Background Neoadjuvant cisplatin-based combination chemotherapy for muscle-invasive bladder cancer (MIBC) improves overall and disease-free survival. However, there is much debate over the optimal neoadjuvant regimen. Gemcitabine plus cisplatin (GC) has been the neoadjuvant regimen of choice for many institutions for patients with MIBC based on data extrapolated from the metastatic setting. Based on recent data, many institutions are transitioning to variations of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) as the neoadjuvant regimen of choice. Objective To assess the effectiveness and safety of neoadjuvant chemotherapy with gemcitabine plus cisplatin in patients with muscle-invasive bladder cancer prior to cystectomy. Methods This is a single-center, retrospective, cohort study at Duke University Hospital (DUH). Patients included had MIBC and received gemcitabine plus cisplatin chemotherapy prior to a cystectomy. The primary endpoint was to assess the pathologic complete response (pCR) rate in MIBC after treatment with gemcitabine and cisplatin. Patients were split into two groups, those who received their chemotherapy at DUH, and those who received their chemotherapy at an outside facility. Results Overall pCR rate for all patients (n = 36) was 14%. The pCR rates for patients in the Duke Chemotherapy Group (n = 17) and in the Community Chemotherapy Group (n = 19) were 24% and 5%, respectively. GC was overall well tolerated in most patients with few adverse events ≥ grade 3. Conclusions This retrospective study demonstrates a consistent pCR rate (24% in Duke Chemotherapy Group) for neoadjuvant GC in MIBC compared with other literature. The overall pCR rate for all patients was 14%.
Hazardous drug (HD) use in the perioperative environment poses unique challenges and risks for exposure that can have adverse consequences for perioperative personnel. The United States Pharmacopeial Convention has implemented new standards to address the safe handling and administration of HDs by health care workers. To comply with these standards and minimize perioperative personnel's occupational exposure to HDs, a multidisciplinary team at an academic medical center in Boston that was performing an increased number and variety of operative and other invasive procedures using antineoplastic agents updated their protocol for the safe use of HDs in the OR. This article discusses HDs and the risks they pose to health care workers and outlines the new HD safety protocol for the OR that was part of a performance improvement plan to ensure compliance with new standards and staff member safety in the perioperative setting.
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