Amends (Page 7) Surgery News - August 2008 - News From the College: Dedicated Effort (Page 8) Surgery News - August 2008 - News From the College: Dedicated Effort (Page 9) Surgery News - August 2008 - News From the College: Dedicated Effort (Page 10) Surgery News - August 2008 - News From the College: Dedicated Effort (Page 11) Surgery News - August 2008 - Opinion: NOTESworthy? (Page 12) Surgery News - August 2008 - Pediatric Surgery: Burn Remedy (Page 13) Surgery News - August 2008 - Pediatric Surgery: Burn Remedy (Page 14) Surgery News - August 2008 - Pediatric Surgery: Burn Remedy (Page 15) Surgery News - August 2008 - Pediatric Surgery: Burn Remedy (Page 16)
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