Real world evidence: Abiraterone use post-docetaxel in metastatic castrate-resistant prostate cancer.

OBJECTIVES: The COU-AA-301 trial demonstrated that in men with metastatic castrate-resistant prostate cancer using abiraterone post-docetaxel increased overall survival. This study aims to assess this conclusion in a real world context. DESIGN: Retrospective chart review of a provincial Pharmacy BDM Database (a pharmacy dispensing software) and a provincial Electronic Chart (ARIA). Dispensing data, information on the state of the disease before and after abiraterone use, and information regarding effects of abiraterone were gathered. SETTING: Cancer centers in Alberta, Canada. PATIENTS: Metastatic castrate-resistant prostate cancer (CRPC) patients on abiraterone outside of a clinical trial who have previously had docetaxel chemotherapy for CRPC between February 2012 and May 2014. PRIMARY OUTCOME: Overall survival from the time of abiraterone initiation. RESULTS: Overall survival increase of 17 months was consistent with the survival increase of 14.8 months observed in the pivotal trial. CONCLUSION: Abiraterone is a valuable therapy post-docetaxel for metastatic CRPC, as in a real world context it demonstrated an increase in overall survival that was consistent with the findings of the clinical trial despite including a patient population of older age and lower performance status.

Baxter elastomeric pumps: Weighing as an alternative to visual inspection.

Purpose Elastomeric pumps are used to administer 46-hour infusions of 5-fluorouracil (5FU). Baxter suggests patients visually monitor their pumps to ensure that infusions are proceeding correctly. This can be confusing and lead to concerns about under- or over-dosing. Baxter has not considered weighing pumps as a validated method for monitoring. This study aims to validate weighing as a more accurate method for patients and healthcare professionals, and describe real life Baxter Infusor™ variability. Methods Patients who had been started on a 46-hour 5FU infusion returned to the clinic approximately 24 h after starting treatment. The pump was weighed on a StarFrit kitchen scale, and date, time, and weights recorded. Patients were asked if they had a preference for weighing or visually inspecting their pump. Results Pumps ( n = 103) were weighed between 17.25 and 27.5 h after connection. The average weight of a pump was 189 g. Of 103 pumps weighed, 99 weighed less than expected, corresponding to average flow rates of 5.69 mL/h over the elapsed time. The expected flow rate is 5 mL/h with 10% variability. Average flow rates within the 17.25- to 27.5-hour window were 4.561 mL/h, which is 8.78% slower than expected, but within the 10% known variability. Forty-seven percent of patients didn't have a preference for either method, but for those who did have a preference, more than twice as many preferred weighing. Conclusion With proper education, weighing Baxter Infusors at home with kitchen scales can be an accepted and objective alternative to the current recommendation of visual inspection.

Impact of Clostridioides difficile length of treatment on rates of recurrence in patients on concurrent antibiotics.

BACKGROUND: Clostridioides difficile infection (CDI) is principally health care-associated, with a substantial impact on morbidity and mortality. The guidelines recommend CDI therapy for 10 days; however, it is often extended in practice when concurrent antibiotics are used. The impact of the extended duration of therapy remains unclear. OBJECTIVE: To compare the rates of CDI recurrence in patients receiving standard duration of therapy (SDT) with those receiving extended duration of therapy (EDT) for the treatment of hospital-acquired CDI (HA-CDI) while receiving concurrent antibiotics. METHODS: A retrospective chart review was conducted between October 2017 and 2019. Adult HA-CDI patients who received a minimum 10 days of CDI therapy and were on concurrent antibiotics were stratified into SDT and EDT groups. Rates of CDI recurrence (at 90 and 180 days) and incidence of new-onset vancomycin-resistant enterococcus (VRE) were compared. RESULTS: Two hundred twenty-three patients met the inclusion criteria (SD-106, EDT-117). CDI recurrence rates at 90 and 180 days were not statistically significant between SDT and EDT groups (22% vs 26%, P = .40% and 26% vs 31%, P = .47). Although the incidence of VRE within the extended group was higher, it was not statistically significant (6% vs 9%, P = .29). CONCLUSIONS: No significant difference in rates of recurrence or new-onset VRE was observed between SDT and EDT in HA-CDI patients.

Lean body mass as an independent determinant of dose-limiting toxicity and neuropathy in patients with colon cancer treated with FOLFOX regimens.

Evidence suggests that lean body mass (LBM) may be useful to normalize chemotherapy doses. Data from one prospective and one retrospective study were used to determine if the highest doses of oxaliplatin/kg LBM within FOLFOX regimens would be associated with dose-limiting toxicity (DLT) in colon cancer patients. Toxicity over four cycles was graded according to NCI Common Toxicity Criteria V2 or V3 (Common Terminology Criteria for Adverse Events, National Cancer Institute, Bethesda, MD). Muscle tissue was measured by computerized tomography (CT) and used to evaluate the LBM compartment of the whole body. In prospective randomized clinical trials conducted in France (n = 58), for patients given FOLFOX-based regimens according to body surface area, values of oxaliplatin/kg LBM were highly variable, ranging from 2.55 to 6.6 mg/kg LBM. A cut point of 3.09 mg oxaliplatin/kg LBM for developing toxicity was determined by Receiver Operating Characteristic (ROC) analysis, below this value 0/17 (0.0%) of patients experienced DLT; in contrast above this value 18/41 (44.0%) of patients were dose reduced or had treatment terminated owing to toxicity (≥Grade 3 or neuropathy ≥Grade 2); for 9/41 the DLT was sensory neuropathy. These findings were validated in an independent cohort of colon cancer patients (n = 80) receiving FOLFOX regimens as part of standard care, in Canada. Low LBM is a significant predictor of toxicity and neuropathy in patients administered FOLFOX-based regimens using conventional body surface area (BSA) dosing.